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.