Another Academic with Solutions to Problems that Don't Exist

By Kevin E. Noonan --

Speaking of Oakland, Gertrude Stein famously said "There is no there, there."  The quote comes to mind when reading much of the academic literature on patenting genes and diagnostic method claims, which continues to follow the pattern of "there could be a problem, there should be a problem, in the future there might be a problem, so the fact that there is no evidence that there is a problem is irrelevant to my theory about the best way to solve the problem."

The latest example of this genre is by Geertui Van Overwalle (at right), from the Centre for Intellectual Property Rights, University of Leuven, Belgium, in an article in Science entitled "Turning Patent Swords into Shares."  The article sets forth the "usual suspects" of premises:  claims that "genes are difficult to design around," and that patents could hamper research and development, clinical access and availability of high-quality tests."  This portion of the article raises the first (of many) red flags in its citations:  the threat to "clinical access and availability of high-quality tests" is supported by no citation (representing the problem that "should exist"), and the statement that "genes are difficult to design around" is supported by a citation that reads (in very small type at the end of the article) "[i]n some empirical studies, a negative impact of patents could not be found (citing Walsh et al., 2005, "Science and Law: View from the Bench: Patents and Material Transfers," Science 309: 2002-03)" -- really, there are several such studies, all with the same message.  In other words, despite the empirical evidence that there is no current problem, the Professor postulates that there is, and then devises ways to address the non-existent problem.  This portion of the article also cites the SACGHS report, another example of an attempt to identify and address a problem that proved elusive at best.

The article similarly cites the possibility of a "patent thicket" caused by gene and diagnostic method patenting, but then supports the argument with the now thoroughly discredited (except in academia) "tragedy of the anticommons" idea (see "The Tragedy of a Bad Idea").  The article even admits that the problem does not exist:

Empirical data do not yet confirm existence of a patent thicket in genetics at large . . . .  However, thicket problems in genetic diagnostics could grow with shifts (i) from monogenetic to multifactorial testing (multiplex diagnostics) and (ii) toward diagnostics based on genome-wide association studies driven by the high-throughput of single nucleotide polymorphism platforms and next-generation sequencing possibilities.

And then:

Although not an illustrative example of this phenomenon, the Myriad decision has invigorated concerns about potential negative effects of a dense and dispersed patent landscape.

Having arrived at this description of the problem, Professor Van Overwalle proposes solutions, most taking as their starting point practices prevalent in Europe.  These include compulsory licensing, as has been instituted in France, Belgium, and Switzerland (despite the fact that "they have not yet been put to work"; but, the Professor informs us, "they may have an indirect, preventive effect on unduly restrictive licensing behavior by patent owners").  Another possibility is the exercise of "march-in" rights by the National Institutes of Health under provisions of the Bayh-Dole Act (35 U.S.C. §§ 200-213).  Also mentioned is a "diagnostic use" exemption, as proposed in the SACGHS report.

The Professor does recognize that a ban on gene patents could be as detrimental to "development of drugs and therapies" as it could be beneficial to "upstream" research, although there is no evidence that gene patents have affected such "upstream," non-commercial research at all, and ample evidence that basic research is unaffected by patents on genes (see "The Fantastical Economics of the Gene Patenting Debate").  Nevertheless, the article proposes that gene patents be limited only for those uses appreciated at the time the patent application was filed.  While seemingly a "reasonable" compromise, in reality such a restriction would result merely in prophetic disclosure on the one hand, and would (paradoxically) make it easier to obtain patent rights on newly discovered applications or uses of a claimed gene sequence -- such as a diagnostic method relating change or mutations in the gene to disease or the propensity for disease.  Of course, this is not much different from the current situation, and in addition it is unlikely that patent claims for genes (which are overwhelmingly limited to isolated, full-length copies thereof) are infringed or even necessary to practice such diagnostic methods (patented or otherwise).

Turning to less coercive possibilities, the Professor proposes patent pools or clearinghouses, using as examples the American Society of Composers, Authors and Publishers (ASCAP) for copyright and MPEG LA, the latter group organized to promote distribution of gene sequences in such a manner.  Unfortunately, the article cannot stay true to the concept that such an arrangement can be voluntary, and thus posits that the government may need to force such collaborations.

