David P. Langlois (DL 2319) SUTHERLAND ... - FDA Law Blog

Case 1:09-cv-04665-DLC Document 49-2 Filed 03/30/2010 Page 32 of 45The ‘584 and ‘404 Patents22. Takeda alleges that it is the owner through assignment of U.S. Patent No. 5,965,584(“the ‘584 patent”) and U.S. Patent No. 6,329,404 (“the ‘404 patent”). See Complaint, 13-16.23. As Takeda acknowledges in its Complaint, the ‘584 patent contains two separatecategories of patent claims. The first category concerns, in Takeda’s words, “a pharmaceuticalcomposition comprising pioglitazone or salts thereof in combination with a biguanide (e.g.,metformin) ….” The second category concerns, in Takeda’s words, “methods for treating diabeteswhich comprise administering a therapeutically effective amount of pioglitazone or salts thereof incombination with a biguanide, such as metformin.” See Complaint, 13. In other words, the ‘584patent contains (a) drug product (composition) claims, and (b) method-of-use claims.24. The ‘404 patent is similarly structured. As Takeda acknowledges in its Complaint,the ‘404 patent contains two separate categories of patent claims. The first category concerns, inTakeda’s words, “a pharmaceutical composition comprising pioglitazone or salts thereof incombination with an insulin secretion enhancer (e.g., a sulfonylurea, such as repaglinide orglimepiride) ….” The second category concerns, in Takeda’s words, “methods for treating diabeteswhich comprise administering a therapeutically effective amount of pioglitazone or salts thereof incombination with an insulin secretion enhancer.” See Complaint 15. Like the ‘584 patent, the‘404 patent contains (a) drug product claims, and (b) method-of-use claims.25. No claim in either the ‘584 patent or the ‘404 patent claims the drug productpioglitazone alone or the use of pioglitazone alone. The drug substance pioglitazone is covered bya different patent, U.S. Patent No. 4,687,777 (the ‘777 patent), which expires on January 17, 2011.9067383.131