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Federal Circuit Broadens Hatch-Waxman Safe Harbor

By Tanya Roth, Esq. on August 08, 2012 | Last updated on March 21, 2019

The Federal Circuit Court of Appeals dealt a small victory to Amphastar Pharmaceuticals and Watson Pharmaceuticals in a patent case against Momenta Pharmaceuticals.

Last Friday, the court vacated the grant of a preliminary injunction after the district court denied an emergency motion to dissolve or stay the injunction.

Essentially, the Federal Circuit's opinion came down to the fact that the district court had applied the wrong interpretation of the Hatch-Waxman safe harbor.

The Hatch-Waxman safe harbor provision gives a party immunity from a patent infringement suit when the testing of the patented invention has the purpose of securing regulatory approval from the FDA.

For patent attorneys, especially those involved in pharmaceutical litigation, a strong understanding of the judicial interpretation of the Hatch-Waxman safe harbor can be crucial. Courts have analyzed the scope of this safe harbor for years and this recent Federal Circuit decision sheds more light on how this safe harbor applies.

In the past, the U.S. Supreme Court has held that the scope of the safe harbor applied not only to drugs but also to medical devices. Further, SCOTUS held that the safe harbor extended to pre-clinical research as well as clinical research.

Now, the Federal Circuit has expanded that definition to say that the safe harbor would also apply to post-FDA approval activity, so long as the activity was commercial in nature.

The greater patent litigation is still pending in the current case and the Federal Circuit's opinion was a small part of the overall decision. But with the court stating that Momenta had not established a likelihood of success on the patent infringement claim, the case is being looked at with a fresh perspective.

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