Foreign drug majors’ latest gambit — restraining the Drug Controller

Patent-related rows between Indian and multinational drug companies are here to stay. If anything, the fight between the two lobbies will get fiercer by the day.

A new trend noticed in the last few months bolsters that claim. Multinational drug companies have silently obtained court verdicts, chiefly from the Delhi High Court, which clip the rights of India’s Drug Controller to review marketing approvals for drugs invented and owned by foreign firms.

The first case went against Cipla last month for Sorafenib — an anti-cancer drug from Bayer Corporation. Cipla had sought the Drug Controller’s approval to market the drug in India but before a review of the company’s marketing application could be undertaken, German drug major Bayer Corporation took objection and dragged Cipla into a legal battle. Bayer also audaciously made the regulator and Indian government a party to the case.

According to news reports, Bayer pleaded that Cipla’s drug, if examined and granted marketing rights, will be seen as a spurious drug as per the Drugs and Cosmetics Act.
Bayer asked the Drug Controller vide its letter of July 31, 2008 to reject Cipla’s application and conduct a hearing before taking a decision. The main contention brought forward by Bayer was that it would lead to “multiplicity of proceedings” and “serious prejudice to the rights of the petitioner, who is the owner of the patent.”

According to patent experts, Bayer has the right to defend its patents, but to block a drug approval mechanism is tantamount to questioning the administrative rights of the Drug Controller.

Again, on the part of the judiciary, it is unfair to expect that the Drug Controller would know the legal tenets of patenting. The case is likely to snowball into a major controversy and though multinational companies seem to have scored an early win, the legal ramifications will not be favourable for them in the longer term. For long, despite resistance from the Indian drug regulators, multinational drug companies had wanted to link up marketing approvals with the patenting system. This is an extremely vexatious issue and could be misused by both Indian and multinational companies.

An almost similar incident relates to Bristol Myers Squibb obtaining an order from the Delhi High Court that restrains the Drug Controller from reviewing an application from Hetero Drugs for dasatinib or Nexavar, another anti-cancer drug. In this particular case, the Delhi High Court has been harsh in directing what the Drug Controller should do.

In an unequivocal verdict, Justice Rajiv Sahai Endlaw wrote, “It is expected that the Drug Controller General of India while performing statutory functions will not allow any party to infringe any laws and if the drug for which the approval has been sought is in breach of the patents, the approval ought not be granted to the defendants.”

Patent experts are now arguing if restraining the Drug Controller from granting approvals is an additional safety measure by multinational companies to prevent any copies of their patented products in India.

It is important to remember that Cipla launched its versions of anti-cancer drug erlotinib, patented by Roche and branded Tarceva, even after the Swiss company was granted product patent in India.

Shamnad Basheer, one of the active voices in drug patenting succinctly wrote in his popular blog Spicy IP, “It is deeply troubling that the injunction order (on dasatinib) creates a linkage between patents and the drug regulatory process and directs the DCGI to desist from granting approval if the application implicates the patent rights of BMS… The order places the onus of “patent policing” on the DCGI that is ensuring that none of the generic drug applications submitted for approval violate the patent rights of any originator drug company. Given that the DCGI already struggles with its primary responsibility of ensuring that drugs approved for the market are both safe and effective, burdening it with no special patent expertise and the additional duty of policing patent rights is downright imprudent.”

Given that Indian companies are faced with a dried-up product pipeline in the next few years and multinationals are desperately trying to find double-digit growth in emerging markets such as India, monopolistic rights will be tenaciously defended. Cheap life saving drugs to poor patients will remain an unfulfilled reality as hostilities continue between Indian and multinational drug companies.

Pillman is an executive closely linked to the global pharma industry.