ANDA Filing Before the Asserted Patent's Issuance Precludes Infringement Claim Under the Hatch-Waxman Act: D.N.J. | Practical Law

ANDA Filing Before the Asserted Patent's Issuance Precludes Infringement Claim Under the Hatch-Waxman Act: D.N.J. | Practical Law

In Ferring B.V. v. Actavis, Inc., the US District Court for the District of New Jersey dismissed a patent owner's 35 U.S.C. § 271(e)(2)(A) infringement claim under the Hatch-Waxman Act because the Abbreviated New Drug Application (ANDA) was filed and approved before the asserted patent's issuance.

ANDA Filing Before the Asserted Patent's Issuance Precludes Infringement Claim Under the Hatch-Waxman Act: D.N.J.

by Practical Law Intellectual Property & Technology
Published on 02 Jun 2016 • USA (National/Federal)
In Ferring B.V. v. Actavis, Inc., the US District Court for the District of New Jersey dismissed a patent owner's 35 U.S.C. § 271(e)(2)(A) infringement claim under the Hatch-Waxman Act because the Abbreviated New Drug Application (ANDA) was filed and approved before the asserted patent's issuance.
On May 26, 2016, in Ferring B.V. v. Actavis, Inc., the US District Court for the District of New Jersey granted a motion to dismiss an infringement claim under 35 U.S.C. § 271(e)(2)(A) of the Hatch-Waxman Act because the relevant Abbreviated New Drug Application (ANDA) was filed and approved before the asserted patent's issuance ( (D.N.J. May 26, 2016)).
On November 13, 2009, Ferring Pharmaceuticals AS received FDA approval for New Drug Application No. 02-2430 for tranexamic acid tablets. On December 27, 2012, Watson Laboratories, Inc. received FDA approval for ANDA No. 202093 to market generic tranexamic acid tablets, and subsequently began selling such products. On June 23, 2015, US Patent No. 9,060,939 was issued to Ferring B.V., which claims tranexamic acid formulations.
After receiving its patent, Ferring B.V., Ferring International Center S.A., and Ferring Pharmaceuticals Inc. (Ferring) sued Watson and related companies (Watson), alleging that Watson infringed the '939 patent under:
Watson moved to dismiss the Section 271(e)(2)(A) infringement claim under Federal Rules of Civil Procedure (FRCP) 12(b)(1) and 12(b)(6), arguing that the issuance of the '939 patent after the ANDA's filing and approval:
  • Defeats the court's subject matter jurisdiction over the claim.
  • Prevents Ferring from stating a claim for relief.
The district court granted Watson's motion to dismiss under FRCP 12(b)(6), explaining that:
  • Neither the statutory language nor the legislative history of the Hatch-Waxman Act support a cause of action under 271(e)(2)(A) where the relevant ANDA is filed before the asserted patent's issuance.
  • The artificial act of infringement created by Section 271(e)(2)(A) is not necessary here because Ferring can bring a direct infringement claim against Watson under Section 271(a) based on Watson's commercial sales of the accused product.