Cipla Takes on Roche Again: Valcyte vs Valcept

“This is the second instance of Cipla launching a low-cost version of Roche’s patent-protected drug after India’s amended patent law began to recognise product patents or patents for specific drugs instead of protection to the processes through which medicines are produced. While Roche had dragged Cipla to the court on the earlier occasion, it is yet to seek legal remedy on valganciclovir.

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Cipla’s joint managing director Amar Lulla confirmed his company has launched valganciclovir under the brand name Valcept in Indian market. While Valcept is priced at Rs 245 per tablet, Roche’s maximum retail price for its medicine branded as Valcyte is over Rs 1,000, trade sources said.

Valganciclovir is used to prevent eye infections in people who have less immune power (HIV/AIDS patients, for instance)…

In June this year, the Delhi Network of Positive People (DNP+), an organization representing the needs of people living with HIV/AIDS (PLHAs), had filed a post-grant opposition against the decision. Cipla’s product launch has come at a time when the patent office is considering the post-grant opposition.

“Unlike the earlier case, Roche cannot approach the court to see legal intervention as the decision of the authority itself is being challenged through a post-grant opposition. The courts will not intervene unless the patent office gives its view on the post-grant opposition,” Gopakumar Nair, a Mumbai-based patent expert, said.

Cipla had in January this year launched a copycat version of erlotinib, a lung cancer medicine, on which Roche has patent protection in India. The price tag was one-third of Roche’s branded medicine Tarceva. Roche had sued Cipla for infringement of patent in the Delhi High Court. The high court, which completed hearing on the case on September 15, is expected to announce its verdict within two months.”

The Mint ran a report several months earlier suggesting that Cipla would take on Roche again in the near future. And true to their prediction, Cipla has once provided fodder for patent junkies.

What is SpicyIP’s Take on This?

For one, I am surprised at Cipla’s timing. As our readers are aware, arguments in the Tarceva case before the Delhi appellate court concluded on September 15 and judgment has been reserved. Chosing this very moment to outrightly challenge another one of Roche’s patents appears to be bad legal strategy.

More importantly, given that post grant opposition proceedings are pending in this case, the courts may (a Mint report suggests that Roche might take this litigation to the Chennai courts and away from Delhi), injunct Cipla, at least till such time as the post grant opposition proceedings are concluded. The courts may reason it thus:

The post grant proceedings could either go in Roche’s favour (patent held valid) or against Roche (patent held invalid). If the former, then the courts could take up Roche’s injunciton application again and decide on merits. If the latter, then the suit becomes infructuos.

On a related note, I plan to continue blogging on the Roche vs Cipla (Tarceva) case. The reason I stress this is because some of our well wishers wrote in to ask me as to whether I’d stopped reporting on this case owing to the various threats made to my family members. Once again, I wish to reiterate that such threats will not deter us from our avowed task of increasing transparency by a fair and objective reporting of key IP cases/issues.

As our earlier posts stressed, Cipla strategically dropped its “public interest” and pricing argument before the appellate court. An argument that formed the very basis of Justice Bhat’s ruling in Cipla’s favour.

Cipla’s key argument now is that there is no infringement, as the patent in suit does not cover Cipla’s product, Erlocip. We’ll have to wait and watch to see how the Delhi High Court finally rules on this.