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 -
News & Analysis as of

Health Alert (Australia) - October 12, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Australia. High Court 7 October 2015 - D'Arcy v Myriad Genetics Inc [2015] HCA 35 The High Court has unanimously...more

Life Sciences Alert: High Court of Australia unanimously decides that isolated genetic material is not patentable in Australia

In D'Arcy v Myriad Genetics Inc [2015] HCA 35 (D'Arcy v Myriad) the High Court of Australia has unanimously held (by way of three separate judgments: majority decision (French CJ, Kiefel, Bell, and Keane JJ) and two...more

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

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

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

Physiology/Medicine Nobels Awarded for Discoveries of “Natural Products”

In re Roslin Institute, a Fed. Cir. panel consisting of Judges Dyk, Moore and Wallach ruled that methods of isolating cffDNA were not patent eligible. Judge Dyk, writing for the panel endorsed the “markedly different”...more

Australia High Court Rules Against Gene Patents

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

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

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

High Court of Australia determines isolated BRCA1 gene not patentable in Australia

The High Court of Australia has unanimously overturned previous decisions from lower courts and has held that certain claims to Myriad's patent for isolated BRCA1 nucleic acid molecules are not patentable in Australia...more

Strong Support for Sequenom’s Petition for Rehearing En Banc

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

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

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

Further Guidance from the PTO

And yet diagnostic methods are still wandering in the wilderness… The PTO has issued yet another revision of its Subject Matter Eligibility Guidance for Examiners. The ?rst of these Guidance documents arrived in March...more

Federal Circuit’s Latest Patent Subject Matter Decision in Ariosa v. Sequenom Renders Many Biotech Patents at Risk

On June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., finding that Sequenom’s patent claiming methods of using cell-free fetal DNA (“cffDNA”) for prenatal diagnosis test is...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

News from Abroad: High Court of Australia Hears Myriad Appeal

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

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

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? [Video]

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

The ACLU, Working for the Man

The ACLU championed its efforts in the AMP v. Myriad case as being another instance of the group fighting for the rights of the many and the powerless against corporate America and the oligarchical few. In a paradox, it now...more

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

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 -- Update: (Or, and then there was one were none)

As discussed for the past month, Myriad has finally given up trying to defend its BRCA gene testing franchise. The one remaining matter, Myriad's case against GeneDx has settled, as announced by the company today....more

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

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...

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

Validity of Sequenom Patent Still to Be Decided

Although Sequenom has settled its dispute over U.S. Patent 6,258,540 with some parties, its case against Ariosa Diagnostics, Inc. remains active. Thus, we all should be waiting with bated breath to see whether the Federal...more

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