A US district court on Friday upheld the validity of two patents covering Amgen's Enbrel (etanercept) in response to a lawsuit the company filed against Novartis' Sandoz unit over the latter's biosimilar Erelzi (etanercept-szzs). In the ruling, US District Judge Claire Cecchi rebuffed Sandoz's claims that the patents covering Enbrel should be invalidated because they described concepts covered by previous patents.
Commenting on the decision, Amgen CEO Robert Bradway said "protecting intellectual property is critical to incentivise innovation and the large investments in R&D that are required to bring new medicines to patients and fully develop their therapeutic potential."
Amgen noted that the patent infringement lawsuit against Novartis was filed in conjunction with Roche, which is the owner and licensor of the two patents in question. According to Amgen, Novartis had acknowledged before the trial that Erelzi infringes seven claims in US patents 8,063,182 and 8,163,522, with the case only proceeding because Novartis challenged the validity of those claims. Amgen added that it has entered into an agreement with Novartis with respect to a preliminary injunction regarding Erelzi that was set out in the court's order in June 2018, and which remains in place following the latest ruling.
Meanwhile, Carol Lynch, head of Sandoz's US operations, said her company "disagrees with the court's ruling, which prevents us from launching an additional treatment option for patients with autoimmune and inflammatory diseases." She stated "Amgen asserted two patents that it obtained from Roche, in what we believe is an attempt to extend its US compound patent protection for [Enbrel] to 2029," adding that "we will appeal this decision."
Novartis received FDA approval of Erelzi in 2016 for all indications of the reference product at the time. Although the drugmaker had identified Erelzi as one of five biosimilars it hoped to introduce by 2020, it has so far been unable to launch the medicine due to the ongoing patent litigation with Amgen. Meanwhile, EU regulators approved Erelzi in 2017.
Sales of Enbrel improved by 5% year-on-year to $1.4 billion in the second quarter (for additional analysis, see ViewPoints: Amgen's big ticket item just got bigger).
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