Takeda Pharms. U.S.A., Inc. v. Mylan Pharms., Inc.

Colcrys® (colchicine)

September 27, 2023

GENERICally Speaking

Case Name: Takeda Pharms. U.S.A., Inc. v. Mylan Pharms., Inc., Civ. No. 19-2216-RGA, 2023 WL 6295453 (D. Del. Sept. 27, 2023) (Andrews, J.)

Drug Product and Patent(s)-in-Suit: Colcrys® (colchicine); technically, 22 patents, though the court did not reach Takeda’s patent claims.

Nature of the Case and Issue(s) Presented: Takeda has 17 Orange Book-listed patents for Colcrys and previously sued a number of generic manufacturers, including Mylan, that submitted ANDAs relying on that drug product. The parties settled that lawsuit in 2017. As part of that settlement, the parties executed a license agreement, which allowed Mylan to sell generic colchicine after a certain date. The license, as is typical, identified certain events that would trigger an earlier launch, including “[t]he date that is [a specified time period] after the date of a Final Court Decision (as defined in Exhibit A) holding that all unexpired claims of the Licensed Patents that were asserted and adjudicated against a Third Party are either (i) not infringed, or (ii) any combination of not infringed and invalid or unenforceable.”

Mylan believed that a separate case, in which Takeda asserted eight of its Orange Book-listed patents against West-Ward, triggered an early launch. In particular, in the purportedly triggering case, Takeda stipulated to dismiss five of the asserted patents with prejudice, and the court ordered the dismissal. The court then adjudicated the remaining claims, finding non-infringement. As a result, Mylan told Takeda that it intended to launch, and Takeda sued for infringement and breach of contract. Takeda moved for a preliminary injunction, which the court denied after finding that Takeda “failed to show that it is likely to succeed on the merits or that it will suffer irreparable harm.” The Federal Circuit affirmed that finding.

Then the court bifurcated Takeda’s claims, electing to resolve the breach of contract claim first. After completing discovery, Mylan moved for summary judgment, arguing that the license agreement is unambiguous and permits Mylan to launch. The court agreed and granted summary judgment in favor of Mylan.

Why Mylan Prevailed: The parties’ dispute turned on the phrase “asserted and adjudicated.” Mylan read the terms together, arguing that the clause requires a Final Court Decision only for a claim asserted and adjudicated. Thus, when Takeda dismissed certain patents, they were no longer asserted and need not be adjudicated to trigger Mylan’s launch. The dismissed patents were, in short, not relevant. Takeda, for its part, argued that all asserted claims were asserted but not all claims (i.e., the dismissed claims) were subject to a non-infringement holding.

The court agreed with Mylan, separating the license term from preclusion issues and finding that “the plain meaning of the term [adjudicated] makes clear that judicial analysis and a resolution is required for a claim to be ‘adjudicated.’” Thus, voluntary dismissal does not constitute “adjudication.” And “asserted” and “adjudicated” work together in the clause in question. Indeed, to read the clause as Takeda argued “would give Takeda 100% control to make sure that [the launch clause] never applies.” And “[t]he provision in the Agreement is to protect Mylan so that it is not outpaced by competitors, not the other way around.”

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