Replies to post #157973 on Biotech Values

[dav1234]

In the pre-approval context, determining whether a defendant's use of a patented invention in drug-development research was "solely for uses reasonably related to the development and submission of information" [**30] to the FDA will normally be a straightforward inquiry. In the post-approval context, that inquiry [*18] may be substantially more difficult because the drug maker simultaneously may be engaged in the ordinary commercial manufacture and sale of the product in question. In such circumstances, a more nuanced analysis is required. 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.

i like this ,what are your odds on SC accepting case?

great post by the way