August 28, 2015
The ongoing legal battles over the scope of reproductive rights protected by the 14th Amendment – with claims of constitutionally protected values of liberty and privacy invoked – continue, going back to the signature case of Roe v. Wade in 1973 and furthered tailored by Planned Parenthood v. Casey (1992), among other cases. Other arguments for the protection of reproductive autonomy are grounded in gender equality. Fast forwarding to the rapidly developing technological landscape of genetic testing, reproductive medicine has steadily refined the options available for prenatal testing to provide prospective parents with ever more accurate – and earlier obtained – medical information. The most dramatic development has been the availability of non-invasive prenatal diagnosis (NIPD) that relies on obtaining fetal DNA (cell-free detal DNA, cffDNA) from maternal blood as early as 4 weeks into gestation and to test for a number of genetic/chromosomal disorders, including Down syndrome (attributed to the presence of an extra chromosome 21, leading to a trisomy). NIPD has reduced the need for invasive procedures, such as chorionic villi sampling and/or amniocentesis. As prenatal testing becomes more sophisticated, an ongoing political battle rages over whether abortion rights should be restricted based on the intent or rationale of the mother for seeking the procedure. This has led to both state and federal efforts to restrict abortion when it is sought on the basis of gender, race or genetic anomaly (e.g., Down syndrome). Currently, a bill, HB 135, is pending in Ohio that would ban any abortion that is sought sought because prenatal testing reveals Down syndrome. North Dakota enacted a similar bill in 2013 (that same bill would have prohibited abortions about as early as 6 weeks; that portion was struck down by the Eighth Circuit in July of this year). To date, there are no reports of enforcement of these selective bans on abortion. Yet they raise not only the most obvious legal issue of whether such laws impinge on the constitutional right enshrined by Roe (or present the “undue burden” prohibited in Casey). They raise a novel issue of whether the legal rights accorded to the mother can vary according to genetic status of a fetus. Beyond that, express litigation over the constitutional concerns of the fetus itself would lead into the legal personhood legal battles that have been fought already (and overwhelmingly seen the defeat of attempted personhood ballot initiatives and legislation) (see earlier posts here and here). Thus, an indirect genetically-determined legal climate of maternal rights emerges if these laws work as intended – with the twist that the relevant genetic information is derived from the fetus. While is appears that these laws are unworkable as a practical matter, these bills can formally require the provider to question the mother about her motives and can impose felony charges on a physician violating the ban. The Ohio bill is likely to pass, and join the North Dakota bill alone in targeting maternal rights on the basis of a fetal genetic anomaly. Proponents of these bills have argued that, for example, the current climate of genetic testing only encourages the elimination of offspring with detectable genetic abnormalities, with the result that Down syndrome births become increasingly uncommon, and they invoke a kind of disability discrimination argument in support of these measures (however, that leads back to the fetal personhood debate). Opponents argue that the Roe-based constitutional right to seek an abortion – while certainly cabined by many modern legislative limitations – is not conditioned on maternal motive or the genetic status of the fetus, but is simply motivated by a desire to limit women's reproductive choices.
