Takeaway: The Supreme Court is assessing a case between competing cholesterol medications, which will review Section 112 of the Patent Act and the question of patent enablement.
For the second time in the law's history, the U.S. Supreme Court has agreed to review Section 112 of the Patent Act. Biotech company Amgen is requesting that the court consider how much a patent must disclose in order to meet enablement requirements. The court will decide whether patent specifications must allow skilled artisans to "reach the full scope" of the invention, or whether the ability to "make and use" the invention is sufficient.
In February 2021, the Federal Circuit found that Amgen did not meet enablement requirements for two patents related to cholesterol medication. This meant that the Federal Circuit would not revive a previous verdict that Amgen won against Sanofi and Regeneron Pharmaceuticals over their competing cholesterol medications.
The reassessment of Section 112 of the Patent Act and the question of patent enablement could greatly affect the future of pharmaceutical patents, more specifically foundational and first-of-their kind medications. Pharmaceutical companies often file broad patents that are narrowed over time through research.