News & Analysis as of

DNA Section 101

BakerHostetler

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

BakerHostetler on

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

Fenwick & West LLP

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

Fenwick & West LLP on

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

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

Fox Rothschild LLP on

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

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

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

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

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

Holland & Knight LLP on

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

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

Downs Rachlin Martin PLLC

Current State of Patent Eligibility and Potential Reform

Will there be patent eligibility reform following the Senate Committee hearings? Major points of contention during the hearings were (1) the patentability of human genes, (2) whether proposed changes to 35 U.S.C. § 112(f)...more

Robins Kaplan LLP

The Federal Circuit Adds Partial Clarity to the Eligibility of Patents Directed to Purity

Robins Kaplan LLP on

For a long time, the hallmarks of patentability of an invention were basically two: is it new? is it non-obvious? If both answers were “yes,” then—provided that the patent itself was properly written—you’d get your patent. A...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

McDonnell Boehnen Hulbert & Berghoff LLP

Subject Matter Eligibility Guidance -- Example on Screening for Gene Alterations

Last month, the U.S. Patent and Trademark Office issued further guidance for determining subject matter eligibility under 35 U.S.C. § 101. In addition to a memorandum on subject matter eligibility determinations that was...more

Patterson Belknap Webb & Tyler LLP

Ariosa Files Opposition to Sequenom’s Cert Petition

Ariosa Diagnostics, Inc., Natera, Inc., and DNA Diagnostics Center, Inc. have filed briefs in opposition to Sequenom’s petition for writ of certiorari to the Supreme Court for review of the Federal Circuit’s decision holding...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

Fish & Richardson

Claims Directed to Detection of Gene Variants Patent-Ineligible, Notwithstanding Mental Activity Requirement

Fish & Richardson on

Genetic Technologies Ltd. v. Merial L.L.C., __ F.3d __ (Fed. Cir. Apr. 8, 2016) (Prost, DYK, Taranto) (D. Del.: Stark) (4 of 5 stars) - Federal Circuit affirms judgment that patent claims are invalid under § 101. Genetic...more

Fenwick & West LLP

Litigation Alert: Federal Circuit’s Ariosa Decision, Good Chance for Rehearing En Banc

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In June of this year, the Federal Circuit panel in Ariosa Diagnostics, Inc. v. Sequenom, Inc. invalidated a patent on the grounds of patent-ineligible subject matter. 788 F.3d 1371 (Fed. Cir. 2015). While the case is one of...more

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