Argument Preview

Two cases that attracted amicus briefs are being argued on Monday, June 8. The cases are related. Takeda Pharmaceuticals U.S.A brought separate breach of contract and patent infringement claims against two different alleged infringers, Mylan Pharmaceuticals Inc. and Alkem Laboratories Limited. In both cases, Takeda appeals the district court’s denial of its motions for preliminary injunctions. Takeda argues that license agreements between Takeda and the accused infringers do not allow for the production of generic versions of Takeda’s patented product at this time. Here is our argument preview.

As mentioned, there are two cases. One is Takeda Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc., and the other is Takeda Pharmaceuticals U.S.A v. Alkem Laboratories Limited. In both cases, the parties make almost identical arguments. Furthermore, Hikma Pharmaceuticals USA, Inc. and Hikma Pharmaceuticals International Limited filed nearly identical briefs supporting Takeda in each case. As a result, here we provide only one argument preview, for Takeda Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc.

This case involves a dispute regarding the proper interpretation of Section 1.2(d) of a license agreement between Takeda and Mylan. Based on its interpretation of the license agreement, the district court held that Mylan was entitled to launch its generic version of Takeda’s FDA-approved colchicine tablet product. As a result, the court denied Takeda’s motion for a preliminary injunction.

Takeda focuses in its opening brief on Section 1.2(d) of the license agreement, which allows Mylan to launch a generic version of the drug in certain circumstances. According to Takeda, the relevant part of that section applies only when there is “a final decision holding that all of the unexpired claims of the Patents-in-Suit that were asserted and adjudicated are either (i) ‘not infringed’ or (ii) ‘any combination of non-infringed and invalid or unenforceable.” Takeda argues that “the district court put forth an interpretation whereby a holding of noninfringement, 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 response brief, Mylan argues that “[t]he District Court properly held that the court’s decision in the [prior litigation] met the requirements of Section 1.2(d) and thus” Mylan had the right to launch its product. Mylan points to the fact that, “[s]ince . . . five patents Takeda voluntarily dismissed from the [prior litigation] were neither ‘asserted’ nor ‘adjudicated’ for the purposes of Section 1.2(d), it necessarily follows that the [prior judgment] held that ‘all unexpired claims of the Licensed Patents that were asserted and adjudicated against a Third Party’ were ‘not infringed,’ thus triggering [Mylan’s] launch rights under Section 1.2(d) of the License Agreement.”

In its reply brief, Takeda contends that Mylan made an admission in its response, and that it “only confirms that the district court abused its discretion in denying a preliminary injunction.” Takeda argues that Mylan does not deny that for the five patents “asserted in the [prior litigation], there was no ‘holding’ on the issues of noninfringement, invalidity, or unenforceability, as required by Section 1.2(d).” Takeda goes on to state that “the purpose of the License Agreement is to provide Mylan a date certain on which it can enter the market with its generic colchicine product.” And Takeda takes the position that, “because Mylan’s license was not triggered by the [prior litigation], Mylan has breached the License Agreement and willfully infringed the Patents-in-Suit.”

As previoulsy noted, this case attracted an amicus brief. That amicus brief, filed by Hikma Pharmaceuticals USA, Inc. and Hikma Pharmaceuticals International Limited, supports Takeda. According to Hikma, it “has a strong interest in this matter . . . because the present dispute between Takeda and Mylan . . . turns on the holding in a prior patent litigation [what the parties call the West-Ward Litigation] between Takeda and amici Hikma involving Hikma’s Mitigare® colchicine capsule product.” Hikma clarifies that “[a]ll asserted claims in those five adjudicated patents were dismissed with prejudice by a stipulation without any holding of non-infringement, invalidity, or unenforceability.” As a result, Hikma argues that these claims could not have been “asserted” or “adjudicated,” and “the West-Ward Litigation did not trigger provision 1.2(d) in Takeda’s agreement with Mylan.”

We will provide an argument recap and report on the Federal Circuit’s disposition of the case.