News & Analysis as of

Pharmaceutical Patents Supreme Court of the United States

DLA Piper

Purdue Appeals Federal Circuit Obviousness Decision to the Supreme Court

DLA Piper on

Purdue Pharma (Purdue) has filed a petition for a writ of certiorari challenging a recent Federal Circuit decision upholding the invalidation of several Purdue patents on grounds of obviousness....more

Jones Day

U.S. Supreme Court Invites Solicitor General to Submit Briefing on "Skinny Labels"

Jones Day on

On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma...more

McDonnell Boehnen Hulbert & Berghoff LLP

Subject Matter Eligibility in the 21st Century: Echoes of pre-§ 103 Obviousness*

The evolution of subject matter eligibility after the Supreme Court's decisions in Prometheus v. Mayo, Alice v. CLS Bank, and Association for Molecular Pathology v. Myriad Genetics has resulted in a regime of predictable...more

Fuerst Ittleman David & Joseph

Lilly v. FDA: Two Stories Collide to Make this GLP-1 Case a Tale of Our Time

I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more

McDonnell Boehnen Hulbert & Berghoff LLP

In re Cellect in View of Supreme Court's "Long Conference" – Part II

In view of the Supreme Court's "long conference" on September 30th, it seems timely to review the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc. (Fed. Cir. 2024)

Ever since the Supreme Court's decision in Dickinson v. Zurko, federal courts (including the Federal Circuit) are compelled under the Administrative Procedures Act to review factual determinations by the U.S. Patent and...more

McDonnell Boehnen Hulbert & Berghoff LLP

Astellas Pharma, Inc. v. Sandoz Inc. (Fed. Cir. 2024)

One of the anticipated consequences of the Supreme Court's Loper decision is that it will unleash judges to impose their statutory interpretations of administrative agencies' applications of the law within their areas of...more

Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Threading the Needle: Navigating the Matrix Created by the U.S. Supreme Court and Unified Patent Court   

As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. We recently reviewed the Unified...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2024 #3

Allergan USA, Inc. v. MSN Laboratories Private Ltd., Appeal No. 2024-1061 (Fed. Cir. August 13, 2024) In this week’s Case of the Week, the Federal Circuit clarifies rules relating to when an applicant’s patent can be...more

Lathrop GPM

Broad Biotech Patent Claims-the Saga Continues

Lathrop GPM on

There now is increased interest about the written description and enablement requirements for patent applications claiming antibodies. This may stem from the recent U.S. Supreme Court decision in Amgen v. Sanofi, finding lack...more

McDermott Will & Schulte

Pay for Delay Is Sometimes Okay

The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a...more

BakerHostetler

[Podcast] Biotechnology, Chemical and Pharmaceutical: Supreme Showdown

BakerHostetler on

In 2023, a lawsuit that had wound its way through the judicial system for nearly 10 years finally had its day in the U.S. Supreme Court – and made waves in the biotechnology, chemical and pharmaceutical communities. Our...more

Bradley Arant Boult Cummings LLP

Spring Has Sprung Obviousness Trends from the Federal Circuit

There have been only a few precedential decisions from the Federal Circuit related to obviousness since spring sprung. While these decisions have produced mixed results for the lower courts, clinical study protocols have held...more

McDonnell Boehnen Hulbert & Berghoff LLP

RegenxBio Inc. v. Sarepta Therapeutics, Inc. (D. Del. 2024)

A consequence (predominantly negative) of the Supreme Court's recent foray into defining (however inadequately) the contours of patent-eligible subject matter is to give the district courts (and to a somewhat lesser extent,...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit IP Appeals: Summaries of Key 2023 Decisions (8th Edition): Amgen Inc. v. Sanofi, 598 U.S. 594 (2023)

The Supreme Court’s lone patent case from last term does not break new ground on enablement law. The Court’s core holdings—that a patent specification must enable the full scope of the claimed invention and therefore that...more

Knobbe Martens

USPTO Says Wands Still Controls Enablement Analysis Post-Amgen

Knobbe Martens on

On January 9, 2024, the USPTO published guidelines for its patent examiners when evaluating compliance with the enablement requirement in light of the U.S. Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et...more

Venable LLP

New USPTO Guidelines: After the Supreme Court's Amgen Decision, In re Wands Factors Remain Applicable Enablement Framework

Venable LLP on

On January 10, 2024, the United States Patent and Trademark Office (USPTO) issued "Guidelines for Assessing Enablement in Utility Applications and Patents in View of the U.S. Supreme Court Decision in Amgen Inc. et al. v....more

Womble Bond Dickinson

Enablement Post-Amgen and New USPTO Guidelines

Womble Bond Dickinson on

On January 10, 2024, the United States Patent and Trademark Office (USPTO) published Guidelines, applicable to any technology, for ascertaining compliance with the enablement requirement in view of the U.S. Supreme Court...more

Herbert Smith Freehills Kramer

Law360: Supreme Court Amgen Ruling's Major Effect On Enablement

Eight months ago, the U.S. Supreme Court interpreted the enablement requirement in the May 18, 2023, Amgen Inc. v. Sanofi decision.[1] Although the court did not change the law, affirming the U.S. Court of Appeals for the...more

McDermott Will & Schulte

PTO Continues to Wave Wands in Assessing Enablement

In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance...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

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Provides Guidance on Standards for Enablement Requirement

On January 10th, the U.S. Patent and Trademark Office published a Notice in the Federal Register (89 Fed. Reg. 1563) regarding proposed Guidance on how the Office will apply the enablement requirement under 35 U.S.C. § 112(a)...more

McDonnell Boehnen Hulbert & Berghoff LLP

Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

Proper construction of claim limitations reciting the chemical property of pH (which denotes the concentration of hydrogen ions in a solution as an indication of acidity) has arisen several times in district court and Federal...more

Haug Partners LLP

Baxalta’s Antibody Patent Held Invalid under Amgen’s Enablement Standard by the Federal Circuit

Haug Partners LLP on

In Baxalta, Inc. v. Genentech, Inc., the Court of Appeals for the Federal Circuit upheld a summary judgment finding from the District of Delaware (Judge Timothy B. Dyk) that claims 1-4, 19 and 20 of Baxalta’s patent directed...more

291 Results
 / 
View per page
Page: of 12

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide