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.


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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?
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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 http://ncjolt.org/. Here are links to the full Conley, Cook-Deegan and Lazaro-Munoz article the abstract (NC JOLT is Open Access):
http://ncjolt.org/myriad-after-myriad-the-proprietary-data-dilemma/
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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.
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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.
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Filed under FDA LDT Regulation, General Interest, Industry News, Legal & Regulatory

Property Rights and the Human Body

11808967A Canadian court made headlines this month when it decided, as a preliminary matter, that human tissue removed from the body for diagnostic medical tests is “personal property” that belongs to the hospital where the procedure was performed. The case was a medical negligence action brought against two doctors by the estate of Snezana Piljak, a woman who was diagnosed in 2009 with colorectal cancer and died in 2011. At issue in the case is whether the doctors were negligent in failing to diagnose the cancer in 2008 when a colonoscopy was performed on Ms. Piljak. The doctors had petitioned the Canadian court for access to liver tissue biopsied from Ms. Piljak in 2009 at Toronto’s Stonybrook Hospital. The court had to address the matter of tissue ownership before it could consider whether the defendant-doctors had a right to access the liver tissue in order to investigate whether Ms. Piljak had hereditary non-polyposis colorectal cancer (HNPCC or Lynch Syndrome). If the HNPCC were indicated by an examination of the tissue, the defendant-doctors would use that fact to mount a defense against the accusations of negligence. The court ruled that the tissue was personal property of the hospital (though it ultimately denied the defendant-doctors’ request to examine it for technical reasons). The decision that human tissue is “personal property” has important legal ramifications that might affect the biotech industry and genetic research community outside of Canada. The question of ownership of biospecimens has often been tangled up with the status of the biospecimens as personal property, though they are distinct questions.
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Filed under Biobanking, Genomics & Medicine, Genomics & Society, Patents & IP, Privacy

Biometrics: A Developing Regulatory Landscape for a New Era of Technology

eyeball_nJames Bond and Ethan Hunt have been using facial recognition, fingerprint scanning, and optical readers for years on the silver screen. In the real world, the use of technology that identifies unique physical characteristics of individuals (“biometrics”) is rapidly becoming more prevalent. In fact, the Department of Homeland Security uses facial scanning to identify potential terrorists, federal agencies have adopted fingerprint technology to confirm the identity and immigration status of aliens, and private entities have begun implementing palm and retina scanners and other identifiers to complete financial transactions or control access to secure information. Even the new iPhone 5 contains “Touch ID” technology, where a sensor quickly reads the user’s fingerprint and automatically unlocks the phone for the correct fingerprint.
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Filed under Bioinformatics/IT, General Interest, Privacy

ACMG Backs Down a Bit

57 sauceA 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 types of variants in the Table should be examined and the results reported to the ordering physician.” Specifically, the ACMG recommended that whenever a lab does whole genome or whole exome sequencing on a patient, it should examine all 57 [now 56] genes on the list included in the Recommendations and report any clinically significant findings to the ordering physician. It would then be the duty of that physician “to provide comprehensive pre- and post-test counseling to the patient.” Most controversially, the ACMG recommended that the test findings “be reported without seeking preferences from the patient and family and without limitation due to the patient’s age.” As I characterized it in the July post, “patients should be given the 57-gene screening whether they want it or not and told the results even if they say they don’t want them.”
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Filed under Genetic Testing/Screening, Genomic Policymaking, Genomic Sequencing, Genomics & Medicine, Informed Consent

Judicial and Legislative Reactions in California to Maryland v. King, 133 S. Ct. 158 (2013)

window where the light gets inThis year’s first news in the area of genetics and criminal law comes to us from California, where both the judicial and legislative branches are reacting to the U.S. Supreme Court decision in Maryland v. King. In Maryland v. King, the Supreme Court upheld DNA fingerprinting as a routine booking procedure for serious crimes as authorized by Maryland’s DNA Collection Act. Justice Kennedy’s opinion in King indicated it was intended to be a narrow ruling, focused on the specific facets of Maryland’s state statute. This narrow scope effectively left other DNA fingerprinting schemes open to constitutional challenges if they could be distinguished from the details of the Maryland statute. Among those schemes are California’s Proposition 69 and the Federal DNA Fingerprint Act of 2005. The latter scheme was upheld en banc (all the judges of the circuit sitting together, rather than in the usual three-judge panel) by the Third Circuit Court of Appeals in United States v. Mitchell in 2011 (United States v. Mitchell, 652 F.3d 387 (3rd Cir. 2011) (en banc), pet. for cert. filed (Nov. 22, 2011) (No. 11-7603, 11A384), cert. denied – S.Ct. – (Mar. 19, 2012).
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Filed under Genetic Testing/Screening, Genomics & Society, Privacy

District Court Denies Myriad’s Preliminary Injunction Against Ambry

MyriadIn 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 legal point of view. Above all, it is not surprising. Reluctant as I am to say “I told you so,” well, I told you so.

As we previously reported, after the Supreme Court decided AMP v. Myriad Genetics, a number of competitors, including Ambry, jumped into the BRCA testing market. Myriad started suing them in the Utah federal district court, beginning with Ambry (filed July 9, 2013) and Gene by Gene (July 10). The cases were soon consolidated, to be handled together by Judge Shelby. In both cases, Myriad alleged that the defendant’s testing would infringe patent claims that had not been struck down by the Supreme Court’s AMP decision, which had held that DNA that had merely been isolated from the body was not patentable subject matter. In both cases, Myriad sought a preliminary injunction: a pre-trial order that the defendant must cease its testing activity for the duration of the case. If Myriad then prevailed at trial, the injunction would become permanent. The defendants denied Myriad’s allegations, opposed the preliminary injunction, and filed massive antitrust counterclaims alleging that Myriad has used its patents in unlawful ways to monopolize the BRCA testing market.
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Filed under Genetic Testing/Screening, Genomics & Medicine, Genomics & Society, Myriad Gene Patent Litigation, Patent Litigation, Patents & IP, Pending Litigation, Pending Regulation