August 19, 2015
In June, the Federal Circuit ruled that a prenatal testing method for detecting fetal DNA in maternal serum was not patentable, violating the prohibition against the patenting of natural phenomena (see here). In the case, Ariosa Diagnostics, Inc. v. Sequenom Inc. (2015), a representative claim from U.S. Patent No. 6,258,540 is as follows:
1. A method for detecting a paternally inherited nucleic acid of fetal origin performed on a maternal serum or plasma sample from a pregnant female, which method comprises amplifying a paternally inherited nucleic acid from the serum or plasma sample and detecting the presence of a paternally inherited nucleic acid of fetal origin in the sample.In the invalidity challenge asserted by Ariosa when the company was sued for patent infringement by Sequenom, Ariosa argued that the method claim effectively covered (or preempted) all uses of the newly observed natural phenomenon - namely, the presence of fetal DNA in maternal blood. The method is centered on that discovery - detect the fetal DNA and perform genetic assessments on that sample, thereby avoiding more risky invasive prenatal procedures. The trial court, and then the Federal Circuit, concluded that the method patent claims were invalid, that they did attempt to patent a natural phenomenon, not an actual invention. As the Federal Circuit stated:
Thus, in this case, appending routine, conventional steps to a natural phenomenon, specified at a high level of generality, is not enough to supply an inventive concept. Where claims of a method patent are directed to an application that starts and ends with a naturally occurring phenomenon, the patent fails to disclose patent eligible subject matter if the methods themselves are conventional, routine and well understood applications in the art.Now, Sequenom has filed a petition at the Federal Circuit, asking for an en banc review of the court's panel decision in June. Sequenom challenges the panel's application of a test for patent eligibility derived from the Supreme Court's 2012 decision in Mayo v. Prometheus. Further, Sequenom argues that the impact of the patent denial on future method patent claims that center on a newly discovered natural phenomena is devastating to future innovation:
The full Court’s intervention is particularly necessary because, if this Court does not step in and draw this line, the panel’s rule threatens to swallow many more meritorious inventions along with this one. The core of nearly every major innovation is the discovery of a fact about the natural world that motivates inventors to combine existing techniques to achieve new practical results. Accordingly, the panel’s test would threaten an invention implementing the discovery that a certain form of Ebola virus provokes an immune response that prevents infection (to take just one timely example). Nearly all vaccines have this problem: The hard part is determining the natural law that a given attenuated virus creates lasting immunity; once you know that, the rest is “routine.” The same goes for future holy-grail discoveries like simple, non-invasive methods of detecting early-stage cancer— ironically, the cheaper and simpler the method discovered, the less patentable it will be. In truth, the problem goes well beyond diagnostics or even medicine: If combining conventional techniques in an unconventional fashion, motivated by a discovery about nature’s laws, is unpatentable subject matter, it is hard to see how any process claim can survive.The Ariosa decision particularly impacts method claims, not composition of matter claims (which were already severely impacted by AMP v. Myriad in 2013). Whether the Federal Circuit decides to accept the petition and rehear the case en banc is unknown; what is known, however, is that the Ariosa decision does jeopardize the validity of similar method claims to the detection of many biochemical or molecular relationships, just at a time when much of modern biotech research is devoted to uncovering exactly that kind of information.
August 15, 2015
The Equal Employment Opportunity Commission (EEOC) has filed a federal complaint against a Virginia employer, Bedford Weaving, Inc., alleging that the company illegally sought medical information from a job applicant, and used that information to deny her a job. The lawsuit relies on the Americans with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act (GINA), both of which are enforced by the EEOC. The ADA, enacted in 1992, prohibits an employer from taking any adverse position against an applicant or an employee based on a real or perceived disability. GINA, enacted in 2008, prohibits inquiries regarding family or personal medical history; such inquiries might reveal genetic disorders or susceptibilities that an employer might use in hiring, retaining or promoting employees. Title II of GINA prevents employers from requesting genetic information or making employment decisions based on genetic information:
Under Title II of GINA, it is illegal to discriminate against employees or applicants because of genetic information. Title II of GINA prohibits the use of genetic information in making employment decisions, restricts employers and other entities covered by Title II (employment agencies, labor organizations and joint labor-management training and apprenticeship programs - referred to as "covered entities") from requesting, requiring or purchasing genetic information, and strictly limits the disclosure of genetic information.More background from the EEOC:
Bedford Weaving operates a weaving manufacturing facility in Bedford, Va. According to the complaint, Bedford Weaving's employment application asked applicants questions about their family medical history, solicited disability-related information, and contained questions about applicants' personal medical history.
Pamela Hedrick applied for work at the facility in August 2013 and filled out an application at that time. Hedrick suffers from chronic obstructive pulmonary disease and asthma, which she disclosed on her application in response to Bedford Weaving's illegal medical questions. EEOC's complaint stated that Bedford Weaving told Hedrick it had no vacant positions, while in fact it had at least two vacant positions for which Hedrick was qualified. EEOC charged that Bedford Weaving failed to hire Hedrick because of her disability, which Bedford Weaving became aware of because Hedrick disclosed disability-related information on her application.
