The Intellectual Property Rights Regime in India & US: The Evolving Landscape February 15, 2014, The Hyatt Regency Hotel, New Delhi D. CALAB GABRIEL

SCOPE Peculiar provisions of Indian Patents Act Recent guidelines for examination issued by patent office Tips for successful patent litigation in India

PECULIAR FEATURES OF INDIAN PATENTS ACT, 1970 FOREIGN FILING PERMISSION PRE/POST GRANT OPPOSITION WORKING NO PATENT TERM EXTENSION BIOLOGICAL MATERIALS – DISCLOSURES NO DATA PROTECTION EXHAUSTION OF RIGHTS SECTION 3(d) COMPULSORY LICENSING BOLAR LIKE PROVISION NBA PERMISSION BEST MODE REQUIREMENT

SOME FINDINGS OF SUPREME COURT REGARDING SECTION 3(d) [Novartis case] Incremental inventions can be patented provided sufficient evidence of enhanced efficacy Efficacy for pharma means therapeutic efficacy Mere bioavailability not sufficient to prove therapeutic efficacy At least In-vivo animal model studies is required to establish therapeutic efficacy Factors like less toxicity, reduced side effects, etc. left open Questions regarding what is significant efficacy, known substance, derivative and many others, remain unanswered. 41/18/2014K&S Partners

SECOND MEDICAL USE Section 3(d) New Use of a Known substance Section 3(e) Mere admixture Section 3(i) Method of Treatment 11/18/ /18/2014K&S Partners

RECENT GUIDELINES FOR EXAMINATION ISSUED BY IPO Already made effective – Traditional Knowledge (TK) and biological material – Biotechnology In the pipeline – Computer related inventions (CRI) – Pharmaceuticals

GUIDELINES ON TK Term traditional knowledge not defined Section 3(p) prohibits patenting of an invention which in effect, is traditional knowledge or which is an aggregation or duplication of known properties of traditionally known component or components Screening and marking at receiving stage; narrow interpretation of novelty and inventive step Example - If the subject-matter as claimed relates to extracts/alkaloids and/or isolation of active ingredients of plants, which are naturally/inherently present in plants, such claims cannot be considered as novel and/or inventive when use of such plants is pre- known as part of teachings of Traditional Knowledge.

GUIDELINES ON BIOTECH RELATED INVENTIONS Narrow interpretation of novelty and inventive step Patenting of biological material such as isolated nucleic acids made subject to greater scrutiny Disclosure with regard to source and origin of biological material – linkage with Biological Diversity Act, 2000 Efforts to incorporate International Non-Proprietary Names (INN) of compounds in specification in pharma applications on the anvil

PROPOSED GUIDELINES ON CRIs Computer programs per se, Algorithms, mathematical method and business method are not patentable [Section 3(k)]. However, patentability of the computer programme depends on the interpretation of the expression ancillary thereto and developed thereon

TIPS FOR PATENT LITIGATION IN INDIA Choosing the jurisdiction Patent/designs : where defendant resides, carries on business, where infringing activities occur Trademark/Copyright: where Plaintiff resides, carries on business or defendant resides, carries on business, where infringing activities occur Which Court to choose: District Court Vs. High Court Mapping the defendant Nature of infringing activities : trader/manufacturer? The extent and duration of infringement The financial/other strengths of defendant Caution notice or filing of the suit

TIPS FOR PATENT LITIGATION IN INDIA Expert evidence - technical evidence by way of affidavits/test data Check the prosecution history for any prosecution history estoppel Corresponding foreign filing information Is the patent under any scrutiny? Age of the patent – how much time left in the term Marking of the products, market watch

THANK YOU D. Calab Gabriel