News & Analysis as of

Written Descriptions Claim Construction Pharmaceutical Patents

Wilson Sonsini Goodrich & Rosati

Method of Treatment Claim’s Limiting Preamble Must Satisfy the Written Description Requirement

On March 13, 2025, the U.S. Court of Appeals for the Federal Circuit issued a decision in the case of In Re: Xencor, Inc. In this Appeal from the Appeals Review Panel of the Patent Trial and Appeal Board (ARP), with regard to...more

Robins Kaplan LLP

In re Entresto

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Entresto® (valsartan/sacubitril) - Case Name: In re Entresto, 125 F.4th 1090 (Fed. Cir. Jan. 10, 2025) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by Lourie, C.J.) (Appeal from D. Del., Andrews, J.)  Drug...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Written Description and Enablement Depend on What a Patent 'Claims,' Not What the Claims Cover

The Federal Circuit recently reversed a district court decision that found a patent that did not describe after-arising technology failed to satisfy the written description requirement. In so doing, the Federal Circuit...more

McDermott Will & Emery

Complex or Not Written Description Is Evaluated Against Claims

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit reversed a district court’s ruling of invalidity for lack of written description, finding that the district court erred in its analysis of written description because patents...more

Knobbe Martens

A Patent Must Describe What Is Claimed, Not What Infringes

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Before Lourie, Prost, and Reyna. Appeal from the U.S. District Court for the District of Delaware. Summary: A patent was not invalid for lack of written description for failing to describe the specific infringing embodiment...more

Alston & Bird

Patent Case Summaries | Week Ending January 10, 2025

Alston & Bird on

Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., et al., Nos. 2023-2218, -2220, -2221 (Fed. Cir. (D. Del.) Jan. 10, 2025). Opinion by Lourie, joined by Prost and Reyna. The FDA approved a New Drug Application from...more

Bradley Arant Boult Cummings LLP

Is SCOTUS Looking to Change the Enablement Requirement for Patents?

The Supreme Court is set to hear oral arguments in Amgen, Inc. v. Sanofi (No. 21-757) on Monday, March 27, 2023. The highly contentious question before the high court focuses what an applicant must show to meet the enablement...more

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

2021 PTAB Year in Review: Analysis & Trends: Case Studies and Trends at the PTAB Involving 35 U.S.C. § 112

Over the last 20-plus years, US Court of Appeals for the Federal Circuit cases concerning written description and enablement have become a hot-button issue in the chemical and life sciences practices. The year 2021 was no...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.

PTAB Strategies and Insights: January 2022 - Does the Limit Exist?: Negative Limitations in Novartis v. Accord

In an appeal, Novartis Pharmaceuticals v. Accord Healthcare, Inc., the issue of whether a patent provides sufficient written description of a negative limitation split the panel at the Federal Circuit. Novartis...more

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

PTAB Strategies and Insights: January 2022

The PTAB Strategies and Insights newsletter provides timely updates and insights into how best to handle proceedings at the USPTO. It is designed to increase return on investment for all stakeholders looking at the entire...more

Haug Partners LLP

AztraZeneca AB v. Mylan Pharms. Inc.: Claim Construction of a Percentage Term Guided by the Written Description and Prosecution...

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On December 8, 2021, the Federal Circuit in AztraZeneca AB v. Mylan Pharms. Inc. held that the claim construction of a percentage term should “‘most naturally align[] with the patent’s description of the invention,’ as...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2021 #2

AstraZeneca AB v. Mylan Pharmaceuticals Inc., Appeal No. 2021-1729 (Fed. Cir. Dec. 8, 2021) - Our Case of the Week again focuses on numerical values in claims. Last week we addressed a case involving whether there was...more

Buckingham, Doolittle & Burroughs, LLC

Dear Patenticity: Patent Prophet

Dear Patenticity, I have a chemical invention and I want to obtain the broadest coverage I can. The problem is I have not done much lab work, so I only have a couple real examples. I know that the written description...more

McDermott Will & Emery

Broad Genus of HCV Compounds Wasn’t Enabled or Described

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In a case relating to compounds for the treatment of the Hepatitis C virus (HCV), the US Court of Appeals for the Federal Circuit upheld a district court’s grant of judgment as a matter of law (JMOL) for lack of enablement...more

Knobbe Martens

Federal Circuit Review - October 2019

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The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more

Bradley Arant Boult Cummings LLP

Yet Another Pharmaceutical Patent Falls Under the Scrutiny of 35 U.S.C. § 112

Last week, the Federal Circuit confirmed that Idenix Pharmaceuticals will not be the proud recipient of what was previously regarded as the largest damages award ever recorded in a U.S. patent case. In fact, the majority’s...more

Knobbe Martens

Federal Circuit Review - August 2019

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Mere Potential for Future Appeal Does Not Prevent Triggering Estoppel of Inter Partes Reexamination When Party Fails to Seek Relief in the First Instance - In Virnetx Inc. v. Apple Inc., Appeal Nos. 2017-1591, -1592,...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

Bradley Arant Boult Cummings LLP

A Federal Circuit Prescription to Take Away the Pain for Generics - Intellectual Property News

The Federal Circuit recently reversed a lower court’s ruling of validity under the § 112 written description requirement effectively opening the door for a number of generic drug manufacturers to enter the market with a...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - March 2019 #3

PATENT CASE OF THE WEEK - Natural Alternatives Int’l v. Creative Compounds, LLC, Appeal No. 2018-1295 (Fed. Cir. Mar. 15, 2019) In an appeal from a judgment on the pleadings, the Federal Circuit reversed, issuing an...more

Robins Kaplan LLP

GENERICally Speaking - Vol. 4, No. 1

Robins Kaplan LLP on

The Hatch-Waxman Litigation and Life Sciences practice groups at Robins, Kaplan, Miller & Ciresi L.L.P. are pleased to offer the latest edition of their quarterly publication regarding ANDA patent litigation issues and the...more

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