Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp.,

Hikma launched the accused product, Mitigare, an oral single-ingredient colchicine product indicated for prophylaxis of gout flares in adults.

Winter 2014

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Takeda Pharms. USA, Inc. v. West-Ward Pharm. Corp., Civ. No. 14-1268-SLR, 2014 U.S. Dist. LEXIS 155981 (D. Del. Nov. 4, 2014) (Robinson, J.) (Given statements made in the accused product’s proposed labeling, Plaintiff could not show likelihood of success and irreparable harm to warrant a preliminary injunction.) 

Drug Product and Patent(s)-in-Suit: Colcrys® (colchicine); U.S. Pats. Nos. 7,964,648 (“the ’648 patent”), 7,981,938 (“the ’938 patent”), 9,097,655 (“the ’655 patent”), 8,440,722 (“the ’722 patent”), 7,964,647 (“the ’647 patent”) 

Nature of the Case and Issue(s) Presented: Hikma launched the accused product, Mitigare, an oral single-ingredient colchicine product indicated for prophylaxis of gout flares in adults. Hikma did not file its application concerning Mitigare with the FDA as an ANDA. Instead, Hikma sought approval through the NDA pathway under § 505(b)(2). Moreover, Hikma omitted specific mention of uses for which Takeda had patent protection.

Takeda sought, and the Court granted, a temporary restraining order (“TRO”) to preserve the status quo while the parties more fully briefed Takeda’s motion for preliminary injunction, which the Court ultimately denied.

Why West-Ward Pharm. Prevailed:  The Court made various findings in support of its holding that Takeda has not shown a likelihood of success that the accused product would infringe the patents-in-suit. First, the Court found that specific intent to induce infringement could not be inferred. Colchicine had been used for the treatment of gout flares long before Takeda’s patents issued. Hikma’s proposed label omits explicit directions for uses covered by Takeda’s patent. The Court explained that its decision to grant a TRO was based on whether it was likely that patients who were taking colchicine for prophylaxis of gout flares would follow the patented methods of treating acute flares and when co-administering with other drugs. “On the expanded record submitted by the parties, I find reason to question my earlier conclusions.” The issue now before the Court was whether Hikma has actively encouraged patients to infringe, as demonstrated by Takeda through record evidence.

Hikma argued that its proposed label not only lacks any affirmative directions for the treatment of acute gout flares, but it actually disclaims an indication for acute gout flares. The Court found that Hikma’s label only “necessarily leads” to consultation with a healthcare provider who may, or may not, consult with Colcrys’ prescribing information and who may, or may not, follow the patented method of use for treatment of the acute gout flare. Moreover, Takeda concedes that Hikma’s label “fails to specify how to reduce the dose or dose frequency” of colchicine. Hikma’s label characterizes the concomitant use of Mitigare and CYP3A4 inhibitors as something that “should be avoided,” and the Court found, based on precedent, that “there is a rather significant difference between a warning and an instruction.” Ultimately the Court found that there is no evidence that any healthcare provider has actually practiced the methods of the patents-in-suit and, indeed, there were declarations of record that included evidence that “avoidance” of co-administration is the normal practice, given the risks of toxicity and the many opinions for each of the drugs.

Next, the Court found that Takeda had demonstrated irreparable harm based on the prosect that generic Mitigare will likely take over the colchicine market. The substitution from Takeda’s Colcrys product will be immediate and significant. But the Court further found that Takeda had not linked its harm to the allegedly infringing conduct.

Because Takeda failed to demonstrate it will likely prove induced infringement at trial or suffer irreparable harm, a preliminary injunction is not warranted. But the Court offered an alternative: the status quo will be maintained if: (i) Takeda takes an immediate, expedited appeal; and (ii) the bond increases $500,000 per day until further order of the Court or the Federal Circuit.

Oren D. Langer


Managing Partner, New York Office
Member of Executive Board

Ryan M. Schultz


Pronouns: he/him

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