The Financial Times reports:

The Controller General of Patents last week granted the first product patent in pharmaceuticals to Roche India Pvt Ltd, the Indian arm of Swiss drugmaker F Hoffmann La Roche, for its biotech drug Pegasys (Peinterferon apha-2a), official sources told FE. ….The company had applied for the patent under the Mailbox facility for post-1995 inventions.

Pegasys, a recombinant DNA technology drug, is one of the advanced drugs in the Interferon series of proteins, which has varied end uses, mainly for treatment of serious viral infections and consequent diseases like cancer. It has specific application in adults who have hepatitis C and signs of liver damage.

Coming close on the heels of a rejection of Novartis’s Gleevec application, this grant will be music to the ears of multinational pharma, the major filers of pharma mailbox applications.

Needless to state, Indian generic manufacturers that were producing Pegasus will now to stop, unless they avail of the proviso to section 11A which encompasses an ‘automatic compulsory licensing scheme’. This provision states in pertinent part that in the case of those mailbox applications that result in the grant of a patent, a compulsory licence would issue to those generic companies that made a ‘significant investment’ and were ‘producing and marketing’ a drug covered by the mailbox application prior to 2005. Such licence is subject to a payment of a ‘reasonable royalty’.Therefore companies like Shanta Biotech that were producing generic versions of Pegasus prior to 2005 can continue to do so, provided they pay reasonable royalties. As to what is ‘reasonable’ is going to prove contentious in the years to come and will be the trigger for many litigations.

It is advisable that the government begin to work out guidelines for determinging as to what is ‘reasonable’ so that there is some sense of objective determination and certainty associated with this term.


Shamnad Basheer

Shamnad Basheer

Prof. (Dr.) Shamnad Basheer founded SpicyIP in 2005. He's also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof. Amartya Sen. Professional History: After graduating from the NLS, Bangalore Prof. Basheer joined Anand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Later, he was the Honorary Research Chair of IP Law at Nirma University and also a visiting professor of law at the National Law School (NLS), Bangalore. Prof. Basheer has published widely and his articles have won awards, including those instituted by ATRIP, the Stanford Technology Law Review and CREATe. He was consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also served on several government committees.

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