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Republic of the Philippines

CONGRESS OF THE PHILIPPINES


Metro Manila
Fifteenth Congress
Third Regular Session
Begun and held in Metro Manila, on Monday, the twenty-third day of July, two thousand twelve.
REPUBLIC ACT NO. 10372
AN ACT AMENDING CERTAIN PROVISIONS OF REPUBLIC ACT NO. 8293, OTHERWISE KNOWN AS THE
"INTELLECTUAL PROPERTY CODE OF THE PHILIPPINES", AND FOR OTHER PURPOSES
Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:
Section 1. Section 6 of Republic Act No. 8293, otherwise known as the "Intellectual Property Code of the
Philippines", is hereby amended to read as follows:
"SEC. 6. The Organizational Structure of the IPO. x x x
"6.2. the Office shall be divided into seven (7) Bureaus, each of which shall be headed by a Director and
assisted by an Assistant Director. These Bureaus are:
"x x x
"(f) the Administrative, Financial and Personnel Services Bureau; and
"(g) the Bureau of Copyright and Other Related Rights."
Section 2. Section 7 of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 7. The Director General and Deputies Director General.
"x x x
"(b) Exercise exclusive appellate jurisdiction over all decisions rendered by the Director of Legal Affairs, the
Director of Patents, the Director of Trademarks, the Director of Copyright and Other Related Rights, and the
Director of the Documentation, Information and Technology Transfer Bureau. the decisions of the Director
General in the exercise of his appellate jurisdiction in respect of the decisions of the Director of Patents, the
Director of Trademarks and the Director of Copyright and Other Related Rights shall be appealable to the
Court of Appeals in accordance with the Rules of Court; and those in respect of the decisions of the Director
of the Documentation, Information and Technology Transfer Bureau shall be appealable to the Secretary of
Trade and Industry;
"(c) Undertake enforcement functions supported by concerned agencies such as the Philippine National
Police, the National Bureau of Investigation, the Bureau of Customs, the Optical Media Board, and the local
government units, among others;
"(d) Conduct visits during reasonable hours to establishments and businesses engaging in activities violating
intellectual property rights and provisions of this Act based on report, information or complaint received by
the office; and
"(e) Such other functions in furtherance of protecting IP rights and objectives of this Act."
Section 3. A new Section 9A is hereby inserted after Section 9 of Republic Act No. 8293, to read as follows:
"SEC. 9A. The Bureau of Copyright and Other Related Rights. the Bureau of Copyright and Other Related
Rights shall have the following functions:
"9A.1. Exercise original jurisdiction to resolve disputes relating to the terms of a license involving the
authors right to public performance or other communication of his work;
"9A.2. Accept, review and decide on applications for the accreditation of collective management
organizations or similar entities;
"9A.3. Conduct studies and researches in the field of copyright and related rights; and
"9A.4. Provide other copyright and related rights service and charge reasonable fees therefor."
Section 4. Section 171.3. of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 171. Definitions. x x x
"171.3. Communication to the public or communicate to the public means any communication to the
public, including broadcasting, rebroadcasting, retransmitting by cable, broadcasting and retransmitting by
satellite, and includes the making of a work available to the public by wire or wireless means in such a way
that members of the public may access these works from a place and time individually chosen by them;"
Section 5. Section 171.9. of Republic Act No. 8293 is hereby amended to read as follows:
"171.9. Reproduction is the making of one (1) or more copies, temporary or permanent, in whole or in part,
of a work or a sound recording in any manner or form without prejudice to the provisions of Section 185 of
this Act (Sec. 41[E], P.D. No. 49a);"
Section 6. There shall be two new subsections to be added at the end of Section 171.11. to be known as 171.12.
and 171.13., both to read as follows:
"171.12. Technological measure means any technology, device or component that, in the normal course of
its operation, restricts acts in respect of a work, performance or sound recording, which are not authorized
by the authors, performers or producers of sound recordings concerned or permitted by law;
"171.13. Rights management information means information which identifies the work, sound recording or
performance; the author of the work, producer of the sound recording or performer of the performance; the
owner of any right in the work, sound recording or performance; or information about the terms and
conditions of the use of the work, sound recording or performance; and any number or code that represent
such information, when any of these items is attached to a copy of the work, sound recording or fixation of
performance or appears in conjunction with the communication to the public of a work, sound recording or
performance."
Section 7. the Chapter Title of Chapter VII, Part IV, the Law on Copyright, is hereby amended to read as follows:
"CHAPTER VII
TRANSFER, ASSIGNMENT AND LICENSING OF COPYRIGHT"
Section 8. Section 180 of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 180. Rights of Assignee or Licensee. 180.1. the copyright may be assigned or licensed in whole or
in part. Within the scope of the assignment or license, the assignee or licensee is entitled to all the rights
and remedies which the assignor or licensor had with respect to the copyright.
"180.2. the copyright is not deemed assigned or licensed inter vivos, in whole or in part, unless there is a
written indication of such intention.
"x x x
"180.4. Any exclusivity in the economic rights in a work may be exclusively licensed. Within the scope of the
exclusive license, the licensee is entitled to all the rights and remedies which the licensor had with respect to
the copyright.
"180.5. the copyright owner has the right to regular statements of accounts from the assignee or the licensee
with regard to assigned or licensed work."
Section 9. Section 181 of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 181. Copyright and Material Object. the copyright is distinct from the property in the material object
subject to it. Consequently, the transfer, assignment or licensing of the copyright shall not itself constitute a
transfer of the material object. Nor shall a transfer or assignment of the sole copy or of one or several copies
of the work imply transfer, assignment or licensing of the copyright. (Sec. 16, P.D. No. 49)"
Section 10. Section 183 of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 183. Designation of Society. the owners of copyright and related rights or their heirs may designate
a society of artists, writers, composers and other right-holders to collectively manage their economic or
moral rights on their behalf. For the said societies to enforce the rights of their members, they shall first
secure the necessary accreditation from the Intellectual Property Office. (Sec. 32, P.D. No. 49a)"
Section 11. Section 184.1. of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 184. Limitations on Copyright. x x x
"(1) the reproduction or distribution of published articles or materials in a specialized format exclusively for
the use of the blind, visually- and reading-impaired persons: Provided, That such copies and distribution
shall be made on a nonprofit basis and shall indicate the copyright owner and the date of the original
publication."
Section 12. Section 185.1. of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 185. Fair Use of a Copyrighted Work. 185.1. the fair use of a copyrighted work for criticism,
comment, news reporting, teaching including limited number of copies for classroom use, scholarship,
research, and similar purposes is not an infringement of copyright. Decompilation, which is understood here
to be the reproduction of the code and translation of the forms of a computer program to achieve the
interoperability of an independently created computer program with other programs may also constitute fair
use under the criteria established by this section, to the extent that such decompilation is done for the
purpose of obtaining the information necessary to achieve such interoperability.
"x x x."
Section 13. Section 188.1. of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 188. Reprographic Reproduction by Libraries. 188.1. Notwithstanding the provisions of Subsection
177.1., any library or archive whose activities are not for profit may, without the authorization of the author or
copyright owner, make a limited number of copies of the work, as may be necessary for such institutions to
fulfill their mandate, by reprographic reproduction:
"x x x
"(c) Where the making of such limited copies is in order to preserve and, if necessary in the event that it is
lost, destroyed or rendered unusable, replace a copy, or to replace, in the permanent collection of another
similar library or archive, a copy which has been lost, destroyed or rendered unusable and copies are not
available with the publisher."
Section 14. Sections 190.1. and 190.2. of Republic Act No. 8293 are deleted in their entirety.
Section 15. Section 190.3. of Republic Act No. 8293 is hereby renumbered and amended as the sole provision
under Section 190 to read as follows:
"SEC 190. Importation and Exportation of Infringing Materials. Subject to the approval of the Secretary of
Finance, the Commissioner of Customs is hereby empowered to make rules and regulations for preventing
the importation or exportation of infringing articles prohibited under Part IV of this Act and under relevant
treaties and conventions to which the Philippines may be a party and for seizing and condemning and
disposing of the same in case they are discovered after they have been imported or before they are
exported. (Sec. 30, P.D. No. 49)"
Section 16. Section 191 of Republic Act No. 8293 is hereby amended to read as follows:
"SEC 191. Deposit and Notice of Deposit with the National Library and the Supreme Court Library. At any
time during the subsistence of the copyright, the owner of the copyright or of any exclusive right in the work
may, for the purpose of completing the records of the National Library and the Supreme Court Library,
register and deposit with them, by personal delivery or by registered mail, two (2) complete copies or
reproductions of the work in such form as the Directors of the said libraries may prescribe in accordance
with regulations: Provided, That only works in the field of law shall be deposited with the Supreme Court
Library. Such registration and deposit is not a condition of copyright protection."
Section 17. Section 198 of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 198. Term of Moral Rights. 198.1. the right of an author under Section 193.1. shall last during the
lifetime of the author and in perpetuity after his death while the rights under Sections 193.2. 193.3. and
193.4. shall be coterminous with the economic rights, the moral rights shall not be assignable or subject to
license. the person or persons to be charged with the posthumous enforcement of these rights shall be
named in a written instrument which shall be filed with the National Library. In default of such person or
persons, such enforcement shall devolve upon either the authors heirs, and in default of the heirs, the
Director of the National Library."
Section 18. Section 203 of Republic Act No. 8293 is hereby amended to read as follows;
"x x x
"203.2. the right of authorizing the direct or indirect reproduction of their performances fixed in sound
recordings or audiovisual works or fixations in any manner or form;
"203.3. Subject to the provisions of Section 206, the right of authorizing the first public distribution of the
original and copies of their performance fixed in sound recordings or audiovisual works or fixations through
sale or rental of other forms of transfer of ownership;
"203.4. the right of authorizing the commercial rental to the public of the original and copies of their
performances fixed in sound recordings or audiovisual works or fixations, even after distribution of them by,
or pursuant to the authorization by the performer; and
"203.5. the right of authorizing the making available to the public of their performances fixed in sound
recordings or audiovisual works or fixations, by wire or wireless means, in such a way that members of the
public may access them from a place and time individually chosen by them. (Sec. 42, P.D. No. 49A)."
Section 19. Section 204.1. of Republic Act No. 8293 is hereby amended to read as follows;
"204.1. Independently of a performers economic rights, the performer shall, as regards his live aural
performances or performances fixed in sound recordings or in audiovisual works or fixations, have the right
to claim to be identified as the performer of his performances, except where the omission is dictated by the
manner of the use of the performance, and to object to any distortion, mutilation or other modification of his
performances that would be prejudicial to his reputation."
Section 20. Section 208 of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 208. Scope of Right. x x x
"208.4. the right to authorize the making available to the public of their sound recordings in such a way that
members of the public may access the sound recording from a place and at a time individually chosen or
selected by them, as well as other transmissions of a sound recording with like effect."
Section 21. Section 212 of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 212. Limitations on Rights. the provisions of Chapter VIII shall apply mutatis mutandis to the rights
of performers, producers of sound recordings and broadcasting organizations."
Section 22. Section 216 of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 216. Infringement. A person infringes a right protected under this Act when one:
"(a) Directly commits an infringement;
"(b) Benefits from the infringing activity of another person who commits an infringement if the person
benefiting has been given notice of the infringing activity and has the right and ability to control the
activities of the other person;
"(c) With knowledge of infringing activity, induces, causes or materially contributes to the infringing
conduct of another.
"216.1. Remedies for Infringement. Any person infringing a right protected under this law shall be liable:
"x x x
"(b) To pay to the copyright proprietor or his assigns or heirs such actual damages, including legal
costs and other expenses, as he may have incurred due to the infringement as well as the profits the
infringer may have made due to such infringement, and in proving profits the plaintiff shall be
required to prove sales only and the defendant shall be required to prove every element of cost
which he claims, or, in lieu of actual damages and profits, such damages which to the court shall
appear to be just and shall not be regarded as penalty: Provided, That the amount of damages to be
awarded shall be doubled against any person who:
"(i) Circumvents effective technological measures; or
"(ii) Having reasonable grounds to know that it will induce, enable, facilitate or conceal the
infringement, remove or alter any electronic rights management information from a copy of a
work, sound recording, or fixation of a performance, or distribute, import for distribution,
broadcast, or communicate to the public works or copies of works without authority, knowing
that electronic rights management information has been removed or altered without
authority.
"x x x
"The copyright owner may elect, at any time before final judgment is rendered, to recover instead of actual
damages and profits, an award of statutory damages for all infringements involved in an action in a sum
equivalent to the filing fee of the infringement action but not less than Fifty thousand pesos (Php50,000.00).
In awarding statutory damages, the court may consider the following factors:
"(1) the nature and purpose of the infringing act;
"(2) the flagrancy of the infringement;
"(3) Whether the defendant acted in bad faith;
"(4) the need for deterrence;
"(5) Any loss that the plaintiff has suffered or is likely to suffer by reason of the infringement; and
"(6) Any benefit shown to have accrued to the defendant by reason of the infringement.
"In case the infringer was not aware and had no reason to believe that his acts constitute an infringement of
copyright, the court in its discretion may reduce the award of statutory damages to a sum of not more than
Ten thousand pesos (Php10,000.00): Provided, That the amount of damages to be awarded shall be
doubled against any person who:
"(i) Circumvents effective technological measures; or
"(ii) Having reasonable grounds to know that it will induce, enable, facilitate or conceal the
infringement, remove or alter any electronic rights management information from a copy of a work,
sound recording, or fixation of a performance, or distribute, import for distribution, broadcast, or
communicate to the public works or copies of works without authority, knowing that electronic rights
management information has been removed or altered without authority.
"x x x
"216.2. In an infringement action, the court shall also have the power to order the seizure and impounding of
any article which may serve as evidence in the court proceedings, in accordance with the rules on search
and seizure involving violations of intellectual property rights issued by the Supreme Court. (Sec. 28, P.D.
No. 49a)
"The foregoing shall not preclude an independent suit for relief by the injured party by way of damages,
injunction, accounts or otherwise."
Section 23. Section 217.2. of Republic Act No. 8293 hereby amended to read as follows:
"217.2. In determining the number of years of imprisonment and the amount of fine, the court shall consider
the value of the infringing materials that the defendant has produced or manufactured and the damage that
the copyright owner has suffered by reason of the infringement: Provided, That the respective maximum
penalty stated in Section 217.1. (a), (b) and (c) herein for the first, second, third and subsequent offense,
shall be imposed when the infringement is committed by:
"(a) the circumvention of effective technological measures;
"(b) the removal or alteration of any electronic rights management information from a copy of a work,
sound recording, or fixation of a performance, by a person, knowingly and without authority; or
"(c) the distribution, importation for distribution, broadcast, or communication to the public of works
or copies of works, by a person without authority, knowing that electronic rights management
information has been removed or altered without authority."
Section 24. Section 218.1. of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 218. Affidavit Evidence. x x x
"(c) the copy of the work or other subject matter annexed thereto is a true copy thereof.
"The affidavit shall be admitted in evidence in any proceedings under this Chapter and shall be prima
facieproof of the matters therein stated until the contrary is proved, and the court before which such affidavit
is produced shall assume that the affidavit was made by or on behalf of the owner of the copyright."
Section 25. A new Section 220A shall be inserted after Section 220.2. of Republic Act No. 8293 to read as follows:
"SEC. 220A. Disclosure of Information. Where any article or its packaging or an implement for making it is
seized or detained under a valid search and seizure under this Act is, or is reasonably suspected to be, by
an authorized enforcement officer, in violation of this Act, the said officer, shall, wherever reasonably
practicable, notify the owner of the copyright in question or his authorized agent of the seizure or detention,
as the case may be."
Section 26. Section 226 of Republic Act No. 8293 is hereby amended to read as follows:
"SEC. 226. Damages. No damages may be recovered under this Act after the lapse of four (4) years from
the time the cause of action arose. (Sec. 58, P.D. No. 49)."
Section 27. Chapter XX of Republic Act No. 8293 is hereby amended by adding a new section at the end thereof to
be denominated as Section 230, to read as follows:
"SEC. 230. Adoption of Intellectual Property (IP) Policies. Schools and universities shall adopt intellectual
property policies that would govern the use and creation of intellectual property with the purpose of
safeguarding the intellectual creations of the learning institution and its employees, and adopting locally-
established industry practice fair use guidelines. These policies may be developed in relation to licensing
agreements entered into by the learning institution with a collective licensing organization."
Section 28. Section 230 of Republic Act No. 8293 is hereby renumbered as Section 231, and all succeeding
sections of the same Act are hereby renumbered accordingly.
Section 29. Implementing Rules and Regulations. Within one hundred eighty (180) days from the effectivity of
this Act, the Intellectual Property Office, in consultation with the National Book Development Board, the National
Library, the Supreme Court Library and other relevant agencies, shall promulgate the rules and regulations
necessary to effectively implement the provisions of this Act.
Section 30. Repealing Clause. All laws, decrees, executive orders, issuances or regulations inconsistent with the
provisions of this Act are hereby revised or amended accordingly.
Section 31. Separability Clause. If any part of this Act is declared unconstitutional or invalid, such parts or
provisions thereof not so declared shall remain valid and subsisting.
Section 32. Effectivity Clause. This Act shall take effect fifteen (15) days after its publication in at least two (2)
newspapers of general circulation.
Approved,

