August 31, 2011

AMP v. USPTO: Plaintiffs Request Rehearing at Federal Circuit

The plaintiffs in AMP v. USPTO have filed at the Federal Circuit to request a rehearing of the case in which they have challenged the eligibility of the patent claims to the BRCA1 and BRCA2 genes. Petition here. The Federal Circuit decided against the eligibility of the composition of matter claims (genes), with reasoning that relied on a structural differences between native and isolated DNA. The plaintiffs contend now that the court was in error, as the genes are claimed by function ( “codes for a BRCA1 polypeptide"), not structure, and thus they maintain their argument that there is no functional difference between a native residing or isolated DNA molecule, as each is capable of performing (and isolated in order to do so) as a gene/DNA template whether in vitro or in vivo. The petition further calls for a reconsideration as to which of the multiple plaintiffs have standing, asserting that geneticist Ellen Matloff and the American College of Medical Genetics are parties with valid standing to contest the patent claims.

August 30, 2011

Parental Imprint on Children's DNA: Liability?

A report from the University of Wisconsin raises the possibility that epigenetic changes result to the the DNA of children as a function of the stress in their living environment; results are published in the journal Child Development. The DNA of children (from cheekswabs to check for methylation changes to DNA) was measured and analzyed according to the reported stress level in the family environment. Children in more stressful circumstances evidenced greater changes to their DNA.  Epigenetics - does your DNA become marked/tagged/altered in response to stress? - is a more recent sub-field in molecular biology, and it aims to account for the effect of prenatal or lifestyle (writ large) influences on genetic constitution. For example, a gene can become chemically altered by biochemical events in response to stress or environmental injury, with the result that a gene may underperform as a result. These are kinds of genetic modifications that ensue pre-birth, for example, post-birth and are not found in the newborn genome.  It's a kind of stress catalogue. So could a genomic record of epigenetic insult now support theories of legal liability in a genetic tort action for indifferent, stressful or abusive parenting?  

August 28, 2011

Genetic Predisposition and Workplace Exposure to Carcinogens: Discrimination?

The intersection of genetics and the workplace is evolving; the most obvious pressure point is that possibility that employer-provided health insurance will be used to procure genetic testing, raising potential for privacy violations as well as workplace decisions that are based on the knowledge of an employee’s genetic makeup. Most often cited is the prototypical example of an employee who learns that she tests positive for the mutation in the Huntingon’s disease gene and faces the certainly that this degenerative and life-shortening disease will develop. There are other concerns for the use of genetic information  by employers. The well-known case of the Burlington Northern Santa Fe Railway Co. engaging in surreptitious genetic testing of employees who claimed compensation benefits for work-derived carpal tunnel led to the filing of an employment/genetic discrimination suit and settlement mediated by the Equal Employment Opportunity Commission (EEOC) in 2001, which relied on enforcement through the Americans with Disabilities Act. The railroad was intent on contesting the workmen’s compensation claims by asserting that the employees had a genetic predisposition to carpal tunnel syndrome. The evolving field of molecular toxicology aims to link new techniques of genetic definition with classic toxicology testing, to develop a more precise profile for how chemical affect (human or other) life. Now comes a scientific report that a genetic mutation has been linked to the development of mesothelioma, a deadly cancer of the lining of the lungs, often seen in workers exposed to asbestos. There have been many claims for compensation for workers exposed to asbestos who later developed mesothelioma; this fact is often cited in the decline of many asbestos companies (e.g., Johns-Manville) who could not survive the onslaught of litigation brought by employees and filed for bankruptcy. For the law, the recent report on mesothelioma raises the specter of possible employer-contesting of workplace claims, as well as future studies to define a risk spectrum for those who will encounter asbestos.

August 24, 2011

N.J. Expands DNA Database to Arrestees

To the ever-expanding scope of state DNA databases, add this from New Jersey: the state DNA database has now been expanded to require those arrested of certain violent crimes to submit a DNA sample for inclusion in the N.J. DNA database. The enabling legislation was signed into law yesterday. In the event that charges are dismissed or an acquittal ensues, an individual can apply for expungement of the DNA record from the database. N.J. now joins about 20 other states which authorize the collection of DNA from arrestees; states vary as to which crimes will trigger the testing. For example, while the N.J. law on arrestee DNA collection applies to certain violent crimes, California and North Dakota collect DNA from those arrested for any felony.

