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MOD III- PATENTS PPT

PATENT HISTORY
 IP regime originated from Western Europe, France and British region-American system-
rest of the world.
 Statuto mineraria (State of Venice)[Emigration/exportation]-Statute of Monopolies
(Letters Patent)-Article 1, Section 8, Clause 8 and 18 of US Constitution.*
 TRIPS
 INDIA PATENTS LAW- 1856-1911 (exclusive privileges-14 years)-1959 (Rajgopala
Ayyangar Committee)-1970-TRIPS-Amendment 1999-2002-2005.
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 Being a signatory to TRIPS, India was under a contractual obligation to amend its Patents
Act to comply with its provisions. India had to meet the first set of requirements on
1st January 1995 to give a pipeline protection till the country starts granting product
patent.
 On 26th March, 1999, Patents (Amendment) Act, 1999 came into force retrospective
effect from 1st January, 1995. The main amendments are as follows:
 Section 5(2) was introduced which provides for filing of applications for patent in the
field of drugs, medicines and agro-chemicals. These applications were kept pending in
the mailbox or black box. This mailbox was to be opened on 1st January 2005.
 Provision of Exclusive Marketing Rights (EMR) was brought in by way of Chapter IV
A. Thus, pipeline protection was provided for pharmaceutical and agro-chemical
manufacturers whose applications for product were lying in black box.
 Section 39 was omitted from the Act, thereby enabling the Indian residents to file the
applications for in an outside India simultaneously.
 Chapter II (A) was inserted in the Indian Patent Rules dealing with International
Applications under PCT.
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 The second phase of amendment was brought in by the Patents (Amendment) Act, 2002
which came into force on 20th May 2003. The main features of the amendments included:
 i. Term of patent was extended from 14 to 20 years, wherein the date of patent was the
date of filing of complete specification. Also the difference in term of a drug/food patent
and other patent was removed.
 ii. The definition of "invention" was made in conformity with the provisions of TRIPS
Agreement by introducing the concept of inventive step, thereby enlarging the scope of
invention.
 iii. Deferred examination system was introduced.
 iv. Introduction of the provision of publication of application after 18 months from the
date of filing thereby bringing India at par with the rest of the world.
 v. Microorganisms became patentable, whereas inventions relating to traditional
knowledge were included in the list of "what are not inventions".
 vi. The concept of unity of invention in accordance with EPC and PCT.
 vii. Section 39 was reintroduced thereby prohibiting the Indian residents to apply
abroad without prior permission or first filing in India.
 viii. Provisions of Appellate Board were brought in by inserting section 116. All
appeals to the decision of the Controller would be appealable before the Appellate
Board. The Head Quarter of the Appeallate Board is to be in Chennai.
 ix. Section 117 provided for Bolar provision for the benefit of agrochemical and
pharmaceutical industry.
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 The third and final amendment to the Patents Act, 1970 came by way of Patents
(Amendment) Ordinance, 2004, which was later replaced by The Patent (Amendment)
Act, 2005, and Patents (Amendment) Rules, 2006 with retrospective effect from 1st
January, 2005. With the third amendment India met with the international obligations
under the TRIPS. Significant achievements of this amendment were:
 Deletion of section 5, opening of mailbox and grant of product patents. Thus this
amendment led to the dawn of the "product patent regime" in India.
 Abolition of Exclusive Marketing Rights (EMR).
 Current Position:
 The present Indian position in respect of patent law is governed by the provisions of the
Patents Act, 1970 as amended by the Patents (Amendment) Act, 2005 (hereinafter
referred to as the Act) and Patents Acts Rules, 2006 (hereinafter referred to as the Rules)
 The Head Patent Office is located at Kolkata and its branch offices are located at Delhi,
Mumbai and Chennai. Patent system in India is administered by the Controller General of
Patents, Designs, Trademarks and Geographical Indications. Each office has its own
territorial jurisdiction for receiving patent applications and is empowered to deal with all
sections of Patent Act.
 The jurisdiction for filing the patent application depends upon:
 Indian applicant(s): determined according to place of residence, place of business of the
applicant or where the invention actually originated.
 Foreign applicant(s): determined by the address for service in India.
WHAT IS PATENT
 Patent is an exclusive monopolistic right given by the sovereign to an inventor for an
invention.
 Patent is territorial in nature.
 Granted for limited time period (20 years)
 Exclusive monopoly (Limited*)- manufacturing, using or selling as per the law of the
land.
 Types: Process- Product
 Granted on first to file basis (not first to invent basis)
 It can be Opposed and Challenged.
 Voluntary –Compulsory Licensing
 Granted from the date of filing not from day of grant (date of priority)

