Boehringer patent on HIV drug Denied in India
Indian Patent Office has denied Germany’s Boehringer Ingelheim a patent on its key HIV drug, Nevirapine, for a version sold as Viramune XR (extended release).
VIRAMUNE XR was approved in US on Mar 25, 2011 (100 mg and 400 mg, TABLET) and OB listed US patent will expire on Mar. 12, 2015.
The application on the Nevirapine extended release formulation was refused since it was found to be “obvious” and lacking inventive step, violating Section 3 (d) of the Indian Patent Act — a provision under which Novartis lost the patent on its blockbuster drug Glivec in 2013.
Briefly, Viramune XR was found to be merely a new form of something already known, without demonstration of any enhanced therapeutic efficacy. Section 3(d) — an important safeguard in the patent law ..
specifically relevant for pharma and chemical industries — prohibits grant of patents to new forms of known substances, unless the new form results in enhanced efficacy over the known substance.
The MNC had applied for a patent in India on the extended release of the HIV drug in July 2009, on which domestic company Cipla filed a pre-grant opposition in 2011, and later launched its generic version.
The application was examined by the Indian Patent Office, which raised objections in its examination report in January 2014 over obviousness and Section 3(d). The German company filed a response through its agents Remfry & Sagar. Cipla then filed a pre-grant opposition through S Majumdar & Co.
The applicant (Boehringer) did not respond to the pre-grant opposition and also did not appear at the hearing fixed for the same on September 15, 2015, since the applicant did not appear in the hearing fixed under section 25(1) before the controller, and no arguments were offered to rebut the objections raised in the FER (first examination report), and by the opponent, therefore the application for grant of patent is refused.
Full Decision Controller decision
