For those interested in the FDA approval process (and who isn’t!), the Jan. 22/29 issue of JAMA contains a worthwhile set of articles. Downing et al’s article, “Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012,” in particular, has gained attention (from, for example, the Wall Street Journal and Forbes). The article describes a study of the clinical trial evidence supporting FDA drug approvals, and the authors conclude that the quality of that clinical trial evidence “varie[s] widely.” As someone who used to work at FDA, this result strikes me as utterly unsurprising (and I imagine many FDA lawyers and scholars had the same reaction).
Guest Poster, Prof. Ryan Calo, former director of the SLS Center for Internet and Society
When the popular fantasy writer Robert Jordan died in 2007, his estate handpicked Brendan Sanderson to help finish Jordan’s epic Wheel of Time series. I thought Sanderson did a lovely job on the final books and decided to read one of his previous novels, Mistborn: The Final Empire. It turns out that Sanderson’s tale of inequality, though in respects overdone, enjoys strange and unexpected parallels to ongoing research into the bioscience of class.
In the latest salvo in Myriad Genetic’s bloody patent disputes with its BRCA-testing competitors, Myriad has sued LabCorp after the company announced it was to begin offering its own BRCA-testing product, BRCAssure. This brings to six the total number of companies held at the point of Myriad’s bayonet: Ambry Genetics, Gene-by-Gene, Quest, GeneDx, Invitae, and now, LabCorp. With the threat of these lawsuits, a purely commodified BRCA-testing market is not coming online any time soon.
From a purely patent law perspective, Myriad has several pretty good claims. Out of the patents in play in its loss before the Supreme Court earlier this year, Myriad still retains a number of valid claims: claims directed to BRCA cDNA and primers and probes used for BRCA sequencing, generally. In addition, Myriad has since acquired a number of new patents that have yet to be touched by any federal court. In both of these cases, Myriad’s competitors will need to prove by “clear and convincing evidence” that those claims are invalid–a particularly high bar.
Nonetheless, I think Myriad’s “scorched earth” litigation policy is suicidal. Why? For two, interrelated reasons: (1) because of a rule the Supreme Court established over forty years ago in a case called Blonder-Tongue Labs., Inc. v. University of Illinois; and (2) because of the current composition of the lower appellate court, the Federal Circuit. I’ll briefly explain both and then talk about how they come together to augur poorly for Myriad. Read the rest of this entry »
And it’s not the California Court of Appeals for the First District, the lower court in People v. Buza.
In People v. Lowe, the California Court of Appeals for the Fourth District, Division One (the “Inland Empire”), had upheld against a Fourth Amendment claim a conviction based in part on DNA identification stemming from a sample taken from an arrestee. The California Supreme Court granted and then, after the U.S. Supreme Court’s decision in Maryland v. King, sent it back to the lower court for reconsideration in light of that case. (It did the same with People v. Buza, which had gotten more attention because there the lower court had held the DNA provisions violated the federal constitution.)
Beginning in January, CLB will host its annual Workshop Series. The Workshop brings leading law professors and other academics from throughout the U.S. to present papers of interest to Stanford students, faculty, and members of the community. In previous years, the the Workshop has covered a variety of topics at the intersection of law and the biosciences, including bio-patents, DNA privacy, reproductive rights, science policy, bioethics, health insurance, neuro-law, and others.
The 2013 CLB Workshop Series will be hosted here, at Stanford Law School, and begin on January 7, 2014. All talks run from 4:15 p.m. to 6:15 p.m.; rooms will be posted closer to the talks’ dates. The Workshop is open to all students, faculty, and members of the Stanford community.
2014 CLB Workshop Series Schedule
January 7, David Kaye (Penn State)
“Why So Contrived? The Fourth Amendment and DNA Databases After Maryland v. King”
January 14, Michelle Oberman (Santa Clara)
“What’s Law Got to Do With It? Travels Through the Abortion War”
January 21, Ryan Abbott (Southwestern)
“Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices”
January 28, Rebecca Susan Dresser (Wash. U.)
“Taking Subjects Seriously: A New Look at Research Ethics”
February 4, Victoria Stodden (Columbia)
“Do Software Patents Slow Scientific Discovery?”
February 11, Lawrence O. Gostin (Georgetown)
“Imagining Global Health with Justice”
February 18, Dan Burk (Irvine)
“The Curious Incident of the Supreme Court in Myriad Genetics”
February 25, Jill R. Horwitz (UCLA)
“Who Pays for Workplace Wellness?”
