News & Analysis as of September 18, 2024

Supreme Court of the United States

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Myriad Genetics is a publicly-traded molecular diagnostic company headquartered in Salt Lake City, Utah. Myriad's business model centers around isolating particular genes and determining their role in the development and progression of disease. Myriad's patenting practices have elicited considerable controversy with many opponents charging that Myriad cannot rightfully patent human genes. Opponents argue that human genes are naturally occurring and not patent-eligible subject matter. Myriad counters that the practice of isolating genes is a process distinct from the genes themselves and thus, is patentable. The U.S. Supreme Court is currently considering the validity of Myriad's patents in AMP v. Myriad Genetics. less -

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

McDonnell Boehnen Hulbert & Berghoff LLP on 9/14/2023

In those (in retrospect) halcyon days more than a decade ago (before Mayo, Myriad, Alice, and the subject matter eligibility quagmire arose), perhaps the most significant Supreme Court decision was KSR Int'l Co. v. Teleflex...more

Justice Barrett to Bring Clarity to Patent Eligibility Law?

Fenwick & West LLP on 2/26/2021

Each time the U.S. Supreme Court has addressed patent eligibility, the law surrounding what can and cannot be patented has become murkier. Most recently, the wake of the Supreme Court’s Alice ruling has led to irreconcilable...more

Can we patent products found in nature? It's complicated. An update on Australia's Myriad decision...

JD Supra Perspectives on 10/19/2015

It remains to be seen if this new Myriad decision in Australia will be extended as it was in the U.S. to prevent virtually any product found in nature from being patented....more

Australian High Court Rules Gene Patents Unpatentable

BakerHostetler on 10/14/2015

Like the United States Supreme Court, the High Court of Australia has determined that Myriad’s patents directed to purified and isolated DNA molecules encoding the BRCA genes are unpatentable. Indeed, the Australian Court...more

News from Abroad: High Court Rules Myriad's BRCA Genes Not Patentable Subject Matter in Australia

McDonnell Boehnen Hulbert & Berghoff LLP on 10/9/2015

Just over one year after the Full Federal Court of Australia unanimously upheld an earlier Federal Court decision that naturally occurring nucleic acid molecules are patentable in Australia, the High Court of Australia has...more

Australia High Court Rules Against Gene Patents

Foley & Lardner LLP on 10/9/2015

Colleagues in Australia have been spreading the bad news: The High Court of Australia followed the lead (?) of the U.S. Supreme Court and determined that Myriad cannot patent the isolated BRCA1 gene in Australia. Thanks to...more

Protecting Diagnostic Innovation – Two Actor Infringement Liability

Foley & Lardner LLP on 8/25/2015

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

Can Any DNA Claims Still Be Patented?

Foley & Lardner LLP on 1/22/2015

In a decision issued December 17, 2014, in In Re BRCA1- And BRCA2-Based Hereditary Cancer Test Patent Litigation (Myriad II), the Federal Circuit invalidated Myriad’s primer claims and detection method claims under 35 USC §...more

The USPTO Patent Subject Matter Eligibility Guidance TRIPS Over Treaty Requirements

Foley & Lardner LLP on 7/30/2014

The “Myriad-Mayo” patent subject matter eligibility guidance issued March 4, 2014 reflects the USPTO’s interpretation of Supreme Court cases interpreting and applying 35 USC § 101 to claims involving laws of nature, natural...more

Why Are Method of Treatment Claims and Method of Manufacture Claims Subject to Scrutiny Under the USPTO Patent Subject Matter...

