The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. (See Forte Biosciences Inc v....more
The U.S. Supreme Court’s May 2023 decision in Amgen, Inc. v. Sanofi (Amgen) sent shock waves through the patent world, particularly in the chemical and biotech segments, due to its invalidation of Amgen patents based on a...more
On January 10, 2024, the USPTO released new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al. The guidelines clarify that the...more
Standards for patenting antibodies have substantially tightened over the last few years restricting scope of antibody claims—or, in some cases, undermining the validity of granted patents. Most recently, Singapore updated...more
The US Court of Appeals for the Federal Circuit invalidated yet another set of antibody genus claims, finding the case “materially indistinguishable” from those in the 2023 Supreme Court of the United States case, Amgen v....more
United Therapeutics Corporation v. Liquidia Technologies, Inc., Appeal Nos. 2022-2217, 2023-1021 (Fed. Cir. July 24, 2023) In the Federal Circuit’s only precedential patent case this week, the Court considered questions...more
Some chemical innovators have found the recent Supreme Court decision in Amgen v. Sanofi to suggest that chemical inventions will be subject to new and draconian disclosure standards going forward. A few have even suggested...more
The Court’s reasoning in Amgen v. Sanofi upholds the Federal Circuit’s long-standing requirement to enable the full scope of a claimed invention. Since the Patent Act of 1790, patent law has required describing inventions...more
On May 18, the U.S. Supreme Court in Amgen Inc. v. Sanofi unanimously affirmed the Federal Circuit’s finding that Amgen’s patent claims to cholesterol-lowering antibodies were not enabled under 35 U.S.C. § 112. The Court...more
On May 18, 2023, the Supreme Court affirmed the Federal Circuit’s (CAFC) decision on enablement in Amgen Inc. v. Sanofi, 987 F.3d 1080 (CA Fed. 2021). The Court thus left in place a significant decision making it more...more
The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained...more
The U.S. Supreme Court’s unanimous decision in Amgen Inc. v. Sanofi (referred to as the Amgen decision) likely makes it more difficult for life sciences companies to obtain broad patents claiming an entire genus of antibodies...more
In a unanimous opinion in Amgen Inc. v. Sanofi, the Supreme Court held that two functional genus patent claims were not enabled under 35 U.S.C. § 112(a).1 In doing so, it affirmed both the Federal Circuit’s previous decision...more
Last week, the Supreme Court granted Amgen’s petition for certiorari to reconsider the enablement requirement for genus claims. The Supreme Court will review whether the Federal Circuit panel in Amgen v. Sanofi improperly...more
The U.S. Supreme Court has agreed to hear a case that is extremely significant for companies that operate in the biotechnology, pharmaceutical, and chemical sectors. At issue in Amgen v. Sanofi is a determination of the...more
The standard for written description in the life sciences seems to have tightened lately, leading patent applicants to wonder what level of written support and working example data is necessary to support genus claims....more
Genus claims have long been an important component of patent strategy, extending coverage around a lead compound to stop would-be competitors. Recent decisions from the Federal Circuit, however, highlight a tightening...more
Addressing the issue of written description in the context of antibody-related genus claims, the US Court of Appeals for the Federal Circuit reversed a $1.2 billion jury verdict and found genus claims using functional...more
On August 9, the U.S. Food and Drug Administration (FDA) published a notice announcing its implementation of the U.S. Court of Appeals for the D.C. Circuit’s April 2021 decision in Genus Medical Technologies LLC v. U.S. Food...more
As we reported last month, the Federal Circuit panel in Amgen v. Sanofi affirmed the district court’s judgment as a matter of law invalidating genus claims in U.S. Patent Nos. 8,829,165 and 8,859,741 that recite functional...more
In our earlier post, we questioned whether the Federal Circuit would continue to invalidate genus claims directed to biologics, and the answer is yes. Not surprisingly, the Federal Circuit panel in Amgen v. Sanofi affirmed...more
In a law review article entitled “The Death of the Genus Claim,” which published in the aftermath of the Federal Circuit decision in Idenix v. Gilead, 941 F.3d 1149 (Fed. Cir. 2019), the authors stated that, “in the past...more
2018 saw a number of important trademark cases decided across the United States. Two cases illustrated the similarities between genericness analysis and one of the likelihood of confusion factors considered by the Trademark...more