A preview of the biotechnology-related election issues on the November 6 ballot illustrates both direct and indirect implications of the upcoming vote. Two areas of biotechnology and the law will be clearly impacted by the results of state and national elections - the partial regulation of genetically engineered food through labeling, and the federal funding of embryonic stem cell research. The most directly consequential measure (yes/no) is in California. There is a state ballot initiative to require the labeling of genetically engineered (GE) foods in California, Prop 37; if adopted, it would be the first such state mandate to be imposed (see here). Thus, on November 7th, California could be looking at implementing a regime of mandatory labeling for GE foods, and we could expect legal challenges to follow with likely First Amendment challenges to the labeling, where the contours of the commercial speech doctrine would be at issue (e.g., somewhat analogous to International Dairy Foods Association v. Amestoy (2nd. Cir. 1996), where the 2nd Circuit invalidated a Vermont measure requiring hormone-related labeling of dairy products).
It is also foreseeable that the outcome of the Presidential election will indirectly (but seriously) affect the status of stem cell research in the U.S. – specifically the ongoing controversy over the federal funding of embryonic stem cell research (see here). In 2009, President Obama reversed the Bush-era policy of disallowing the use of federal funds for the derivation of new embryonic stem cell lines; as a result, the National Institutes of Health (NIH) is allowed to award grants for such research. The Romney website contains a policy on stem cell research; while not directly addressing the use of federal funds for embryonic stem cell research, the statement is written to focus on alternatives: “Adult stem cell research and alternative methods to derive pluripotent stem cells, such as altered nuclear transfer and direct reprogramming, are scientific paths that carry much promise and avoid raising ethical concerns.” Governor Romney vetoed a Massachusetts bill in 2005 that would have allowed “therapeutic cloning” – the creation of a cloned embryo to derive genetically compatible embryonic stem cells (this debate was extant in federal legislative battles at that time, with Democrats and Republicans having opposing positions). The 2012 campaign site contains this statement: “When confronted with the issue of stem cell research as governor of Massachusetts, Mitt Romney chose to support life by vetoing a bill that would have allowed the cloning of human embryos.” Actually, this is a veto more grounded in a rejection of deliberate embryo creation rather than the stem cell research itself. Thus, this statement does not address whether Romney would allow the funding to derive embryonic stem cells from leftover or discarded embryos that were created not for research, but in the process of assisted reproductive technologies (e.g., at fertility clinics). However, from all available evidence, it can be inferred that the Romney position will be to undo the Obama policy of federal funding for new stem cell lines from unused embryos. Thus, on November 7th, the stem cell community wil either encounter the status quo (Obama) or the possible elimination of federal funds for embryonic stem cell research (Romney); a Romney win would also obviate the current legal challenges to the Obama policy. On a final note, the larger specter of federal support for scientific research is implicated in the national race, particularly as questions of government scope and resources have factored in so highly. A group of 68 Nobel Prize winners endorsed President Obama recently, largely based on their view that Obama “delivered on his promise to renew our faith in science-based decision making and has championed investment in science and technology,” while concluding that Romney would “devastate a long tradition of support for public research and investment in science.”
October 31, 2012
October 29, 2012
Court Rules on Challenges to Genetically Engineered Crops in National Wildlife Refuges
There is an update on the lawsuits brought by a coalition of food safety and environmental advocates to challenge the U.S. Fish and Wildlife Service (FWS) for their practice of granting permission for the planting of genetically engineered (GE) soybeans and corn in the national wildlife refuges (see here). The national wildlife refuges are a "national network of lands and waters for the conservation, management, and where appropriate, restoration of the fish, wildlife, and plant resources." The legal actions were filed on a regional basis and alleged that FWS has allowed the planting of GE crops in refuges without conducting an Environmental Impact Statement (EIS) as required by the National Environmental Policy Act (NEPA). These plantings are part of a FWS program that designates a portion of a refuge for agricultural purposes. One of the concerns is that many of the GE crops are Roundup Ready crops, engineered for herbicide-resistance, and GE crop plantings result in more introduction of herbicides into the natural habitat. Thus, the plaintiffs have alleged two forms of harm to a refuge from GE crops: genetic contamination of natural species and chemical harms from the herbicides. NEPA, passed in 1970, requires that any action undertaken by a federal agency that may have environmental consequences be thoroughly evaluated by conducting a rigorous environmental review (the EIS) of possible impacts and consideration of alternatives. NEPA effectively allows for citizen challenges to a broad range of federal actions that pose environmental risk through the use of a procedural objection, as exemplified by these lawsuits.