SIGNIFICANCE
 Stimulate Technology and industrial growth (M/s Bishwanath Prasad Radheyshyam v.
Hindustan Metal Industries- AIR 1980)
 Through reward of monopolistic rights stimulated more contribution towards field of
Research and technological development- Key factor towards economic prosperity of the
nation.
 A world wide exchange of technical information.
 Disclosure of inventions made possible without fear of loss of benefits.
 Section 2(1)(j) of the Patent Act, 2005, defines the "invention" as a new product or as
process involving an inventive step and capable of industrial application.”
 Under the Act "New invention" is defined under section 2(1)(l) of the Patents Act
 "New invention" means any invention or technology which has not been anticipated by
publication in any document or used in the country or elsewhere in the world before the
date of filing of patent application with complete specification, i.e., the subject matter
has not fallen in public domain or that it does not form part of the state of the art.
 Thus, according to this definitions, Act talks of 3 basic ingredients of Patents:
 -NOVELTY/NEW
 -UTILITY/INDUSTRIAL APPLICATION
 -NON-OBVIOUSNESS/ INVENTIVE STEP
 -STATUTORY SUBJECT MATTER /SECTION 3
 “NUNS TEST”
 NEW means that which is not already CLAIMED/ PUBLISHED or PUBLICILY
USED

NOVELTY
 Absolute novelty, i.e. the invention should have neither been used anywhere in the world
nor published in any part of the world.
 The later sections of the act for the purpose of anticipation and opposition proceedings
deal with the relative novelty i.e. not used in India and not published** in any part of the
world.
 Further, entire Act refers to the word invention and not new invention. Therefore, for all
purposes relative novelty is the criterion.
 Exceptions To The Novelty Rule: few exceptions where the rule of novelty is not
applicable-
 Subject matter published without the consent of the inventor.
 The invention was published in consequence of the display in an exhibition notified by
the Government or reading the paper before a Learned Society*.
 Previous communication to Government of India.
 Public working for reasonable trials.
CASES ON NOVELTY
 CSIR TURMERIC CASE
 Mariappan v. Safiullah 2008 (38) PTC 341
 Novartis A.G & Others v. Union of India 2013 (54) PTC 1 (SC)
 Grace period of 12 months is given in such cases to file the patent application.
 ** Published in any medium-newspaper, journal, magazine, elctronic database,
product demo and exhibitions… so on.
 If published- there is prior art in the form of written description, oral description,
by use etc……

INVENTIVE STEP/ NON OBVIOUSNESS


 "Inventive Step" is defined under Section 2 (1) (ja) of the "Act".
 Prior 2005 Amendment- inventive step meant a feature that makes the invention not
obvious to a person skilled in the art.
 Act of 2005- "Inventive step means a feature of an invention that involves technical
advancement as compared to the existing knowledge or having economic significance or
both and that makes the invention not obvious to a person skilled in the art.”
 synonymous to the phrase “capable of industrial application” in section 2 (1)(ac) or
in footnote 5 to Article 27.

NON OBVIOUSNESS+ TECHNICAL ADVANCEMENT/ ECONOMIC SIGNIFICANCE*


 M/s Bishwanath Prasad Radheyshyam v. Hindustan Metal Industries- AIR 1980 The
court said “it is important that in order to be patentable an improvement on something
known before or a combination of different matters already known, should be something
more than a mere workshop improvement; and must independently satisfy the test of
invention or an ‘inventive step.’
 Non-Obviousness- wherein the work has unexpected properties as compared to the
closest prior art that was in need to be created and others failed to produce and think of
the same that has landed the inventor some commercial success.
 In addition to novelty , potentiality is to depend, upon the non obvious nature of the
‘subject matter’ sought to be patented to a person having ordinary skill in the pertinent
art.
 Patent ought not to be granted for every trivial advancement.
 Minor improvements were considered as reflecting the work of a skillful mechanic for
which protection ought not be granted .
 It is often difficult to determine whether a given improvement is a mere Mechanical
advancement or the result of the exercise of creative faculty amounting to a meritorious
invention .
 The fact that the invention seems simple after it is made does not determine the question.
(Expanded Metal Co. v. Bradford) [214 US 366]
 In Bajaj Auto limited versus TVs Motor Company limited Madras High Court observed
that the term ‘obvious’ is a circumstance where a person of skill in the field, ongoing
through specifications can complete the product. Therefore even if any of the two
ingredients i.e., technical advance or economic significance are both available such
invention enables a person of skill in the field , on going through the specifications to
complete the product , such invention can never be treated as an inventive step and
consequently no patent can be validly issued .
INDUSTRIAL APPLICATION/UTILITY
 If an invention can be created, used and reproduced with same characteristics as many
times as necessary, it has utility.
 The patent protection is not available to purely abstract or intellectual creation. Potential
to be used or made in industry is sufficient evidence for proof of industrial application.
 Capability of industrial application does not require proof of actual use.
 In Indian vacuum Brake Co. v. E.S Luard AIR 1926 Cal. 152-The Calcutta High Court
has held that mere usefulness was not sufficient to support a patent.
 Incremental patenting in the case of Novartis AG v. union of India –And in the case of
Lallubhai Chakubhai Jariwala v. Chairman Lala Co. (AIR 1936 Bom. 99)The court had
observed that mere collection of two or more things however without some exercise of
invented faculty in combining them was not subject matter of patent . Novelty was
essential , for otherwise there would be no consideration moving from patentee.

