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Presented by: venkata kumar sahu M.Pharm(Ceutics) Anna University Tirchirappalli.
Intellectual Property is a property
that arises from the human intellect. It is a product of human creation.
Intellectual Property is the creation
of the human intellectual process and is therefore the product of the human intellect or mind.
Why to Protect Intellectual Property?
When secure & protected
Why to Protect Intellectual Property??
Protect investment in time, money or
other resources used to create new contribution to technology, commerce and entertainment. Fosters economic growth Provides incentives for technological innovation, and
Why to Protect Intellectual Property?
Attracts investment that will create new
jobs and opportunities.
Governments encourage Creators to
disclose their creations to the public in order to promote the progress of science and useful arts which are the engines of development - investors demand this guarantee
Intellectual Property Rights are a Collection of Rights Patent Integrated Circuits Right Industrial
Design Geographical Indication
How to Protect Intellectual Property?
Invention by a patent or as trade
secret. Utility models by a certificate or secret. Industrial Design by a certificate. Trade and Service Mark by a certificate. Copyright by reducing to a fixed form.
How does a patent system work?
Earlier New inventions were kept close secrets with in family or organization. No proper documentation. Handed over others orally.
Today Inventor share the knowledge behind the invention in order to get patent. Patent provided exclusive right to inventer. After expiration of patent, invention is in public domain for free Society at loss. exploitation and Sometime secrets further development. Balancelost.n rights of inventor and utility of invention bet were 8
Patent /publish Publish
Disclosure Long Wait Cost of patenting Cost of renewal Policing
+ Exclusive Rights Debar others
Commercial exploitation License it
No commercial benefit Camouflage
Immediate Recognition No Cost involved
Preempt Others to get patent rights
AWARDED BY USPTO(united state patent & trademark office)
TYPES OF PATENT
May be granted to anyone who
invents a new,original ornamental design for an article of manufacture
It protects only the apperance of
the article but not the structural or funtional features
FEATURES OF DESIGN PATENT
It protects ornamental ,
Design Improved decorative apperance Shape of the invention Configuration
DESIGN OF COKE BOTTLE
FOR IT’S BOTTLE
for it’ design
Patented for it’s design and filed in USPTOAthlete’s shoe
US PATENTED EAR RINGS IN 1980 FOR IT’S DESIGN
Life period:14 YEAR Fee : $2000-$2500 No need for maintanence fee Limitation: only protect the design of the invention not the idea of invention Merit: *easy to get *less cost than utility patent
New inventions or functional
improvements can get utility patent
It may be a,
product machine a process composition of matter Called also as non provisional patent
Novel Silicone fatty esters:
OH group of silicone+esters of fatty acid or anhydride Use: as s good soonthing and lubricating agent in cloths & fibers Patented on August 4 “1994 for it’ s funtional activity.
DOVE SOAP-PATENTED FOR IT’S CLEANISING PROPERTY
sodium cocyl isothionate,ste aric acid,coconut oil,sodium tallowate as active ingredients
PATENED FOR IT’S ANTIDANDROFF ACTIVITY
ZPTO as a
main active ingredient,it reduces epidermal turnover and inhibits pityosporum ovale
Features of utility patent
It provides the right to prevent
others from making,using,selling&importing a product Life period:20 years Fee structure: $3000- $5000 Maintanance fee should be paid at the intervals of 31/2.71/2,111/2 yrs to USPTO
Anyone who has invented or
discoveredand asexually reproduced any distinct, new variety of plant including cultivated sports,mutants,hybrids,newly found seedlings other than tuber propagated plant can get this patent
Life period:17 yrs Fee structure:&2000
EXAMPLE-DIDI SALMON TWO
view of a flowering plant of 'Didi Salmon Two'.
close-up view of
typical flowers and leaves of 'Didi Salmon Two'.
