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Podcast No. 9

Hey, CLB Podcast listeners–we’ve got No. 9 for you. This month, we feature Hank Greely with…

Fellow Jake Sherkow on Bowman v. Monsanto, the patented soybean seed case;
Hank with soon-to-be former fellow Matt Lamkin on MERS and pandemic fatigue;
Fellow Jake Sherkow on patenting the gut microbiome;
and himself on de-extinction.

You can hear the podcast, here:

And special thanks always to David Preston, our sound engineer, editor, mixer, producer, and more!

The Supreme Court decision in Maryland v. King – Meh

Late in Voltaire’s book, Candide, we meet a Venetian nobleman called Signor Pococurante, who, as his name indicates, cares little for anything – great art, excellent music, brilliant literature, beautiful gardens, or gorgeous women.  With regard to the Supreme Court’s two DNA cases this term, I feel a bit like Signor Pococurante – I don’t much care.  (Happily, I do not share his disdain for other good things.)

The Supreme Court released its decision today in Maryland v. King, finding, by a five to four vote, that Maryland’s statute requiring people arrested of certain felonies to provide a DNA sample at arrest, so that the arrestee’s DNA profile could be included in the state, and ultimately federal, DNA forensic database does not violate the Fourth Amendment to the federal constitution.  And, rather oddly, I find I don’t much care.  Here’s why. Read the rest of this entry »

Maryland v. King: A Mouthful of Contradictions

The Supreme Court’s opinion in Maryland v. King came out earlier today, concerning whether the Fourth Amendment permits the collection of DNA samples upon arrest. In an interesting 5-4 split (with Breyer joining the conservative wing, and Scalia the liberal one), the Court answered in the affirmative. And while I agree with the opinion on public policy (and scientific) grounds, its legal analysis leaves something to be desired. Read the rest of this entry »

Podcast No. 8

Hey, CLB Podcast listeners–we’ve got No. 8 for you. This month, we feature Hank Greely with…

Fellow Jake Sherkow on the Indian Supreme Court Gleevec decision;
Fellow Matt Lamkin on disability law and social realities;
and himself on the ethical issues surrounding the sequencing of the HeLa genome.

You can hear the podcast, here:

Purdue Pharma & OxyContin: Regulatory Gamesmanship? A Debate

Recently, the FDA declared that it was no longer accepting applications for generic formulations of Oxycontin. The reason? Because Purdue Pharma, OxyContin’s manufacturer, had developed–and received approval for–an “abuse-resistant” formulation of the drug. Whether this is an example of regulatory gamesmanship or the fruits of incentivizing public safety is up for debate. With that in mind, the CLB blog is proud to host a short  debate between CLB Fellow, Jake Sherkow, and Duquesne School of Law Professor, Jacob Rooksby.

The format is simple–each has ~500 words of opening statement followed by ~250 words of rebuttal. You decide which Jacob is right. (Or if both are. Or, if neither.) As Jacob Rooksby is the away team, he gets to bat first, while Jake Sherkow gets “last licks.” Read the rest of this entry »

Podcast No. 7

Hey, CLB Podcast listeners–we’ve got No. 7 for you. This month, we feature Hank Greely with…

- SLS 1L, Amanda Rubin, on the annoucement of President Obama’s Brain Map Initiative;
- SLS 1L, Roland Nadler, on the electrifying work of transcranial direct current stimulation;
- Fellow Jake Sherkow on the less electrifying, but still very important, Amgen v. Connecticut Retirement Plans case decided by the Supreme Court;
- and himself on mice with human neurons.

You can hear the podcast, here:

(And music bumper information can be found here.)

Mini-Podcast with Shubha Ghosh

CLB recently had the pleasure of sitting down with Shubha Ghosh from the University of Wisconsin for a mini-podcast to talk about his recent book, Identity, Invention, and the Culture of Personalized Medicine Patenting. You can hear the mini-podcast here:

Ryan Calo on Brain-Computer Interfaces and Privacy

Dr. John Ioannidis on The (Un)Reliability of Biomedical Evidence

AMP v. Myriad Genetics Oral Argument Recap

Today’s oral arguments in Association for Molecular Pathology v. Myriad Genetics were wide-ranging–and often-times confusing. Almost all of the Justices seemed struggled with basic principles of laboratory genetics, and several seemed hung up on various points of basic patent law. Nonetheless, Myriad’s composition claims–that is, gene patent–claims seem in jeopardy. Whether that jeopardy will translate into five or more votes, however, remains to be seen. Read the rest of this entry »

Mini-Podcast with Andrew Torrance

CLB recently had the pleasure of sitting down with Andrew Torrance from the University of Kansas for a mini-podcast to talk about law and the biosciences. You can hear it here:

Patenting Cancer Vaccinations

Elvina Chow

On February 10, 2013, Nature Medicine published an article, which discloses that the partially disabled cowpox virus, known as JX-594, has been shown to combat cancer. Scientists have manipulated the vaccinia virus by removing the self-replicating gene and inserting another gene that helps recruit immune cells to cancerous tumors, thereby creating the engineered virus JX-594. Read the rest of this entry »

Yet More Mini-Podcasts

As a coda to our Law and the Biosciences workshop this year, we have mini-podcasts from our last three speakers: Carl Elliot from the University of Minnesota, Alta Charo of the University of Wisconsin, and Nita Farahany of Duke University. You can find them here:

Breaking News – White House Announces "BRAIN" initiative

“Brain Research Through Advancing Innovative Technologies” will be the subject of over $100 million in federal investment.  DARPA will contribute $50 million, NIH $40 million, and NSF $20 million.   They will partner with the Allen Institute ($60 million), Kavli Foundation ($4 million), Salk Institute ($28 million), and Howard Hughes Medical Institute ($30 million).  It’s not clear what all these dollar figures really mean, but it almost certainly beats a poke in the eye with a sharp stick.