Contrary to
public Mere
order/morality, discovery of a Formulation
serious injury to scientific of/or
Frivolous/ human, animal principle. discovery of
contrary to or planet and any living thing
natural laws environment or non living
substance in
the nature

Discovery of a new
A mathematical or form of a known
business method or a substance which
computer program does not result in
per se or algorithms. the advancement
of efficacy of that
substance

Plants or animals in whole


NOT PATENTABLE
or nay part other than INVENTIONS
micro organisms including Mere discovery of a
seeds, varieties and new property of new
species and essentially use of a known
biological processes for substance or a known
production or process, machine or
propagation of plants and apparatus unless such
animals known process results
in a new product.

Process for Mere admixture


medicinal, surgical, resulting in the
curative or aggregation of
prophylactic or other properties of the
treatment of human Arrangement or components or the
beings or other A method of rearrangement process for producing
processes. agriculture or or duplication of new substances
horticulture known devices ,
functioning
independently.
• A literary, dramatic, musical and artistic works or any other aesthetic creation,
whatsoever including cinematographic work and and television productions.
• A mere scheme or rule or method of performing mental act or method of playing
game.
• A presentation of information.
• Topography of integrated circuits.
• An invention, which in effect is traditional knowledge or which is an application or
duplication of known properties of traditionally known component(s).
• Inventions related to Atomic energy (Section 4)
• Novartis A.G v. Union of India (2007) 4 MLJ 1153
• Novartis A.G v. Union of India AIR 2013 SC

SECTION 6-11
 Patent is filed by the inventor, assignee of the inventor or any legal representative
authorized to file the same right before his death/ Patent Attorney, patent agent.
 Employer-employee relationship shall be governed by the contractual obligations.
 It can be lost by public disclosure , use, sale or offer for sale of an invention, before
filing application in most countries.
• Filing an application for Patent
• Date of priority is the date of filing
• Filing a request for examination
• No examination without receiving a request for examination
• Date of filing the request for examination of an application is the basis for the
prosecution
STAGES OF FILING
 STEP 1: File a preliminary or complete specification
-Preliminary application would only mention the field of invention and not details of the same .
-Complete specification in an application would mean final claims off the patentee.
STEP 2: Application timeline is secured
- If in the preliminary application where it is filed- a complete specification should be filed
within 12 months of the date of preliminary application.
-failure to submit within 12 months time limit it will result in abandonment of preliminary
application.
STEP 3: Publication of final specification
- The final specification after scrutiny of the proper forms will be published in the journal
of the patent office.
- Filing an application for Patent
- Date of priority is the date of filing
- Filing a request for examination
- No examination without receiving a request for examination
- * (Examination happens only after publication of the application.
- The Applicant has to request for Examination within 48 months from the priority
date.
- Request for early examination is possible before the Indian Patent Office by
additional fee payment.).

