Robinson Bradshaw

Topic: Myriad Genetics

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 […]

Government Refuses to March-In Under Bayh-Dole—Again

The Bayh-Dole Act was in the news at the end of 2010. Three patients suffering from Fabry disease, a rare genetic condition that impairs the victim’s ability to metabolize fat and can lead to kidney failure and heart disease, petitioned the National Institutes of Health (NIH) to exercise the government’s “march-in” rights under Bayh-Dole (pdf) […]

Prometheus Unbound—Again

The latest news from the field of biotechnology patents is in: the Federal Circuit has handed down its opinion (again) in Prometheus v. Mayo (pdf), the closely watched diagnostic method case. The verdict is the same as before: Prometheus’s patents satisfy the § 101 test for patentable subject matter. On Monday, we wrote about the Federal Circuit’s […]

Restricting Gene Patents: A Pro-Market Agenda

This commentary is contributed by James P. Evans, clinical professor genetics and medicine at the University of North Carolina and Editor-in-Chief of Genetics in Medicine. Gene patents have been controversial since they were first granted in the US over two decades ago. The controversy is now reaching a fevered pitch after a surprising US District […]

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 […]

Induced Infringement Heads to Supreme Court Amid Myriad Takeover Speculation

On Monday we wrote about the Salzberg Screen—a do-it-yourself alternative to Myriad’s BRACAnalysis test to identify deleterious mutations in the BRCA genes. We wondered whether the Salzberg Screen, which is intended to allow users to “circumvent [Myriad’s] gene patents,” could expose its designers to indirect patent infringement liability. In a related development, this week the […]

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 […]

Swine Still Soaring: Federal Circuit Judge Expresses Sympathy for Myriad Analysis

Back in March, we headlined our discussion of the district court judgment in the Myriad case “Pigs Fly.” Guess what?—they’re still aloft. On August 4, in a highly technical patent case that, appropriately enough, involved “porcine virus DNA,” one Federal Circuit judge—dissenting Judge Timothy B. Dyk—suggested that he might agree with the basic principle of […]