Two counties in Oregon recently passed bans on the planting of genetically engineered (GE) crops; the Jackson and Josephine County measures passed handily. The Jackson County ordinance:
It is a county violation for any person or entity to propagate, cultivate, raise or grow genetically engineered plants in Jackson County.
These efforts began in Jackson County where proponents of the ban (local farmers) gathered enough signatures in 2013 to put a local GE ban on the ballot in the spring of 2014. That effort stirred opposition from seed companies and other parties, which reacted by pushing for a legislative fix to preempt such local agricultural governance. The result is that both of these newly-enacted county bans exist against the backdrop of a recently enacted state law that prohibits local counties from interfering with agricultural choice:
A local government may not enact or enforce a local law or measure, including but not limited to an ordinance, regulation, control area or quarantine, to inhibit or prevent the production or use of agricultural seed, flower seed, nursery seed or vegetable seed or products of agricultural seed, flower seed, nursery seed or vegetable seed.
The Oregon county measures are in line with other counties around the country that have enacted such bans (e.g., in Washington, Hawaii, California). In Oregon and the other states with such bans, the rationales advanced for the ban on GE crops include the avoidance of genetic contamination of non-GE crops by neighboring GE crops (e.g., pollen drift). (Several years ago, an apparent genetic contamination of the wheat crop in eastern Oregon elevated concerns about other potential instances of genetic contamination). A further motivation for a GE ban arises from the nature of the engineering itself – these crops are generally engineered for herbicide resistance (Monsanto's Roundup Ready technology) – meaning that the crops can withstand widespread application of these weed-killers. As a result, heavy use of potentially dangerous herbicides is encouraged by the planting of these GE crops, and proponents of such a ban point to the potential environmental and health complications from widespread use of the herbicide. The Oregon counties also have significant numbers of organic farming operations which could face exposure to GE materials or herbicides, scenarios that conflict with established principles of organic farming.
An apparent clash between the new county ordinances (at least for Josephine County) and the state’s new preemption statute looms, lodged against a backdrop of the significant home rule environment for localities that is found in Oregon; Jackson County was granted a waiver from the state law because the ballot initiative had been established before the law was passed. A similar legal showdown could emerge in Hawaii, which has passed a state preemption statute following the enactment of local GE crop bans. The shifting legal landscape between assertions of local governance and reactive preemption is also occurring with respect to state mandates for the labeling of GE food and pending federal preemption efforts to nullify such laws (see earlier post here). In a further sign of Oregon's attention to the legal issues raised by GE crops and GE food, a citizens' effort is underway to get a mandatory GE food labeling law on the ballot for November, 2014.
In its first law enforcement action in the personalized genomics sector, the Federal Trade Commission (FTC) has entered a final consent order against several personal genomics companies for engaging in business practices that deceived consumers. In general, personalized genomics companies follow several business models. A company may offer genetic testing services in which a consumer pays to have her DNA analyzed for mutations that, in the company's claim, are alleged to correlate with various medical conditions or susceptibilities. In another model, genomics companies provide genetic testing and also offer products which are alleged to treat or alleviate the medical conditions identified by the DNA testing. GeneLink, Inc. and its former subsidiary, foru International Corporation, followed the second model and offered what were claimed to be “genetically guided personalization of nutrient and skin care formulations” as part of a general anti-aging portfolio of services and products. The FTC filed a complaint against GeneLink and foru for statements and practices that violate the Federal Trade Commission Act, which prohibits false advertising and “unfair or deceptive trade practices.” The FTC complaint recited promotional materials from GeneLink:
[B]y analyzing and understanding your unique genetic strengths and weaknesses, you can eliminate the guesswork and “genetically guide” the optimal nutritional supplement or skincare formulation to match your LifeMap Healthy Aging Assessment®.
The FTC cited the scope of the claims made by GeneLink:
According to ads and other promotional materials, the supplements could treat serious conditions like diabetes, heart disease, arthritis, and insomnia. Claims for the skin serum cited a “double blind, randomized and controlled study” and promised the product would “compensate for particular deficiencies in areas of skin aging, wrinkling, collagen breakdown, irritation, and the skin’s ability to defend against environmental stress.”
The violation of the FTC Act was recited in the complaint:
12. Through the means described in Paragraph 11, respondents have represented, expressly or by implication, that genetic disadvantages identified through respondents’ DNA Assessments are scientifically proven to be mitigated or compensated for with nutritional supplementation.