STEP 4: Examination* involves


 (i) Ascertaining
 (a) Novelty (by Prior Art Search)
 (b) Utility
 (c) Inventive Step
 (d) Statutory Subject Matter
 (e) Application Formalities
 (ii) Issue of First Examination Report
 The applicant files response to the FER within 6 months.
 Amendments can be made by way of:
(i) Correction
(ii) Disclaimer
(iii) Explanation
 If the response is satisfactory, the Examiner recommends Grant and the Controller Grants
Patent for the invention.
 STEP 5: OPPOSITION
-The specification is published for the public to have an opportunity to oppose the patent on
specified grounds laid down by the law
-Pre –grant opposition has six months time from the time of publication to file an opposition with
the patent office
-Any person in the public is entitled to file the opposition
- If the opposition is successful the patent application will be rejected. Or it will proceed for
process of patenting
Post grant opposition is allowed after grant of patent for a period of one year .
 STEP 6: GRANT of Patent.
GENERAL PATENT APPLICATION TIMELINE
RIGHTS OF PATENTEE
 As per Article 284 of the TRIPS (Trade-Related Aspects of Intellectual Property
Rights), Agreement provides the following Rights and Obligations of Patentee:
 A registered Patent should confer the following exclusive Rights on its owner:
 where the Patent’s subject matter is a product, to prevent any third parties, which is also
not having the consent of the owner, from the following acts of using, making, offering
for selling, sale, or importing for these purposes such product of the owner;
 where the Patent’s subject matter is a process, to prevent any third parties, which is also
not having the consent of the owner, from the following acts of using, making, offering
for selling, sale, or importing for these purposes at least the product that is obtained
directly by such a process.
 The owner of the Patent should also have the right to transfer by succession or assign the
Patent and to conclude the licensing contracts.
 What are the Rights of Patentee as per the Patent Act, 1970?
 A grant of Patent in India gives the Patentee the exclusive model to utilize or make the
patented invention or utilize the patented procedure related to the invention. Certain
Rights and Obligations of Patentee are enshrined under the Patent Act, 1970. The
various kinds of Rights of Patentee are as follows:
 Where the grant of Patent is done for a product, the exclusive right to prevent any third
party, who is no having his/her consent, from any act of offering, using, making for sale,
importing or exporting for such products in the territory of India;
 Where the subject matter associated with the Patent is a process, the exclusive right to
prevent any third party, who is no having his/her consent, from any act of offering, using,
making for sale, importing or exporting for such products that are directly obtained from
the process in the territory of India;
 Moreover, the product produced by the Patentee should not be such that it cannot be
patented in India as per Section 48 of the Patent Act, 1970.
 Right to exploit the Patent
When the new invention is a product, the Patentee has the exclusive rights to use, make, import,
or sell for these purposes related to an invention in India. On the other hand, when the invention
of the inventor is a procedure or process of manufacturing of any article or substance, the right to
exploit means the exclusive right exercise or use the procedure or method in the territory of
India.  
 Right to Grant License
The Patentee of a Patent is given the right to grant license or transfer rights or enter into some
arrangement for some consideration. The assignment or license to be valid and legitimate it is
required to be in writing and should be registered with the Controller of Patent. Unless a
document of assignment of a Patent is not registered, it is not admitted as evidence of title of the
Patent, and such a rule is applicable to the assignee, not the assignor. (As per Section 69(5) of
the Patent Act, 1970)     
 Right to Surrender
By giving notice in the prescribed manner, the Patentee of a Patent has the right to surrender a
Patent at any time and at his/her own discretion. The advertisement for such an offer of surrender
is required to be done in the Journal. The publication is done to give an opportunity to the people
to oppose the offer of surrender of the Patentee. This is done when the Patentee apprehends
his/her non-performance of the Patent in the future and upon which he/she decides to surrender
the Patent.
 Right to sue for Infringement
The Patentee has the right to sue for Infringement of Patent in District Court has the jurisdiction
to try the suit.
 Right to Use and Enjoy Patent
The Patentee of the Patent has the exclusive right to exercise, make, utilize, convey or offer or
the patented substance or article in India or to practice or utilize or the process or techniques
associated with the invention. Such rights can be exercised either by the Patentee himself/herself
or by his/her licensees or agents.
OBLIGATION OF PATENTEE
 Duty to Disclose
 Sec 8 of the Patent Act, 1970, accomplishes the obligation to disclose of the
Patentee. Section 8(1) of the Patent Act, 1970, tells that the Patentee has an obligation to
disclose all required data related to the remote uses of comparative or same invention
documented by him/her or through him/her or through someone by him/her at the time of
applying or within 6 months of applying.
 The Patentee of a Patent is required to record an announcement of all the listed
particulars viewing the applications and, in addition to the above, an endeavor to disclose
all the points of interest of any subsequent applications that might be documented at the
future stages.
 Section 8(2) of the Patent Act, 1970, puts an obligation on the Patentee to provide all
the data required by the Controller of Patent with regards to the relating of any
remote applications at whatever point demand is made by the Controller of Patents
within a time period of 6 months of such a demand by the Controller of Patent. The first
part of the obligation of Patentee begins when a man records an application of Patent. On
the other hand, the second part begins after a demand is made by the Controller of Patents
under the Patents Act, 1970.
 Duty to Request for Examination
Not like other Intellectual Property Rights, the Registration process of Registration of Patent
does not accommodate any kind of programmed examination of the grant of Patent application.
In the procedure above mentioned, as indicated by Section 11(B) of the Patents Act, 1970, the
obligation is thrown on the Patentee himself/herself to ask for the Controller of Patents to look at
the growth or development connected for Patent.
 Duty to Respond to Objections
The Controller of Patent before accepting the examination request passes it to the analyst who
looks at the growth and gives a report to the Controller of Patent known as the First Examination
Report (FER). On certain cases there may be some protests which will be brought up in the First
Examination Report, it is the right of Patentee to reply to such opposition complaints and
consent to the corresponding within a time period of a year of the issuance of the First
Examination Report (FER) falling which the application of the Patentee will be considered to be
surrendered by the Controller of Patent.
 Duty to clear all Objections
It is the obligation of the owner of the Patent to respond to the raised objections as well as to
clear and remove each one of the raised objections and, in addition, certain oppositions raised
against his/her invention. In the event that the Controller of Patent has not fulfilled he/she, it may
also require a meeting also. Furthermore, it is the obligation of the owner of Patent to go for a
consultation and clear all the objections and, in addition, oppositions, if are raised any, against
the invention of the inventor.
 Duty to Pay Statutory Fees
The Patentee has an obligation to pay all the statutory expenses required to get a grant of a Patent
in the process of Registration without failure generally, his/her application for the grant of Patent
won’t be managed. Sec 142 of the Patent Act, 1970, accomplishes the provisions recognized
with payment of charges and, in addition, the consequences for non-payment of such prescribed
fees.
After this process is imitated to and the Patentee of Patent clears every one of the restrictions and
protests raised against his/her invention, if the Controller of Patent is fulfilled, he/she will grant a
Patent to the invention and publishes it in the Journal, or generally, the Controller rejects such a
Patent.

