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Patent-Eligible Subject Matter DNA Patents

Patent-Eligible Subject Matter refers to the types of inventions that can be legally patented. The criteria for patentability varies depending on the jurisdiction. In the United States, for instance, if a... more +
Patent-Eligible Subject Matter refers to the types of inventions that can be legally patented. The criteria for patentability varies depending on the jurisdiction. In the United States, for instance, if a researcher discovers a naturally occurring substance, the substance itself cannot be patented. This issue was examined in a United States Supreme Court case, AMP v. Myriad, in regard to the patentability of human genes.  less -
BakerHostetler

Characterization of Claim Elements as “Conventional” Results in Section 101 Subject Matter Ineligibility

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In an attempt to broaden a patent’s disclosure and provide Section 112 support for features that are not explicitly disclosed within the patent’s specification (such as reagents, assays, techniques, etc.), patent applications...more

Holland & Knight LLP

Patents on Measuring cfDNA to Detect Rejection of Transplanted Organs Held Invalid

Holland & Knight LLP on

When a person who has received an organ transplant experiences rejection, DNA from the transplanted organ is released into the bloodstream as the organ's cells are attacked by the person's immune system. The circulating DNA...more

MoFo Life Sciences

The “Big Bang” For Sequence Listings: New Requirements In Place July 1, 2022

MoFo Life Sciences on

Life sciences patent applications often contain DNA, RNA, and amino acid sequences in the specification, claims, or figures that are required to be provided in the form of a sequence listing. The inclusion of sequences in...more

Fenwick & West LLP

Illumina’s Response Is Short and Sweet in Opposing Ariosa’s Petition for Certiorari

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Illumina has now filed its brief in opposition, completing the certiorari petitions/responses for all parties in the concurrent American Axle and Ariosa patent eligibility cases. True to form, neither of the filings in...more

Kramer Levin Naftalis & Frankel LLP

Federal Circuit Holds Stanford’s Genetics Method Claims Abstract Under Section 101

On March 25, the Federal Circuit issued an opinion in In re Board of Trustees of the Leland Stanford Junior Univ., No. 2020-1288 (Fed. Cir. Mar. 25, 2021), affirming the Patent Trial and Appeal Board’s rejection of the...more

McDonnell Boehnen Hulbert & Berghoff LLP

An Analytic Approach to Patent Eligibility

The transcendental conundrum in patent law in these times is how to overcome the misinterpretation of the Supreme Court's decisions on patent eligibility law by district courts and the Federal Circuit.  That these courts...more

Akin Gump Strauss Hauer & Feld LLP

District Court Rules DNA Analysis Claims Reciting Mathematical Algorithms Ineligible Under § 101

The District Court for the Northern District of Ohio dismissed Cybergenetics Corp.’s infringement suit after determining that the asserted claims—which recite mathematical algorithms for analyzing data taken from a DNA...more

Knobbe Martens

Federal Circuit Review - August 2020

Knobbe Martens on

Claims Covering Human Engineering That Exploit a Naturally-Occurring Phenomenon Are Patent Eligible - In Illumina, Inc. V. Ariosa Diagnostics, Inc., Appeal No. 19-1419, the Federal Circuit modified its earlier decision...more

Knobbe Martens

Claims Covering Human Engineering That Exploits a Naturally-Occurring Phenomenon Are Patent Eligible

Knobbe Martens on

ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC. Before Lourie, Moore, and Reyna. Modified opinion following Ariosa rehearing petition. Summary: The Federal Circuit modified its earlier decision and clarified the difference...more

Morrison & Foerster LLP

Casting A New Light On Diagnostic Patents: “Methods Of Preparation” Patent-Eligible

The ability of life sciences companies to rely on patent protection for diagnostic methods has been eroded over the last ten years, although recent court decisions evidence a rebuilding framework. While courts have...more

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

Fox Rothschild LLP

Illumina v. Ariosa: Carving Out A New “Bucket” Of Section 101 Patent Eligible Claims

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Case Summary- On March 17, 2020, the Federal Circuit found that patents claiming methods of preparing an extracellular fraction of cell-free DNA that is enriched in fetal DNA were patent eligible and not invalid under 35...more

McDermott Will & Emery

“Method of Preparation” Claims Found Patent-Eligible Under §101

McDermott Will & Emery on

Addressing the issue of patent eligibility under §101, the US Court of Appeals for the Federal Circuit reversed a district court, explaining that the method of preparation claims at issue are not directed to a...more

Kilpatrick

Federal Circuit Finds Method of Preparation Claims Patent Eligible

Kilpatrick on

On March 17, 2020, a divided Federal Circuit panel (“CAFC”) reversed a District Court decision and found that claims directed to a method of preparing a fraction of fetal cell-free DNA were patent eligible under 35 U.S.C. §...more

Weintraub Tobin

Federal Circuit: Sequenom’s Fetal DNA Claims Are Patent Eligible

Weintraub Tobin on

An unborn baby’s DNA (“fetal DNA”) can be used to determine the sex of the baby as well as to test for conditions such as Down’s syndrome. In the past, procedures to get samples of fetal DNA for testing involved sticking a...more

Robins Kaplan LLP

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

Robins Kaplan LLP on

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

Knobbe Martens

Claims Using Naturally-Occurring Phenomenon in Method of Preparation Found Patent Eligible

Knobbe Martens on

ILLUMINA, INC. v. ARIOSA DIAGNOSTICS, INC. Before Lourie, Moore, and Reyna. Appeal from the Northern District of California. Summary: Use of a natural phenomenon in a method of preparation claim found patent eligible...more

Foley & Lardner LLP

Federal Circuit Finds Eligibility In Non-Diagnostic Method

Foley & Lardner LLP on

In Illumina, Inc. v. Ariosa Diagnostics, Inc., a divided panel of the Federal Circuit found claims directed to methods of preparing DNA samples for analysis satisfy the patent eligibility requirement of 35 USC § 101. Although...more

Wilson Sonsini Goodrich & Rosati

Federal Circuit Upholds Patents Drawn to Methods of Separating Fetal Cell-Free DNA from Maternal Cell-Free DNA

The Federal Circuit, in Illumina, Inc., v. Ariosia, reversed the summary judgment decision of a lower trial court and upheld—as patent subject matter eligible—claims in two patents (U.S. 9,580,751; U.S. 9,738,931). The...more

McDonnell Boehnen Hulbert & Berghoff LLP

BRCA2 Gene Mutations Associated with Risk of Childhood Lymphoma

The BRCA2 gene is one member of a pair of genes that changed the patent landscape several years ago, when the Supreme Court ruled that "mere" isolation was insufficient to render genomic embodiments thereof patent eligible,...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

Holland & Knight LLP

Federal Circuit Ruling Kills Labrador Retriever Genotyping Patent

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The Federal Circuit provided an undesirable reminder to The University of Bern (and many other patent owners): a positive and valuable contribution does not necessarily equate to patentable subject matter. Here, the Court...more

King & Spalding

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

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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

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

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