Robinson Bradshaw

Topic: BRCA-2

Myriad Updates: Clinical Data as Trade Secrets and a Pending Certiorari Decision

Earlier this month, my colleagues John Conley, Robert Cook-Deegan, James Evans and I published a policy article in the European Journal of Human Genetics (EJHG) entitled “The next controversy in genetic testing: clinical data as trade secrets.” The EJHG article is open access so you can read the entire article at the EJHG website, but here […]

Applying Mayo to Myriad: Latest Decision Brings No New News (Plus: Why the Final Myriad Decision Might Not Matter for Personalized Medicine)

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 unanimous decision earlier this year in Prometheus v. Mayo. Or perhaps we should say that the latest chapter was “rewritten” as, in a move that […]

Weekly Roundup: UK Insurance Genetics Moratorium Renewed & Breast Cancer Patents, Research in the News

With so many developments at the intersection of genomics and the law, there is often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. In this post we recap several recent key developments and, at bottom, round up all of the […]

How Will Myriad Respond to the Next Generation of BRCA Testing?

Robert Cook-Deegan contributed to this commentary. Dr. Cook-Deegan is Director of the Center for Genome Ethics, Law & Policy at Duke University Institute for Genome Sciences and Policy’s and is currently on leave at the Fondation Brocher in Hermance, Switzerland. The past few months have brought a number of significant research and commercial developments in the BRCA […]

Personalized Medicine Regulation Needs More Than Band-Aids

[Editor’s Note: This post originally appeared as a guest column at Xconomy.] Last week, New York State assemblyman J. Gary Pretlow introduced the descriptively named “act to amend the insurance law, in relation to requiring coverage for genetic testing in accident and health insurance polices.” While not accompanied by a press release, or widely covered […]

Swine Soar Higher in Myriad Thanks to US Government’s Amicus Brief

This past March Judge Robert Sweet handed down an unexpected summary judgment ruling in the Myriad gene patent litigation (see: Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims). Myriad quickly appealed Sweet’s district court decision to the Court of Appeals for the Federal Circuit (CAFC). After several months of courtroom quiet, the briefs began rolling […]

A Do-It-Yourself Genomic Challenge to Myriad, the FDA and the Future of Genetic Tests

Over the weekend, Steven L. Salzberg and Mihaela Pertea published a short but significant article in the journal Genome Biology. In “Do-it-yourself genetic testing,” Salzberg and Pertea describe the creation of “a computational screen that tests an individual’s genome for mutations in the BRCA genes, despite the fact that both are currently protected by patents.” […]

Update: Continued Speculation on Myriad’s Motives Down Under

Last week, we wondered what Myriad Genetics had in mind by offering to surrender one of its Australian breast cancer patents as a “gift…to the people of Australia.” This week, in an interview with Turna Ray of the Pharmacogenomics Reporter, Luigi Palombi, director of the Genetic Sequence Right Project at The Australian National University, attempted […]

Surrendering a Gene Patent: An International Twist in Myriad Debate

Several months ago we reported that a group of Australian plaintiffs had initiated litigation challenging the validity of Myriad’s Australian BRCA patents. Much like its U.S. counterpart, the Australian lawsuit represents a frontal attack on the patentability of genes. Here in the U.S., the gene patent litigation shows no signs of reaching a swift resolution. Over […]

Pigs Fly: Federal Court Invalidates Myriad’s Patent Claims

Late on the afternoon of Monday, March 29, 2010, Judge Robert W. Sweet of the United States District Court for the Southern District of New York issued a jaw-dropping summary judgment ruling (pdf) in Association for Molecular Pathology v. USPTO that invalidates certain of Myriad Genetics’ patents related to the BRCA 1 and 2 breast […]