Friday, July 31, 2020

Takeda loses appeal at CAFC in colchicine case

The outcome:

Takeda Pharmaceuticals U.S.A., Inc. appeals the decision of the United States District Court for the District of
Delaware denying a preliminary injunction based on the
court’s conclusion that Takeda failed to show that it was
likely to succeed on the merits or that it would be irreparably harmed absent a preliminary injunction. For the reasons described below, we affirm.

The matters at issue:

In 2016, Takeda sued Mylan Pharmaceuticals Inc. for
patent infringement based on Mylan’s recently submitted
Abbreviated New Drug Application (“ANDA”) for a generic
version of Takeda’s Colcrys® product, which is a branded
version of the drug colchicine.
Takeda alleged that Mylan
infringed seventeen patents listed in the Food and Drug
Administration’s Orange Book as covering Colcrys® (“Licensed Patents”). See Takeda Pharm. U.S.A., Inc. v. Mylan
Pharm. Inc., No. 1:16-cv-987-RGA (D. Del.). The parties
ultimately resolved the litigation through a Settlement
Agreement and License Agreement, effective November 7,
2017 (“License Agreement”)

The opinion does mention the use of colchicine:

Both Colcrys® and Mitigare® are 0.6 mg colchicine products that are administered orally, and both are
indicated for the prevention of gout. Compare J.A. 719,
with J.A. 763.

The drug colchicine has been used to treat gout for a long time (Ben Franklin used it) but the proper dosage was not worked out in the old days.

Judge Newman's dissent begins:

This appeal is from the district court’s denial of injunctive relief, despite the explicitly agreed provision for an immediate injunction on breach of the License Agreement. I
respectfully dissent, for judicial refusal to enforce settlement terms violates fundamental principles of contract law
and commerce, and negates the strong public policy favoring settlement of litigation on agreed terms.


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