News & Analysis as of

Diagnostic Method Section 101

McDonnell Boehnen Hulbert & Berghoff LLP

Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)

Federal Circuit Hands Down Modified Opinion in Illumina, Inc. v. Ariosa Diagnostics, Inc. Earlier this year, the Federal Circuit (somewhat surprisingly) found claims of two Sequenom patents directed to methods for...more

Flaster Greenberg PC

Impact of Federal Circuit’s Opinion in 'Athena' on Medical Diagnosis Patents

Flaster Greenberg PC on

Is a new method of diagnosing a disease patentable? Can it survive a motion to dismiss? And, irrespective of the current precedent, should a new method of diagnosing a disease be patentable? These are questions the U.S. Court...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit Decision Provides Opening for Preparation Methods in Diagnostic Space, But Not for Diagnostic Claims

The Federal Circuit held that two patents directed to methods of preparing samples for use in diagnostic methods are patent eligible under Section 101, reversing a decision from the District Court for the Northern District of...more

McDonnell Boehnen Hulbert & Berghoff LLP

CareDX, Inc. v. Natera, Inc. (D. Del. 2020)

Ever since the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories was handed down in 2012, diagnostic method claims have been routinely invalidated by the district courts and those decisions...more

Kramer Levin Naftalis & Frankel LLP

Supreme Court Won’t Take Up Patent Eligibility for Medical Diagnostics

The cloud of uncertainty over patent eligibility of patents for medical diagnostic methods remains. On Monday, the Supreme Court declined the opportunity to revisit patent eligibility under its two-step Mayo test when it...more

Troutman Pepper

Supreme Court Denies Review In Three Section 101 Cases

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On January 13, 2020, the U.S. Supreme Court denied certiorari in the following cases...more

Kramer Levin Naftalis & Frankel LLP

The Whole Enchilada: The Necessity of Looking at Claims as a Whole to Determine Patent Eligibility

On Jan. 10, the Supreme Court will decide whether it will review the Federal Circuit's decisions in the Athena v. Mayo, HP Inc. v. Berkheimer and Hikma v. Vanda cases. The Solicitor General, at the invitation of the Supreme...more

Foley & Lardner LLP

A Patent-Eligible Diagnostic Method Claim

Foley & Lardner LLP on

On Friday I will be speaking at the AUTM Eastern Regional Meeting, on a panel discussing patent eligibility issues for life sciences inventions. My topic relates to what the USPTO refers to as “nature-based products,” but...more

Sunstein LLP

Federal Circuit Asks Congress to Override Supreme Court's Denial of Patents for Diagnostics

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In a remarkable collection of opinions that have no direct effect on the law, the Federal Circuit has implicitly given its support to efforts in Congress to override the Supreme Court’s decision in Mayo v. Prometheus, which...more

Bradley Arant Boult Cummings LLP

For the First Time, a Medical Treatment Patent Is Ruled Invalid Under Mayo/Myriad

As discussed in a previous blog post, since Mayo v. Prometheus, critics of medical treatment patents have advocated that such patents should be banned from patenting. While such arguments seemed futile based on the consistent...more

McDermott Will & Emery

Fractured Federal Circuit Maintains Ineligibility of Diagnostic Methods

McDermott Will & Emery on

In an opinion evidencing the split in opinion regarding the patent eligibility of diagnostic methods, the US Court of Appeals for the Federal Circuit denied a petition for panel rehearing or rehearing en banc, leaving in...more

Knobbe Martens

Federal Circuit Review - July 2019

Knobbe Martens on

Broad Claim Language and Unpredictability in the Art Lead to Non-Enablement - In Enzo Life Sciences, Inc. v.  Roche Molecular Systems, Inc., Appeal Nos. 2017-2498, -2499, -2545, -2546, broad patent claims were invalid as...more

Bradley Arant Boult Cummings LLP

Detecting Disease Is Not a “Tangible and Useful Result” Eligible for Patenting

The federal appeals court with jurisdiction over questions of patent law has consistently held that methods of diagnosing a disease or other biological condition violate the Supreme Court’s ban on patenting “natural...more

