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Sunovion Pharms., Inc. v. Sandoz, Inc.

United States District Court for the Eastern District of North Carolina, Eastern Division

September 1, 2011, Decided; September 1, 2011, Filed

No. 5:10-MD-1500-H(3); No. 4:08-CV-89-H(3)



This matter is before the court  [*3] on a motion to dismiss for lack of subject matter jurisdiction filed by defendant Sandoz, Inc. ("Sandoz") [DE #275], as well as defendant Sandoz's appeal of an order extending the thirty-month stay of FDA approval [DE #304]. On December 3, 2010, United States Magistrate Judge William A. Webb issued a Memorandum & Recommendation/Order recommending denial of Sandoz's motion to dismiss. Judge Webb further determined that Sandoz had failed to cooperate reasonably in expediting the litigation and extended the thirty-month stay of FDA approval for a period of sixty days. Sandoz has filed written objections to the recommended decision and order, plaintiffs have responded, and both parties have submitted supplemental briefs on the jurisdictional issue as requested by the court.


Sepracor, Inc., 1 together with UCB, S.A., and UCB, Inc. ("UCB") initiated this action against Sandoz upon filing a one-count complaint alleging infringement of U.S. Patent No. 5,698,558 ("the '558 patent"). The '558 patent is a method-of-use patent claiming use of levocetirizine dihydrochloride 5 mg tablets ("levocetirizine") in the treatment of seasonal and perennial allergic rhinitis. Plaintiffs  [*4] are the record owner and exclusive licensee of the '558 patent. On May 25 2007, the United States Food and Drug Administration ("FDA") approved plaintiff's New Drug Application to market XYZAL ® (levocetirizine) for the treatment of seasonal and perennial allergic rhinitis, as well as urticaria (commonly known as hives).

In or around May 2008, Sandoz filed an Abbreviated New Drug Application ("ANDA") seeking FDA approval to market a generic levocetirizine prior to expiration of the '558 patent. Originally, Sandoz sought approval of its generic levocetirizine for both FDA-approved uses: (1) treatment of allergic rhinitis; and (2) treatment of urticaria. For the first use, Sandoz included a paragraph IV certification asserting that plaintiffs' patent was invalid, unenforceable or would not be infringed. Because urticaria is not an indication claimed by the '558 patent, Sandoz filed a section viii statement declaring that  [*5] intended use is not covered by the '558 patent.

On February 5, 2010, Sandoz submitted to the FDA a proposed amendment of its ANDA "revising its patent certification from a paragraph IV to a section viii statement." Sandoz informed the FDA that it was no longer seeking approval of its generic levocetirizine for treatment of allergic rhinitis, the only use covered by the '558 patent. Sandoz asserts that this amendment divested the court of subject matter jurisdiction over plaintiffs' infringement claim and that dismissal is, therefore, required.

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2011 U.S. Dist. LEXIS 99077 *; 2011 WL 3875397

SUNOVION PHARMACEUTICALS, INC., et al., Plaintiffs, v. SANDOZ, INC., Defendant.

Prior History: Sepracor, Inc. v. Barr Pharms., Inc., 2010 U.S. Dist. LEXIS 141863 (E.D.N.C., Dec. 3, 2010)


patent, infringement, thirty-month, certification, levocetirizine

Civil Procedure, Judicial Officers, Magistrates, Standards of Review, Patent Law, Jurisdiction & Review, Subject Matter Jurisdiction, General Overview, Business & Corporate Compliance, Governments, Agriculture & Food, Federal Food, Drug & Cosmetic Act, Judges, Discretionary Powers