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Bayer, Natco cancer, generics news

September 24, 2012 7:00 AM UTC

India's Intellectual Property Appellate Board (IPAB) rejected a petition from Bayer seeking a stay of an order granting Natco a compulsory license in India to manufacture and market a generic version of Bayer's kidney and liver cancer drug Nexavar sorafenib. In March, the Indian Patent Office granted the compulsory license for Nexavar because Bayer did not make the drug available to the public at a "reasonably affordable price." The license allows Natco to sell sorafenib in India at a price not exceeding Rs8,880 ($164) for a month's supply of 120 tablets. Bayer markets Nexavar in India at a price of about Rs280,000 ($5,180) a month.

Bayer said in its petition that the compulsory license was unnecessary as sorafenib already is available to the public at a reasonable price - Rs5,400 ($100) a month - from generics company Cipla Ltd. (Mumbai, India). The pharma also said that it was unable to import Nexavar and sell it at a reasonable price because Cipla flooded the market with its cheap generic. The appeals board held that it was Bayer's responsibility as the patentee to satisfy the public interest requirement. Furthermore, the board said that the requirement of "reasonably affordable" can only be based on the purchasing power of the public, not on whether Bayer can afford the drug. The opinion also noted that the presence of Cipla's generic in India will be subject to the outcome of a separate patent infringement suit filed by Bayer against Cipla. The case is pending in the Delhi High Court. Bayer's Indian patent covering Nexavar expires in 2021. ...