SC ruling in Merck-Glenmark case should allay US pharma lobby concerns

Without getting into the merits of the Merck Sharp and Dohme Corporation versus Glenmark Pharmaceuticals case, which is best left to judicial authorities, the Supreme Court restraining the Indian company for the moment from selling copies of Merck's diabetes drugs is an important development for the pharma industry.

It should hopefully allay the concerns often raised by a section of the US pharma lobby that India encourages domestic manufacture at the cost of global multinationals or that some of the global MNCs are facing legal challenges. For, if the current order is any indication, it is not as if application of patent law has any domestic industry bias or that effective judicial remedy is not available.

This is also important because even the United States Trade Representative in its Special 301 report of April 2015 makes it a point to mention that the United States "notes with concern the continuing challenges involved with the enforcement of patent rights in India, including challenges that some patent holders reportedly face in securing injunctions against firms that manufacture patented inventions without authorization from the patent holder."

In addition, when approving such marketing without authorisation, "Indian state governmental authorities reportedly do not have a mechanism to confirm whether the item to be manufactured is under patent. Recent cases such as Merck v. Glenmark and Cipla v. Roche illustrate this problem and underscore the need for greater regulatory coordination between officials in state and central governments."

Indian industry representatives have been arguing against this.

In fact, the Indian Pharmaceutical Alliance in its written submission for the 2014 Special 301 Out-of-Cycle Review of India, had in October last year stated that "We submit that the difficulties in obtaining injunctions as well as apprehensions about the lack of patent linkage have been overstated to the USTR. There are several other cases where injunctions have been granted to pharmaceutical patent holders before the grant of manufacturing authorization. For example, Bayer has obtained injunctions in the Delhi High Court restraining manufacture against two parties developing Rivaroxaban under a development license, which is permissible under Section 107A(a) the Patents Act, a provision similar to the Bolar exemption in the US."