The questions asked on the employment application and the alleged failure to hire due to the information disclosed, violate the Americans with Disabilities Act which prohibits employers from making disability-related inquiries of an applicant before a job offer, and from refusing to hire an individual due to a real or perceived disability. The questions also violate the Genetic Information Nondiscrimination Act (GINA), the federal law that prohibits employers from requesting genetic information, including family medical history, or using that information in the hiring process.
The EEOC seeks back pay, compensatory damages and punitive damages as well as injunctive relief.In 2014, the EEOC settled a class action enforcement action against an employer that violated GINA by making prohibited pre-employment medical inquiries (see here). As illustrated by the new EEOC filing, while GINA is centrally concerned with prohibiting discriminatory practices in the workforce that are based on the genetic status of applicants or employees, it includes strong prohibitions against employer acquisition of such genetic information, whether directly (genetic testing) or indirectly (family history). An academic study published earlier this year found that the general public is largely unaware of GINA or the legal protections against genetic discrimination. That conclusion is noteworthy, as a major impetus for GINA's passage was to alleviate fears by employees that genetic test results sought in medical care might lead to adverse action by an employer. However, most employees in the U.S. are not aware of these legal protections; nonetheless, the use of genetic testing in medical care today continues to increase.
July 30, 2015
As genetic engineering emerged from laboratories in the 1970’s into the biotechnology industry in the 1980’s, the possibility of government regulation arose, with a central question of whether a drug, for example, produced by genetic engineering rather than conventional chemical synthesis, required a distinct regulatory response. In another version of that same question: did a genetically modified plant require a distinct biotechnology regulatory treatment or could the plant fit into established oversight routes for plants produced through convention breeding techniques? In its most generic form, the debate that began in the 1980's wrestled with whether biotechnology processes produce inherently distinct products that demanded novel regulatory responses. According to the Coordinated Framework for the Regulation of Biotechnology announced by White House Office of Science and Technology Policy (OSTP) in 1986, the answer was generally no; a product or an engineered organism could be evaluated by the traditional agencies and laws that already existed to identify and manage risk. The coordinated framework thus divided the primary regulation of biotechnology products among three agencies – the Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA). That scheme was updated in 1992, and that document continued to be the last word in regulatory design. Now the White House OSTP has announced that it will initiate a modernization of the 1992 policy. In a just-published memorandum to the three federal agencies, the OSTP first provides a definition of “biotechnology products” that will be the targets of the review:
For the purpose of this memo, “biotechnology products” refers to products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. It also covers some of the products produced by such plants, animals, and microbes or their derived products as determined by existing statutes and regulations. Products such as human drugs and medical devices are not the focus of the activities described in this memo.In a briefing document on its blog, the OSTP has described the process ahead:
The goal of the effort is to ensure public confidence in the regulatory system and improve the transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system. Here is a bit more detail about the effort’s three components:A modernized jurisdictional design could address some overlap between the responsible agencies, while also considering newer technologies and their placement into the scheme. For example, new organisms or products from the more recent field of synthetic biology might not fit the traditional category of “genetically engineered” which contemplated a small number of discrete and planned changes into an existing organism. A recent study from the Venter Institute on the regulatory challenges raised by synthetic biology endorsed the basic earlier principle that a product should be evaluated for its own discrete risk profile even when produced through synthetic biology; however, the study notes that specific jurisdictional boundaries between the three federal agencies and specific legal authorities need to be updated to account for an expanding portfolio of genetic engineering modalities that will produce even more novel organisms than the first wave of genetic engineering.
First, the Administration will update the Coordinated Framework, after public input, by clarifying the current roles and responsibilities of the EPA, USDA, and FDA in the regulatory process. This update will help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies.
Second, the Administration will develop a long-term strategy, after public input, to ensure that the Federal regulatory system is well-equipped to assess efficiently any risks associated with the future products of biotechnology. This will include performing periodic horizon-scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system, and creating user-friendly digital tools for presenting the agencies’ authorities, practices, and basis for decision-making.
Third, the Administration will commission an outside, independent analysis of the future landscape of the products of biotechnology. The Administration has already asked the National Academies of Sciences, Engineering, and Medicine to conduct such an analysis.
