- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
In Long-Awaited Decision in Etanercept Litigation, Court Sides With Amgen Over Sandoz
A judge for the United States District Court for the District of New Jersey has ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi.
A judge for the United States District Court for the District of New Jersey has ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi. Sandoz’s biosimilar etanercept, referencing the brand-name Enbrel, was approved by the FDA in 2016, but has not launched in the US market due to the patent suit brought by Amgen, Immunex, and Roche.
The case relates to claims of US Patent 8,063,182, which covers the fusion protein etanercept, and US Patent 8,163,522, which covers the method of manufacturing Enbrel. The 2 patents expire in 2028 and 2029, respectively. Roche was the first to file applications for these patents, and Amgen (which sells Enbrel) and its subsidiary Immunex obtained rights to the patents from Roche.
Prior to a 2-week bench trial in September 2018, Sandoz did not contest infringement of the patents, but asked the court to find the patents invalid because of a lack of written description and enablement, obviousness, and obviousness-type double patenting. United States District Judge Claire C. Cecchi, JD, found that Sandoz failed to show by clear and convincing evidence that the patents are invalid.
Robert Bradway, chairman and chief executive officer of Amgen, said in a statement that the company was pleased with the outcome of the trial, and that “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.”
Carol Lynch, president of Sandoz US and head of North America, said in a statement that “Sandoz respectfully disagrees with the Court’s ruling…valid intellectual property should be respected, however, we continue to consider the patents in this case to be invalid. Amgen asserted [2] patents that it obtained from Roche, in what we believe is an attempt to extend its US compound patent protection for etanercept to 2029.”
In an email to The Center for Biosimilars®, a Sandoz representative indicated that the company will appeal the ruling in the US Court of Appeals for the Federal Circuit, and also said that both parties have agreed to an expedited appeal.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
