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【技术产业】最高法院判决可能威胁阿斯利康重
The U.S. patents protecting AstraZeneca’s $3.4 billion-a-year drug Seroquel, used to treat mental illness, will run out in 2011. To shore up the franchise, AstraZeneca just won approval for Seroquel XR, an extended-release formulation of the drug whose patent isn’t set to expire until 2017.
But a recent Supreme Court ruling could threaten AstraZeneca’s longer-lasting patent.
“An extended-release formulation fits the facts of that case very well,” Stephen R. Albainy-Jenei, a patent lawyer who specializes in biotech and pharmaceuticals and writes the blog Patent Baristas, told the Health Blog this morning. “For things that are patented, it’s going to be slightly easier to get them knocked out.”
It’s a typical Big Pharma strategy — fight generic competition by extending brand life by tweaking the formulations. At the moment, generics companies make copycats of sleeping pill Ambien and ADHD remedy Adderall. But long-acting versions of the drugs have no direct competition.
Last month, the Supreme Court gave more leeway to challenges that seek to overturn patents based on combinations of previously known ideas. Combinations that would be obvious to an expert are not patentable, and the Court said the definition of obviousness should be broader for combination patents.
Pharmaceutical companies rely on combination patents to protect extended-release formulations. But no cases have been tested since the Supremes’ ruling came down, so it’s not clear how much the decision will shift the rules of the game for Seroquel XR and all its XR and CR brethren.
“What’s going to make the difference is whether the formulation shows unexpected results,” said Albainy-Jenei, whose firm, Frost Brown Todd, has ties to manufacturers of both branded drugs and generics. Extended-release patents could still stand up, but only if “you found a particular formulation that might not have been obvious.” [标签:content1][标签:content2]
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作者:admin@医学,生命科学 2011-03-25 17:42
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