Cinacalcet - USA

On Jul 16, 2019, Court of appeals for the third circuit affirmed Delaware court’s decision & denied preliminary injunction sought by Amgen.

Previously, on May 02, 2019 Delaware court denied Amgen’s request for preliminary injunction as it failed to show a likelihood of success on its claim that Cipla breached the agreement by selling the product (reported here on this blog).

The second sentence of § 5.6 provide:

“[n]otwithstanding anything to the contrary in this Settlement Agreement, if any Third Party that has made an At Risk Launch of a Generic Cinacalcet Product (where such At Risk Launch is before or after an at risk launch by [Cipla]) is not found to have infringed one or more valid and enforceable claims of the [’]405 patent or has not ceased or agreed to cease selling such Generic Cinacalcet Product following an At Risk Launch, then Amgen shall not be entitled to seek or recover any relief from [Cipla] for [Cipla’s] at risk sales, offers for sale, distribution, or importation of [Cipla’s] product”.

Third circuit concluded that based on reading of the second sentence of § 5.6, Amgen was not authorized to seek relief against Cipla for its launch. The parties agree that (1) Teva, a Third Party under the Settlement Agreement, made an at risk launch of its generic cinacalcet, and (2) the district court found that Teva did not infringe the ’405 patent. Therefore, a condition in the second sentence of § 5.6 was satisfied when Cipla launched its generic cinacalcet, and thus, Amgen may not seek relief against Cipla for its at risk launch, which consequently was not prohibited by the Settlement Agreement. As a result, Amgen has not demonstrated a likelihood of success on its breach of contract claim.