The concept of divisional patent application


provides the inventor with the opportunity to
protect multiple inventions disclosed in one
patent
DIVISION
if in one parent patent application, the patent
APPLICATION claims does not relate to a single invention and
discloses two or more inventions, the patent law
provides the patent applicant to file a further
patent application as a divisional patent
application.
A patent of addition is
an application made for
a patent in respect of
improvement or
modification of the
Patent of
invention described or
Addition
disclosed in the main
application for which
Convention application refers to a the patentee has
patent application filed in
already applied for or
accordance with the terms of an
international patent treaty like the has obtained a patent.
Patent Cooperation Treaty.
Conventional The Patent Cooperation Treaty is an
international agreement for filing
Application patent applications
It protects an inventor of a member
country by ensuring priority for
his/her inventions over all or any
inventor from non member
countries.
COMPULSORY LICENSING
 Compulsory licensing is a measure which is provided by the patent act to ensure that the
patentee do not misuse their patent rights.
 Compulsory Licensing is given only for public health and nutrition.
 Simply speaking, it is a license given to a 3rd party to manufacture, use, or sell the
product or use the process that provides a new way of doing something which has been
already granted patent without the permission of the owner.
 This is done for the public health, or in national emergency and health crisis. As this
license works against the owner of the patent there are conditions that are given by the
government to be fulfilled.
 Compulsory Licensing was first given to a company in 2012. Under the Indian Patent
Act, conditions for granting of compulsory licensing are given. The conditions which
need to be fulfilled in order for a compulsory license to be granted are given under
section 84 and 92 of the Indian Patent Act, 1970. If any company wants a compulsory
license of any product then they should follow these two sections. 
 It is one of the flexibilities in the field of patent protection included in the WTO’s
agreement on intellectual property — the TRIPS (Trade-Related Aspects of Intellectual
Property Rights) Agreement.
 It existed in the TRIPS Agreement, ever since it took effect in January 1995.
 Indian Patent Act,1970 Section 84, provides that after three years from the date of the
grant of a patent, any person can apply for the compulsory license, on certain grounds:
 The reasonable requirements of the public with respect to the patented invention have not
been satisfied
 the patented invention is not available to the public at a reasonably affordable price
 Lastly, the patented invention is not used in the territory of India.
 Indian Patent Act,1970, Section 92, authorizes the central government to issue a
compulsory license at any time after the grant of the patent, in the case of:
 National emergency; or
 Extreme urgency; or
 Case of public non-commercial use
 Only 1 compulsory license has been issued in India by the Patent Office on March 9,
2012. The license was issued to Natco Pharma for the generic production of Bayer
Corporation’s Nexavar, which is a life-saving medicine used for treating Cancer(Liver &
Kidney).
 Conditions for Issuing Compulsory License
 The person or company applying for a licence has to have tried, within a reasonable
period of time, to negotiate a voluntary licence with the patent holder on reasonable
commercial terms. Only if that fails can a compulsory licence be issued.
 When a compulsory licence has been issued, the patent owner has to receive payment.
The TRIPS Agreement says “the right holder shall be paid adequate remuneration in the
circumstances of each case, taking into account the economic value of the authorization”,
but it does not define “adequate remuneration” or “economic value”.
 The scope and duration of the licence must be limited to the purpose for which it was
granted, it cannot be given exclusively to licensees and it should be subject to legal
review.
 Harmful restrictions so as to interfere with reasonable exercise of rights of the licensees
must not be put.
 Avoid misuse of monopolistic rigfhts. SEE Section 140.
 Fee payment procedure for Compulsory License
 The fee is set by the law or through any arbitration or adjudication process. 
 Copyright law Many countries provide copyright law for compulsory licensing of
copyrighted works for certain uses.
 In most cases, the fee or royalty to be paid for a work that is copyrighted under the
compulsory license is defined by the local law, however, it can be negotiated.
 The fee may be determined through negotiations but must contain terms within the
boundaries of the compulsory license.
 The Compulsory license provisions is aimed at curbing the practice of meeting the
demand for patented articles solely by importation from abroad thereby
discouraging
 -transfer of technology,
 -development in existing trade & industry,
 -non-establishment of new trade & industry,
 -refusal to grant licenses to work the patent locally,
 -imposing unreasonable terms on licenses thereby discouraging voluntary licensing
and imposing restrictive conditions on the use,
 -sale or lease of the patented articles thereby prolonging the patent monopoly rights
even after the patent has expired.
 -Revocation of the patent for non-working has been adopted in almost all countries.
 In considering the application for the grant of compulsory license, the Controller
shall take into account the nature of the invention; the time which has elapsed since
the sealing of the patent; the measures already taken by the patentee or any licensee
to make full use of the invention; the ability of the applicant to work the invention to
the public advantage; capacity of the applicant to undertake the risk in providing
the capital and working the invention; whether the applicant has made efforts to
obtain a license from a patentee on reasonable terms and conditions and such efforts
have not been successful within a reasonable period (6 months) as the Controller
may deem fit.
 Where the Controller is satisfied that a prima facie case has been made, the
Controller will direct the applicant to serve copies of the application on patentee
and any other person appearing in the Register of Patents and upon hearing the
parties may give his decision. An appeal lies to the appellate board. The Controller
can terminate the compulsory license when circumstances that gave rise to the grant
no longer exist.
 Further, in determining royalty Controller shall keep in mind the nature of the
invention; the expenditure incurred in making and developing the invention;
expenditure in obtaining patent and its maintenance; patented invention is worked
and the licensee gets reasonable profit; patented article is available to public at
reasonably affordable price; license granted is non-exclusive; the right of the
licensee is non assignable; that the license is for a balance period of the term of the
patent or shorter term
 Industries under Compulsory Licensing in India
 Only 6 industries fall under the compulsory licensing category in India.
 They are listed below:
 -Distillation and brewing of alcoholic drinks.
 -Cigars and Cigarettes of tobacco and manufactured tobacco substitutes.
 -Electronic Aerospace and Defence equipment: all types.
 -Industrial explosives including detonating fuses, safety fuses, gun powder, nitrocellulose
and matches.
 -Hazardous chemicals.
 -Drugs and Pharmaceuticals (As per the modified Drug Policy issued in S
 The Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) does not
specifically list the reasons that might be used to justify compulsory licensing. However,
the Doha Declaration on TRIPS and Public Health confirms that countries are free to
determine the grounds for granting compulsory licences and to determine what
constitutes a national emergency.
SURRENDER/REVOCATION/RESTORATION
 Section 63- Patentee can surrender by notice to the Controller.
 Offer made- Advertisement of offer- Notification to other interest holders in the register-
interested person* may issue notice to the controller issuing opposition to such surrender-
Satisfaction of controller for allowing so.
 REVOCATION 64-66
 RESTORATION OF LAPSED PATENT. (60-62)
 * Assignee, licensee, Co-patentee, Mortgagee.

