Blog Big Molecule Watch March 04, 2020

Federal Circuit Hears Argument Regarding the Denial of Genentech’s Motion to Preliminarily Enjoin Amgen’s Sales of Trastuzumab

We previously reported on Genentech’s appeal of the district court’s denial of Genentech’s motion for a preliminary injunction against Amgen’s launch of trastuzumab. Yesterday, a Federal Circuit panel (Judges Prost, Wallach, and Bryson) heard argument regarding on Genentech’s appeal. The argument, much like the appellate briefing, focused on the issue of irreparable harm, and the following two facts that the district court found weighed against a finding of irreparable harm: (1) after Amgen launched at-risk, Genentech allowed two other trastuzumab biosimilars on the market; and (2) Genentech waited too long to file the motion for a preliminary injunction – about 14 months after Amgen’s notice of commercial marketing (“NCM”) and about one month after FDA approved Amgen’s biosimilar.

Allowing launch of other trastuzumab biosimilars: Judge Prost asked Genentech whether allowing two other biosimilar products into the market after Amgen’s launch cuts against a finding that Amgen’s launch would cause irreparable harm. Genentech argued that the entry of the additional biosimilars makes it harder to ascertain the harm caused by Amgen’s launch.

Judge Prost also asked Amgen what test to employ to determine whether license grants prevent a finding of irreparable harm. Amgen responded that the issue is very fact specific, noting that the district court considered, among other things, the financial terms and when entry would occur. As examples of licenses that might not weigh against a finding of irreparable harm, Amgen pointed to licenses that did not allow direct competition and contrasted that with the licenses here, which were granted to Genentech’s direct competitors.

Delay in filing: Judge Wallach asked Genentech to explain why there was no undue delay in seeking a preliminary injunction. Genentech argued that when Amgen provided its NCM, no harm was imminent because Amgen’s biosimilar was not approved. Genentech further noted that in mid-2018, Amgen received a Complete Response Letter (CRL) that required a response in December 2018 and that once the CRL response was submitted, Amgen would not get another FDA response for six months. Judge Prost pointed out that Genentech knew that FDA’s response could be an approval. Genentech further argued that even when Amgen received approval in June 2019, it had not yet made a decision to launch, and that Genentech sought a preliminary injunction once Amgen said it actually intended to launch.

Judge Bryson asked Amgen what test should be applied, for example, should patentee seek a preliminary injunction when the patentee knows when the challenger can launch, or when the patentee knows that the challenger will launch? Amgen responded that Genentech knew that Amgen was planning to launch in July 2019 and should have moved for a preliminary injunction sooner.

Other arguments that were addressed include the following: (1) Amgen argued that the passage of time moots this appeal, for example, because the trial in the underlying case is scheduled to begin on April 20, 2020; (2) Genentech suggested that the district court’s decision did not address all of the relevant facts; and (3) Amgen noted that Genentech did not seek a narrowly tailored preliminary injunction, in that Genentech sought to enjoin all uses of Amgen’s product, including uses without patent protection.

Stay tuned to Big Molecule Watch for further developments.

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