Robinson Bradshaw

Category: Genomics

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 […]

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

Just 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 […]

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 […]

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

The 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 […]

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

The 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 […]

Genetic Discrimination Case Against School District is Appealed to Ninth Circuit

As 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 […]

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

The 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 […]

Australia revokes Myriad’s three patent claims on isolated BRCA1 DNA

In a decision issued on October 7, 2015, the High Court of Australia (High Court) ruled unanimously in D’Arcy v. Myriad Genetics Inc., [2015] HCA 35, that three BRCA1 patent claims held by Myriad Genetics, Inc. under Australian Patent 686,004 were invalid. While Myriad’s patent had actually expired on August 11, 2015, the court decision […]

How Privacy Law Affects Medical and Scientific Research

Over the last five or so years my law practice has focused increasingly on privacy law, both domestic and international. In hindsight, this was a predictable outcome: as an intellectual property lawyer, many of my clients do business on the Internet or are engaged in scientific research and development, with many of the latter in […]