Genetic Diagnostic Testing: The "Anti-Commons" Revisited?

    By Kevin E. Noonan --

"Monopoly" is a loaded buzzword when it comes to patents.  It is imprecise, indeed incorrect, but it can be effective in appealing to prejudices that emphasize a negative view of patent rights.  It also effectively telegraphs the writer's own prejudices, so that when it is used in the title of a putatively academic article it can be particularly jarring.

Such an article appears on-line today in the March 26th edition of Nature, in a commentary by Robert Cook-Deegan (lower left), Subhashimi Chandrasekharan, and Mishra Angrist (lower right) of the Institute for Genome Science and Policy at Duke University.  Entitled "The dangers of diagnostic monopolies," it is reminiscent of nothing so much as Eisenberg and Heller's "The Tragedy of the Anti-Commons" in 1998, positing potential problems in the (then) uncertain future of gene patenting, in the context of little support for the espoused position.

The authors of today's Nature commentary admit, in the first paragraph, that the recent report from the Health and Human Services Secretary's Advisory Committee on Genetics, Health and Society disclosed little to no "irreparable" harm to genetic diagnostics from patenting, but assert that "neither have [patents] proven greatly advantageous."  At best, the authors' own research "detect[ed] no pervasive effects of patenting that consistently help or hinder clinical access to genetic testing."  This is consistent with the overwhelming majority of studies showing that the anti-commons aren't tragic after all.  Nonetheless, the authors contend that there are "some" problems that "could be addressed" to benefit everyone -- "patients, researchers, health professionals and companies alike."

The authors' primary concerns are (here we go again) "monopoly situations" -- i.e., when patents are exclusively licensed to one provider.  Why this is a concern is unclear, since they report that "prices of patented and exclusively licensed tests are not dramatically or consistently higher than those of tests without a [wait for it] monopoly."  Moreover, the patent incentive is "usually not necessary."  But the authors go on to state that the effects of patents ("monopolies," of course) on test quality are "equivocal."  And the relationship between quality issues relating to Myriad's BRCA test could not "be ascribed only to the monopoly" (although they assert without support that "[t]est quality is a general problem but monopolies can exacerbate it").  It would be reasonable to conclude from the information discussed in the article to this point that patents are, if anything, neutral with regard to genetic diagnostic tests.

Even benefits associated with sole providers (exclusive patent licensees), such as establishing standards of care, are described as being suspect.  The authors answer the question: "Is a standard of care set by a single provider desirable?" by noting that European companies "take various [alternative] approaches" before performing BRCA tests.  If BRCA tests are reliable, however, what is the benefit of alternative testing?  The authors do not say, merely that "[i]f [if] alternatives are valuable, exclusive licenses limit their availability."  If available alternatives are not patented by the exclusively-licensed single provider, it is unclear how exclusive licenses for BRCA tests could limit availability for those (other, distinct, unpatented) tests.

The authors also bemoan the "fact" that exclusive licenses (actually, the patents underlying them) are difficult to design around.  There is a flaw in the logic behind this assertion, however.  Noting that "[m]ost genetic disorders are heterogeneous -- different genes and mutations lead to clinically similar syndromes," the authors state that "[a]n exclusive license to one or a few common genes or mutations can drive testing to one provider."  On the contrary, the existence of such heterogeneity suggests that it should be difficult for one patentee to cover the entire field, and that continued research on such diseases and the heterogeneous genetic bases thereof should provide a variety of tests controlled by a variety of patentees (much like the co-existence of varieties of pharmaceuticals that address the same underlying pathology).

The authors do raise a legitimate issue -- whether full-genome sequencing efforts will encounter a "patent thicket" comprising patent holders owning rights to specific genetic polymorphisms.  These concerns are real but not realistic, in view of the technical obstacles for the technology (not performing the sequencing but accurately interpreting the data to provide a useful genetic diagnostic test) and the developing legal obstacles to diagnostic testing in general, in view of the Federal Circuit's decisions in Classen Immunodiagnostics, Inc. v. Biogen Idec, In re Bilski, and Justice Breyer's patent musings in the Laboratory Corp. v. Metabolite Labs., Inc. case.  They also ignore the reality that most of the patents existing today will have expired before any of these issues are likely to have been sufficiently resolved to make genomic sequence-based diagnosis a commonly-available diagnostic tool.

The authors eventually arrive at their message -- that "patient rights" should "trump" patent rights for genetic diagnostic tests.  Indeed, the authors identify six "obstructive practices" that should "negate gene patent enforcement," consistent with their goal of whose rights should be trumped.  These include exclusive rights-holders whose policies do not permit:

• Basic and clinical research, including genetic testing in clinical trials or health-services research;
• Performing a test in a form that it does not offer (such as prenatal or preimplantation diagnosis);
• Testing in a territory where the company does not offer a test but has exclusive rights;
• Getting second opinions or verification testing;
• Testing those not covered by its payment agreements with insurers and health plans; and
• Research and development to make testing more comprehensive, more accurate or less expensive.

Opponents of patents frequently raise the issue of "patient rights," typically conflating issues such as reproductive rights or genetic privacy with patent issues, and simplistically framing the issue as one of individual "rights."  These authors do not make these mistakes, but they do seem to forget the realities of the U.S. healthcare system.  The "patient rights" they believe should trump patent rights are solely economic ones (since even the accessibility issues devolve to economics).  But in America, the one right patients don't have when it comes to medical treatment or diagnosis is an economic one.  Healthcare in this country depends intimately on what each individual patient can afford, or if they have benefits through their employer, what their employer provides.  The patent system didn't create this situation and weakening patenting won't solve it.

What weakening the patent system will do is make it less likely that the fundamental research done at universities (where researchers are indeed not motivated by patent concerns) will be translated into useful genetic diagnostic tests.  There is enormous expense required to convert the genetic observations made in a laboratory into a validated diagnostic test that physicians can rely upon in making diagnostic and therapeutic decisions.  This is as it should be -- such tests should be thoroughly vetted before patients are asked to make critical decisions about their health in reliance upon them.  Without the exclusivity provided by patents, there would be little incentive for investors to take the risk that the result of such expenditures will be a robust, reliable genetic diagnostic test.  Restricting patent rights in ways that reduce patent exclusivity can be expected only to reduce these incentives.  This outcome would impinge on a more fundamental patient right than the ones discussed by the authors -- the right to quality and reliable clinical care based on innovation in the genetic bases of human disease.  While the sentiment underlying the authors' commentary may be admirable, they have identified the wrong villain.  In that, of course, (at least lately) they have no monopoly.

Comments

[Julie]

-Basic and clinical research, including genetic testing in clinical trials or health-services research

-Research and development to make testing more comprehensive, more accurate or less expensive

Might the above already be exempt from infringement of an existing patent under 271(e)(1)?

[Kevin E. Noonan]

Dear Julie:

Provided these activities were performed for ANYTHING used to support a regulatory filing, you could be right. I think the auhors' point was that companies like Myriad Genetics could use the patent right to preclude these activities (I am skeptical about their claim) UNLESS they were exempt under 271(e)(1).

Thanks for the comment.