Corny Science

The journal Nature reported on November 28, 2013, the retraction of a published scientific article claiming that laboratory rats fed genetically-modified ("GM") maize suffered substantial health problems.  As the journal reported,

Bowing to scientists' near-universal scorn, the journal Food and Chemical Toxicology today fulfilled its threat to retract a controversial paper claiming that a genetically modified (GM) maize causes serious disease in rats, after the authors refused to withdraw it.

Elsevier, the publisher of Food and Chemical Toxicology, explained its decision to retract the article as follows:

there is a legitimate cause for concern regarding both the number of animals in each study group and the particular strain selected. The low number of animals had been identified as a cause for concern during the initial review process, but the peer review decision ultimately weighed that the work still had merit despite this limitation. A more in-depth look at the raw data revealed that no definitive conclusions can be reached with this small sample size regarding the role of either NK603 or glyphosate in regards to overall mortality or tumor incidence. Given the known high incidence of tumors in the Sprague-Dawley rat, normal variability cannot be excluded as the cause of the higher mortality and incidence observed in the treated groups.

There are interesting times - sensu the oft-cited, but apparently apocryphal, Chinese curse - for the science and public opinion of GM food.  While robust scientific evidence that GM food causes harm to humans remains elusive, a vocal opposition maintains that GM food is unhealthy.

This retraction, by Food and Chemical Toxicology, is not the first.  In 2007, I published an article, entitled "Intellectual Property as the Third Dimension of GMO Regulation," that discusses similar previous GM publication shlamazels (available for free download here).  Disputes over food are often primal in character.  They have led to war, revolution, famine, and disease.  People behave from instinct when their access to healthy food appears threatened.  For this reason, ensuring that information about food is derived from reliable science is vital.  Publication of flawed food science is not merely unpalatable for peer review journals, it can cause painful political indigestion.

there is a legitimate cause for concern regarding both the number of animals in each study group and the particular strain selected. The low number of animals had been identified as a cause for concern during the initial review process, but the peer review decision ultimately weighed that the work still had merit despite this limitation. A more in-depth look at the raw data revealed that no definitive conclusions can be reached with this small sample size regarding the role of either NK603 or glyphosate in regards to overall mortality or tumor incidence. Given the known high incidence of tumors in the Sprague-Dawley rat, normal variability cannot be excluded as the cause of the higher mortality and incidence observed in the treated groups. - See more at: http://www.elsevier.com/about/p

there is a legitimate cause for concern regarding both the number of animals in each study group and the particular strain selected. The low number of animals had been identified as a cause for concern during the initial review process, but the peer review decision ultimately weighed that the work still had merit despite this limitation. A more in-depth look at the raw data revealed that no definitive conclusions can be reached with this small sample size regarding the role of either NK603 or glyphosate in regards to overall mortality or tumor incidence. Given the known high incidence of tumors in the Sprague-Dawley rat, normal variability cannot be excluded as the cause of the higher mortality and incidence observed in the treated groups. - See more at: http://www.elsevier.com/about/press-releases/research-and-journals/elsevier-announces-article-retraction-from-journal-food-and-chemical-toxicology#sthash.0DEVUvqe.dpuf

there is a legitimate cause for concern regarding both the number of animals in each study group and the particular strain selected. The low number of animals had been identified as a cause for concern during the initial review process, but the peer review decision ultimately weighed that the work still had merit despite this limitation. A more in-depth look at the raw data revealed that no definitive conclusions can be reached with this small sample size regarding the role of either NK603 or glyphosate in regards to overall mortality or tumor incidence. Given the known high incidence of tumors in the Sprague-Dawley rat, normal variability cannot be excluded as the cause of the higher mortality and incidence observed in the treated groups. - See more at: http://www.elsevier.com/about/press-releases/research-and-journals/elsevier-announces-article-retraction-from-journal-food-and-chemical-toxicology#sthash.0DEVUvqe.dpuf

there is a legitimate cause for concern regarding both the number of animals in each study group and the particular strain selected. The low number of animals had been identified as a cause for concern during the initial review process, but the peer review decision ultimately weighed that the work still had merit despite this limitation. A more in-depth look at the raw data revealed that no definitive conclusions can be reached with this small sample size regarding the role of either NK603 or glyphosate in regards to overall mortality or tumor incidence. Given the known high incidence of tumors in the Sprague-Dawley rat, normal variability cannot be excluded as the cause of the higher mortality and incidence observed in the treated groups. - See more at: http://www.elsevier.com/about/press-releases/research-and-journals/elsevier-announces-article-retraction-from-journal-food-and-chemical-toxicology#sthash.0DEVUvqe.dpuf

there is a legitimate cause for concern regarding both the number of animals in each study group and the particular strain selected. The low number of animals had been identified as a cause for concern during the initial review process, but the peer review decision ultimately weighed that the work still had merit despite this limitation. A more in-depth look at the raw data revealed that no definitive conclusions can be reached with this small sample size regarding the role of either NK603 or glyphosate in regards to overall mortality or tumor incidence. Given the known high incidence of tumors in the Sprague-Dawley rat, normal variability cannot be excluded as the cause of the higher mortality and incidence observed in the treated groups. - See more at: http://www.elsevier.com/about/press-releases/research-and-journals/elsevier-announces-article-retraction-from-journal-food-and-chemical-toxicology#sthash.0DEVUvqe.dpuf