Not observed in all possible envirnmental
conditions Observed in california Variation in temperature.light intensity,genotype changes the phenotype of the plant For commercial purpose: * fibre class covered green house used during late spring day at 27 degree.c&light level about 2000f.c * rooted young plants were planted in containers for upto 5 months
Didi salmon Two
A new and distinct
cultivar of Double Impatiens plant named ‘Didi Salmon Two’, characterized by its compact, upright, outwardly spreading and mounded plant habit; freely branching growth habit; dark greencolored leaves; freely flowering habit; and light redcolored flowers that are fully double and 30 positioned above
HOW WE CAN PROTECT OUR PATENT IN OTHER COUNTRIES?
Should file international patent
appilication under the patent coopearation treaty(PCT) Delays expense of filing in other countries Allowing feasibility of the patent in other country Life period:21/2
TO know about already patented invention………… To know the fee structure
of various type of patent and other details………
Type of Patents in Pharma
Compounds Medical uses Dosing regimens Combinations Formulations delivery systems Metabolites Polymorphs
Prodrugs Isomers Salts Process
and intermediates Assays and other research tools Diagnostic methods
Combo w/RTV Patent Protection
API Compound & Synthesis Patent Protection
Method of Treatment Patent Protection Solvated API Patent Protection
Formulation Patent Protection
DOCUMENT REQUIRED FOR PATENTING
Application form in triplicate Provisional or complete specification in
triplicate Drawings in triplicate (if necessary) Abstract of invention in triplicate Information and undertaking listing the number ,filing date, current status of each foreign patent application in duplicate Priority document if necessary
Typical Filing Process
Start date for patent term
Publication at 1.5 years
International Filing via PCT
PCT National Phase Examination up to issuance
National and Regional Approvals
+/- 6 to 10 y
Country List 1
Country List 2
Country List 3
Expires 20 years after PCT filing Subject to paying annuities
STEPS IN PATENTING
Application for patenting
Application form(7) Specification(9) Priority date Publication of application
Request for examination (11B) Final examination(12)
Opposition to grant Grant and sealing
One application form is intended for one
invention prescribed Must be filled in the patent office The proof of right to make the application must be submitted(In case where an application is made as assignment) International application under PCT(patent cooperation treaty) can also consider as an application if a corresponding application if filled before the controller of India Every application should say
The possession of which invention Owner claiming the first invention
The application must contain a
declaration that the applicant believe that the person so named is the true and first inventor Contain a provisional or complete specification SPECIFICATIONS Contain the detailed preceding and disclosure about invention Determines the patentability of the invention Has the technical aspect and scientific explanation of the invention
Types of specification Both are permanent and independent document
Generally done after
A more detailed
the provisional specification Prepared with greater details and more accuracy It is submitted with in 12 months of date of application After that it can be filled up to 15 months provided
document States nature of invention and process involved in the invention Helps to establish the identity of inventor and register the earliest authorship of invention at the patent office
If two applications are made in the
same name may considered as one if one is modification of other and the applicant must submit one complete specification with respect to all such provisional specifications If application for patent is not applied in conventional one with complete specification it is treated as a provisional specification before acceptance
Title- to the specification and concise but
PARTS OF COMPLETE SPECIFICATION
illustrative it self Opening descriptions-provide preamble to the invention Prior art reference- previous knowledge of present invention(not in India) Objective of invention- purpose of invention and utility aspects Statement of invention-it gives the additional claim written at below and provide supportive statement Claims-defines the monopoly rights and state what the invention want to protect in a lucid manner
Detailed description- illustrative
explanation with all pro and cons of invention and must be sufficient enough to enable national skilled persons to put it into practice PRIORITY DATE It is the date that claim the invention is date of filling the application PUBLICATION OF APPLICATION(IIA) Published in the 18 month after application The publication is notified in the official gazette date of application , number of
