February 29, 2012

Organic Farmers Lawsuit Against Monsanto: Not a "Controversy" Yet

There is a ruling in the federal lawsuit brought by a large coalition of organic farmers against Monsanto, seeking a preemptive ruling (declaratory judgment) of non-infringement and patent invalidity in contemplation of possible inadvertent contamination of their fields by Monsanto's patented transgenic seed materials (sometimes referred to as genetic trespass). To date, Monsanto has vigorously enforced its seed patents against farmers (patent infringement can be alleged whether the use of a patented invention is deliberate or inadvertant). In this case, Judge Buchwald has ruled that the plaintiffs are not entitled to seek a declaratory judgment because a sufficient controversy has not developed to warrant the court’s involvement (noting “plaintiffs’ transparent effort to create a controversy where none exists”); she also placed weight on a letter from Monsanto in which it indicated that it had no intention of suing the plaintiffs (the judge called this “a source of comfort rather than worry”). Thus, the judge has not regarded the controversy as particularly acute or immediate, and will not entertain the lawsuit. Early reaction from the plaintiffs is that they will appeal the ruling to the Federal Circuit. The case has been closely watched as it placed the farmers in a proactive stance, seeking to clarify their legal position and, if successful, remove what they consider to be the ongoing legal threat of a patent infringement lawsuit for activities (involuntary contamination of crops) that were not deliberate or welcome. The judge effectively did not regard the plaintiffs' contention that they refrain from certain plantings due to patent enforcement implications as  warranted, given her view of the defendant's likely response, and certainly not indicative of any legal injury. Although unrelated cases, there is some overlap with the contentions of the plaintiffs in the gene patent case, AMP v. USPTO, in which plaintiffs allege that they could not conduct genetic testing due to fear of patent infringement litigation (AMP is cited by the judge, but some of this works against the farmers here, who cannot point to the same direct assertion of patent rights that Myriad Genetics displayed and which then structured plaintiffs' activities).  

February 24, 2012

9th Circuit Upholds Collection of DNA Samples from Arrestees

The recent trend in the use of DNA evidence by law enforcement has been for states to expand their DNA databases to include samples from those arrested of crimes (a move also supported by President Obama); see state summary here. As could be expected, this extension of mandatory DNA testing to include arrestees (not just those convicted) has been controversial (and most susceptible to legal challenge under the 4th Amendment prohibition against unreasonable searches and seizures). The inclusion of arrestees in the California DNA database was instituted in 2009, following the passing of Proposition 69 in 2004, in which the voters approved of DNA collection from convicted felons. Now, a 3-judge panel of the 9th Circuit has ruled that the California state law that implemented Proposition 69 by requiring the collection of DNA samples from all adults arrested of a felony does not violate the 4th Amendment (this federal court decision conflicts with an earlier state court decision finding the law unconstitutional). The 9th Circuit has previously encountered the constitutionality of DNA collection; in 2004, the court ruled that the collection of DNA samples from parolees did not violate the 4th Amendment. Regarding arrestees, last year the 3rd Circuit also upheld the collection of DNA samples from those arrested of federal crimes; this case has been appealed to the Supreme Court). No doubt, the high court will have the last word on this wave of DNA database expansion; the court most recently encountered the use of DNA evidence in law enforcement last year when it upheld the right to post-conviction DNA testing.

February 22, 2012

WHO Meeting on H5N1 Virus : Delay Publication, Slow Down Research

Last week, an emergency meeting was called by the World Health Organization to consider the recent development of a genetically refined H5N1 influenza with apparent pandemic potential. Those in attendance included virologists, public health officials and scientific publishers. Two issues were paramount. Is this research worth continuing despite possible adverse consequences? Should the full details of the virus production and structure be published? In November, the leading journals  Science and Nature were asked by the U.S. National Science Advisory Board for Biosecurity (NSABB) to publish only redacted versions of the submitted publications detailing the virus work; see here for their reasoning; this issue has been under advisement at these journals. Now, the WHO meeting has come to a recommendation that the scientific articles be published in full with no redactions, but that more delay to consider all ramifications is advisable. This meeting now places WHO into the mix of authorities who are weighing in on these issues; of course, the research under focus was funded by NIH and conducted in the Netherlands and the U.S. It also means that the NSABB is not the only party that is considering how to modulate scientific publication (here, it’s a delay, but that lines up with evaluating the act of publication for its public health consequences). The participants endorsed the value of the research, but agreed that a continued moratorium on further research into this H5N1 virus was advisable to allow fuller deliberation on the biosecurity risks and benefits. More meetings are planned for the future. Apparently, the U.S. continued to argue for redacted publication, which is interesting given the central role of NIH as the funder of the controversial research. So this is a small victory for those who oppose publication controls on scientific research; no doubt, however, that all the attention given to publication decisions resulted in an attention to the underlying research that might not have occurred otherwise.

