Appeals Court Affirms Validity Of Enbrel® (etanercept) Patents Injunction Against Sandoz's Infringement Stands

Rhea-AI Summary

Amgen announced that the United States Court of Appeals for the Federal Circuit upheld the validity of two patents related to Enbrel® (etanercept). This decision affirms an August 9, 2019 ruling from the New Jersey District Court, which ruled against Sandoz Inc. regarding its biosimilar version of Enbrel. The appellate court's decision upholds a permanent injunction preventing Sandoz from manufacturing or selling its product. This victory is significant for Amgen as it protects its intellectual property and market position for Enbrel.

Positive

• Court ruling upholds two key patents for Enbrel, protecting against biosimilar competition.
• Affirmation of the New Jersey District Court's decision supports Amgen's market position.

Negative

• None.

THOUSAND OAKS, Calif., July 1, 2020 /PRNewswire/ -- Amgen today announced that the United States Court of Appeals for the Federal Circuit has held in Amgen's favor on the validity of two patents that describe and claim Enbrel® (etanercept) and methods for making it.

Specifically, the appellate court affirmed an August 9, 2019 decision by the United States District Court for the District of New Jersey that had upheld the validity of two patents asserted against Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (together, Sandoz) based on Sandoz's biosimilar of Enbrel^® (etanercept). 

The patent infringement action was brought against Sandoz by Amgen affiliates Immunex Corporation and Amgen Manufacturing, Limited, along with the owner and licensor of the two patents, Hoffmann-La Roche Inc.  Before trial, Sandoz acknowledged its biosimilar etanercept infringes seven claims of U.S. Patent Nos. 8,063,182 and 8,163,522 (the '182 and '522 patents).

On October 8, 2019, by stipulation of Amgen and Sandoz, the New Jersey District Court entered final judgment and a permanent injunction prohibiting Sandoz from making, using, importing, selling or offering for sale Sandoz's etanercept product.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

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CONTACT: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631 (media)
Megan Fox, 805-447-1423 (media)
Arvind Sood, 805-447-1060 (investors)

 

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SOURCE Amgen

FAQ

What was the recent court ruling regarding Amgen's Enbrel patents?

The United States Court of Appeals upheld the validity of two patents related to Enbrel, affirming the previous ruling against Sandoz's biosimilar.

When was the initial ruling on the Enbrel patents made?

The initial ruling by the New Jersey District Court was made on August 9, 2019.

What is the significance of the court ruling for Amgen?

The ruling protects Amgen's intellectual property and maintains its competitive position in the market for Enbrel.