News & Analysis as of

Genus

MoFo Life Sciences

The PTAB Axes Skin Treatment Patent Under Amgen

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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

Procopio, Cory, Hargreaves & Savitch LLP

USPTO Provides Guidance in Light of Amgen v. Sanofi

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

MoFo Life Sciences

USPTO Enablement Guidelines After Amgen V. Sanofi

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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

MoFo Life Sciences

Standards For Inventiveness And Disclosure For Antibody Claims Across Jurisdictions

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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

McDermott Will & Emery

Beware Enablement of Genus Antibody Claims

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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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2023 #4

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

Buckingham, Doolittle & Burroughs, LLC

Amgen is Not the End of Chemical Innovation

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

Buckingham, Doolittle & Burroughs, LLC

Amgen Ratifies CAFC’s Requirement to Enable a Claim’s Full Scope

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

Fitch, Even, Tabin & Flannery LLP

Supreme Court Rules That Patent Must Enable “Full Scope” of Genus Claims

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

Jenner & Block

Client Alert: Supreme Court Affirms High Enablement Bar for Drug Patents

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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

Proskauer - Life Sciences

The Supreme Court Kept the Door Open to Genus Claims

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

Procopio, Cory, Hargreaves & Savitch LLP

5 Takeaways from the U.S. Supreme Court Decision in Amgen v. Sanofi

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

Vinson & Elkins LLP

The Supreme Court Invalidates Functional Genus Claims

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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

Kilpatrick

Supreme Court Grants Amgen’s Petition for Certiorari to Reconsider Enablement of Genus Claims

Kilpatrick on

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

Procopio, Cory, Hargreaves & Savitch LLP

Pharma-Related Patent Enablement Reaches the Highest Court

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

MoFo Life Sciences

Stepping Stones To Success: Supporting Claims In The Life Sciences

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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

MoFo Life Sciences

Traversing Higher Hurdles For Functional Limitations Under Section 112

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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

McDermott Will & Emery

Another Genus Claim Bites the Dust for Lack of Written Description

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

Hogan Lovells

FDA seeks comments on how to transition approved drug products to device status under Genus - Major regulatory changes for imaging...

Hogan Lovells on

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

Kilpatrick

Amgen Petitions for En Banc Rehearing for Federal Circuit to Reconsider Enablement of Genus Claims

Kilpatrick on

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

Kilpatrick

The Federal Circuit Continues to Invalidate Genus Claims Defined by Function

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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

Kilpatrick

Will the Federal Circuit Continue to Invalidate Genus Claims?

Kilpatrick on

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

International Lawyers Network

Federal Circuit Reminds Us That Extrinsic Considerations Are Narrowly Construed in Trademark Matters

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

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