To date, the plaintiffs' coalition has won rulings in earlier challenges to the planting of GE crops in the national refuges, where the courts have ordered FWS to conduct the requisite EIS (e.g., the Northeast region). In two recent rulings that illustrate the regionally-specific analyses, Judge Boasberg in D.C. District Court upheld the challenge to the Southeast region plantings, ruling that an FWS phaseout in 2013 was not an adequate response to an allegation of incomplete environmental review. In a parallel challenge to GE crop planting in the Midwest region, Judge Boasberg ruled that FWS had made an adequate environmental assessment in view of its stated objective). One might guess that the FWS would decide as a matter of national policy to prepare an EIS for any proposed designation of refuge property for GE plantings. The FWS, however, has been unwilling to establish such a national policy that would routinely institutionalize EIS preparation - instead, has contended with individual lawsuits seeking to get an EIS prepared or to get an environmental assessment evaluated. On balance, it is likely that national wildlife refuge policy is evolving to conclude that the planting of any GE crop on land that is designed to house and maintain natural habitats is no longer compatible with the introduction of GE crops. Certainly, the widespread use of GE crops in general practice undermines any need for a national refuge to be a repository for such species.
To date, the plaintiffs' coalition has won rulings in earlier challenges to the planting of GE crops in the national refuges, where the courts have ordered FWS to conduct the requisite EIS (e.g., the Northeast region). In two recent rulings that illustrate the regionally-specific analyses, Judge Boasberg in D.C. District Court upheld the challenge to the Southeast region plantings, ruling that an FWS phaseout in 2013 was not an adequate response to an allegation of incomplete environmental review. In a parallel challenge to GE crop planting in the Midwest region, Judge Boasberg ruled that FWS had made an adequate environmental assessment in view of its stated objective). One might guess that the FWS would decide as a matter of national policy to prepare an EIS for any proposed designation of refuge property for GE plantings. The FWS, however, has been unwilling to establish such a national policy that would routinely institutionalize EIS preparation - instead, has contended with individual lawsuits seeking to get an EIS prepared or to get an environmental assessment evaluated. On balance, it is likely that national wildlife refuge policy is evolving to conclude that the planting of any GE crop on land that is designed to house and maintain natural habitats is no longer compatible with the introduction of GE crops. Certainly, the widespread use of GE crops in general practice undermines any need for a national refuge to be a repository for such species.
October 24, 2012
Presidential Commission Advances Privacy Concerns in Genetic Testing
The Presidential Commission for the Study of Bioethical Issues (PCSBI) has issued a report on one of the intersections between genetic testing and privacy. The PCSBI was established by President Obama; to date, their only other report focused on the regulatory landscape for synthetic biology (more here). Now, the Commission has published Privacy and Progress in Whole Genome Sequencing, which examines how the increasing availability of whole genome sequencing (WGS, where the full DNA sequence of a genome is obtained) in both clinical and research settings has to be matched with an attention to how such data is used in a manner that protects the privacy of the patient and/or research subject. The report illustrates the legal complexity of privacy in American law generally – a very mixed portfolio of (sectoral) protections. The legal concerns with the widespread introduction of genetic information into science and medicine are several and concern whether an individual has control of when genetic testing occurs, when genetic information can be disclosed, and how genetic information can be used. With respect to genetic information, much of the legal attention has focused on the issue of genetic discrimination, which concerns use, and has not focused on genetic privacy. Most simply, privacy is concerned with disclosure, while discrimination is concerned with misuse. Can the privacy of “genetic information” be protected with existing law? Is a genomic DNA sequence a category of "personally identifiable information" (PII), meriting special protection from unauthorized disclosure? In general, medical information generated during patient care is protected by the Health Insurance Portability and Accountability Act (HIPAA), which makes a provider accountable for maintaining both patient confidentiality and privacy of medical records. But, as the commission notes, it is not clear whether genetic or genomic information is always included in the protected health information that HIPAA addresses. Since 2008, the U.S. has the Genetic Information Nondiscrimination Act (GINA), which protect individuals from discrimination based on the use of their genetic information in employment and health insurance. Notably, it does not extend to the provision of life, long-term care or disability insurance.
