District Court Denies Motion For Judgment In Patent Infringement Lawsuit Under Hatch-Waxman Act

• Jurisdiction: United States,Federal
• Law Firm: Buchanan Ingersoll & Rooney PC
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Author: Grant S. Shackelford
• Published date: 27 April 2023

In a patent infringement lawsuit brought under the Hatch-Waxman Act, the district court in the Northern District of West Virginia recently denied Plaintiffs Bausch Health Ireland Limited and Salix Pharmaceuticals, Inc.'s motion for judgment on the pleadings as to Defendant Mylan's infringement of the patents-in-suit. See Bausch Health Ireland Limited et al v. Mylan Laboratories Limited et al, 1-22-cv-00020 (NDWV Mar. 30, 2023). This decision highlights a distinct and important procedural aspect of lawsuits brought under the Hatch-Waxman Act for infringement allegations of patents covering an FDA-approved drug for which the defendant is seeking approval to market a generic equivalent.

Under the Hatch-Waxman Act, prior to litigation a generic drug applicant is required to certify to the FDA that the patents associated with the brand name drug are "invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted." 21 U.S.C. ' 355(j)(2)(A)(vii). The generic applicant must also send a "Paragraph IV notice letter" to the patent holder that includes "a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed." Id. at ' 355(j)(2)(B)(iv)(II). The question raised by the Plaintiffs in this case is whether a defendant in an ensuing Hatch-Waxman litigation is limited to the invalidity and non-infringement theories raised in their Paragraph IV notice letter.

In this case, the Plaintiffs alleged that Mylan has infringed the patents-in-suit by filing its Abbreviated New Drug Application and seeking approval to sell generic forms of the drug Trulance'. Mylan denied all infringement allegations in its Answer. Nonetheless, Plaintiffs argued that judgment on the pleadings was appropriate because Mylan's Paragraph IV notice letter did not include non-infringement arguments for every asserted claim of the patents-in-suit, and Mylan cannot deviate...