Robinson Bradshaw

Author: John Conley

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 […]

Are Software Patents Dead?—Alice’s Implications for Life Sciences

Not too long ago, getting patents on software and business methods was all the rage. And concern about their effects was profound. In fact, in 2003 I spoke at a Federal Reserve Bank conference devoted to the question of whether such patents were an existential threat to the financial industry. Now, after a series of […]

Conley Q & A on LDTs and the FDA

In her recent post on the FDA’s draft guidance on its proposed oversight of Laboratory Developed Tests (LDTs), Jen Wagner mentioned my interview with Genome Web’s Turna Ray on January 15, 2015. Turna asked me to address some arguments made in a “white paper” written by former U.S. Solicitor General Paul Clement and Harvard law professor […]

Medical Organizations Can’t Shape the Rules for Admitting Expert Testimony

A little more than a year ago I wrote a post about the then-new Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing from the American College of Medical Genetics and Genomics (ACMG). Those Recommendations (since modified somewhat) proposed that whenever a patient undergoes whole-genome or whole-exome sequencing (WES) for any purpose, […]

New Article on Myriad Litigation and the Company’s Evolving Strategy

GLR editor John Conley has just co-authored a new article in the North Carolina Journal of law & Technology about Myriad Genetics’ response to last summer’s Supreme Court case that invalidated its broadest gene patents. The article focuses on Myriad’s business decision to rely less on patents and more on its vast proprietary database, especially […]

ACMG Backs Down a Bit

A year ago, the American College of Medical Genetics and Genomics (ACMG) released its Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing. As I reported in a July 2013 post, the core recommendation was this: “The ACMG recommends that for any evaluation of clinical sequencing results, all of the genes and […]

District Court Denies Myriad’s Preliminary Injunction Against Ambry

In a 106-page opinion issued on March 10, 2014, Judge Robert Shelby of the federal district court in Salt Lake City denied Myriad Genetics’ Motion for Preliminary Injunction in its lawsuit against Ambry Genetics Corporation. For reasons I’ll try to explain, this is a significant development from a practical standpoint, but not earth-shaking from a […]

The Revolt of the Cs: Class Action Filed Against 23and Me

The “Cs” in DTC have revolted, in the form of a consumer class action filed November 27, 2013, in a California federal court (Case 3:13-cv-02847-H-JMA). The suit, called Casey v. 23andMe, alleges that 23andMe falsely and misleadingly advertises its Personal Genome Service (PGS) test kit. The suit charges that these advertising practices violated numerous California […]

Reader Response . . .

James P. Evans, Bryson Distinguished Professor of Genetics & Medicine and Editor-in-Chief of Genetics in Medicine, responds to my post on the FDC “warning letter” to 23andMe: I liked your piece – with one exception. You say you are “libertarian” in the medical realm. This could make sense if you paid for all of your […]

If 23andMe Falls in the Forest, and There’s No One There . . .

Genomics Law Report has paid close attention to the FDA’s potential regulation of laboratory developed tests (or LDTs) over the years. We have decided to address the most recent development – a cease and desist letter sent by the FDA to 23andMe – in two posts — by Jennifer Wagner and by John Conley. On […]