Genomic Policymaking
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 drama. It began with a group of plaintiffs (including researchers, doctors, and breast cancer patients) joining an American Civil Liberties Union-organized lawsuit to invalidate Myriad’s patents on two breast cancer susceptibility genes (BRCA1 and 2) as well as patents on methods of interpreting genetic test results and testing anti-cancer drug efficacy. In a shocking decision, the federal district court in New York threw out all of Myriad’s patents. The Federal Circuit then reversed the district court’s rulings on the gene patents, with the three-judge panel holding unanimously that cDNA is patentable subject matter and holding 2-1 that isolated genomic DNA is patentable as well. The Federal Circuit affirmed the district court’s ruling that Myriad’s methods of interpreting mutations are not patentable, but reversed it in reinstating Myriad’s claims to methods of testing drug efficacy.
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House Holds mHealth Hearings, FDA Promises Final Guidance Forthcoming
Three days of hearings by a House of Representatives committee concluded yesterday with a pledge from an FDA official to finalize long-awaited guidance on the regulation of mobile medical applications “in coming weeks“; at the latest by the end of the FDA’s fiscal year (i.e., September 30th).
The hearings, convened jointly by several subcommittees of the House Energy and Commerce Committee, were announced last week following a pointed letter to the FDA (pdf) from seven committee members on March 1st. In the letter, the Congressmen pressed the FDA for information on the agency’s mHealth regulatory timeline and the implications for innovation and industry of the proposed regulations.
A Preview of Guidance to Come. As covered previously here at the Genomics Law Report, in July 2011 the FDA released draft guidance (pdf) outlining its intent to regulate a limited subset of mobile medical applications based on their perceived risk to patients and consumers.
The FDA, Social Media & Consumer Genomics: A Lot Not to “Like”
Last week, the FDA published on its website a warning letter to AMARC Enterprises, Inc., a marketer of a dietary supplement known as Poly-MVA. (Here is the company’s description of the supplement.) While the letter is not addressed to a high-profile company or product, given that the FDA’s action will likely have broader significance beyond just AMARC and its Poly-MVA supplement, all currently or potentially FDA-regulated entities, including consumer genomics companies, should take note.
The AMARC letter, issued by a regional compliance office and dating to this past December, is unremarkable in most respects. The majority of the letter focuses on website copy, printed information packets, customer testimonials and other materials that appear, at least to the FDA, to represent claims made by AMARC that the Poly-MVA supplement is “intended for use in the cure, mitigation, treatment, or prevention of disease,” thus making it a drug subject to FDA regulatory approval.
All Eyes on Maryland v. King: Recapping the Supreme Court Oral Argument
Seating was in short supply to hear oral arguments before the Supreme Court in what J. Alito referred to as “the most important criminal procedural case that this court has heard in decades,” Maryland v. King. Eager spectators –including this contributor for the Genomics Law Report – lined up along the marble steps of the Supreme Court building and waited amidst biting winter temperatures in excess of four hours before being allowed inside. [I thought to myself, “if I can brave the cold for football, I can brave the cold to see our nation’s highest court in action.”] The second of two cases scheduled for the morning of February 26, 2013, oral arguments for Maryland v. King were already underway when the fortunate final spectators were ushered inside. Katherine Winfree and Michael Dreeben argued for the Petitioners (the State of Maryland) and Kannon Shanmugam argued on behalf of the Respondent (Alonzo King).
The Genomics Law Report has covered the brewing constitutional controversy of DNA fingerprinting upon arrest previously, as U.S. v. Mitchell tentatively settled the matter in the 3rd Circuit, as the 9th Circuit continued to wrestle with Haskell v. Harris, and as various state courts, including Minnesota and Colorado [pdf], faced similar questions.