(Sgd.) JUAN PONCE ENRILE (Sgd.) FELICIANO BELMONTE JR.


President of the Senate Speaker of the House of Representatives

This Act which is a consolidation of Senate Bill No. 2842 and House Bill No. 3841 was finally passed by the Senate
and the House of Representatives on December 11, 2012 and November 26, 2012, respectively.

(Sgd.) EMMA LIRIO-REYES (Sgd.) MARILYN B. BARUA-YAP


Secretary of Senate Secretary General
House of Representatives

Approved: FEB 28 2013


(Sgd.) BENIGNO S. AQUINO III
President of the Philippines
EN BANC
[ A.M. No. 10-3-10-SC, October 18, 2011 ]
RULES OF PROCEDURE FOR INTELLECTUAL PROPERTY RIGHTS CASES
RESOLUTION
Acting on the recommendation of the Sub-Committee on the Rules of Procedure for Intellectual Property Rights
Cases submitting for this Court's consideration and approval the proposed Rules of Procedure for Intellectual
Property Rights Cases, the Court resolved to APPROVE the same. These Rules shall take effect fifteen (15) days
after their publication in two (2) newspapers of national circulation.
October 18, 2011.
(Sgd.) RENATO C. CORONA
Chief Justice
(Sgd.) ANTONIO T. CARPIO
Associate Justice
(Sgd.) PRESBITERO J. VELASCO, JR.
Associate Justice
(Sgd.) TERESITA J. LEONARDO-DE CASTRO
Associate Justice
(Sgd.) ARTURO D. BRION
Associate Justice
(Sgd.) DIOSDADO M. PERALTA
Associate Justice
(Sgd.) LUCAS P. BERSAMIN
Associate Justice
(Sgd.) MARIANO C. DEL CASTILLO
Associate Justice
(Sgd.) ROBERTO A. ABAD
Associate Justice
(Sgd.) MARTIN S. VILLARAMA, JR.
Associate Justice
(Sgd.) JOSE PORTUGAL PEREZ
Associate Justice
(Sgd.) JOSE C. MENDOZA
Associate Justice
(Sgd.) MARIA LOURDES P.A. SERENO
Associate Justice
(Sgd.) BIENVENIDO L. REYES
Associate Justice
(Sgd.) ESTELA M. PERLAS-BERNABE
Associate Justice
EN BANC
A.M. No. 10-3-10-SC
RULES OF PROCEDURE
FOR INTELLECTUAL PROPERTY RIGHTS CASES
Rule 1
GENERAL PROVISIONS
SEC 1. Title. These Rules shall be known and cited as the "Rules of Procedure for Intellectual Property Rights
Cases."
SEC. 2. In what courts applicable. These Rules shall be observed by the Regional Trial Courts designated by
the Supreme Court as Special Commercial Courts.
SEC. 3. Applicability of the regular rules. When the court determines that the civil or criminal action involves
complex issues, it shall issue a special order that the regular procedure prescribed in the Rules of Court shall apply,
stating the reason therefor.
Where applicable, the Rules of Court shall apply suppletorily to proceedings under these Rules.
SEC. 4. Executory nature of orders. Any order issued by the court under these Rules is immediately executory
unless restrained by a superior court.
SEC. 5. Verification and supporting documents. Any pleading, motion, opposition, defense or claim filed by
any interested party shall be supported by verified statements that the affiant has read the same and that the factual
allegations therein are true and correct of his personal knowledge or based on authentic records, and shall contain
as annexes such documents as may be deemed by the party submitting the same as supportive of the allegations in
the affidavits.
SEC. 6. Duty of the clerk of court. It shall be the duty of the branch clerk of court to notify in writing the Director-
General of the intellectual Property Office (IPO) of any action, suit or proceeding involving a copyright, trademark,
service mark, patent, industrial design, utility model, undisclosed information and technology transfer agreement.
Such notice shall set forth: the names and addresses of the litigants and the copyright, trademark, service mark,
patent or design registrations involved and, where applicable, the numbers of their certificates of registration. The
notice shall be submitted within one (1) month after the filing thereof.
CIVIL PROCEDURE
Rule 2
NATURE OF PROCEEDINGS
SEC 1. Scope. Rules 2 to 9 shall apply to all civil actions for violations of intellectual property rights provided for
in Republic Act 8293 or the Intellectual Property Code, as amended, including civil actions for infringement of Patent
(Section 76), Utility Model (Section 108) and Industrial Design (Section 119), Trademark Infringement (Section 155
in relation to Section 163), Unfair Competition (Section 168 in relation to Section 163), actions concerning trademark
license contracts (Section 150 in relation to Section 163), actions concerning imported merchandise or goods
bearing infringing marks or trade names (Section 166 in relation to Section 163), actions for cancellation of the
registration of a collective mark (Section 167 in relation to Section 163), False Designations of Origin; False
Description or Representation (Section 169 in relation to Section 163), Breach of Contract (Section 194), civil
actions for infringement of copyright, moral rights, performers' rights, producers' rights, and broadcasting rights
(Sections 177, 193, 203, 208, 211, and 216), and other violations of intellectual property rights as may be defined by
law.
SEC. 2. Special Commercial Courts in the National Capital Judicial Region with authority to issue writs of
search and seizure enforceable nationwide. Special Commercial Courts in Quezon City, Manila, Makati, and
Pasig shall have authority to act on applications for the issuance of writs of search and seizure in civil actions for
violations of the Intellectual Property Code, which writs shall be enforceable nationwide. The issuance of these writs
shall be governed by the rules prescribed in Re: Proposed Rule on Search and Seizure in Civil Actions for
Infringement of Intellectual Property Rights (A.M. No. 02-1-06-SC, which took effect on February 15, 2002). Within
their respective territorial jurisdictions, the Special Commercial Courts in the judicial regions where the violation of
intellectual property rights occurred shall have concurrent jurisdiction to issue writs of search and seizure.
Rule 3
COMMENCEMENT OF ACTION
SECTION 1. Pleadings. The only pleadings allowed to be filed are the complaints, compulsory counterclaims
and cross-claims pleaded in the answer, and the answers thereto. All pleadings shall he verified.
SEC. 2. Who may file an action under these Rules. Any intellectual property right owner, or anyone
possessing any right, title or interest under claim of ownership in any intellectual property right, whose right may
have been violated, may file an action under these Rules.
Any person who is a national or who is domiciled or has a real and effective industrial establishment in a country
which is a party to any convention, treaty or agreement relating to intellectual property rights or the repression of
unfair competition, to which the Philippines is also a party, or extends reciprocal rights to nationals of the Philippines
by law, shall be entitled to file an action under these Rules.
Any foreign national or juridical person who meets the requirements of the immediately preceding paragraph, and
does not engage in business in the Philippines, may also file an action under these Rules.
SEC. 3. Form and contents of the complaint. The complaint shall be verified and shall state the full names of
the parties to the case. Facts showing the capacity of a party to sue or be sued, or the authority of a party to sue or
be sued in a representative capacity, or the legal existence of an organized association of persons that is made a
party, must be averred. In case of juridical persons, proof of capacity to sue must be attached to the complaint.
The complaint shall contain a concise statement of the ultimate facts constituting the complainant's cause or causes
of action. It shall specify the relief(s) sought, but it may add a general prayer for such further or other relief(s) as may
be deemed just or equitable.
The affidavits in question-and-answer format referred to in Sec. 5 hereof and the relevant evidence shall be made
part of the complaint.
The complaint shall include a certification that the party commencing the action has not filed any other action or
proceeding involving the same issue or issues before any tribunal or agency nor is such action or proceeding
pending in other quasi-judicial bodies; Provided, however, that if any such action is pending, the status of the same
must be stated, and should knowledge thereof be acquired after the filing of the complaint, the party concerned shall
undertake to notify the court within five (5) days from such knowledge.
When the party-litigant is a corporation, the verification/certification of non-forum shopping required should be
executed by a natural person duly authorized by the corporation, through a special power of attorney or a board
resolution for the purpose, attached to the complaint.
The complaint shall further be accompanied by proof of payment of docket and other lawful fees.
Failure to comply with the foregoing requirements shall not be remedied by mere amendment of the complaint. The
court, motu proprio, shall dismiss the case without prejudice.
The submission of a false certification or non-compliance with any of the undertakings therein shall constitute
indirect contempt, without prejudice to the corresponding administrative, civil and criminal liabilities. If the acts of a
party or his counsel clearly constitute willful and deliberate forum shopping, the same shall be a ground for summary
dismissal with prejudice and shall constitute direct contempt.
SEC. 4. Prohibited pleadings. The following pleadings are prohibited:
a) Motion to dismiss;
b) Motion for a bill of particulars;
c) Motion for reconsideration of a final order or judgment, except with regard to an order of destruction
issued under Rule 20 hereof;
d) Reply;
e) Petition for relief from judgment;
f) Motion for extension of time to file pleadings or other written submissions, except for the answer for
meritorious reasons;
g) Motion for postponement intended for delay;
h) Third-party complaint;
i) Intervention;
j) Motion to hear affirmative defenses; and
k) Any pleading or motion which is similar to or of like effect as any of the foregoing.
SEC. 5. Affidavits. The affidavits required to be submitted with the complaint shall be in question and-answer
format numbered consecutively, and shall state only facts of direct personal knowledge of the affiants which are
admissible in evidence. The affidavits shall also show the competence of the affiants to testify to the matters stated
therein.
A violation of this requirement may subject the party or the counsel who submits the same to disciplinary action, and
shall be a ground for the court to order that the inadmissible affidavit or portion thereof be expunged from the
records.
SEC. 6. Failure to file complaint where a writ of search and seizure is issued. Upon motion of the party
whose goods have been seized, with notice to the applicant, the issuing court may lift its writ and order the return of
the seized goods if no case is filed with the appropriate court and/or appropriate quasi-judicial agency, including the
Intellectual Property Office of the Philippines, within thirty-one (31) calendar days from the date of issuance of the
writ.
If no motion for the return of the seized goods is filed within sixty (60) days from the issuance of the writ under the
preceding paragraph, the court shall order the disposal of the goods, as may be warranted, after hearing with notice
to the parties.
Rule 4
ANSWER
SEC 1. Summons. The summons and the complaint, including its attachments, shall be served not later than five
(5) days from receipt of the complaint by the court to which it is assigned or raffled.
SEC. 2. Service of summons, orders and other court processes. Summons, orders and other court
processes may be served by the sheriff, his deputy or other proper court officer or for justifiable reasons, by the
counsel or representative of the plaintiff or any suitable person authorized by the court issuing the summons.
Any private person who is authorized by the court to serve summons, orders and other court processes shall, for
that purpose, be considered an officer of the court.
When the defendant is a foreign private juridical entity, service may be made on its resident agent designated in
accordance with law for that purpose, or, if there be no such agent, on the government official designated by law to
that effect, or on any of its officers or agents within the Philippines.
If the foreign private juridical entity is not registered in the Philippines or has no resident agent, service may, with
leave of court, be effected out of the Philippines through any of the following means:
a) By personal service coursed through the appropriate court in the foreign country with the assistance of
the Department of Foreign Affairs;
b) By publication once in a newspaper of general circulation in the country where the defendant may be
found and by serving a copy of the summons and the court order by registered mail at the last known
address of the defendant;
c) By facsimile or any recognized electronic means that could generate proof of service; or
d) By such other means as the court may, in its discretion, direct.
Should either personal or substituted service fail, summons by publication shall be allowed. In the case of juridical
entities, summons by publication shall be done by indicating the names of the officers or their duly authorized
representative.
SEC. 3. Answer. Within fifteen (15) days from service of summons, the defendant shall file his answer to the
complaint and serve a copy thereof on the plaintiff. Affirmative and negative defenses not pleaded in the answer
shall be deemed waived, except when the court has no jurisdiction over the subject matter, when there is another
action pending between the same parties for the same cause, or when the action is barred by a prior judgment or by
the statute of limitations. Cross-claims and compulsory counterclaims not asserted in the answer shall be
considered barred. The answer to counterclaims or cross-claims shall be filed and served within ten (10) days from
service of the answer in which they are pleaded.
SEC. 4. Effect of failure to answer. Should the defendant fail to answer the complaint within the period stated
above, the court, motu proprio or on motion of the plaintiff, shall render judgment as may be warranted by the
allegations of the complaint, as well as the affidavits and other evidence on record, unless the court in its discretion
requires the plaintiff to submit additional evidence. Such reception of additional evidence may be delegated to the
clerk of court. In no case shall the court award a relief beyond or different from that prayed for; Provided, that the
court may, in its discretion, reduce the amount of damages and attorney's fees claimed for being excessive or
otherwise unconscionable.
SEC. 5. Affidavits. The affidavits required to be submitted with the answer shall be in questionand-answer
format numbered consecutively, and shall state only facts of direct personal knowledge of the affiants which are
admissible in evidence. The affidavits shall also show the competence of the affiants to testify to the matters stated
therein.
A violation of this requirement may subject the party or the counsel who submits the same to disciplinary action, and
shall be ground for the court to order that the inadmissible affidavit or portion thereof be expunged from the records.
Rule 5
MODES OF DISCOVERY
SEC 1. In general. A party can avail of any of the modes of discovery not later than thirty (30) days from the
joinder of issues.
SEC. 2. Objections. Any mode of discovery, such as interrogatories, request for admission, production or
inspection of documents or things, may be objected to within ten (10) days from receipt of the request for discovery
and only on the ground that the matter requested is manifestly incompetent, immaterial, or irrelevant or is
undisclosed information or privileged in nature, or the request is for harassment. The requesting party may comment
in writing within three (3) days from receipt of the objection. Thereafter, the court shall rule on the objection not later
than ten (10) days from receipt of the comment or the expiration of the three-day period.
SEC. 3. Compliance. Compliance with any mode of discovery shall be made within ten (10) days from receipt of
the request for discovery, or if there are objections, from notice of the ruling of the court.
SEC. 4. Sanctions. The sanctions prescribed by the Rules of Court in relation to the modes of discovery shall
apply.
Rule 6
PRE-TRIAL
SEC 1. Pre-trial; mandatory nature. Within five (5) days after the period for availing of, or compliance with, any
of the modes of discovery prescribed in Rule 5 hereof, whichever comes later, the handling court shall immediately
set the case for pre-trial and direct the parties to submit their respective pre-trial briefs. The parties shall file with the
court and furnish each other copies of their respective pre-trial briefs in such manner as to ensure receipt by the
court, and the other party at least five (5) days before the date set for the pre-trial.
The parties shall set forth in their pre-trial briefs, among other matters, the following:
a) Brief statement of the nature of the case, which shall summarize the theory or theories of the party in
clear and concise language;
b) Allegations expressly admitted by either or both parties;
c) Allegations deemed admitted by either or both parties;
d) Documents not specifically denied under oath by either or both parties;
e) Amendments to the pleadings;
f) Statement of the issues, which shall separately summarize the factual and legal issues involved in the
case;
g) Names, addresses and contact numbers of affiants and their judicial affidavits supporting the parties'
respective positions on each of the issues;
h) All other pieces of evidence, whether documentary or otherwise, and their respective purposes;
i) Specific proposals for an amicable settlement;
j) Possibility of referral to mediation or other alternative modes of dispute resolution;
k) Requests for closed door hearings in cases involving trade secrets, undisclosed information and patents;
and
l) Such other matters as may aid in the just and speedy disposition of the case.
SEC. 2. Nature and purpose of pre-trial. Upon appearance of the parties during the pre-trial, the court shall
order the parties to appear before the Philippine Mediation Center in accordance with mediation rules of the
Supreme Court.
Should the parties fail to settle the case after mediation, the pairing court shall conduct judicial dispute resolution
(JDR) conferences upon request of the court handling the case in accordance with the guidelines of the Supreme
Court.
Pending mediation before the Philippine Mediation Center and JDR with the pairing court, the court handling the
case shall suspend the proceedings. If either mediation or JDR fails, the case shall be returned to the court with
dispatch for the pre-trial.
Before the pre-trial, the court may require the marking of documentary or object evidence by the branch clerk of
court or any authorized court personnel.
During the pre-trial, the court shall, with its active participation, ensure that the parties consider in detail all of the
following:
a) The possibility of an amicable settlement;
b) Facts that need not be proven, either because they are matters of judicial notice, or expressly or deemed
admitted;
c) Permissible amendments to the pleadings;
d) The possibility of obtaining stipulations and admissions of facts and documents;
e) Objections to the admissibility of testimonial, documentary and other evidence;
f) Submission of judicial affidavits of witnesses and objections to the form or substance of any affidavit, or
part thereof;
g) Simplification of the issues; and