The PCSBI report particularly focuses on how genetic information derived in the research setting will be protected from unauthorized disclosure, a project that not only requires the cooperation of researchers and health institutions, but auxiliary participants, such as database managers. Very generally, the U.S. does have norms for the protection of human subjects generally, most notably the Common Rule, which establishes standards to protect human research subjects and is applicable to all federally-funded research. While a patient can rely on HIPAA for some medical privacy, the research subject needs to be protected against the unauthorized disclosure of personally identifiable genetic information outside the medical care setting. One of its most significant recommendations is that no WGS be conducted without the consent of the individual. While that may sound straightforward and sensible, this point is relevant to the uses of surreptitious genetic testing that occur in criminal law, for example, but could be performed in other contexts (e.g., this issue addressed with the pending California bill on genetic privacy, SB 1267, which would “prohibit any person, as defined, from obtaining, analyzing, or disclosing genetic information without the written authorization of the individual to whom the information pertains”). The report notes a very uneven set of protections against unauthorized genetic testing and disclosure across the states. In total, the report calls attention to the wide array of entities that are involved in the processing of genetic information – not only scientific and medical, but third party data handlers – and calls for standardization of informed consent procedures to protect individual choice regarding genetic testing and its disclosure. It asks funders of such research to monitor privacy protections as a part of their review. While the report did focus on the ethical introduction of WGS into wider use, its recommendations are relevant to all types of genetic information and might serve to incorporate privacy safeguards as a routine dimension of genetically-based medical care and research.
The PCSBI report particularly focuses on how genetic information derived in the research setting will be protected from unauthorized disclosure, a project that not only requires the cooperation of researchers and health institutions, but auxiliary participants, such as database managers. Very generally, the U.S. does have norms for the protection of human subjects generally, most notably the Common Rule, which establishes standards to protect human research subjects and is applicable to all federally-funded research. While a patient can rely on HIPAA for some medical privacy, the research subject needs to be protected against the unauthorized disclosure of personally identifiable genetic information outside the medical care setting. One of its most significant recommendations is that no WGS be conducted without the consent of the individual. While that may sound straightforward and sensible, this point is relevant to the uses of surreptitious genetic testing that occur in criminal law, for example, but could be performed in other contexts (e.g., this issue addressed with the pending California bill on genetic privacy, SB 1267, which would “prohibit any person, as defined, from obtaining, analyzing, or disclosing genetic information without the written authorization of the individual to whom the information pertains”). The report notes a very uneven set of protections against unauthorized genetic testing and disclosure across the states. In total, the report calls attention to the wide array of entities that are involved in the processing of genetic information – not only scientific and medical, but third party data handlers – and calls for standardization of informed consent procedures to protect individual choice regarding genetic testing and its disclosure. It asks funders of such research to monitor privacy protections as a part of their review. While the report did focus on the ethical introduction of WGS into wider use, its recommendations are relevant to all types of genetic information and might serve to incorporate privacy safeguards as a routine dimension of genetically-based medical care and research.