February 20, 2012

Gene Patents: PTO Undertakes Study on Access to Genetic Testing

Although the litigation over the validity of gene patents is ongoing (petition for certiorari in Association for Molecular Pathology (AMP) v. United States Patent and Trademark Office (PTO) is currently at the Supreme Court; we may know this week if the case is accepted), the 2011 America Invents Act included a provision mandating that the PTO undertake "a study on effective ways to provide independent, confirming genetic diagnostic test activity where gene patents and exclusive licensing for primary genetic diagnostic tests exist considering how gene patents affect the ability of patients to obtain second opinions in genetic testing where patent rights may limit or constrain market options" (this is most obviously directed at the conflicts over how Myriad Genetics has managed the genetic testing market for BRCA1 and BRCA2 testing; options for second or confirmatory opinions are limited). A first hearing at the PTO was held last week; a range of views was presented in testimony. The potential accommodation for the special needs of practitioners and patients who encounter patent-related barriers to genetic testing is not a new issue; extensive study by the HHS Secretary’s Advisory Committee for Genetics, Health and Society resulted in a 2010 report which recommended that Congress enact an exemption to patent infringement for those providing genetic testing to patients (in testimony by AMP last week at the PTO, that approach was endorsed). However, the proposal was never enacted, despite an unsuccessful (and controversial) attempt by Rep. Debbie Wasserman-Schultz to add an amendment to the AIA establishing a safe harbor for confirmatory genetic testing; she then sponsored this PTO study requirement. The current PTO study, therefore, could end up with the same recommendation as the SACGHS made (and back to Congress) if the evidence adduced is persuasive to the PTO. This will also be affected by whether the Supreme Court takes the AMP case; if not, pressure will remain on Congress to alleviate patient obstacles to some genetic tests by creating an infringement exemption for the provision of medical services.

February 10, 2012

Genetically Engineered Salmon: Veterinary Drug or Food Additive?

There is a battle over the possible introduction of genetically engineered salmon into the American food supply. Aqua Bounty Technologies (ABT) seeks approval of its genetically engineered (GE) salmon (AquaAdvantage), in which the Chinook growth hormone gene is introduced into Atlantic salmon and engineered so that the gene is expressed year-round (rather than seasonally), greatly speeding up the maturation process; the company forecasts that the salmon has the “potential to grow to market size in half the time of conventional salmon.” In Alaska, significant opposition exists to the introduction of the product into the seafood market. The company has applied for FDA approval of the salmon; now comes a legal challenge to the FDA’s classification of the product in a manner that could alter the stringency of review.  The current paradigm for the review of the ABT salmon is that the added gene is reviewed as if treated with a veterinary drug: "the rDNA construct in the resulting GE animal is thus a regulated article that meets the drug definition" - and is thus overseen by the FDA's Center for Veterinary Medicine (CVM) in the FDA. In 2010, a CVM report stated that there were no significant safety or environmental issues raised by the ABT salmon. Now, Consumers Union, Center for Food Safety and Food and Water Watch filed a petition which asks the FDA to classify the added gene as a food additive, rather than as a veterinary drug. If the growth hormone gene is a food additive, the FDA would be required to conduct an inquiry into whether the added component is GRAS (generally regarded as safe); this would trigger a broader food safety review. Note the temporal distinction when the gene is treated as a drug administered to fish during maturation or as a food additive (administered) eaten by people. Clearly, the food additive classification is one that could be applied to the product as it is meant to be consumed. There are parallels with many of the genetically engineered crops, which contain genes that have agronomic benefit in the field (withstanding herbicide or conferring pest resistance) and then remain in the crop as it becomes a food substance. Here is the same shift: a fish engineered to grow faster (for economic gain) becomes the food product with a novel gene. Does that trigger the food additive review process?  Can a veterinary-based review supply adequate oversight for the introduction of a genetically engineered food product? To date, the GE crops do not undergo a rigorous food safety review because the FDA regards the introduced DNA as GRAS.  Will the ABT salmon (as potentially the first GE animal food product to enter the food supply) encounter the paradigm shift sought by the petition?