BOLAR PROVISION
Section 107 A* (a) of the Patents Act provides that any act of making, constructing, using,
selling or importing a patented invention solely for uses reasonably related to the development
and submission of information for regulatory approval will not amount to infringement.
 This provision is helpful for persons who wish to exploit the patent after the expiry of the
terms of the Patent as they can obtain the marketing approval before the term of patent
expires and can immediately manufacture after the expiry of the term of Patent.
Parallel Importation
 Section 107 A (b) provides for Parallel Importation of patented products. The provision
declares that importation of patented products, by any person from a person who is duly
authorized under the law to produce and sell or distribute the product, would not be
considered as infringement.
 The phrase "duly authorized under the law" was inserted in place of "duly authorized by
the patentee" by the Patent (Amendment) Act, 2005. Effectively, this provision refers to
and relies on the applicable local laws of the country exporting the goods to India.
 The provision allows export from a country where there is no protection of the article
patented in India.
 Parallel Importation provision has been introduced as a mechanism to help in price
control through the act of competition. The
 Principle of exhaustion of right is also applicable in this provision.
The patent (Amendment) Act, 2002
READ WITH SECTION 107
Section 107 of the Patents Act talks about the defenses in suits for infringement. It says that
every ground on which the patent may be revoked under section 64 shall be available as a
ground for defense.
In any suit for infringement of a patent by the making, using or importance of any
machine, apparatus or other article or by the using of any process or by the importation,
use or distribution of any medicine or drug, it shall be a ground for defense that such
making, using, importation or distribution is in accordance with any one or more of the
conditions specified in section 47.

 Cross Border Licensing:


Grant of Compulsory License to manufacture and export patented pharmaceutical products to
any country having insufficient or no manufacturing capacity by an Indian manufacturer is
possible either through the importing country granting compulsory license to the Indian
manufacturer or through allowance of importation of the patented pharmaceutical products from
India by notification.
 This provision is based on Para 6 of DOHA Declaration on TRIPS Agreement.
CASE LAWS:
-Momenta Pharms., Inc. v. Teva Pharms. USA Inc., 809 F.3d 610 (Fed. Cir. 2015), cert. denied
sub nom. Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 137 S. Ct. 68 (2016)
-Monsato Company v. Coromandal Indag Products (P) Ltd. 1986 (SEE FOOTNOTES)
-Windsurfing v. Jabur 1985
Originating as a concept from U.S Because approval by the U.S. Food and Drug
Administration (FDA) is a long, sometimes arduous process, U.S. law provides a research
or experimental use exemption with respect to regulated products. Congress enacted the
Drug Price Competition and Patent Term Restoration Act of 1984 (the "Hatch-Waxman
Act") which created the Section 271(e)(1), which is often referred to as the "Safe Harbor"
or "Bolar" exemption. The Bolar exemption insulates certain activities from patent
infringement. Specifically, Section 271(e)(1) reads:
 It shall not be an act of infringement to make, use, offer to sell, or sell within the United
States or import into the United States a patented invention (other than a new animal drug
or veterinary biological product (as those terms are used in the Federal Food, Drug,
and Cosmetic Act and the Act of March 4, 1913) which is primarily manufactured
using recombinant DNA, recombinant RNA, hybridoma technology, or other processes
involving site specific genetic manipulation techniques) solely for uses reasonably related to
the development and submission of information under a Federal law which regulates
the manufacture, use, or sale of drugs or veterinary biological products.
Importantly, the Bolar exemption is equally applicable to generic and branded
pharmaceuticals, medical devices, biologics, and biosimiliars and exempts a wide variety of
activities reasonably related to gaining information relevant to gaining FDA approval.
While both pre- and post-approval activity can be exempt, only limited types of post-
approval conduct is exempt.
# Momenta Pharms., Inc. v. Teva Pharms. USA Inc., 809 F.3d 610 (Fed. Cir. 2015), cert.
denied sub nom. Amphastar Pharms., Inc. v. Momenta Pharms., Inc., 137 S. Ct. 68 (2016)