August 22, 2011

Genome-Based Repositioning: Bioinformatics Delivers

The field of bioinformatics, generally described as the use of computer-based data processing applied to problems in the life/medical sciences has now delivered a promising set of results: expression profiles (a biochemical fingerprint of what is happening in the body) were compared between known diseases and known drugs in order to identify "cousins" - where both drug and disease have similar effects on the body. This was a random matching pool, looking to identify drugs which might have previously undiscovered relationship - i.e., potential use - for other medical conditions. In this report, scientists at Stanford reported some previously unrecognized connections between, for example, topiramate, an anticonvulsant drug, now shown to have a parallel biochemical signature with inflammatory bowel disease (IBD), suggesting a potential new application for the drug. Original papers here and here. The repackaging of old drugs for new uses is also referred to as repositioning (or repurposing). Legal issues? New uses for old drugs are potentially patentable, but the drugs themselves are likely to be either coming off patent or already in the public domain, so the focus turns to method patent claims, which recite a way of using a drug in a process (e.g., therapeutic application). From a regulatory perspective, the drugs may have already passed through the FDA-required clinical approval process, so safety profiles are established. But efficacy would still need to be studied (do they work?). From the view of R&D, here's an approach to drug discovery that doesn't require finding new chemicals, but simply (sort of) enlarging the profile of drugs that are already known.

August 16, 2011

Cancer Progress in Embattled Gene Therapy Field

The field of gene therapy - the premise of providing therapeutic benefit by introducing genes into a patient - has been beleagured by a lack of promising clinical results, coupled with a history of erratic clinical attempts, with the most prominent example being that of patient Jesse Gelsinger, who was improperly managed as a patient in a gene therapy trial, leading to his death.  A lack of truly informed consent regarding conflicts of interest held by the researchers running the trial meant that the Gelsinger family was underinformed about the risks and biases that attended to the clinical trial. This episode of mismanagement of the patient- researcher relationship has served as a cautionary tale for other biotechnology therapies which are studied by those with a financial stake in a (positive) outcome. Beyond this individual case, gene therapy trials are still subject to the regulatory review of the NIH Recombinant DNA Advisory Committee (RAC). Against this backdrop, the recent report of a significant remission achieved using genetically altered T cells from leukemia patients illustrates again the promise of gene therapy, coupled with the theoretical assumption that the patient's immune system can be harnessed to fight cancer cells. Article in New England Journal of Medicine.

August 15, 2011

Genetically Engineered Salmon: Labels?

The development of genetically engineered salmon and its potential introduction into the American food supply has encountered opposition from Congressional members, who have called on the FDA to suspend its review process for the salmon. There is opposition on other fronts. Legislation has been introduced in California that would specifically target genetically engineered salmon for labeling.  Mandatory labeling is a strategy that has largely been ineffective as a tool to educate the public regarding their consumption of GE food, due to the fact that the FDA has not required the labeling of genetically engineered food.

August 12, 2011

NIH Proceeding on Genetic Test Registry

In March of last year, the National Institutes of Health (NIH) announced its intention to compile a Genetic Test Registry (GTR), which would provide an authoritative source of available genetic tests in the U.S.  Currently, there are at least 2384 diseases for which some form of genetic testing is available, according to the online Genetests database, maintained by the National Center for Biotechnology Information.  The genetic testing field has come under criticism and scrutiny for the lack of standardization and regulatory oversight, well documented by the HHS Secretary's Advisory Commitee on Genetics, Health and Society here. The establishment of the NIH registry is expected to increase the amount of information provided for the available tests, which theoretically will increase scrutiny and evaluation, but it is important to note that the federal registry will host provider-generated information but will not serve as a neutral reviewing authority.

August 10, 2011

Stem Cell Decision in Federal District Court

In the ongoing dispute over whether embryonic stem cell research can be supported with funds from the federal government, a federal district court has ruled that the National Institutes of Health (NIH) can fund this work. The District Court for the District of Columbia issued its ruling in a challenge by two researchers opposed to the policy. The plaintiffs had argued that the existng Dicker-Wickey amendment, passed by Congress in 1995, which prohibits the funding of “research in which a human embryo or embryos are destroyed” should be interpreted to exclude embryonic stem cell research. The court disagreed, reasoning that NIH had the discretion to characterize the stem cell research as distinct from any research in which embryos are actually destroyed, thus avoiding the Congressional prohibition. Stem Cell Decision Dist. D.C. 2011

August 9, 2011

Fetal DNA Gender Testing in an Unbalanced World

This week's Journal of the American Medical Association (JAMA) reports a meta-analysis of prenatal testing methods for predicting gender, concluding that noninvasive (blood-based) DNA testing has progressed to the point where fetal DNA can be reliably detected, as early as 7 weeks, but most reliably at 20 weeks. Abstract. Certainly, prenatal testing that poses less risk to mother and fetus is generally welcome, but, in this case, such testing must be evaluated against the backdrop of global gender ratios of births. Improved methods of gender prediction inevitably lead to increased demand for gender selection of offspring, an issue that consistently shows general societal preferences for male over female offspring. The discussion of "missing women" that has entered global population debates notes that men may outnumber women due to higher mortality for women, undercare for girls, and prenatal selection. Thus, new technologies that make gender selection even more efficient and convenient will only exacerbate the problem. The World Health Organization and other international groups have called for the UN and national authorities to understand the public health dimensions of gender imbalance and work to limit the use of prenatal gender selection technologies.