News & Analysis as of September 21, 2024

Genetic Materials

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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 -

Current State of Patent Eligibility and Potential Reform

Downs Rachlin Martin PLLC on 7/9/2019

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

News from Abroad: IP Australia Releases Myriad Examination Guidelines

McDonnell Boehnen Hulbert & Berghoff LLP on 1/14/2016

Following the recent public consultation in view of the Australian High Court's decision in D'Arcy v Myriad Genetics ("Myriad"), IP Australia has released new Examination Guidelines for applications which may be affected by...more

News from Abroad: Australian High Court Has Ruled in Myriad Gene Patent Case

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

The Australian High Court yesterday unanimously overturned six lower court judges and dismissed some very careful reasoning to not only follow the U.S. Supreme Court in invalidating claims to the BRCA1 and 2 gene sequences,...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

News from Abroad: Isolated Nucleic Acids Not Patentable in Australia

McDonnell Boehnen Hulbert & Berghoff LLP on 10/8/2015

D'Arcy v. Myriad Genetics Inc & Anor [2015] HCA 35 - The High Court of Australia today handed down its decision in D'Arcy v Myriad, deciding once and for all that isolated nucleic acids do not define patent-eligible...more

News from Abroad: Isolated Gene Sequences Suffer A Cruel Fate in the Hands of the High Court of Australia

McDonnell Boehnen Hulbert & Berghoff LLP on 10/8/2015

D'Arcy v Myriad Genetics Inc [2015] HCA 35 - The High Court of Australia has today handed down its decision in D'Arcy v Myriad Genetics Inc [2015] HCA 35, unanimously striking down the validity of the first three claims...more

News from Abroad: High Court of Australia Hears Myriad Appeal

McDonnell Boehnen Hulbert & Berghoff LLP on 6/17/2015

The High Court of Australia today heard the long anticipated appeal from the unanimous decision of a 5-judge bench of the Full Federal Court to allow Myriad's claims to isolated nucleic acids. The question before the...more

Game Over for Myriad - (Or, and then there was one)

McDonnell Boehnen Hulbert & Berghoff LLP on 2/11/2015

As discussed at the end of January, Myriad has given up its Quixotic quest to validate its BRCA gene testing franchise and has abandoned its several lawsuits (many of which were consolidated before the District of Utah under...more

Federal Circuit to Myriad: Neither DNA Primers nor Comparing Gene Sequences Are Patent-Eligible Subject Matter - In re BRCA1- and...

McDermott Will & Emery on 2/5/2015

In the latest decision addressing the patentability of Myriad’s BRCA1- and BRCA2-related patents, the U. S. Court of Appeals for the Federal Circuit invalidated a number of Myriad’s composition of matter claims and method...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

An Early Test for the USPTO’S Eligibility Analysis

Foley & Lardner LLP on 12/23/2014

Just last week, the USPTO released its revised subject matter eligibility guidance (2014 Interim Guidance on Patent Subject Matter Eligibility “Interim Guidance” reviewed in my prior post of December 16th, 2014). The Interim...more

Myriad Set for Another Round

Foley & Lardner LLP on 9/30/2014

On Monday October 6th, the U.S. Court of Appeals for the Federal Circuit will entertain oral argument in another case involving Myriad’s BRCA1/BRCA2 diagnostic tests. In re BRCA1- and BRCA2- Based Hereditary Cancer Test...more

Australia Upholds Patent Eligibility of Isolated DNA

Foley & Lardner LLP on 9/9/2014

The Full Federal Court of Australia affirmed that isolated nucleic acids, i.e. whether it be DNA or RNA, are patentable subject matter in Australia. While an appeal to the High Court of Australia may be possible, absent an...more

Breaking News – Full Federal Court Confirms Patentability of Isolated Genes

K&L Gates LLP on 9/5/2014

A five-judge bench of the Full Court of the Federal Court of Australia (Full Court) has today unanimously decided that Myriad Genetics Inc's (Myriad) patent covering the isolated BRCA1 gene (Patent) is patentable subject...more

Docs @ BIO: USPTO Provides Update on Myriad-Mayo Guidance

McDonnell Boehnen Hulbert & Berghoff LLP on 7/2/2014

At last week's BIO International Convention in San Diego, Andrew Hirshfeld, USPTO Deputy Commissioner for Patent Examination Policy, and June Cohan, a Legal Advisor with the USPTO's Office of Patent Legal Administration, took...more

Guest Post: Myriad -- An Obvious and Patent-Friendly Interpretation

McDonnell Boehnen Hulbert & Berghoff LLP on 6/5/2014

MyriadIs Myriad truly authority for the proposition that naturally occurring nucleic acid sequences and a host of other naturally occurring materials are no longer patent-eligible? Was it really the intention of the Supreme...more

In re Roslin Institute (Fed. Cir. 2014) - Dolly the Sheep Not Patent Eligible Subject Matter

McDonnell Boehnen Hulbert & Berghoff LLP on 5/9/2014

Earlier today, the Federal Circuit affirmed a determination by the Patent Trial and Appeal Board affirming the rejection of claims 155-159 and 164 of U.S. Application No. 09/225,233 as being directed to unpatentable subject...more

Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents

McDonnell Boehnen Hulbert & Berghoff LLP on 10/22/2013

After a brief hiatus that saw Counsyl and Quest Diagnostics file declaratory judgment actions in alternate venues, Myriad has filed yet another lawsuit against a genetic diagnostics company that brought its own BRCA gene...more

Genes and Information: The Problem of Disease-specific Databases

McDonnell Boehnen Hulbert & Berghoff LLP on 10/16/2013

One of the many untruthful positions taken by the ACLU in the AMP v. Myriad Genetics case was that DNA is merely information, like a computer program, and as such Myriad's patent claims were invalid as reciting...more

Myriad Preliminary Injunction Hearing to Be Held September 11, 2013

Foley & Lardner LLP on 9/9/2013

The hearing on Myriad’s motion for a preliminary injunction against Ambry Genetics is scheduled for September 11, 2013, before Judge Robert A. Shelby at the U.S. District Court for the Central District of Utah....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

Myriad’s Trade Secret Trump Card: The Myriad Database of Genetic Variants

Foley & Lardner LLP on 7/18/2013

One of the most interesting arguments that Myriad made in its Motion for Preliminary Injunctive Relief in its infringement action against Ambry Genetics Corporation relates to the database of genetic information that Myriad...more

The Future Of Patentable DNA: A Myriad Of Possibilities

Polsinelli on 7/9/2013

In This Issue: - Summary - Case Analysis - Implications ..Prokaryotic Nucleic Acid Sequences ..Short Segments of Eukaryotic DNA ..Promoters/Regulatory regions ..Isolated Proteins ...more

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