Pigs Return to Earth: Federal Circuit Reinstates Most—But Not All—of Myriad’s Patents

The Federal Circuit’s long-awaited decision (pdf) in Association for Molecular Pathology v. USPTO (the Myriad gene patent litigation) was issued this past Friday.  As we were writing, with the economy having slowed to a barely perceptible crawl and a government default looming more likely by the hour, there were plenty of reasons to believe that the sky was falling.  But the Myriad decision was not, and is not, one of them.

For the most part, the Federal Circuit’s 2-1 decision returned the law to the state it was in before District Judge Sweet’s opinion turned things upside-down last March.  Although full of interesting rhetoric, the court’s three lengthy opinions (a total of 105 pages) are less remarkable for what they decide than for what they invite higher authorities—the Supreme Court and the Congress—to decide down the road.

First, the scorecard.  The court’s judgment—that is, the holding, or outcome—was joined by Judges Lourie and Moore.  A third member of the panel, Judge Bryson, dissented in part, meaning that he joined only a portion of the judgment (more on that below) and disagreed with another part.


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Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Society, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

Newborn Blood Spot Litigation: 70 Days to Destroy 5+ Million Samples

Burned holeSometime in the next few months, Texas will destroy more than 5 million blood samples collected from newborn babies across the state over the past seven years. The lawsuit that led to this result—agreed to as part of a settlement reached between the state and a civil rights group representing a group of parents—illustrates a number of interesting points about the law and litigation of genetics issues.

As we discussed in A Closer Look at Biobanking of Newborn Blood Spots, states collect blood samples from most infants born in the United States each year, with the goal of detecting and treating a variety of potentially serious conditions. The Texas Department of State Health Services (DSHS) has been collecting newborn blood samples from babies born within the state since the 1960s. Texas currently tests for conditions including cystic fibrosis, endocrine disorders, fatty acid disorders, and others—28 disorders in all (pdf). At least some of the samples are apparently subjected to genetic testing for hemoglobinopathy, phenylketonuria, and galactosemia.


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Filed under Biobanking, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Informed Consent, Pending Litigation, Pending Regulation, Privacy