By Dr. Gopakumar G. Nair Advisor to Pharmexcil, India Gopakumar Nair Associates Url: Ahmedabad, 24 th November, 2010

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

Intellectual property (IP) refers to creations of the mind : inventions, literary and artistic works, and symbols, names, images, and designs used in commerce.

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.

Think Away From The Box

7 Patent Patent US Trademark Multi-Haler™ Design No Trade Secret Know-how Copyright TM (Amendment) Bill, 2009 passed by Rajya Sabha on 10 th August, 2010 Novel & Inventive External Appearance Confidential Informn & Undisclosed Tech Package Insert/ Information Leaflet

TRIPS The TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement came into being with the establishment of the WTO (World Trade Organization) effective from 1 st January, 1995.

 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

TRIPS – Article 27 Patentable Subject Matter 1.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][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.

TRIPS – Article 27 Patentable 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][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.

What is a Patent ? 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

 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)

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))

Patent - Patentability An invention can be patented if it is  NOVEL : Must be New, Must DISTINGUISH from “State of the Art” (PRIOR ART)  Must have INVENTIVE STEP Non-obvious to a person “Skilled in the Art”  Must have INDUSTRIAL APPLICATION Must be Useful Must have Utility  Must not be covered by Sec. 3 and Sec. 4.

Non-Obvious 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.

Inventive Step 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.

Utility / Industrial Application  Be Useful  Must work / be workable  At least one recognized, verifiable and practical end-use

Patentability Filter 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

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)

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

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

Patent – Filing of Application 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

Complete Specification  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

Prosecution of a Patent 1) Optional-Early Publication OR 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.

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

 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.

 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

Patent Filing Strategies  Only National Filing  Only Convention filing (US /EU etc.)  National + Convention Country  National + US + EU  Only PCT  National + PCT Any or all 142 States (With permission) INTELLECTUAL PROPERTY RIGHTS ARE TERRITORIAL

 Provisional Application  Complete Application  Convention Application  Application for Patent of Addition (CIP)  Cognate Application  Divisional Application  PCT International Application  PCT National Phase Application

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 LICENSING GOVERNMENT USE

RIGHTS  Exclusive 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 invention  Exemption 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 / 3 rd Party use.  Prohibit or Restriction of publication of patent information considered relevant for defense purposes. quid pro quo

CBD CONVENTION ON BIODIVERSITY UPOV Plant Varieties Protection Act Data Exclusivity GNAs

Sources  Incremental Innovations  Need-based Solutions  Intensive Research  Disruptive inventions  Serendipity

 NCE/NME  API  Product Patent  Process Patent  ‘Me too’ derivatives – Imati nib, Erlot nib  Formulation  Dosage Forms – Tablet, Capsule, etc  Release Profile – Controlled, Slow etc.  NDDS - Transdermal Patches, Transmucosal Drug Delivery.  New Use – Aspirin (analgesic & blood thinner) Famo tidine Tio tidine