Fish Attorneys Author IP Litigator Article, "Regenxbio v. Sarepta: Make Sure You're Safely Within the Safe Harbor Before Using a 'Research Tool'"


Disclaimer: Fish and Richardson P.C. represents REGENXBIO Inc. in this matter.

The Hatch-Waxman Act provides a safe harbor for activities that would otherwise constitute patent infringement so long as those activities are reasonably related to the submission of a product for FDA approval. However, are patented products that are not themselves subject to FDA approval, but used to develop products that are subject to FDA approval, also protected under the Hatch-Waxman safe harbor? While courts have reached different conclusions on this question, one recent district court decision answered it with a resounding "no."

PDF copy available.