Foley & Lardner LLP on 7/16/2014

The USPTO has asked for written comments on its patent subject matter eligibility guidance by July 31, 2014. In this article, I discuss why therapeutic method claims and method of manufacture claims should not be subject to...more

Docs @ BIO: The Rest of the Story - Bloomberg BNA Hosts Panel on Subject Matter Eligibility

McDonnell Boehnen Hulbert & Berghoff LLP on 7/9/2014

Last month at the BIO convention, Randy Kubetin, Managing Editor of Bloomberg BNA's Life Sciences Law & Industry Report moderated a panel entitled "Patent Eligibility from the Trenches: Practical Implications of the Supreme...more

Federal Circuit Dismisses WARF Stem Cell Case – A Missed Opportunity

Foley & Lardner LLP on 6/16/2014

Recently in Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 2013-1377 (Fed. Cir. 2014), the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) dismissed Appellant Consumer Watchdog’s appeal on the...more

USPTO Holds Forum on Subject Matter Eligibility -- Part II

McDonnell Boehnen Hulbert & Berghoff LLP on 5/15/2014

Last Friday, the U.S. Patent and Trademark Office held a four-hour long forum to receive public feedback on the Myriad-Mayo Guidance, which was issued by the Office on March 4. According to the Office's Guidance webpage, the...more

USPTO Holds Forum on Subject Matter Eligibility -- Part I

McDonnell Boehnen Hulbert & Berghoff LLP on 5/13/2014

Update From the May 9, 2014 USPTO Patent Eligibility Guidelines Forum

Foley & Lardner LLP on 5/12/2014

On May 9, 2014, the USPTO hosted a forum to receive public feedback on the patent subject matter eligibility guidance for examiners circulated on March 4, 2014. The USPTO heard formal presentations from ten speakers...more

Patent-Eligibility of Stem Cells Under New USPTO "Myriad-Mayo" Guidance

Foley & Lardner LLP on 4/29/2014

In March, the U.S. Patent and Trademark Office (USPTO) implemented new procedures to address whether inventions that relate in whole or in part to laws of nature and naturally occurring products are patent-eligibility in...more

Thoughts on the USPTO's Patent Eligibility Guidelines (and What to Do About Them)

McDonnell Boehnen Hulbert & Berghoff LLP on 3/19/2014

The U.S. Patent and Trademark Office recently issued (without public notice or opportunity to comment) its interpretation of the standards for subject matter eligibility in view of the Supreme Court's recent decisions in Mayo...more

USPTO Issues Guidance for Examining Process Patents

Foley & Lardner LLP on 3/7/2014

On March 4th, 2014, the U.S. Patent and Trademark Office (USPTO) issued “2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or...more

USPTO to Apply Myriad Beyond Isolated DNA

Foley & Lardner LLP on 3/5/2014

Today, the United States Patent and Trademark Office (“USPTO”) issued a Guidance, advising examiners and the public of the factors for determining whether an invention satisfies the U.S. Supreme Court’s interpretation of 35...more

Ambry Responds to Myriad Lawsuit

McDonnell Boehnen Hulbert & Berghoff LLP on 8/8/2013

Asserts Affirmative Defenses and Antitrust Counterclaims and Asks for Declaratory Judgment - On Monday Ambry filed its Answer to Myriad's complaint for patent infringement, and asserted patent misuse as an affirmative...more

The Real Impact for Healthcare and Biotechnology of the Supreme Court's Decision in Myriad Genetics

Bradley Arant Boult Cummings LLP on 7/19/2013

On June 13, 2013, the Supreme Court issued a decision supposedly resolving the patentability of DNA in Association for Molecular Pathology v. Myriad Genetics. Immediately, all parties on both sides of the case declared...more

Post-Myriad Strategies for Claiming Biotech Inventions in the United States

Akerman LLP on 7/16/2013

The United States Supreme Court recently ruled that genes or other naturally-occurring pieces of DNA are patent ineligible subject matter in Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. No....more

Intellectual Property Newsletter - June 2013

King & Spalding on 7/10/2013

In This Issue: *News from the Bench - Unanimous Supreme Court Ruling on Gene Patentability: Natural DNA “No”/ cDNA “Yes” - CAFC Reverses Denial of Permanent Injunction Based on Perceived Future...more

IP Update, Vol. 16, No. 6, June 2013

McDermott Will & Emery on 6/27/2013

Patents / Patent Eligible Subject Matter - Supreme Court to Myriad: Isolated DNA Sequences Are Not Patent-Eligible Subject Matter -- AMP et al. v. Myriad Genetics, Inc.: In a 9–0 decision the Supreme...more

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