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Myriad Finally Reaches the Supreme Court (But Only For a Moment)
Yesterday, the Supreme Court (as we predicted last week that it might) GVR’d the certiorari petitions (pdf) of both parties in the Myriad Genetics case. Big news, right? Not really. What this means is...
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Applying Mayo to Myriad: Latest Decision Brings No New News (Plus: Why the...
The latest chapter in the Myriad gene patent litigation was written yesterday, with the Federal Circuit issuing its much anticipated opinion (pdf) after rehearing the case following the Supreme Court’s...
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Supreme Court to Rule on Patentability of Human Genes
Robert Cook-Deegan contributed to this commentary. Dr. Cook-Deegan is a research professor in the Institute for Genome Sciences and Policy and the Sanford School of Public Policy at Duke University....
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Some Thoughts on Myriad After the Supreme Court Argument
On April 15, the Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics. This was another significant step—probably the penultimate one—in the long-running Myriad...
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Monsanto: Planting the Seeds of Discord
Few patent cases in recent years have provoked as much public outcry as Bowman v. Monsanto Co. (pdf) —in fact, I’d rank it second behind only Myriad. The case concerns Monsanto’s right to control...
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Myriad, Finally: Supreme Court Surprises by not Surprising
After what seemed like an eternity, the epic saga known as AMP v. Myriad Genetics has finally come to a close. On June 13, 2013, the Supreme Court ruled (1) that isolated genomic DNA (gDNA) is not...
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Undeterred by the Supreme Court, Myriad Starts Suing
As soon as the Supreme Court issued its decision in AMP v. Myriad Genetics, Myriad issued public statements saying that it had many surviving patents that would perpetuate its BRCA testing monopoly. We...
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The ACMG Gene Screening Recommendations
In March, the American College of Medical Genetics and Genomics (ACMG) released its much-anticipated Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing. The...
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Readers Respond to ACMG Recommendations Post
The GLR received some interesting comments on my recent post about the American College of Medical Genetics Gene Screening Recommendations. Here are two of the comments. As we are still in the early...
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Myriad Back in Court Again — This Time as a Defendant
Myriad Genetics is once again embroiled in litigation over its BRCA-related patents. But this time Myriad is the defendant. Counsyl, Inc., a San Francisco-based company that focuses on genetic carrier...
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If 23andMe Falls in the Forest, and There’s No One There . . .
Genomics Law Report has paid close attention to the FDA’s potential regulation of laboratory developed tests (or LDTs) over the years. We have decided to address the most recent development – a cease...
View ArticleReader Response . . .
James P. Evans, Bryson Distinguished Professor of Genetics & Medicine and Editor-in-Chief of Genetics in Medicine, responds to my post on the FDC “warning letter” to 23andMe: I liked your piece –...
View ArticleThe Revolt of the Cs: Class Action Filed Against 23and Me
The “Cs” in DTC have revolted, in the form of a consumer class action filed November 27, 2013, in a California federal court (Case 3:13-cv-02847-H-JMA). The suit, called Casey v. 23andMe, alleges that...
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District Court Denies Myriad’s Preliminary Injunction Against Ambry
In a 106-page opinion issued on March 10, 2014, Judge Robert Shelby of the federal district court in Salt Lake City denied Myriad Genetics’ Motion for Preliminary Injunction in its lawsuit against...
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ACMG Backs Down a Bit
A year ago, the American College of Medical Genetics and Genomics (ACMG) released its Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing. As I reported in a...
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New Article on Myriad Litigation and the Company’s Evolving Strategy
GLR editor John Conley has just co-authored a new article in the North Carolina Journal of law & Technology about Myriad Genetics’ response to last summer’s Supreme Court case that invalidated its...
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Medical Organizations Can’t Shape the Rules for Admitting Expert Testimony
A little more than a year ago I wrote a post about the then-new Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing from the American College of Medical...
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Conley Q & A on LDTs and the FDA
In her recent post on the FDA’s draft guidance on its proposed oversight of Laboratory Developed Tests (LDTs), Jen Wagner mentioned my interview with Genome Web’s Turna Ray on January 15, 2015. Turna...
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Are Software Patents Dead?—Alice’s Implications for Life Sciences
Not too long ago, getting patents on software and business methods was all the rage. And concern about their effects was profound. In fact, in 2003 I spoke at a Federal Reserve Bank conference devoted...
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How Privacy Law Affects Medical and Scientific Research
Over the last five or so years my law practice has focused increasingly on privacy law, both domestic and international. In hindsight, this was a predictable outcome: as an intellectual property...
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