INFRENGMENT OF PATENT
 Acts like:
-Colorable imitation of an invention*
-Immaterial variation to the invention*
-Mechanical Equivalent#
-Taking essential features of the invention@ amounts to infringement of patent.
 Important to ask three questions:
1.Extent of monopolistic rights conferred by the patent which has to be ascertained by a
construction of the specification, particularly the claims
2. Whether the alleged act amounts to making, using or exercising a process patent method or
process in the case of a process patent; and
3. Whether what then alleged infringer is doing amounts to an infringement of the monopoly
conferred by the patent grant.
• CASES - Slight Modification of Product or process #Subsitute of same features to
produce same results
• @ Doctrine of Pith and Marrow-refer the cases>>
• Dunlop Pneumatic tyre Co. Ltd. V. Neal (1899) 16 RPC 247
• Dudgeon v. Thompson (1877) 3 App Cas 34.

Other defenses available against Infringement of Patents


 When a defendant proves that he has no intention of infringement.
 In case of res judicata and estoppels.
 When the plaintiff is not entitled or competent to sue for infringement.
 When the defendant has a license to use the patented product or process.
 When the patent is revoked on grounds of it being illegal.
 In the case of pharmaceutical drugs/medicines, the government can allow to manufacture
patented products for public good.
 In case the infringement is obvious in nature and not novel.
PROCEDURAL
I. Who can Sue:
Patantee (includes co-owner), exclusive licensee (license be registered), Compulsory Licensee (If
Patentee neglects/refuses to institute Proceedings), A licensee (Contractually authorized to do
so), Assignee (only when the registration is complete-not beforehand, if pending registration is
granted during the proceeding duly instituted he/she becomes the co-plaintiff).
II. Jurisdiction: Section 104
Except for revocation of patent that can be instituted in high court only (Section 64),
All suits of patent infringement shall be instituted in no court lower than the district court.
III. Period of Limitation:
Suit has to be instituted within 3 years of date of infringement.
III. Burden of proof:
 Section 101 of the Indian Evidence Act, 1872, says “whoever desires any court to give
judgment … dependent on the existence of facts which he asserts must prove that those
facts exist. When a person is bound to prove the existence of any fact, it is said that the
burden of proof lies on that person”.
 Onus of adducing evidence to prove the facts on which allegations are based lies on the
plaintiff. The burden of proof in patent infringement litigation lies on the patentee or
plaintiff to adduce factual evidence that the patent has been infringed.
 However, if the subject matter of a patent is a process, and the patentee or person
deriving title or interest is able to prove that the infringed product is identical to the
product directly obtained by the patented process the burden of proof may shift to the
defendant to prove that the process used by him is different from the patented process.
The burden of proof in case of process patent is also dealt with in section 104A of the Patents
Act, 1970, which provides that “In any suit for patent infringement involving a process for
obtaining a product, the court may direct the defendant to prove that the process used by him to
obtain the product, identical to the product of the patented process, is different from the patented
process.”**
CASES- ** In Communications Component Antenna Inc v ACE Technologies Corp and ors,
the Delhi High Court recently held that if the defendant withholds its best and easily
obtainable evidence, an adverse inference can be drawn against it. The court stated that “in
a patent infringement action, once the plaintiff, prima facie establishes infringement, the
onus shifts on the defendants, to disprove the same. The complete silence by the defendants
shows that there is, in fact, withholding of relevant and crucial information from the
court”.
In Farbewerke Hoechst etc v Unichem Laboratories and ors the Bombay High Court held
that the burden of proof in the process patent is based on section 106 of the act which
provides that “when any fact is especially within the knowledge of any person, the burden
of proving that fact is upon him”.
In another recent case, Shogun Organics Ltd v Gaur Hari Guchhait and ors, the same court
further ruled on the burden of proof. Shogun Organics, a company engaged in the
research, manufacture, and sale of mosquito repellent applied for a permanent injunction
restraining the defendants from infringing its process patent. The patent related to the
manufacture of an insecticide. The plaintiffs purchased base material from the defendants
but established that, after the grant of the patent the defendants sold their product with the
addition of various compounds and content specific to the plaintiff’s patented process. The
