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Transcript of By Dr. Gopakumar G. Nair Advisor to Pharmexcil, India Gopakumar Nair Associates Url: Email:...
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ByDr. Gopakumar G. NairAdvisor to Pharmexcil, IndiaGopakumar Nair AssociatesUrl: www.gnaipr.netEmail: [email protected], 24th November, 2010
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Property Right
INTELLECT – PROPERTY – RIGHT
Idea Expression COPYRIGHT
Idea Innovation Invention PATENT
Idea Quality + Identity TRADEMARK
Idea Appearance DESIGN
Idea Keep Confidential No Disclosure
TRADE SECRETS
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Intellectual property (IP) refers to
creations of the mind: inventions,
literary and artistic works, and
symbols, names, images, and designs
used in commerce.
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Creativity is the ability to Think / come up with new idea design new “inventions” produce “works of art” solve problems in new ways, or
develop a new idea based on an “original” knowledge.
novel, or unconventional approach.
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Think Away Think Away From The From The
BoxBox
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7
Patent US7395821
TrademarkMulti-
Haler™
Design No.
211208
Trade SecretKnow-how
Copyright
TM (Amendment) Bill, 2009 passed
by Rajya Sabha on 10th August, 2010
Novel & Inventive
External Appearance
Confidential Informn&
Undisclosed Tech
Package Insert/ Information Leaflet
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TRIPSTRIPS
The TRIPS (Trade Related Aspects
of Intellectual Property Rights)
Agreement came into being with
the establishment of the WTO
(World Trade Organization)
effective from 1st January, 1995.
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UN organization dedicated to
promoting the use and protection
of works of the human spirit. Headquarters in Geneva,
Switzerland. 184 nations as member states. Manages all IPs. Training through Academy and
Seminars
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TRIPS – Article 27TRIPS – Article 27Patentable Subject Matter1. Subject to the provisions of paragraphs 2 and 3, patents
shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.
[1] Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.
2. Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.
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TRIPS – Article 27TRIPS – Article 27Patentable Subject Matter 3. Members may also exclude from patentability:(a) diagnostic, therapeutic and surgical methods for the
treatment of humans or animals;(b) plants and animals other than micro-organisms, and
essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof. The provisions of this subparagraph shall be reviewed four years after the date of entry into force of the WTO Agreement.
[1] For the purposes of this Article, the terms "inventive step" and "capable of industrial application" may be deemed by a Member to be synonymous with the terms "non-obvious" and "useful" respectively.
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A patent is a protection given to a patentee for an invention for a limited term by the government for disclosing the invention
Right to exclude others from using your invention.
Owner has a qualified right to use the invention
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A conditional grant
Balance of Rights and Obligations
Subject to other laws of land
Granted to owner of invention/assignee
(Recent judgments of HC and SC takes note of third party interests in granting / refusing injunctions)
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Three Statutory Benchmarks for Patentability as per the Patents Act, 1970:
1. Novelty
2. Inventive Step (Section 2(1)(ja))
3. Industrial Applicability (Section 2(1)(ac))
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An invention can be patented if it is
NOVEL: Must be New, Must DISTINGUISH from “State of the
Art” (PRIOR ART)
Must have INVENTIVE STEPNon-obvious to a person “Skilled in the
Art”
Must have INDUSTRIAL APPLICATIONMust be UsefulMust have Utility
Must not be covered by Sec. 3 and Sec. 4.
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THE DIFFERENCES BETWEEN THE
CLAIMED INVENTION and the PRIOR ART are
such that the subject matter as a whole
WOULD NOT HAVE BEEN OBVIOUS at the
time the invention was made to a PERSON
SKILLED IN THE ART, to which the subject
matter pertains.
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Section 2(1)(ja):
"inventive step" means a feature of an
invention that involves technical
advance 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.
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Be Useful
Must work / be workable
At least one recognized, verifiable
and practical end-use
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Prior use/ prior publication/ prior disclosure
Industrial applicability Novelty Non-obviousness- inventiveness Sec. 3 - Not patentable Written description / enablement
requirements Application/ specification/ claims Patent prosecution Maintenance / Defense after grant
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What is not Patentable
(a) Frivolous, Contrary To Natural Laws
(b) Contrary To Public Order Or Morality, Prejudice To Human, Animal Or Plant Life Or Health Or To The Environment;
(c) Mere Discovery Of Scientific Principle, Abstract Theory, Living Thing Or
Non- living Substances
(d) Mere Discovery Of New Form, New Property, New Use Of A Known Process, Machine Or Apparatus (EFFICACY)
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What is not Patentable
(e) Mere Admixture (SYNERGY)
(f) Mere Arrangement, Re-arrangement, Duplication of known devices.
