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A New Jersey court upheld the validity of patent claims for Amgen’s anti-inflammatory blockbuster biologic, Enbrel (etanercept).
The United States District Court for the District of New Jersey ruled in Amgen's favor on the validity of two patents that describe and claim Enbrel (etanercept), the company’s anti-inflammatory biologic, and methods for making it, Amgen announced in an Aug. 9, 2019 press release. Enbrel is Amgen’s top-selling drug with $5 billion in 2018 sales and is indicated for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.
Amgen affiliates Immunex Corp. and Amgen Manufacturing, Ltd, along with the owner and licensor of the two patents, Hoffmann-La Roche Inc., brought the patent infringement action in Federal Court against Sandoz Inc., Sandoz International GmbH, and Sandoz GmbH (together, Sandoz). Before trial, Sandoz, a division of Novartis, acknowledged that its biosimilar etanercept infringes seven patent claims in US Patent Nos. 8,063,182, “Human TNF receptor fusion protein,”and 8,163,522, “Human TNF receptor”. Trial proceeded only on Sandoz's challenges to the validity of those claims. The Court found that Sandoz had not met its burden to prove all seven asserted claims invalid.
Immunex/Amgen and Sandoz have entered into an agreement with respect to a preliminary injunction regarding Sandoz's etanercept as set out in the Court's order of June 7, 2018.
"We are pleased with today's decision recognizing the validity of these patents. Protecting intellectual property is critical to incentivize innovation and the large investments in research and development that are required to bring new medicines to patients and fully develop their therapeutic potential for patients," said Robert A. Bradway, chairman and CEO at Amgen, in a company press release.
Responding to the ruling, Sandoz has said it will appeal to the US Court of Appeals for the Federal Circuit, according to an Aug. 9, 2019 press release issued by the company.
“Sandoz respectfully disagrees with the Court’s ruling, which prevents us from launching an additional treatment option for patients with autoimmune and inflammatory diseases,” said Carol Lynch, president of Sandoz US and head of North America, in the press release. “Valid intellectual property should be respected; however, we continue to consider the patents in this case to be invalid. Amgen asserted two patents that it obtained from Roche, in what we believe is an attempt to extend its US compound patent protection for etanercept to 2029. We will appeal this decision and look forward to presenting our case to the Federal Circuit and bringing Erelzi to US patients as soon as possible.”
Sandoz is the first biosimilar company to receive FDA approval for a biosimilar etanercept, Erelzi (etanercept-szzs), which has been approved for nearly three years, the company stated. However, the company has been unable to launch the medicine because of the ongoing patent litigation from Amgen. FDA approved Erelzi on Aug. 30, 2016 for all indications included in Enbrel’s product label.