Colchicine – USA

On Jan 27, 2020, Judge Richard G. Andrews of Delaware denied Takeda’s motion for a Preliminary Injunction to prohibit Defendant Mylan Pharmaceuticals Inc. from launching a generic version of the drug Colcrys®.

In 2016, Mylan filed ANDA with the FDA, seeking approval of a generic colchicine product & subsequently Takeda sued Mylan for infringement of its 17 patents. Parties then settled their lawsuit on November 7, 2017. As part of that settlement, the parties signed a License Agreement, which allows Mylan to sell a generic colchicine product, but only after a specified date.  Section 1.2 provides several situations, however, in which Mylan can launch its generic product before that date.

Section 1.2(d) states that Mylan is entitled to launch a generic at:

“The 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”

Exhibit A defines a "Final Court Decision" as "the entry by a federal court of a final judgment from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken."

According to Mylan, Section 1.2(d) was triggered by this court’s decision in a separate case, Takeda Pharm. , US.A., Inc. v. West-Ward Pharm. Corp., No. 14-cv-1268-RGA (Mitigare product). In this litigation, Takeda asserted eight of its Colcrys patents against West-Ward, but, during summary judgment briefing, it dismissed five of them "with prejudice".  Court thus granted summary judgment of non-infringement on the remaining three patents.

On October 28, 2019, Mylan notified Takeda that it planned to "immediately start selling" a generic colchicine product "pursuant to the Parties' November 7, 2017 license agreement. Takeda sued Mylan on December 2, 2019 for patent infringement and breach of contract. Takeda then filed this motion for a Preliminary Injunction three days later, seeking to enjoin Mylan from launching the generic product.

Court’s analysis:

Court said that the critical issue here is whether Section 1.2(d) of the License Agreement permits Mylan to launch its generic colchicine product. Court said that it is undisputed that summary judgment decision in West-Ward was a "Final Court Decision."

Takeda argued that the West-Ward decision did not trigger Section 1.2(d) because court only ruled on the three patents that were still at issue, and not on the other five that Takeda had dismissed with prejudice. For Section 1.2(d) to apply, a court must find that "all unexpired claims of the Licensed Patents that were asserted and adjudicated against a Third Party are" not infringed or invalid. According to Takeda, only three patents were "adjudicated," while a total of eight were "asserted." Therefore, Takeda reasons, the summary judgment decision did not cover "all" unexpired claims of the Licensed Patents at issue.

Court however, disagreed & said that correct reading of the Section 1.2(d) applies to patent claims that were "asserted and adjudicated," not to patent claims that were "asserted or adjudicated." In West-Ward, claims from eight patents were "asserted," but claims from only three patents were "asserted and adjudicated." Thus, only those three patents matter for purposes of Section 1.2(d). Of the three patents that were "asserted and adjudicated" in West-Ward, "all" of their unexpired claims were found not infringed. That decision thus triggered Section 1.2(d), which "entitle[ s ]" Mylan to launch a generic version of Colcrys. Therefore Takeda has not shown it is likely to succeed on the merits of its patent infringement or breach of contract claims.

Takeda asserts that Mitigare, the drug in dispute in West-Ward, is not a generic version of Colcrys, and therefore the parties did not envision that a judgment involving Mitigare could trigger Section 1.2(d). Court said that Section 1.2(d) makes no mention of generic Colcrys products. By contrast, Sections 1.2(b) and 1.2(f) refer to the sale of a "Generic Equivalent" of Colcrys, and Section 1.2(e) refers to the sale of "Authorized Generic Products" of Colcrys. The parties therefore clearly knew how to condition provisions of the contract on the launch of generic Colcrys products, but they chose not to condition Section 1.2(d) in such a way. Moreover, West-Ward is a "Third Party" for purposes of Section 1.2(d). The Agreement defines a "Third Party" as a "Person other than a Party or an Affiliate of a Party," i.e., Takeda or Mylan. Section 1.2(d) is therefore not limited to situations where Takeda has sued claiming that a generic version of Colcrys infringes some or all of the Licensed Patents. The "Third Party" does not have to be another generic drug competitor. Rather, the provision can be triggered by a Takeda lawsuit against any entity other than Mylan or its affiliates.

Thus, Plaintiff's Motion for a Preliminary Injunction was DENIED. Court also did not grant any stay pending appeal, except that, in order to give Plaintiff an opportunity to seek immediate relief in the Court of Appeals, Defendant is ORDERED to maintain the status quo until end of the day January 31, 2020.

On same day (Jan 27, 2020) Takeda filed appeal in CAFC.