Explanation of Section 3d of Patents Act, 1970 and Medicines

Pre-2005 amendment of Patent law, product patenting to pharmaceutical substances were not acknowledged. Introduction of section 3(d) of patent act has helped in preventing the multinational pharmaceutical companies from extending the life of a patent or from ‘ever greening the product’. Hence, this very provision attempts to regulate the granting of such patents by limiting the scope of protection available for derivatives of known substances and new uses of known substance, which results in only a trivial development. This provision of was challenged in the case of Novartis AG vs. Union of India[1], when Novartis patent application for newer version... Read More

Germany’s Boehringer Repudiated Patent on HIV Drug- Nevirapine

The Indian Patent Office has repudiated Germany's Boehringer Ingelheim patent on its key HIV drug- Nevirapine, Patent Application Number: 4724/DELNP/2009 entitled “Extended release formulation of Nevirapine”, for a version sold as Viramune XR (extended release), once again forestalling attempts by Big Pharma for "exclusivity" extension on their patented drugs to reportedly block entry of reasonably priced generics. Boehringer Ingelheim, one of the few family-owned pharma company globally, is working on biosimilars, immuno-oncology and, new treatment options for psychiatric disorders like forms of depression or schizophrenia etc. Globally, it has a strong pipeline in oncology, respiratory, stroke and diabetes prescription medicines... Read More

Revocation of Valganciclovir patent by Controller of Patents, Chennai

Recently in a matter remanded from IPAB to Controller of Patents, Chennai, a decision of revoking Roche's patent IN207232 for Valganciclovir was delivered after hearing both the parties. The subject patent was granted on January, 2009 followed which post grant oppositions were separately filed by CIPLA, Matrix, Ranbaxy and Bakul Pharma along with two NGOs Delhi Network of Positive People and lndian Network for People living with HIV/AIDS & The Tamil Nadu Networking People with HIV/AIDS (hereinafter INP+ and TNNP+), wherein INP+ and TNNP+ were allowed by the Apex court to raise all contentions in the form of an intervention... Read More

Section 3(D) of Indian Patent Act Strikes Again

India revoked yet another drug patent granted to a German MNC, Boehringer Ingelheim, for its respiratory drug, Spiriva (crystalline tiotropium bromide monohydrate) at a time when the US is putting pressure on Indian government for not providing adequate patent protection to multinational drug companies. In its decision, the patent office held that Boehringer failed to establish any technical advancement or any economic significance for the compound, and the monohydrate crystal form also fails to demonstrate any new therapeutic efficacy and therefore cannot fulfill the requirement of a patentable invention under Section 3(d) of the Patents Act. Facts and highlights of... Read More

Recent decision of Delhi High Court in the case of GILEAD PHARMASSET, LLC V. UNION OF INDIA & ANR

Recently, the Delhi high court on dated 30th January 2015 set aside an order of the Deputy Controller of Patents and Designs. The impugned order rejected a patent to US drug maker Gilead for its hepatitis C drug “Sovaldi” on dated 13th January 2015. The detailed judgment can be found here. Facts of the case: M/S GILEAD PHARMASSET, INC, USA, filed a patent application on 30/05/2003 in USA and the corresponding application was filed in India through PCT on 27/12/2005 vide application no. 6087/DELNP/2005 ("A (2'R)-2'-DEOXY-2'FLUORO-2'-C-METHYL NUCLEOSIDE"). Two Entities, NATCO Pharma Ltd. and Delhi Network of Positive People +IMAK filed applications... Read More