onus therefore shifted to the defendants to prove that the process adopted by them was
different from the patented process.
REMEDIES
 SECTION 104-106
Section 108 mentions the remedies plaintiff can claim upon proof of infringement.
1. INJUNCTION (PERPETUAL and INTERLOCUTORY)
2. DAMAGES OR ACCOUNTS OF PROFIT
3. DELIVERY UP or DESTRUCTION OF INFRINGED GOODS
4. CERTIFICATE OF VALIDITY.
INJUNCTION
 A preventive civil remedy.
 It is of two kinds:
Permanent injunction: Invoked when the case is conclusively decided by the court on merit.
The interim injunction is transferred to a permanent injunction if the defendant is found guilty of
patent infringement rights and the decision is on the side of plaintiff. Defendant is absolved from
the liability if proved innocent; the interim injunction dissolves. It is limited to the duration of
the patent.
Temporary/ interlocutory injunction: Limited to a specific period or till the case is finally
decided on merit. It mitigates the risk of injustice to the plaintiff during the pendency of suit. Its
object is to protect the plaintiff against injury by violation of his right for which he could not be
adequately compensated in damages recoverable in the action if the uncertainty were resolved in
his favor at the trial.[An interlocutory injunction is invoked by the court at the initial stages of
the suit filed by the plaintiff. This is passed in order to prevent the defendant from getting further
profits by using other patented products.
Invoking an injunction requires:
-Prima facie case
-Paten its valid and infringed
-Sufficiently old and worked
-Balance of convenience in favor of plaintiff
-Irreparable loss to plaintiff.
CASES- #NATIONAL RESEARCH AND DEVELOPMENT CORPORATION OF INDIA
v. DELHI CLOTH AND GENERAL MILLS Co. Ltd. AIR 1980 Del. 132
Cadila Pharmaceuticals Ltd. Instacare Laboratories Pvt. Ltd. 2001 PTC 472 (Guj.)
Franz Xaver Huemer v. New Yash Engineers 1996 PTR 103
M.C Jayasingh v. Mishra Dhatu Nigam Ltd. (MIDHANI) and Others. 2007
DAMAGES OR ACCOUNT OF PROFITS
 The owner of a patent is entitled to either damages or an account of profits. He may either
obtain damages in respect of losses caused by infringing activities of the defendant or an
account of profits obtained by the infringer – but he cannot seek both. When drafting
particulars of claim, the claimant will generally request these remedies as the alternative.
It will be granted in addition to the remedy of injunction.
 Where plaintiff chooses the remedy of account of profits, he will be entitled to claim only
that profit which was enjoyed by the defendant by using the plaintiff’s invention. It is
unreasonable to give the profits of patentee which were not earned by the use of his
invention.*
 In Ravi Raj Gupta v. Acme Glass Mosaic Industries,**  the court held that the patent
sought to be enforced and alleged to have been infringed by the defendant was not an
invention within the meaning of Section 2(j) of the Patents Act, 1970. Therefore, the
plaintiff was not entitled to the grant of an ad interim injunction as prayed for. However,
to protect the interest of the plaintiff in the event of his ultimately succeeding in the suit,
the defendant was directed to maintain a complete, true and accurate account of the
manufacture and sale of the tiles.
CASES- *United Shoe and Nail Company Ltd. v. Stewart & co., (1888)5 RPC 260 at
pp.266-67 **56(1994) DLT 673
DAMAGES OR ACCOUNT OF PROFIT
 May be awarded either of the two.
 Damages will be awarded as compensation for loss or injury to the plaintiff caused due to
actions of the defendant.
 Accounts of profit is calculated on the basis of the actual use of the patentee’s invention by
infringer during the commission of act or infringement.
CASES:
 Microsoft corporation v. K. Mayuri and others. 2007(35) PTC 415 (Del).
 Meters v. Metropolitan Gas Meters. (1911) 28 RPC 157.
DELIVERY UP OR DESTRUCTION OF INFRINGING GOODS AND CERTIFICATE OF
VALIDITY
 An order for delivery up or destruction is made with a view to prevent the defendant from
making use of the infringing article which might be in his possession.
 A discretionary order.
 The properties in the articles which are made in violation of a patent resides in an infringer
though he is restricted/prevented from using them.
Certificate of validity:
If in any proceeding before the appellate court or high court (in case of revocation), the validity
of any claim of a specification is contested and that claim is found by the appellate board or the
court to be valid, the court may certify that the validity of a claim was contested in a proceeding
and upheld. Section 113.
 SECTION 106 BARE READING.
CASES- # Gandhimathi Appliances Ltd. L.G Varadaraju and Others 2003 MLJ 85
# Novartis A.G v. Mehar Pharma and Anr. 2005 (30) PTC 160 (Bom).
# Dhanpat Seth v. Nil Kamal Plastic Crates Ltd. 2006 (33) PTC 339
# F. Hoffman La Roche v. Cipla Limited 2008.

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