On August 30, 2023, a Hawaii court ruled on 3M’s motion to compel blood sampling for the purposes of genetic testing in an asbestos matter. Hawaii First Circuit Judge James H. Ashford granted 3M’s motion in the McCabe v. 3M...more
The advent of 23andMe, ancestryDNA, and other direct-to- consumer genetic testing products permit patients, from the comfort of their own homes and personal computers, to identify and assess their unique risk of developing...more
On March 6, 2018, the U.S. Food and Drug Administration (“FDA”) authorized, with special controls, the first direct-to-consumer test to detect the presence of genetic mutations in the BRCA1 and BRCA2 genes (“BRCA genes”). ...more
Salt Lake City-based Myriad Genetics, Inc. announced that its BRACAnalysis CDx® test accurately identifies patients with ovarian cancer for a second-line treatment with olaparib. The announcement came as a result of a...more
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
The United States Patent And Trademark Office (USPTO) issued a memorandum on May 4, 2016 (May 2016 Memo) to the Patent Examining Corps to provide further Examiner instructions relating to subject matter eligibility under 35...more
The collective experience of the Members of the Coalition for 21st Century Medicine in trying to obtain much needed patent protection for their novel, life-saving technologies has led to one inescapable conclusion: It is...more
One of the effective arguments made by the ACLU in the AMP v. Myriad case was that somehow permitting patents on genes implicated a patient's privacy right in her genetic material. This was also the theme of their public...more
This is the 54th in a series of WorkCite articles concerning the Patient Protection and Affordable Care Act and its companion statute, the Health Care and Education Reconciliation Act of 2010 (referred to collectively as the...more
On October 23, the U.S. Department of Labor, the Department of Health and Human Services, and the Department of the Treasury (collectively, the “Departments”) jointly issued answers to frequently asked questions regarding the...more
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
Through new FAQs and final regulations, the U.S. Departments of Labor (“DOL”), Health and Human Services (“HHS”) and the Treasury (the “Departments”) have further clarified various issues related to the preventive care...more
The Departments of Labor (DOL), Health and Human Services (HHS), and Treasury (collectively, the Departments) issued guidance in the form of FAQs on the ACA’s preventive services mandate. The ACA requires non-grandfathered...more
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
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
This is the 49th in a series of WorkCite articles concerning the Patient Protection and Affordable Care Act and its companion statute, the Health Care and Education Reconciliation Act of 2010 (referred to collectively as the...more
Last week, diagnostics services provider Quest Diagnostics and Inserm, the French National Institute of Health and Medical Research institution, announced the launch of BRCA Share, a new datashare initiative that will provide...more
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
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
Last year in AMP v Myriad Genetics, the U.S. Supreme Court concluded that isolated, naturally occuring DNA are not patent eligible, which caused considerable consternation in the biotech community. However, this does not...more
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
On March 13, Myriad Genetics filed a Notice of (interlocutory) Appeal with the Federal Circuit. Myriad is seeking to have the Court review and reverse the District Court's denial of the company's preliminary jnjunction...more
The old adage "Be careful what you wish for" comes to mind regarding Myriad Genetics' motion to the Judicial Panel on Multidistrict Litigation under 28 U.S.C. § 1407, that cases relating to the company's BRCA gene patents be...more
In a decision issued March 10, 2014, Judge Shelby of the U.S. District Court for the District of Utah denied Myriad’s motion for a preliminary injunction against Ambry Genetics Corp. While Ambry had challenged the validity of...more
In a 106-page opinion, U.S. District Court Judge Robert J. Shelby on Monday denied Myriad Genetics motion for preliminary injunction in Myriad Genetics v. Ambry Genetics. Characteristic of its aggressive defense of its...more