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2014-2015 Workshop Series: Mini-Podcasts with Tim Caulfield and Michele Goodwin

Mini-podcasts for the last two speakers of the Fall installment of the 2014-2015 Law and the Biosciences Worshop series are up! Listen to Hank Greely discuss “The Obesity Gene” with Tim Caulfield and fetal protection laws with Michele Goodwin.

 

The Nuances of Preemption in the Generic Drug Context

On Tuesday, the Supreme Court declined to review a California court’s decision that a plaintiff could sue generic drug companies on certain failure-to-warn claims. If you’ve been following the Supreme Court’s drug-labeling-preemption decisions over the last 5 or 6 years, you might find this news a little surprising at first glance. After all, as I explained in a blog post about a year ago, state failure-to-warn claims are generally preempted by federal law for generic drugs. But, once you dig into the facts of the California case – Teva Pharmaceuticals v. Superior Court – the outcome isn’t all that surprising, and it highlights some of the nuances of when state failure-to-warn-claims are, and are not, preempted in the generic drug context.

So what happened in this case?

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New podcast posted!

In this edition, we discuss sunscreen regulations, fetal DNA testing patents, intermittent fasting, and Ebola.

Intermittent Fasting: Try This at Home for Brain Health

If you’re a regular listener to the CLB podcast, you’ll hear me, in our next episode (coming soon!) discussing the latest neuroscience research on intermittent energy restriction (IER). IER, as the name implies, involves intermittently restricting energy intake, or calories. You can do this in several ways. In one method you severely restrict calories (think 400-500 total intake per day) two to three days a week; in another you confine your food intake to an 8-hour period every day; and in yet another you fast once a week for  a 24- to 36-hour period.

Sound intriguing? Difficult? Impossible? Read on . . .

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Chao and Womack on Patentable Subject Matter Rejections at the PTO

An article published last month on Law360 (behind paywall) discusses recent developments in the law of patent eligibility, which is enforced through Section 101 of title 35. We have covered patent eligibility issues on this blog before in connection with diagnostic patents and patents on isolated DNA, and these posts (and others) have a great deal of helpful background information on the applicable law. By way of a brief recap, Section 101 limits patent eligibility to processes, machines, manufactures, and compositions of matter. The courts have held, however, that even if a patent claim nominally falls into one of these categories, the claim is not patent eligible if it is directed to a law of nature, a product of nature, or an abstract idea. The courts have recently explained that, to survive a patent eligibility challenge, the claim must be directed to an inventive application of a law of nature or abstract idea. And if the material is alleged to be a product of nature, it must be markedly different from the natural counterpart.

The authors of the article, Professor Bernard Chao of University of Denver Sturm School of Law and Lane Womack of Kilpatrick Townsend & Stockton LLP, briefly survey the landscape of Section 101 case law and go on to discuss a few patent applications that the U.S. Patent and Trademark Office (PTO) recently rejected on patent eligibility grounds. Although the highest-profile patents are those that have been the subject of court cases, Chao and Womack—though based on an “admittedly unscientific and small sample”—show how the law works on the ground. The authors focus on rejections of composition of matter claims under the product of nature doctrine. In particular, they document a PTO rejection of claims to isolated human monoclonal antibodies that “neutralize[] a HIV-1 virus in vitro” because these antibodies are not markedly different from antibodies amplified from patient B-cells. The authors also discuss a patentable subject matter rejection of claims to compositions that include peptides for interfering with replication of cancer.

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Watching Your Spouse Die on a Television Reality Show: De-Identification as a Myth, in Death and Life

Much biomedical research relies on the idea of “de-identification.” The Common Rule, the federal regulation on human subjects research, applies, as a general matter, if the researchers make some kind of intervention with the research subject or if they use “identifiable private information” about the research subject. But the “Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”

If the private information was not collected by the researcher (it comes from someone’s medical record or was collected as part of someone else’s research) and the research subject’s identity is not known to and cannot “readily be ascertained” by the researcher, it doesn’t count. No consent is required, no IRB review is required – it isn’t “human subjects research.”

And why should it be? If no one knows it is you, you cannot be hurt, or so the argument goes.

