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
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Edwards Angell Palmer & Dodge LLP, Boston, MA