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Court ruling upholds Enbrel patent claim, blocks biosimilar rivals
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A U.S. District Court judge has ruled in favor of Amgen in its lawsuit against Novartis’ Sandoz, which claimed patent infringement on its biologic etanercept by the biosimilar, etanercept-szzs.
During litigation, Amgen argued that the Sandoz biosimilar Erelzi (etanercept-szzs) infringed on two Enbrel (etanercept) patents for active ingredient — U.S. Patent No. 8,063,182 — and manufacturing process — U.S. Patent No. 8,163,522. Owned by Hoffman-La Roche and licensed to Amgen since 1999, these two patents for Enbrel are not expected to expire until 2029.
Although Sandoz previously acknowledged that its biosimilar infringed on Amgen’s patents, the manufacturer countered that these two patents should not have been granted as the concepts were already contained in prior patents. However, Claire C. Cecchi, U.S. District Court judge for the District of New Jersey, rejected this argument.
In her ruling, Judge Cecchi determined that Sandoz had “failed to show by clear and convincing evidence that the Patents-in-Suit are invalid” and ruled that the manufacturer had failed to meet the burden of proof to justify the patent infringements of its biosimilar.
“We are pleased with [this] decision recognizing the validity of these patents,” Robert A. Bradway, chairman and CEO at Amgen, said in a press release. “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.”
This court ruling is also likely to inform how Amgen plans to deter other biosimilars from entering the market. Earlier this year, Amgen filed a similar lawsuit against Samsung Bioepis for its etanercept biosimilar, Eticovo (etanercept-ykro), but this case has not yet reached the courts.
“The ruling in Amgen v. Sandoz will no doubt have an impact on the litigation strategy Amgen adopts as it goes forward against Samsung Bioepis,” Alisha Kay Taylor, JD, an attorney at Richards Patent Law PC, told Healio Rheumatology. “The ruling may not only have huge ramifications on the multibillion-dollar Enbrel business of Amgen, but for biologics at large.”
With this victory, Amgen could hold market exclusivity for the molecule through 2029. Although the primary patent on Enbrel was filed in 1990 — and expired in 2010 — Amgen also holds 19 active patent applications and approved patents that could effectively guard Enbrel’s commercial exclusivity in the U.S. for another decade. Despite this recent setback, Sandoz intends to appeal the decision in the U.S. Circuit Court of Appeals.
“Sandoz respectfully disagrees with the Court’s ruling, which prevents us from launching an additional treatment option for patients with autoimmune and inflammatory diseases,” Carol Lynch, president of Sandoz US and Head of North America, said in a press release. “Valid intellectual property should be respected, however, we continue to consider the patents in this case to be invalid. We will appeal this decision, and look forward to presenting our case to the Federal Circuit and bringing Erelzi to U.S. patients as soon as possible.”
As for what this court ruling means for the burgeoning biosimilar marketplace, considerable speculation remains. However, what is certain is that Enbrel generated nearly $5 billion in revenue in the U.S. last year, and after a year-to-date decline in stock prices compared to 2018, shares in Amgen spiked by 6% in the wake of the court decision.
“This is a boon to corporate investors that will continue to maintain higher drug prices for consumers,” Stephen B. Hanauer, MD, Clifford Joseph Barborka Professor of Medicine and medical director of the Digestive Health Center at Northwestern Feinberg School of Medicine, told Healio Rheumatology in an interview.– by Rob Volansky
For more information:
- Stephen B. Hanauer, MD, can be reached at 676 N. St Clair Street – Suite 1400, Chicago IL, 60611; email: shanauer@northwestern.edu.
- Alisha Kay Taylor, JD, can be reached at Willis (Sears) Tower, 233 S. Wacker Dr., 84th Floor, Chicago, IL 60606; email:alisha@richardspatentlaw.com.
Disclosure: Hanauer reports associations with a number of device and pharmaceutical companies, including Abbvie, Amgen, Janssen, Novartis, and Samsung Bioepis. Taylor reports no relevant financial disclosures.