13. In truth and in fact, genetic disadvantages identified through respondents’ DNA Assessments are not scientifically proven to be mitigated or compensated for with nutritional supplementation. Therefore, the representation set forth in Paragraph 12 was, and is, false or misleading.
Following a period of public comment, a final consent order was entered to settle the charges brought against the companies. The companies are now prohibited from offering products for purposes not supported by credible scientific data and the level of scientific support required for health-related claims is specified:
“[C]ompetent and reliable scientific evidence” shall consist of at least two adequate and well-controlled human clinical studies.
This FTC action no doubt puts the personalized genomics sector on notice that dubious claims for genetic “treatments” will be subject to FTC monitoring and enforcement actions. This action also exemplifies how the FTC, as the federal consumer protection agency, employs its broad mandate to capture many potentially deceptive business practices in a high-technology areas: the companies were also charged with inadequate data security practices with respect to the collection of consumer information, and the consent order further requires the companies to institute appropriate data security measures for any future data collection. More generally for the genomics sector, the FTC action follows the Food and Drug Administration's (FDA) 2013 warning to 23andme, one of the leading providers of personalized DNA testing, that its services constituted the marketing of an unapproved medical device in violation of the Federal Food, Drug and Cosmetic Act; the company then took corrective actions in removing certain health-related reporting from its products.
Last week, the Federal Circuit issued an opinion, In re Roslin Institute (Edinburgh), that addressed the eligibility of patent claims to a cloned mammal. The Roslin Institute in Scotland accomplished the cloning of the sheep, Dolly, in 1997. This feat was the first reported cloning of a mammal accomplished by the technique of somatic cell nuclear transfer (SCNT). Subsequently, Roslin received U.S. Patent No. 7,514,258 in 2009 directed to the SCNT cloning method. Claim 1:
1. A method for producing a mammalian cultured inner cell mass cell by nuclear transfer comprising:
(i) inserting a nucleus of a quiescent mammalian differentiated cell into an enucleated mammalian oocyte of the same species to reconstruct an embryo;
(ii) culturing the reconstructed embryo; and
(iii) isolating and culturing inner cell mass cells obtained from said cultured, reconstructed embryo to obtain a cultured inner cell mass cell.
The current patenting dispute arose from Roslin’s attempt to patent the actual clones derived from SCNT. These are product claims; here is representative Claim 155:
155. A live-born clone of a pre-existing, nonembryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.
The Patent Trial and Appeal Board (Board) rejected the proposed claims for failure to satisfy 35 U.S.C. § 101 (patentable subject matter) 35 U.S.C. § 102 (novelty) and 35 U.S.C. § 103 (nonobviousness). With respect to the patentable subject matter issue, the Board described the claims as directed to a natural phenomenon, which is not patentable. Roslin attempted to distinguish the clones from the naturally occurring animals by noting environmentally-induced phenotypic differences in a clone and by noting that the SCNT technique creates a clone with mitochonodrial DNA contributed by a donated egg. These arguments were not successful. The Federal Circuit discounted any patentable difference afforded by the presence of new phenotypic differences from the natural animal or by the presence of unrelated mitochondrial DNA – Roslin arguing for some functional difference in phenotypic divergence and for a structural/functional difference with the mitochondrial DNA. In both cases, these alleged differences were unclaimed and the Federal Circuit therefore discounted these arguments. The legal relevance of the differences between a natural organism and a scientifically altered one dates back to the beginning of the era of patenting the products and techniques in biotechnology (and even earlier). Genetically engineered animals and organisms are eligible for patenting, as established by the Supreme Court in Diamond v. Chakrabarty (1980). In that opinion, a bacterium genetically engineered to degrade oil was deemed to be an invention:
Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature's handiwork, but his own; accordingly it is patentable subject matter under § 101.
Here, the Federal Circuit found no invention in the existence of the clone, even while noting technical achievement:
[R]oslin’s chief innovation was the preservation of the donor DNA such that the clone is an exact copy of the mammal from which the somatic cell was taken. Such a copy is not eligible for patent protection.
The court reaffirmed the relevance of the Chakrabarty standard:
Roslin argues that such copies are either compositions of matter or manufactures within the scope of § 101. However, Dolly herself is an exact genetic replica of another sheep and does not possess “markedly different characteristics from any [farm animals] found in nature.” (citing Chakrabarty).
