August 28, 2015

More States See Legislation That Conditions Abortion Rights on the Genetic Status of the Fetus

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

Sequenom Seeks En Banc Rehearing After Federal Circuit's Denial of Prenatal DNA Testing Patent

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

EEOC Files GINA Lawsuit Against Employer for Unlawful Collection of Genetic Information

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.