Amgen, Inc. v. Sanofi
United States Supreme Court
598 U.S. 594, 143 S. Ct. 1243 (2023)
- Written by Angela Patrick, JD
Facts
High levels of low-density-lipoprotein (LDL) cholesterol in a human can lead to serious health problems. A human protein called PCSK9 inhibits the human body’s ability to remove LDL cholesterol. Amgen, Inc. (plaintiff) developed and patented an antibody that bound to PCSK9 in a manner that blocked its actions and therefore boosted the human body’s ability to naturally remove LDL cholesterol. The same year, Sanofi (defendant) patented a different antibody that performed the same function. Three years later, Amgen obtained two more patents. These patents claimed to cover all antibodies that bound to a specific part of PCSK9 and blocked its harmful actions. The patents identified 26 antibodies that met this description and provided two methods for identifying additional antibodies in the class: roadmap and conservative substitution. Essentially, both methods only directed scientists to test any new or modified antibodies to see if they performed the identified functions. Amgen sued Sanofi for infringing on the new patents. In defense, Sanofi argued that the new patents were invalid. Specifically, Sanofi contended that the new patents did not satisfy patent law’s enablement requirement because they did not enable a skilled person to make and use the potentially millions of antibodies claimed in the patents. The district court ruled that the patents were invalid. The United States Court of Appeals for the Federal Circuit affirmed the ruling. The United States Supreme Court granted certiorari.
Rule of Law
Issue
Holding and Reasoning (Gorsuch, J.)
What to do next…
Here's why 832,000 law students have relied on our case briefs:
- Written by law professors and practitioners, not other law students. 46,400 briefs, keyed to 994 casebooks. Top-notch customer support.
- The right amount of information, includes the facts, issues, rule of law, holding and reasoning, and any concurrences and dissents.
- Access in your classes, works on your mobile and tablet. Massive library of related video lessons and high quality multiple-choice questions.
- Easy to use, uniform format for every case brief. Written in plain English, not in legalese. Our briefs summarize and simplify; they don’t just repeat the court’s language.