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Cipla wins patent case over Tarceva -CH Unnikrishnan
-Live Mint

Cipla Ltd won a landmark patent case against Swiss drug maker F Hoffmann-La Roche Ltd in the Delhi high court on Friday over the Indian company’s generic copy of lung cancer drug Tarceva after a four-year court battle.

Justice Manmohan Singh observed in his 280-page judgement that it had been scientifically proven that Cipla’s generic version was a polymorph B variant of Roche’s patented drug and that it didn’t actually infringe any patent in India. Roche’s patent on the drug is valid, the court said.

The judgement order is not yet available for a detailed review.

The ruling was the first in a patent case in India under the current patent. Roche had filed the case in January 2008, alleging that Cipla had infringed its patent by launching a generic copy of Tarceva in the local market.

The case had drawn worldwide attention as it was the first time a local drug maker had gone ahead with the launch of a generic copy of a patented drug after the country introduced its product patent regime for pharmaceuticals in 2005.

“It’s a landmark judgement in a patent case as the court has taken all efforts to analyse the claims of both parties in terms of legality and scientific evidences to finally reach a fair conclusion,” said Pratibha Singh, a Delhi-based patent lawyer who represented Cipla.

While Tarceva costs about Rs.1.4 lakh for a month’s treatment, Cipla priced it at about Rs.25,000 for the same dosage. Roche had introduced patient-access schemes to make the drug available at discounted rates for those who couldn’t afford the high prices. A Cipla official said its sales of the generic version amount to about Rs.10 lakh annually in the local market.

Roche has the option of challenging the order before a higher bench of the court. Roche officials were not immediately available for comment. A Roche spokeswoman at its Basel headquarters did not reply to a Mint query. Cipla managing director S. Radhakrishnan said, “The court ruling will benefit patients in India. While Roche has the option to challenge the order, we feel confident about the strong ground that we had in the case to fight.”

Roche had, in fact, applied for a patent for the polymorph B version of erlotinib, which is the generic name of the drug, at the Indian patent office. But the application was rejected on the grounds that it doesn’t qualify for a patent in India.

Indian patent law doesn’t qualify variants of a basic drug molecule (erlotinib in this case) unless such versions demonstrate an enhanced therapeutic efficacy.

With Friday’s judgement, Cipla’s cheaper cancer drug Erlocip can be sold without any threat of patent violation, Singh said. “It’s not only a win for Cipla, but for the local pharma industry, which has been fighting against patent evergreening attempts of multinational companies,” she said.

“The order clearly demonstrates a fair judiciary practice in the area of intellectual property rights in the country,” said Dilip G. Shah, secretary general of Indian Pharmaceutical Alliance, a lobby group of Indian drug firms.

In January 2008, the Delhi high court had refused an injunction against Cipla to prevent its sales of generic erlotinib as sought by Roche. This was mainly on the ground that the Roche patent was challenged in the patent office by at least three local drug makers through the revocation route and the decision on this was awaited. Following this, Roche had appealed to a division bench of the high court and later to the Supreme Court. But the case was sent back to the high court on the grounds that the decision on patent validity was awaited, and also because an injunction on Cipla’s product may impact patients already on the treatment.