In the 2010 Bayer-Cipla case on “patent linkage”, a single-judge bench of the Delhi High Court and, subsequently, a division bench had refused to ask the government to link the patent status of a drug to grant of marketing approval for generic versions.
The former said the “courts were not expected to fill the gaps in public policy spaces” and the latter not only reiterated that stance but also saw merit in the contention that patent linkage is a “TRIPS-plus” concept. Nevertheless, the issue, which is of great import to enforcement of patent rights in India, has engaged the court again, in what could provide a ray of hope to multinational pharmaceutical companies.
The high court on Friday sought the response of Mumbai-based Glenmark Pharmaceuticals on US drug major Merck Sharp and Dohme’s (MSD) appeal against the single-judge bench order a week ago refusing to restrain the Indian firm from manufacturing and selling anti-diabetes drugs brand-named Zita and Zita-Met. MSD had argued that Glenmark violated its patents in India for drug products Januvia and Janumet (containing the molecule sitagliptin) and said that the drug regulator’s decision to give marketing approval for Glenmark’s products virtually facilitated the alleged patent infringement.
The single-judge bench had earlier said that though the plaintiff (MSD) had not made out a case for grant of interim relief, but added that its observations in the interim order would not have any bearing on (what would be) the final decision in the matter. Pertinently, the Bayer-Cipla case is pending consideration of the court on the patent infringement aspect, which, according to legal experts, can’t be extricated from the issue of linkage in this case (the Supreme Court had disposed of a special leave petition filed by the German major, leaving the question for the high court to deal with the patent infringement suit).
So the question of (the absence of) patent linkage is before the court — more clearly in the Glenmark-MSD case and implicitly in the Bayer-Cipla case.
Sections of the domestic industry opposing patent linkage for its potential to deny/delay entry of generic drugs into the market point out that even developed countries, including in the European Union, have turned cautious in implementing such a policy. “The grant of patent does not automatically create any presumptive validity to deny marketing approval for a product,” said DG Shah, secretary general, Indian Pharmaceutical Alliance. In fact, the Delhi High Court division bench’s order in the Bayer-Cipla case quoted a legal scholar thus: “Patents remain by far the most controversial of the IP rights harmonised under TRIPS. Not only do patents confer significantly stronger rights of exclusivity than IP regimes, the subject matter of patents-technology most directly impinges on economic prosperity. In the case of pharmaceuticals, access to patented technology can literally become an issue of life and death.” The single-bench order had said patent linkage transformed patent rights, “which are private property rights that depend on the owner’s promptitude and desire to enforce them into public rights…”
In India, the central drug regulator — the Drugs Controller General of India — grants manufacturing and marketing approval of the drug under the provisions of the Drugs and Cosmetics Act, while patents are granted under the Patents Act, which saw major amendments in 2005. What the drug MNCs want is a legal provision linking patents with marketing approvals. In practice, the DCGI and even the state drug controllers routinely give approvals for generic versions of the patented drugs and these authorities also lack the “institutional expertise to deal with complex patent issues”. The question is how the patent (a legal right) can be enforced in such a situation. In other words, the issue is that of overlapping laws.
In fact, the high court had dealt with this also. “…when there was an overlap between the provisions in the two enactments, the court should not do violence to one, and undermine its purpose.” The reference here obviously is to the Drugs and Cosmetics Act. Will the Glenmark-MSD case result in a review of this position is what industry watchers and legal experts are keen to know.
An executive from a top drug maker who asked not to be identified, said: “The loopholes (in the Indian system) ensure that even getting a patent isn’t protection enough… The government wants to control prices of various drugs and even take away the rights of patent-holders if it feels the drug is overpriced… It’s not surprising that pharma firms are up in arms.”
Incidentally, Glenmark also challenged the MSD’s patents for Januvia and Janumet, saying the US firm has no patent rights over the compound sitagliptin phosphate used in its anti-diabetes drugs, Zita and Zita-Met, in India (MSD’s patent in India is for sitagliptin).