Hatch-Waxman Act Certification Sufficiency of Notice for Paragraph IV Certification Still in Limbo

Mondaq Business Briefing, May, 2002

Noting the complexity of the Hatch-Waxman Act (H-W) statutory scheme, the U.S. Court of Appeals for the Federal Circuit upheld a dismissal, with prejudice, of a patent suit filed against a U.S. Food and Drug Administration (FDA) applicant who had certified under the H-W that its generic drug did not infringe the patent in question. Minnesota Mining and Mfg. Co. v. Barr Laboratories, Inc., Case Nos. 01-1369, -1370 (Fed. Cir., May 1, 2002).

This case involves the interaction between the 180-day waiting period under the H-W, 21 U.S.C. [section] 355(j)(5)(B)(iv)(II), for a second manufacturer of a generic drug and the sufficiency of notice of no patent infringement under "the paragraph IV certification" procedure.

3M is the manufacturer of Tambocor[registered]...