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Alert 326 India - Cipla v Roche - generic industry rejoices!
For the last two years, the Delhi High Court has been the battle ground for a pharma war between Roche and Cipla over Roche's patent for the anticancer drug erlotinib sold by Roche as 'Tarceva'. On 24 April 2009 the Division bench of the Delhi High Court dismissed Roche's appeal against a refusal by the single judge of the same court to restrain Cipla from manufacturing, offering for sale, selling and exporting its version of erlotinib allegedly in violation of the Patent.
Background
The dispute started in January, 2006 after Cipla announced its intention to sell its generic version of erlotinib under the name Erlocip. Roche sued Cipla for patent infringement in 2008 and sought an interlocutory injunction.
The dispute started in January, 2006 after Cipla announced its intention to sell its generic version of erlotinib under the name Erlocip. Roche sued Cipla for patent infringement in 2008 and sought an interlocutory injunction.
Cipla counter-claimed that the Patent was invalid and should be revoked. Cipla also argued that the balance of convenience was in its favour, linking it to the price difference between the two drugs and the public interest in making life-saving drugs available at an affordable price.
Single judge ruling
The single judge refused the interlocutory injunction, holding that while Roche had established a strong case in support of its patent infringement claim, the 'public interest' and lower pricing of Cipla's drug tilted the balance in favour of Cipla.
Division bench ruling
The Division bench dismissed Roche's appeal. It did not agree that Roche had established a prima facie case. It was of the view that the validity of the Patent was in serious doubt. The bench also seemed to agree with Cipla's argument that Roche's patent was a derivative of a known compound and did not meet the requirement of increased efficacy as required by Section 3(d) of the Patents Act.
The bench felt that the materials produced by Cipla indicated that Erlocip was not covered by the Patent.
The Bench came down heavily on Roche:
1. for their failure to disclose the complete specification of the Patent;
2. for not filing X ray diffraction data for Tarceva and Erlocip that would have shown the crystalline structure of the tablets and whether they corresponded to the Patent.
It did not fully consider the public interest and pricing of the drug, basing its judgment on the ground that Cipla had raised a credible challenge to the validity of the Patent.
Our Comment
The single judge's judgment has sharpened the debate over patent protection in India. The debate has focused on whether the use of the 'public interest' and 'affordability of medicines' arguments by the generic drug manufacturers, to their advantage, will have an impact on India positioning itself as a low cost research destination.
Roche is likely to appeal the order to the Supreme court. With the Indian pharma industry growing annually at 9%, obviously much is at stake for pharma majors.
The single judge's judgment has sharpened the debate over patent protection in India. The debate has focused on whether the use of the 'public interest' and 'affordability of medicines' arguments by the generic drug manufacturers, to their advantage, will have an impact on India positioning itself as a low cost research destination.
Roche is likely to appeal the order to the Supreme court. With the Indian pharma industry growing annually at 9%, obviously much is at stake for pharma majors.
