Takeda v. Mylan was decided on July 31, 2020, on appeal from the District of Delaware. In 2016, Plaintiff Takeda sued Defendant Mylan for patent infringement. The parties ultimately settled. The license agreement allows Mylan to sell a generic product in the event that a court decision “hold[s] 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.” Under the license agreement, the parties stipulated that a breach “would cause Takeda irreparable harm.” Concurrent with its litigation against Mylan, Takeda also pursued infringement claims against Hikma. “[I]n December 2018, the district court granted summary judgment in favor of Hikma, holding that Hikma did not infringe any asserted claim of” three of the licensed patents. Mylan subsequently launched its generic product. Takeda then sued Mylan for breach of contract and patent infringement. The district court denied Takeda’s motion for a preliminary injunction, finding that “Takeda failed to show it is likely to succeed on the merits or that it will suffer irreparable harm.” Takeda appealed.
The Federal Circuit affirmed the denial of a preliminary injunction.
A plaintiff seeking a preliminary injunction must establish 1) that it is likely to succeed on the merits, 2) that it is likely to suffer irreparable harm in the absence of preliminary relief, 3) that the balance of equities tips in its favor, and 4) that an injunction is in the public interest.
The district court correctly determined that Takeda is unlikely to succeed on the merits. The Federal Circuit “agree[d] with the district court that the final judgment in the [Hikma] Litigation likely triggers [the section] of the License Agreement[] permitting Mylan to market its generic … product.”
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The district court correctly determined that Takeda failed to show that it will be irreparably harmed without a preliminary injunction. By its terms, the license agreement “only offers Takeda a basis for establishing irreparable harm in the event Mylan breached [the agreement].” Because the Federal Circuit concluded “that it is unlikely Takeda can show that Mylan breached the License Agreement,” the Federal Circuit further concluded that the irreparable harm provision “is not useful for establishing irreparable harm in this case.” “Without the stipulation of irreparable harm, Takeda makes no credible assertion that it cannot be compensated by monetary damages.” Takeda argued “generally that each sale by Mylan reduces the units sold by Takeda and that Mylan’s sustained launch likely will cause Takeda to incur irreversible price erosion and long-term loss of market share.” “Takeda’s nonspecific and unsupported assertion that Mylan’s sales likely will cause irreparable harm falls far short of establishing that irreparable harm has occurred, or will likely occur, absent a preliminary injunction.”
Judge Newman dissented, arguing that “[t]he settlement agreement provides for an immediate injunction.”