Generic versions of Nexavar should be permitted for a number of reasons. Consider the facts.
The Patents Controller on March 12, 2012 had in a well-reasoned landmark order awarded the Hyderabad-based Natco Pharma a compulsory licence (CL) on sorafenib tosylate, an anti-cancer drug made by the patentee Bayer. Bayer had appealed against this order. The recent decision by the Chennai-based IPAB (Intellectual Property Appellate Board) upholds the order essentially validating the arguments of the earlier decision. Natco was refused voluntary licence by Bayer earlier, which made the grounds for issuing the CL stronger.
The earlier order had relied on Section 84 (1) (a, b and c) of the Patents Act, which says after three years of grant of a patent, a CL can be issued to any applicant on any of the following grounds, namely: (a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price, or (c) that the patented invention is not ‘worked’ (manufactured to some satisfactory extent) in the territory of India.
Bayer’s branded version of sorafenib, Nexavar, cost the patient Rs 2.80 lakh per month for 120 tablets (or Rs 33.65 lakh per year), whereas the generic version of the same was being offered by Natco for Rs 8,880 for a month’s dosage. Cipla which was marketing the drug at a price that cost the patient around Rs 30,000 for a month’s dosage, reduced the price such to less than Rs 7,000 per month. Clearly, the Bayer version of sorafenib was overpriced and hence deemed unaffordable.
The IPAB also concurred that reasonable requirements of the public were not satisfied nor the patent worked within India. The term ‘working the patent’ is not defined in the Patents Act. The IPAB has admitted ‘working’ could mean importation in some circumstances. But it is not clear why Bayer could not make the drug in India, if Natco and Cipla could.
CLs are, let us be clear, well within the TRIPS and Doha Agreements. One would urge the Government of India to issue CLs on all such useful drugs such as the anti-cancer drugs — trastuzumab, ixabepilone and dasatinib — and many others for AIDS, etc. instead of going about it piecemeal (as apparently advised by the Department of Industrial Policy and Promotion). They are all as a class unaffordable. A Department of Pharmaceuticals committee has come out with a formula for price negotiation for patented drugs.
The formula they have proposed is illogical. And more importantly, once we agree to price negotiation, the logic of issuing CLs becomes weak. Indeed it is a move calculated to kill, defacto if not dejure, the law on granting CLs.
The author is with LOCOST and All India Drug Action Network.