On January 2, the New York Times published an extraordinary article entitled Dying in the E.R., and on TV Without His Family’s Consent by Charles Ornstein, a reporter for ProPublica. It recounted how Anita Chanko, a 75-year-old widow, watching an ABC reality television show, NYMed, suddenly realized that she was watching her husband’s death in the emergency room. More than a year earlier, the 83-year-old man had been hit by a garbage truck while crossing the street and had died in the NewYork-Presbyterian hospital. The televised version blurred his face, but not the face of the surgeon, the description of the accident, or the sound of her late husband’s voice, asking “Does my wife know I’m here?”

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Tailored Drug Ads: Creepy or Who Cares?

Yesterday, Bloomberg reported that drugmakers are working with third-party companies to link pharmacy records with online accounts, to tailor drug ads to a person’s particular needs.  In other words, if you buy drug X at the pharmacy – the example drug trotted out in the Bloomberg piece is Viagra – a drugmaker will know you bought drug X, and will tailor online ads accordingly (buy more of drug X! buy drug Y, which treats the same condition as drug X! etc). The links between pharmacy records and online accounts, called “matchbacks,” are made without names changing hands, meaning drugmakers don’t know the names of the patients that they are targeting with particular ads.  But, nevertheless, a number of quotes in the article raise privacy concerns.  And when I tweeted this story, my spouse’s immediate response was “creepy.”

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Video of CLB’s Genetic Testing Conference is Available!

If you missed our October 13th conference on how the United States should regulate genetic testing, you can now watch video of the conference.  It was a fascinating day, with speakers from industry, government, professional associations, genetic counseling, and academia contributing their perspectives.  Check it out here!

You Don’t Miss the Cow Until the Barn is Empty*

As someone with training in both neuroscience and the law, it is maybe not surprising that I’m inclined to think (speculate, worry, etc.) about how current and future scientific and technological advances might affect society for good or bad. Luckily for me, as a fellow with the Stanford Program in Neuroscience and Society (SPINS) it’s also my job to think and write about these things, and so I do. I also read the work of many others—scientists, ethicists, lawyers, and journalists—who think and write about these issues.

But living and working in the microcosm I do, it’s easy to suffer from distorted perception—specifically, to make certain incorrect assumptions about how others process the topics I think about daily. I recognize that not everyone shares my position on a particular issue. But this recognition, in itself, overlooks a third option: that many simply may not care about the issue as much as I do. Or maybe even at all.

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2014-2015 Workshop Series: Mini-Podcast with Teneille Brown

Check out our latest mini-podcast with CLB workshop speaker Teneille Brown (University of Utah). Teneille spoke with Hank Greely about her paper “Cancer Exceptionalism and False Hope at the End of Life.”

Tun-Jen Chiang on Patentable Subject Matter

Patent law is usually justified on utilitarian grounds. To be sure, significant contrary views have appeared in recent scholarship. For example, Professor Robert Merges’ work provides a partly Lockean  account of intellectual property. The dominant view, nonetheless, is that the rules of patent law serve consequentialist goals of inducing invention, commercialization, and disclosure.  In support of this view, scholars often cite the moribund state of the “moral utility” doctrine and the Constitution itself, which empowers Congress to enact laws that would “promote the Progress of Science and Useful Arts.” Professor Tun-Jen Chiang’s forthcoming article, “Competing Visions of Patentable Subject Matter,” challenges this account as a descriptive matter insofar as it relates to the judicially recognized exclusions from patentability.

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Friedman & Lithwick on King v. Burwell: Stay Calm and Stay Calm?

Barry Friedman and Dahlia Lithwick have a post in Slate entitled “Obamacare Is Doomed! Everybody Panic!” Here.

I regularly read, enjoy, and respect SLS grad Dahlia’s work and I hope she and Professor Friedman (of NYU) are right.  And they are clearly right that panic is a not good reaction.  Panic is the worst emotion: never useful and never even enjoyable. I recommend in this case concern and righteous anger.

Cases do get taken without circuit splits, sometimes in situations of overwhelming importance, sometimes when the Court thinks a lower court decision is just blatantly wrong.  These subsidies don’t seem, to me at least, to fit the first category. I worry, a lot, that at least four and maybe five justices think they fit the second.

Friedman and Lithwick argue that this is a case that is important to decide quickly because of the disruption a negative ruling would cause.  But why, exactly, would finding out in June 2015 that you won’t have health insurance be less disruptive than finding out in, say, February 2016?

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Bad News for Obamacare – and America

Or so I think.

On Friday, November 7, the U.S. Supreme Court agreed to hear (granted the petitioner’s writ of certiorari) in King v. Burwell. In King, a panel of the Fourth Circuit unanimously rejected the argument that the federal government cannot, under the Affordable Care Act, subsidize low income consumers who buy health plans in the 36 states where the federal government, and not the states, runs the system’s “health exchanges.”