Foley & Lardner LLP

Federal Circuit Agrees Genotyping Method Is Not Eligible For Patenting

Foley & Lardner LLP on

In Genetic Veterinary Sciences, Inc. v. Laboklin GMBH & Co., the Federal Circuit upheld the district court decision that held claims directed to methods for genotyping a Labrador Retriever invalid under 35 USC § 101 at the...more

Knobbe Martens

Federal Circuit Review - April 2019

Knobbe Martens on

Just Because Something May Result From a Prior Art Teaching Does Not Make it Inherent in that Teaching - In Personal Web Technologies, LLC v. Apple, Inc., Appeal No. 2018-1599, the Federal Circuit clarified that the mere...more

Knobbe Martens

Federal Circuit Review - March 2019

Knobbe Martens on

Federal Circuit Determines Time-Barred Petitioner Joined to an IPR Has Appellate Standing - In Mylan Pharmaceuticals Inc. v. Research Corporation Tech., Appeal Nos. 2017-2088, -2089, -2091, the Federal Circuit held that a...more

Sunstein LLP

March 2019 IP Update - Once Again, the Federal Circuit Strikes Down Claims Directed to a Diagnostic Method

Sunstein LLP on

In Athena Diagnostics Inc. v. Mayo Collaborative Services, LLC, the Federal Circuit has once again held that claims directed to a diagnostic method are invalid under 35 U.S.C. § 101 for being directed to ineligible subject...more

Knobbe Martens

Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC: Claims Reciting Conventional Method Steps found Patent Ineligible

Knobbe Martens on

On February 6, 2019, the Federal Circuit decided Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, affirming a District Court for the District of Massachusetts decision that the claims at issue were patent...more

Knobbe Martens

Athena Diagnostics, Inc. v. Mayo Collaborative Services

Knobbe Martens on

Federal Circuit Summaries - Before Judge Newman, Lourie and Stoll. Appeal from the United States District Court for the District of Massachusetts. Summary: Claims reciting only conventional steps to detect a natural...more

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

Federal Circuit Upholds Invalidity of Athena’s Claims Directed to Methods for Diagnosing Neurological Disorders

In Athena Diagnostics, Inc. v. Mayo Collaborative Services, a divided panel of the Federal Circuit has provided another guidepost in the search for patent-eligible subject matter in the diagnostic industry. The Court upheld a...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit Affirms Section 101 Ineligibility Determination of Genetic Diagnostic Methodology Patent

The Federal Circuit recently affirmed a decision from the District Court for the Northern District of California granting appellee Cepheid’s summary judgment motion against appellant Roche Molecular Systems (“Roche”) and held...more

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

Global Patent Prosecution Newsletter - October 2018: How To Do The Two-Step In The United States: The Current State of...

In the wake of the Supreme Court’s Mayo and Alice decisions, uncertainty has surrounded what inventions are patent eligible in the United States. In Mayo and Alice, the Supreme Court developed a two-step test to determine...more

Knobbe Martens

Roche Molecular Systems, Inc. v. Cepheid

Knobbe Martens on

Federal Circuit Summary - Before O’Malley, Reyna, and Hughes. Appeal from the District Court for the Northern District of California. Summary: Testing for the presence of a bacterium that causes tuberculosis and the...more

Sunstein LLP

July 2018 IP Update: New Guidance for Patenting Method-of-Treatment Inventions

Sunstein LLP on

The U.S. Patent and Trademark Office (USPTO) issued a memorandum on June 7 (the “Memorandum”), providing much-needed guidance to patent examiners as to whether method of treatment claims are to be considered patent-eligible...more

Foley & Lardner LLP

PTAB Puts Method Of Treatment Patents Under The 101 Knife

Foley & Lardner LLP on

While the Supreme Court decisions in Myriad and Mayo have been applied to diagnostic-type claims, method of treatment patents were thought to be safe from the recent judicial expansion of the patent-(in)eligibility doctrine....more

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