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


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