February 28, 2013

Supreme Court Hears Arguments in 4th Amendment Challenge to DNA Profiling of Arrestees

The Supreme Court heard oral arguments this week in Maryland v. King, a case that challenges the constitutionality of Maryland's DNA Collection Act, which authorized law enforcement to take DNA samples from those arrested for a “crime of violence, an attempted crime of violence, a burglary, or an attempted burglary” (see here). The DNA collection and profiling of those individuals leads to their inclusion in the state and federal CODIS DNA databases (current CODIS statistics show about 1.2 million arrestee profiles in the national database, and about 10 million profiles of convicted offenders). 4th Amendment challenges to DNA profiling generally center on determining the “reasonable expectation of privacy” that an individual has in her own DNA; however, that has been a status-dependent calculation in criminal procedure (those convicted of crimes have a diminished expectation; those arrested of crimes also have a lowered expectation, but this case will determine whether their privacy interest is still strong enough to counter the government’s entitlement to their DNA). The government must demonstrate the state interests advanced by the DNA profile collection; in the case of arrestees, states argue that the use of an arrestee’s DNA profile aids is solving cold cases. To date, federal courts have split on this issue. In 2011, in U.S. v. Mitchell, the 3rd Circuit upheld the federal DNA Fingerprint Act, enacted in 2006, which authorizes DNA collections from those arrested for federal crimes. Last year, in Haskell v. Harris, the 9th Circuit upheld the California state law that authorized DNA collection from arrestees. However, Haskell has now been reheard by the 9th Circuit en banc (see here), and this case has taken a new turn with new research from the ENCODE consortium suggesting that DNA profiling may be more biologically informative than previously thought. Is a DNA profile in CODIS no longer a neutral identifier, and thus, is the profile even more revealing than was believed? If so, that strengthen’s an individual’s privacy interest in her DNA profile (and by implication, in the collection and/or retention of the DNA sample). 

This is the first case on the use of DNA databases in criminal law that the Supreme Court has taken; lower federal appellate courts have generally upheld the use of mandatory DNA collection and profiling from those convicted of crimes (state laws can vary, however, in the types of offenses that warrant such inclusion). The justices appeared divided, and the recurring analogy of fingerprint analysis was referenced to determine the level of instrusiveness that DNA profiling presents. An amicus brief filed by my colleague David Kaye and forensic scientists concludes that current CODIS DNA profiling does not capture medical, physical or behavioral information. Several justices appeared unconvinced that Maryland’s interest is solving cold cases was sufficient to justify the DNA profiling of arrestees, and were concerned with a “slippery slope” toward more casual usage, as evidenced by a question from Chief Justice Roberts: “Under your theory, there’s no reason you couldn’t undertake this procedure with respect to anybody pulled over for a traffic violation?” 

Last year, in U.S. v. Jones, the Court ruled that the warrantless use of GPS tracking on a motor vehicle by law enforcement violated the 4th Amendment. Both Jones (GPS) and King (DNA) will provide further elaboration for how 4th Amendment protections coexist with rapidly changing technological capabilities that are available to law enforcement. However, even adjudicated technologies will continue to evolve. That was noted in the oral arguments this week, where reference was made to advances in DNA analysis that will speed up testing, such that an immediate result could be used for bail determinations. That technical development could shift the legal analysis, perhaps bolstering the state’s case. However, that is not the situation now. Ironically, both the plaintiff’s and the state’s arguments occur against rapidly advancing DNA testing methodologies and DNA genomic analyses, so that the state may bolster its case with later-developed tests that expand the uses of arrestee DNA profiles; at the same time, new genomic research potentially bolsters a plaintiff’s argument that a DNA profile is not a neutral identifier, but a data-laden archive of personal information, thus increasing the privacy interest of the individual and perhaps the unreasonableness of the search. Against that backdrop, the Court must focus on a snapshot of what is possible now and what is known now and issue a 4th Amendment analysis that will be necessarily time-bound, but perhaps open to updating as changing technologies rewrite factual assumptions.

February 24, 2013

HHS Issues New Guidelines for Federal Funding of High-Risk Influenza Research

The Department of Health and Human Services (HHS) has released guidelines for the federal funding of research on highly pathogenic avian influenza (HPAI) H5N1 viruses. The need to specifically address whether and how such research would be funded was made clear when two NIH-supported publications detailed the creation of modified HPAI viruses that exhibited enhanced transmissibility in mammals (i.e., highly lethal avian flu viruses had acquired the potential to transmit easily among humans) (see here and here). Much of the controversy that ensued focused on whether such research should be published (because the furor arose after the research was completed), but the background issue of funding controls on such potentially risky research remained unaddressed. Now, the HHS guidelines (which will largely target NIH-funded research) provide a sequence of review for such grant proposals: standard peer review for scientific merit, NIH review applicable to dual use research of concern (DURC), followed by a new and specific HHS department-level review which can recruit any relevant authorities to advise on the merits of funding such research. The guidelines contain seven criteria that will be used to identify projects worth funding:

