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.
Read the rest of this entry »

Filed under Genomic Policymaking, Genomics & Society, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP, Pending Litigation

Supreme Court to Rule on Patentability of Human Genes

Robert Cook-Deegan contributed to this commentary. Dr. Cook-Deegan is a research professor in the Institute for Genome Sciences and Policy and the Sanford School of Public Policy at Duke University.

The Supreme Court today granted a writ of certiorari (meaning they agreed to hear the appeal) in Assoc. for Molecular Pathology v. Myriad Genetics, Inc., et al., the famous case centered on patents covering two human genes: BRCA1 and BRCA2.

Of note is that the Court limited its grant of the appeal to the first of the three questions posed by the petitioners/plaintiffs: “Are human genes patentable?


Read the rest of this entry »

Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

Myriad Updates: Clinical Data as Trade Secrets and a Pending Certiorari Decision

Earlier this month, my colleagues John Conley, Robert Cook-Deegan, James Evans and I published a policy article in the European Journal of Human Genetics (EJHG) entitled “The next controversy in genetic testing: clinical data as trade secrets.”

The EJHG article is open access so you can read the entire article at the EJHG website, but here is the abstract:


Read the rest of this entry »

Filed under Biobanking, General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Genomics & Society, Industry News, International Developments, International News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation

Myriad Finally Reaches the Supreme Court (But Only For a Moment)

Yesterday, the Supreme Court (as we predicted last week that it might) GVR’d the certiorari petitions (pdf) of both parties in the Myriad Genetics case.

Big news, right? Not really.

What this means is that the Court Granted cert in Myriad, but for the limited purpose of Vacating the Federal Circuit’s July 2011 decision and Remanding the case to that court for reconsideration in light of the Supreme Court’s decision last week in Prometheus.


Read the rest of this entry »

Filed under General Interest, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Industry News, Legal & Regulatory, Myriad Gene Patent Litigation, Patents & IP, Pending Litigation