BASICS OF IPR By Dr Gopakumar G Nair

BASICS OF IPR By Dr. Gopakumar G. Nair Advisor to Pharmexcil, India Gopakumar Nair Associates Url: www. gnaipr. net Email: gopanair@gnaipr. net Ahmedabad, 24 th November, 2010

IP Evolution 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

What is Intellectual Property? Definition by WIPO Intellectual property (IP) refers to creations of the mind: inventions, literary and artistic works, and symbols, names, images, designs used in commerce. and

Creativity (creation of the mind) Creativity is the ability to Ø Think / come up with new idea Ø design new “inventions” Ø produce “works of art” Ø solve problems in new ways, or develop a new idea based on an “original” knowledge. Ø novel, or unconventional approach.

Think Away From The Box Generate Ideas…. . And Own Them…. . IPR !

IP Portfolio Novel & Inventive Patent US 7395821 Copyright TM (Amendment) Bill, 2009 passed by Rajya Sabha on 10 th August, 2010 Trademark Multi-Haler™ Package Insert/ Information Leaflet Trade Secret Know-how 7 External Appearance Confidential Informn & Undisclosed Tech Design No. 211208

Product Patents In India

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.

WIPO Ø UN organization dedicated to promoting the use and protection of works of the human spirit. Ø Headquarters in Geneva, Switzerland. Ø 184 nations as member states. Ø Manages all IPs. Ø 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] 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] 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

What is a Patent ? Ø A conditional grant Ø Balance of Rights and Obligations Ø Subject to other laws of land Ø 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 Ø NOVEL: Must be New, Must DISTINGUISH from “State of the Art” (PRIOR ART) Ø Must have INVENTIVE STEP Non-obvious to a person “Skilled in the Art” Ø Must have INDUSTRIAL APPLICATION Must be Useful Must have Utility Ø 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 Ø Be Useful Ø Must work / be workable Ø 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

Patents Act, 1970 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 Nonliving Substances (d) Mere Discovery Of New Form, New Property, New Use Of A Known Process, Machine Or Apparatus (EFFICACY)

Patents Act, 1970 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

Patents Act, 1970 What is not Patentable (k) Mathematical Or Business Method Or A Computer Program Per Se Or Algorithms; (l) Literary, Dramatic, Musical Or Artistic Other Aesthetic Work (m) Mere Scheme, Rule, Method Of Mental Act, Playing Game; (n) A Presentation Of Information; (o) Topography Of Integrated Circuits; (p) Traditional Knowledge Work, Performing

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 Ø Title Ø Technical Field Ø Background and Prior Art Ø Current Problem / Drawback / Gap Ø Solution to the problem/improvement Ø Summary of Invention Ø Detailed Description Ø Experiments/Trials/Examples (incld. Tabular column if any) Ø Claims Ø 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 – 20 yrs from date of filing.

Patent Grant Procedure Filing of patent application Early Publication Prior art search Publication after 18 months Request for examination Pre Grant Opposition / Representation by any person. Examination: Grant or Refusal Publication of Grant of patent Post Grant Opposition to grant of patent (Constitution of Opposition Board) Decision By Controller

Indian Patent Office Procedures v Inventor & Consumer friendly. (Balance of Rights & Obligations). v Research & Regulatory Exemption during Patent Life (Sec 47(3), Sec. 107 A(a)). v Four Patent Offices in four regions (Unique to India). v IAS - Senior Techno-legal officer appointed as CG. v Patent Office procedures revamped, revitalized, digitalized and made transparent. v Out of box solutions being implemented to expedite office actions. v India becoming ISA / IPEA.

Objectives of Search (Search Options) Ø Ø Ø Ø Ø 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 Ø Working Around Ø Patent Watch / Monitor Patent Ø Patent Family

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

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

TRIPS Plus – Tougher Patentability (Balance against unfair monopoly) 1. Inventive Step & Sec 3 2. Pre & Post grant opposition 3. Revocation through IPAB 4. Counter-claim for revocation in an infringement suit. COMPULSORY LICENSING GOVERNMENT USE

Rights & Obligation/Exemptions Of Patentee(s) RIGHTS Ø Exclusive right to make, use, sell or import the patented invention. Ø Exclude others from unauthorized use of the patented invention. Ø Grant licenses, Assign rights or enter into agreements. Ø To sue others for infringement. Ø To surrender patent rights. quid pro quo OBLIGATION/EXEMPTIONS ØDisclosure of the invention ØExemption for research, experimentation, imparting instructions to pupils. ØUse of Inventions for Government’s own purposes or for public services. ØAcquisition of Inventions by Central Government. ØCompulsory License / 3 rd Party use. ØProhibit or Restriction of publication of patent information considered relevant for defense purposes.

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

Innovations Sources Ø Incremental Innovations Ø Need-based Solutions Ø Intensive Research Ø Disruptive inventions Ø Serendipity The Evolution

Famotidine Ø Ø Ø Ø Ø NCE/NME API Product Patent Tiotidine Process Patent ‘Me too’ derivatives – Imatinib, Erlotnib Formulation Dosage Forms – Tablet, Capsule, etc Release Profile – Controlled, Slow etc. NDDS - Transdermal Patches, Transmucosal Drug Delivery. Ø New Use – Aspirin (analgesic & blood thinner)