XELLIA APS ANDA
On January 6, 2014, Merck & Co., Inc. received from Wendy M. Ward, Esq. of Merchant & Gould P.C. a letter, dated January 3, 2014 (the “January 3 letter”), stating that Xellia ApS had submitted to the FDA an ANDA, assigned as No. 205923, seeking approval to market caspofungin acetate injectable, IV (infusion), in 50 mg and 70 mg dosage forms (“the Xellia ApS Products”). 14.
The January 3 letter stated that the Xellia ApS ANDA included certifications pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that the ’300 patent would not be infringed by the manufacture, use, or sale of the Xellia ApS Products, and/or that the claims of the ’300 patent are invalid or unenforceable. 15.
The Xellia ApS ANDA refers to and relies upon the Merck NDA for CANCIDAS
INFRINGEMENT OF U.S. PATENT NO. 5,952,300
Plaintiff repeats and realleges paragraphs 1-15 above as if fully set forth herein. 17.
By filing its ANDA No. 205923 under 21 U.S.C. § 355(j) for the purpose of obtaining approval to engage in the commercial manufacture, use or sale of the Xellia ApS Products before the expiration of the ’300 patent, Xellia ApS committed an act of infringement under 35 U.S.C. § 271(e)(2). 18.
If Xellia ApS commercially makes, uses, offers to sell, or sells the Xellia ApS Products within the United States, or imports the Xellia ApS Products into the United States, or induces or contributes to any such conduct during the term of the ’300 patent, it would further infringe the ’300 patent under 35 U.S.C. §§ 271(a), (b), and/or (c).