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Intellectual Property Protection Pharmaceutical Patents Appeals

Jones Day

April 2025 Institution Rate Slips Below 45 Percent

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The PTAB has published its monthly statistics wrap up for April 2025. As expected, those statistics show a significant decline in the institution rate compared to the first six months of the fiscal year. In those first six...more

McDermott Will & Schulte

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

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

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

Alston & Bird

Patent Case Summaries | Week Ending March 14, 2025

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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

McDermott Will & Schulte

Inventor’s Motivation to Combine Does Not Control Obviousness

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

McDonnell Boehnen Hulbert & Berghoff LLP

Aurobindo v. Merck Sharp and Dohme -- Oral Argument

The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more

McDermott Will & Schulte

Eye-Catching: Biosimilars Injunction Prevails

Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a...more

Robins Kaplan LLP

Silvergate Pharms., Inc. v. Bionpharma Inc.

Robins Kaplan LLP on

Epaned® (enalapril maleate) - Case Name: Silvergate Pharms., Inc. v. Bionpharma Inc., Civ. Nos. 18-cv-1962, 19-cv-1067, 2024 WL 4417104 (D. Del. Oct. 4, 2024) (Goldberg, J.)  Drug Product and Patent(s)-in-Suit: Epaned®...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Highlights the Importance of Separating Claim Construction and Infringement Analysis When Dealing with...

Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc., No. 23-2218 (Fed. Cir. 2025) — On January 10, 2025, the Federal Circuit reversed the district court’s opinion that claims of a Novartis patent are invalid for lack...more

McDermott Will & Schulte

Skilled Artisan’s View Is Decisive in Assessing Asserted Claim Drafting Error

The Court of Appeal (CoA) of the Unified Patent Court (UPC) clarified the legal standard for correcting obvious type inaccuracies in patent claims, explaining that the view of a skilled person at the filing date is decisive...more

McDermott Will & Schulte

The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

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Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a...more

White & Case LLP

Federal Circuit Limits the Application of Obviousness-Type Double Patenting for Patents in the Same Family

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On August 13, 2024, a three-judge panel of the Court of Appeals for the Federal Circuit issued a decision, authored by Judge Lourie, in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061, which limits the...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Upholds Rifaximin Patent Rulings, Affirms ANDA Approval Restrictions

In Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals, Inc. 2023-1952 (Fed. Cir. April 11, 2024), this case involves appellate review of a district court’s findings regarding patent obviousness and infringement in...more

McDermott Will & Schulte

Same Product in Different Packaging May Constitute Separate Market for Antitrust Purposes

Addressing an issue of first impression, the US Court of Appeals for the Second Circuit concluded that two medications that contain the same ingredients but are packaged in different forms constitute separate markets for...more

A&O Shearman

Federal Circuit affirms district court finding of no induced or contributory infringement of generic depression drug

A&O Shearman on

In H. Lundbeck A-S v. Lupin Ltd., Case No. 2022-1194 (Fed. Circ. December 7, 2023), Plaintiffs, H. Lundbeck A/S (“Lundbeck”) and Takeda Pharmaceutical Company Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals...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

McDermott Will & Schulte

If the Label Is Skinny Enough – No Inducement Under Hatch-Waxman

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The US Court of Appeals for the Federal Circuit made explicit what has long been considered implicit based on Warner-Lambert and its progeny, namely, that plaintiffs asserting an induced infringement theory to bar the entry...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

Fitch, Even, Tabin & Flannery LLP

Calculating Patent Term Extension for FDA Delay: Original Patent or Reissue Patent Issue Date?

The Federal Circuit appeal in Merck Sharp & Dohme B.V., Merck Sharp & Dohme, LLC v. Aurobindo Pharma USA, Inc. et al., concerns whether patent term extension (PTE) for regulatory delay, in particular delay for FDA drug...more

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

Mind Your Ps and Qs, and Your PTAs Too

Last week, the Federal Circuit held that obviousness-type double patenting trumps patent term adjustment, opening the door for invalidity attacks that to date had been questionable. In re Cellect was an appeal from a...more

A&O Shearman

Half an hour for a bifurcation: UPC Central Division rejects preliminary objection after first oral hearing

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The decision concerns the time of filing and admissibility of a revocation action at the Central Division when a parallel infringement action is filed at a local division (Art. 33(4) UPCA). Art 33(4) UPCA states that...more

Knobbe Martens

Silence Is No Support for Negative Claim Limitation

Knobbe Martens on

NOVARTIS PHARMACEUTICALS CORP. V. HEC PHARM CO., LTD. Before Moore, Hughes, and Linn (dissenting). Appeal from the United States District Court for the District of Delaware. Summary:  Silence regarding the presence or...more

Knobbe Martens

Is Evidence of Generic Industry Skepticism Enough to Preclude a Finding of a Motivation to Combine?

Knobbe Martens on

AURIS HEALTH, INC., v. INTUITIVE SURGICAL OPERATIONS, INC., Before Dyk, Prost, and Reyna. Appeal from the Patent Trial and Appeal Board (PTAB). Summary: Evidence of generic industry skepticism cannot, by itself, form...more

Knobbe Martens

Cancer Drug Patent Not Dead Yet

Knobbe Martens on

(Mar. 31, 2022) Last Friday, ImmunoGen won an appeal at the Federal Circuit in ImmunoGen, Inc. v. Hirshfeld. The lawsuit is a civil action to order the granting of U.S. Application No. 14/509,809 (‘809), titled “Anti-FOLR...more

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