Tuesday, December 18, 2012 11:07:50 AM
It looks like they are saying that the Classen case was correctly decided based on all the "research"-related use of the patents involved, and that the Momenta "plain language" argument (i.e. routine commercial (i.e. non-research) use of a patent post-approval was not explicitly prohibited) was a legitimate argument. It seemed to me that - in the case of Momenta - that the ongoing use of a patent solely for ongoing quality-control purposes could be considered infringement, except that the HW verbiage doesn't explicitly spell that out. Especially when a statement like this is included -
A drug maker's use of a patented invention in routine commercial activity is not immune from infringement liability merely because, for example, the company may periodically report adverse reactions to the FDA. See 21 C.F.R. 314.80 and 600.80. That is because the ordinary commercial exploitation of a patented invention is not “reasonably related to the development and submission of information” for the FDA, even if such exploitation sometimes generates information useful to the FDA. That conclusion is reinforced by the ordinary meaning of the statutory term “development,” which implies more than merely the collection of information incidental to commercial transactions.
JMO, I don't claim any special interpretive abilities when it comes to legal arguments.
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