H. Lundbeck A/S v. Lupin Limited

Opinion

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

H. LUNDBECK A/S, TAKEDA ) PHARMACEUTICAL COMPANY LTD., ) TAKEDA PHARMACEUTICALS U.S.A, ) INC., TAKEDA PHARMACEUTICALS ) INTERNATIONAL AG, and TAKEDA ) PHARMACEUTICALS AMERICA, INC., =) ~C.A. No. 18-088-LPS ) CONSOLIDATED Plaintiffs, ) v. ) ) APOTEX INC., et al., ) ) Defendants. ) tS) MEMORDANUM ORDER At Wilmington, this 8" day of January, 2021, the Court, having considered Defendants Sandoz Inc. and Lek Pharmaceuticals d.d.’s Motion for Partial Judgment on the Pleadings under Fed. R. Civ, P. 12(c) and to Dismiss for Lack of Subject Matter Jurisdiction under Fed. R. Civ. P. 12(b)(1), and the papers submitted in connection therewith (see D.I. 908-11, 937, 944; see also 985 at 7); IT IS HEREBY ORDERED that the Motion (D.I. 908) is GRANTED. The substance of the motion is not disputed. Plaintiffs’ request that Sandoz be required to provide notice if it amends its ANDA to add a section viii statement is denied. As Sandoz states, “Plaintiffs cite no statutory or other legal authority to support this unprecedented request.” (D.I. 944 at 2; see also generally Watson Labs., Inc. v. Sebelius, 2012 U.S. Dist. LEXIS 185685, at *9 (D.D.C. Oct, 22, 2012) (“Filing a section viii statement is not an act of infringement, so it does not require applicants to provide notice to the pioneer applicant or wait thirty months for FDA approval.”). IT IS FURTHER ORDERED that: 1. Counts V-VI of the Third Amended Compiaint for Patent Infringement Against

Sandoz Inc. and Lek Pharmaceuticals d.d. (D.I. 809) are dismissed without prejudice. 2. Sandoz Inc.’s Ninth and Tenth Counterclaims set forth in Defendants Sandoz Inc. and Lek Pharmaceuticals d.d.’s Answer and Affirmative Defenses and Sandoz’s Inc.’s Counterclaims to Third Amended Complaint for Patent Infringement (D.I. 845) are dismissed without prejudice. 3, The parties shall bear their own attorneys’ fees and costs.

HONORABLE LEONARD P. STARK. UNITED STATES DISTRICT JUDGE