h) Such other matters as may aid in the speedy and summary disposition of the case.
SEC. 3. Effect of failure to appear. The failure of the plaintiff to submit a pre-trial brief within the specified period
or to appear in the pre-trial shall be a cause for the dismissal of the complaint with prejudice, unless otherwise
ordered by the court. The defendant who submits a pre-trial brief and who appears during the pre-trial shall be
entitled to a judgment on the counterclaim unless the court requires evidence ex parte for a judgment. Any cross-
claim shall be dismissed.
The failure of the defendant to submit a pre-trial brief within the specified period or to appear in the pre-trial shall be
a cause for the dismissal of the counterclaim. The plaintiff who submits a pre-trial brief and who appears during the
pre-trial shall be entitled to a judgment on the complaint unless the court requires evidence ex parte for a judgment.
SEC. 4. Termination. The pre-trial shall be terminated not later than thirty (30) working days after its
commencement, excluding the period for mediation and judicial dispute resolution (JDR).
SEC. 5. Record of pre-trial. The proceedings in the pre-trial shall be recorded, excluding mediation and JDR.
Within ten (10) days after the termination of the pre-trial, the court shall issue an order which shall recite in detail the
matters taken up in the pre-trial, the actions taken on such matters, the amendments allowed in the pleadings, and
the agreements or admissions made by the parties as to any of the matters considered. The court shall rule on all
objections to or comments on the admissibility of any documentary or other evidence, including any affidavit or any
part thereof. The court shall indicate whether the case shall be submitted for decision immediately after pre-trial, or
on the basis of position papers, or after clarificatory hearing, or after trial.
SEC. 6. Submission of position papers. If the case is to be submitted for decision on the basis of position
papers, the court, in the Pre-Trial Order, shall direct the parties to file simultaneously their respective position
papers, setting forth the law and the facts relied upon by them and attaching thereto affidavits of their witnesses in
question-and-answer format numbered consecutively, and other evidence on the factual issues defined in the order,
together with their respective draft decisions, if so desired, within a non-extendible period of thirty (30) days from
receipt of the order. No reply or rejoinder shall be allowed.
SEC. 7. Clarificatory hearing or hearings following pre-trial. If there are matters to be clarified, the court shall
include in the Pre-Trial Order the schedule of clarificatory hearing or hearings, which must commence within thirty
(30) days from the termination of the pre-trial, and be completed not later than fifteen (15) days thereafter.
At least three (3) days before the scheduled clarificatory hearing, the parties may submit clarificatory questions
which the court, in its discretion, may propound.
SEC. 8. Schedule of trial. If the court deems it necessary to hold trial, the court shall include in the Pre-Trial
Order the schedule of hearings to be conducted expeditiously and completed not later than sixty (60) days from the
date of the initial trial which must commence within thirty (30) days from the termination of the pre-trial.
Rule 7
CLARIFICATORY HEARING AND TRIAL
SEC. 1. Clarificatory hearings. During clarificatory hearing or hearings, the parties must have representatives
and their counsels ready for questioning by the court.
Immediately after termination of such clarificatory hearing or hearings, the court shall order the parties to
simultaneously file, within ten (10) days from such date, their respective position papers as required under Section
6, Rule 6, above.
SEC. 2. Clarificatory hearing or hearings following submission of position papers. Upon submission of the
parties' position papers immediately after the pre-trial as required under Sec. 6 of the preceding Rule, and the court
deems it necessary to hold clarificatory hearing or hearings on any matter before rendering judgment, it shall set the
case for such purpose.
The order setting the case for clarificatory hearing must be issued not later than fifteen (15) days after receipt of the
last position papers or the expiration of the period for filing the same and the clarificatory hearing must be scheduled
within fifteen (15) days from the issuance of such order and completed not later than fifteen (15) days.
During said clarificatory hearing or hearings, the parties must have representatives and their counsels ready for
questioning by the court.
SEC. 3. Judicial affidavits. The judicial affidavits shall serve as the direct testimonies of the witnesses during
trial, subject to cross-examination by the adverse party.
SEC. 4. Period of trial. A period not exceeding thirty (30) days shall be allotted to the plaintiff and a similar
period to the defendant in the manner prescribed in the Pre-Trial Order. The failure of a party to present a witness
on a scheduled trial date shall be deemed a waiver of such trial date. However, a party may present such witness or
witnesses within the party's remaining allotted trial dates. No extension shall be allowed by the judge except for
justifiable reasons.
SEC. 5. Offer of and ruling on exhibits. Evidence presented during the trial and not otherwise admitted by the
parties or ruled upon by the court during the pre-trial shall be offered orally immediately after the completion of the
presentation of evidence of the party concerned. The opposing party shall immediately raise the objections on the
offer of exhibits and thereafter, the court shall at once rule on the offer and objections in open court.
In case the court requires the submission of written formal offer of exhibits, the same shall be submitted to the court
within five (5) days from completion of the presentation of the evidence of the party, furnishing copies thereof on the
other party, who may submit comments or objections to the formal offer within five (5) days from receipt. The court
shall make its ruling on the offer within five (5) days from the expiration of the period to file comments or objections.
SEC. 6. Mandatory submission of draft decisions. Immediately after an oral ruling on the last offer of
evidence, the court shall order the parties to simultaneously submit their respective draft decisions, within a non-
extendible period of thirty (30) days. In case the ruling is in writing, the court shall order the parties to simultaneously
submit their respective draft decisions within a nonextendible period of thirty (30) days from receipt of the order.
Rule 8
JUDGMENT
SEC 1. Judgment immediately after pre-trial. Where the case is submitted for decision immediately after pre-
trial in accordance with Sec. 5, Rule 6, the court shall render judgment within forty-five (45) days after pre-trial.
SEC. 2. Judgment after submission of position papers. Within forty-five (45) days after receipt of the last
position paper, affidavits, documentary and real evidence, or the expiration of the period for filing the same under
Sec. 6 of Rule 6 and Sec. 1 of Rule 7, the court shall render judgment on the basis of the parties' position papers,
affidavits, documentary and real evidence.
SEC. 3. Judgment after clarificatory hearing. Within forty-five (45) days after termination of clarificatory
hearing or hearings under Sec. 7 of Rule 6 and Sec. 2 of Rule 7, the court shall render judgment.
SEC. 4. Judgment after trial. Within sixty (60) days after receipt of the draft decision of the parties under Sec. 6
of Rule 7, the court shall render judgment.
SEC. 5. Judgments executory pending appeal. Unless restrained by a higher court, the judgment of the court
shall be executory even pending appeal under such terms and conditions as the court may prescribe.
Rule 9
APPEAL
SEC 1. Who may appeal. Any party may appeal from a judgment or final order.
SEC. 2. How appeal taken. All decisions and final orders shall be appealable to the Court of Appeals through a
petition for review under Rule 43 of the Rules of Court.
The petition for review shall be taken within fifteen (15) days from notice of the decision or final order of the Regional
Trial Court designated by the Supreme Court as Special Commercial Courts. Upon proper motion and the payment
of the full amount of the legal fee prescribed in Rule 141, as amended, and before the expiration of the reglementary
period, the Court of Appeals may grant an additional period of fifteen (15) days within which to file the petition for
review. No further extension shall be granted except for the most compelling reasons and in no case to exceed
fifteen (15) days.
CRIMINAL PROCEDURE
Rule 10
NATURE OF PROCEEDINGS
SEC 1. Scope. Rules 10 to 15 shall apply to all criminal actions for violations of intellectual property rights
provided for in Republic Act 8293 or the Intellectual Property Code, as amended, including Repetition of
Infringement of Patent (Section 84), Utility Model (Section 108) and Industrial Design (Section 119), Trademark
Infringement (Section 155 in relation to Section 170), Unfair Competition (Section 168 in relation to Section 170),
False Designations of Origin; False Description or Representation (Section 169.1 in relation to Section 170),
infringement of copyright, moral rights, performers' rights, producers' rights, and broadcasting rights (Section 177,
193, 203, 208 and 211 in relation to Section 217), and other violations of intellectual property rights as may be
defined by law.
SEC. 2. Special Commercial Courts in the National Capital Judicial Region with authority to issue search
warrants enforceable nationwide. Special Commercial Courts in Quezon City, Manila, Makati, and Pasig shall
have authority to act on applications for the issuance of search warrants involving violations of the Intellectual
Property Code, which search warrants shall be enforceable nationwide. Within their respective territorial
jurisdictions, the Special Commercial Courts in the judicial regions where the violation of intellectual property rights
occurred shall have concurrent jurisdiction to issue search warrants.
Accordingly, the Executive Judges are hereby relieved of the duty to issue search warrants involving violations of
the Intellectual Property Code in criminal cases as stated in Sec. 12, Chapter V of A.M. No. 03-8-02-SC (Guidelines
on the Selection and Appointment of Executive Judges and Defining their Powers, Prerogatives and Duties).
Rule 11
COMMENCEMENT OF ACTION
SECTION 1. How commenced. The filing of criminal cases falling within the scope of this Rule shall be by
information after a prior verified complaint is filed under Rule 12 on Preliminary Investigation.
When the information is filed, the verified complaint and the affidavits of witnesses together with other evidence, in
such number of copies as there are accused plus two (2) copies for the court's files, shall be attached thereto.
In case of failure to attach the complaint, affidavit and evidence, the court shall order the investigating prosecutor,
through the court's designated prosecutor, to submit the said requirements before the pre-trial.
SEC. 2. Where to file. The information, together with attachments, shall be filed with the court referred to in
Section 2 of Rule 1, which has jurisdiction over the territory where any of the elements of the offense occurred.
SEC. 3. When warrant of arrest may issue. Within ten (10) days from the filing of the information, the judge
shall personally evaluate the information together with the resolution of the prosecutor and its supporting
documents. The judge may immediately dismiss the case if the evidence on record clearly fails to establish probable
cause, if he finds probable cause, he shall issue a warrant of arrest, or a commitment order if the accused has
already been arrested. In case of doubt on the existence of probable cause, the judge may order the prosecutor to
present additional evidence within five (5) days from notice and the issue must be resolved by the court within fifteen
(15) days from the presentation of the additional evidence.
SEC. 4. Disposition of goods seized pursuant to search warrant. If a criminal action has been instituted, only
the trial court shall rule on a motion to quash a search warrant or to suppress evidence obtained thereby or to
release seized goods.
It shall be the duty of the applicant or private complainant to file a motion for the immediate transfer of the seized
goods to the trial court, which motion shall be immediately acted upon by the issuing court.
If no criminal action has been instituted, the motion to quash a search warrant or to suppress evidence obtained
thereby or to release seized goods may be filed in and resolved by the issuing court. If pending resolution of the
motion, a criminal case is meanwhile filed in another court, the incident shall be transferred to and resolved by the
latter court.
Upon motion of the party whose goods have been seized, with notice to the applicant, the issuing court may quash
the search warrant and order the return of the seized goods if no criminal complaint is filed within sixty (60) days
from the issuance of the search warrant.
If no criminal action is filed before the office of the prosecutor and no motion for the return of the seized goods is
filed within sixty (60) days from the issuance of the search warrant, the issuing court shall require the parties,
including the private complainant, if any, to show cause why the search warrant should not be quashed.
SEC. 5. Prohibited motions. The following motions shall not be allowed:
a) Motion to quash the information, except on the ground of lack of jurisdiction;
b) Motion for extension of time to file affidavits or any other papers; and
c) Motion for postponement intended for delay.
Rule 12
PRELIMINARY INVESTIGATION
SEC 1. Complaint. The complaint shall be filed with the Department of Justice or the office of the prosecutor that
has jurisdiction over the offense charged:
a) The complaint shall state the full name of the complainant and the facts showing the capacity or authority
of the complaining witness to institute a criminal action in a representative capacity, and the legal existence
of an organized association of persons that is instituting the criminal action. In case of juridical persons,
proof of capacity to sue must be attached to the complaint. Where the complainant is a juridical person not
registered in the Philippines, documents proving its legal existence and/or its capacity to sue, such as a
certificate of registration or extracts from relevant commercial registries or offices having jurisdiction over
said entities, shall be accepted if these are originals or in case of public documents, certified true copies
thereof executed by the proper officer of such registries or offices.
Where the complainant is a foreign national or is domiciled or has a real and effective industrial
establishment in a country which is a party to any convention, treaty or agreement relating to intellectual
property rights or the repression of unfair competition to which the Philippines is also a party, or extends
reciprocal rights to national of the Philippines by law, the verified complaint must contain such facts showing
entitlement to file the action.
b) The complaint shall state the address of the respondent and shall be in such number of copies as there
are respondents, plus two (2) copies for the investigating prosecutor. The complaint shall be subscribed and
sworn to before any prosecutor or government official authorized to administer oath, or, in their absence or
unavailability, before a notary public. The administering officer must certify that he personally examined the
complainant and that he is satisfied that the complainant voluntarily executed and understood the complaint.
c) The complaint shall be accompanied by the affidavits of the complainant and his witnesses, as well as
other supporting documents to establish probable cause. Notarized affidavits of witnesses shall be allowed
and admitted as part of the complaint, provided that affidavits executed by non-residents of the Philippines
shall be duly authenticated by the concerned Philippine consular or diplomatic office.
d) In instances where multiple complaints are filed by the same complainant, copies of the supporting
documents shall be admitted after they are compared with and shown to be faithful reproductions of the
originals or certified documents referred to in subparagraphs (a) and (c) above.
SEC. 2. Procedure. The preliminary investigation shall be conducted as follows:
a) Within ten (10) days after the filing of the complaint, the investigating prosecutor, on the basis of the
complaint and the affidavits and other evidence accompanying the same, may dismiss the case outright for
being patently without basis or merit and order the release of the accused if in custody, and/or seized
articles in custody, if any.
b) When the complaint is not dismissed pursuant to the immediately proceeding paragraph, the
investigating prosecutor, within ten (10) days from the filing of the complaint, shall issue an order to the
respondent attaching thereto a copy of the complaint and its supporting affidavits and documents, and
require the respondent to submit his counter-affidavit and the affidavits of his witnesses and other
documentary evidence in the format required under Section 1 hereof, wherever applicable, serving copies
thereof on the complainant not later than ten (10) days from receipt of said order. The counter-affidavits shall
be subscribed and sworn to and certified as provided in paragraphs (b) and (c) of Section 1 hereof. The
respondent shall not be allowed to file a motion to dismiss in lieu of a counter-affidavit.
c) If the respondent cannot be served with the order of the investigating prosecutor, or if served, does not
submit counter- affidavits within the ten (10) day period, the investigating prosecutor shall resolve the
complaint based on the evidence presented by the complainant.
d) The investigating prosecutor may set a hearing if there are facts and issues to be clarified from a party or
a witness. The parties can be present at the hearing but without the right to examine or cross-examine. They
may, however, submit to the investigating prosecutor questions which may be asked to the party or witness
concerned.
Within ten (10) days from the last written submission by the parties or the expiration of the period for such
submission, the investigating prosecutor shall determine whether or not there is sufficient ground to hold the
respondent for trial.
SEC. 3. When accused lawfully arrested without warrant. When a person is lawfully arrested without a
warrant, the information may be filed by a prosecutor without need of such investigation provided an inquest had
been conducted in accordance with existing Rules.
Before the information is filed, the person arrested may ask for a preliminary investigation in accordance with this
Rule, but he must sign a waiver of the provisions of Article 125 of the Revised Penal Code, as amended, in the
presence of his counsel. Notwithstanding the waiver, he may apply for bail and the investigation must be terminated
within fifteen (15) days from its inception.
After the filing of the information in court without preliminary investigation, the accused may, within five (5) days from
the time he learns of its filing, ask for a preliminary investigation with the same right to adduce evidence in his
defense as provided in this Rule.
Rule 13
ARRAIGNMENT AND PRE-TRIAL
