How Safe is the Safe Harbor?

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 biological products.

Over time, courts have held that the safe harbor applies to both drugs and devices and expanded the use of the patented technology to any activities “reasonably related” to FDA approval,” including data developed in clinical trials for FDA approval. As long as there is a reasonable basis to believe that a patented technology may be used for an FDA submission, the use is protected under the safe harbor.  Merck KGaA v. Integra Lifesciences, 545 U.S. 193 (2005).

In 2015, patent-holders were given a gift from the Federal Circuit when it held that ongoing post-approval commercial manufacturing activities do not fall under the safe harbor. But what the court giveth, it also taketh away.  For in 2016, the District Court held (and the Federal Circuit affirmed without input) in Classen Immunotherapies v. Elan Pharms that the safe-harbor protects data in a supplement to revise labeling.  In this case, Elan used Classen’s patented research tool to study the effect of food on the bioavailability of the already-approved drug Skelaxin.  The clinical data was then submitted to FDA in a citizen petition and an sNDA to revise its labeling.  The District Court concluded that Elan’s use of the research tool was protected by the safe harbor because the post-approval submissions were not routine and were necessary to update the Skelaxin product label regardless of the fact that the use was technically a post-approval commercial activity.

Classen filed this Cert Petition arguing that Elan’s use was outside the scope of the safe harbor because the use of the patented technology for post-marketing safety research was “routine.” Classen also complained that Elan not only used the data for submission to FDA, but also to patent a new use of the drug; protecting Elan under the safe harbor in spite of this additional use, Classen contends, means that the safe harbor will protect any data that is at some point submitted to FDA even if it is not the primary intent.  Classen argues that Elan’s clear commercial post-marketing purposes should play a role in a finding of infringement.

The Supreme Court has not granted cert yet – obvious, since Elan has not even filed its response – but it will be interesting to see if the Court decides to weigh in on the admittedly nebulous distinction between routine and not-routine. It seems that Classen wants to draw the line between pre-market commercial use and post-market commercial use.  But this raises a question of how much commercial use should be considered given that the statute clearly anticipates commercial use.  Is commercial use really the deciding factor, or is it actually routine vs. non-routine?  As recently as 2016, the Supreme Court adopted the routine test, so it’s unlikely that the Court will take the opportunity to further refine the distinction, but it seems like we’ll find out soon.