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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.