The Delhi High Court will hear the final arguments this Thursday in a high-profile injunction application by Roche against Indian generic company Cipla, which launched a generic version of Tarceva despite the fact that Roche obtained a patent for erlotinib – the active ingredient in the drug – last year.
Roche obtained a patent for erlotinib in September and sells the drug for Rs4,800 ($122) a tablet. Earlier this month Cipla was quoted in the Indian press as saying that they intended to launch their own version of the drug that will sell for Rs1,600 ($41) a tablet.
Roche sued Cipla for patent infringement in the Delhi High Court and applied for a temporary injunction. During hearings on January 23 and 24, Cipla counterclaimed that the patent was invalid and should be revoked.
“The Court's determination on these topics, is in fact urgently needed to establish precedents and vibrant patent jurisprudence in India,” Manisha Singh-Nair, partner of Indian law firm Lex Orbis told Managing IP.
India’s patent law allows companies to oppose patents both before and after grant, but Pratibha Singh, a lawyer acting for Cipla in the case, said that the company is unlikely to file a post-grant opposition now it has asked for a revocation in court. NATCO, another Indian drug maker, filed an unsuccessful pre-grant opposition against Roche’s application for erlotinib.
Singh confirmed to Managing IP that the Court will hear the final arguments over the injunction on Thursday and that it is expected to issue its judgment two weeks after that. She said: “The basic question that the judge has to decide is: is it a derivation of an earlier patented molecule?”
Section 3(d) of India’s Patent Act, which was challenged by Novartis in the courts last year, could feature in the case. Section 3(d) restricts what can be patented. In particular, the section states that salts and other derivatives of known substances “shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy”.
Cipla claims that erlotinib is a derivative of an earlier substance called gefatinib, and therefore should not have been granted a patent, unless increased efficacy can be proved.
The litigation concerns Indian patent number 196774, which was issued in July last year against a mailbox application dated March 1996. In March 1999 the Indian government amended its patent law to allow companies to file mailbox pharmaceutical patent applications prior to the launch of India's product patent regime. The law applied retrospectively from January 1 1995 and the Patent Office began to examine them in 2005, after the law was changed to allow product patents to be issued for pharmaceuticals.
Pfizer filed the original application for the erlotinib patent in the US in 1996 (5747498). Genentech and OSI Pharmaceuticals market the drug in the US, while Roche owns the rights in the rest of the world.
