Takeda loses battle to stop Mylan from selling generic gout drug

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Takeda Pharmaceuticals (NYSE: TAK) failed to stop Mylan (NASDAQ: MYL) from selling a generic version of its Colcrys, a treatment for gout flares and familial Mediterranean fever.

In December 2019, Takeda filed a lawsuit accusing Mylan of breach of contract and patent infringement for selling Colchicine, a generic version of Colcrys, before the agreed-on entry date.

The Tokyo-based pharmaceutical company requested the United States District Court for the District of Delaware grant a preliminary injunction to stop the Netherlands-based pharmaceutical company from commercially manufacturing and selling its generic Colchicine product.

In January this year, U.S. District Court Judge Richard Andrews rejected Takeda’s request for a temporary injunction. The judge ruled that it “failed to show it is likely to succeed on the merits or that it will suffer irreparable harm.”

Takeda’s argument to stop Mylan from selling a generic version of gout drug

Takeda appealed the district court’s denial of its request for a preliminary injunction. In its argument, the Tokyo-based pharmaceutical company asserted that “the district court erred in determining that it is unlikely to succeed” because it misinterpreted its License Agreement with Mylan by ignoring the term “all” in Section 1.2(d) and by giving effect only to the word “adjudicated.”

“The district court put forth an interpretation whereby a holding of non-infringement, invalidity, or unenforceability on only a subset of the patents asserted—without a decision one way or the other with respect to the remaining patents—triggers Section 1.2(d).”

Takeda argues that “the district court erred in concluding that Section 1.2(d) was likely triggered by [a prior] decision” because “not all the claims that were asserted in that case were held to be not infringed or a combination of not infringed, invalid, or unenforceable by a Final Court Decision.”

In its argument, the Tokyo-based pharmaceutical company also stated that Section 1.10 of the License Agreement stipulated that it would be irreparably harmed if Mylan breached Section 1.2.

Takeda failed to show it could suffer irreparable harm

The U.S. Court of Appeals for the Federal Circuit rejected Takeda’s arguments and affirmed the district court’s decision.

In a 2-1 ruling on July 31, the Appeals Court said it agrees with the district court that “Takeda has not shown that it would be irreparably harmed absent a preliminary injunction.” It also agrees that Takeda failed to show that it is “likely to succeed on the merits or that it would be irreparably harmed absent a preliminary injunction.”

“We conclude that the district court did not abuse its discretion in denying Takeda’s request for a preliminary injunction. We have considered Takeda’s remaining arguments and find them unpersuasive. For the foregoing reasons, the district court’s denial of Takeda’s request for a preliminary injunction is affirmed.”

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