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

March 31, 2022

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

March 31, 2022

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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.


The opinions expressed are those of the authors on the date noted above and do not necessarily reflect the views of Fish & Richardson P.C., any other of its lawyers, its clients, or any of its or their respective affiliates. This post is for general information purposes only and is not intended to be and should not be taken as legal advice. No attorney-client relationship is formed.