May 24, 2014

Two Oregon Counties Ban the Planting of Genetically Engineered Crops

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.

May 16, 2014

FTC Settles Litigation That Targeted Deceptive Marketing of Genetic Tests and Treatments

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.

May 12, 2014

Federal Circuit: Animal Clones Are Not Patentable Subject Matter

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).