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

Case 1:09-cv-04665-DLC Document 49-2 Filed 03/30/2010 Page 4 of 4511. Upon information and belief, Teva admits that the approved indications forACTOPLUS MET ® drug products are set forth in the FDA-approved labeling for such drugproducts. Except as expressly admitted above, Teva denies the allegations in Paragraph 11.12. Upon information and belief, Teva admits the allegations in Paragraph 12.The Patents in Suit13. United States Patent No. 5,965,584 (“the ‘584 patent”) speaks for itself. Tevaadmits that the ‘584 patent, entitled “Pharmaceutical Composition,” lists on its face an issue date ofOctober 12, 1999 and lists on its face as inventors Hitoshi Ikeda, Takashi Sohda and HiroyukiOdaka, but specifically denies that the patent was duly issued. Teva further admits that the ‘584patent lists on its face as an assignee Takeda Chemical Industries, Ltd. Teva further admits thatwhat purports to be a copy of the ‘584 patent is attached to the Complaint as Exhibit A. To theextent Paragraph 13 states conclusions of law, no response is required. Except as expresslyadmitted above, Teva denies the allegations in Paragraph 13.14. Upon information and belief, Teva admits that the ‘584 patent, if valid andenforceable, expires on June 19, 2016. Teva further admits that the ‘584 patent lists on its face asan assignee Takeda Chemical Industries, Ltd. Except as expressly admitted above, Teva denies theallegations in Paragraph 14.15. United States Patent No. 6,329,404 (“the ‘404 patent”) speaks for itself. Tevaadmits that the ‘404 patent, entitled “Pharmaceutical Composition,” lists on its face an issue date ofDecember 11, 2001 and lists on its face as inventors Hitoshi Ikeda, Takashi Sohda and HiroyukiOdaka, but specifically denies that the patent was duly issued. Teva further admits that the ‘404patent lists on its face as an assignee Takeda Chemical Industries, Ltd. Teva further admits thatwhat purports to be a copy of the ‘404 patent is attached to the Complaint as Exhibit B. To the9067383.13