Three years after it switched to a globally aligned tighter patent regime, the Union government is facing increasing pressure to use legal flexibilities that allow the public access to affordable versions of costly life-saving drugs on patents.
Natco Pharma’s new plans to apply for a special permit or compulsory licence to produce a generic version of Pfizer’s HIV-AIDS patented drug Celzentry (generic name Maraviroc) are in line with that pattern. Given Natco’s filing for a compulsory licence to produce Roche-Pfizer’s cancer drugs for exporting to Nepal earlier this year, these plans would fit well with its strategic view to test the waters—that is, to see if the government will actually make use of specific provisions under WTO-TRIPs. These are meant to help developing countries overcome serious constraints in enabling wider access to patented drugs, due to their monopoly—exorbitant—pricing.
The new plan, however, goes a step further—it seeks to break a drug patent for the domestic market, while the earlier case, which is yet to be decided, was solely for exporting the drugs in question. A critical issue arising here is that the law stipulates a patent should have been worked for three years before a compulsory licence can be considered for the home market. Pfizer was granted its patent for Maraviroc last year, but hasn’t launched it in India yet. As we have said on these pages earlier, the big question is whether the three-year clause is not being overstretched. Only if a patent is not worked because regulatory processes are still pending on the part of government, is there merit in the clause. Else, if the genuine constraints of affordability and availability of the drug hold, the case for compulsory licensing should be considered—on its merit.
Whether Maraviroc is significant enough for public health concerns for the patent to be fought is not yet established, but the larger signals from the government’s response would be interesting. Pressure is mounting from patient groups and NGOs for the government to define clearly when a drug patent can be broken in the cause of ensuring affordability and availability of vital as well as life-saving drugs. What’s worth watching out for is how the patent controller will deal with the ground realities of implementing compulsory licensing—not only is its interpretation contentious, but the government will also likely be hesitant to earn the ill-will of drug multinationals and their governments. India needs to get its priorities in order.
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