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7 July 2020BiotechnologyMuireann Bolger

Roche loses appeal to block market entry of rival cancer drug

A  Roche subsidiary will be unable to block  Amgen from producing the cancer drug Mvasi (bevacizumab), the  Court of Appeals for the Federal Circuit has ruled.

Roche's Genentech unit manufactures and sells a drug used to treat certain types of cancer under the name Avastin, which is similar to Mvasi. Genetech claimed that Amgen failed to provide adequate notice before selling its own version.

According to US law, companies must notify a biotech company 180 days before launching their competing product under the law.

Genentech filed two motions at the District Court of Delaware seeking to preclude Amgen from commercially marketing Mvasi “until such time as Amgen . . . provides notice of its intent to commercially market such [a] product” and “180 days have elapsed”.

The district court denied both motions, ruling that Amgen’s October 2017 commercial marketing notice for Mvasi satisfied the necessary notice requirements ahead of its launch in July 2019.

Genentech appealed this decision, arguing the notice was invalid because it referred to another version of Mvasi, which had a different manufacturing site and label.

The Federal Circuit disagreed, holding that despite these later additions, “Amgen’s biological product, Mvasi, did not change”.

The Federal Circuit concluded that: “We have considered the parties’ remaining arguments and do not find them persuasive. Because the district court correctly determined that Amgen provided the required notice…and therefore properly denied Genentech’s motions for failure to establish likely success on the merits, we affirm.”

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More on this story

Big Pharma
1 May 2019   Amgen and Roche have filed a joint patent infringement claim against Samsung’s biopharmaceutical company Bioepis.
Americas
26 September 2018   The inter partes review process has had a huge impact on biosimilar litigation, but it isn’t truly fulfilling its goal of being an alternative to district court litigation.
Biotechnology
30 July 2020   Swiss company Roche has partnered with Belgium-based biopharmaceutical company UCB to develop an antibody treatment for people living with Alzheimer’s disease.