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COURT RULINGS

Indian High Court Upholds Right to Copy Roche Drug

In battle with Cipla, Roche loses ability to block Tarceva generics, for now.

MICHAEL FITZHUGH

The Burrill Report

“Cipla and other Indian drugmakers can now move ahead with selling low-cost generic versions of Tarceva.”

Cipla, one of the India’s leading generic drugmakers, has convinced Delhi’s High Court to dismiss a Roche suit claiming the Indian company infringed its patent on the lung cancer drug Tarceva.

Cipla and other Indian drugmakers can now move ahead with selling low-cost generic versions of Tarceva, which is used to treat non-small cell lung cancer, a growing problem in India due to rising tobacco use among both men and women.

The companies have been battling since 2008 over whether Cipla would be legally entitled to sell its version of the drug, marketed as Erlocip. Erlocip costs $29 (Rs 1,600) per tablet compared to about $88 (Rs 4,800) per tablet for Roche’s Tarceva, according to The Economic Times.

Roche may still appeal the decision.

In May, Cipla said it would slash prices across its cancer drug line-up, reducing the price of its generic competitor to Bayer’s Nexavar 76 percent, a move that Cipla chairman and managing director Y.K. Hamied called a “humanitarian approach by Cipla to support cancer patients.”

The high court decision falls during a volatile chapter in the relationship between multinational Big Pharma companies and India’s government, which is attempting to control the high costs of modern medicines in the country by paving the way for the country’s advanced generic drugmakers to clone brand name drugs at times.

Another test in that arena kicked of this week as Novartis re-opened its challenge to India’s 2006 rejection of the company’s patent application for the cancer drug Glivec. The results of that trial will provide another closely watched read-out on just how hospitable or not India’s intellectual property climate may be for drug innovators going forward.



September 14, 2012
http://www.burrillreport.com/article-indian_high_court_upholds_right_to_copy_roche_drug.html

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