If the Supreme Court rejecting Swiss pharmaceuticals firm Novartis’s application for a patent for its anti-cancer drug Glivec earlier this week wasn’t devastating enough for pharma MNCs, the Delhi High Court’s refusal to grant relief to US firm Merck Sharp & Dohme on Friday showed up patently problematic gaps in India’s pharmaceuticals regulatory system—Merck had asked the court to stop local Indian firm Glenmark Pharmaceuticals from selling versions of its patented drugs since the patent was still in force. While an interim injunction was not given, the main case is yet to be heard—given the huge pressure of cases in courts, it is not clear how long the case, and the inevitable appeals process, will take to be concluded. Unlike Novartis whose drug didn’t have a patent, Merck’s diabetes drugs Januvia and Janumet were granted patents by the Controller General of Patents in India.
The Indian system, however, functions on a parallel track system. While the patent controller grants patents, the drug regulator—the Drugs Controller General of India (DCGI) along with state-level regulators—can grant manufacturing-cum-marketing rights to firms as well for generic drugs. Theoretically, and there are several such cases, a drug can be granted an Indian patent by the patent controller while a branded generic version of the drug can be granted clearance by the DCGI or any of the state regulators. In the first four years of a drug’s launch, it is considered to be “new” and marketing-cum-production rights can only be granted by the DCGI since there are some reporting rules—of drug allergies for instance—that need to be followed. Once this period is over, however, a company can go to any state drug controller and get permission and then market all over the country. In the Glenmark case, permission to market Zita and Zita-met were granted by the Sikkim drug controller.
Since grant of manufacturing-cum-marketing rights can infringe upon patent rights, you’d think the former would not be granted without checking with the patent controller. For a variety of reasons, mainly to do with the fact that the Drugs and Cosmetics Act under which the regulators function, this does not get done. Indeed, German pharmaceuticals firm Bayer has filed a special leave petition in the Supreme Court asking the Court to examine this obvious lacuna in the Indian patenting system. Given the difficulty in getting patents that are granted in other jurisdictions like the US, the loopholes in the law that ensure even getting a patent isn’t protection enough, and the fact that the government wants to control prices of various drugs—and even take away the rights of patent-holders if it feels the drug is over-priced—it’s not surprising that pharmaceutical firms are up in arms. And unlike in the past when only MNCs were patenting drugs, this time around, several Indian firms have staked their future on patenting new drugs.