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Delhi High Court Upholds Roche’s Patent Claims on Lung Cancer Drug (Tarceva) against Cipla

A division bench of Delhi High Court on 27th Nov 2015 held that the Indian drug manufacturer Cipla infringed Swiss pharmaceutical company Roche’s patent on Erlotinib hydrochloride, marketed under the name of “Tarceva”.

Roche was granted a patent in India on Erlotinib hydrochloride (Tarceva) in 2007. Roche sued Cipla for patent infringement in January 2008 soon after Cipla announced its intent to launch a generic version of Erlotinib (i.e. Erlocip) at Rs.1,600 per tablet, compared to Roche’s selling price of Rs.4,800 per tablet.

The verdict came on the pleas of Cipla and Roche, both of which had challenged the single judge’s order of September 7, 2012. The single judge in his order had held that Cipla was not infringing Roche’s patent and refused to grant any injunction against Cipla, and it allowed the Indian drug firm to continue selling its generic product, Erlocip. The judge had also refused to revoke the patent of the Swiss company as sought by Cipla.

A division bench of justices Pradeep Nandrajog and Justice Mukta Gupta held that the single judge “erroneously compared the products of Roche and Cipla when he ought to have mapped the claims of the suit patent against Cipla’s product”.

Cipla in its plea had urged that while the patent sought to be enforced was for polymorphs A+B of Erlotinib hydrochloride, the product under manufacture by both Roche and Cipla was polymorph B, which ought to be assumed to be in the public domain and, hence, the Indian company’s activities were non-infringing in nature.

Roche in its plea had contended that the basic patent was not confined to any polymorphic form of Erlotinib hydrochloride and, hence, as long as the compound was present in Cipla’s product Erlocip, it infringes the patent.

The division bench in its decision held that:

“This (the patent claim) is a sufficiently broad claim that is clearly not limited to any polymorphic version of erlotinib hydrochloride, but to erlotinib hydrochloride itself,”. “This compound may exist in several polymorphic forms, but any and all such forms will be subsumed within this patent. Therefore as Cipla’s Erlocip is admittedly one particular polymorphic form of the Erlotinib Hydrochloride compound (Polymorph B), it will clearly infringe IN’774 patent.”

The court, however, refused to issue any injunction against Cipla restraining it from manufacturing the medicine, after observing that the life of the patent granted to Roche was ending in March 2016. However, the Court has directed Cipla to render accounts to Roche and make payment for the patent infringement.

“…keeping in view the fact that the life of the patent in favour of Roche in India would expire in March, 2016 we do not grant the injunction as prayed for by Roche against Cipla (because as noted above there was no interim injunction in favour of Roche and due to said reason Cipla continued to manufacture and sell Erlocip),” held court.

Also, the division bench in its 106-page judgment said that as Cipla “could not establish prima facie that the suit patent was obvious”, its plea for invalidating Roche’s patent on the ground of ‘obviousness’, “fails”. In addition, Cipla had demanded Roche’s patent be revoked under Section 3(d) of the Indian Patent Act that essentially bars incremental innovations unless significant efficacy is proven.

Bringing clarity to Section 3(d), the judges wrote: “We understand Section 3(d) as a positive provision that in fact recognizes incremental innovation while cautioning that the incremental steps may sometimes be so little that the resultant product is no different from the original. The inherent assumption in this is that infringement of the resultant product would therefore be an infringement of the original i.e. the known substance and by no stretch of imagination can Section 3(d) be interpret as constituting a defence to infringement.”

Roche welcomed the decision of the Court which upheld the patent covering Erlotinib hydrochloride (Tarceva) and found Cipla to have infringed it.

About the Author: Antony David, Senior Patent Associate at Khurana & Khurana, Advocates and IP Attorneys and can be reached at: [email protected].

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