GERMAN DRUGMAKER BAYER FILES PATENT CASE AGAINST CIPLA

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GERMAN drugmaker Bayer has filed a patent infringement case against Cipla, the largest domestic drugseller, to stop the Mumbaibased company from selling its generic version of Bayer’s controversial cancer medicine Nexavar (chemical name Sorafinib Tosylate).

The Delhi High Court (HC) has issued notice to Cipla and the next hearing is scheduled for April 23, Cipla’s lawyer for the case Prathiba Singh said.

The Bayer India spokesman cannot be contacted for comments while Cipla’s joint MD Amar Lulla said he cannot immediately confirm the development and also whether Cipla has got the marketing nod for its generic drug.

Separately, Cipla and Bayer are locked in an intense legal battle over the same drug. Bayer is seeking to prevent the Indian drug regulator DCGI from giving marketing approval to Cipla’s generic version of Nexavar, thereby establishing a provision known as patent linkage. Once a patent linkage is established the DCGI cannot give marketing approval to a generic version of any patented drug.

Global pharma companies have been lobbying to introduce patent linkage in the country but the move has been strongly opposed by local drugmakers and health activists say it will delay the entry of low-cost drugs. This decision of this case, pending with the Supreme Court, is closely followed by both global and local drugmakers.

Even as the outcome of the case is awaited, Bayer decided to file a patent infringement case against Cipla.

Typically, patent holders file patent infringement case when a generic company gets the marketing approval or launches its low cost drug. Cipla’s application for its generic version of Nexavar has been pending with the DCGI for some months. But patent lawyer Varun Chhonkar says under the Indian patent law any act of making a product for commercial use of a patented product amounts to an infringement of patent. Cipla has been waiting for the permission to launch its drug at a price that is expected to be at less than half the price of Bayer’s version which cost about Rs 2.85 lakh for a monthly dose of 120 tablets.

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