Patents

IP Organisations • World Intellectual Property Organisation (WIPO) • Patent Cooperation Treaty (PCT) • European Patent Office (EPO) • GCC Patent Office • Eurasian Patent Office (EAPO) • Africa Regional Industrial Property Office (ARIPO) • National IP Offices (Oman Ministry of C&I) 1 Intellectual Property Attorneys IP agent functions plus: 1. Legal advice 2. Infringement & Validity Opinions 3. Litigation action in Court 4. Contracts & Licences 2 Infringement Opinion • Attorney reviews existing patents in detail. • Your invention is compared to an existing valid patent to see if yours “reads on” or is described by the previous patent claims. 3 Mission of IPR in India • • Patents are good barometer of creativity & tenacity and ability to build knowledge Enables the prospects for future research & rewards researcher for its originality • IITB, in first 20 months has filed 23 patent applications in India, and abroad through PCT route Pfizer, GSK are top filers of Patents in India • Journal of intellectual property rights , Vol 8 , Nov 2003 Patent Search • A search of prior art in existing patents, publications and catalogs may be online. • The more thorough search costs more and is done by person visiting the patent office. 5 Patentability Requirements Invention, that is: New at priority date, Practically useful, and not obvious to a 1. Novelty 2. Utility 3. Innovation skilled person in view of prior art 6 Indian Patent Law 05 • “ Extension of product patents to all fields of technology including, drugs, food & chemicals “( any invention , under clause m) • “ Protection to the NCE “ • Guarding the country against the use of dual technologies • Affordability & pricing sensitive 7 Patents • • Intended to provide incentive for effort and expense of invention. Patented inventions can be used by others through licensing and royalty arrangements. 8 Patents • • • • • • New, non-obvious, and useful. Specifications (including claims and drawings as needed) and an oath. First to invent, not first to file. Patent searches automated over web. Patent regulations differ throughout the world. No world-wide, universal patent. 9 What to Patent ! • Patents offer IP protection through the legal system. • Attorneys are needed to defend a patent. • A large corporation can out-maneuver a small company and tie up decisions in litigation for many years. • Patents may not be useful for product with short life < time for patent grant. 10 Patents: Invented Product or Process   Device / Machine/Apparatus Composition of Matter Method / Process New use of a known Invention Genetically modified species Improvements: >90% of Patents 11     Patent Rights Exclusivity  Vaild for 20 years from priority date subject to:    Payment of maintenance fees Modification or invalidation by courts Re-examination by IP Office  No inherent rights to use the invention  Offensive rights to stop others from openly making, using, distributing or selling the invention, or its improvements  License or transfer rights, for a price 12 IP Length and Strength IP Realm Patents Trade Secrets Copyrights Length Strength 20 Years from High Date of Filing Indefinite Medium to Low Life+70 // Low < of 95/120 Indefinite Trademarks Medium 13 Patent Stats – U.S. and the World • Patents granted in US from 1987 to 2000: 3.1 million – Foreign patents: 1.2 million patents – Japan - 45,000 patents – Germany - 23,000 patents – China - 930 patents – India - 902 patents 14 SCOPE OF PROTECTION Types of Pharmaceutical Inventions STRONGEST • Product - Covers active compound per se, regardless of process or use • • Enantiomers, Salts, Hydrates, Polymorphs Formulation/Composition - Covers mixture of active drug with specific excipients • • Use - Covers use of compound for particular use Process - Covers chemical process to make active compound • Combination – Covers compound in combination with other active compound • Metabolite – Covers biodegraded compound 15 5 Benefits of IPR Protection  Competitive technological edge  Access to international markets  Licensing Revenues  Franchising opportunities  Asset for attracting venture capital  Counter-litigation defence 16 PRE-GRANT OPPOSITION  No change to provisions relating to pre-grant opposition of patents as provided in the 2003 Bill.  The law now will provide for both Pre-grant and Post-grant opposition in the Patent Office.  However, the pre-grant opposition provision (new Sec. 25) provides for limited representation (no hearing) opportunity for third parties on two grounds restricted to Patentability and nondisclosure or wrongful disclosure alone (earlier 9 grounds) 7 17 COMPULSORY LICENSING INDIA  Post Doha Declaration, the JPC Report completely rewrites this Chapter but does little to change the structure of the law that 1. favors parties that are not patent owners 2. favors Indian based manufacturers 3. triggers grounds for imposition a CL for virtually any use of the exclusive rights granted by a patent  In national emergency, extreme urgency, public non commercial use including public health crises relating to AIDS, TB, Malaria and other epidemics 9 18 COMPULSORY LICENSING Local working requirements ambiguous- while the words “manufacture in India” are deleted, the words “ patented invention has not been worked in India” has been newly inserted. There remain several examples of importation discrimination outside the Compulsory Licensing provisions. 