BRAIN is to be led by two prominent neuroscientists:  Bill Newsome at Stanford (great scientist, good guy) and Cori Bargmann at Rockefeller University (don’t know her, though know her name).

BRAIN is to have an ethics component, to be handled (initially?) by the President making requests to the President’s Commission for the Study of Bioethical Issues (PCSBI).  PCSBI has at least two members were versed in neuroethics and law and neuroscience:  Nita Farahany and Jonathan Moreno.  In the long run I think any one general bioethics commission won’t prove adequate – I’d prefer “let a hundred flowers bloom,” though that requires water, fertilizer, and (of course) money for those flowers.  But this is astart.

Here’s the White House announcement:  White House.

Here’s a useful NY TImes article about the project:  NYT.

How important this will turn out to be, of course, remains to be seen. It is not a commitment at the level of the Human Genome Project, but there doesn’t seem to be the same kind of target available as there was for the HGP. I’m optimistic – but that’s probably just my brain talking.  :)

Hank Greely

CORRECTIONS MADE:  I not only misspelled Dr. Bargmann’s name, but I placed her at the wrong university in Manhattan – she is at Rockefeller University.

CLB's Jacob Sherkow on Mayo v. Prometheus and the Method of Invention

The CLB’s own Jacob Sherkow has a great piece on The Yale Law Journal Online analyzing a little-noticed, but potentially very significant, aspect of the Supreme Court’s recent decision in Mayo v. Prometheus:

The Mayo Court’s novel test for patent eligibility—whether or not an invention involves “well-understood, routine, conventional activity, previously engaged in by researchers in the field”—focuses on how an invention is accomplished rather than what an invention is. That concern with the method of invention poses several normative, statutory, and administrative difficulties. Taken seriously, the “how” requirement will likely have broad effects across all levels of patent practice.

You can find the article here.  It’s well worth the read.

Mark Lemley on FTC v. Actavis Oral Argument

As part of CLB’s Supreme Court Law and the Biosciences Oral Argument Reduxes (CLBSCOTUSLABOAR), we have Stanford’s own Mark Lemley discussing oral arguments in last week’s FTC v. Actavis case. You can listen to the interview here:

Critics skeptical about announcements by GSK and Roche to make available more clinical trial data

Prashant Reddy Thikkavarapu, CLB Student Fellow

Following in the footsteps of GSK’s decision to release all clinical trial data (which we blogged about here), Swiss pharmaceutical major Hoffman La’ Roche has announced that it too would make available more clinical trial data.

Unlike GSK which was probably motivated to release more clinical trial data after facing a $ 3 billion dollar fine, Roche’s reason was most likely the criticism it faced for not disclosing data from certain clinical trials regarding the safety and efficacy of Tamiflu or ‘oseltamivir’. Roche had made quite the killing in profits through the sale of its patented ‘oseltamivir’ when the World Health Organization declared a pandemic during the bird-flu crisis and approved Tamiflu as the preferred treatment. As a result of the alert declared by WHO most national governments had stocked up significantly on Tamiflu. There has however been an active campaign since 2009, by the Cochrane Collaboration (a public health group) and the British Medical Journal to access more data on the clinical trials of Tamiflu to examine whether the drug was actually as safe and effective as claimed by Roche. In response to the appeals by this campaign, Roche had agreed in 2009 to provide researchers with more information on the clinical trials but has allegedly not released any information in the last 3 years. Read the rest of this entry »

TUESDAY: Dr. John Ioannidis on The Reliability of Biomedical Evidence and How to Improve It

TUESDAY, APRIL 2, 2013

4:30 PM – 6:00 PM

Stanford Law School, Room 280B

Dr. Ioannidis is the C.F. Rehnborg Chair in Disease Prevention at Stanford University and is Professor of Medicine and Director of the Stanford Prevention Research Center at Stanford University School of Medicine. His 2005 paper in PLoS Medicine, “Why most Published Research Findings are False,” has been the most-downloaded article in the history of the Public Library of Science and was described by the Boston Globe as an instant cult classic. His work combines skills in clinical research methodology and evidence-based medicine with the challenges of current molecular medicine and genomics.

This talk is free and open to the public.  Register here.

Standing, the FDA, and Dial Soap

When I hear, “FDA,” I generally think of the government regulator of serious, potentially dangerous drugs: thalidomide, fen-phen, tasmar. I typically don’t think of hand soap. But if you, like millions of others around the world, use certain antibacterial hand soaps, you’re in fact using an FDA regulated “drug.” The problem is that with respect to certain antibacterials, the FDA has never finalized its regulations of those drugs. And due to a rather peculiar procedural loophole, those drugs have entered the market without the FDA determining that they’re either safe or effective. The FDA’s failure to finalize that determination–and the plaintiffs’ standing to challenge it–were precisely the issues presented in Natural Resources Defense Counsel v. FDA, decided by the Second Circuit last week. Read the rest of this entry »

De-Extinction TEDx Conference on Friday, March 15

This is a topic that the CLB has followed and, in fact, I am one of about 25 speakers at this TEDx extravaganza at the headquarters of the National Geographic Society in Washington, D.C.  The event runs from 8:00 am to 5:00 on Friday, March 15.  If you can’t make it to the NGS headquarters, it is being webcast live.  Go here for details. The recordings will also be posted on the TEDx site in about three weeks.

Should be fascinating!

Hank Greely