How Safe is the Safe Harbor?

By Sara W. Koblitz — As the breadth of the “patent safe harbor” continues to expand under the Federal Circuit’s growing body of relevant case law, some patent holders are looking to the Supreme Court to push back. In a Petition for Certiorari filed last week in Classen Immunotherapies v. Elan Pharmaceuticals (and sent to us by Alex MacCormick over at Center Lane, LLC), patent-holders challenge the District Court’s (as affirmed by the Federal Circuit) interpretation of routine and non-routine. Codified in 35 U.S.C. § 271(e), the safe harbor exempts drug development and approval from patent infringement: 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…

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