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The Intellectual Property Appellate Board (IPAB) in Chennai has concluded the hearing of Bayer's appeal against the Indian Patent Office's compulsory licencing case. The German drug giant had appealed against the Patent Office's first compulsory licence to NATCO. According to sources, both the parties involved Bayer and Natco Pharma, have made their arguments before the two-member bench of the IPAB, Justice Prabha Sridevan, and DPS Parmar, Technical Member (Patents) on September 3 and 4. The arguments are now over and the bench has issued no deadline for the verdict.
On March 9 this year, the Indian Patent Controller PH Kurian issued the first-ever compulsory licence to the Hyderabad-based NATCO pharma to replicate and manufacture a generic version of Nexavar (sorafenib tosyalte), a blockbuster anti-cancer drug which brought down the price by 97%. Bayer had filed an appeal against the compulsory licence order before the IPAB. It has in particular sought to have the operation of the CL order stayed till the appeal hearings are completed and IPAB passes its decision.
The Patent Controller had earlier ruled that the Bayer price (Rs 280,000 per month) was too high for most Indians and only about 2% could afford that. The compulsory license achieved its objective with the price of sorefanib tosylate coming down to Rs 8,880. Bayer argued that the fact that they had brought down the price to Rs 30,000 wasn't considered by the Patent Controller. They also said that revoking the compulsory license won't hurt 'public interest' because Cipla was already selling the drug for Rs 5,400.
Meanwhile, Leena Menghaney of the M decins Sans Fronti res (MSF) has criticised Bayer for resorting to litigation on this issue. "Bayer's appeal against this landmark ruling in India is predictable. They're using litigation rather than addressing the reality that their prices are too high," "It is not the use of a compulsory licence that should be challenged, but the continued pursuit of excessively high profits over public health needs," she said.
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