There certainly exists the possibility that any or even many of the possible problems identified in this and other academic articles could one day exist.  Of course, it is equally (if not more) likely that gene patents will have expired before the technology advances to a point where a patent thicket would have developed.  The history of the past thirty years reflects that possibility:  from an initial glacial pace of gene patenting (due in part to the focused effort to isolate particular genes that encode therapeutically useful molecules, and in part to the need for development of biotechnology) to the flood of genetic sequence unleashed by the Human Genome Project and it commercial counterparts.  It is certainly the case that success in deciphering the relationship between disease and genetic markers thereof has proceeded much more slowly than expected, and it is unlikely that the pace will quicken in the near term.  But patents -- i.e., exclusive rights -- to genes will expire more or less "all at once" in about 2020, being twenty years from the end of the HGP and about 20 years (or more) from the filing date of most gene patents from that time.  Thus, just when the potential for a patent thicket might become relevant (if we are lucky enough that robust genetic markers for disease have been so rapidly developed), the thicket will disappear.

There is a greater potential for diagnostic method patents to raise the kinds of issues referenced in the article, but the complexity of ascertaining these types of genetic relationships, and the potential for these relationships to remain undisclosed if diagnostic methods are unprotected by patenting, is likely to result in a public calculus that trades the relatively short period of exclusivity to the patentee for the economic incentives needed to develop commercial embodiments of these tests.  Perhaps the most frightening prospect set forth in Professor Van Overwalle's article is that diagnostic method patents would be unenforceable against "clinicians using their own 'homemade' gene-based tests."  To the extent that such tests are compared with tests by companies like Myriad, which has never had a reported false positive, it seems that women would be better served having researchers do research (clinical or otherwise) and commercial clinical labs perform such clinical tests.  For diagnoses as important as the propensity to develop cancer, patients deserve no less.

Perhaps the most dangerous aspect of such articles, however, is the tendency for policymakers and even courts (who are not immune to the blandishments of academic "research") to base their decisions on the persistent argument that there is an existing problem that needs a solution.  Darwin said that "[f]alse facts are highly injurious to the progress of science, for they often endure long; but false views, if supported by some evidence, do little harm, for every one takes a salutary pleasure in proving their falseness."  The non-existent problem becomes the unquestioned premise, and as any student of elementary logic can tell you, a syllogism is only as strong as its premises.  Thus can well-intentioned leaders promulgate policies that have harmful unintended consequences, all in the service of solving a problem that simply does not exist.

Comments

[Allen]

Uggg.... The academics love this debate because it fits into their theses of destroying the world order. In reality, gene "inventions" are just a routine product of robotic high-throughput screening. They are a "so what" invention that are entirely obvious. The courts should not bother with the esoteric arguments and just stick to basic patent principles. Folks might be surprised that the patent law will parallel their policy arguments and incidentally save the world from the Armageddon of gene patents.

C. Allen Black, Jr. Ph.D., J.D.

[David Koepsell]

Have you read this paper by Heidi Williams? It suggests that the studies you cite are wrong: http://www.nber.org/~heidiw/papers/5_12_10a_hlw.pdf

that is, if one is prone to arguments based upon utility.

[Kevin E. Noonan]

Dear David:

Yes, I did see that, and I need the time to understand it properly.

But I remember that there are a lot of assumptions built into her conclusions, and one naysayer among so many studies from so many countries and so many other researchers suggests to me that Heidi is wrong, rather than the other way around.

By the way, have you seen this:

http://www.youtube.com/watch?v=Fl4L4M8m4d0

As I recall your wife is a scientist - she might think it's funny.

Thanks for the comment.

[Kevin E. Noonan]

Dear Allen:

Except, that "patentability shall not be negatived my the manner in which an invention is made." So if they are new (and, when the patents were filed they were) and useful (since the PTO requires evidence of a utility for the gene product), then I don't see how the argument in your comment gets over the statutory preclusion for "robot-produced" inventions (genes or anything else).

Keep in mind, Kubin was decided on its facts (and ones the court unfortunately got wrong in the first place) - I don't see a lot of Kubinesque rejections coming down from the PTO (at least ones that can't be distinguished).

Thanks for the comment.

[6]

A good article Kev, but you needn't approach the situation with such an attitude. Your basic premise about the problem never materializing until it is pretty much going away is interesting. But I will say this, while to an old timer like yourself 20 years seems like a day or two, to us youngsters 20 years seems like kind of a long time, even the 9 years from now till 2020 seems like a long time.

