ACLU (Predictably) Opposes Patent Subject Matter Eligibility Proposal

By Kevin E. Noonan --

It is perhaps not surprising that several medical groups, as well as other organizations with little regard for the patent system, and their legal accomplice, the American Civil Liberties Union, would oppose the recent efforts to amend the subject matter eligibility section of the statute (35 U.S.C. § 101) to correct the imbalances caused by recent U.S. Supreme Court jurisprudence on the matter.  After all, one of the pillars of the current standard for (in)eligibility was the Court's decision in AMP v. Myriad Genetics, championed by the ACLU beginning with the District Court case challenging "gene patenting" (an effort, not inconsequentially, that has taken the place of Nazis marching through the predominantly Jewish suburb of Skokie, IL in the group's fundraising efforts).  This opposition has taken the form of a letter to Senators Coons (D-DE) and Tillis (R-NC) as well as Representatives Collins, Johnson, and Stivers setting forth these groups' views.

Before getting into the substance of their allegations of the sky-falling effects of enactment of any revisions to the statutory status quo, two important realities need to be understood.  First, despite all the trumpeting and bally-hoo that ensued after the Supreme Court's Myriad decision was handed down, human genes remain patent-eligible.  Admittedly, the species of genes that can be patented has been limited, from genes isolated as they exist in the chromosome to a particular, processed form of the gene called "complementary DNA" or cDNA.  While this limitation can restrict the capacity for a small subset of human genes to be patented, the overwhelming majority of the ~30,000 genes present in the human genome remain patent eligible in the cDNA form.

The second important (overlooked) fact is that most human genes are not patentable.  The reason for the distinction is that patent-eligibility is a categorical criterion, while patentability depends on the circumstances of the invention in light of the prior art.  The genomic sequence of the totality of human genes (as well as the ~80% of the genome that does not encode proteins) has been publicly available since the turn of the 21st Century, due in large part to such luminaries as Sir John Shulston who were motivated precisely to prevent (or forestall or at least retard) patenting of human genes.  And for those human genes for which patent applications were filed at that time, the statutory limit of patent term as 20 years from filing ensures that there are very few such patents that have not expired (or been abandoned); Myriad's BRCA gene patents, for example, are almost all expired or will be in short order.

Thus, no matter what Congress may do, the historical fact is that the "gene age" is over and if there was ever a diminution of innovation, medical progress, or benefit to humanity occasioned by these patents, that time is truly past.

This is not to say that the Supreme Court's precedent has not made mischief with regard to patenting "natural products" (see "Sherry Knowles Addresses Real World Impact of Myriad-Mayo Guidance at BIO Symposium"); how the Court's Myriad precedent has been interpreted, by both the Patent Office and the lower courts is a source of concern that is blithely ignored by the ACLU and their clients.

Turning to the ACLU's letter, it is clear from the introductory sentence, stating that the signatories are "civil rights, medical, scientific, patient advocacy, and women's health organizations," that the ACLU turned its Rolodex to the groups it assembled for the Myriad case to once again raise an alarm over ephemeral consequences (and, sadly resulting in consequences these groups or at least their members would not have envisioned with approval; see "The ACLU, Working for the Man") that could result by enactment of the revisions suggested in the latest proposal.  The letter states that the proposed revisions to patent subject matter eligibility standards would "authorize patenting products and laws of nature, abstract ideas, and other general fields of knowledge" (they wouldn't, of course; they would just substitute per se, categorical standards to ones better suited to identifying that subject matter whose patenting would not "promote progress of the useful arts").

But the ACLU and friends have expanded the litany of their worries from the Myriad days -- the letter announces that they consider "[m]ost troubling[]" the prospect of "patenting of human genes and naturally-occurring associations between genes and diseases," which they claim "will prevent the discovery of novel treatments for diseases including cancer, muscular dystrophy, Alzheimer's disease, heart disease, and other rare and common diseases."  It would be understandable to think from this rhetoric that, before the Myriad decision no one ever discovered "novel treatments for diseases including cancer, muscular dystrophy, Alzheimer's disease, heart disease, and other rare and common diseases," when the truth of the matter is that, perhaps with the exception of Alzheimer's disease, the history of the past thirty years has been the discovery of treatments for such diseases, supported by the patent system to permit these treatments to come to market.  In addition, the letter claims, revising patent law as proposed would "create barriers to patients' access to potentially lifesaving genomic tests, eliminate access to confirmatory testing and dramatically increase the cost of tests that have benefited from innovation that led to reduced costs of DNA sequencing technology."  Sadly, of course, the true sequellae of the Myriad decision has been to permit corporate testing labs to expropriate the scientific advances which, as in Myriad, tend to come from academia and startup biotechnology companies; the even sadder reality is that access to medicine and diagnostic testing is thwarted by insufficient insurance coverage not patents.  Indeed, one of the reasons genetic diagnostic testing is (relatively) widely accepted (and reimbursed) is due to the success Myriad had in convincing skeptical insurance providers (public and private) in the late 1990's that something as frightening and serendipitous as cancer could be predicted with reliability at all (see "In Defense of Patenting").  And as for the letter's further allegation that the proposed revisions to statutory patent eligibility would "stymie competition for developing and improving diagnostic and medical tests, and increase the cost and hinder advancement of targeted therapeutics involving genomic markers" that would result in "higher costs for patients, payers, and the healthcare system overall," what will be stymied would be investment in such new technologies (except for those established businesses for whom innovation upsets their established channels of commerce and thus tend to avoid truly groundbreaking inventions).