SEC 1. Arraignment. The arraignment shall be conducted in accordance with Rule 116 of the Rules of Court. If
the accused is in custody for the crime charged, he shall be immediately arraigned. If the accused enters a plea of
guilty, he shall forthwith be sentenced. After arraignment, the court shall immediately schedule the case for pre-trial.
SEC. 2. Referral to mediation. Before conducting the trial, the court shall call the parties to a pretrial. Upon
appearance of the parties during pre-trial, the judge shall order the parties to appear before the Philippine Mediation
Center for court-annexed mediation on the civil aspect of the criminal action. The pre-trial judge shall suspend the
court proceedings while the case is undergoing mediation. Upon termination of the mediation proceedings, the court
shall continue with the pre-trial.
SEC. 3. Pre-trial. During the pre-trial, a stipulation of facts may be entered into, or the propriety of allowing the
accused to enter a plea of guilty to a lesser offense may be considered, or such other matters as may be taken up to
clarify the issues and to ensure a speedy disposition of the case. However, no admission by the accused shall be
used against him unless reduced to writing and signed by the accused and his counsel. A refusal or failure to
stipulate shall not prejudice the accused.
The pre-trial shall be terminated not later than thirty (30) days from the date of its commencement, excluding the
period for mediation and JDR.
Should a party desire to present additional affidavits or counter affidavits as part of his direct evidence, he shall so
manifest during the pre-trial, stating the purpose thereof. If allowed by the court, the additional affidavits of the
prosecution or the counter-affidavits of the defense shall be submitted to the court and served on the adverse party
not later than three (3) days after the termination of the pre-trial. If the additional affidavits are presented by the
prosecution, the accused may file his counter-affidavits and serve the same on the prosecution within three (3) days
from such service.
Before the pre-trial, the court may require the marking of documentary or object evidence by the branch clerk of
court or any authorized court personnel.
SEC. 4. Non-appearance at the pre-trial. If the counsel for the accused or the prosecutor does not appear at
the pre-trial and does not offer an acceptable excuse for his lack of cooperation, the court may impose proper
sanctions or penalties.
SEC. 5. Record of pre-trial. Within five (5) days after the termination of the pre-trial, the court shall issue an
order stating the matters taken up therein, including but not limited to:
a) Plea bargaining;
b) The stipulations or admissions entered into by the parties;
c) Whether, on the basis of the stipulations and admissions made by the parties, judgment may be rendered
without the need of further proceedings, in which event judgment shall be rendered within thirty (30) days
from issuance of the order;
d) A clear specification of material facts which remain controverted;
e) Trial dates of each party;
f) Such other matters intended to expedite the disposition of the case.
Rule 14
TRIAL
SEC 1. Affidavits and other evidence at the trial. The Court shall hear the evidence of the parties on the trial
dates agreed upon by them during the pre-trial. The affidavits of the witnesses of the parties which form part of the
record of the case, such as those submitted: (a) during the preliminary investigation; and/or (b) during the pre-trial,
shall constitute the direct testimonies of the witnesses who executed them. Such witnesses may be subjected to
cross examination by the adverse party.
SEC. 2. Conduct of trial. The court shall conduct hearings expeditiously so as to ensure speedy trial. Each party
shall have a maximum period of sixty (60) days to present his evidence-in-chief on the trial dates agreed upon
during the pre-trial.
SEC. 3. Submission of memoranda. Upon termination of trial, the court may order the parties to submit within a
non-extendible period of thirty (30) days their memoranda setting forth the law and the facts relied upon by them.
SEC. 4. Judgment. The court shall promulgate the judgment not later than sixty (60) days from the time the case
is submitted for decision, with or without the memoranda. A copy of the judgment shall be furnished the IPO.
Rule 15
APPEAL
SEC 1. Who may appeal. Any party may appeal from a judgment or final order, unless the accused will be
placed in double jeopardy.
SEC. 2. How appeal taken. The appeal shall be taken in the manner provided under Rule 122 of the Rules of
Court.
Rule 16
COMMON RULES ON ADMISSIBILITY AND WEIGHT OF EVIDENCE
SECTION 1. Evidence of good faith. In cases of patent infringement, trademark infringement, and copyright
infringement, fraudulent intent on the part of the defendant or the accused need not be established. Good faith is not
a defense unless the defendant or the accused claims to be a prior user under Sections 73 and 159 of the
Intellectual Property Code or when damages may be recovered under Sections 76, 156, and 216 of the Code.
SEC. 2. Foreign official documents. All official records kept in a foreign country, including certificates of
registration, shall be admissible if authenticated by the proper consular office of the Philippines having jurisdiction
over the country where such records and/or certificates are kept. However, such authentication of foreign official
documents may be the subject of the agreement of the parties.
SEC. 3. Deposition of foreign witness. The deposition of any witness abroad shall be taken within six (6)
months from the date of the order allowing the deposition, unless the failure to take the deposition within the period
is caused by a fortuitous event, fraud, accident, mistake or excusable negligence.
SEC. 4. Presumptions in the Intellectual Property Code. The presumptions in the Intellectual Property Code
on patents, trademarks and copyright shall apply to these Rules.
SEC. 5. Suppletory application of the rules on discovery and evidence. Unless inconsistent with these
Rules, the rules on discovery and evidence under the Rules of Court shall apply.
Rule 17
EVIDENCE IN PATENT CASES
SECTION 1. Burden of proof in patent infringement; presumption regarding process patents.
a) The burden of proof to substantiate a charge for patent infringement rests on the party alleging the same,
subject, however, to sub-Section b) below, and other applicable laws.
b) If the subject matter of a patent is a process for obtaining a product, any identical product is presumed to
have been obtained through the use of the patented process if; (i) the product is new; or (ii) there is
substantial likelihood that the identical product was made by the process and the owner of the patent has
been unable, despite reasonable efforts, to determine the process actually used. In such cases, the court
shall then order the defendant or alleged infringer to prove that the process to obtain the identical product is
different from the patented process, subject to the court's adoption of measures to protect, as far as
practicable, said defendant or alleged infringer's manufacturing and business secrets.
SEC. 2. Patents issued presumed valid.
a) In all cases, a letters patent issued by the Intellectual Property Office - Bureau of Patents, or its
predecessor or successor-agencies, is prima facie evidence of its existence and validity during the term
specified therein against all persons, unless the same has already been cancelled or voided by a final and
executory judgment or order.
b) Moreover, letters patents issued by the Intellectual Property Office Bureau of Patents, or its
predecessor or successor-agencies, are presumed to have been validly issued by said government agency
in accordance with applicable laws, unless otherwise contradicted or overcome by other admissible
evidence showing that the same was irregularly issued.
SEC. 3. Presumption regarding knowledge of existing patent rights. For purposes of awarding damages in
patent infringement cases, it is presumed that the defendant or alleged infringer knew of the existence of a patent
over a protected invention or process, if: (a) on the patented invention or product manufactured using the patented
process; (b) on the container or package in which said article is supplied to the public; or (c) on the advertising
material relating to the patented product or process, are placed the words "Philippine Patent" with the number of the
patent.
SEC. 4. Request for technical advice. In patent infringement cases, the court, motu proprio or upon motion by a
party, may order the creation of a committee of three (3) experts to provide advice on the technical aspects of the
patent in dispute. Within thirty (30) days from receipt of the order creating the committee, each side shall nominate
an expert, who shall then both be appointed by the court. The court shall appoint the third expert from a list
submitted by the experts of each side. All fees and expenses relating to the appointment of a committee shall be
initially equally shouldered by the parties but may later on be adjudicated by the court in favor of the prevailing party.
To assist in the trial involving highly-technical evidence or matters, the court may also request the IPO to provide
equipment, technical facilities, and personnel.
SEC. 5. Application to utility models and industrial designs. The above rules shall likewise be applicable to
infringement cases involving utility models and industrial designs.
Rule 18
EVIDENCE IN TRADEMARK INFRINGEMENT
AND UNFAIR COMPETITION CASES
SECTION 1. Certificate of registration. A certificate of registration of a mark shall be prima facie evidence of:
a) the validity of the registration;
b) the registrant's ownership of the mark; and
c) the registrant's exclusive right to use the same in connection with the goods or services and those that
are related thereto specified in the certificate.
SEC. 2. Well-known mark. In determining whether a mark is well-known, account shall be taken of the
knowledge of the relevant sector of the public, rather than of the public at large, including knowledge in the
Philippines which has been obtained as a result of the promotion of the mark. The following criteria or any
combination thereof may be taken into account in determining whether a mark is well-known:
a) the duration, extent and geographical area of any use of the mark; in particular, the duration, extent and
geographical area of any promotion of the mark, including advertising or publicity and the presentation, at
fairs or exhibitions, of the goods and/or services to which the mark applies;
b) the market share, in the Philippines and in other countries, of the goods and/or services to which the
mark applies;
c) the degree of the inherent or acquired distinction of the mark;
d) the quality-image or reputation acquired by the mark;
e) the extent to which the mark has been registered in the world;
f) the exclusivity of registration attained by the mark in the world;
g) the extent to which the mark has been used in the world;
h) the exclusivity of use attained by the mark in the world;
i) the commercial value attributed to the mark in the world;
j) the record of successful protection of the rights in the mark;
k) the outcome of litigations dealing with the issue of whether the mark is a well-known mark; and
l) the presence or absence of identical or similar marks validly registered for or used on identical or similar
goods or services and owned by persons other than the person claiming that his mark is a well-known mark.
Provided, further, that the mark is well-known both internationally and in the Philippines.
SEC. 3. Presumption of likelihood of confusion. Likelihood of confusion shall be presumed in case an
identical sign or mark is used for identical goods or services.
SEC. 4. Likelihood of confusion in other cases. In determining whether one trademark is confusingly similar to
or is a colorable imitation of another, the court must consider the general impression of the ordinary purchaser,
buying under the normally prevalent conditions in trade and giving the attention such purchasers usually give in
buying that class of goods. Visual, aural, connotative comparisons and overall impressions engendered by the
marks in controversy as they are encountered in the realities of the marketplace must be taken into account. Where
there are both similarities and differences in the marks, these must be weighed against one another to see which
predominates.
In determining likelihood of confusion between marks used on non-identical goods or services, several factors may
be taken into account, such as, but not limited to:
a) the strength of plaintiffs mark;
b) the degree of similarity between the plaintiffs and the defendant's marks;
c) the proximity of the products or services;
d) the likelihood that the plaintiff will bridge the gap;
e) evidence of actual confusion;
f) the defendant's good faith in adopting the mark;
g) the quality of defendant's product or service; and/or
h) the sophistication of the buyers.
"Colorable imitation" denotes such a close or ingenious imitation as to be calculated to deceive ordinary persons, or
such a resemblance to the original as to deceive an ordinary purchaser giving such attention as a purchaser usually
gives, as to cause him to purchase the one supposing it to be the other.
SEC. 5. Determination of similar and dissimilar goods or services. Goods or services may not be considered
as being similar or dissimilar to each other on the ground that, in any registration or publication by the Office, they
appear in different classes of the Nice Classification.
SEC. 6. Intent to defraud or deceive. In an action for unfair competition, the intent to defraud or deceive the
public shall be presumed:
a) when the defendant passes off a product as his by using imitative devices, signs or marks on the general
appearance of the goods, which misleads prospective purchasers into buying his merchandise under the
impression that they are buying that of his competitors;
b) when the defendant makes any false statement in the course of trade to discredit the goods and business
of another; or
c) where the similarity in the appearance of the goods as packed and offered for sale is so striking.
SEC. 7. Generic marks. A registered mark shall not be deemed to be the generic name of goods or services
solely because such mark is also used as a name of or to identify a unique product or service.
The test for determining whether the mark is or has become the generic name of goods or services on or in
connection with which it has been used shall be the primary significance of the mark to the relevant public rather
than purchaser motivation.
Rule 19
EVIDENCE IN COPYRIGHT CASES
SEC 1. When copyright presumed to subsist. In copyright infringement cases, copyright shall be presumed to
subsist in the work or other subject matter to which the action relates, and ownership thereof shall be presumed to
belong to complainant if he so claims through affidavit evidence under Section 218 of the Intellectual Property Code,
as amended, unless defendant disputes it and shows or attaches proof to the contrary in his answer to the
complaint. A mere denial of the subsistence of copyright and/or ownership of copyright based on lack of knowledge
shall not be sufficient to rebut the presumption.
SEC. 2. Effect of registration and deposit. Registration and deposit of a work with the National Library or the
Intellectual Property Office shall not carry with it the presumption of ownership of the copyright by the registrant or
depositor, nor shall it be considered a condition sine qua non to a claim of copyright infringement.
SEC. 3. Presumption of authorship. The natural person whose name is indicated on a work in the usual
manner as the author shall, in the absence of proof to the contrary, be presumed to be the author of the work. This
presumption applies even if the name is a pseudonym, provided the pseudonym leaves no doubt as to the identity of
the author.
The person or body corporate whose name appears on an audiovisual work in the usual manner shall, in the
absence of proof to the contrary, be presumed to be the maker of said work.
SEC. 4. International registration of works. A statement concerning a work, recorded in an international
register in accordance with an international treaty to which the Philippines is or may become a party, shall be
construed as true until the contrary is proved, except:
a) Where the statement cannot be valid under Republic Act No. 8293, as amended, or any other law
concerning intellectual property; or
b) Where the statement is contradicted by another statement recorded in the international register.
Rule 20
ORDER OF DESTRUCTION
SEC 1. Order of destruction. At any time after the filing of the complaint or information, the court, upon motion
and after due notice and hearing where the violation of the intellectual property rights of the owner is established,
may order the destruction of the seized infringing goods, objects and devices, including but not limited to, sales
invoices, other documents evidencing sales, labels, signs, prints, packages, wrappers, receptacles, and
advertisements and the like used in the infringing act.
Such hearing shall be summary in nature with notice of hearing to the defendant or accused to his last known
address to afford the defendant or accused the opportunity to oppose the motion.
SEC. 2. Conditions for order of destruction. The court may only issue an Order of Destruction, subject to the
following conditions:
a) An inventory and photographs of the seized infringing goods have been taken before destruction at the
place where the seized infringing goods are stored;
b) The taking of the inventory and photographs must be witnessed and attested to by: (1) the accused or
counsel or agent, or in their absence, an officer of the barangay where the seized infringing goods are
stored; (2) the complainant, his representative or counsel; (3) the public officer who seized the items or a
representative of his office; and (4) a court officer authorized by the court to supervise the destruction of the
seized infringing goods;
c) Representative samples of the seized infringing goods have been retained in a number and nature as to
suffice for evidentiary purposes;
d) An inventory of the representative samples has been made by the persons enumerated under (b) above;
e) The court officer authorized to supervise the destruction has submitted a report thereon, within five (5)
days from the date of destruction, to which is attached (i) the inventory and photographs of the seized
infringing goods and (ii) the inventory of the representative samples; and
f) The applicant has posted a bond in an amount fixed by the court.
SEC. 3. Admissibility of representative samples. Representative samples of the goods, objects and devices
referred to in this Rule, together with the inventory and photographs of the same, shall be admissible in lieu of the
actual items.
Rule 21
REPORTORIAL REQUIREMENTS
SECTION 1. Reportorial requirements. Within thirty (30) days from the issuance of the decision or final order,
the court shall furnish the IPO a copy of the decision or final order.
Rule 22
TRANSITORY PROVISION
SECTION 1. Transitory provision. These Rules shall be applicable to all pending intellectual property cases,
whenever practicable as determined by the court.
Rule 23
EFFECTIVITY
SECTION 1. Effectivity. These Rules shall take effect fifteen (15) days after their publication in two (2)
newspapers of national circulation.
REPUBLIC ACT NO. 8293
INTELLECTUAL PROPERTY CODE OF THE PHILIPPINES