July 23, 2015
Today, the full House of Representatives passed H.R. 1599, the Safe and Accurate Food Labeling Act, by a vote of 275-150. The bill would amend the Federal Food, Drug, and Cosmetic Act regarding the FDA’s interaction with genetically engineered (GE) food products (often called genetically modified organisms, i.e., GMOs). The general purpose of the bill is to establish that GMO regulation should be managed at the federal level only. The bill was written to counter the most common form of state regulation of GMOs, namely, the state laws that mandate the labeling of GMO-derived food products. This includes the Vermont Act 120, scheduled to take effect in 2016, and the Maine and Connecticut laws which are conditional labeling mandates that are only triggered upon the passage of similar laws by neighboring states (see here). The bill contains an express preemption:
(b) Prohibitions against mandatory labeling of food developed using genetic engineering.—No State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any covered product (as defined in section 291 of the Agricultural Marketing Act of 1946, as added by section 201 of this Act) in interstate commerce, any requirement for the labeling of a covered product indicating the product as having been produced from, containing, or consisting of a genetically engineered plant, including any requirements for claims that a covered product is or contains an ingredient that was produced from, contains, or consists of a genetically engineered plant unless the State (or a political subdivision thereof) establishes either of the following programs for the regulation of such claims...The use and management of GMO crops and derived foods continues to be of great interest at the state legislative level. Here is the official summary of H.R. 1599:
This bill amends the Federal Food, Drug, and Cosmetic Act to require the developer of a bioengineered organism intended as food to submit a premarket biotechnology notification to the Food and Drug Administration (FDA). A “bioengineered organism” (commonly called a “genetically modified organism” or “GMO”) is a plant or part of a plant that has been modified through recombinant DNA techniques in a way that could not be obtained using conventional breeding techniques.H.R. 1599 now goes to the Senate, which is not expected to take it up before September. Supporters of the bill are interested in preempting the wave of state attempts and successes at imposing mandatory labeling of GMO-derived foods and believe that Congress can finally shut down mandatory labeling through express preemption of state efforts. Supporters of mandatory GMO food labeling, knowing that the FDA has refused to impose a federal GMO labeling requirement for years, believe that state efforts constitute legitimate responses to consumer interest in GMO food labeling (most surveys note overwhelming support for labeling in the U.S). Although the conflict over product labeling has received the most attention, the bill has other particulars that define a more robust federal regulatory role – allowing the use of the term “natural” when food has GMO-derived content, specifying an acceptable pathway for manufacturers to claim “non-GMO”, and a possibly more general authority to regulate the use of GMO crops – for example, could planting bans on planting GMO crops that are enacted at a county level (see here) also be extinguished as the bill “preempts state and local restrictions on GMOs?” However, after several decades of state-based GMO labeling battles, H.R. 1599 appears to deliver a kind of nuclear option to these efforts, generally relying on a preemption analysis under the Supremacy Clause of the U.S. Constitution to nullify state laws. The state law battles have occurred because of the FDA's refusal to mandate the labeling of GMO food. One counter-measure that still remains at the federal level is an ongoing effort to require the FDA to impose a mandatory GMO labeling scheme at the federal level - see S.511, the Genetically Engineered Food Right-to-Know Act - but this bill has no chance, given the political realities manifest by the passage of H.R. 1599.
The premarket notification must include the developer’s determination that food from, containing, or consisting of the GMO (GMO food) is as safe as a comparable non-GMO food. For the GMO to be sold as food, the FDA must not object to the developer’s determination. If the FDA determines that there is a material difference between a GMO food and a comparable non-GMO food, the FDA can specify labeling that informs consumers of the difference.
A food label can only claim that a food is non-GMO if the ingredients are subject to certain supply chain process controls. No food label can suggest that non-GMO foods are safer than GMO foods. A food can be labeled as non-GMO even if it is produced with a GMO processing aid or enzyme or derived from animals fed GMO feed or given GMO drugs.
The FDA must allow, but not require, GMO food to be labeled as GMO.
The FDA must regulate the use of “natural” on food labels.
This bill amends the Agricultural Marketing Act of 1946 to require the Agricultural Marketing Service to establish a program to certify non-GMO food.
This bill preempts state and local restrictions on GMOs or GMO food and labeling requirements for GMOs, GMO food, non-GMO food, or “natural” food.