The Supreme Court’s recent decision in the case of Amgen Inc. v. Sanofi (No. 21-757) could chart a new course for both the pharmaceutical industry and patent law. In this decision, the Supreme Court provided clarity on what the Patent Act means by ‘enablement,’ raising the bar for the level of detail needed in certain…
For biotech, much is riding on the Supreme Court’s Amgen v. Sanofi decision
The U.S. Supreme Court’s decision in Amgen v. Sanofi could have far-reaching consequences for the biotech industry. The court will consider how much a patent must disclose to comply with enablement requirements. In February 2021, the Federal Circuit ruled that two Amgen patents (8,829,165 and 8,859,741) for the cholesterol drug Repatha (evolocumab) do not meet…