Examination by the National or Regional Patent Offices Done in two steps ie request for examination and final
Former is done with in 48 months from date of filling and essentially requires a request from applicant Second one checks Documents are as per requirement or not For any lawful ground of objection Contain results of search for previous publication or claim
Make report with in 18 months from the date of
Formal examination Substantive examination Novelty Inventive Industrial Applicable
OPPOSITIO TO GRANT PATENTING Person interested to oppose may notice with
in 4 months of advertisement of acceptance Opposition is based on section 25 GROUNDS OF OPPOSITION
Obtaining wrong fully Prior publication Prior public use or prior public knowledge Obviousness or lack of innovative step Non patentable invention Insufficient description of invention Failure to describe the information related to foreign inventions If conventional application is not made with in specified time
GRANT AND SEALING
Complete specification accepted Time specified to oppose is expired Opposed but finally decided in favor of
Sealing requires request with in 6
month from the date of advertisement of acceptance of complete specification Else remained pending before the controller or appellate board request is made within prescribed period of final decision on proceedings
(Trade related aspects of intellectual property rights)
International agreement administered
by WTO, sets minimum standards for intellectual property. Negotiated at the end of Uruguay ground of GATT in 1994 TRIPS is the most important multilateral instrument for the globalization of intellectual property laws. DOHA declaration- it’s a WTO statement clarifies the scope of TRIPS and to interpret in light of goal “to promote access to medicines for all”
TRADE RELATED INTELLECTUAL PROPERTY RIGHTS(TRIPS)
TRIPS has 7 parts and 73 Articles Part1(Art1-8)General Provisions and basic principles Part II standards concerning the availability, scope and use of IPR (Art 9-40) Part III Enforcement (Art 41-61) Part IV Acquisition and maintenance of IPR and inter parties procedures (Art 62)
Part V Dispute prevention and
settlement (Art 63 and 64) Part VI Transitional arrangements (Art 65-67) Part VII Institutional arrangements (Art 68-73)
OBJECTIVES OF TRIPS
Protection and the enforcement of all
intellectual property rights Promotion of technological innovation Mutual advantage of producers and user of technological knowledge Conductive to social and economic welfare, to a balance of rights and obligations
provide strong protection for IPR Distortions reduce and impediments
to international trade and ensure that measures and procedures to enforce IPR, do not themselves become barriers to legitimate trade Recognizing the need for multilateral frame work of principles, rules and disciplines dealing with international trade in counterfeit goods.
NATURE AND SCOPE OF OBLIGATIONS
Members shall give effect to the
provision of this agreement and to determine appropriate method of implementing the provisions of this agreement within their own legal system and practice In respect of the relevant IPR those natural or legal persons that would meet the criteria for eligibility protection provided in Paris Convention(1967) Berne Convention
INTELECTUAL PROPERTY CONVENTION
Paris Convention(1967) Berne
Convention (1971), Rome Convention and Treaty on intellectual property in respect of integrated circuits MOST FAVOURED NATION TREATMENT Deriving from international agreements on judicial assistance or law enforcement of general nature and not confined to the protection of intellectual property The entry in to force of WTO agreement are notified to the council for TRIPS and do not constitute an arbitrary or
NATIONAL TREATMENT In respect of performers produces of phonograms and broadcasting organizations applies in respect of rights provided under this agreement
MULTILATERAL AGGREMENT ON ACQUISITON OR MAINTAINANCE OF PROTECTION The obligations provided in multilateral agreements concluded under auspices of WIIPO relate in to acquisition or maintenance of IPR
PRINCIPLES OF IPR
In formulating and amending their
laws and regulations adopt measures necessary to protect public health and nutrition Appropriate measures with the provision of this agreement needed to prevent the abuse of intellectual property rights by right holders The resort to practices which unreasonably restrained trade or adversely affect the international
POST TRIPS EXPANSIONISM
Creation of anti-circumvention laws
to protect right management systems, achieved by WIPO treaty. The wording of trips 27 is nondiscrimination used to justify an extension of patent system Restrict the possibility of compulsory licenses for patent in recent bilateral trade agreements.
