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Miller Canfield

Jepson Claims No Substitute for Written Description in Patents

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Federal Circuit Holds That the Preamble of Jepson-Style Claims Must Be Supported by an Adequate Written Description - U.S. patent claims have a preamble, and, in most cases, the preamble is not limiting. Jepson-style...more

DLA Piper

Federal Circuit Refines Obviousness Framework for Drug and Biologic Dosing Regimens

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The United States Court of Appeals for the Federal Circuit recently affirmed a district court ruling that a pharmaceutical dosing claim limitation was unpatentable due to obviousness-type double patenting. The court found...more

Goodwin

The Court of Appeals for the Federal Circuit’s In Re Xencor Decision: Jepson Claims Require Written Description for Their...

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On March 13, 2025, the US Court of Appeals for the Federal Circuit (Federal Circuit) issued a decision titled In Re: Xencor, Inc. (the Xencor decision). The Xencor decision affirms the decision of the Appeals Review Panel...more

American Conference Institute (ACI)

[Event] 21st Annual Conference on Paragraph IV Disputes - April 29th - 30th, New York, NY

Attend ACI's 21st Annual Conference on Paragraph IV Disputes and join leaders from brand and generic pharmaceutical companies, renowned outside counsel, esteemed members of the judiciary, government, and academia to: -...more

Foley & Lardner LLP

GLP-1 Receptor Agonists and Patent Strategy: Securing Patent Protection for New Use of Old Drugs

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GLP-1 receptor agonists (GLP-1RAs) were initially approved for diabetes treatment (e.g., Ozempic®) but have revolutionized weight management (e.g., Wegovy®) and are now being explored for treating a wide range of health...more

McDonnell Boehnen Hulbert & Berghoff LLP

Immunogen, Inc. v. Stewart (Fed. Cir. 2025)

After creating something of a frisson due to the apprehension that the Federal Circuit might be convinced to re-evaluate whether it was a necessary element for establishing obviousness for the skilled artisan to have had a...more

Goodwin

Eight on AI: Quick Considerations on Patenting Drug Discovery Therapeutics using Artificial Intelligence (AI) and Life...

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Many life science companies are using AI/ML to identify new disease targets and new therapeutics, predict the efficacy and toxicity of potential clinical therapeutic candidates, design clinical trials and dosing or treatment...more

Akin Gump Strauss Hauer & Feld LLP

Patentee’s Own Clinical Trial Renders Unpatentable Patent Claims Directed to Antibody Treatment

In a final written decision of an inter partes review proceeding, the Patent Trial and Appeal Board found all 12 claims of a challenged patent unpatentable as either anticipated or obvious. Each ground of unpatentability...more

Sheppard Mullin Richter & Hampton LLP

In re Couvaras, No. 2022-1489 (Fed. Cir. June 14, 2023)

This case addresses obviousness under 35 U.S.C. § 103 in relation to a method of increasing prostacyclin release to reduce hypertension in a patient. In particular, this case discusses issues relating to motivation to...more

MoFo Life Sciences

Obviousness In Drug Combinations – Unexpected Results Vs. Unexpected Mechanisms Of Action

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Ascertaining the differences between prior art and claims at issue requires interpreting the claim language and considering both the invention and the prior art references as a whole. The Supreme Court emphasized “the need...more

Haug Partners LLP

Mylan Failed to “Immediately Envisage” the Compounds in Merck’s Patent Covering Januvia

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In Mylan Pharm. Inc. v. Merck Sharp & Dohme Corp., the Federal Circuit considered whether prior disclosure of a genus of compounds and their pharmaceutically acceptable salts was sufficient to anticipate, under 35 U.S.C....more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - October 2022

Provisur Technologies, Inc. v. Weber, Inc., Appeal Nos. 2021-1942, -1975 (Fed. Cir. Sept. 27, 2022) - In this week’s Case of the Week, the Federal Circuit reviewed an IPR decision and addressed the Patent Trial and Appeal...more

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

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

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

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions

[co-author: Jamie Dohopolski] Last year, the continued global COVID-19 pandemic forced American courts to largely continue the procedures set in place in 2020. The U.S. Court of Appeals for the Federal Circuit was no...more

McDonnell Boehnen Hulbert & Berghoff LLP

Horizon Medicines LLC v. Alkem Laboratories Ltd. (Fed. Cir. 2021)

Joint inventorship has been called "one of the muddiest concepts in the muddy metaphysics of patent law" because the "exact parameters of what constitutes joint inventorship are quite difficult to define." Mueller Brass Co....more

Knobbe Martens

Federal Circuit Review - September 2021

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Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more

Knobbe Martens

Arguments to the Patent Office That Contradict Information Submitted to the FDA Support Inference of Deceptive Intent

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BELCHER PHARMACEUTICALS v. HOSPIRA, INC. Before Reyna, Taranto, and Stoll. Appeal from the District of Delaware. Summary: A patentee committed inequitable conduct by advancing an argument during patent prosecution...more

BakerHostetler

Promoting the Progress of Science: Avoiding Inherent Obviousness

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You’ve thought long and hard about how your company’s clinical stage invention is novel over anything that’s ever been done before. Your analysis is finished, right? Not even close. The novelty barrier to patentability can be...more

BakerHostetler

Promoting the Progress of Science: Avoiding Inherent Anticipation

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Congratulations! Your team has made a critical discovery based on its analysis of your company’s clinical data. You want to file a patent application so that your company can secure patent rights for that discovery. Simple,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Denies Certiorari in Actavis Laboratories v. Nalproprion Pharmaceuticals

In the Supreme Court's recent clarifying campaign through the Federal Circuit's U.S. patent law jurisprudence, one section of the statute, 35 U.S.C. §112(a) has been noticeably left unscathed. Indeed, avoidance of this...more

Goodwin

An Interview with Prof. Arti Rai about the Role of “Patent Thickets” in U.S. Biosimilar Market Entry

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Last week, Big Molecule Watch sat down with Professor Arti Rai to discuss an article she recently co-authored, “How logically impossible patents block biosimilars.” The article, published earlier this month in the...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2019 #3

PATENT CASE OF THE WEEK - General Electric Co. v. United Techs. Corp., Appeal No. 2017-2497 (Fed. Cir. July 10, 2019) - The Case of the Week focuses on standing to bring an appeal of an adverse decision by the PTAB in...more

Nutter McClennen & Fish LLP

Supreme Court Ruling in Helsinn Provides Much-Needed Clarity for Inventors

On January 22, the Supreme Court clarified an important issue of patent law that had been left open since the enactment of the America Invents Act several years ago. ...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2018 #3

PATENT CASE OF THE WEEK - Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., Appeal Nos. 2017-2078, -2134 (Fed. Cir. Sept. 10, 2018) The Federal Circuit affirmed the district court’s ruling following a bench trial,...more

Jones Day

French Cour de Cassation Clarifies Requirement of Plausibility

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The Decision: The French Cour de cassation, in a case concerning a dosage regime patent, recently clarified the "plausibility" requirement, an element of sufficiency of disclosure or inventive step. The Result: The wording...more

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