News & Analysis as of

Mayo v. Prometheus Diagnostic Method

Flaster Greenberg PC

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

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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

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

Foley & Lardner LLP

A Patent-Eligible Diagnostic Method Claim

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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

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

King & Spalding

Federal Circuit Continues Trend of Finding Diagnostic Inventions to Be Patent-Ineligible

King & Spalding on

On August 9, 2019, the Federal Circuit issued a public opinion in Genetic Veterinary Sciences, Inc. v. LABOKLIN GmbH & Co. KG, finding claims directed to methods for detecting a genetic marker for a canine hereditary disease...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

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

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

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

PTAB Strategies and Insights - February 2019: Focus2019 #6 - Important Scientific Discovery Does Not Guarantee U.S. Patent...

A method of diagnosing neurological disorders invented by researchers at Oxford University and the Max-Planck Society was found patent ineligible by the Federal Circuit in the case Athena Diagnostics, Inc. v. Mayo...more

Bradley Arant Boult Cummings LLP

Patenting Diagnostics and Biomarkers Six Years After Mayo

In 2012, the U.S. Supreme Court decided the landmark case of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), which was hailed by some as banning patents on methods of medical diagnosis. It...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

Canada Provides More Guidance On Patent Eligibility Of Diagnostic Method Claims

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While the patent eligibility of diagnostic method claims remains questionable in the United States, the Canadian Intellectual Property Office has issued updated guidance on the types of diagnostic method claims that can–and...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

Fenwick & West LLP

USPTO's Patent Subject Matter Eligibility Roundtable on Dec. 5, 2015

Fenwick & West LLP on

On December 5, 2016 the USPTO will hold its second Patent Subject Matter Eligibility Roundtable to discuss issues in patent eligibility. The USPTO published a list of eighteen questions in anticipation of the event, dealing...more

Foley & Lardner LLP

Federal Circuit’s Recent Primer on Patent-Eligibility

Foley & Lardner LLP on

A method of producing a desired population of multi-cryopreserved hepatocytes was held to be patent-eligible because the challenged claims did not recite a judicial exception. Rapid Litig. v. CellzDirect, Inc.., 2015-1570...more

Foley & Lardner LLP

Supreme Court Declines Sequenom Review

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Last week the United States Supreme Court denied Sequenom’s petition to review the Federal Circuit’s holding in Sequenom Inc. v. Ariosa Diagnostic Inc., 788 F.3d 1371 (2015) that claims directed to detecting fetal DNA in...more

Foley & Lardner LLP

Supreme Court Declines to Review Sequenom Ruling

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The U.S. Supreme Court has denied certiorari in Sequenom, Inc. v. Ariosa Diagnostics, Inc. (No. 15-1182), declining to review the Federal Circuit’s June 12, 2015, decision that certain methods of detecting paternally...more

K&L Gates LLP

U.S. Patent Office Issues New Examples of Patent Eligibility Analysis of Life Sciences Claims

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On May 4, 2016, the United States Patent Office published a subject matter eligibility update for determining patent eligibility under 35 U.S.C. § 101. The Update supplements the previous guidelines and includes additional...more

Foley & Lardner LLP

New USPTO Guidance On Patent Eligibility Of Diagnostic Methods

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The patent eligibility examples published by the USPTO on May 5, 2016 include two new examples relating to diagnostic methods and two new examples relating to “nature-based” products. This article will consider the diagnostic...more

BakerHostetler

Supreme Court Asked to Clarify Limits on Diagnostic Method Patents

BakerHostetler on

Arguing that the current state of the law weakens the patent system and poses a danger to life science innovators, biotechnology company, Sequenom, Inc., has filed a writ of certiorari with the U.S. Supreme Court, asking the...more

Foley & Lardner LLP

Another Diagnostic Patent Falls Under 101

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In Genetic Techs Ltd v Merial LLC (Fed. Cir., April 8, 2016), the Federal Circuit invalidated yet another diagnostic patent for failing to satisfy 35 U.S.C. § 101 on the ground that the claims recite nothing more than a law...more

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