BRCA

News & Analysis as of

New Final Regulations and FAQs Provide Guidance on Preventive Services Coverage

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

Departments Issue Additional Guidance on Preventive Services

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

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

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

New FAQs Regarding Preventive Services Under Healthcare Reform McGuireWoods Healthcare Reform Guide: Installment No. 49

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

Quest Diagnostics and Inserm Launch BRCA Data-Sharing Initiative

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, 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

Myriad Set for Another Round

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

Patent Protection for Isolated Genetic Sequences Upheld in Australia

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

Breaking News – Full Federal Court Confirms Patentability of Isolated Genes

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

Myriad Appeals Adverse Preliminary Injunction Decision

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

Panel on Multidistrict Litigation Consolidates Myriad Cases in Utah District Court

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

District Court Doubts Patent Eligibility of Myriad BRCA Claims

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

Utah Judge Denies Myriad's Preliminary Injunction Motion

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

Gene-by-Gene Cries Uncle, Settles with Myriad Genetics

Gene-by-Gene, Inc. was one of the first direct-to-consumer (DTC) genetic diagnostics companies to announce that it would offer BRCA1/BRCA2 testing after the Supreme Court's decision last June that certain of Myriad Genetics'...more

Task Force Recommendation for BRCA-Related Genetic Testing

The U.S. Preventive Services Task Force (“USPSTF”) recently issued a report regarding the effectiveness of BRCA1/BRCA2 genetic tests for women and within the report, issued recommendations for preventive screening for women...more

Top Stories of 2013: #7 to #10

Reflecting upon the events of the past twelve months, Patent Docs presents its seventh annual list of top biotech/pharma patent stories. For 2013, we identified fourteen stories that were covered on Patent Docs last year...more

In Defense of Patenting

Fritz Machlup, an economist, once said that if we didn't have a patent system it would be irresponsible to recommend one, but since we have one, it would be irresponsible to abolish it. An Economic Review of the Patent...more

Myriad Genetics Sues LabCorp over BRCA Gene Testing

The very latest company targeted by Myriad Genetics for offering a genetic diagnostic test encompassing the human BRCA 1 and BRCA 2 genes is LabCorp (Laboratory Corporation of America), located in Burlington, North Carolina. ...more

Myriad Genetics Sues Invitae over BRCA Gene Testing and Invitae Sues Right Back

The latest company targeted by Myriad Genetics for offering a genetic diagnostic test encompassing the human BRCA 1 and BRCA 2 genes is Invitae Corp. located in San Francisco. Myriad sued Invitae on Monday in the District of...more

Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents

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

Diagnostics Giant Quest Files Declaratory Judgment Action against Myriad Genetics

Myriad is facing yet another challenge to its remaining BRCA gene testing franchise, this time from Quest Diagnostics joined by its R&D arm, Nichols Institute. Quest is "the world's leading provider of diagnostic information...more

Bay Area Genetic Diagnostics Company Files Declaratory Judgment Action against Myriad Genetics

Whether relying on Carl von Clausewitz or Jack Dempsey for the sentiment, Counsyl, Inc., a genetic diagnostic testing company has decided that the best defense against Myriad Genetics is a good offense and, accordingly, has...more

Preliminary Injunction in Myriad v. Ambry and Gene-by Gene: Myriad Replies

Not to be outdone by defendants Ambry Genetics and Gene-by-Gene's 109-page brief in opposition to Myriad's Preliminary Injunction Motion, Myriad has now filed a Reply Brief weighing in at 140 pages (page limits in briefs...more

Why Does Myriad Think It Can Win BRCA Gene Lawsuits?

Earlier this month, Myriad Genetics filed patent infringement lawsuits against Ambry Genetics (on July 9th) and Gene-by-Gene (on July 10th). Filed with the complaint in the Ambry lawsuit was a Motion for Preliminary...more

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