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IPR’s and the Hatch-Waxman 30-Month Stay of FDA Approval

August 12, 2014

IPR’s and the Hatch-Waxman 30-Month Stay of FDA Approval

August 12, 2014

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When a patentee (the “brand”) files suit under the applicable provision of the Hatch-Waxman Act (“the Act”), 35 U.S.C. § 271(e)(2)(A), against a generic company (the “generic”) that has submitted an ANDA with a paragraph IV certification, the FDA cannot approve the ANDA for 30 months from the date of the patentee’s receipt of the so-called notice letter. 21 U.S.C. § 355(j)(5)(B)(iii). The court can lengthen or shorten the stay due to the lack of cooperation by the generic or the brand, respectively, or a preliminary injunction against the generic. Id. Thus, the length of the stay is subject to equitable considerations. —Read more on Fish’s Litigation Blog


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.
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