A Blog About Intellectual Property Litigation and the District of Delaware

Entries for tag: Safe Harbor

Honestly, it's not a very safe harbor
Honestly, it's not a very safe harbor Youngje Park, Unsplash

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, …