Indian generics manufacturer Cipla can get marketing approval for its generic cancer treatment Soranib, the Delhi High Court ruled Tuesday, and the Indian drug regulatory authority does not have to check its patent status first. The court this week rejected a complaint by drug multinational Bayer against the Union of India, the Drug Controller General of India and generic drug producer Cipla.

Bayer sought a court order requiring DCGI to consider the patent status of kidney cancer drug, sorafenib tosylate (sold under the brand name Nexavar), before granting marketing approval for a generic version of the drug.

At issue was whether it is legitimate to link a potential violation of IP rights to processes regulating a drug’s entry onto the market that are generally based on drug quality, efficacy and safety (IPW, Public Health, 25 February 2009).

Bayer was granted a patent in India for Sorafenib in March 2008. As the 20-year term of the patent is not yet up, Bayer argued that Cipla’s version of the drug, Soranib, could not be considered a legitimate generic. Instead it must be seen as “spurious,” and therefore not valid for marketing approval, according to the High Court’s report of its judgement.

The judgement is available here [pdf].

Cipla countered that this is a misinterpretation of “spurious drugs,” which deceive the consumer as to the drug’s content or manufacturer. Linking the spurious drugs with generics is an attempt to “block marketing of generic drugs, by seeking to re-define “counterfeit” drugs,” said Cipla, according to the court’s report.

Further, Cipla argued that granting regulatory approval for a drug is not equivalent to patent infringement, and that establishing patent infringement must be done through a separate legal process involving separate authorities. There is no linkage, said the generics manufacturer, between granting regulatory approval and establishing a drug’s patent status.

The court sided with Cipla. High Court Judge Ravindra Bhat ruled that unpatented generic drugs could not be declared “spurious drugs.” The judgement states: “A declaration by the drug agency entrusted with the task of deciding applications seeking marketing approval that someone not holding a patent is attempting to get clearance for a ‘spurious drug’ would be pre-emptive, and would negate the provisions requiring that enforcers should follow certain mandatory procedures, and prosecute potential offenders. Such a declaration would be startlingly preclusive, even drastic, whether given by the Drug Controller, or this court.”

Bhat also rejected the idea of “patent linkage.” He pointed to the absence of patent linkage (denial of marketing approval for patent reasons) in Indian law and declared Bayer’s complaint to be “an attempt to ‘tweak’ public policies through court mandated regimes.”

The judgement also pointed to a preliminary review of the pharmaceutical sector [pdf] released by the European Union in November 2008 which warns against such linkages. Some developed countries have cautioned against patent linkages, the judgement says, as they: give regulatory bodies new powers in areas where they lack expertise (intellectual property); transform private property rights in the form of patents into public rights dependent on enforcement by regulatory authorities; potentially undermine attempts to ensure generics are available quickly after a patent expires; and risk violating a World Trade Organization Trade-Related Aspects of Intellectual Property Rights agreement (TRIPS) rule that patent availability be equal across all technological fields (and the linkage system would extend patent rights only for pharmaceuticals). The EU report was recently finalised (IPW, EU Policy, 8 July 2009).

The judge in his final summary even spoke of the need to deter complainants with obviously vast resources from “vexations or luxury litigation” and ordered Bayer to pay around 675,000 Indian Rupees (about US$ 14,000) to the Union of India and Cipla.

“We are very glad that the Court has recognized the aspect of access to drugs and has rejected Bayer’s attempt to introduce a policy change with adverse public health consequences through the court,” said Y. K. Sapru, Chairperson of Cancer Patients Aid Association (CPAA), who intervened in the case, said according to a press release.

Anand Grover, counsel for CPAA and Project Director of Lawyers Collective HIV/AIDS Unit, also welcomed the decision according to the release. The patent system and the drug regulatory system are separate and independent mechanisms, he said. “If introduced, the patent linkage system would have seriously impacted the early entry of generic drugs into the market,” either through compulsory licensing or where there was bona fide belief that a patent has been wrongly granted, said Grover. Bayer’s complaint, he said, was an attempt to introduce a TRIPS-plus requirement in India. Grover is currently the UN Special Rapporteur on the right to health, and recently authored a report on public health, IP, and human rights (IPW, Human Rights, 16 June 2009).

Médicins sans Frontières (MSF) in Germany spoke of a huge success for patients in poor countries and asked the European Union to re-think their policies with regard to generic drugs that the organization thinks to be adverse to the cheaper drugs. The issue was on the agenda in the ongoing EU-India Free Trade Agreement negotiation, according to Oliver Moldenhauer, who coordinates the MSF drug campaign.

A Bayer spokesperson said the company was disappointed by the judgement and was considering further legal steps, according to German media reports. Cipla has stated plans to separately challenge the validity of Bayer’s patent on Sorafenib, according to the judgement.