BENEFITS OF TRIPS
The product patent will provide
Indian companies, opportunities to compete against MNC Encourage innovation and bring efficiencies of global standard Liberalization and changes in patent regimes, triggered most towards efficiency As per WTO & TRIPS Agreement ,on expiry of patent term the drugs will open to generic manufacture to
TRIPS AGREEMENT FOR PHARMACEUTICALS
A twenty year patent form No discrimination between locally
produced and imported products Compulsory licensing of patented technology is strictly limited and cannot be used as a target to a particular industry Patent rights must be extended to all fields of technology with out discrimination
GATT-General agreement on tariff & trade GATT consist of
Provision in GATT annexed to the final act
adopted at the conclusion of the second session of preparatory committee of UN conference in trade and employment The provision of legal instruments entered in to force under GATT 1947 before the date of entry of WTO agreement Protocol and certifications relating to tariff concessions Protocols of accession concerning provisional application and withdrawal Decisions on waivers granted under article XXV of
THE UNDERSTANDING SET FORTH
understanding the interpretation of article2 in to 1B GATT 1994 Understanding the interpretation of article XVII of GATT 1994 Understanding on balance of payment provisions of GATT 1994 Understanding the interpretation of article XXIV of GATT 1994 Understanding in respect of waivers of obligation under GATT 1994 Understanding the interpretation of article XXVIII of GATT 1994
The Marrakech protocol to GATT 1994
OBJECTIVES Creating credible & reliable system of international trade rules Ensuring fair & equitable treatment of all participants. Stimulating economic activity through guar rented policy bindings Promoting trade & development through to progressive liberalisation .
Patent Is a grant of a monopoly right
by an Authority to an inventor/ assignee to use, sell, distribute, license his invention his invention for a limited term in return of complete disclosure that shall be available for public use after the expiry of the term.
A patent provides protection for the
invention to the owner of the patent
The Patent Law of 1856 The Patent and Designs Act, 1911. The Patents Act, 1970
Mailbox provision Exclusive Marketing Rights (EMRs)
Scope of patentable inventions Grant of new rights Extension of the term of protection Provision for reversal of burden of conditions for compulsory license
III and Final Amendment-2005
area of Introduction of product patents in the chemicals, pharmaceuticals, agricultural
• • • • • • • • • • •
Preliminary INVENTIONS NOT PATENTABLE APPLICATIONS FOR PATENTS EXAMINATION OF APPLICATIONS EXCLUSIVE MARKETING RIGHTS OPPOSITION TO GRANT OF PATENT ANTICIPATION PROVISIONS FOR SECRECY OF CERTAIN INVENTIONS PATENTS OF ADDITION GRANT AND SEALING OF PATENTS AND RIGHTS CONFERRED THEREBY
• • • • • • •
AMENDMENT OF APPLICATIONS AND SPECIFICATIONS RESTORATION OF LAPSED PATENTS REGISTER OF PATENTS SURRENDER AND REVOCATION OF PATENTS POWERS OF CONTROLLER GENERALLY APPEALS USE OF INVENTIONS FOR PURPOSES OF GOVERNMENT AND ACQUISITION OF INVENTIONS BY CENTRAL GOVERNMENT INTERNATIONAL ARRANGEMENTS PENALTIES
WHO CAN APPLY
Application may be made, either alone or
jointly with another, by the inventor, assignee, legal representative of deceased inventor or assignee.
The inventor is entitled to be mentioned
in the patent if he applies to do so.
Application may be made jointly by two or
more corporations as assignees.
An invention means any new and useful
art, process, method or manner of manufacture; machine, apparatus or other article; or substance produced by manufacture, and includes any new and useful improvement of any of them, and an alleged invention.
WHAT IS NOT PATENTABLE
An invention that is frivolous or that claims anything obviously contrary to well-established natural laws An invention the primary or intended use of which would be contrary to law or morality or injurious to public health The A method or process of testing applicable during the process of manufacture mere discovery of a scientific principle or the formulation of an abstract theory duplication of known devices
The mere arrangement or rearrangement or
DOCUMENTS REQUIRED EXAMINATION & PUBLICATION OPPOSITIONS GRANT/ SEALING OF PATENT TERM OF PATENT SALIENTFEATURES OF THE INDIAN
PATENT ACT 1970
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