Lessons From Amgen v. Sanofi

• Jurisdiction: United States,Federal
• Law Firm: Oblon, McClelland, Maier & Neustadt, L.L.P
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Biotechnology & Nanotechnology
• Author: Mr Richard D. Kelly
• Published date: 10 July 2023

Amgen provides a window on the Supreme Court approach to patent issues - look to history and established policy as our patent law is not code based but rather common law based. The Court noted that the "enablement requirement" is found essentially unchanged in every version of the patent law since 1790. While Amgen concerned the enablement provision, the same approach applies to patent eligibility, the "judicial exceptions," which have existed in our case law since the early 19^th century. In deciding Amgen the Supreme Court did not consider previous Federal Circuit decisions but looked to history of the enablement provision which involved Court decisions from the 19^th and early 20^th century. While Amgen was the Court's first antibody case, it found analogous cases which provided guidance as to how the enablement requirement had been interpreted. Since U.S. patent law is based on common law, this is the appropriate approach to provide the needed predictability. Without understanding the policy behind the exceptions, one will continue to wander aimlessly from one case to the next.

This is the first of a series of posts applying our common law precedents to understand judicial exceptions and the policy behind them. Without understanding the policy one will wander aimlessly from one case to the next.

Abstract Idea

The Federal Circuit Judges have called out for help with abstract idea exception. However, such help exists in British cases interpreting the Statute of Monopolies¹, 19^th century cases, the Curtis and Robinson mid- and late 19^th century patent treatises , and the respective 20^th century Court decisions when read as a whole, not in pieces. Reading the cases individually misses the common characteristics of abstract ideas. Further, since these cases build on each other to provide a cohesive body of law, one needs to consider their teachings together. By looking at them as individual events, one loses sight of the policy behind the exception and the common characteristics all abstract ideas have in common.

The concept that one could not patent an abstract idea began with the British courts interpretation of the term "manufacture" used in the Statute of Monopolies. The courts considered scientific principles to be ideas, and natural laws were not "manufacture", technology². The constitution's reference to "useful arts" is synonymous with today's term "technology." The initial U.S. patent laws were "founded on the principles and usages which have grown...