Sunday 9 September 2012

Roche Vs. Cipla : Court rules in favour of Cipla

In an infringement action initiated by F. Hoffman-La Roche Holding AG against generic drug company, Cipla Ltd for manufacturing and marketing the generic version of its patented anti-lung cancer drug Erlotinib Hydrochloride, the Delhi High Court on September 7, 2012 has held that Cipla’s drug, Erlocip, did not infringe the Roche’s patented drug, Tarceva. The court also said that Roche's patent over Tarceva is valid in India.
The 280 page decision pronounced by Justice Manmohan Singh is the outcome of the infringement action initiated by Roche in January 2008. The court observed that Cipla’s generic version drug was a polymorph B variant of Roche’s patented drug and that such drug has not infringed upon Roche’s patented drug. Section 3 (d) of the Indian Patents (Amendment) Act 2005, allows patenting of inventions which are variants of a basic compound if such versions results in the enhancement of the known efficacy of that substance.
Roche's Tarceva is priced at Rs.1.40 lakh ($2,533) for a month's treatment, while Cipla's version cost about Rs.25,000, i.e., approximately six times cheaper for the same dosage.
Now, Roche has the option to challenge such decision as appeal to a division bench of the Delhi High Court.

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