U.S. District Court for the Southern District of New York Judge Denise Cote ruled yesterday that a patent owned by Takeda Pharmaceutical Co. Ltd (U.S. Patent No. 4,687,777, “Thiazolidinedione derivatives, useful as antidiabetic agents”) was valid, ruling that the defendants failed to carry their burden against Takeda. The consolidated defendants (Mylan Laboratories Inc, Mylan Pharmaceuticals, Inc., UDL Laboratories, Inc., Alphapharm Pty. Inc, and Genpharm, Inc.), according to Judge Cote, “failed to carry [their] burden of showing either a material misstatement or omission [by Takeda]” and “also failed to present any evidence of intent to deceive the PTO.” Takeda claimed in its September, 2003, and March, 2004, filings that the defendant generic drug companies were infringing a patent that Judge Cote called “remarkable” in her opinion, and the joint defendants claimed that Takeda misrepresented its list of compounds disclosed to the USPTO during prosecution, and that this patent, covering the Type-2 diabetes drug ACTOS® (co-marketed by Takeda and Indianapolis based Eli Lilly & Company), was invalid for this reason. This opinion contains legal analyses regarding obviousness, ANDA filings, and inequitable conduct.

Judge Denise Cote’s Decision: LINK
Link to Yahoo! Asia News Story: LINK
U.S. Patent No. 4,687,777: LINK