Background on Maryland v. King. Alonzo Jay King, Jr. was arrested in 2009 and charged with first- and second-degree assault. As part of his initial arrest, King submitted to DNA fingerprinting collected by law enforcement under the Maryland DNA Collection Act. More than half the states [pdf] have statutes similar to Maryland’s, and there is also a similar federal statute (the DNA Fingerprint Act of 2005 [pdf]). King admitted to his involvement and was ultimately convicted of second-degree assault, a misdemeanor and an offense not qualifying on its own for DNA collection upon arrest under Maryland’s law.
mHealth on the Horizon: Federal Agencies Paint Regulatory Landscape with Broad Brushstrokes
For years, and with increasing frequency, health care and information technology companies have touted the potential of mobile medical and health applications and technologies to improve the quality and delivery of health care through the use of technology. While the future of mobile health (frequently referred to as “mHealth”) is undoubtedly filled with promise, the legal and regulatory landscape in which mHealth technologies reside is only now beginning to take shape.
As mHealth developers, funders and even users consider investing in the field, or including in particular mHealth technologies, they should keep in mind the emergent and fluid nature of the mHealth regulatory landscape. Here, we outline the likely key players and discuss several recent and projected initiatives with respect to the oversight of mHealth technologies:
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.
The Supreme Court today granted a writ of certiorari (meaning they agreed to hear the appeal) in Assoc. for Molecular Pathology v. Myriad Genetics, Inc., et al., the famous case centered on patents covering two human genes: BRCA1 and BRCA2.
Of note is that the Court limited its grant of the appeal to the first of the three questions posed by the petitioners/plaintiffs: “Are human genes patentable?”
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 is the abstract:
ENCODE, CODIS, and the Urgent Need to Focus on what is Scientifically and Legally Relevant to the DNA Fingerprinting Debate
Sara Huston Katsanis, MS is an Associate in Research at the Institute for Genome Sciences & Policy at Duke University.
On September 5, 2012, a coordinated release of 30 articles in Nature, Cell, Science, Genome Research, Genome Biology and other journals published the long-awaited findings of The Encylopedia of DNA Elements (ENCODE) Consortium. The press coverage of ENCODE data is deafening at this point, and ENCODE’s relevance to GLR readers may not be immediately apparent.
Across the U.S., numerous groups are challenging the integration of CODIS profiles (sometimes called “DNA Fingerprints”) into the routine booking procedures upon arrest for certain crimes (depending on the state), placing genetic profiling among other standard procedures such as fingerprinting and mug shot photographs. The GLR has covered these legal challenges previously (including here, here, and here).
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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 surprised approximately nobody, and as we predicted earlier this spring, the Federal Circuit reached precisely the same result in its opinion today as it did last July when it issued its first substantive ruling in the Myriad litigation. Below, we examine how the Federal Circuit applied Mayo to Myriad, what the next step in the Myriad litigation is likely to be (spoiler alert: it’s another appeal) and why we think the final opinion in this case, whenever it arrives and whatever it says, might not matter all that much.
Applying Mayo to Myriad. As mentioned, the only major change since the last time the Federal Circuit ruled in Myriad, and the reason for the re-hearing, was the Supreme Court’s decision earlier this spring in Mayo.
However, Mayo was about method patents and the boundary between a patent-eligible method and a law of nature. It was not about product patents or the product of nature doctrine. Since the Federal Circuit had already invalidated all but one of Myriad’s method patents even before the Supreme Court tightened the criteria for method patents in Mayo, it was hard to see much of substance changing the second time around.
Removing the Cables: New FCC Rule Paves Way for Utilization of Wireless Medical Technology
Amit Bhagwandass is a rising third-year student at University of North Carolina School of Law.
New rules adopted by the Federal Communications Commission (FCC) have an appreciable impact on the way that hospitals, nursing homes and other inpatient and outpatient health care providers will monitor their patients in the future. The new FCC rules enable the use of Medical Body Area Networks (MBANs). MBANs are low-power wideband networks consisting of multiple body-worn sensors that transmit various patient data to a control device that collects data from the sensors.
Wireless devices operating on the MBAN spectrum can be used to continuously monitor a patient’s health by measuring indicators such as blood glucose levels, blood pressure and electrocardiogram results. Additionally, wireless health devices can include mobile devices and associated applications of increasing relevance to consumer health and personalized medicine, such as mobile-device enabled sensors that monitor vital signs for any number of traits or conditions like blood pressure, glucose levels or even the early signs of an asthma attack.