October 15, 2012
Petition Filed for Supreme Court Review of Federal Funding for Embryonic Stem Cell Research
A petition for certiorari has been filed in Sherley v. Sebelius, the ongoing challenge to the NIH Guidelines for the federal funding of embryonic stem cell research funding (previous coverage). The recent decision from the Court of Appeals for the D.C. Circuit rejected the claim of the plaintiffs that the funding violates the Dickey-Wicker amendment, which prohibits the use of federal funds for any research in which an embryo is harmed or destroyed. That provision was interpreted by the court to not cover the process for deriving embryonic stem cells from embryos, thus not placing the NIH stem cell policy in violation of the funding ban. The challenging researchers continue to claim that such an interpretation is erroneous. In the D.C. Circuit decision, the concurring opinions acknowledged the murky legal climate for federal funding of embryonic stem cell research, noting the automatic attachment of the Dickey-Wicker amendment to HHS funding bills without much new deliberation since 1996. Judge Brown wrote: "Given the weighty interests at stake in this encounter between science and ethics, relying on an increasingly Delphic, decade-old single paragraph rider on an appropriations bill hardly seems adequate." The petition advances several procedural arguments against the D.C. Circuit’s decision; one alleges a violation of the Administrative Procedure Act (alleging the 2009 Obama Executive Order unlawfully relieved NIH from completion of its formal rule-making obligations) and a misinterpretation of the law of the case doctrine (does it include decisions made at the preliminary injunction stage?). The petitioners cite a conflict among the circuits over the law of the case doctrine, trying to entice the Court into a review. Before we hear from the Court on this petition, the upcoming election will intervene – and the contrasting positions of Obama and Romney will either uphold or dismantle the current NIH policy. There has been very little federal litigation on embryonic stem cell research, but we now have more than a decade’s worth of political instability over the issue, with another indirect political referendum on November 6th. It should be noted that the recent attempts at personhood legislation (also at the federal level) are contemporary initiatives to ban embryonic stem cell research, as they would codify the legal status of the embryo as a fully constitutionally-protected individual; that would likely outlaw embryonic stem cell research. A Romney victory could be expected to reverse the NIH policy and render this litigation moot; an Obama victory would not.
October 6, 2012
Supreme Court to Decide Extent of Patent Exhaustion for Genetically Engineered Crops
In a case that presents a novel question regarding the scope of patent rights in a biotechnology invention, the Supreme Court has agreed to hear the appeal in Bowman v. Monsanto (Fed. Cir. 2011). Here, Monsanto sued an Indiana farmer, Vernon Hugh Bowman, for patent infringement for his use of patented seed for the growth of second-generation genetically engineered (GE) soybeans. The patented crop is the Monsanto Roundup Ready soybeans, which contain a gene that encodes EPSPS, a glyphosate-tolerant enzyme. The genetically modified plants express the enzyme and thus and exhibit resistance to the herbicide glyphosate– specifically, to the application of the Monsanto product, glyphosate, sold as Roundup. The purpose is to create a crop through genetic engineering that can withstand the application of the herbicide (weed-killer). Bowman was accused of patent infringement by buying GE commodity seed from a grain elevator which he then used for replanting (replication), which Monsanto characterized as an unauthorized use of a patented invention. The doctrine of patent exhaustion in patent law generally operates to limit the control that an inventor holds over the life of a lawfully sold patented article – the first sale of a patented invention is authorized, and then exhausts the control that the patent holder retains over subsequent uses (absent some valid conditional sale agreement that accompanies the sale). Would that doctrine extend to a claim that a later sale of originally-patented GE seed to Bowman and his use in planting became an act of patent infringement because the seed replicates and he “made” an infringing article? In 2011, the Federal Circuit ruled that Bowman’s planting of the GE seed he purchased created an act of patent infringement, rejecting an interpretation of the exhaustion doctrine that would recognize the special attributes of seeds, which embody the property of replication and “manufacture” of an originally-patented invention. Did the company’s patent rights extend to this later series of events, or did they exhaust upon the first sale of the patented seed? In his petition, Mr. Bowman presented the following question to the Supreme Court:
Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?The Supreme Court has provided some recent guidance on patent exhaustion in Quanta v. LG (2008), where they held that a sale that “substantially embodies” the patented invention exhausts the patent rights. Interestingly, the U.S., as amicus curiae, urged the Court not to take the case, warning that “if this Court granted certiorari, however, its decision could also affect the enforcement of patents for man-made cell lines, DNA molecules, nanotechnologies, organic computers, and other technologies that involve self-replicating features.” The Court did take the case, however, and it signals that it does wish to consider the prospect that the inherent property of self-replication in some biotech-related inventions does not demand unexhausted patent rights.