News & Analysis as of September 19, 2024

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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... more +

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 -

Federal Circuit Weighs In On Patent Eligibility Of Isolated Vitamin

Foley & Lardner LLP on 2/23/2023

It has been a while since the Federal Circuit weighed in on the patent eligibility of so-called “natural product” claims. While the finding of non-eligibility in ChromaDex, Inc. v. Elysium Health, Inc. is not surprising, it...more

Story Telling

McDonnell Boehnen Hulbert & Berghoff LLP on 3/29/2020

Patent law (and, consequently, patent lawyers) can be viewed as having at least a slightly tighter tether on concrete, factual reality than other areas of the law, at least to the extent that making patent-related legal...more

Illumina, Inc. v. Ariosa Diagnostics, Inc. (Fed. Cir. 2020)

McDonnell Boehnen Hulbert & Berghoff LLP on 3/20/2020

The latest Federal Circuit decision on subject matter eligibility in the life sciences came down (by a divided court) in favor of eligibility, in Illumina, Inc. v. Ariosa Diagnostics, Inc. The claims at issue fell into the...more

A Step-by-Step Approach to Patent Subject Matter Eligibility Reform

McDonnell Boehnen Hulbert & Berghoff LLP on 2/19/2020

There is a belief in some quarters that the most significant barrier to patent subject matter eligibility reform is an implacable opposition by companies in the high tech sector because those companies are convinced that the...more

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

Patent Eligibility for “Natural” Food and Beverage Ingredients and Products

King & Spalding on 8/29/2018

Since the Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), there has been considerable uncertainty regarding what constitutes patentable subject matter. In a...more

Sections 101 and 112: Eligibility, Patentability, or Somewhere in Between?

Womble Bond Dickinson on 3/24/2017

We wrote earlier about the Supreme Court’s renewed interest in patent eligibility and seemingly unintended confusion between the patent eligibility requirements of 35 U.S.C. § 101 and the remaining patentability requirements...more

Patent Rights in the U.S.: Is the Pendulum Finally Swinging Back to Center?

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 9/30/2016

The U.S. patent system has long struggled to strike a balance that both encourages patent rights and prevents patent abuse. Finding that balance requires giving patent owners the right amount of patent enforcement power,...more

Top Stories of 2015: #11 to #15

McDonnell Boehnen Hulbert & Berghoff LLP on 1/5/2016

After reflecting upon the events of the past twelve months, Patent Docs presents its ninth annual list of top patent stories. For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe...more

Does a Nucleic Acid Constitute Patent Eligible Subject Matter Under Australian Law?

JD Supra Perspectives on 10/18/2015

Clearly the High Court has given an answer to a question, but was that question the one we anticipated? That in itself is an open question!...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: 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

Strong Support for Sequenom’s Petition for Rehearing En Banc

Patterson Belknap Webb & Tyler LLP on 9/10/2015

In Ariosa Diagnostics Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015), a Federal Circuit panel held that Sequenom Inc.’s prenatal diagnosis patent claims patent ineligible subject matter under the two-step test of Mayo...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

Sequenom Seeks Rehearing En Banc

Foley & Lardner LLP on 8/18/2015

Sequenom, Inc. has filed a petition for rehearing en banc of the Federal Circuit decision that held its diagnostic method claims invalid under 35 USC § 101. (You can read my synopsis of that decision here). Stakeholders in...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

Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

Foley & Lardner LLP on 6/15/2015

On Friday, June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court's finding that Sequenom’s claims are invalid under 35 USC § 101. The court's...more

Koepsell and Noonan on Gene Patenting

McDonnell Boehnen Hulbert & Berghoff LLP on 5/29/2015

In 2009, the first edition of Dr. David Koepsell's book "Who Owns You: The Corporate Gold Rush to Patent Your Genes" was published. With the second edition of his text about to be published, Dr. Koepsell allowed Patent Docs...more

Is Biotech Patentable Subject Matter?

Robins Kaplan LLP on 4/28/2015

The issue of patent eligibility has been a hotly litigated issue in the field of intellectual property law, and both the Federal Circuit and the Supreme Court have issued numerous decisions in recent years--particularly in...more

Protecting food industry innovations as the scope of patentable subject matter narrows

Snell & Wilmer on 3/24/2015

Strong intellectual property increases the value of a company. Copyrights, trademarks, patents, and trade secrets are some avenues to protect intellectual property, but understanding when they’re available and understanding...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

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