Amgen v. Sanofi/Regeneron: Trial Starting in Biologics Patent Case

A jury trial starts Monday, March 7, in the patent case between plaintiff Amgen Inc. and defendants Sanofi and Regeneron over two biologic drugs, Amgen’s Repatha and Sanofi/Regeneron’s Praluent. The case is before Judge Sue Robinson in the District of Delaware. Both products, which are  monoclonal antibodies used to treat patients with high cholesterol that cannot be controlled by diet or statins, have the potential to be multibillion-dollar drugs.

Amgen asserted seven patents that it claims cover Praluent, but the trial is limited to only eight claims in three patents. The patents generally cover monoclonal antibodies that bind to a certain liver enzyme in specific areas to block the enzyme’s activity. That enzyme normally binds to receptors in the liver and prevents those receptors from removing LDL cholesterol from the blood. By binding to the enzyme, the monoclonal antibodies leave more receptors available to remove LDL cholesterol from the blood.

The trial is scheduled for seven days. The parties have stipulated infringement and will argue invalidity based on obviousness, written description, and enablement. Amgen also asserted a claim of willfulness in its recent amended complaint, but that issue will be determined in a separate proceeding if necessary.

Big Molecule Watch will continue to track this case and other litigation involving the biologics, so check back for the latest news and analysis.