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Thread: Bigger and more important than Hollinsworth etc ... FTC v. Actavis is where it's at!

  1. #1

    Bigger and more important than Hollinsworth etc ... FTC v. Actavis is where it's at!

    The Supreme Court of the US heard a case this week that will affect millions of Americans, and it has nothing to do with homosexuality or race. And no one has heard of it...
    Federal Trade Commission v. Actavis is a case on patent law and the intersection with anti-trust and anti-competitive behavior. And it directly ratchets up the costs of drugs for millions of Americans. In 2010, nearly HALF of all Americans had taken a prescription drug in the preceding 10 months. Do the math.

  2. #2
    But to understand the case, you need to understand the Hatch Waxman Act. The Act is actually kind of brilliant. Let's say Company A has created and patented revolutionary drug A. Generic company B wants to sell, you guessed it, a generic version of Drug A, however, it can't touch the thing until the 20 year patent has expired. BUT, under the Hatch Waxman Act, B has some interesting options. First, it does now have to go through full FDA approval process to get the generic version of Drug A passed. Why would it?
    But to do that research and that approval process would violate the patent, so the Act allows generic companies to file what is called a Paragraph IV certification saying one or more of the following:

  3. #3
    • B's use of the drug is noncommercial
    • B's use of the drug does not or will not infringe the patent (usually because either the generic company is going to wait until the 20 year period to expire [unlikely] or because their use is supposedly significantly different as to not fall under the patent's claims
    • The patent is invalid (usually over prior art issues)

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