Supreme Court Voids Amgen’s Patents using “Undue Experimentation” Standard

In Appeal no. 21-257 (May 18, 2023), the Supreme Court affirmed the judgement of the Fed. Cir. by ruling that all of the claims of Amgen’s U.S. Patent nos. 8,829,165 and 8,859, 741 were invalid due to their failure to meet the enablement requirement of s. 112(a). For an introduction of the landmark decision, please re-read my post of Feb. 13, 2021 which summarizes the issues addressed by the Fed. Cir. Judge Lourie summarized the claims as “claiming a monopoly over all antibodies that (1) bind to specific proteins on a naturally occurring protein known as PCSK9, and (2) block PCSK9 from impairing the body’s mechanism for impairing the body’s mechanism to remove LDL cholesterol from the blood stream.”

Continue reading

Posted in Enablement | Tagged , , , | Leave a comment

From SLW International: Info on the Unitary Patent and the Unified Patent Court

Guest contribution from SLW International:

A short paper with information on the Unitary Patent and the Unified Patent Court can be found here.

Posted in EP and UK Practice, Int'l Practice and Policy, Non-U.S. Practice, Uncategorized | Tagged , , | Leave a comment

Chromadex v. Elysium Health – It’s Only Natural!

On February 13, 2023, a Fed. Cir. panel of Judges Prost, Chen and Stoll (Prost writing) held, in Appeal no. 2022-1116, that the asserted claims 1-3 of U.S. Patent No. 8,197, 807 are directed to unpatentable subject matter, namely to a natural product, nicotinamide riboside (“NR”). Since the panel relied heavily on its opinion in Natural Alternatives International, Inc. v. Creative Compounds, LLC., 918 F.3d 1338 (Fed. Cir, March 15, 2019), it would be helpful to read my post of March 18, 2019. With respect to the composition claims in suit in Natural Alternatives, claim 6 of U.S. Patent No. 7,504,376 depended from claim 1, a claim that almost certainly would have been found patent ineligible. It recited a “naked” composition comprising a simple mixture of two natural products, glycine and beta-alanine, its esters and amides, and beta-alanine di-peptide and another dipeptide.

Continue reading

Posted in Patent Eligible Subject Matter | Tagged , , , , | Leave a comment

“Inequitable Conduct: Refresher and Update” Panel on March 16

I will be on a panel,  “Inequitable Conduct: Refresher and Update,” with Danny Huntington of Rothwell Figg and William Covey of the PTO OED. The panel will take place on Thursday, March 16 at the 2023 IPOwners Spring SummitTM in Washington, DC. This one-day IPO conference addresses topics relevant for in-house IP attorneys and will also be useful for outside counsel. The summit includes networking opportunities on March 16 and a welcome reception the prior evening. You can find more info at: 2023 IPOwners Spring Summit™ – Intellectual Property Owners Association.


Posted in Inequitable Conduct/Rule 56, Uncategorized | Tagged , , , | Leave a comment