Judge Burke faced an interesting hypothetical last week regarding the rarely invoked safe harbor provision of 35 U.S.C. § 271(e)(1). For those unfamiliar, the safe harbor provision provides that:
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . 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 Sole Use Question
The issue in Wilson Wolf Manufacturing Corp. v. Sarepta Therapeutics, Inc., C.A. No. 19-2316-RGA-CJB, …