Readers know I’m sympathetic to the idea of patent reform, but I have to agree with Derek Lowe’s skepticism as he tears a hole in the Michael Heller story told to the WSJ Law Blog about an alleged Alzheimer’s drug that will “earn billions” but can’t be tested because of patent gridlock. A must read as he eviscerates the law and science behind that statement, and read the follow-up as well. As Lowe points out,
the safe harbor provisions of the 1984 Hatch-Waxman Act, as reaffirmed in the 2005 Merck v. Integra decision by the Supreme Court [protects] from infringement [claims] in the use of a patented compound for purposes of submitting regulatory filings. And the language of the ruling makes it look like it’s intended to cover all sorts of patented technologies as well.
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In FDA; patent litigation
