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  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...

  2. #2
    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.

  3. #3
    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?

  4. #4
    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:




  5. #5
    • 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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