ACLU and Myriad Both Seek Further Federal Circuit Review
As we suspected they might, the plaintiffs in Association for Molecular Pathology v. Myriad Genetics have filed a petition (pdf) seeking a rehearing of the recent federal Circuit decision. More surprisingly, Myriad has also, though its petition (pdf) is very narrowly focused.
The Plaintiffs’ Petition. Two things are interesting about the plaintiffs’ petition from a procedural standpoint. First, the ACLU lawyers requested rehearing by the three-judge panel that decided the case earlier this summer, not en banc rehearing by all members of the court. (But a majority of the judges of the full court could still decide to rehear the case en banc; they could do so if they found that the case “involves a question of exceptional importance.”) Second, the plaintiffs have asked for rehearing on only two of the issues they lost: that isolated genes are proper subject matter for product patents, and that only one of the named plaintiffs—Dr. Harry Ostrer, formerly of NYU—has standing to bring the case. The plaintiffs did not challenge that portion of the panel’s decision that upheld—unanimously—Myriad’s patents on a method of screening potential cancer therapeutics.
Does Familiarity Breed Acceptance? New Program Encourages Young Doctors to Get Personal with DTC Genomics.
The Genomics Law Report launched its new series What ELSI is New? yesterday with guest commentaries from Hank Greely and Misha Angrist. One of the issues that both Greely and Angrist tackle—from different angles and with decidedly different styles—is the widely acknowledged shortage of health care professionals qualified to understand and interpret genomic information of increasing prevalence and complexity.
By sheer coincidence, yesterday’s Boston Globe profiled a new program at Beth Israel Deaconess Medical Center that invites pathology residents to learn about DTC genetic testing in a novel way: by becoming customers themselves.
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A Closer Look at Biobanking of Newborn Blood Spots
Under established state public health programs, hospitals nationwide collect blood samples from the majority of the more than 4 million U.S. newborns each year to screen for genetic and metabolic disorders. This is widely viewed as a valuable program that can lead to early diagnosis and treatment of potentially serious conditions and is normally controversial only when the parents object to testing.
At present, although there is some national coordination of newborn screening programs, there is no uniform policy governing the disposition of newborn blood samples after screening is complete. Some states store the samples for a limited period of time and then discard them. Others, including Minnesota and Michigan, permit researchers to use the samples, including to conduct pilot studies designed to develop additional newborn screening tests. Michigan is even facilitating (although not funding) the development of a “Neonatal BioTrust” in the hopes of drawing biomedical companies to the state.
And additional guidance from the federal government is likely forthcoming. Late last year the National Institute of Child Health and Human Development, a division of the National Institutes of Health (NIH), awarded the American College of Medical Genetics (ACMG) a $13.5 million, 5-year contract for the development of a National Newborn Screening Translational Research Network. One of the network’s many aims is to facilitate the creation of a “reliable repository of residual dried bloodspots that is either virtual or physical and comprised of those stored by state newborn screening programs and other resources.”
