News & Analysis as of

Pharmaceutical Patents Patents Appeals

McDermott Will & Emery

Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

McDermott Will & Emery on

Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more

McDermott Will & Emery

No Article III Appellate Standing Under the Sun

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit dismissed Incyte’s appeal of a Patent Trial & Appeal Board decision, holding that a disappointed validity challenger lacked appellate standing to challenge the Board’s final...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Pharmaceutical Patent Protections

This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more

Knobbe Martens

Hard to Stomach: Things You Say to Prosecute a Patent Can and Will Be Used Against You

Knobbe Martens on

AZURITY PHARMACEUTICALS, INC. v. ALKEM LABORATORIES LTD. Before Murphy, Moore, and Chen. Appeal from the United States District Court for the District of Delaware. Arguments and amendments made during prosecution of a parent...more

McDermott Will & Emery

Transatlantic Terminology: Skilled Artisan Could Equate UK, US Word Meanings

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board unpatentability determination, finding that a skilled artisan would have found the term “sterile” in a UK publication to mean the same as...more

Proskauer - The Patent Playbook

Federal Circuit Affirms Stem Cell Product-by-Process Claims: Lessons in Claim Construction and Inherency from Restem LLV v. Jadi...

The Federal Circuit issued a precedential opinion on March 4, 2025, that serves as valuable guidance for product-by-process claims, particularly in the context of inherency in claim construction. In Restem, LLC v. Jadi Cell,...more

A&O Shearman

Federal Circuit Affirms PTAB Decision On Unpatentability, With The PTO Stepping In After Appellee Withdrew

A&O Shearman on

On April 15, 2025, the U.S. Court of Appeals for the Federal Circuit (“CAFC”) affirmed the Patent Trial and Appeal Board’s (“Board”) decision finding all challenged claims of Sage Products, LLC’s patents anticipated based on...more

McDermott Will & Emery

Prosecution Disclaimer Alive and Well, Especially in Closed Claim

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a district court’s noninfringement determination, finding that the presence of a disclaimed compound in the accused product precluded infringement. Azurity Pharm., Inc....more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd.

Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., Appeal No. 2023-1977 (Fed. Cir. Apr. 8, 2025) In our Case of the Week, the Federal Circuit affirmed that defendant Alkem’s proposed generic antibiotic did not...more

A&O Shearman

How to commence main proceedings before the UPC: deadlines and court fees

A&O Shearman on

Patent holders must start Unified Patent Court (UPC) proceedings on the merits within a certain period if they do not want to risk the revocation of provisional measures. The UPC has now clarified that filing the statement of...more

Irwin IP LLP

Federal Circuit Finds Loophole Allowing Patents To Cover Later Developed Technologies

Irwin IP LLP on

In re Entresto, 125 F.4th 1090 (Fed. Cir. 2025) - After Novartis’ patent on the blockbuster blood pressure medication Entresto was found invalid at the district court for covering technology that was developed after the...more

Foley & Lardner LLP

Jepson Claim Format Does Not Avoid Written Description Scrutiny

Foley & Lardner LLP on

Current written description jurisprudence can make it difficult to obtain broad antibody patents, leading practitioners to explore alternative claiming strategies in an effort to bypass the limited scope afforded under the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Recor Medical, Inc. v. Medtronic Ireland Mfg. (Fed. Cir. 2025)

The inter partes review provisions of the Leahy-Smith America Invents Act have been criticized for the propensity of the Patent Trial and Appeal Board (PTAB) to find invalid all or at least some of the challenged claims,...more

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

Hatch-Waxman Requires Patent Term Extension for Reissued Patents To Be Based on Original Patent

The Federal Circuit held in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., 23-2254 that a reissued patent receives patent term extension (PTE) based on the issue date of the original patent, not the reissue patent,...more

Cooley LLP

End of the Road for Jepson Format Claims in the Life Sciences?

Cooley LLP on

In In re: Xencor, Inc., the US Court of Appeals for the Federal Circuit confirmed that the limiting preamble of a Jepson claim must be supported by the specification with “sufficient written description.” In its decision, the...more

Irwin IP LLP

Federal Circuit Finds Against Generics Where Hatch-Waxman's Full Five-Year Extension Fixes Delay For Pharmaceutical FDA-Review  

Irwin IP LLP on

Merck Sharp & Dohm B.V. v. Aurobindo Pharma USA, Inc. et al (Fed. Cir. March 13, 2025) - The Hatch-Waxman Act seeks to strike a balance in the pharmaceutical industry by incentivizing drugs makers to develop innovative...more

Dorsey & Whitney LLP

Common Sense Approach Prevails in Determining Subject Matter Eligibility of Compositions of Matter

Dorsey & Whitney LLP on

Over the last 15 years, the discussion over the types of subject matter that are considered patent eligible under 35 U.S.C. § 101 has been mostly focused on the software and biological fields. Several years ago, the Federal...more

McDermott Will & Emery

What’s the (Re)issue? Patent Term Extensions for Reissue Patents

McDermott Will & Emery on

Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more

Foley & Lardner LLP

Federal Circuit Decision Could Encourage More Reissue Patents

Foley & Lardner LLP on

The Patent Term Extension (PTE) provisions of 35 U.S.C. § 156 compensate pharmaceutical patent owners for time they are not able to enjoy commercial market exclusivity because their products are not yet approved by the U.S....more

Goodwin

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

Goodwin on

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

Knobbe Martens

Jepson Claim Preamble Requires Written Description Support for Conventional Aspects of the Invention

Knobbe Martens on

IN RE: XENCOR, INC. Before Hughes, Stark, and Schroeder (sitting by designation).  Appeal from the U.S. Patent and Trademark Office, Patent Trial and Appeal Board. To provide adequate written description for a Jepson claim,...more

Alston & Bird

Patent Case Summaries | Week Ending March 14, 2025

Alston & Bird on

CQV Co., Ltd. v. Merck Patent GmbH, No. 2023-1027 (Fed. Cir. (PTAB) Mar. 10, 2025). Opinion by Cunningham, joined by Chen and Mayer. CQV petitioned the Patent Trial and Appeal Board for post-grant review of a Merck patent...more

McDonnell Boehnen Hulbert & Berghoff LLP

DNA Genotek Inc. v. Spectrum Solutions LLC (Fed. Cir. 2025)

Sometimes important contributions to innovation can come from the mundane rather than the extraordinary. One (perhaps apocryphal) example comes from the story of the early development of television by Philo Farnsworth (the...more

McDermott Will & Emery

Inventor’s Motivation to Combine Does Not Control Obviousness

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed a district court decision rejecting claims of a patent application directed to a dosing regimen for a cancer treatment, finding the claims to be obvious where the...more

WilmerHale

Federal Circuit Patent Watch: Federal Circuit Orders Remanded Case Reassigned to New Judge, Finding That Trial Judge’s Statements...

WilmerHale on

Precedential and Key Federal Circuit Opinions - HD SILICON SOLUTIONS LLC v. MICROCHIP TECHNOLOGY INC. [OPINION] (2023-1397, 2/6/2025) (Lourie, Stoll, Cunningham) - Lourie, J. The Board affirmed the Final Written...more

467 Results
 / 
View per page
Page: of 19

"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