March 4, Francis X. Shen (Minnesota)
“Synapses and Social Policy: Legislative Use (and Misuse) of Brain Science”
I forgot to mention this in my long post on the Haskell re-argument, but I thought it presented an interesting example of the costs and benefits of some rhetorical styles.
In Maryland v. King, Justice Scalia wrote the dissent in his usual understated (not) way. Near the end of that dissent, he wrote “Make no mistake about it: As an entirely predictable consequence of today’s decision, your DNA can be taken and entered into a national DNA database if you are ever arrested, rightly or wrongly, and for whatever reason.”
During the re-argument of Haskell, Judge Milan Smith (not Judge Randy Smith, who was also on the panel) repeatedly cited this language from Justice Scalia to show that Maryland v. King did control this case. Justice Scalia, who had sat in on the conference, said that this was what the case meant; therefore, how could the Ninth Circuit judges try to limit it?
It was a nice instance of trying to use someone’s perhaps excessive arguments against him. Scalia’s “parade of horribles,” which he clearly intended as potential, was used to against him to say that the Court must have already accepted that position.
As a matter of pure logic, I don’t think that works. That the dissent foresees terrible results from a majority opinion does not mean that the majority has accepted those terrible results. But it is a nice little move – and possibly a reminder to people “parade of horribles” arguments to qualify them carefully.
Back in June, a few days after the Supreme Court decision in Maryland v. King, I put up a long post on the possible ways California’s law requiring DNA “donation” from people arrested but not yet convicted of crimes might be distinguished from the Maryland law upheld by the Supreme Court. I followed it with a few shorter ones, here, here, and sort of, here. Today the Ninth Circuit heard re-argument, en banc, of Haskell v. Harris, the federal court challenge to the California statute. (A parallel state court suit, People v. Buza, was drop kicked by the California Supreme Court back to the lower appellate court for it to reconsider in light of Maryland v. King. As far as I can tell, nothing further has happened yet in that case.)
Happily, the Ninth Circuit decided to live stream this oral argument, making it available freely over the web to anyone interested. I watched the live stream and tweeted during it. Now I want to use this blog post to get down my first reactions, staring with four qualifications.
At 2:00 pm on Monday, December 9, an en banc panel (11 judges) of the United States Court of Appeals for the Ninth Circuit will argue, again, the constitutionality of California’s law requiring arrestees to provide DNA immediately for CODIS profiling. The district court judge upheld the law and a 2-1 decision of the appellate panel affirmed. The court granted rehearing en banc and heard the case argued in early September 2012 – eight weeks before the Supreme Court granted cert in Maryland v. King.
The Ninth Circuit then put the case on holding pending the Supreme Court decision. When that decision came down, it ordered supplemental briefs about the meaning of Maryland v. King for this case. It then ordered this re-argument.
Back in June, I put up a long post on the possible ways the court could distinguish California’s law from the Maryland law upheld by the Supreme Court, and followed it with a few shorter ones, here, here, and sort of, here. On Monday we’ll all have a chance to see what the en banc panel thinks – at least as far as their questions can show that.
To watch, go here shortly before 2:00 pm on Monday, December 9; click on Haskell v. Harris; and hope it works. Should be fun!
By Roland Nadler, 2L, Stanford Law School, Student Fellow, CLB
As many of our readers will know, last week the Food and Drug Administration let the regulatory hammer fall on 23andMe, last of the major direct-to-consumer personal genomics firms (at least, the last one dealing in single-nucleotide polymorphism analysis). As Hank Greely detailed in this space previously, the company seems to have exhausted the agency’s patience by engaging in an advertising blitz while maintaining a baffling radio silence vis–à–vis its regulator for six months. The move has touched off some truly stimulating debate in the law and biosciences communities; our local NPR, for instance, hosted a lively Forum segment featuring some familiar voices.
There is certainly plenty to debate. On the more formal legal side of things, commentators have been trading arguments regarding whether FDA can properly exercise jurisdiction over these sorts of direct-to-consumer tests in the first place, an issue which boils down in large part to whether it is correct to say that the product is “intended” for diagnostic use. But looming perhaps larger is the policy debate: should we be regulating this sort of personal genomic service, and if so, how aggressively? As the above-linked radio segment makes clear, the ongoing sparring over this question pits “health exceptionalists” — who believe that a certain level of paternalism is quite justified when it comes to health and medicine, where expertise can be a matter of life and death — against more libertarian–leaning individualists, who counter that consumers are perfectly capable of using their genomic information sensibly, that the market will provide adequate resources and guidance to help them do so, and that, anyhow, no government has the right to stand between individuals and (companies offering them) information about their own bodies.