Strict Examination Criteria needed for Drug Patents

Background Patentability of pharmaceutical drugs and other issue associated with the patent have been a moot point all over the world. Like other developing countries, India has also started granting patent rights to pharmaceutical drug products since the year 2005. The biggest concern that comes up in this scenario is of ‘Ever greening strategies’ which are dealt in section 3(d) of the Indian Patent Act, 1970. The said section proscribes the grant of patent to a new form of a known substance unless it substantially enhances the therapeutic efficacy of the drugs. Thus, the need to strike a balance between... Read More

Analysis of the rejection of Lumacaftor (Polymorph) patent application in India

We have been receiving requests from our Pharma clients/readers of the blog for the analysis of the decision/ facts that led to rejection of Lumacaftor (Polymorph) patent application in India since last year. Here is our take: Details of the Patent Application and important dates: Patent application number in India 2056/KOLNP/2010 Title of the invention SOLID FORMS OF 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL) BENZOIC ACID Applicant VERTEX PHARMACEUTICALS INCORPORATED International application number/ International filing date PCT/US2008/08545/   04/12/2008 Priority Application Number/ Priority date US61/012,162   07/12/2007 National phase Filing date 04/12/2008 Publication date 03/09/2010 Request for examination date 25/11/2010 Pre-Grant Opposition under... Read More

Analysis of the rejection of Lumacaftor (Polymorph) patent application in India

We have been receiving requests from our Pharma clients/readers of the blog for the analysis of the decision/ facts that led to rejection of Lumacaftor (Polymorph) patent application in India since last year. Here is our take: Details of the Patent Application and important dates: Patent application number in India 2056/KOLNP/2010 Title of the invention SOLID FORMS OF 3-(6-(1-(2,2-DIFLUOROBENZO[D][1,3] DIOXOL-5-YL) CYCLOPROPANECARBOXAMIDO)-3-METHYLPYRIDIN-2-YL) BENZOIC ACID Applicant VERTEX PHARMACEUTICALS INCORPORATED International application number/ International filing date PCT/US2008/08545/   04/12/2008 Priority Application Number/ Priority date US61/012,162   07/12/2007 National phase Filing date 04/12/2008 Publication date 03/09/2010 Request for examination date 25/11/2010 Pre-Grant Opposition under... Read More

Merk’s patent valid but Teva’s Nasonex generic non-infringing

In Merck Sharp & Dohme Corp.  (hereinafter referred to be as “Merck”) v. Teva Pharms. United States, Inc. (hereinafter referred to be as “Teva”) decided on November 16, 2016, Teva’s application of Abbreviated New Drug Application (hereinafter referred to as “ANDA”) no. 205149 had triggered Merck to file infringement suit against Teva in respect of US patent number 6127353 (hereinafter referred to be as “353” patent) which is currently listed against NDA number of New Drug Application (hereinafter referred to as “NDA”) number 020762. The‘353 patent is set out to expire in April 03, 2018 with Pediatric Exclusivity. NDA 020762... Read More

Combating Opioid Misuse – COMBAT (Curb Opioid Misuse By Advancing Technology Act of 2016)

The Congress recently introduced a bill on the COMBAT Act (Curb Opioid Misuse By Advancing Technology Act of 2016) to incentivize the development of abuse-deterrent opioids by amending the Federal Food, Drug, and Cosmetic Act to extend the exclusivity period for certain drug products developed or labeled so as to reduce drug abuse, and for other purposes. Implications on Exclusivity to Certain New Drug Applications (NDAs) – The COMBAT Act would amend Section 505(c)(3)(E) of the Federal Food, Drug, and Cosmetic Act i.e. 21 U.S.C. 355(c)(3)(E) by adding at the end the following: (vi) With respect to an application described... Read More

IP Workshop held at Hotel Hilton, Jaipur

IIPRD in association with Khurana and Khurana, Advocates and IP attorneys has recently conducted an IP Workshop on 8th of February, 2016 at “Hotel Hilton”, Jaipur. Hereinbelow are the snapshots of activities conducted at the workshop - As a part of our ongoing Educational and Awareness Programme on IPR, IIPRD takes pride to have successfully completed yet another Programme on IPR - “IP Leveraging and Management” at Hotel Hilton, Jaipur. The objective was to sensitize the Industrialists, Scientists, Educationalists and other attendees towards growing need of effectively leveraging Intellectual Properties. The Participants include IP practitioners working in law firms as... Read More

Medecins Sans Frontieres (msf) Challenges Pfizer’s Patent Application on Pneumonia Vaccine in India

Médecins Sans Frontières (MSF) also known as Doctors Without Borders, an international humanitarian-aid non-governmental organization, has filed a pre-grant opposition in India to prevent US pharmaceutical company "Pfizer" from getting a patent on the pneumococcal conjugate vaccine (PCV13, marketed as Prevenar 13®). Prevenar 13® is the world's largest selling vaccine for infants and toddlers, that helps prevent invasive disease caused by 13 types of Streptococcus pneumoniae. Prevenar 13® contains extracts from thirteen of the most common types of Streptococcus pneumoniae bacteria which are responsible for causing invasive diseases such as pneumonia, blood poisoning and meningitis.  The vaccine works by preparing... Read More

Indian Patent Office Rejected Compulsory License Application (C.L.A. No.1 of 2015) for “Saxagliptin” Filed by Lee Pharma Ltd.

In an order dated 19th January 2016, the Controller of Patents rejected the compulsory license application of Hyderabad based drug maker Lee Pharma Ltd. to manufacture generic version of AstraZeneca's anti-diabetic drug Saxagliptin. The Controller of Patents rejected the application on the grounds that substitutes to the drug Saxagliptin are readily available in the Indian market and the Lee Pharma's claim that requirements of public with respect to the patented invention are not being satisfied has not been proven. Lee Pharma filed an application under Section 84 (1) of the Patents Act 1970 on 29th June 2015, seeking grant of... 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

Delhi High Court Upholds Roche’s Patent Claims on Lung Cancer Drug (Tarceva) against Cipla

A division bench of Delhi High Court on 27th Nov 2015 held that the Indian drug manufacturer Cipla infringed Swiss pharmaceutical company Roche's patent on Erlotinib hydrochloride, marketed under the name of "Tarceva". Roche was granted a patent in India on Erlotinib hydrochloride (Tarceva) in 2007. Roche sued Cipla for patent infringement in January 2008 soon after Cipla announced its intent to launch a generic version of Erlotinib (i.e. Erlocip) at Rs.1,600 per tablet, compared to Roche's selling price of Rs.4,800 per tablet. The verdict came on the pleas of Cipla and Roche, both of which had challenged the single... Read More