Biobanking

Property Rights and the Human Body

11808967A Canadian court made headlines this month when it decided, as a preliminary matter, that human tissue removed from the body for diagnostic medical tests is “personal property” that belongs to the hospital where the procedure was performed. The case was a medical negligence action brought against two doctors by the estate of Snezana Piljak, a woman who was diagnosed in 2009 with colorectal cancer and died in 2011. At issue in the case is whether the doctors were negligent in failing to diagnose the cancer in 2008 when a colonoscopy was performed on Ms. Piljak. The doctors had petitioned the Canadian court for access to liver tissue biopsied from Ms. Piljak in 2009 at Toronto’s Stonybrook Hospital. The court had to address the matter of tissue ownership before it could consider whether the defendant-doctors had a right to access the liver tissue in order to investigate whether Ms. Piljak had hereditary non-polyposis colorectal cancer (HNPCC or Lynch Syndrome). If the HNPCC were indicated by an examination of the tissue, the defendant-doctors would use that fact to mount a defense against the accusations of negligence. The court ruled that the tissue was personal property of the hospital (though it ultimately denied the defendant-doctors’ request to examine it for technical reasons). The decision that human tissue is “personal property” has important legal ramifications that might affect the biotech industry and genetic research community outside of Canada. The question of ownership of biospecimens has often been tangled up with the status of the biospecimens as personal property, though they are distinct questions.
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All Eyes on Maryland v. King: Recapping the Supreme Court Oral Argument

1037193_dna_fingerprint_5Seating 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.


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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:


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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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Patenting and Personal Genomics: 23andMe Receives its First Patent, and Plenty of Questions

Earlier this week 23andMe, the Silicon Valley-based personal genomics company, was awarded its first patent: US Patent Number 8,187,811, entitled “Polymorphisms associated with Parkinson’s disease”.

23andMe co-founder Anne Wojcicki announced the issuance of the patent via a post on the company’s blog late Monday evening, attempting to strike a tenuous balance between her company’s oft-championed philosophical devotion to providing individuals with “unfettered access to their genomes” and its desire to commercialize the genomic information so many of those very same individuals have shared, free of charge, with 23andMe. With its new patent, 23andMe also injected itself into the middle of what Wojcicki herself described as the “hot debate” surrounding the patentability of “inventions related to genetics.” Wojcicki’s announcement appeared to catch more than a few of the company’s customers by surprise, sparking concern about the company’s intentions on 23andMe’s blog, Twitter and elsewhere, along with rapid and pointed commentaries from Stuart Hogarth and Madeleine Ball, among others.

Of the various questions asked of and about 23andMe and its new patent, these may be the three most common: Where did this patent come from, and why didn’t I hear about it before? What does 23andMe’s patent cover? How is 23andMe going to use its patent? Let’s take each question in turn.


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Filed under Biobanking, Direct-to-Consumer Services, General Interest, Genetic Testing/Screening, Genomics & Society, Industry News, Informed Consent, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP

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).


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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.


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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.


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Pennsylvania Seeks Expansion of its Forensic DNA Database

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.

Last month, the Pennsylvania General Assembly voted in favor of a bill that would expand the Commonwealth’s criminal database. PA Senate Bill 775 authorizes law enforcement to begin DNA fingerprinting of individuals upon arrest or charge for certain specified crimes (as opposed to only upon conviction) and authorizes familial searching of the state’s forensic database. After third consideration, the amended version of PA Senate Bill 775 passed by a vote of 42-6. The bill has been referred to the judiciary.

The bill had been introduced in March of 2011 by Pennsylvania Senate Majority Leader Dominic Pileggio, who was later joined by a dozen colleagues (including nine Republican and three Democratic sponsors). It immediately garnered the attention of genetics law scholars, including Penn State Dickinson’s School of Law Professor David Kaye, who submitted a thorough statement (pdf) for the Pennsylvania General Assembly’s consideration.


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