Designs On Thanksgiving

The wonderful design patent blog, The Ordinary Observer, has an entertaining and enlightening discussion of proper apportionment of damages in design patent infringement cases.  Just in time for American Thanksgiving, enjoy "The Turducken Problem."

Lexvivo wishes everyone Happy Thanksgiving!

The Evil Twins Debating

The University of Richmond School of Law's Seventh Annual "Evil Twins Debate" was held on November 15, 2013.  Professor Mark Janis of the Indiana University Maurer School of Law and I (Professor Andrew Torrance of the University of Kansas School of Law) debated the topic "Design Patents: Great Idea, or Greatest Idea?"  For the sake of argument, I represented the Greatest Idea position while Mark argued in favor of the Great Idea side.  Here is the video of the Evil Twins Debate on the University of Richmond School of Law YouTube channel:
Intellectual property experts, Professor Jim Gibson and Professor Chris Cotropia, deserve immense credit for making the Evil Twins Debate the wonderful institution it has become.  Thanks very much, Jim and Chris, for inviting me to be a 2013 Evil Twin.

Gene Choices & Choice Genes

The United States Patent and Trademark Office ("USPTO") issued United States Patent Number 8,543,339 to 23andMe, Inc. on September 24, 2013.  The patent is entitled "Gamete Donor Selection Based On Genetic Calculations."  Here is the abstract:

Gamete donor selection includes receiving a specification including a phenotype of interest, receiving a genotype of a recipient and a plurality of genotypes of a respective plurality of donors, determining statistical information pertaining to the phenotype of interest based at least in part on different pairings of the genotype of the recipient and a genotype of a donor in the plurality of donors, and identifying a preferred donor among the plurality of donors, based at least in part on the statistical information determined.

Here is Claim 1 of the patent, as issued by the USPTO:

A system for gamete donor selection comprising: one or more processors configured to: receive a specification including a phenotype of interest that can be present in a hypothetical offspring; receive a genotype of a recipient and a plurality of genotypes of a respective plurality of donors; determine statistical information including probabilities of observing the phenotype of interest resulting from different combinations of the genotype of the recipient and genotypes of the plurality of donors; and identify a preferred donor among the plurality of donors, based at least in part on an evaluation of the statistical information determined, including: to compare the probabilities of observing the phenotype of interest resulting from different combinations of the genotype of the recipient and the genotypes of the plurality of donors to identify the preferred donor; and a memory coupled to the processor, configured to provide the processor with instructions.

Assuming that 23andMe develops this concept into a commercial service, choosing the genetic traits of one's baby may soon be as easy as a few mouse-clicks and the swipe of a credit card.  As I suggested in a 2008 article entitled "Patenting Human Evolution" (freely available here) and a 2009 article entitled "Open and Proprietary Biological Innovation in Human Genetic Enhancement" (freely available here), patents may soon be a selective force that helps drive human evolution.  Perhaps this patent is a harbinger. 

23andFDA

Knowledge of the human genome promises much to humanity.  One common suggestion is that sequencing a person's genome will unlock powerful opportunities for diagnosis and therapy.  A leader in the commercial market for human genomics is Google's neighbor, 23andMe, Inc., of Mountain View, California.  It fashions itself "The leading health and ancestry DNA service."  The Food and Drug Administration ("FDA") appears to think that 23andme has moved its services into the market prematurely.  In a "WARNING LETTER" sent to the company on November 22, 2013, the FDA states that it has yet to approve 23andme's product, which the agency characterizes as

a device within the meaning of section 201(h) of the [Food, Drug and Cosmetic] Act ["FDCA"], 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.

In its letter, the FDA orders 23andme to take its product off the market immediately:

23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device. The PGS is in class III under section 513(f) of the FD&C Act, 21 U.S.C. 360c(f). Because there is no approved application for premarket approval in effect pursuant to section 515(a) of the FD&C Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the FD&C Act, 21 U.S.C. 360j(g), the PGS is adulterated under section 501(f)(1)(B) of the FD&C Act, 21 U.S.C. 351(f)(1)(B).  Additionally, the PGS is misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because notice or other information respecting the device was not provided to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

This federal regulatory enforcement action is sure to galvanize the human genomics industry into action.  One possibility is to spur efforts to comply better with the FDCA.  Another is that 23andme will challenge the FDA's allegations, perhaps by disputing whether the FDCA does, in fact, apply to genomics testing.  It is not a foregone conclusion that the federal courts will side with the FDA, even though they do tend to give federal agency decisions considerable deference.

