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

genome sequenceIn 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 set important precedent relevant to intellectual property in genetics/omics and precision medicine.

The D’Arcy case itself, along with other litigation in the U.S. involving Myriad’s gene patents, has been discussed previously on Genomics Law Report (See generally here). Mutations in the BRCA1 gene confer increased risk of breast and ovarian cancer. The Myriad scientists were first to clone and sequence BRCA1, the gene that Mary-Claire King had linked to cancer susceptibility in a landmark paper in Science in 1990. Myriad identified several BRCA1 mutations. Myriad’s Australian Patent 686,004 contains 30 separate claims. Yvonne D’Arcy challenged the validity of the first three claims in Myriad’s patent, which claimed the isolated BRCA1 sequences with mutations conferring increased risk of breast and ovarian cancer.
Read the rest of this entry »

Filed under Genetic Testing/Screening, Genomics & Medicine, Legal & Regulatory, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP

How Privacy Law Affects Medical and Scientific Research

eyeball_nOver 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 the health care area. These are the very kinds of people who need to worry about privacy—of their customers, users, patients, and subjects. As they started on focusing on privacy concerns, these clients turned to their IP lawyers for help, and my Robinson Bradshaw colleagues and I have tried to stay ahead of their needs.

As a consequence of my growing privacy practice, I am regularly called on to give overviews to other lawyers as well as non-lawyers in the scientific and business communities. I thought it might be useful to devote a GLR post to a privacy law summary targeted at readers who conduct medical and other scientific research. Privacy law is a transnational mess, so this will be a bit longer than I’d like—my apologies, and please don’t shoot the messenger—but I’ll try to cut through the legal jargon.
Read the rest of this entry »

Filed under International Developments, Legal & Regulatory, Privacy

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 Supreme Court cases that brought about a dramatic shift in the approach taken by the lower courts and the Patent Office, the question is whether those patents are still alive. The answer is that they are, but barely, and their prognosis is bad.

Do these developments matter to people in the life sciences? The answer is a resounding yes. If we then ask why software patentability matters, the answer is that life sciences are increasingly focused on software-dependent data analysis.

These points were brought home to me when I spoke at another, more recent conference—the Bio-IT World Conference in Boston this past April.
Read the rest of this entry »

Filed under Bioinformatics/IT, Industry News, Legal & Regulatory, Patent Litigation, Patents & IP

Conley Q & A on LDTs and the FDA

FDA v LDTIn 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 Laurence Tribe on behalf of their client, the American Clinical Laboratory Association. The main point that Clement and Tribe made was that the FDA lacks legal authority to oversee LDTs, at least in the way that it’s proposing to do so. As I told Turna, I don’t necessarily disagree with their position; in fact, I’m skeptical about the FDA’s authority to do this. Also, like Jen, I’m not persuaded the proposed FDA initiative is likely to work well from a practical perspective. Nonetheless, I agreed to play along in a devil’s advocate exercise, making the counterarguments I’d make if representing the FDA. Here’s a brief summary of my arguments:
Read the rest of this entry »

Filed under Badges, FDA LDT Regulation, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Legal & Regulatory, Pending Regulation, Uncategorized

Groundhog Day: FDA and Proposed Oversight of LDTs

FDA v LDTOnce again, attention in Washington, DC has turned to the Food and Drug Administration (FDA) and its proposed oversight of all laboratory developed tests (LDTs). The occasion for this attention was the FDA’s separate releases on October 3, 2014 of its proposed LDT framework and proposed notification and medical device reporting guidance. The former describes the basic structure for how the FDA intends to exercise its authority over LDTs as medical devices (e.g., risk classification and enforcement discretion categories), and the latter describes the process by which laboratories offering LDTs must notify the FDA of all LDTs (i.e., registration) and the adverse event reporting requirements that would apply to LDTs as medical devices (i.e., reporting of deaths, serious injuries, malfunctions, etc.). The agency hosted a public meeting on January 8-9, 2015 to discuss the proposed guidance and is accepting written public comments until February 2, 2015. [No joke: Comments are, in fact, due on Groundhog Day.]

• Comments on the proposed LDT framework (Docket No. FDA-2011-D-0360) can be submitted here.
• Comments on the proposed notification and medical device reporting (Docket No. FDA-2011-D-0357) can be submitted here.

The public meeting featuring speakers and panelists was organized into six topical sessions covering test components and labeling; clinical validity and intended use; categories for continued enforcement discretion; notification and adverse event reporting; classification and prioritization; and quality system regulation. The FDA has promised to post the transcript (and, in the meantime, some live tweets from the meeting will remain available on @DNAlawyer’s feed). Dr. Jeff Shuren started the meeting with a reminder that the FDA’s proposed guidance was based on discussions held five years ago, in 2010. (Prior GLR coverage is here.)
Read the rest of this entry »

Filed under Badges, FDA LDT Regulation, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Pending Regulation

