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Edwards Angell Palmer & Dodge LLP, Boston, MA
Takeda v. Mylan
Takeda Counsel EAPD Enlists CaseSight to Fight Off ANDA Claims THE MAT TER
Actos Market Under Threat by Generic Drug Makers

In 2005 Mylan Inc. sought to launch a generic version of Takeda Chemical Industries’ successful Type 2 diabetes that effectively gave Judge Cote the background and facts drug ACTOS® (pioglitazone hydrochloride). In their she needed to render in Takeda’s favor.
Abbreviated New Drug Application (ANDA) fi lings to the CaseSight’s tutorials helped EAPD convincingly fi ght off FDA, Mylan and three others argued Takeda’s Actos patent the claim of obviousness by showing to the judge the was invalid due to obviousness and inequitable conduct. complex nature of the lead compound in question in the Takeda hired Edwards Angell Palmer & Dodge (EAPD) to prior art, and its millions of potential variations. The tutorials bring suit in the Southern District of New York against Mylan also demonstrated abundant evidence of Takeda’s good and the others to roll back the ANDA bid, assert the validity faith before the PTO, rendering the defendants’ arguments of the patent, and reassert the profi table ACTOS market.
regarding disclosures before the PTO immaterial. EAPD called on CaseSight to design case presentation assets that would clarify and simplify to the judge the THE OUTCOME
complex nature of the chemical patent under dispute, and Actos Validity Upheld, Takeda’s Market and Brand
clearly demonstrate Takeda’s novelty and good conduct in Enhanced
Judge Cote ruled that the Takeda patent covering pioglitazone hydrochloride, the active ingredient in its THE CASESIGHT EFFECT
diabetes drug ACTOS, was valid and enforceable against DVD Tutorials Effectively Teach, Convince Judge of
Patent Validity
Cote wrote in her February 21, 2005 ruling, “the [ACTOS] Due to the sheer complexity of the compounds under Patent discloses a remarkable invention. After decades dispute and the diffi cult legal arguments employed by the of work to develop an anti-diabetic treatment, Takeda defendants, Judge Denise Cote of the U.S. District Court discovered a pharmaceutical agent that was both effective for the Southern District of New York asked EAPD before and nontoxic. This represented a signifi cant advance over the trial for two DVDs that she could review on a standard compounds disclosed in the prior art. Faced with the task home DVD player: one, an organic chemistry tutorial on the of proving their cases by clear and convincing evidence, background and development of pioglitazone hydrochloride, both Alphapharm and Mylan have failed to make even a and the other, a synopsis of the patent validity arguments.
rudimentary showing that the invention was obvious or that Using engaging 3D animation imagery, CaseSight’s Takeda engaged in inequitable conduct. Their challenges to Presentation Consultant and expert designers worked with the EAPD team to create two clear, convincing programs 6 9 C A N A L S T, T H I R D F L O O R • B O S T O N M A 0 2 11 4 | P H O N E 6 17. 9 3 3 . 8 5 0 0 | FA X 6 17. 7 2 3 . 6 0 8 0 | C A S E S I G H T I N C . C O M


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