And, presuming you're right, and at the same time perhaps she is right, let us say the problem only really affects 2-3 years worth of research/diagnostics etc. around the years 2017-2023. Not a big huge deal, but still a deal.

Oh and also 101.

Oh and also right on Allen. You're probably right, and the fact that we have such absurdities like the ol' "not negatived by..." included in our law is testament to the destructive force that our legacy system leaves us with in return for whatever supposed benefits it provides. If, for instance, an "inventor" happens to be walking down the road of progression of the useful arts one day and finds an invention laying there, then it dam well ought be negatived by the manner in which it was made, as it was by definition obvious. Not to worry, KSR indicates that courts can tell that a reliance on that artifact in the law by attributing more to it than an overruling of flash of genius is very likely misplaced.

"Keep in mind, Kubin was decided on its facts (and ones the court unfortunately got wrong in the first place)"

Where, iirc you could never completely produce those facts upon which you would still apparently like to rely even unto this day. But keep soldiering on about that one Kev.

[Skeptical]

6,

You are obviously a patent minimalist in the likes of Douglas (minimal as in zero).

I do not want to assume that you do know that those with Primary responsibility for making the law (and that would not be the judges or justices) EXPRESSLY stated that your view was an incorrect interpretation of the law and thus made the law explicit so that such views would not gain traction.

As a fan of history, it is with some chagrin that I witness the historical cycle of anti-patent fervor being played out (yet again) with the Flash of Genius doctrine. The doctrine has been thoroughly discredited and only those who do not understand patent law gravitate to that doctrine.

[6]

"You are obviously a patent minimalist in the likes of Douglas (minimal as in zero)."

Oh come off it Skep. I create patents with my own two hands. And I don't believe I'm selling my soul to the devil, so to speak, when I do it.

"I do not want to assume that you do know that those with Primary responsibility for making the law (and that would not be the judges or justices) EXPRESSLY stated that your view was an incorrect interpretation of the law and thus made the law explicit so that such views would not gain traction."

Oh, you can assume that very safely. You can also assume that I read KSR just like everyone else did.

Now Skep, I have no desire to fight with you today. But come on now, don't go forgetting who drafted those laws. So far as I understand it, we may as well say it was the ABA et al. lawyer crowd including the soon to be judge Rich as a ringleader. Of course, they were pulling a few senator's strings, but everyone apparently knew good and well what was going on. Didn't I just get through saying that this relic left in the law is testament to the destructive force that our legacy system leaves us with? I think I did, so consider that rhetorical.

But like I said, we all have our views on these issues, there's no need to fight over it.

Oh, and yeah, I'm not that fond of FOG. But gravitating "towards it" is simply a natural response to our having drifted too far in the opposite direction. As I'm sure you're well aware.

[lorac]

In the debate on "gene" patents, the emotional appeal - e.g., ACLU action, van Overwalle article - seems to gain the upper hand, by playing on reader's sympathies and fears. One of the main difficulties in countering such arguments is that rationality and logic don't often carry the same force (or get headline attention). While I appreciate your clear analysis and critique, I struggle with how to counteract the emotional responses and especially, be pro-active. Unfortunately, it usually seems as if we're chasing the nay-sayers and thus, not making headway.

[Kevin E. Noonan]

Dear lorac:

Well, I think it is important to dispel arguments based on falsehoods. Such as "who owns you?" Answer: no one (13th Amendment). Or "these patents hinder basic research." Answer: >9,000 basic research patents on BRCA1 and BRCA2 genes since the patents were granted. Or that patents deny access to testing or medicine to people who cannot afford them. Answer: insurance companies make those decisions, which are based on their bottom lines.

The other tactic is to describe the world that would exist if the ACLU gets its way - reduced access to medicine, fewer drugs, and diagnostic methods protected by trade secret rather than patent, so less disclosure and perpetual monopoly. Or that universities would be harmed, because corporations (foreign and domestic) will be able to simply steal the results of their research, rather than licensing it.

Those on this side of the debate make a mistake when they try to counter appeals to emotion with detailed explanations of two arcane areas - patent law and biotechnology. Better to "flip the script" on these arguments with the equally emotional argument that supporters of the ACLU are risking their grandchildren having poorer health care, poorer health and a lower life expectancy than we do.

Thanks for the comment.