As a fan of this expanded health coverage, I think that’s bad because it puts that expansion at risk based on a drafting glitch in the Act. More broadly, though, I think it is bad because the Court’s decision to take a case like this now, with only one appellate court decision on the topic, looks unnecessary, political, and, indeed, partisan. And that, too, is bad for the country ­– and the Court.

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Audio of Prof. Mello’s Talk Is Posted!

For those who missed it, audio of Prof. Michelle Mello‘s really interesting talk, “Clinical Trials and Big Data: Moving Forward with Data Sharing,” is now available.  Listen here!

Not Just Another Expanded Access Reform Proposal

Last week, the Wall Street Journal’s Pharmalot blog reported that Rep. Michael McCaul (R-Tx) plans to introduce legislation to reform expanded access.  (Expanded access, or compassionate use, refers to the use of an investigational drug outside of a clinical trial, when the purpose is to treat a patient’s serious or life-threatening condition, rather than to study the drug.)

If you’re familiar with FDA’s expanded access regulations and their history, you might be underwhelmed by this news.  There have been many efforts aimed at reforming expanded access – from litigation to proposed federal legislation to recently enacted state legislation – which generally have focused on the government allowing patients access earlier in drug development and with fewer safeguards (or obstacles, depending on your perspective).  Usually, these proposals haven’t focused on what many identify as the real barrier to access: industry’s understandable reluctance to provide unapproved drugs outside of clinical trials.*

Rep. McCaul’s proposal, however, sounds somewhat different than past reform efforts.

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Is Another Mass-Market tDCS Device Imminent?

Roland Nadler, SLS, ’15

One of the most important developments in the history of transcranial direct current stimulation (a non-pharmacological cognitive enhancement technology I have covered in previous posts) has been the advent of commercially available brain stimulation devices.  The most widely used mass-market device is foc.us, which is advertised as a brain-boosting device for competitive video gaming.  A forthcoming empirical study from one of my Stanford Law colleagues has found that the practice of do-it-yourself brain stimulation changed significantly when foc.us became available.  No surprise — many curious would-be brain-zappers, suddenly spared the challenge of tinkering together a homemade tDCS device, were suddenly provided with the opportunity to purchase one ready-made.  An influx of neophyte users to online DIY communities followed.

We might be poised for another such influx.  Businessweek has reported that a startup with the so-Silicon-Valley-it-hurts moniker Thync has drummed up $13 million in venture capital funding (from the firm of notorious and legally beleaguered beach-blockading tycoon Vinod Khosla).  Their goal?  To bring a tDCS device to market for end-users within a year.  Now, $13 million may sound like hardly a sneeze here in the Valley’s biotech sector, but as capital for medical technology goes, it is substantial.  Given the well-established nature of the underlying technology, I do not think there is much reason to doubt that Thync will deliver on its promise to create and sell this product.

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2014-2015 Workshop Series: Mini-Podcast with Anna Laakman

Our mini-podcast with the first speaker in our 2014-2015 workshop series is up! Listen to Hank Greely and Anna Laakman (Lewis and Clark) discuss Prof. Laakman’s paper, “The New Genomic Semicommons.”

Ebola: The Tolling Bell

As of September 28, the World Health Organization (WHO) estimates that, so far, over 7100 people have been infected with and over 3300 have died from the Ebola virus. These estimates of what has happened are almost certainly far too low; the estimates of what will happen are terrifyingly high. The current Ebola epidemic may well become the worst human disaster in this century. And we are not doing enough about it. Read the rest of this entry »

“How Should the U.S. Regulate Genetic Testing?” Conference Registration Now Open

On Monday, October 13, the Stanford Center for Law and the Biosciences will present a free, full day conference on “How Should the U.S. Regulate Genetic Testing?”  We have a line-up of speakers from industry, professional groups, payors, academia, and governments, including the FDA, to discuss this timely issue.  The conference is free and open to the public, but we do require registration so we can guarantee you a seat (and a free lunch!).  Follow this link for a list of speakers, a registration “button,” and other details.

Hank Greely

Director

Stanford Center for Law and the Biosciences

Another New Podcast!

Podcast listeners: The September 2014 podcast is up!  Hear us discuss biosimilar drugs, popular brain myths, orphan drugs, and the ebola crisis.