1) The virus anticipated to be generated could be produced through a natural evolutionary process;
2) The research addresses a scientific question with high significance to public health;
3) There are no feasible alternative methods to address the same scientific question in a manner that poses less risk than does the proposed approach;
4) Biosafety risks to laboratory workers and the public can be sufficiently mitigated and managed;
5) Biosecurity risks can be sufficiently mitigated and managed;
6) The research information is anticipated to be broadly shared in order to realize its potential benefits to global health; and
7) The research will be supported through funding mechanisms that facilitate appropriate oversight of the conduct and communication of the research. 

It is clear that HHS will entertain funding for such projects where a near-necessity can be shown ("
no feasible alternative methods to address the same scientific question") – in addition to actual scientific merit and compliance with DURC funding standards. This elevates the standard for HPAI H5N1 virus grant proposals to meet – essentially instituting a cost-benefit analysis at the start. Publication issues are not directly addressed (the NSABB remains available to consider that eventuality); however, the guidelines do contemplate dissemination of results ("anticipated to be broadly shared") – that fact only highlighting the need to ensure that the research results that are released are demonstrably related to real public health concerns.

February 12, 2013

Supreme Court Oral Argument Set for AMP v. Myriad Genetics

Association for Molecular Pathology v. Myriad Genetics: the oral argument at the Supreme Court is set for April 15, 2013. The litigation is a challenge to the eligibility of genes as patentable subject matter; specifically, to Myriad Genetics’ patents on the BRCA1 and BRCA2 genes. The question presented at the Court is the following: Are human genes patentable? See here and here for more background.

I have filed an amicus brief in support of the Petitioners (original plaintiffs). The brief makes three central points. First, DNA (and a gene) is a molecule which requires a specific patent eligibility analysis that accounts for its complexity, where it is both a chemical and a template. The genetic code is embodied in DNA, and is a law of nature; patenting of genes preempts the genetic code because it violates the prohibition on patenting laws of nature. Second, the gene is ineligible for patenting as a product of nature; that analysis requires that the structure and the function of a proposed invention be considered. The isolated gene retains its natural structure and implements its natural function, and there is not an inventive distinction between the cellular gene and the isolated gene, violating the prohibition on patenting products of nature. Third, the symmetry formulation for patent eligibility from the Court’s Mayo v. Prometheus decision last year requires that a patent be scored for its inventive contribution, measured against its potential to limit innovation. When that comparison is applied to gene patenting, I conclude that because gene discovery does not qualify as an inventive contribution (based on the previous two arguments above) and because the patenting of genes has exacted demonstrable costs on innovation in the genetic testing field, the resulting asymmetry violates Mayo’s requirement that the costs of a patent not exceed its benefits. The brief concludes, based on all of these arguments, that the Court should invalidate the patent claims to the BRCA1 and BRCA2 genes.

February 9, 2013

Influenza Research Moratorium Formally Ends, But Not in U.S.

The research moratorium called by influenza researchers following published experiments that created novel and possibly pandemic-capable genetically engineered H5N1 influenza viruses has formally ended (see here and here for more background). This voluntary halt in research on highly pathogenic avian influenza (HPAI) H5N1 began in January 2012, and was described as “a pause to this important research to provide time to explain the public health benefits of this work, to describe the measures in place to minimize possible risks, and to enable organizations and governments around the world to review their policies (for example, on biosafety, biosecurity, oversight, and communication) regarding these experiments.” The new statement supports the resumption of such research in countries where the biosafety and biosecurity concerns have been addressed. “Scientists should not restart their work in countries where, as yet, no decision has been reached on the conditions for H5N1 virus transmission research.” The U.S. is one of those countries. In fact, the NIH has undertaken a review of its policies for conducting dual-use research, which would include these influenza virus experiments. The new statement also notes international disagreement regarding the level of physical containment for the research, whether BL-3 or BL-4 (Canada). The U.S.-based H5N1 experiments have been conducted in less secure BL-3 facilities. Currently HHS has been collecting comments on the possible designation of H5N1 (or specifically HPAI H5N1) as a select agent; the practical consequences would be that laboratories would need to register with the government and follow strict CDC regulations for the physical conditions in which experiments with these viruses could occur. There is professional disagreement regarding the advisability of a select agent classification. The NIH has promised to release finalized guidelines for funding such research in the near future, which will be the result of a more detailed look by NIH at its own funding policies. The controversial research in both H5N1 publications was supported with grants from NIH.