Took effect on 1 January 1998. (See Section 241 of RA 8293).


As amended by the following subsequent laws/rules:
1. RA 10372 entitled "An Act Amending Certain Provisions Of Republic Act
No. 8293, Otherwise Known As The "Intellectual Property Code Of The
Philippines", And For Other Purposes" (approved February 28, 2013);
2. RA 9502 entitled "An Act Providing For Cheaper And Quality Medicines,
Amending For The Purpose Republic Act No. 8293 Or The Intellectual
Property Code, Republic Act No. 6675 Or The Generics Act Of 1988, And
Republic Act No. 5921 Or The Pharmacy Law, And For Other Purposes"
(approved June 6, 2008); and
3. RA 9150 entitled "An Act Providing For The Protection Of Layout-Designs
(Topographies) Of Integrated Circuits, Amending For The Purpose Certain
Sections Of Republic Act No. 8293, Otherwise Known As The Intellectual
Property Code Of The Philippines And For Other Purposes" (approved
August 6, 2001).
4. RA 10088 entitled "An Act To Prohibit And Penalize The Unauthorized Use,
Possession And/Or Control Of Audiovisual Recording Devices For The
Unauthorized Recording Of Cinematographic Films And Other Audiovisual
Works And/Or Their Soundtracks In An Exhibition Facility, Providing
Penalties Therefor And For Other Purposes" (approved May 13, 2010),
which amends this law insofar as it is inconsistent with the former; and
5. RA 9239 entitled "An Act Regulating Optical Media, Reorganizing For This
Purpose The Videogram Regulatory Board, Providing Penalties Therefor,
And For Other Purposes" (approved February 10, 2004).
RA 8293 repealed the three major laws in intellectual property and
their amendments: RA 165 (June 20, 1947) otherwise known as "The
Patent Law," as amended by RA 637, 864, and PD 1263; RA 166
(June 20, 1947) otherwise known as "The Trademark Law", and
PD 49 (Nov. 14, 1972) otherwise known as the "Copyright Law"
insofar as they are inconsistent with RA 8293. It also expressly
repealed Articles 188 and 189 of the Revised Penal Code and
Presidential Decree No. 285. (see Section 239.1 of RA 8293)
acceSSlaw2009
The provisions of RA 8293 on invention patents are prospective in
nature while the provisions of RA 8293 on utility models, industrial
designs, copyright and trademarks may be applied retroactively unless
trademark, utility model and industrial design applicants elect to
prosecute their applications under the law under which they were filed
(cf. Secs. 235 and 239.3 of RA 8293) or it results in the diminution of
protection (cf. Secs. 236 and 239.3 of RA 8293).
6. See further RA 10055 entitled "An Act Providing The Framework And
Support System For The Ownership, Management, Use, And
Commercialization Of Intellectual Property Generated From Research And
Development Funded By Government And For Other Purposes" (approved
March 23, 2010).
7. See also PD 812 entitled "Decree On Legal And Cultural Deposit" (issued
October 16, 1975).
8. See further TAPI AO 157-14 (Subject: Guidelines on Intellectual Property
Rights Assistance Program (IPRAP)) (issued October 2014); TAPI AO 158-
14 entitled (Subject: Guidelines for the Implementation of Industry Based
Invention Development (IBID) Assistance Program) (issued September
2014); EO 737 entitled "Establishing Intellectual Property Research And
Training Institute As The Research And Training Arm Of The Intellectual
Property Office" (issued July 11, 2008); EO 736 entitled "Institutionalizing
Permanent Units To Promote, Protect And Enforce Intellectual Property
Rights (IPR) In Different Law Enforcement And Other Agencies Under The
Coordination Of The National Committee On Intellectual Property Rights
(NCIPR)" (issued June 21, 2008); and EO 346 entitled "Transferring The
Intellectual Property Office (IPO) From The Office Of The Executive
Secretary To The Department Of Trade And Industry" (issued August 9,
2004).
9. See also A.M. No. 10-3-10-SC entitled "Rules Of Procedure For Intellectual
Property Rights Cases" (issued October 18, 2011); SC AO 113-95 "Re:
Designation of Special Courts For Intellectual Property Rights" (issued
October 2, 1995); and EO 60 entitled "Creating The Inter-Agency
Committee On Intellectual Property Rights" (issued February 26, 1993).

Part I, Section 3 - International Conventions and Reciprocity


The Philippines is a party to the following international treaties:
1. Berne Convention For The Protection of Literary and Artistic Works as
revised in Brussels (Brussels Act) that was ratified by the Philippine Senate
on 26 June 1948. The instrument of Accession was signed by the President
on 26 June 1950. It entered into force for the Philippines on 01 August 1951;
2. International Convention for the Protection of Performers, Producers of
Phonograms and Broadcasting Organizations (Rome Convention). The
Philippine instrument of accession was signed by the President on 24 May
1984 and was deposited with the Secretary General of the United Nations on
25 June 1984. The Convention entered into force for the Philippines on 25
September 1984;
3. Paris Convention for the Protection of Industrial Property Rights (Paris
Convention). The convention was ratified by the Philippine Senate on 10
May 1965. The Philippine instrument of ratification was deposited on 11
August 1965. The agreement entered into force with respect to the
Philippines on 27 September 1965;
4. Convention Establishing the World Intellectual Property Organization. The
convention entered into force for the Philippines on 14 July 1980;
5. Budapest Treaty on the International Recognition of the Deposit of
Microorganisms for the Purposes of Patent Procedure. The treaty entered
into force for the Philippines on 21 October 1981;
6. Agreement on Trade Related Aspects of Intellectual Property, Including
Trade In Counterfeit Goods of the General Agreement on Tariffs and Trade
(TRIPS). The TRIPS Agreement was one of the Multilateral Agreements
annexed to the Agreement Establishing the World Trade Organization. It was
adopted on 15 April 1994 at Marrakesh, Morocco and ratified by the Senate
on 14 December 1994. The instrument of ratification was signed by
President Fidel V. Ramos on 16 December 1994; and
7. The Patent Cooperation Treaty. The Philippine Senate ratified the Patent
Cooperation Treaty (PCT) on 05 February 2001. It entered into force on 17
August 2001. The IPO issued the Philippine Rules on PCT Applications (22
October 2001), as amended by Office Order No. 13, Series of 2002, (14
February 2002).
Republic of the Philippines
CONGRESS OF THE PHILIPPINES
Metro Manila

Fourteenth Congress
First Regular Session

Begun and held in Metro Manila, on Monday, the twentythird day of


July, two thousand seven.

[ Republic Act No. 9502 ]

AN ACT PROVIDING FOR CHEAPER AND QUALITY MEDICINES, AMENDING FOR THE
PURPOSE REPUBLIC ACT NO. 8293 OR THE INTELLECTUAL PROPERTY CODE,
REPUBLIC ACT NO. 6675 OR THE GENERICS ACT OF 1988, AND REPUBLIC ACT NO. 5921
OR THE PHARMACY LAW, AND FOR OTHER PURPOSES

Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled:

CHAPTER 1
GENERAL PROVISIONS

SECT)ON . Short Title . This Act shall be known as the "Universally Accessible Cheaper and
Quality Medicines Act of ".

SECT)ON . Declaration of Policy . )t is the policy of the State to protect public health and, when
the public interest or circumstances of extreme urgency so require, it shall adopt appropriate
measures to promote and ensure access to affordable quality drugs and medicines for all.
Pursuant to the attainment of this general policy, an effective competition policy in the supply and
demand of quality affordable drugs and medicines is recognized by the State as a primary
instrument. )n the event that full competition is not effective, the State recognizes as a reserve
instrument the regulation of prices of drugs and medicines, with clear accountability by the
implementing authority as mandated in this Act, as one of the means to also promote and ensure
access to quality affordable medicines.

