We've discussed before how difficult it is to successfully invoke the safe harbor provision of 271 at the motion to dismiss stage. This is especially so since a plaintiff generally need not look very hard to find statements from the Defendant that they are, like, totally about to sell eleventy-billion-dollars worth of the drug in question. How then, can a defendant—with all inferences taken against them—show that the otherwise infringing product is "solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products?"
The defendant in Allergan, Inc. v. Revance Therapeutics, Inc., No. 21-1411-RGA, 2022 U.S. Dist. …
