Courts in Unsettled Territory turn to the Map Available: United States v. Mitchell
We recently covered the Ninth Circuit’s split decision in Haskell v. Harris,1 which found DNA Fingerprinting of arrestees pursuant to California’s Prop 69 to be constitutionally sound. We also reported the Minnesota Supreme Court findings in In re Welfare of M.L.M. and State v. Johnson, rejecting challenges of DNA Fingerprinting based on 4th Amendment and Equal Protection grounds.
An Update from Colorado. An ongoing prosecution, United States v. Fricosu,2 became the most recent constitutional challenge to DNA fingerprinting upon arrest. The defendant, Ramona Fricosu, had her DNA sampled as part of her arrest pursuant to the DNA Fingerprinting Act of 2005, 42 U.S.C. §14135(a). She filed a motion challenging the constitutionality of the practice, requesting that the court order her DNA sample and CODIS profile be destroyed. Fricosu challenged the constitutionality of the practice on Fourth Amendment grounds. On February 22, 2012, Colorado District Judge Blackburn denied the motion (pdf).
Myriad Finally Reaches the Supreme Court (But Only For a Moment)
Yesterday, the Supreme Court (as we predicted last week that it might) GVR’d the certiorari petitions (pdf) of both parties in the Myriad Genetics case.
Big news, right? Not really.
What this means is that the Court Granted cert in Myriad, but for the limited purpose of Vacating the Federal Circuit’s July 2011 decision and Remanding the case to that court for reconsideration in light of the Supreme Court’s decision last week in Prometheus.
Prometheus Patents Struck Down, 9-0: Mayo Collaborative Services v. Prometheus Laboratories, Inc. Analysis
In a strong rebuke to the Federal Circuit, a unanimous U.S. Supreme Court held (pdf), on March 20, 2012, that Prometheus Laboratories’ claims to methods of administering drugs to treat gastrointestinal autoimmune diseases do not meet the patentable subject matter standard of section 101 of the Patent Act. The representative claim quoted by the Court recites, “A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder” comprising two steps: (a) administering one of a class of drugs (thiopurines) and (b) determining the level of a specified metabolite, “wherein” a level below a given threshold “indicates a need to increase the amount of said drug subsequently administered” [to improve efficacy], and a level above the threshold “indicates a need to decrease the amount of said drug subsequently administered” [to avoid toxicity].
History of the Case. Mayo originally bought and used Prometheus test kits that employed the patented method, but it then decided to sell and market its own test, which was similar, but not identical. Prometheus sued for patent infringement. The district court found that Mayo’s test would infringe the Prometheus patents, but it then held the patents invalid as essentially claiming unpatentable laws of nature–in this case, the relationship between the levels of the specified metabolite and the efficacy or toxicity of the relevant drugs.
On Genetic Rights and States: a Look at South Dakota and Around the U.S.
SD H.B. 1260, introduced in South Dakota on January 26, 2012, is an act that would govern the use of genetic information. By any standards – and especially by legislative standards – the two-page bill (pdf) is succinct and should not be considered a state variation of GINA, as the bill does not speak to non-discrimination issues.
The bill’s brevity should not, however, be mistaken for a narrowness of purpose. In under 200 words, the South Dakota bill, if passed, would (1) grant property rights to individuals in their DNA samples and genetic information, (2) prohibit surreptitious testing, (3) call into question many forensic and law enforcement uses of DNA, (4) eliminate newborn blood spot screening without explicit consent and (5) impose broadly worded informed consent requirements on all collections and uses of individual genetic data. So much for inefficient government.
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Ninth Circuit Issues Long-Awaited Ruling on Constitutionality of DNA Fingerprinting
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.
In December 2009 the Northern District of California upheld the constitutionality of California’s Prop 69, which authorizes DNA fingerprinting as part of the routine booking process of individuals charged with felonies. There, in Haskell v. Brown, the defendants challenged California’s Prop 69 by arguing it violated both the 4th and 14th Amendments since, respectively, DNA fingerprinting upon felony arrest was, according to defendants, an unreasonable search and a violation of informational privacy.
Minnesota the Latest to Weigh in on DNA Fingerprinting of Arrestees
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.
