SHARE

November 10, 2022

Supreme Court to Consider Enablement Requirement

You've Reached Your
Free Article Limit This Month
Register for free to get unlimited access to all Law.com OnPractice content.
Register Now

The Supreme Court of the United States agreed to consider how much a patent must disclose in order to meet the enablement requirement under 35 U.S.C. § 112. Amgen Inc., et al. v. Sanofi, et al., Case No. 21-757 (Supr. Ct. Nov. 4, 2022) (certiorari granted). The question presented is as follows:

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to "make and use" the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art "to reach the full scope of claimed embodiments" without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial time and effort.

Amgen owns two patents that describe antibodies that bind to PCSK9 protein and lower LDL cholesterol levels by blocking PCSK9 from binding to LDL receptors. After a jury determined that Sanofi failed to prove that the asserted claims were invalid for lack of enablement, the district court granted Sanofi's post-trial motion for invalidity based on lack of enablement. The US Court of Appeals for the Federal Circuit affirmed, finding that the scope of the claims encompassed millions of antibodies and that the patent thus did not meet the enablement requirement because practicing the full scope of the claims would require "undue experimentation."

The Supreme Court declined to consider the first question presented in Amgen's petition: whether enablement should be a question of law (under current Federal Circuit precedent) or be designated a question of fact to be decided by a jury. In granting certiorari, the Supreme Court proceeded contrary to the recommendation of the US Solicitor General.

ALM expressly disclaims any express or implied warranty regarding the OnPractice Content, including any implied warranty that the OnPractice Content is accurate, has been corrected or is otherwise free from errors.

More From McDermott Will & Emery

Merck Fosters Healthcare Of The Future

By McDermott Will & Emery attorneys McDermott Will & Emery December 02 , 2022

Artificial intelligence and machine learning have led a digital transformation in healthcare, expanding providers’ resources and improving the lives of people around the world.

A Tsunami of Lawsuits Is Expected to Slam Institutions in the Wake of New York Adult Survivors Act

By Greer Griffith McDermott Will & Emery December 01 , 2022

A new revival window opened on Thanksgiving Day for filing sexual assault and abuse lawsuits that would otherwise be time-barred by the New York statute of limitations.

Tax Court Holds That Deficiency Petition 90-Day Time Limit Is Jurisdictional

By Andrew R. Roberson McDermott Will & Emery December 01 , 2022

Last summer, the Supreme Court of the United States held that the 30-day time limit to file a Collection Due Process (CDP) petition is a non-jurisdictional deadline subject to equitable tolling (Boechler, P.C. v. Commissioner).

More From Trademarks

Spoliation Series: Discovery Abuses Can Lead to Case-Ending Sanctions

By Kathryn C. Cole Greenberg Traurig December 01 , 2022

In Abbott Laboratories, et al., v Adelphia Supply USA (EDNY May 2, 2019), Plaintiffs filed a motion for case-ending sanctions against defendants H&H Wholesale Services, Inc., Howard Goldman, and Lori Goldman (for purposes of this blog, “Defendants”).

Construing the Construction: Federal Circuit Chips Away at IPR Win

By Thomas DaMario McDermott Will & Emery November 29 , 2022

Addressing claim construction issues in inter partes review (IPR) proceedings before the Patent Trial & Appeal Board (Board), the US Court of Appeals for the Federal Circuit affirmed an obviousness finding as to some claims but reversed and remanded an obviousness finding as to another claim because of a claim construction error.

Court Uncorks New Way to Serve Trademark Complaints

By Amol Parikh McDermott Will & Emery November 29 , 2022

The US Court of Appeals for the Ninth Circuit concluded that Section 1051(e) of the Lanham Act permits a plaintiff in a district court case to serve a complaint against a foreign defendant via the Director of the US Patent & Trademark Office (PTO).

Featured Stories
Closeclose
Search
Menu

Working...