Insights

Amgen Inc. et al. v. Sanofi et al. is a patent litigation case that is currently pending before the Supreme Court of the United States. The case concerns the validity of Amgen's patents related to a type of cholesterol-lowering drug called PCSK9 inhibitors, which Sanofi allegedly infringed upon by developing and marketing their own PCSK9 inhibitor drug, Praluent.

The legal dispute between Amgen and Sanofi began in 2014, when Amgen accused Sanofi and its partner Regeneron of infringing on its patents for PCSK9 inhibitors. Amgen claimed that Sanofi's product, Praluent, infringed on its patents for two specific antibodies that target PCSK9.

In 2016, a jury found that Sanofi had indeed infringed on Amgen's patents and awarded Amgen $70 million in damages. However, Sanofi appealed the decision, and in 2017, the Federal Circuit Court of Appeals overturned the verdict, ruling that Amgen's patents were invalid because they covered a natural phenomenon - the discovery that inhibiting PCSK9 could lower cholesterol levels.

The Federal Circuit Court of Appeals also found that Amgen's patents were too broad and did not meet the requirements for patentability, and therefore Sanofi's Praluent did not infringe on them. Amgen then appealed the decision to the Supreme Court, which agreed to hear the case in January 2021. Specifically, the Supreme Court will consider whether the Federal Circuit erred in holding that Amgen's patent claims were invalid for lack of enablement, and whether Sanofi has the burden to prove that Amgen's claimed invention was enabled.

The outcome of the case is expected to have far-reaching implications for the biotech industry, particularly with regard to the patentability of naturally occurring phenomena and the level of specificity required in patent claims. The biotech industry has been closely watching this case, as it could impact the ability of biotech companies to protect their intellectual property and develop new drugs. A decision from the Supreme Court is expected in the coming months.