SECT)ON . Construction in Favor of Protection of Public Health . All doubts in the


implementation and interpretation of the provisions of this Act, including its implementing rules
and regulations, shall be resolved in favor of protecting public health.

SECT)ON . Definition of Terms . For purposes of this Act, the following terms are to mean as
follows:

a Compulsory License is a license issued by the Director General of the )ntellectual


Property Office to exploit a patented invention without the permission of the patent
holder, either by manufacture or through parallel importation;

1
b Drug outlet refers to drugstores, pharmacies, and any other business establishments
which sell drugs and medicines;
c Drugs and medicines refers to any chemical compound or biological substance, other
than food, intended for use in the treatment, prevention or diagnosis of disease in
humans or animals, including but not limited to:
any article recognized in the official United States PharmacopoeiaNational
Formulary USPNF , official (omeopathic Pharmacopoeia of the United States,
Philippine Pharmacopoeia, Philippine National Drug Formulary, British
Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, )ndian
Pharmacopoeia, any national compendium or any supplement to any of them;
any article intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease in humans or animals;
any article other than food intended to affect the structure or any function of the
human body or animals;
any article intended for use as a component of any articles specified in clauses
, , and not including devices or their components, parts, or accessories;
herbal and/or traditional drugs which are articles of plant or animal origin used
in folk medicine which are:
i recognized in the Philippine National Drug Formulary;
ii intended for use in the treatment or cure or mitigation of disease
symptoms, injury or body defects in humans;
iii other than food, intended to affect the structure or any function of the
human body;
iv in finished or readytouse dosage form; and
v intended for use as a component of any of the articles specified in clauses
i , ii , iii , and iv ;
d Essential drugs list or national drug formulary refers to a list of drugs prepared and
periodically updated by the Department of (ealth on the basis of health conditions
obtaining in the Philippines as well as on internationally accepted criteria;
e )mporter refers to any establishment that imports raw materials, active ingredients
and finished products
p for its own use or for distribution to other drugg establishments or
outlets;
f Manufacture includes any process or part of a process for making, altering, finishing,
packing, labeling, breaking or otherwise treating or adapting any drug with a view to its
sale and distribution, but does not include the compounding or dispensing of any drug
in the ordinary course of retail business;
g Manufacturer refers to any establishment engaged in the operations involved in the
production of a drug with the end view of storage, distribution, or sale of the product;
h Multisource pharmaceutical products refers to pharmaceutically equivalent or
pharmaceutically alternative products that may or may not be therapeutically equivalent.

2
Multisource pharmaceutical products that are therapeutically equivalent are inter-
changeable;
i Retailer refers to a licensed establishment carrying on the retail business of sale of
drugs and medicines to customers;
j Trader refers to any licensed establishment which is a registered owner of a drug
product that procures the materials and packaging components, and provides the
production monographs, quality control standards and procedures, but subcontracts the
manufacture of such products to a licensed manufacturer;
k TR)PS Agreement or Agreement on TradeRelated Aspects of )ntellectual Property
Rights refers to the international agreement administered by the WTO that sets down
minimum standards for many forms of intellectual property regulation; and
l Wholesaler refers to a licensed establishment or drug outlet who acts as merchant,
broker or agent, who sells or distributes for resale or wholesale drugs and medicines.

CHAPTER 2
AMENDMENTS TO REPUBLIC ACT NO. 8293, OTHERWISE KNOWN AS
THE INTELLECTUAL PROPERTY CODE OF THE PHILIPPINES

SECT)ON . Section of Republic Act No. , otherwise known as the )ntellectual Property
Code of the Philippines, is hereby amended to read as follows:

SEC. . Non-Patentable Inventions . The following shall be excluded from patent


protection:
. . Discoveries, scientific theories and mathematical methods, and in the case of
drugs and medicines, the mere discovery of a new form or new property of a known
substance which does not result in the enhancement of the known efficacy of that
substance, or the mere discovery of any new property or new use for a known
substance, or the mere use of a known process unless such known process results in a
new product that employs at least one new reactant. For the purpose of this clause,
salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures
of isomers, complexes, combinations, and other derivatives of a known substance shall
be considered to be the same substance, unless they differ significantly in properties
with regard to efficacy;
" . . x x x;
" . . x x x;
" . . x x x;
" . . x x x; and
" . . x x x."

SECT)ON . Section of Republic Act No. , otherwise known as the )ntellectual Property
Code of the Philippines, is hereby amended to read as follows:

SEC. . Inventive Step . . . An invention involves an inventive step if, having regard to

3
prior art, it is not obvious to a person skilled in the art at the time of the filing date or
priority date of the application claiming the invention. (n)
. . )n the case of drugs and medicines, there is no inventive step if the invention
results from the mere discovery of a new form or new property of a known substance
which does not result in the enhancement of the known efficacy of that substance, or the
mere discovery of any new property or new use for a known substance, or the mere use
of a known process unless such known process results in a new product that employs at
least one new reactant.

SECT)ON . Section of Republic Act No. , otherwise known as the )ntellectual Property
Code of the Philippines, is hereby amended to read as follows:

SEC. . Limitations of Patent Rights . The owner of a patent has no right to prevent third
parties from performing, without his authorization, the acts referred to in Section hereof
in the following circumstances:
. . Using a patented product which has been put on the market in the Philippines by
the owner of the product, or with his express consent, insofar as such use is performed
after that product has been so put on the said market: Provided , That, with regard to
drugs and medicines, the limitation on patent rights shall apply after a drug or medicine
has been introduced in the Philippines or anywhere else in the world by the patent
owner, or by any party authorized to use the invention: Provided, further , That the right
to import the drugs and medicines contemplated in this section shall be available to any
government agency or any private third party;
. . Where the act is done privately and on a noncommercial scale or for a non
commercial purpose: Provided , That it does not significantly prejudice the economic
interests of the owner of the patent;
. . Where the act consists of making or using exclusively for experimental use of the
invention for scientific purposes or educational purposes and such other activities
directly related to such scientific or educational experimental use;

. . )n the case of drugs and medicines, where the act includes testing, using, making
or selling the invention including any data related thereto, solely for purposes
reasonably related to the development and submission of information and issuance of
approvals by government regulatory agencies required under any law of the Philippines
or of another country that regulates the manufacture, construction, use or sale of any
product: Provided , That, in order to protect the data submitted by the original patent
holder from unfair commercial use provided in Article . of the Agreement on Trade
Related Aspects of )ntellectual Property Rights TR)PS Agreement , the )ntellectual
Property Office, in consultation with the appropriate government agencies, shall issue
the appropriate rules and regulations necessary therein not later than one hundred
twenty days after the enactment of this law;
. . Where the act consists of the preparation for individual cases, in a pharmacy or
by a medical professional, of a medicine in accordance with a medical prescription or
acts concerning the medicine so prepared; and
4
. . Where the invention is used in any ship, vessel, aircraft, or land vehicle of any
other country entering the territory of the Philippines temporarily or accidentally:
Provided , That such invention is used exclusively for the needs of the ship, vessel,
aircraft, or land vehicle and not used for the manufacturing of anything to be sold within
the Philippines. Secs. and , R.A. No. a

SECT)ON . Section of Republic Act No. , otherwise known as the )ntellectual Property
Code of the Philippines, is hereby amended to read as follows:

SEC. . Use of Invention by Government . . . A Government agency or third person


authorized by the Government may exploit the invention even without agreement of the
patent owner where:
" a The public interest, in particular, national security, nutrition, health or the development
of other sectors, as determined by the appropriate agency of the government, so
requires; or
" b A judicial or administrative body has determined that the manner of exploitation, by the
owner of the patent or his licensee, is anticompetitive; or
" c )n the case of drugs and medicines, there is a national emergency or other circumstance
of extreme urgency requiring the use of the invention; or
" d )n the case of drugs and medicines, there is public noncommercial use of the patent by
the patentee, without satisfactory reason; or
" e )n the case of drugs and medicines, the demand for the patented article in the
Philippines is not being met to an adequate extent and on reasonable terms, as
determined by the Secretary of the Department of (ealth.

. . Unless otherwise provided herein, the use by the Government, or third person
authorized by the Government shall be subject, where applicable, to the following
provisions:
" a )n situations of national emergency or other circumstances of extreme urgency as
provided under Section . c , the right holder shall be notified as soon as
reasonably practicable;
" b )n the case of public noncommercial
non commercial use of the patent by the patentee, without
satisfactory reason, as provided under Section . d , the right holder shall be
informed promptly: Provided , That, the Government or third person authorized by
the Government, without making a patent search, knows or has demonstrable
ground to know that a valid patent is or will be used by or for the Government;
" c )f the demand for the patented article in the Philippines is not being met to an
adequate extent and on reasonable terms as provided under Section . e , the
right holder shall be informed promptly;
" d The scope and duration of such use shall be limited to the purpose for which it was
authorized;
" e Such use shall be nonexclusive;
5
"f The right holder shall be paid adequate remuneration in the circumstances of each
case, taking into account the economic value of the authorization; and
" g The existence of a national emergency or other circumstances of extreme urgency,
referred to under Section . c , shall be subject to the determination of the
President of the Philippines for the purpose of determining the need for such use
or other exploitation, which shall be immediately executory.

. . All cases arising from the implementation of this provision shall be cognizable by
courts with appropriate jurisdiction provided by law. No court, except the Supreme
Court of the Philippines, shall issue any temporary restraining order or preliminary
injunction or such other provisional remedies that will prevent its immediate execution.
. . The )ntellectual Property Office )PO , in consultation with the appropriate
government agencies, shall issue the appropriate implementing rules and regulations
for the use or exploitation of patented inventions as contemplated in this section within
one hundred twenty days after the effectivity of this law.

SECT)ON . Section . of Republic Act No. , otherwise known as the )ntellectual Property
Code of the Philippines, is hereby amended to read as follows:

SEC. . Civil Action for Infringement . . . The making, using, offering for sale, selling, or
importing a patented product or a product obtained directly or indirectly from a patented
process, or the use of a patented process without the authorization of the patentee
constitutes patent infringement: Provided , That, this shall not apply to instances covered by
Sections . and . Limitations of Patent Rights ; Section Use of )nvention by
Government ; Section . Compulsory Licensing ; and Section A Procedures on
)ssuance of a Special Compulsory License under the TR)PS Agreement of this Code.
" . . x x x;
" . . x x x;
" . . x x x;
" . . x x x; and
" . . x x x."

SECT)ON . Section of Republic Act No. , otherwise known as the )ntellectual Property
Code of the Philippines, is hereby amended to read as follows:

SEC. . Grounds for Compulsory Licensing. The Director General of the )ntellectual
Property Office may grant a license to exploit a patented invention, even without the
agreement of the patent owner, in favor of any person who has shown his capability to
exploit the invention, under any of the following circumstances:
. . National emergency or other circumstances of extreme urgency;
. . Where the public interest, in particular, national security, nutrition, health or the
development of other vital sectors of the national economy as determined by the
appropriate agency of the Government, so requires; or
. . Where a judicial or administrative body has determined that the manner of
exploitation by the owner of the patent or his licensee is anticompetitive; or
6
. . )n case of public noncommercial use of the patent by the patentee, without
satisfactory reason;
. . )f the patented invention is not being worked in the Philippines on a commercial
scale, although capable of being worked, without satisfactory reason: Provided , That the
importation of the patented article shall constitute working or using the patent; Secs.
, A, B, R.A. No. a and
. . Where the demand for patented drugs and medicines is not being met to an
adequate extent and on reasonable terms, as determined by the Secretary of the
Department of (ealth.

SECT)ON . A new Section A is hereby inserted after Section of Republic Act No. ,
otherwise known as the )ntellectual Property Code of the Philippines, to read as follows:

SEC. A.
A. Procedures on Issuance of a Special Compulsory License under the TRIPS
Agreement. A. . The Director General of the )ntellectual Property Office, upon the
written recommendation of the Secretary of the Department of (ealth, shall, upon filing of a
petition, grant a special compulsory license for the importation of patented drugs and
medicines.
The special compulsory license for the importation contemplated under this provision shall
be an additional special alternative procedure to ensure access to quality affordable
medicines and shall be primarily for domestic consumption: Provided , That adequate
remuneration shall be paid to the patent owner either by the exporting or importing country.
The compulsory license shall also contain a provision directing the grantee the license to
exercise reasonable measures to prevent the reexportation of the products imported under
this provision.
The grant of a special compulsory license under this provision shall be an exception to
Sections . and . of Republic Act No. and shall be immediately executory. No
court, except the Supreme Court of the Philippines, shall issue any temporary restraining
order or preliminary injunction or such other provisional remedies that will prevent the
grant of the special compulsory license.
A. . A compulsory license shall also be available for the manufacture and export of
drugs and medicines to any country having insufficient or no manufacturing capacity in
the pharmaceutical sector to address public health problems: Provided , That, a
compulsory
l li
license has
h been
b granted
d by
b such h country or such h country has,
h by
b
notification or otherwise, allowed importation into its jurisdiction of the patented drugs
and medicines from the Philippines in compliance with the TR)PS Agreement.
A. . The right to grant a special compulsory license under this section shall not limit
or prejudice the rights, obligations and flexibilities provided under the TR)PS
Agreement and under Philippine laws, particularly Section . and Section of the
)ntellectual Property Code, as amended under this Act. )t is also without prejudice to the
extent to which drugs and medicines produced under a compulsory license can be
exported as allowed in the TR)PS Agreement and applicable laws.

7
SECT)ON . Section of Republic Act No. , otherwise known as the )ntellectual Property
Code of the Philippines, is hereby amended to read as follows:

SEC. . Period for Filing a Petition for a Compulsory License. . . A compulsory license
may not be applied for on the ground stated in Subsection . before the expiration of a
period of four years from the date of filing of the application or three years from the
date of the patent whichever period expires last.
. . A compulsory license which is applied for on any of the grounds stated in
Subsections . , . , . , and . and Section may be applied for at any time
after the grant of the patent. Sec. , R. A. No.

SECT)ON . Section of Republic Act No. , otherwise known as the )ntellectual Property
Code of the Philippines, is hereby amended to read as follows:

SEC. . Requirement
q to Obtain a License on Reasonable Commercial Terms. . . The
license will only be granted after the petitioner has made efforts to obtain authorization from
the patent owner on reasonable commercial terms and conditions but such efforts have not
been successful within a reasonable period of time.
. . The requirement under Subsection . shall not apply in any of the following
cases:
" a Where the petition for compulsory license seeks to remedy a practice determined
after judicial or administrative process to be anticompetitive;
" b )n situations of national emergency or other circumstances of extreme urgency;
" c )n cases of public noncommercial use; and
" d )n cases where the demand for the patented drugs and medicines in the Philippines
is not being met to an adequate extent and on reasonable terms, as determined by
the Secretary of the Department of (ealth.
. . )n situations of national emergency or other circumstances of extreme urgency,
the right holder shall be notified as soon as reasonably practicable.
. . )n the case of public noncommercial use, where the government or contractor,
without making a patent search, knows or has demonstrable grounds to know that a
valid patent is or will be used by or for the government, the right holder shall be
informed promptly. n
. . Where the demand for the patented drugs and medicines in the Philippines is not
being met to an adequate extent and on reasonable terms, as determined by the
Secretary of the Department of (ealth, the right holder shall be informed promptly.

