NIH Refuses to March In—Again—And National Academies Challenge Human Subjects Regulation

The last few days have seen two significant news items from Washington. First, the National Institutes of Health have refused—yet again—to exercise their “march-in” rights to grant third-party licenses to a patented drug developed with federal funding. The drug in question is enzalutamide, a prostate cancer treatment marketed under the brand name Xtandi by Japanese pharmaceutical company Astellas Pharma. Xtandi was derived from federally supported research at UCLA. Under such circumstances, NIH has the statutory authority to grant a license to a third party if the grantee or its assignee “has not taken, or is not expected to take within a reasonable time effective steps to achieve practical application of the subject invention.” “Practical application” means that that the invention must be “available to the public on reasonable terms.”
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Filed under Legal & Regulatory, Patents & IP, Uncategorized

Cleveland Clinic Pathologist Urges Contract Solution for Return of Genomic Data

The Cleveland Clinic’s Roger Klein responds to my previous GLR post:

Roger-Klein-MD-JDThe Office of Civil Rights’ interpretation of the requirements of 45 CFR § 164 could pose problems for clinical laboratories and the professionals who practice within them. Although the issue of providing benign variants for a single gene, at least prospectively, would be straightforward, a broad definition of the designated medical record set could result in considerable complexity when one considers large-scale sequencing. Some excluded data can be of variable reliability, may be prospectively filtered by software, or may otherwise be omitted from the patient report because of professional interpretation and judgment. One can legitimately argue that this interpretation and judgment, as reflected in the patient report, should serve as the gateway to the official medical record.
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Filed under Genetic Testing/Screening, Genomic Sequencing, Genomics & Medicine, Genomics & Society

UNC Geneticist Comments on Testing Laboratories’ Duty to Return Genomic Data to Patients

UNC’s Karen Weck responds to my previous GLR post:

I agree in principle that patients have the right to access their genomic data; however, in practice it is much more complicated (as things often are). Giving a patient his/her raw sequencing data would be meaningless – it is the interpretation of the clinical significance of sequence data that is important when reporting results. This latter requires the expertise of molecular genetic laboratorians and clinical geneticists. We do not return all genomic sequence variants to individuals in exome sequencing, for example when we determine that they are unlikely to be contributory to their disease or medical health. It is important to those of us doing this that we retain the ability to use our professional judgement to determine what should be reported to patients as medically relevant, primarily so as not to dilute important medical information with irrelevant information.

Karen E. Weck, MD
Professor of Pathology & Laboratory Medicine and Genetics
Director, Molecular Genetics
University of North Carolina at Chapel Hill

Filed under Genetic Testing/Screening, Genomic Sequencing, Genomics & Society

ACLU v. Myriad Genetics, Round 2: The Problem of Governance-by-Guidance

MyriadJust about everyone interested enough in genomics and the law to read this post will know that the American Civil Liberties Union waged a long and ultimately successful legal campaign to invalidate Myriad Genetics’ patent claims to isolated BRCA genes, mutations of which are linked to breast and ovarian cancer. Now the ACLU has launched a second front, this time attacking Myriad’s post-patent business model of maintaining its vast and unique database of genotype-phenotype associations as a trade secret. GLR reported on that evolving strategy two years ago.

The new ACLU attack has, thus far, received modest attention in the scientific press, and some of what has been reported is inaccurate. In this post I will briefly review what has actually happened and then try to sort out fact from fiction in the reportage. The bottom line is that the federal government has not created new stealth regulations dealing with the disclosure of genomic data to patients. It has, however, used the practice of governance-by-guidance to make significant new policy, which is problematic enough in its own right.
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Filed under Genomic Policymaking, Genomics & Society, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP, Pending Litigation

Litigating the Accountability of Clinical Genomics Laboratories

Seeking Accountability from Clinical Genomics Laboratories

A wrongful death case pending in a federal court in Columbia, SC—Williams v. Quest Diagnostics, Inc., et al.—demonstrates the very high stakes involved with clinical genomics testing. The case also underscores the ongoing struggle to (1) establish accountability when mistakes happen and (2) establish a reasonable and effective level of governmental oversight for the laboratories performing such tests. The case could have dramatic implications for the future practice of genomic medicine, and regardless of how this specific case ultimately plays out in the courtroom, the allegations should serve as a serious wake up call to those involved in genomics for clinical purposes in any way.
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Filed under General Interest, Genetic Testing/Screening, Genomics & Medicine, Legal & Regulatory, Pending Litigation

Recent Developments in European Law with Implications for the U.S. Life Sciences Industry

Safe HarborThe last several months have seen several developments in European privacy and intellectual property that have significant implications for life sciences interests—both commercial and academic—in this country. Here is a brief review:

