Pharma patent development in 2012

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  • 1. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, 26-27, M G Road, PHARMA PATENT Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, DEVELOPMENT # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 IN 2012 SUCHITRA BAI EMAIL info@altacit.com ALTACIT GLOBAL WEBSITE www.altacit.com
  • 2. MEANING OF PATENT? CHENNAI3rd Floor, ‘Creative Enclave’, • A patent is a property right granted to the inventor148-150, Luz Church Road, Mylapore, possessing the criteria of Novelty, Inventive step and Chennai - 600 004. Tel: +91 - 44 - 2498 4821 Industrial Applicability. BANGALORE Suite 920, Level 9, Raheja Towers, • Novelty refers to invention which is new and is not 26-27, M G Road, Bangalore - 560 001. disclosed before the filing of the application. Tel: +91 - 80 - 6546 2400 COIMBATORE • The owner of a patent has the right to exclude others BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. from making, using, offering for sale, or selling his Tel: +91 - 422 – 6552921 or her invention for a period of 20 years from the filing of the patent application. An invention is any new or useful process, machine, article of manufacture, or composition of matter. EMAIL info@altacit.com WEBSITE www.altacit.com
  • 3. LAWS GOVERNING PATENTS IN INDIA CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, A.THE PATENTS ACT, 1970. 26-27, M G Road, B.THE PATENTS RULES, 2003 Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com
  • 4. TRIPS AGREEMENT CHENNAI a. Set of minimum standards.3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 b. Signed by approx. 153 parties and is subjected to dispute BANGALORE settlement body Suite 920, Level 9, Raheja Towers, 26-27, M G Road, c. Enforcement Mechanisms. Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 d. Subjected to National Treatment [MFN means that every [ COIMBATORE BB1, Park Avenue, time a country lowers a trade barrier or opens up a market, it # 48, Race Course Road, Coimbatore - 641018. has to do so for the same goods or services from all its Tel: +91 - 422 – 6552921 trading partners — whether rich or poor, weak or strong] and Most-favoured-NationTreatment (MFN) Principles [Means that every time a country lowers a trade barrier or opens up a market, it has to do so for the same goods or services from all its trading partners — whether rich or EMAIL info@altacit.com poor, weak or strong]. WEBSITE www.altacit.com
  • 5. COMPULSORY LICENSE CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, i. Right to use the patent without permission of the Mylapore, Chennai - 600 004. patent holder subject to certain conditions (Art. 31 Tel: +91 - 44 - 2498 4821 BANGALORE TRIPS) Suite 920, Level 9, Raheja Towers, ii. Authorization of such use shall be considered on its individual merits; 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE iii. Such use may only be permitted if, prior to such BB1, Park Avenue, # 48, Race Course Road, use, the proposed user has made efforts to obtain authorization from the right holder on reasonable Coimbatore - 641018. Tel: +91 - 422 – 6552921 commercial terms and conditions and that such efforts have not been successful within a reasonable period of time. This requirement may be waived by a Member in the case of a national EMAIL emergency or other circumstances of extreme info@altacit.com urgency or in cases of public non-commercial use. WEBSITE www.altacit.com
  • 6. GROUNDS FOR COMPULSORY LICENCE CHENNAI3rd Floor, ‘Creative Enclave’, • Section 84: (1) At any time after the expiration of148-150, Luz Church Road, Mylapore, Chennai - 600 004. three years from the date of the grant of a patent, any person interested may make an application to Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, the Controller for grant of compulsory licence on 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 patent on any of the following grounds, namely: COIMBATORE — BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. • (a) that the reasonable requirements of the public Tel: +91 - 422 – 6552921 with respect to the patented invention have not been satisfied, or • (b) that the patented invention is not available to the public at a reasonably affordable price, or • (c) that the patented invention is not worked in the EMAIL info@altacit.com WEBSITE territory of India. www.altacit.com
