GSK v. Teva Induced Infringement Liability Despite Skinny Label | AMRN Message Board Posts

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Msg  7859 of 8065  at  11/27/2020 4:33:32 PM  by

ex_hacker202


 In response to msg 7857 by  cmm3rd
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Re: GSK v. Teva Induced Infringement Liability Despite Skinny Label

  Chief Judge Prost contended that the case effectively extends patent life far beyond the expiration of composition patents, allowing brands to maintain monopolies where any new use for the old drug remains on patent – even if the generic or biosimilar does not seek FDA approval for that use. In Chief Judge Prost's words: "Contrary to Congress's intent, the Majority … allows one patented method to discourage generics from marketing skinny labels—thus, slowing, rather than speeding, the introduction of low-cost generics."
 
Prost doesn't appear to really understand this case in his (her?) rush to allow generics into the market as fast as possible despite patent protection - Teva did NOT seek FDA approval for the CHF indication, FDA oddly (nobody has explained why) forced Teva to add the carved-out indication back on the label, putting Teva in jeopardy. Teva promoted it as equivalent and that was a big part of why they infringed, but it's not the entire reason - note GSK didn't sue until the label change, while it appears Teva was marketing it as equivalent from the very start. If what Prost believed was true the H-W Act would have accomplished nothing, carve-outs couldn't exist.


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