1. Final Approval of Pending EU General Data Protection Regulation

On April 14, 2016, the Parliament of the European Union gave final approval to the long-discussed GDPR. It will replace the current regime of country-by-country laws under the 1995 Data Protection Directive. Whereas an EU Directive requires implementation by individual EU member states, the GDPR is a Regulation (much like a federal law in this country) that will take immediate effect in all EU countries in the spring of 2018.
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Filed under General Interest, International Developments, Legal & Regulatory, Pending Regulation, Privacy, Privacy, Privacy

Genetic information as “perceived disability”: Chadam v. PAUSD

Chadam v. PAUSD, as previously covered on Genomics Law Report, is a case in which parents of a school boy are alleging that a school district violated their son’s rights when it made the decision that it would transfer the boy to another school because of his genetic information. Specifically, the allegation is that when the boy moved to the area and registered for school, (1) the school district learned of the boy’s genetic information related to cystic fibrosis, (2)  the boy was regarded as disabled by the school district, and (3) on the basis of this perceived disability, the school district decided to transfer the boy to another school to protect two other students at the school who have cystic fibrosis. The school district’s decision was apparently based on the idea that the boy, because of his genetic markers, posed a cross-infection risk to the students with cystic fibrosis. Individuals with cystic fibrosis, because their respiratory symptoms create host environments favorable to microbiological pathogens, are often separated from one another to minimize risk of spreading germs to one another. Mere carriers of the genetic markers associated with cystic fibrosis do not pose such cross-infection risks.
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Filed under Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, GINA, Pending Litigation

The Patent Dispute Over Gene Editing Technologies: The Broad Institute, Inc. vs. The Regents of the University of California

CRISPR-Cas9 editing of the genomeThe patent dispute already called “the biggest in biotech history” is only getting started. On January 11, 2016, Administrative Law Judge (ALJ) Deborah Katz officially declared an interference over patents for the CRISPR-Cas gene editing technologies. An interference is a U.S. Patent and Trademark Office (USPTO) administrative proceeding conducted to determine which of multiple claimants to a particular invention has priority rights. Since the patents in question were filed before the March 2013 effective date of the America Invents Act, priority will be awarded to the claimant who was the first to invent the technology in question. This dispute pits Feng Zhang, the Broad Institute, and MIT against Jennifer Doudna and the University of California-Berkeley as well as Emmanuelle Charpentier, Krzysztof Chylinski, and the University of Vienna. Law professor Jacob S. Sherkow has followed the case closely and has provided useful background information on Stanford’s Law and Biosciences Blog.
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Filed under Genomics & Society, Legal & Regulatory, Patent Litigation, Patents & IP, Pending Litigation

Genetic Discrimination Case Against School District is Appealed to Ninth Circuit

classroom-1534186As Stephanie M. Lee reported for Buzzfeed in a well-written account (which contains links to the relevant court documents), an appeal was filed in January with the Ninth Circuit Court of Appeals in the case of Chadam v. Palo Alto Unified School District (4:13-CV-04129-CW). At issue in the case is whether the school district violated a boy’s rights when it decided to force him to transfer schools. The student’s parents allege the transfer decision was because he is a carrier of a genetic variant associated with Cystic Fibrosis or CF (although he has not exhibited symptoms of the disease), and the appeal argues the trial court erred in dismissing the complaint that the school district’s decision to transfer violated his rights under Title II of the American’s with Disabilities Act or ADA (42 U.S.C.A. §12131 et seq.), Section 504 of the Rehabilitation Act of 1973 (29 U.S.C.A. § 794), and the First Amendment of the U.S. Constitution. At the trial court level, the school district successfully defended its decision to transfer the boy by arguing it relied on medical advice and made the decision in an attempt to protect other children at the school who have CF.
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Filed under Badges, Genomics & Medicine, Genomics & Society, GINA, Privacy

EEOC Tries to Harmonize ACA’s Promotion of Employer Wellness Programs with GINA’s Ban Against Employer Access to Genetic Information of Employees and Employees’ Family Members

Gina name tagThe Equal Employment Opportunity Commission (EEOC) is responsible for enforcing Title II of the Genetic Information Nondiscrimination Act (GINA), which prohibits employers from requesting genetic information (defined broadly) from their prospective, current, or former employees. GINA contains only six limited exceptions to this prohibition, one of which is an exception for wellness programs in which the employee’s participation is voluntary.

On October 30, 2015 the EEOC issued a proposed rule to amend GINA regulations in an attempt to harmonize them with the Affordable Care Act’s promotion of employer wellness programs to lower health care costs.
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Filed under Badges, General Interest, GINA, Legal & Regulatory, Privacy, Privacy, Privacy