The letter goes on to provide an encomium for recent patent eligibility jurisprudence, highlighting the signal victory for the ACLU in Myriad and particularly noting the unanimity of the Supreme Court's decisions (which paradoxically does not necessarily demonstrate their correctness, erudition, or deep and penetrating thought concerning the patent issues at bar).  More troubling is the unsupported allegations that follow, that these decisions "have created a legal foundation that is promoting innovation across numerous sectors."  (It is worth noting that the only support for the assertion that human gene patent ineligibility should lead to lower cost diagnostic tests cited in the letter is an article by a journalist, written the day the Supreme Court handed down its Myriad decision.  One would think that the experience, putatively represented by the co-signers of the letter, six years after the Myriad decision, would yield ample, real-world evidence of this speculation but it's nowhere to be found in the letter.)

In something of a factual (but not emotional or rhetorical) nonsequitur, the letter then recites the purported sins of Myriad, backed not by court findings but by allegations from an amicus brief from the American Medical Association and other medical groups.  (It is significant that plaintiffs and their ACLU counsel did not attempt to invalidate Myriad's patents for misuse or other misbehavior, but used allegations of misbehavior to drum up support for invalidating the patents on categorical grounds.)  Included in these allegations in the letter is the slander that "[t]he patents authorized Myriad to block all manner of scientific inquiry into the genes shutting down research at academic medical centers throughout the country," a statement belied by the more than 10,000 academic research papers that could be found in Medline and other databases having been published between 1997 (when the University of Utah or its licensee Myriad was granted the patents) and 2013 (when the Supreme Court invalidated a small subset of those patent claims).

This false litany leads to a reiteration of the ACLU's Myriad rhetoric:  that there is a "fundamental truth" that "genes and other naturally occurring matter and relationships should never be granted to anyone as intellectual property."  But the consequence of taking that "truth" to its logical extreme is that nothing in the natural world, no matter how changed by human intervention, could be patented.  It is nothing less than hubris (and like much hubris, arising from ignorance) to think that only that which arises solely without reliance on the natural world deserves patent protection.  And the further roll call of intellectual luminaries and medical, religious, and interest groups recited as supporting the Myriad decision just shows that excellence and achievement in one field does not lead to wisdom is another (see William Shockley and Peter Duesberg as illustrative examples).

As might have been expected, the ACLU's concern has been inflamed by language in the draft proposed legislation that the judicial exceptions (laws of nature, natural phenomena, and abstract ideas) and case law supporting them would be abrogated.  This tactic raises many more concerns that importuning the ACLU and its friends and supporters, the most worrisome of which being that the Supreme Court would, at best, decide that such abrogation was unconstitutional for being beyond the patenting powers granted to Congress in Article I and, at worst, give rise to even more stringent limitations on patent eligibility (no doubt applauded by the ACLU and their co-signers of this letter).  The reality is, of course, more measured and reasoned than that:  what is proposed is replacing the poorly defined, inconsistently applied, subjective, per se judicial (instead of statutory) "exceptions" with legislation, vetted through the political process and (with luck) capable of consistent, predictable application in ways that do not turn patenting into a lottery dependent on the whims of district court or appellate judges or, indeed, the Supreme Court.  (It is ironic that the letter casts the consequences of this legislation as creating uncertainty, when even the casual observer will find plainly evident that it has been the Supreme Court's recent decisions, and its unwillingness to revisit them, that has caused the greatest uncertainty that the legislation proposes to correct.)  The ACLU's letter castigates the proposed legislation for wiping out "one hundred and fifty years of case law" but of course that's the point; said more properly the legislation will remove the uncertainties created by this case law.

The letter ends with the disingenuous suggestion that "[t]o the extent that there are problems with the current application of the law that must be solved, narrower paths to addressing them are preferable to rewriting current 101 standards and overturning over a century of precedent." Not only does the letter contain no hint regarding what those "narrow paths" might be, it is unlikely that any such path would be acceptable to the ACLU and their supporters.

One thing is certain:  there are competing memes involved in the patent subject matter eligibility debate, and for the pro-patent proponents to prevail this time it will take more political savvy than was exhibited during the Myriad case.

Comments

[EG]

Hey Kevin,

Nothing new here, as the ACLU remains hypocritical, two-faced, and forked-tongued.

[Greg DeLassus]

"More troubling is the unsupported allegations that... these decisions "have created a legal foundation that is promoting innovation across numerous sectors"... One would think that the experience, putatively represented by the co-signers of the letter, six years after the Myriad decision, would yield ample, real-world evidence of this speculation but it's nowhere to be found in the letter."

Exactly right. The empirical evidence is entirely to the contrary (URL below). The ACLU's claim has nothing but uninformed crystal ball gazing to back it.

https://patentlyo.com/patent/2019/03/patent-eligibility-investment.html

[Pro Say]

Good is bad. Bad is good.

Up is down. Down is up.

Welcome to the "1984" world of the ACLU.