The recent 2013 Supreme Court decision on the patenting of isolated genes, Association for Molecular Pathology v. Myriad Genetics, was also cited for its analysis of the fault line between natural products and inventive-level human alteration:
In Myriad, the Court concluded that “isolated,” naturally occurring DNA strands are not eligible for patent protection. 133 S. Ct. at 2111. Here, as in Myriad, Roslin “did not create or alter any of the genetic information” of its claimed clones, “[n]or did [Roslin] create or alter the genetic structure of [the] DNA” used to make its clones. Myriad, 133 S. Ct. at 2116.
The Federal Circuit did acknowledge that strict nuclear genetic identity might not be fatal:
To be clear, having the same nuclear DNA as the donor mammal may not necessarily result in patent ineligibility in every case. Here, however, the claims do not describe clones that have markedly different characteristics from the donor animals of which they are copies.
Further work remains to be done on clarifying the relative roles of structure and function in the elucidation of “differences” because these very different attributes can be conflated in patent eligibility analysis. The Roslin decision’s reliance on “marked differences” leaves more of that work to be done. Roslin still holds valuable patent rights in the use of the SCNT technique itself, which can be used for reproductive cloning (as here) or therapeutic cloning (see recent post on SCNT-derived human stem cells).
Stem cell scientists report the successful use of somatic cell nuclear transfer (SCNT) to create human embryonic stem cells (hESC) from an adult donor, effectively creating a population of therapeutically available cells to treat disease. This general technique, called therapeutic cloning, affords an opportunity to treat patients with genetically identical stem cells for any number conditions where new cells or replacement cells are needed (e.g., diabetes, Parkinson’s, spinal cord injuries). The investigators were able to generate of embryonic stem cells from a 35-year old and a 75-year old donors. Earlier research had demonstrated the generation of hESC if fetal or infant cells were the donors. Because human embryos were created and used to derive the hESC, the new research revives debates over the potential for advances in therapeutic stem cell research to simultaneously open the door to the misuse of these techniques for reproductive cloning, the generation of a cloned embryo that could be implanted and brought to term (a dual-use characterization).
This debate is not new – these questions emerged at the first publication and use of somatic cell nuclear transfer (SCNT) to create the cloned sheep, Dolly, in 1997. In that period, with the recognition that advancing technical achievements might result in attempts to try human reproductive cloning, legislative efforts to ban both therapeutic and reproductive cloning or only reproductive cloning emerged at the state and national level in the U.S., as well as internationally. Subsequent research since 1997 revealed that cloning (using somatic cell nuclear transfer, SCNT) was easier to achieve with animals than with humans, until now, which is why this new research puts human cloning back into debate. The flash points in the legal debate are several: whether embryos can be created for the sole purpose of producing genetically optimal stem cells, whether embryos can be destroyed during the derivation of human embryonic stem cells – and then the dual-use dilemma where the creation of an embryo could be a predicate to stem cell derivation or to reproduction. The Bush administration imposed a ban on federal funding for the derivation of hESC, and only allowed funds to be used on existing cell lines. In 2009, the Obama administration reversed that course and issued guidelines which allowed federal funds to be used to derive new embryonic stem cell lines from already-existing embryos (from fertility clinics). NIH maintains a hESC registry that catalogues cell lines that can be studied with federal funds. In 2011, a legal challenge to the Obama policy emerged from several adult stem cell researchers who alleged that allowing federal funds for hESC research violated the federal Dickey-Wicker amendment, which prohibits the creation of embryos for research or the destruction of embryos during research (see earlier post). In Sherley v. Sebelius (D.C. Cir. 2012), the D.C. Circuit upheld the Obama policy, finding that destruction of embryos that occurs in the ESC derivation process was not a part of individual ESC research projects using already derived ESCs:
Therefore, ESC research is no more “research in which...embryos are...subjected to risk” than it was “research in which...embryos are...destroyed.”
With the demonstration that hESC can be derived from older human donors, human therapeutic cloning appears more viable and commercially attractive (older patients with degenerative conditions are a prime target). Will this lead to a demand for new cloning-related laws to avoid the dual-use potential? It’s unlikely right now, as the new research is an expansion of already existing technologies, rather than a paradigm-shifting breakthrough. Yet, making human embryo cloning technically possible revives the concerns that animated late-1990s legislative activity. For example, recently introduced legislation, H.R. 2433, distinguishes federal support for embryonic stem cell research from any endorsement of "human cloning:"
Defines "human cloning" to mean the implantation of the product of transferring the nuclear material of a human somatic cell into an egg cell from which the nuclear material has been removed or rendered inert into a uterus or the functional equivalent of a uterus.