SECT)ON . Section of Republic Act No. , otherwise known as the )ntellectual Property
Code of the Philippines, is hereby amended to read as follows:

SEC. . Rights Conferred. . . Except in cases of importation of drugs and medicines


allowed under Section . of this Act and of offpatent drugs and medicines, the owner of a
registered mark shall have the exclusive right to prevent all third parties not having the
owners consent from using in the course of trade identical or similar signs or containers for

8
goods or services which are identical or similar to those in respect of which the trademark is
registered where such use would result in a likelihood of confusion. )n case of the use of an
identical sign for identical goods or services, a likelihood of confusion shall be presumed.
There shall be no infringement of trademarks or trade names of imported or sold patented
drugs and medicines allowed under Section . of this Act, as well as imported or sold off
patent drugs and medicines: Provided , That, said drugs and medicines bear the registered
marks that have not been tampered, unlawfully modified, or infringed upon, under Section
of this Code.
" . . x x x."

SECT)ON . Section of Republic Act No. , otherwise known as the )ntellectual Property
Code of the Philippines, is hereby amended to read as follows:

SEC. . Limitations to Actions for Infringement . Notwithstanding any other provision of


this Act,, the remedies given
g g infringed
to the owner of a right g under this Act shall be limited as
follows:
" . . x x x;
" . . x x x;
" . . x x x and
" . There shall be no infringement of trademarks or tradenames of imported or sold
drugs and medicines allowed under Section . of this Act, as well as imported or sold
offpatent drugs and medicines: Provided , That said drugs and medicines bear the
registered marks that have not been tampered, unlawfully modified, or infringed upon
as defined under Section of this Code.

SECT)ON . Implementing Rules and Regulations on Amendments to Republic Act No. 8293,
otherwise known as the Intellectual Property Code of the Philippines . Unless otherwise provided
herein, the )ntellectual Property Office, in coordination with the Department of (ealth and the
Bureau of Food and Drugs, shall issue and promulgate, within one hundred twenty days
after the enactment of this Act, the implementing rules and regulations to effectively implement
the provisions of this Act that relate to Republic Act No. , otherwise known as the )ntellectual
Property Code of the Philippines.

CHAPTER 3
DRUGS AND MEDICINES PRICE REGULATION

SECT)ON . Drugs and Medicines Price Regulation Authority of the President of the Philippines .
The President of the Philippines, upon recommendation of the Secretary of the Department of
(ealth, shall have the power to impose maximum retail prices over any or all drugs and medicines
as enumerated in Section . The power to impose maximum retail prices over drugs and
medicines shall be exercised within such period of time as the situation may warrant as
determined by the President of the Philippines. No court, except the Supreme Court of the
Philippines, shall issue any temporary restraining order or preliminary injunction or preliminary
mandatory injunction that will prevent the immediate execution of the exercise of this power of
the President of the Philippines.

9
SECT)ON . Drugs and Medicines Price Monitoring and Regulation Authority of the Secretary of the
Department of Health . To implement the policies of this Act under this Chapter, the Secretary of
the Department of (ealth is hereby authorized to establish and initiate a price monitoring and
regulation system for drugs and medicines within one hundred twenty days after the
enactment of this Act. The Secretary of the Department of (ealth may also create such bodies,
consultative councils, from which advice may be sought in the implementation of a drug or
medicine price monitoring and regulation policy. Such bodies or consultative councils created by
the Secretary of the Department of (ealth shall coordinate its efforts together with other
government agencies.

SECT)ON . Functions and Responsibilities of the Secretary of the Department of Health .


Pursuant to Section of this Act, the Secretary of the Department of (ealth shall have the
following powers:

A Power to Recommend the Maximum Retail Price of Drugs and Medicines Subject to
Price Regulation Upon application or motu proprio when the public interest so
requires, the Secretary of the Department of (ealth shall have the power to determine
the maximum retail prices of drugs and medicines which shall be recommended to the
President of the Philippines for approval. )n order that affordable prices of drugs and
medicines from the different manufacturers, importers, traders, distributors,
wholesalers, or retailers shall be made available to the public, the Secretary of the
Department of (ealth, as he/she may deem fit and after a proper determination, shall
have such approved maximum retail prices of drugs and medicines published; )n
recommending the maximum retail price, the Secretary of the Department of (ealth
shall consider the following factors:

a Retail prices of drugs and medicines that are subject to regulation in the
Philippines and in other countries;
b The supply available in the market;
c The cost to the manufacturer, importer, trader, distributor, wholesaler or
retailer of the following, but not limited to:
i The exchange rate of the peso to the foreign currency with which the drug or any of
its component, ingredient or raw material was paid for;
ii Any change in the amortization cost of machinery brought about by any change in
th exchange
the h t off the
rate th peso tot the
th foreign
f i currency with ith which
hi h the
th machinery
hi
was bought through credit facilities;
iii Any change in the cost of labor brought about by a change in minimum wage; or
iv Any change in the cost of transporting or distributing the medicines to the area of
destination;
d Such other factors or conditions which will aid in arriving at a just and
reasonable maximum price; and
No retailer shall sell drugs and medicines at a retail price exceeding the maximum
retail price approved by the President of the Philippines as provided in Section of

10
Act: Provided , That, the Secretary of the Department of (ealth shall immediately
undertake a study on the prevailing prices of drugs and medicines subject to price
regulation and provide an initial list of drugs and medicines, which maximum retail
prices he/she shall recommend to the President of the Philippines.
B Power to )nclude Other Drugs and Medicines in the List Subject to Price Regulation
Upon application or motu proprio when the public interest so requires and after proper
determination, the Secretary of the Department of (ealth may order the inclusion of
drugs and medicines to the list subject of price regulation under Section hereof.
C Power to )mplement CostContainment and Other Measures The Secretary of the
Department of (ealth shall have the power to implement the fair price of drugs and
medicines for purposes of public health insurance and government procurement based
on the order of the President of the Philippines imposing maximum retail prices; and
The Secretary of the Department of (ealth shall have the power to implement any other
measures that the government may avail of to effectively reduce the cost of drugs and
medicines that shall include, but not limited to, competitive bidding, price volume
negotiations, and other appropriate mechanisms that influence supply, demand and
expenditures on drugs and medicines.

D Power to )mpose Administrative Fines and Penalties After due notice and hearing, the
Secretary of the Department of (ealth shall have the power to impose administrative
fines against any person, manufacturer, importer, trader, distributor, wholesaler,
retailer, or any other entity, in such amount as it may deem reasonable, which in no case
shall be less than Fifty thousand pesos Php , . nor more than Five million pesos
Php , , . for violations of the maximum retail price approved by the President
of the Philippines pursuant to the provisions of this Chapter.
E Power to Deputize Government Entities The Secretary of the Department of (ealth
shall have the power to call upon and deputize any official, agent, employee, agency, or
instrumentality of the national and local government for any assistance that it may
deem necessary to carry out the purposes of this Chapter.
F Other Powers Necessary to )mplement Provisions of this Chapter The Secretary of the
Department of (ealth shall exercise such powers and functions as may be necessary to
implement and enforce the provisions of this Chapter of this Act, including the power to
require the production and submission of records, documents, books of account, bills of
lading, input documents, records of purchase and sale, financial statements, and such
other documents, information and papers as may be necessary to enable the Secretary
of the Department of (ealth to carry out its functions, duties, and responsibilities.
Accordingly, within thirty days from the effectivity of this Act and every December
st of every year thereafter, every manufacturer, importer, trader, distributor,
wholesaler, and retailer of a drug and medicine whether included in or excluded from
the list of drugs and medicines that are subject to price regulation shall furnish the
Secretary of the Department of (ealth a list, containing on the minimum the
corresponding prices and inventory, of all drugs and medicines it manufactures,
imports, trades, distributes, wholesales, or retails, data pertaining to the factors enume

11
rated under Section A , and any and all necessary information that the Secretary
of the Department of (ealth may require.

SECT)ON . Procedures for Inquiries, Studies, Hearings, Investigations, and Proceedings . All
inquiries, studies, hearings, investigations and proceedings conducted by the Secretary of the
Department of (ealth shall be governed by the rules adopted by him/her, and in the conduct
thereof shall not be bound by the technical rules of evidence.

SECT)ON . Effectivity of the Decisions or Orders of the Secretary of the Department of Health . All
decisions or orders of the Secretary of the Department of (ealth pursuant to Section
Paragraphs A Power to Recommend the Maximum Retail Price of Drugs and Medicines Subject
to Price Regulation, B Power to )nclude Other Drugs and Medicines in the List Subject to Price
Regulation, C Power to )mplement CostContainment and Other Measures, D Power to )mpose
Administrative Fines and Penalties, E Power to Deputize Government Entities, or F Other
Powers Necessaryy to )mplement
p p , shall be immediatelyy operative.
Provisions of this Chapter, p

SECT)ON . Review of the Decisions or Orders of the Secretary of the Department of Health . A
party adversely affected by a decision, order or ruling of the Secretary of the Department of
(ealth may, within thirty days from notice of such decision, order or ruling, or in case of a
denial of a motion for reconsideration thereof, within fifteen days after notice of such denial,
file an appeal with the Court of Appeals, which shall have jurisdiction to review such decision,
order or ruling. The filing of a petition for a writ of certiorari or other special remedies in the
Supreme Court shall in no case supersede or stay any decision, order or ruling of the Secretary of
the Department of (ealth, unless the Supreme Court shall so direct, and the petitioner may be
required by the Supreme Court to give bond in such form and of such amount as may be deemed
proper.

SECT)ON . List of Drugs and Medicines that are Subject to Price Regulation . The list of drugs
and medicines that are subject to price regulation shall include, inter alia :

a All drugs and medicines indicated for treatment of chronic illnesses and life threatening
conditions, such as, but not limited to, endocrine disorders, e.g., diabetes mellitus;
gastrointestinal disorders, e.g., peptic ulcer; urologic disorders, e.g., benign prostatic
hyperplasia BP( ; cardiovascular diseases, e.g., hypertension; pulmonary diseases, e.g.,
pulmonary tuberculosis PTB , asthma; autoimmune diseases, diseases e.g.,
e g systemic lupus
erythematosus SLE ; skin diseases, e.g., psoriasis; neuropsychiatric disorders; other
infectious diseases, e.g., human immunodeficiency virusacquired immune deficiency
syndrome ()VA)DS ; and other conditions such as organ transplants and neoplasm;
b Drugs and medicines indicated for prevention of diseases, e.g., vaccines,
immunoglobulin, antisera;
c Drugs and medicines indicated for prevention of pregnancy, e.g., oral contraceptives;
d Anesthetic agents;
e )ntravenous fluids;
f Drugs and medicines that are included in the Philippine National Drug Formulary
PNDF Essential Drug List; and

12
g All other drugs and medicines which, from time to time, the Secretary of the Department
of (ealth determines to be in need of price regulation.

SECT)ON . Illegal Acts of Price Manipulation . Without prejudice to the provisions of existing
laws on goods not covered by this Act, it shall be unlawful for any manufacturer, importer, trader,
distributor, wholesaler, retailer, or any person engaged in any method of disposition of drugs and
medicines to engage in acts of price manipulation such as hoarding, profiteering, or illegal
combination or forming cartel, as defined under Section of Republic Act No. , otherwise
known as the Price Act, and all other acts committed in restraint of trade.

SECT)ON . Penalty for Illegal Acts of Price Manipulation . Any person or entity who commits
any act of illegal price manipulation of any drug and medicine subject to price regulation shall
suffer the penalty of imprisonment for a period of not less than five years nor more than
fifteen years or shall be imposed a fine of not less than One hundred thousand pesos
Php , . nor more than Ten million pesos Php , , . , at the discretion of the
court. The court may also order the suspension or revocation of its license to operate LTO ,
professional or business license. Whenever any act of illegal price manipulation of any drug and
medicine subject to price regulation is committed by a juridical person, its officials or employees,
or in case of a foreign corporation or association, its agent or representative in the Philippines
who are responsible for the violation, shall be held liable therefore.

SECT)ON . Display of Maximum Retail Price Fixed and Approved by Order of the President of the
Philippines for Drugs and Medicines Subject to Price Regulation .

a Within a reasonable period as may be determined by the Secretary of the Department of


(ealth, and: Provided , That it conforms to existing drug product labeling requirements,
every manufacturer, importer, distributor, wholesaler, trader, or retailer of a drug and
medicine intended for sale shall display the retail price which shall not exceed the
maximum retail price approved by order of the President of the Philippines. The
maximum retail price shall be printed on the label of the immediate container of the
drug and medicine and the minimum pack thereof offered for retail sale with the words
RETA)L PR)CE NOT TO EXCEED preceding it, and UNDER DRUG PR)CE REGULAT)ON
on a red strip.

b Within a period as may be determined by the Secretary of the Department of (ealth


from time to time, every manufacturer, importer, or trader shall issue a price list to
wholesalers, distributors, retailers and to the Secretary of the Department of (ealth,
indicating the retail price, the maximum retail price, and such other information as may
be required by the Secretary of the Department of (ealth.

SECT)ON . Reports from Local Government Units (LGUs) and the Department of Trade and
Industry (DTI) . All local government units and the Department of Trade and )ndustry shall help
ensure the implementation of pricing policies provided under this Chapter by submitting
quarterly price monitoring reports to the Secretary of the Department of (ealth of drugs and
medicines identified by the latter, and any and all necessary information that the Secretary of the
Department of (ealth may require.
13
SECT)ON . Role of the Department of Health (DOH) and the Department of Trade and Industry
(DTI) . The Department of (ealth and the Department of Trade and )ndustry shall conduct
independent periodic surveys and studies of the selling prices of all drugs and medicines referred
to in Section of this Act all over the country as well as their share or effect on the family income
of the different economic groups in the country for purposes of serving as data base for
government efforts to promote access to more affordable medicines, as well as evaluating the
effectivity of the measures undertaken to promote access to more affordable medicines. The DT)
shall always officially provide the Secretary of the Department of (ealth copies of these
independent reports.

