Bayer Suffers Nexavar Setback As India's Supreme Court Dismisses Linkage of Patent With Generic Marketing Approval

MUMBAI - German pharma and healthcare firm Bayer suffered yet another jolt in its two-year attempt to establish a patent linkage to registration of generic versions of its kidney and liver cancer drug Nexavar (sorafenib) as India's Supreme Court dismissed the company's pleas and referred the case back to the Delhi High Court.

India's highest judicial authority also directed the Delhi High Court to decide within six months Bayer's allegations of patent infringement on Nexavar against Indian company Cipla. Bayer had questioned the authority of the Drug Controller General of India to grant approvals to generic knock-offs for its brand after Bayer's product had obtained patent rights in India.

Similar to the present decision, last year the Delhi High Court rejected Bayer's plea to prohibit the industry regulator from granting marketing approval to Cipla (Also see "Indian Court Nixes Bayer's Nexavar Patent Plea; Cipla Allowed To Market Generic Versions" - Scrip, 19 Aug, 2009.).

Following the 2009 ruling, a Bayer official told PharmAsia News, "Bayer is disappointed and disagrees with the court's decision and will consider its legal options in this regard," he said, hinting that the case will now go to a joint bench. But the same communications official did not take calls or answer mail this time for a comment.

Before the 2009 ruling came in, the Delhi High Court had admitted Bayer's petition and put on hold the approvals to generic drugs on Bayer counsel's pleas. The court in that decision had noted, "In case a license to market is granted to respondent [Cipla], the same would lead to multiplicity of proceedings besides it would lead to serious prejudice to the rights of the petitioner, who is the owner of the patent."

Patent Linkage Debate Rolls On

The Organization of Pharmaceutical Producers of India - a lobby group that mostly represents multinational companies - has asked repeatedly for a linkage between patent grants and the registration of generic versions of patented products for stronger IP protection.

However, this view has been met with strong opposition from Indian drug makers who claim that patent linkages are not mandated by any international agreements on intellectual property and should be assessed separately. Representatives from the Indian industry also strongly condemned Bayer's views as noted in its earlier petition that any generic version of its product should be termed as "spurious."

Leena Menghaney, campaign coordinator for patient advocacy group Medecins Sans Frontieres told PharmAsia News, "Had Bayer's plea for 'patent linkage' been accepted by the court, it would have undermined the registration of affordable generic medicines and public health safeguards contained in India's patent legislation."

Anand Grover, counsel for the Cancer Patients Aid Association said, "In India, we do not have a patent linkage system. The patent system and the drug regulatory system are two separate and independent mechanisms and this is Parliament's intent. We hope that Bayer and other pharmaceutical companies respect this fact. A patent holder cannot use the DCGI, a government agency, to enforce its private rights. This was an attempt to introduce a TRIPS-plus requirement in India, which has been rejected."

A recent discussion document floated by the Department of Industrial Policy and Promotion expressed threats to provisions like compulsory licensing in light of takeovers of large Indian companies by multinational drug makers. One of the points raised in the document argued, "If large Indian generic companies with the capability to manufacture drugs based upon a compulsory license (when they are issued to them) are themselves taken over, then the regime of cheap and effective drugs may be threatened," (Also see "Indian Firms Must Be In Indian Hands, Says Government Paper; Highlights Threats to Compulsory Licensing And Drug Pricing" - Scrip, 25 Aug, 2010.).

- Vikas Dandekar ([email protected])