understanding the enablement requirement

Amgen Inc. v. Sanofi: Understanding the Enablement Requirement

The enablement requirement refers to the requirement of 35 U.S.C. 112 (a) or pre-AIA 35 U.S.C. 112, that the specification of a patent describes how to make and use the invention. Summarily, the invention that one skilled in the art must be enabled to make and use is that defined by the claim(s) of the application or patent. (35 USCS § 112).

The recent Supreme Court decision in Amgen Inc. v. Sanofi has big implications for enablement in patents and how they work. Here’s the breakdown of the case and key takeaways:

The Main Issue

The Amgen and Sanofi dispute was over patents related to medicines that lower cholesterol. The Supreme Court looked at whether Amgen’s patents were valid, specifically if they gave enough information for others to make and use the claimed inventions.

Background

Both companies developed drugs that target a protein called PCSK9 to reduce cholesterol. Amgen received patents in 2014 claiming a wide group of antibodies, the molecules that make the drugs work.

What Amgen Claimed

Amgen’s patents weren’t just about specific antibodies. They went broader, claiming the whole “genus” or group of antibodies that could block PCSK9. This included 26 specific ones they listed and a bunch more they did not describe in detail.

The Problem

Sanofi argued that Amgen’s patents were too broad. They said that making all the antibodies in the claimed group would need a lot of trial and error, and Amgen failed to explain how to achieve this.

The Court’s Decision

The Supreme Court agreed with Sanofi. Amgen’s patents did not give clear enough instructions for someone in the field to make and use all the claimed antibodies without a ton of experimentation.

Why It Matters

The ruling reaffirms a key rule in patent law: if you claim a lot, you have to explain a lot. The Supreme Court reminded everyone that a patent is a kind of deal. In exchange for protection, the patent holder has to share enough details about their invention so others can understand and use it.

Takeaways

If an inventor wishes to patent a broad group of claims, like a category of medicines, you need to be specific in your patent about how to make and use them. Amgen’s mistake was claiming a large group without giving enough guidance. This decision is a signal to be clear and helpful in patent descriptions, striking a balance between covering a lot and giving enough details.

In summary, if you want to claim a large group of things, you need to disclose guidance on how to achieve it. An inventor can’t just simply say, ‘Here’s the general idea—now figure it out.’ The Supreme Court has ruled against this ideology in patent law.

Written by Olayinka Oladele, Law Clerk at KM&D Law


References:

35 USCS § 112

Amgen Inc. v. Sanofi, 143 S. Ct. 1243

https://www.uspto.gov/web/offices/pac/mpep/s2164.html