11 19 COMPULSORY LICENSING Many triggers reasonable requirements of public 1. Reasonably affordable prices 2. existing trade or industry or development /establishment prejudiced 3. demand not met to an adequate extent on reasonable terms 4. a market for exports not developed 5. if not worked in India on a commercial scale 6. if working is being prevented by importation. 13 20 Situational Amendments • Least Developing countries would be allowed importation of patented pharmaceutical products from India Even after the Mail Box is opened, companies already manufacturing the patented products would be allowed to do so after paying a reasonable royalty to the patent holder ! • Patents ,NR Subbaram, Former controller of patent office 21 Indian Patent Ordinance 05 Patent Forms issued (Rules 2003 ) • Form 20 : 39/70, Revision of terms & conditions for licence • Form 21 : 39/70, Request for the termination of the compulsory licence • Form 22 : 39/70, Registeration of the patent agent • Form 23 : 39/70, Restoration of the name in the register of patent agents 22 Indian Patent Ordinance 05 • Section 102 : means acquisition of patent for public purpose by government • Bolar provision 107A (a): Immediately after the expiry of the term the non patentees can go for the preparatory action , which should be specified • Parallel import 107A (b) : provides import of same ingredient from the cheapest source of production 23 Indian Patent Ordinance 05 Patent Forms issued ( Rules 2003 ), section 39 means the Grant Patent section , para • Form 1: 39/70, Application for the grant of patent • Form 2: 39/70 , Provisional/ Complete specification • Form 3: 39/70, Statement & Undertaking • Form 4: 39/70, Request for the extension of time 24 Indian Patent Ordinance 05 • Reduction in the processing time for patents , by simplifying and rationalising procedures • - The Patent Prosecution time 25 Indian Patent Ordinance 05 Patent Forms issued (Rules 2003 ) • Form 5: 39/70 , Declaration to inventorship • Form 6 : 39/70, Change in application of patent • Form 7 : 39/70,Notice of opposition to a patent • Form 8: 39/70, Claim regarding inventorship 26 Indian Patent Ordinance 05 Patent Forms issued (Rules 2003 ) • Form 16:39/70, Registeration of Title or proprietary ship • Form 17 : 39/70, Application for compulsory licence • Form 18 : 39/70, Request for the examination of the patent • Form 19 : 39/70, Revocation of patent for non working 27 Indian Patent Ordinance 05 • EMR will is redundant / excluded • Transitional provision to safeguard EMR , already granted 28 Indian Patent Ordinance 05 Patent Forms issued (Rules 2003 ) • Form 9: 39/70, The request for the publication of the patent • Form 10: 39/70, Application for the amendment of patent • Form 11 : 39/70, Application for direction of controller • Form 12 : 39/70, Request for the grant of patent under specified sections 29 Indian Patent Ordinance 05 Patent Forms issued (Rules 2003 ) • Form 13 : 39/70, Amendment of application for Complete patent specification • Form 14 : 39/70, Notice of opposition to amendment / restoration/ surrender of patent / grant of compulsory licence • Form 15 : 39/70, Application for the restoration of patent 30 Indian Patent Ordinance 05 Patent Forms issued (Rules 2003 ) • Form 24 : 39/70, Application for the review by controller for decision • Form 25 : 39/70, Permission for the patent application outside India • Form 26 : 39/70, Form for authorization of the patent agent • Form 27 : 39/70, Working of the patented invention on a commercial scale in India 31 Indian Patent Ordinance 05 • Section 47 : Empowers government to import , make or use any patent for its own purpose or import drugs for health distribution • Section 66 : revocation of patent in public interest • Section 84 to 94 are for reasonable pricing 32 Cost of Patenting • Under the First Schedule it depends on the statements filed , number of pages, date of filing, before the patent expiry and the cost of the petitions in duplicate 33 Is it Worth the Co$t? • Worth it if needed to: Prevent reverse-engineering Gain monopoly in specific industry Use a a long-term R&D investment • May not be worth it if Invention was: For a short commercial life Only for single or internal users Useful only to average consumers 34 Cost of Patenting Under the 4th Schedule the rough cost split as : • Application for term revision • Application for compulsory licence/ non revoking • Hearing under rule • For notice of opposition / stay (all of above Rs 6000 each ) • Affidavit statement Rs2500 • Hearing cost per day Rs2500 • Publication of document Rs 1000 • Irrelevant citation Rs 1000 • Stamp fee for POA Actuals 35 Data Exclusivity • Requirements needed to be met… – All the indications that the generic drug is seeking approval for must have been approved for the pioneer drug. – All the active ingredients of the generic drug are the same as those in the pioneer drug – The route of administration, the dosage form, and the strength of the generic drug are the same as the pioneer. – The labeling must be the same, except for the manufacturer. – Must have full list of components, full statement of the composition of the drug, full description of the manufacturing processes, samples, and specimens of the labeling. – Applicants must certify, with respect to any patents which cover the pioneer drug, 1) there is no patent, 2) the patent has expired, 3) the date a relevant patent will expire, or 4) that the applicant feels the patent is invalid or will not be infringed by the generic drug. 36 Data Exclusivity • 5 year data exclusivity for the first form of a product that contains a new chemical entity not approved previously – The exclusivity is limited to the conditions of approval 37