News & Analysis as of

Written Descriptions Claim Limitations

McDonnell Boehnen Hulbert & Berghoff LLP

Regents of the University of Minnesota v. Gilead Sciences, Inc. (Fed. Cir. 2023)

The Supreme Court's (re)consideration of the enablement requirement expected in its decision later this year in Amgen v. Sanofi may be the most closely watched patent case since AMP v. Myriad Genetics.  But in a decision...more

Robins Kaplan LLP

Novartis Pharms. Corp. V. Accord Healthcare, Inc. - Gilenya® (Fingolimod Hcl)

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Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 2204163 (Fed. Cir. June 21, 2022) (Circuit Judges Moore, Linn, and Hughes presiding; Opinion by Moore, J.; Dissenting Opinion by Linn, J.)...more

Haug Partners LLP

Federal Circuit Rehearing Panel Vacates its January Decision and Reverses District Court Finding of Sufficient Written Description...

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On June 21, 2022, the Court of Appeals for the Federal Circuit (“CAFC”), in Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., granted petition for panel rehearing, vacated its prior decision, and reversed the...more

McDermott Will & Emery

Heightened Written Description Standard for Negative Limitations?

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Addressing the issue of negative claim limitations, the US Court of Appeals for the Federal Circuit granted a petition for panel rehearing, vacated its prior decision (authored by now-retired Judge O’Malley) and reversed the...more

Harris Beach PLLC

Federal Circuit Imposes Heightened Standard for Written Description Support of Negative Claim Limitations

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In Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) held patent claims invalid for lack of written description where a negative limitation was...more

Weintraub Tobin

When Can a Patent Claim Positively Include the Negative?

Weintraub Tobin on

Most patent claims describe an invention using positive claim limitations that expressly recite the required elements or features of an invention. Sometimes, however, it is necessary, or desirable, to use a negative claim...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

The Federal Circuit recently granted a panel rehearing and vacated a panel decision between these parties decided earlier this year (see Novartis Pharmaceuticals Corp. v. Accord Healthcare), and rendered a decision that...more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Accord Healthcare, Inc.

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Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 16759 (Fed. Cir. Jan. 3, 2022) (Circuit Judges Moore, Linn, and O’Malley presiding; Opinion by O’Malley, J.; Dissenting Opinion by Moore,...more

Haug Partners LLP

Federal Circuit Denies Rehearing in Biogen v. Mylan: Dissent Raises Four Written Description “Points of Error” That En Banc Court...

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On March 16, 2022, the Court of Appeals for the Federal Circuit denied Biogen International GmbH and Biogen MA, Inc.’s (“Biogen”) combined petition for panel rehearing and rehearing en banc in Biogen International GmbH v....more

McDonnell Boehnen Hulbert & Berghoff LLP

Federal Circuit Denies Petition for Rehearing en Banc in Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc.

On March 16th, the Federal Circuit denied Biogen's petition for panel rehearing and rehearing en banc in Biogen Int'l GmbH v. Mylan Pharmaceuticals Inc.  Judges Cunningham and Stoll did not participate in the decision, which...more

McDermott Will & Emery

Count On It, Plural Term Means More Than One

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The US Court of Appeals for the Federal Circuit affirmed Patent Trial & Appeal Board (Board) patentability decisions after determining that the Board did not err in construing multiple terms within the challenged patents....more

Haug Partners LLP

Is Silence Disclosure? The Federal Circuit Clarifies its Position on Negative Claim Limitations

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In Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 21-1070, slip op. at 7 (Fed. Cir. Jan. 3, 2022), the defendant posed two distinct written-description challenges to Novartis’s patent claims, regarding (1) a daily...more

Mintz - Intellectual Property Viewpoints

Written Description Requirement Challenges: Federal Circuit Decision Sheds Light on How Expert Testimony Can Help

Earlier this month, in Novartis Pharms. Corp., Inc. v. Accord Healthcare, Inc., et al., No. 2021-1070, the Federal Circuit issued a helpful decision concerning the not-often-discussed written description requirement. The...more

Snell & Wilmer

Federal Circuit Upholds a Silent Written Description

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In a precedential opinion this week, the Federal Circuit affirmed a district court judgment in favor of Novartis Pharmaceuticals, in an appeal brought by HEC Pharm challenging the written description in Novartis’s 9,187,405...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

When does the absence of evidence turn into evidence of absence, and when does such absence amount to an adequate written description of the absence of a step of a method claim?  This is a question that comes readily to mind...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Sanofi (Fed. Cir. 2021)

A little less than four years ago, the Federal Circuit rendered a decision in Amgen Inc. v. Sanofi that brought clarity to how the Court (and U.S. Patent and Trademark Office) should apply the written description requirement...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

Knobbe Martens

Large Quantity of Routine Experimentation Can Be “Undue Experimentation”

Knobbe Martens on

IDENIX PHARMACEUTICALS LLC v. GILEAD SCIENCES INC. Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of Delaware. Summary: Synthesizing and screening tens of thousands of...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - August 2019 #3

PATENT CASE OF THE WEEK - Nalpropion Pharmaceuticals, Inc. v. Actavis Laboratories, FL, Inc., Appeal No. 2018-1221 (Fed. Cir. Aug. 15, 2019) - This week’s Case of the Week focuses on issues relating to written...more

Mintz - Intellectual Property Viewpoints

Understanding the USPTO’s Interpretation of 35 U.S.C. § 112 for Computer-Implemented Functional Claim Limitations

Patent practitioners, inventors, in-house counsel, and patent examiners alike have been clamoring for more guidance on computer-implemented functional claim limitations invoking § 112(f) since the Federal Circuit’s en banc...more

Bradley Arant Boult Cummings LLP

A Morass of Possible Combinations Does Not Satisfy the Written Description Requirement under 35 U.S.C. § 112

In a decision issued by the Federal Circuit on October 24, 2018, the court affirmed a finding by the Patent Trial and Appeal Board (PTAB) that a multiple sclerosis (MS) treatment claimed in an application owned by FWP IP APS...more

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