Bayer has suffered a setback after a court in India dismissed the German firm’s attempt to prevent the country’s regulator from approving a generic version of its kidney and liver cancer drug Nexavar that is being prepared by Cipla.

In a major boost for Indian generic companies, the Delhi High Court has rejected Bayer’s petition against Cipla, the Drug Controller General of India and the Union of India as the latter’s overseer. The Leverkusen-headquartered group was seeking a ruling that the DCGI should consider the patent status of Nexavar (sorafenib) before granting marketing approval to any copycat drugs, ie the introduction in India of a patent linkage system, tying a regulatory green light for generics with their patent protection.

Cipla had applied to sell a generic version in India of Nexavar even though its patent is protected for a long time yet. Bayer received marketing authorisation for the drug from the DCGI in August 2007 and was granted a patent in India on March 28, 2008. The country operates a 20-year exclusivity policy.

In November, the Delhi court granted Bayer an injunction and stopped the DCGI from approving the copycat, agreeing with the firm that it was a “spurious drug”.

However Justice Ravindra Bhat has now dismissed the case, saying that the litigation was “what may be characterised as a speculative foray” and “an attempt to ‘tweak’ public policies through court mandated regimes. He added that “the petitioner [Bayer] doubtless is possessed of vast resources and can engage in
such pursuits”, and “these attempts, even unsuccessful in the ultimate analysis, achieve short term goals of keeping out competitors, through interim orders”.

He noted “that short-term objective has been achieved, and the petitioner has successfully stalled an independent examination of Cipla’s application”. Justice Bhat went on to say that “it would be a travesty of justice if the court does not direct realisation of realistic costs”, and Bayer needs to pay legal costs of 6.75 lakh to the government and Cipla, which equates to just over $13.8 million, in the next month.

Bayer said it is disappointed with the ruling and will look at its legal options, but the ruling is being seen as setting a precedent for firms to launch generic versions of patented drugs in India, albeit at the risk of paying damages if found guilty of infringement. Cipla is celebrating for now and joint managing director Amar Lulla told the Times of India that this is “an historic judgement” where the multinationals’ “back-door patenting has been threatened. This was a frivolous and perverse case, and an attempt to stifle generics”.

Better news for Bayer came with the firm submitting a new formulation of its erectile dysfunction drug Levitra (vardenafil) in the European Union. The orodispersible tablet, in contrast to other drugs of the same class used for the treatment of ED, allows men “a discreet and convenient intake without water, dissolving on the tongue within seconds”, the company said.

Meantime Bayer’s CropScience unit is buying Athenix Corp, a privately-held company headquartered in Research Triangle Park, USA. No financial terms have been disclosed yet.