February 5, 2012

Public Access to Public Research: A Reversal of Open Access?

The National Institutes of Health (the leading provider of federal funding for biomedical research) has operated under a Public Access policy for about 4 years. This policy requires that any peer-reviewed article which has been partially or wholly supported by NIH be made available to the general public. This is a condition of receiving an NIH grant. This policy followed ongoing controversy and activism over the traditional publication of publicly-funded research in private sector, peer-reviewed journals (making content harder to get for the general public, and expensive for libraries to carry).  So the NIH policy responded to demands for allowing the public to read about the research that it funded.  This is accomplished with the PubMed online database ("the NIH digital archive of full-text, peer-reviewed journal articles") which makes this research available (an archive of over 2 million articles). Now comes a surprising bill introduced in Congress that would reverse this policy – effectively limiting public access to taxpayer-funded research.  HR 3699, the Research Works Act, introduced by, among others, Rep. Carolyn Maloney of New York, would allow private publishers to block open access of scientific publications. The bill is favored by the large private scientific publishing houses. But pushback is strong, with open letters from academics and opposition from advocates who have fought to open up public research to the public. In the age of increasingly open and online data availability, it’s hard to imagine legislation that turns the clock back and reprivatizes public research. Rep. Maloney is a strong supporter of publicly-funded medical research; one hopes that her legislative efforts don’t result in keeping that research out of public view.

February 3, 2012

Newborn Genetic Testing Programs Confront Genetic Privacy Concerns

One of the flashpoints in ongoing controversies over genetic testing is the state newborn screening programs which mandate the collection of blood samples from babies to be tested for a panel of genetic and congenital disorders. These dried blood samples, which represent a fairly comprehensive biological repository of the population, have been collected since the 1960’s and can be characterized today as a “biobank.” As informational privacy is increasingly recognized as a right in the era of genetic-based medicine, the older newborn screening laws are colliding with modern genetic privacy laws. Many states lack any procedures for obtaining parental consent for the retention or future use of the dried blood samples. This was the basis for two lawsuits, in Minnesota and Texas, in which parents challenged the practice of indefinite retention of the newborn blood samples as a violation of laws guaranteeing genetic privacy or parental consent. Settlement of the Texas lawsuit resulted in the destruction of 5 million samples that had been collected since 2002, but were retained without parental consent. In the Minnesota lawsuit, which pitted the state’s Genetic Privacy Act against the newborn screening law, the court decision will at least result in the destruction of samples that were retained without parental consent since the ruling in 2011, and may result in the destruction of the approximately one million samples stored in the biobank since 1997.

The American College of Medical Genetics (ACMG) has asserted that the newborn samples can be retained with sufficient privacy protections, and that the retention of samples provides a source of material for the development and evaluation of future tests: "Such destruction of dried blood spots would significantly and negatively impact the quality and development of newborn screening programs.” While actual test results are reported to parents, according to the ACMG, the use of these samples for future research in a privacy-protective manner can be done by “use of either anonymized (no individual identifying link is retained) or deidentified (individual identity link retained and privacy and confidentiality maintained under the stewardship of the public health programs) dried blood spots.”  But that's the technical implementation. These lawsuits challenge whether parental consent has been obtained and provide a cautionary tale for other jurisdictions. Thus, we may see more attempts by the states to formalize consent protocols in the newborn screening programs in order to capture the emerging concerns over genetic privacy while forestalling the possibility that existing biobanks which developed in an earlier era but hold a wealth of population-wide medical information might be destroyed through court order. It’s clear that the absence of procedural (and now legal) rigor in these programs, coupled with increasing public sensitivity to all kinds of data privacy (including genetic) will undermine confidence and participation in these programs. Moreover, as newborn screening programs present the most ubiquitous contact that the general public has with genetic testing, the care and diligence in their administration certainly shapes the more generalized public view of genetic testing and its promises or drawbacks.