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Threat of ITC Exclusion Order Is Too Speculative to Constitute Irreparable Harm

The US Court of Appeals for the Federal Circuit affirmed a decision by a federal district court denying a defendant’s motion for a preliminary injunction seeking to enjoin a parallel International Trade Commission (ITC) investigation against it. The Federal Circuit agreed that the defendant’s alleged irreparable harm (a “cloud” over its business) was too conclusory and speculative to support relief. Koninklijke Philips N.V. v. Thales Dis Ais USA LLC, Case No. 21-2106 (Fed. Cir. July 13, 2022) (Moore, C.J., Dyk, Chen, JJ)

Koninklijke filed a complaint at the ITC requesting a Section 337 investigation based on alleged infringement by Thales of four patents designated essential to the 3G and 4G telecommunications standards. Koninklijke simultaneously filed a parallel district court action against Thales in the Delaware district court based on those four patents. At the district court, Thales moved for a preliminary injunction seeking to enjoin Koninklijke from pursuing an exclusion order at the ITC because of an alleged breach of contract. The district court denied that motion, and Thales appealed to the Federal Circuit.

Meanwhile, the ITC investigation continued, and the administrative law judge (ALJ) issued an initial determination finding no violation of Section 337 with respect to any of the four patents. Subsequently, the Federal Circuit held oral arguments on the district court appeal, during which the judges questioned whether there could be irreparable harm if the ITC were to adopt the ALJ’s determination and consequently not issue an exclusion order. Thales argued that the threat of an exclusion order had left a “cloud” over its business and cited customer concerns that Thales might not be able to deliver products in the future. The ITC subsequently affirmed the ALJ’s finding of no violation and terminated the investigation without issuing any exclusion order.

A week later, the Federal Circuit issued a decision affirming the district court’s denial of the preliminary injunction motion. The Court held that Thales had failed to meet its burden to establish irreparable harm because it had not presented any evidence that it had actually lost any customers, that any customers had delayed purchases or that it had struggled to gain new customers because of the threat from the ITC investigation. The Court also found that the cloud over Thales’ business and the potential loss of business were too speculative to justify a preliminary injunction.

Practice Note: While the ITC investigation was ongoing, Thales filed a civil action in France against Koninklijke—a fellow European company—alleging that Koninklijke’s attempt to obtain injunctive relief in the United States for standard essential patents constituted an anti-competitive act that violated French civil law. Thales sought EUR 13.5 million in damages for the legal fees that it had incurred in defending the ITC investigation.




Unlikely to Succeed: Preliminary Injunction Denied Despite Stipulation to Irreparable Harm

In a dispute over the terms of a settlement agreement, the US Court of Appeals for the Federal Circuit found that a patent owner was not entitled to a preliminary injunction despite a stipulation that it would be irreparably harmed if the accused infringer breached certain provisions of the agreement. Takeda Pharmaceuticals U.S.A., Inc. v. Mylan Pharmaceuticals, Inc., Case Nos. 20-1407, -1417 (Fed. Cir. July 31, 2020).

Takeda originally sued Mylan to prevent Mylan’s launch of a generic version of Takeda’s branded drug Colcrys. The parties ultimately settled under terms set forth in a settlement/license agreement, including a provision in Section 1.2(d) stating that Mylan would be entitled to launch a generic product after a Final Court Decision holding that all unexpired claims of the licensed patents that were asserted and adjudicated against a third party were either (i) not infringed or (ii) any combination of not infringed and invalid or unenforceable. The licensed patents included 17 Orange-Book-listed patents that Takeda had asserted against Mylan. The parties further agreed that a breach of this provision “would cause Takeda irreparable harm.”

While Takeda and Mylan were negotiating the settlement, another patent litigation that involved some of the licensed patents was ongoing (the West-Ward litigation). The West-Ward litigation involved a different party and a different drug product. Takeda did not assert all 17 patents in the West-Ward litigation. It only asserted eight and ultimately dismissed five with prejudice. On summary judgment, the district court in the West-Ward litigation found that the asserted claims of the remaining three patents were not infringed.

Mylan informed Takeda that it would launch its generic product, arguing that summary judgment in the West-Ward litigation triggered Section 1.2(d), allowing it to launch its generic product because all of the asserted claims remaining in the suit had been found not infringed. In response, Takeda filed a complaint alleging breach of contract and patent infringement, and sought a preliminary injunction to enjoin Mylan from its launch. The preliminary injunction motion was denied. Takeda appealed.

A plaintiff seeking a preliminary injunction must show (i) that it is likely to succeed on the merits, (ii) that it will suffer irreparable harm in the absence of preliminary relief, (iii) that the balance of equities tips in its favor, and (iv) that an injunction is in the public interest. The Federal Circuit’s decision focused on the first two factors: likelihood of success and irreparable harm.

The Federal Circuit’s analysis of the likelihood of success prong turned on the meaning of Section 1.2(d). Takeda argued that Section 1.2(d) had not been triggered because not all unexpired claims that were asserted in the West-Ward litigation had been found not infringed, specifically the asserted claims of the five withdrawn patents. Mylan argued that triggering Section 1.2(d) only required that all unexpired claims that had been asserted and adjudicated to be found not infringed or invalid, and because the asserted claims of the five dismissed patents were not adjudicated, it was not necessary that the dismissed claims be [...]

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