Australian appeals court upholds patents on isolated BRCA1 DNA

Robert Cook-Deegan, MD

Bob Cook-Deegan 0546.05 © Duke University Photography Jim WallaceOn September 5, the Federal Court of Australia (the appeals court) upheld a claim on isolated DNA from the BRCA1 gene. It dismissed Yvonne D’Arcy’s appeal of a case that has attracted international attention. Australian patent 686,004 has never been enforced, so the court decision has little real-world concrete impact. As Richard Gold and Julia Carbone explained in their classic case study, “Myriad Genetics: In the Eye of the Policy Storm,” the patent rights on BRCA1 and BRCA2 were exclusively licensed for use in Australia and New Zealand to Genetic Technologies, Ltd. (GTG), which in turn made them a “gift to the people of Australia.” When the CEO of GTG proposed taking back that gift in the summer of 2008, he provoked a firestorm and the company backed down in October, restating that it would not enforce its patent rights against laboratories offering BRCA testing. The Australian Senate held a series of hearings, and a bill proscribing DNA sequence patents was proposed, but the new government opposed it, and it lapsed. Instead, Australia enacted patent reforms in 2012 that raised the bar for utility and clarified the Australian law’s exemption from infringement liability for research and regulatory approval. Most of the provisions of that law took effect on April 15, 2013, the very day Association for Molecular Pathology v Myriad Genetics (AMP v Myriad) was argued before the U.S. Supreme Court.

Read the rest of this entry »

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

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

96-well plateA 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, the laboratory doing the testing should always sequence and report to the ordering physician the results for 57 (now 56) genes on the ACMG’s list. Among the questions I addressed in that post was this one: “Do those Recommendations become by definition the standard of care for the specialty, immediately or in the near future?” I wondered specifically about a future case in which a doctor ordered WES, the lab analyzed only the genes the doctor was interested in, leaving out some of the ACMG’s 56, and the patient subsequently suffered a bad medical outcome linked to an omitted gene. Would failure to follow the ACMG Recommendation be evidence—maybe even conclusive evidence—of malpractice?
Read the rest of this entry »

Filed under Genetic Testing/Screening, Genomics & Medicine

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

MyriadGLR 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 in its growing European operations. The co-authors are Robert Cook-Deegan, M.D., a research professor of public policy and medicine at Duke, and Gabriel Lazaro-Munoz, J.D., Ph.D., a post-doctoral fellow at UNC’s Center for Genomics and Society (where John is also an investigator). The article was included in NC JOLT’s 2014 Symposium, “Gene Patents After Myriad.” The Symposium also includes articles by Sandra Park of the ACLU, who was involved in the Supreme Court case, and law professors Lori Andrews and Christopher Holman. The Symposium can be accessed at Here are links to the full Conley, Cook-Deegan and Lazaro-Munoz article the abstract (NC JOLT is Open Access):
Read the rest of this entry »

Filed under Uncategorized

Long-Awaited Announcement from the FDA on LDTs

FDA v LDTOn July 31, 2014, the FDA gave Congress notice that in the next 60 days it would be announcing draft guidelines on the regulation of laboratory developed tests (LDTs). This topic has been discussed on the Genomics Law Report frequently for years. [You can access the previous coverage here].

The “Anticipated Details of the Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories: Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” mark a large expansion of FDA regulatory activity into industry practices that have been–depending on your perspective on the scope of the agency’s regulatory power—enjoying the FDA’s discretionary forbearance from regulation or taking place just outside of FDA’s regulatory reach. Indeed, aside from a few “it has come to our attention” letters in Summer 2010 and the second, more forceful warning letter issued to 23andMe in Fall 2013, the FDA has not taken action against companies providing individuals with direct-to-consumer (DTC) access to their personal genetic/genomic information.
Read the rest of this entry »

Filed under Direct-to-Consumer Services, FDA LDT Regulation, Genetic Testing/Screening, Genomics & Medicine, Genomics & Society, Industry News, Legal & Regulatory, Pending Regulation

FTC Takes Action to Protect Consumers from False Genetic Advertising Claims

600px-US-FederalTradeCommission-Seal.svgFor the past few years, discussions regarding the regulatory oversight of direct-to-consumer (DTC) genetic tests have focused heavily on one agency: the FDA. Attention has grown since 2010 when the FDA began hinting the agency would broadly regulate laboratory developed tests (LDTs) and has only intensified since the issuance of the infamous cease-and-desist letter issued to 23andMe in late 2013. Now 23andMe and the FDA are hitting the reset button to begin the long road to restore 23andMe’s Personal Genome Service® one condition or trait at a time (the company announced on June 20, 2014 that it has filed, and the FDA has accepted for review, its first 510(k) application for Bloom Syndrome). The personal genomics industry continues to wait anxiously for the FDA proposed rules on DTC genetic tests, which are on the FDA’s Draft Guidance “B-List” for FY2014 (i.e., DTC genetic tests are not among the FDA’s top priorities).

Perhaps it’s time another administrative agency is brought into the discussion. This year the Federal Trade Commission (FTC) has taken its first actions to protect consumers of genetic tests. The FTC has broad authority to protect consumers from unfair and deceptive trade practices (including false and misleading advertising claims) under Section 5(a) of the FTC Act, 15 U.S.C. 45(a)(1). The FTC also enforces posted corporate privacy policies. The FTC filed charges against two companies in January (Genelink, Inc. and its former subsidiary foru™ International Corporation) and filed charges against a third company in June (L’Oreal USA, Inc.) for “purported personalized genomics products.” The charges related to the marketing of nutrigenetic and dermagenetic products. The matters against the first two companies were resolved by settlement approved on May 12, 2014. The FTC announced a proposed settlement of the charges against L’Oreal on June 30, 2014.
Read the rest of this entry »

Filed under FDA LDT Regulation, General Interest, Industry News, Legal & Regulatory