News & Analysis as of

Life Sciences Diagnostic Method

BakerHostetler

The Supreme Court Again Declines To Reevaluate Subject Matter Eligibility of Diagnostic Claims

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The Supreme Court seemed, at least to a small degree, interested in evaluating the subject matter eligibility of diagnostic claims when it requested that the respondents (Natera Inc. and Eurofins Viracor Inc.) respond to a...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

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

Foley & Lardner LLP

USPTO October 2019 Patent Eligibility Guidance Update Includes New Guidance And Examples For Life Sciences

Foley & Lardner LLP on

The USPTO has released additional patent eligibility guidance to supplement the guidance released in January. While much of the October 2019 Patent Eligibility Guidance Update relates to claims falling under the “abstract...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

White & Case LLP

Managing economic and social change toward a sustainable future: A new era for US patents

White & Case LLP on

How has President Trump's "America First" philosophy affected US patent policy? White & Case partners discussed what an evolving US patent policy will mean for other nations, and to propose effective responses....more

McDermott Will & Emery

Diagnostic Method Found Ineligible, Again

McDermott Will & Emery on

In a post-Mayo v. Prometheus opinion addressing the subject matter eligibility of diagnostic methods based on underlying natural laws, the US Court of Appeals for the Federal Circuit affirmed the district court’s conclusion...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

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

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

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

The (Nuts and Bolts) of Application Formalities in China

China is in the midst of a tremendous patent boom. Worldwide, total patent application filings were up 7.8% in 2015, with China accounting for 84% of the total growth[1]. In 2015, the State Intellectual Property Office of the...more

Knobbe Martens

Preparing Biotech Patent Applications - Ten Strategies for Success

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Obtaining issued patents in the biotechnology space can be a challenge. Here is a list of ten patent strategies we recommend for biotechnology innovators to increase their odds of obtaining valuable intellectual property...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

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

K&L Gates LLP

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

K&L Gates LLP on

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

King & Spalding

Patentable Subject Matter in the Life Sciences: New USPTO Guidance Impacts Diagnostic Methods and Natural Products

King & Spalding on

The United States Patent and Trademark Office issued on May 6, 2016, updated guidance to its patent Examiners that would have an impact on patent applications covering diagnostic methods and natural products. The new...more

Foley & Lardner LLP

USPTO Releases Patent Eligibility Update

Foley & Lardner LLP on

On May 4, 2016, the USPTO released a “May 2016 Subject Matter Eligibility Update” (“Update”) providing guidance to patent examiners on formulating a subject matter eligibility rejection and evaluating an applicant’s response...more

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

USPTO Issues Subject Matter Eligibility Update

On May 5, 2016, the USPTO published a Memorandum to the Patent Examining Corps titled “Formulating a Subject Matter Eligibility Rejection and Evaluating the Applicant’s Response to a Subject Matter Eligibility Rejection.” The...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

Three Pressing Challenges for Personalized Medicine

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Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

King & Spalding

Also In The News - Health Headlines - October 2015 #2

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HHS Publishes Final Federal Health IT Strategic Plan 2015-2020 – On September 21, 2015, the Office of the National Coordinator for Health Information Technology (ONC) of HHS laid out the federal government’s final version of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Patent Profile: Patent Issued for Method of Differentiating Pancreatic Cancer from Benign Pancreatic Disease

The U.S. Patent and Trademark Office recently issued U.S. Patent No. 8,632,983, which is entitled "Biomarkers for pancreatic cancer and diagnostic methods." The '983 patent, which is assigned to the Van Andel Research...more

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