Regardless of the outcome of this particular FDA enforcement action, human genomics is certain to play an acceleratingly-important role in human health.  As the avid Tudorian, Allison Plowden, once wrote, "The laws of genetics apply even if you refuse to learn them."

E Pluribus Verbi

Too many cooks may spoil the broth, but how many authors are too many when collaborating to write an article?  To explore this quandry, my colleagues, Bill Tomlinson (University of California, Irvine), Joel Ross (University of Puget Sound), Paul Andre (Carnegie Mellon University), Eric P. S. Baumer (Cornell University), Donald J. Patterson (University of California, Irvine), Joseph Corneli (Independent), Martin Mahaux (Independent), Syavash Nobarany (University of British Columbia), Nithya Sambasivan (Independent), Marco Lazzari (University of Bergamo), Birgit Penzenstadler (Technische Universität München), David J. Callele (Independent), Gary M Olson (University of California, Irvine), M. Six Silberman (Independent), Marcus Ständer (Darmstadt University of Technology), Fabio Romancini Palamedi (Independent), Albert Ali Salah (Boğaziçi University), Eric Morrill (Independent), Xavier Franch (University of Puget Sound), Florian 'Floyd' Mueller (Independent), Joseph 'Jofish' Kaye (Independent), Rebecca W. Black (University of California, Irvine), Marisa L. Cohn (University of California, Irvine), Patrick C. Shih (University of California, Irvine), Johanna Brewer (Independent), Nitesh Yashbir Goyal (Independent), Pirjo Näkki (VTT Technical Research Centre of Finland), Jeff Huang (Independent), Nilufar Baghaei (Independent), and Craig Saper (The Hilltop Institute at UMBC), and I collaboratively coauthored an article entitled "Massively Distributed Authorship of Academic Papers" that was published on February 17, 2013, in ACM Conference on Human Factors in Computing Systems (CHI 2012) Extended Abstracts (alt.chi).  Here is the abstract:

Wiki-like or crowdsourcing models of collaboration can provide a number of benefits to academic work. These techniques may engage expertise from different disciplines, and potentially increase productivity. This paper presents a model of massively distributed collaborative authorship of academic papers. This model, developed by a collective of 31 authors, identifies key tools and techniques that would be necessary or useful to the writing process. The process of collaboratively writing this paper was used to discover, negotiate, and document issues in massively authored scholarship. Our work provides the first extensive discussion of the experiential aspects of large-scale collaborative research.

Our full article is available for free download on SSRN.  Thank you very much to all of my talented and cooperative coauthors who made this experiment in collaborative writing a pleasure.  Bill Tomlinson deserves massive and special praise for deftly coordinating the creation of the article.

Medtronic v. Boston Scientific

On November 5, 2013, the United States Supreme Court heard oral arguments in Medtronic, Inc. v. Boston Scientific Corporation, et al..  Seth Waxman, a former U.S. Solicitor General, attorney for petitioner, Medtronic, and partner at WilmerHale, explained the legal issue at the heart of the litigation:

Patent law places the burden of proving infringement on the patentee. And until this case, it was settled that the burden does not shift if the issue arises in a declaratory action seeking a judgment of non-infringement.  The [Court of Appeals for the] Federal Circuit imposed a different rule in suits brought under [MedImmune, Inc v. Genentech, Inc., et al.] where the party seeking a declaration of non-infringement is a licensee. That was error.

Allocation of the burden of proof inheres in the governing substantive law while the Declaratory Judgment Act is procedural only and does not change substantive rights. The burden of proof in MedImmune actions, like all other declaratory actions, remains where it would have rested in the equivalent coercive suit brought by that patentee.

Based on what transpired in these oral arguments, the Supreme Court appears skeptical of the burden-shifting rule introduced by the Federal Circuit in MedImmune.  A decision is likely before next summer.

Toronto Mayor Cracks Under Pressure

Rob Ford became mayor of Toronto, Canada, on December 1, 2010.  On November 5, 2013, he made a stunning (though not unexpected) admission:

Question: Do you smoke crack cocaine?
Ford: Yes I have smoked crack cocaine. But no, do I, am I am addict? No. Have I tried it? Probably in one of my drunken stupors, probably approximately about a year ago. I answered your question. You ask the question properly, I’ll answer it. Yes, I’ve made mistakes. All I can do now is apologize and move on.

Ford's tenure as mayor of Toronto has been nasty and brutish, and his abuse of alcohol and use of crack will likely make it short as well.  Like a clock inexorably counting down the last few seconds of one of his beloved football games, his time is almost up.  His resignation is likely just days, or possibly even mere hours, away.  What a tawdry affair in an otherwise good city.