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NIH Refuses to March In—Again—And National Academies Challenge Human Subjects Regulation

The last few days have seen two significant news items from Washington. First, the National Institutes of Health have refused—yet again—to exercise their “march-in” rights to grant third-party licenses to a patented drug developed with federal funding. The drug in question is enzalutamide, a prostate cancer treatment marketed under the brand name Xtandi by Japanese pharmaceutical company Astellas Pharma. Xtandi was derived from federally supported research at UCLA. Under such circumstances, NIH has the statutory authority to grant a license to a third party if the grantee or its assignee “has not taken, or is not expected to take within a reasonable time effective steps to achieve practical application of the subject invention.” “Practical application” means that that the invention must be “available to the public on reasonable terms.”
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Filed under Legal & Regulatory, Patents & IP, Uncategorized

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FDA v LDTIn her recent post on the FDA’s draft guidance on its proposed oversight of Laboratory Developed Tests (LDTs), Jen Wagner mentioned my interview with Genome Web’s Turna Ray on January 15, 2015.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:
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Filed under Badges, FDA LDT Regulation, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Legal & Regulatory, Pending Regulation, Uncategorized

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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Update: 23andMe appeases FDA

FDA v LDTIn an effort to quiet the storm, 23andMe has announced that it does intend to continue seeking FDA approval and that, while that process is ongoing, it will no longer provide health-related information to new customers. Customers whose Personal Genome Service® kits were ordered prior to November 22, 2013 will still have access to that information; however, customers whose PGS was ordered after the FDA warning letter will only have access to ancestry information and their raw data. The company also announced that it would offer a refund to those who ordered the PGS on or after November 22, 2013.

So is this a victory for the FDA? Is this a loss for 23andMe? A setback for consumers? A win for anyone?
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Filed under Badges, Direct-to-Consumer Services, FDA LDT Regulation, Genetic Testing/Screening, Genomics & Medicine, Genomics & Society, Pending Regulation, Uncategorized

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 statutes as well as other laws pertaining to misrepresention, breach of warranty, and unjust enrichment.

A class action is a suit brought by a limited number of “named plaintiffs” or “class representatives” (here just one, 23andMe customer, Linda Casey) on behalf of a large number of other, similarly situated people (the class members) who don’t actually participate in the litigation but would share in any recovery. The class here consists of all of 23andMe’s customers. The case seeks unspecified monetary damages, including at a minimum a refund of whatever the class members paid for the PGS, as well as an order (an injunction) prohibiting 23and Me from engaging in false advertising in the future. If there have been, as estimated, almost half a million PGS purchasers who paid the list price of $99, then the damages are potentially big. The complaint in this case also asks that 23andMe be ordered to pay the fees of the class lawyers. Attorneys’ fees can be huge in class actions, sometimes—and very controversially—running into the millions of dollars.

The complaint makes extensive reference to the November 22, 2013, FDA warning letter as evidence of 23andMe’s false advertising, so it is reasonable to ask whether that letter prompted this suit. That is, did the lawyers see an opportunity to free-ride on the FDA’s work and the negative publicity attendant on the letter? Hard to say: On the one hand, the complaint is long, detailed, and carefully prepared, evidence that’s in been in preparation for a while. On the other, the timing coincidence and the symbiosis of the allegations are suggestive. Across the legal spectrum, class action filings have a tendency to follow bad news for the defendant.

What can we say about the likelihood of success, or at least a valuable settlement, for the plaintiff class and their lawyers? It’s too early to do much more than speculate. Nonetheless, there are a few factors to keep in mind. First, the proposed class has to be initially approved, or “certified,” by the court before the case can continue as a class action. That’s a long (often a year or much more) and complex process involving difficult legal standards. As classes go, this one seems pretty coherent, so at first glance it would seem to have decent prospects for certification. As far as an ultimate winner and loser, the FDA has significantly helped the plaintiff class by setting out in its warning letter several specific advertising claims that it says are unsubstantiated. The class would have to prove at trial that the FDA’s charges are true, but those charges give the class a considerable head start. It is certainly a case with significant potential.

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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Uncategorized

Troubles keep coming for 23andMe

As if the FDA warning letter wasn’t enough, 23andMe, Inc. now has a lawsuit on its hands. The suit, known as Casey v. 23andMe, was initiated on November 27, 2013, in federal court for the Southern District of California (Case 3:13-cv-02847-H-JMA). The suit is being brought as a class action and on the general basis of breach of implied warranties, unjust enrichment, and misrepresentation.
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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Policymaking, Genomics & Medicine, Genomics & Society, Pending Litigation, Uncategorized

Maryland v. King: Three concerns about policing and genetic information*

With its decision in Maryland v. King [pdf], the Supreme Court finally stepped into the debate about the use of DNA databases in the criminal justice system. The United States now has the largest DNA database in the world, with 10.4 million offender profiles and 1.5 million arrestee profiles as of June 2013. In King, the Court was called upon to decide whether the Fourth Amendment prohibits the collection of DNA samples from arrestees without a warrant or probable cause, the traditional requirements of searches and seizures.
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Filed under Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Uncategorized

Twitter Roundup

With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here is a recap of what I was Tweeting recently @genomicslawyer:

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Twitter Roundup

With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here is a recap of what I was Tweeting recently @genomicslawyer:

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Twitter Roundup

With so many developments at the intersection of genomics and the law, there are often a variety of interesting stories that, for one reason or another, don’t find their way into a full-length posting on the Genomics Law Report. Here is a recap of what I was Tweeting recently @genomicslawyer:

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