SECT)ON . Rules and Regulations . The Secretary of the Department of (ealth, in consultation
with the Department of Trade and )ndustry, the Congressional Oversight Committee and other
appropriate government agencies, shall, within one hundred twenty days from the
effectivity of this Act, promulgate the rules and regulations necessary to effectively implement the
provisions of this Chapter.

SECT)ON . Reportorial and Public Notice Requirements .


a The Secretary of the Department of (ealth shall submit a biannual Monitoring Report
of its performance on the implementation of this Act to the Office of the President. This
report submitted to the Office of the President shall be published in a newspaper of
general circulation within thirty days upon submission.
b )t shall also submit annually a report of its performance on the implementation of this
Act to both (ouses of Congress, within fifteen days from the opening of the regular
session. )t shall also regularly report and comply immediately to any order of the
Congressional Oversight Committee.
c The order of the President of the Philippines imposing maximum retail prices on drugs
and medicines, including the conditions implementing it, shall be published within
fifteen days from issuance in at least two newspapers of general circulation. All
wholesalers, manufacturers, distributors, importers, or traders shall have a copy of the
order of the President of the Philippines and provide the same to their clients and
customers for every transaction.
d All drug outlets are required to post in a conspicuous area within its premises a clear
copy of the order of the President of the Philippines which shall be easily accessible to
the consuming public and updated regularly as the situation may warrant.

CHAPTER 4
STRENGTHENING OF THE BUREAU OF FOOD AND DRUGS

SECT)ON . Strengthening of the Bureau of Food and Drugs (BFAD) .

a For a more effective and expeditious implementation of this Act, the Director or head of
the Bureau of Food and Drugs shall be authorized to retain, without need of a separate
approval from any government agency, and subject only to existing accounting and
auditing rules and regulations, all the fees, fines, royalties and other charges, collected

14
by the Bureau of Food and Drugs under this Act and other laws that it is mandated to
administer based on the immediately prior year of operations, for use in its operations,
like upgrading of its facilities, equipment outlay, human resource development and
expansion, and the acquisition of the appropriate office space, among others, to improve
the delivery of its services to the public. This amount, which shall be in addition to the
annual budget of the Bureau of Food and Drugs, shall be deposited and maintained in a
separate account or fund, which may be used or disbursed directly by the Director or
head.

b After five years from the coming into force of this Act, the Director or head of the
Bureau of Food and Drugs shall, subject to the approval of the Secretary of the
Department of (ealth, determine if the fees and charges, mentioned in Subsection a
hereof, are sufficient to meet its budgetary requirements. )f so, it shall retain all the fees
and charges it shall collect under the same conditions indicated in said Subsection a
but shall forthwith, cease to receive any funds from the annual budget of the National
G
Government; if not, the
h provisions
i i off Subsection
S b i a shall
h ll continue
i to applyl untilil such
h
time when the Director or head of the Bureau of Food and Drugs, subject to the approval
of the Secretary of the Department of (ealth, certifies that the above stated fees and
charges the Bureau of Food and Drugs shall collect are enough to fund its operations.

c The Bureau of Food and Drugs shall submit a yearly performance report to the Quality
Affordable Medicines Oversight Committee, as provided in Section of this Act. The
report shall itemize the use of such retained funds in the past year up to the present and
the budgeted use of the same in the succeeding periods.

SECT)ON . Quality Assurance of Drugs . The Bureau of Food and Drugs shall take the necessary
steps to ensure that all drugs authorized for marketing in the country shall conform to
international standards for the content, purity and quality of pharmaceutical products as
established in the )nternational Pharmacopoeia: Provided, That imported products in finished
dosage forms, should be certified under the World (ealth Organization W(O certification
scheme on the quality of pharmaceutical products moving in international commerce: Provided,
further, That the registration for multisource pharmaceutical products should conform to the
W(O guidelines on registration requirements to establish interchangeability.

CHAPTER 5
NON
NON-DISCRIMINATORY
DISCRIMINATORY CLAUSE

SECT)ON . Non-Discriminatory Clause . )t shall be unlawful for any retail drug outlet to refuse
to carry either by sale or by consignment, or offer for sale drugs and medicines brought into the
country, as allowed under Section of this Act which amends Section . of the )ntellectual
Property Code of the Philippines or Republic Act No. , by the government or authorized third
party which have been previously approved for distribution or sale by the Bureau of Food and
Drugs. For this purpose, the said products shall be displayed with equal prominence as all other
products sold in the establishment.

SECT)ON . Refusal to Sell Drugs and Medicines . No manufacturer, importer, trader, distributor,

15
wholesaler shall withhold from sale or refuse to sell to a wholesaler or retailer any drug or
medicine without good and sufficient reasons.

SECT)ON . Penalties. Any person or entity who shall refuse to carry or sell drugs and
medicines pursuant to the provisions of this Chapter shall be punished with a fine of not less than
One hundred thousand pesos Php , . but not more than Five hundred thousand pesos
Php , . , at the discretion of the court. For the succeeding offense, the penalties shall not
be less than Five hundred thousand pesos Php , . but not more than One million pesos
Php , , . , at the discretion of the court, and suspension or revocation of its license to
operate LTO , business or professional license, as the case may be.

SECT)ON . Implementing Rules and Regulations on the Non-Discriminatory Clause. Within one
hundred twenty days from the effectivity of this Act, the Department of (ealth, in
consultation with the Department of Trade and )ndustry, shall promulgate the rules and
regulations necessary to effectively implement the provisions of this Chapter.

CHAPTER 6
AMENDMENTS TO REPUBLIC ACT NO. 6675, OTHERWISE
KNOWN AS THE GENERICS ACT OF 1989

SECT)ON . Section of Republic Act No. , otherwise known as the Generics Act of , is
hereby amended to read as follows:

SEC. . Posting and Publication . The Department of (ealth shall publish annually in
acceptable means of public dissemination in at least two newspapers of general
circulation in the Philippines the generic names, and the corresponding brand names under
which they are marketed, of all drugs and medicines available in the Philippines.

SECT)ON . Section of Republic Act No. , otherwise known as the Generics Act of , is
hereby amended to read as follows:

SEC. . Who Shall Use Generic Terminology .


a All government health agencies and their personnel as well as other government
agencies shall use generic terminology or generic names in all transactions related to
p g, prescribing,
purchasing, p g, dispensing
p g and administeringg of drugs
g and medicines.
b All medical, dental and veterinary practitioners, including private practitioners, shall
write prescriptions using the generic name. The brand name may be included if so
desired.
c Any organization or company involved in the manufacture, importation, repacking,
marketing and/or distribution of drugs and medicines shall indicate prominently the
generic name of the product. )n the case of brand name products, the generic name shall
appear prominently and immediately above the brand name in all product labels as well
as in advertising and other promotional materials.
d Drug outlets, including drugstores, hospital and nonhospital pharmacies and non

16
traditional outlets such as supermarkets and stores, shall inform any buyer about any
and all other drug products having the same generic name, together with their
corresponding prices so that the buyer may adequately exercise his option. Within one
year after the approval of this Act, the drug outlets referred to herein shall post in
conspicuous places in their establishments a list of drug products with the same generic
name and their corresponding prices.
e There shall appear prominently on the label of a generic drug the following statement:
T()S PRODUCT (AS T(E SAME T(ERAPEUT)C EFF)CACY AS ANY OT(ER GENER)C
PRODUCT OF T(E SAME NAME. S)GNED: BFAD.

SECT)ON . Section of Republic Act No. , otherwise known as the Generics Act of , is
hereby amended to read as follows:

SEC. . Required Production . Subject to the rules and regulations promulgated by the
Secretary of (ealth,
(ealth every drug manufacturing company operating in the Philippines shall be
required to produce, distribute and make widely available to the general public an
unbranded generic counterpart of their branded product.

SECT)ON . Section of Republic Act No. , otherwise known as the Generics Act of , is
hereby amended to read as follows:

SEC. . Education Drive. The Department of (ealth jointly with the Philippine
)nformation Agency and the Department of the )nterior and Local Government shall conduct
a continuous information campaign for the public and a continuing education and training
for the medical and allied medical professions on drugs with generic names as an alternative
of equal efficacy to the more expensive brand name drugs. Such educational campaign shall
include information on the illnesses or symptoms which each generically named drug is
supposed to cure or alleviate, as well as in contraindications. The Department of (ealth with
the assistance of the Department of the )nterior and Local Government and the Philippine
)nformation Agency shall monitor the progress of the education drive, and shall submit
regular reports to Congress.

SECT)ON . Section of Republic Act No. , otherwise known as the Generics Act of , is
hereby
y amended to read as follows:

SEC. . Penalty . A Any person who shall violate Section a or b of this Act shall
suffer the penalty graduated hereunder, viz :
a for the first conviction, he shall suffer the penalty of reprimand which shall be officially
recorded in the appropriate books of the Professional Regulation Commission.
b for the second conviction, the penalty of fine in the amount of not less than Ten
thousand pesos Php , . but not exceeding Twentyfive thousand pesos
Php , . , at the discretion of the court.
c for the third conviction, the penalty of fine in the amount of not less than Twentyfive
thousand pesos Php , . but not exceeding Fifty thousand pesos Php , .
17
and suspension of his license to practice his profession for sixty days at the
discretion of the court.
d for the fourth and subsequent convictions, the penalty of fine of not less than One
hundred thousand pesos Php , . and suspension of his license to practice his
profession for one year or longer at the discretion of the court.
B Any juridical person who violates Sections c , d , or shall suffer the penalty of a
fine of not less than One hundred thousand pesos Php , . and suspension or
revocation of license to operate such drug establishment or drug outlet at the discretion of
the court: Provided , That its officers directly responsible for the violation shall suffer the
penalty of fine of at least Forty thousand pesos Php , . and suspension or revocation
of license to practice profession, if applicable, and by imprisonment of not less than six
months nor more than one year or both fine and imprisonment at the discretion of the
court: and, Provided, further , That if the guilty party is an alien, he shall be ipso facto
deported after service of sentence without need of further proceedings.

C The Secretary of (ealth shall have the authority to impose administrative sanctions such
as suspension or cancellation of license to operate or recommend suspension of license to
practice profession to the Professional Regulation Commission as the case may be for the
violation of this Act.
The administrative sanctions that shall be imposed by the Secretary of the Department of
(ealth shall be in a graduated manner in accordance with Section .A.
An administrative case may be instituted independently from the criminal case: Provided
That, the dismissal of the criminal case or the withdrawal of the same shall in no instance be
a ground for the dismissal of the administrative case.

SEC. . Implementing Rules and Regulations to the Amendments to the Generics Act of 1988 .
The Department of (ealth, in consultation with the appropriate government agencies, shall,
within one hundred twenty days from the effectivity of this Act, promulgate the rules
and regulations necessary to effectively implement the provisions of this Act that relate to
Republic Act No. , or the Generics Act of .

CHAPTER 7
AMENDMENTS TO REPUBLIC ACT NO. 5921,, AS AMENDED,,
OTHERWISE KNOWN AS THE PHARMACY LAW

SECT)ON . Section of Republic Act No. , as amended, otherwise known as the Pharmacy
Law, is hereby amended to read as follows:

SEC. . Sale of medicine, pharmaceuticals, drugs and devices. No medicine,


pharmaceutical, or drug, except for those which are nonprescription or overthecounter, of
whatever nature and kind or device shall be compounded, dispensed, sold or resold, or
otherwise be made available to the consuming public except through a prescription
drugstore or hospital pharmacy, duly established in accordance with the provisions of this
Act. Nonprescription or overthecounter drugs may be sold in their original packages,

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bottles, containers or in small quantities, not in their original containers to the consuming
public through supermarkets, convenience stores and other retail establishments.
Pharmaceutical, drug or biological manufacturing establishments, importers and
wholesalers of drugs, medicines, or biologic products, shall not sell their products for resale
except only to retail drug outlets, hospital pharmacies or to other drug wholesalers under the
supervision of a registered pharmacist, and supermarkets, convenience stores, other retail
establishments for overthecounter drugs, duly licensed by the Bureau of Food and Drugs.

SECT)ON . Implementing Rules and Regulations to the Amendments to the Pharmacy Law . The
Department of (ealth, in consultation with the appropriate government agencies, within one
hundred twenty days from the effectivity of this Act, shall promulgate the rules and
regulations necessary to effectively implement the provisions of this Chapter.

CHAPTER 8
MISCELLANEOUS PROVISIONS

SECT)ON . Congressional Oversight Committee. For the effective implementation of this Act,
there shall be created a Congressional Oversight Committee, hereinafter referred to as the Quality
Affordable Medicines Oversight Committee, to be composed of five members from the Senate,
which shall include the Chairpersons of the Senate Committees on Trade and Commerce and
(ealth and Demography, and, five members from the (ouse of Representatives, which shall
include the Chairpersons of the (ouse of Representatives Committees on Trade and )ndustry and
(ealth. The Quality Affordable Medicines Oversight Committee shall be jointly chaired by the
Chairpersons of the Senate Committee on Trade and Commerce and the (ouse of Representatives
Committee on Trade and )ndustry. The ViceChair of the oversight committee shall be jointly held
by the Chairpersons of the Senate Committee on (ealth and Demography and the (ouse of
Representatives Committee on (ealth.

SECT)ON . Appropriations. For the initial implementation of this Act, the amount of Twenty
five million pesos Php , , . , in addition to the budget of the Department of (ealth, shall
be provided for the operations of the Office of the Secretary of the Department of (ealth. The
Quality Affordable Medicines Oversight Committee shall be provided an initial budget of Five
million pesos Php , , . to perform its functions as mandated under this Act. Thereafter,
such sum as may be necessary for its continued implementation shall be included in the annual
General Appropriations Act
Act.

SECT)ON . Separability Clause . Any portion or provision of this Act that may be declared
unconstitutional or invalid shall not have the effect of nullifying other portions and provisions
hereof as long as such remaining portion or provision can still subsist and be given effect in their
entirety.

SECT)ON . Repealing Clause . All laws, decrees, executive orders, proclamations and
administrative regulations or parts thereof inconsistent herewith are hereby repealed or modified
accordingly.

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SECT)ON . Effectivity Clause . This Act shall take effect fifteen days after its publication in
at least two national papers of general circulation.

Approved:

PROSPERO C. NOGRALES
Speaker of the House of Representatives

MANNY VILLAR
President of the Senate

This Act which is a consolidation of Senate Bill No. and (ouse Bill No.
was finally passed by the Senate and the (ouse of Representatives on April , .

MARILYN B. BARUA
BARUA-YAPYAP
Secretary General
House of Representatives

EMMA LIRIO-REYES
Secretary of the Senate

Approved: June 6, 2008

GLORIA MACAPAGAL-ARROYO
President of the Philippines

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