  • 7. NATCO PHARMA CASE CHENNAI3rd Floor, ‘Creative Enclave’, • The Controller General of patents granted a compulsory license148-150, Luz Church Road, and issued the order on 9th March 2012 to NATCO pharma Mylapore, Chennai - 600 004. [Indian Company] to manufacture sorafenib tosylate (patented by Tel: +91 - 44 - 2498 4821 pharmaceutical multinational Bayer – German Company). On BANGALORE Suite 920, Level 9, observing that: (i) reasonable requirements of the public were not Raheja Towers, 26-27, M G Road, Bangalore - 560 001. satisfied (ii) drug was not "reasonably affordable" to the public Tel: +91 - 80 - 6546 2400 (iii) Non-Working of the Patent, a compulsory license was issued COIMBATORE BB1, Park Avenue, under section 84 of Indian patent act. # 48, Race Course Road, Coimbatore - 641018. • Natco is now free to manufacture and sell a generic version of Tel: +91 - 422 – 6552921 Nexavar (a kidney/liver cancer drug that goes by the generic name of Sorafenib Tosylate), but will have to pay a 6% royalty on the net sales (every quarter) to Bayer. Further, it can only charge Rs 8800 for a monthly dose (120 tablets) of the drug. In its written submission, Natco also committed to donating free supplies of the EMAIL medicines to 600 needy patients each year and this commitment info@altacit.com has also been recorded in the compulsory licence (CL) order. WEBSITE www.altacit.com •
  • 8. PFIZER CASE CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Sunitinib, patented by Pfizer/Sugen, a drug used Mylapore, Chennai - 600 004. to treat abnormal protein kinase activity was Tel: +91 - 44 - 2498 4821 BANGALORE revoked by Indian patent office in a post grant Suite 920, Level 9, Raheja Towers, 26-27, M G Road, opposition by Cipla on the grounds of Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 obviousness. COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com
  • 9. ROCHE VS. CIPLA • In India the first Patent infringement suit relating CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Mylapore, to Pharmaceutical patent litigation in the Post Chennai - 600 004. Tel: +91 - 44 - 2498 4821 TRIPS era was decided in this case. BANGALORE Suite 920, Level 9, • The Delhi High Court dismissed Roches patent Raheja Towers, 26-27, M G Road, infringement suit, brought after Cipla launched Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 its own lung cancer drug, Erlocip. COIMBATORE BB1, Park Avenue, • The Court had recognised the validity of Roches # 48, Race Course Road, Coimbatore - 641018. patent and dismissed the court action after Tel: +91 - 422 – 6552921 deciding Ciplas generic and Roches drug had different molecular structures. • This was held to be a landmark judgement and upheld the patent of Roche and, at the same time, ruled that Ciplas version is valid. EMAIL info@altacit.com WEBSITE www.altacit.com
  • 10. CHENNAI3rd Floor, ‘Creative Enclave’, • India’s first pharmaceutical product patent148-150, Luz Church Road, Mylapore, Chennai - 600 004. pegylated interferon alfa-2a (a medicine used to Tel: +91 - 44 - 2498 4821 BANGALORE treat Hepatitis C patented by Roche) which Suite 920, Level 9, Raheja Towers, 26-27, M G Road, survived a post grant opposition was ultimately Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 revoked by the Intellectual Property Appellate COIMBATORE BB1, Park Avenue, board (IPAB) on the grounds of obviousness and # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 not meeting the criteria set out in Section 3(d), much to the delight of patient groups and public health activists. The decision also held that patient groups fall within the purview of the term “person interested” as noted in the Indian EMAIL info@altacit.com Patent Act. WEBSITE www.altacit.com
  • 11. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road, Mylapore, Chennai - 600 004. Tel: +91 - 44 - 2498 4821 BANGALORE Suite 920, Level 9, Raheja Towers, THANK YOU 26-27, M G Road, Bangalore - 560 001. Tel: +91 - 80 - 6546 2400 COIMBATORE BB1, Park Avenue, # 48, Race Course Road, Coimbatore - 641018. Tel: +91 - 422 – 6552921 EMAIL info@altacit.com WEBSITE www.altacit.com