News & Analysis as of

Diagnostic Tests Patent-Eligible Subject Matter

Fox Rothschild LLP

Problems – And Solutions – For Securing Patent Protection Over Diagnostic Technologies

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Drafting claims for methods of diagnosing and treating patients can be challenging since they involve the measurement of patent-ineligible subject matter and because these methods are often performed by multiple parties. ...more

Robins Kaplan LLP

Section 101 Love in the Time of COVID-19, with Apologies to Gabriel García Márquez

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It is a good bet that everyone has a heightened appreciation for diagnostic technology right now. The countries that have fared reasonably well during the ongoing pandemic are those with meticulous testing regimens. After...more

Bradley Arant Boult Cummings LLP

A Method of Diagnostic Sample Preparation Is Held Valid Under Mayo/Myriad, but the Diagnostic Test Was Held Invalid

Nearly five years ago the U.S. Court of Appeals for the Federal Circuit (CAFC) decided the controversial case of Ariosa v. Sequenom. In Sequenom the invention was a radically new method of fetal genetic testing by amplifying...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

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

Foley & Lardner LLP

Australia Holds The Line On Patent Eligibility Of Diagnostic Methods

Foley & Lardner LLP on

In a decision underscoring that the U.S. stands (nearly) alone in holding most diagnostic methods to be not eligible for patenting, the Federal Court of Australia upheld Sequenom’s Australian patent directed to prenatal...more

Wilson Sonsini Goodrich & Rosati

Diagnostic Patent Take-Home Lessons from the Recent Federal Circuit Athena Case

Recently, the U.S Court of Appeals for the Federal Circuit issued a split panel decision in Athena.Athena, which examined the patent subject matter eligibility of four claims in one issued patent, upheld a district court's...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

Mintz - Intellectual Property Viewpoints

Personalized Medicine Gets a Boost from Federal Circuit’s Vanda Pharma Decision – Part II: Enforcement

The Federal Circuit’s decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2707, 2016-2708 April 13, 2018) provided some good news on the subject matter eligibility front for innovators and other stakeholders in...more

Fenwick & West Life Sciences Group

USPTO and EPO Examiners Discuss Key Considerations for Filing Effective Precision Medicine and Bioinformatics Applications in the...

At a symposium and webinar presented by Fenwick & West and Mewburn Ellis, we asked U.S. Patent and Trademark Office and European Patent Office examiners to provide perspective on the preparation and prosecution of patent...more

Burns & Levinson LLP

Does Mayo Preclude the Patenting of Medical Diagnostics?

Burns & Levinson LLP on

On August 4, 2017, the U.S. District Court in the District of Massachusetts found U.S. patent 7267820 (the ‘820 patent), owned by Athena Diagnostics, Inc., to be directed to non-patentable subject matter, and therefore...more

Locke Lord LLP

Medical Diagnostic Patents Found to Claim Patent Ineligible Subject Matter—Motions to Dismiss Granted

Locke Lord LLP on

On August 4, 2017, a pair of decisions reaffirmed that claimed methods which apply routine and conventional techniques to a law of nature are invalid and do not satisfy the “inventive concept” step of the patent eligibility...more

Patterson Belknap Webb & Tyler LLP

Supreme Court Denies Sequenom’s Cert Petition, Leaving the Federal Circuit’s Interpretation of the Mayo/Alice Patent Eligibility...

The Supreme Court today denied Sequenom Inc.’s petition for writ of certiorari, in which Sequenom asked the Court to review a decision of the Federal Circuit invalidating its patent on a breakthrough prenatal diagnostic...more

Saul Ewing Arnstein & Lehr LLP

Federal Circuit Expresses Concern About Patent Eligibility Under Mayo

The “prognosis” for patentability of medical diagnostic claims remains uncertain after an order of the Federal Circuit Court of Appeals (“Court”) denying a petition for an en banc rehearing of its decision in Ariosa...more

BakerHostetler

Federal Circuit denies en banc review of Ariosa v. Sequenom

BakerHostetler on

On December 2, 2015, an almost unanimous Federal Circuit decision was issued denying the en banc rehearing of Ariosa v. Sequenom, a case having significant consequences for diagnostic patents and Section 101 case law in...more

Foley & Lardner LLP

Protecting Diagnostic Innovation – Two Actor Infringement Liability

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In Akamai Techs. Inc. v. Limelight Networks, Inc., (August 13, 2015 Fed. Cir.) an en banc Federal Circuit unanimously held that direct infringement under Section 271(a) can occur...more

Mintz

Federal Circuit Invalidates Diagnostic Method Claims for Prenatal Test Under 35 U.S.C. 101

Mintz on

On June 12, 2015, the Federal Circuit affirmed the finding of U.S. District Court for the Northern District of California (“District Court”) that the method claims in U.S. Patent 6,258,540 (‘540 patent) for detecting...more

Goodwin

Federal Circuit Holds Medical Diagnostic Method Patent Invalid as Claiming Ineligible Subject Matter

Goodwin on

Background - In two recent cases, Mayo v. Prometheus and Alice v. CLS Bank, the Supreme Court established a two-part test for determining eligibility for patenting. In step one, the court asks whether the claim is...more

Dorsey & Whitney LLP

Patent for Technology that “Revolutionized Prenatal Care” Nonetheless Invalid as Patent Ineligible

Dorsey & Whitney LLP on

The Federal Circuit Friday held in Ariosa Diagnostics, Inc. v. Sequenom, Inc. that Sequenom’s patent directed toward its MaterniT21 test—involving methods of detecting and using cell-free fetal DNA— was invalid for lack of...more

Foley & Lardner LLP

Another Patent Challenge for Personalized Medicine

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The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more

Foley & Lardner LLP

California Court Holds Diagnostic Claims Not Patent-Eligible

Foley & Lardner LLP on

In one of the first district court decisions applying the U.S. Supreme Court’s new Myriad patent-eligibility standard, the Northern District of California held that diagnostic claims containing only conventional and existing...more

Foley & Lardner LLP

Supreme Court Asked for Further Clarity on Patent-Eligibility of Diagnostic Claims

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Did the Federal Circuit incorrectly interpret and apply the holding of the U.S. Supreme Court’s decision regarding patent-eligibility of medical methods as set forth in Mayo Collaborative Services v. Prometheus Laboratories,...more

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