There is an increasingly apparent absence of national consensus on whether the practice of collecting a DNA sample and creating a CODIS profile as part of the routine arrest booking procedures (i.e., “DNA fingerprinting”) conforms to the constitutional proscription of unreasonable searches and seizures articulated as the 4th Amendment. We mentioned this topic at the Genomics Law Report previously here, here, and here.
In July 2011, the 3rd Circuit upheld the federal DNA Fingerprinting Act of 20051 in United States v. Mitchell.2 Perhaps perceiving this ruling as a judicial green light, Pennsylvania’s General Assembly, as we recently noted, seems motivated to authorize the practice of DNA fingerprinting upon felony arrest. While the Pennsylvania Senate passed S.B. 775 and referred the matter to the House Judiciary Committee in December 2011, no apparent action has been taken on the measure since then.
Alabama’s “Genetic Information Privacy Act” & the Ongoing Need for Personal Genomics Leadership
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.
Thanks to technological innovation and a corresponding decline in cost, an increasing number of individuals are finding themselves with the task – or at least the opportunity – of accessing and interpreting their own genetic information. Over the past year, several state legislatures have taken notice.
Following on the heels of legislation passed or proposed in California, Vermont and Massachusetts, the Alabama House of Representatives is considering a bill by Representative Henry (pre-filed on January 23, 2012 and scheduled for first read on February 7, 2012) titled the “Genetic Information Privacy Act” (2012 AL H.B. 78). While the bill is relatively brief, its effects as written may reach far beyond those intended.
A New Bar for Informed Consent. First, the bill in its current form would require signature on separate informed consent documents to obtain, retain, or disclose genetic information. As drafted the bill would provide an exception for the insurance industry, permitting a single, integrated informed consent document if the genetic information is being obtained, retained, or disclosed “for the purpose of obtaining insurance” (Page 4, Line 25).
North Carolina One Step Closer to Compensating Victims of its Eugenics Program
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.
Almost a year ago, North Carolina Governor Bev Purdue set up a Task Force charged with determining how the state should compensate victims of its eugenics program. The Final Report (pdf) by that Task Force was submitted to the Governor on January 27, 2012. If the state legislature takes action to implement the Task Force’s recommendations, North Carolina will become the first state (of the 32 states that had eugenics programs) to compensate the victims of its involuntary sterilization program.
Big Changes Coming in EU Privacy Law
The European Union is about to make major changes in its privacy law that will have a significant impact on U.S. companies that do even modest amounts of business in Europe. On January 25, 2011, the European Commission (the EU’s executive branch) released a long-awaited Draft Regulation on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data (pdf).
While it will likely be a year or more before a final regulation takes effect, and there will almost certainly be amendments along the way, American companies – including those involved in the field of personalized medicine, where personal data is paramount by definition – should start paying attention now, since they may have to change the way that they do business in Europe.
Pennsylvania Joins Growing List of States to License Genetic Counselors
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA and a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technologies.
On December 22, 2011, the Pennsylvania General Assembly adopted two bills (H.B. 332 and H.B. 333) to amend the commonwealth’s Medical Practice Act of 1985 (P.L. 457, No. 112) and the Osteopathic Medical Practice Act of 1978 (P.L. 1109, No. 261) to include provisions that regulate genetic counselors. Pennsylvania Governor Corbett approved the bills and signed them into law the same day.
PA’s GC Law in Context. According to the National Conference of State Legislatures’ survey of state requirements for genetic counselors, in 2008 only six states required licenses to practice genetic counseling (California, Illinois, Massachusetts, Oklahoma, Tennessee, and Utah). Pennsylvania is the latest to join a number of states (including Delaware, Hawaii, Indiana, New Jersey, New Mexico, South Dakota and Washington) that have enacted GC licensing laws since 2008. The National Society of Genetic Counselors reports that additional states (e.g. Florida, Michigan, Minnesota, New York, Rhode Island, Texas, and Wisconsin) are considering similar legislation. While the state licensing requirements are similar, state-by-state variation and nuances in the statutes may exist. The following information pertains to Pennsylvania’s new licensing law only.
