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back"Big Pharma Wants More Time" April 17 Business Week Big Pharma Wants More Time
Expect a new skirmish between Big Pharma and the generics. Some leading drugmakers are preparing a push for legal changes to extend their period of protection from generic rivals. Industry executives say that Bristol-Myers Squibb (BMY ) CEO Peter Dolan, who now heads the Pharmaceutical Research & Manufacturers of America, an industry association, is likely to make the effort a top priority. A drug's patent protection typically lasts about 20 years. But it runs from the time a compound is discovered rather than when a drug gets FDA approval and comes to market, usually 8 to 12 years later. Generics makers aggressively attack patents on blockbusters, challenges that, if successful, further shorten the patent protection. There's also five years of "data protection," another right to exclusivity based on clinical trial results. This kicks in at approval. Pharma's complaint? Robert Armitage, Eli Lilly's (LLY ) general counsel, says the resulting exclusive periods under this system aren't long enough, given multiyear clinical trials. He wants 15 years of data protection, along with a 15-year patent, also granted at FDA approval. Such a scheme would effectively lock out generics since they would need to produce their own data in costly clinical trials. With the feds paying for Medicare prescriptions, any change likely to raise the bill will be a tough sell. Says Ira Loss, executive vice-president at Washington Analysis: "They are going to be hard pressed to move this very far."
By Amy Barrett
[Posted at 04/12/2006 04:52 PM by William Stepp on IP in the News Comments Business Week might have spent a few moments looking up "Hatch-Waxman" on the internet. This was an elaborate compromise designed to make it less costly to bring generics to market. In exchange big pharma got an extension on their patents, so that they now last from 2-5 years longer than other types of patents. Is it a surprise that they are back demanding more - this time offering nothing in exchange? [Comment at 04/15/2006 10:08 AM by David K. Levine] Submit Comment |
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