Yet, another bill, H.R. 2164, would prohibit both therapeutic and reproductive cloning with its more expansive definition of human cloning:
(1) Human cloning.--The term `human cloning' means human asexual reproduction, accomplished by introducing the nuclear material of a human somatic cell into a fertilized or unfertilized oocyte whose nucleus has been removed or inactivated to produce a living organism (at any stage of development) with a human or predominantly human genetic constitution.
A patchwork of state laws address cloning: several states maintain bans on all human cloning (prohibit conduct per se, or disallow use of state funds), while other states allow therapeutic, but not reproductive cloning (including authorizing use of state funds). The stem cell field is more scientifically complex now than it was in 1998, with techniques using adult stem cells and induced pluripotent stem cells (neither of which are derived from human embryos) also competing for therapeutic supremacy, and avoiding the legal and moral questions attaching to the derivation and use of hESC.
The Vermont legislature has passed what could be the nation’s first state law requiring the labeling of foods with genetically engineered (GE) ingredients (at the federal level, the FDA does not mandate the labeling of GE-derived foods). The Vermont Senate has now cleared H. 112, which sets labeling standards for raw agricultural commodities and processed food that contain genetically engineered ingredients. In the last several years, a mechanism has emerged for states who want to implement labeling in concert with other states - they passed conditional labeling requirements for foods with GE ingredients that would only take effect if other states were adopting the same standards. Most notably, in 2013, Connecticut and Maine took this approach (see earlier post) and as of now, their laws have not taken effect as they await the required trigger conditions. The new Vermont law also adopts a similar conditional trigger, if that were to accrue before July 1, 2015, but if not – the Vermont law will go into effect on that date, whether other states do so or not. So Vermont is prepared to go it alone. Already, advocates of labeling in Vermont are anticipating the legal consequences of the law, sketching out responses to likely constitutional challenges – on First Amendment grounds (compelled speech) and the dormant Commerce Clause (improper state overreach into a federal sphere of action). Vermont has already experienced a defeat over a labeling law enacted in 1994 that required the labeling of dairy products from cows that were treated with recombinant bovine somatotropin (“rBST”); dairy farmers challenged the law under the First Amendment. In that case, the trial court had characterized the state motivation for the law:
The State does not claim that health or safety concerns prompted the passage of the Vermont Labeling Law. Instead, it bases its justification for mandatory labeling not otherwise required by the FDA on strong consumer interest and the public's "right to know" whether a particular dairy product contains milk produced by cows given rBST.
The 2nd Circuit ruled for the farmers, noting the government’s asserted interest in in satisfying the consumers’ right to know was “insufficient” to justify the speech-related injury claimed by the farmers:
[W]e hold that consumer curiosity alone is not a strong enough state interest to sustain the compulsion of even an accurate, factual statement in a commercial context (citations omitted).
With that characterization in mind, the new Vermont labeling law includes the following statement of objectives:
Because both the FDA and the U.S. Congress do not require the labeling of food produced with genetic engineering, the State should require food produced with genetic engineering to be labeled as such in order to serve the interests of the State, notwithstanding limited exceptions, to prevent inadvertent consumer deception, prevent potential risks to human health, promote food safety, protect cultural and religious practices, protect the environment, and promote economic development.
This clause explicitly expands the state rationale to include matters of health and safety, likely elevating the significance of the government interests at stake, and refuting any charge that the state is only satisfying consumer curiosity, a seemingly trivial government interest to the courts that doomed the 1994 dairy labeling law. There is a flurry of state labeling efforts now underway - there are 33 new GE food labeling bills pending in 19 states, as well as an Oregon ballot initiative on the November 2014 ballot. At the federal level, opponents of mandatory labeling of GE food have introduced a federal bill, H.R. 4432, that would override any state legislation that would amend the Federal Food, Drug, and Cosmetic Act to declare that any labeling with respect to "bioengineering" would constitute “misbranding” and thus violate the federal statute. This bill would explicitly override state labeling laws:
No State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement for the labeling of a food by virtue of its having been developed using bioengineering, including any requirements for claims that a food is or contains an ingredient that was developed using bioengineering.
This bill competes with the previously-introduced H.R. 1699, a federal bill that would mandate nationwide GE food labeling. Both federal bills are unlikely to pass, leaving the state patchwork of labeling efforts and mandates in place.