(g) Omitted (Testing Methods)
(h) Method Of Agriculture Or Horticulture;
(i) Method Of Treatment.
(j) Plants, Animals, Including Seeds Varieties, Species, Biological Processes.
Exception: Microorganisms
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What is not Patentable
(k) Mathematical Or Business Method Or A Computer Program Per Se Or
Algorithms;
(l) Literary, Dramatic, Musical Or Artistic Work, Other Aesthetic Work
(m) Mere Scheme, Rule, Method Of Performing Mental Act, Playing Game;
(n) A Presentation Of Information;
(o) Topography Of Integrated Circuits;
(p) Traditional Knowledge
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When to file :- Earliest – as Provisional Application
Could continue working & file Complete Specification later
- To establish Priority Date- To establish early Ownership- To Pre-empt Others-Complete specification to be filed within 12 months of filing Provisional Application
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Title Technical Field Background and Prior Art Current Problem / Drawback / Gap Solution to the problem/improvement Summary of Invention Detailed Description Experiments/Trials/Examples (incld. Tabular
column if any) Claims Abstract
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1) Optional-Early PublicationOR
18 months publication (automatic)
2) Request for Examination
3) First Examination Report
4) Responses – to & fro
5) Acceptance for Grant OR Rejection
6) Patent Term – 20yrs from date of filing.
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Filing of patent application
Publication after 18 months
Pre Grant Opposition /Representation by any person.
Request for examination
Examination: Grant or Refusal
Publication of Grant of patent
Post Grant Opposition to grant of patent(Constitution of Opposition Board)
Early Publication
Decision By Controller
Prior art search
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Inventor & Consumer friendly. (Balance of Rights & Obligations).
Research & Regulatory Exemption during Patent Life (Sec 47(3), Sec. 107A(a)).
Four Patent Offices in four regions (Unique to India).
IAS - Senior Techno-legal officer appointed as CG. Patent Office procedures revamped, revitalized,
digitalized and made transparent. Out of box solutions being implemented to
expedite office actions. India becoming ISA / IPEA.
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Prior Art State of the Art Patentability (Novelty & Obviousness) Patent Validity / Expiration Legal Status Infringement Analysis – to Avoid / to Sue Freedom to Market Opposition Potential Partners for Licensing In/ Licensing Out,
Alliances, M&A Working Around Patent Watch / Monitor Patent Patent Family
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Only National Filing
Only Convention filing (US /EU etc.)
National + Convention Country
National + US + EU
Only PCT
National + PCT
Any or all 142 States
Any or all 142 States
(With permission)
(With permission)
INTELLECTUAL PROPERTY RIGHTS INTELLECTUAL PROPERTY RIGHTS ARE TERRITORIALARE TERRITORIAL
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Provisional Application
Complete Application
Convention Application
Application for Patent of Addition (CIP)
Cognate Application
Divisional Application
PCT International Application
PCT National Phase Application
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1. Inventive Step & Sec 3
2. Pre & Post grant opposition
3. Revocation through IPAB
4. Counter-claim for revocation in an
infringement suit.
(Balance against unfair monopoly)
COMPULSORY LICENSINGCOMPULSORY LICENSINGGOVERNMENT USEGOVERNMENT USE
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RIGHTSExclusive right to make, use, sell or import the patented invention.Exclude others from unauthorized use of the patented invention.Grant licenses, Assign rights or enter into agreements.To sue others for infringement.To surrender patent rights.
OBLIGATION/EXEMPTIONS
Disclosure of the inventionExemption for research, experimentation, imparting instructions to pupils.Use of Inventions for Government’s own purposes or for public services.Acquisition of Inventions by Central Government.Compulsory License / 3rd Party use.Prohibit or Restriction of publication of patent information considered relevant for defense purposes.
quid pro quo
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CBD
CONVENTION ON BIODIVERSITY
UPOV
Plant Varieties Protection Act
Data Exclusivity
GNAs
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Sources
Incremental Innovations
Need-based Solutions
Intensive Research
Disruptive inventions
Serendipity
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NCE/NME API Product Patent Process Patent ‘Me too’ derivatives – Imatinib, Erlotnib Formulation Dosage Forms – Tablet, Capsule, etc Release Profile – Controlled, Slow etc. NDDS - Transdermal Patches,
Transmucosal Drug Delivery. New Use – Aspirin (analgesic & blood
thinner)
Famotidine
Tiotidine