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A Cure For Patent Pathology? The Supreme Court Reviews The Patentability Of Human Genes



December 7th, 2012
 
by John Golden and William Sage

“Are human genes patentable?”  On November 30, 2012, the U.S. Supreme Court agreed to answer this single question in Association for Molecular Pathology v. Myriad Genetics.  Of course, the petitioners, including health care providers, professional associations, and patients, worded the question to favor the answer they want: “No, human genes are not patentable.”  For Myriad Genetics, the patent owner who would like its patent rights upheld, the question is better phrased as whether one can patent “isolated molecules of deoxyribonucleic acid that were identified and defined by human inventors.”

The practical stakes in the Court’s decision, which should come in the first half of 2013, are enormous.  The U.S. Patent and Trademark Office (USPTO) has issued tens of thousands of patents on genetic sequences over the past few decades, and the U.S. Court of Appeals for the Federal Circuit, the appellate court entrusted with hearing virtually all U.S. patent appeals, has never declared such sequences to be non-patentable subject matter.  For more than a century, patents have issued on isolated versions of naturally occurring substances other than DNA.

Many believe that gene patents are crucial to the modern biotechnology industry.  On the other hand, many researchers and clinicians feel that gene patents, particularly human gene patents, are commonly unnecessary to spur innovation and in fact interfere significantly with scientific and technological progress, whether by slowing or diverting research, impeding the provision of diagnostic tests, or generally increasing costs for clinical and scientific work.

The patents at issue in Myriad make such concerns particularly poignant.  These patents relate to BRCA1 and BRCA2, genes associated with a predisposition to breast cancer.  The obvious public interest in ready access to cancer diagnosis helps account for the fact that petitioners’ lead lawyers are not the normal high-priced advocates for a private company accused of patent infringement.  Instead, those lawyers work for the American Civil Liberties Union Foundation, an organization more commonly associated with battles for civil rights than rights in technological innovations.

The Legal Backdrop

In many ways, Myriad poses the classic dilemma of patent law: how to balance exclusive rights that can help investors recoup the expense of initial innovation against the free use of such innovation once developed.  Patent law has a number of features to promote balance, such as the substantial but limited length of the patent term and the requirement that a patented invention have been nonobvious to one of ordinary skill in the art.  Limiting the kinds of things that are patentable also balances these competing interests.  The Supreme Court has indicated that patents can cover virtually “anything under the sun made by man,” but at least three kinds of things are excluded: laws of nature, natural phenomena, and abstract ideas.  In Myriad, the fundamental question is whether the genetic sequences that Myriad’s patents cover are properly viewed as non-patentable products of nature—i.e., natural phenomena or equivalents of natural laws.

This question begs another.  How much human intervention is needed to turn naturally occurring matter such as DNA into a non-natural and therefore patentable thing?  Virtually every supposed product of human ingenuity consists of naturally occurring matter. A smartphone or automobile is made of naturally occurring atoms that human intervention has arranged in a useful form.  If useful combinations of naturally occurring matter may be patented, why not permit patents for useful “isolations” of naturally occurring matter—i.e., purified or isolated substances that do not appear by themselves in nature?

For more than a decade, the USPTO has followed this logic in granting patents on isolated genetic sequences.  Such sequences have been viewed as non-natural in the sense that they are separated from other genetic material (e.g., the remainder of a chromosome) as well as from other cellular matter with which they would naturally be connected or intermixed.  Hence, the USPTO did not respond to a flood of patent applications on genetic sequences in the late 1990s by declaring gene patents to be generally forbidden.  Instead, through guidelines issued in early 2001, the USPTO allowed patenting of a “genetic composition isolated from its natural state” on condition that the patent applicant “disclos[e] a specific, substantial, and credible utility for the claimed isolated and purified gene.”  The USPTO thereby helped dampen a “gold rush” to patent fragments of newly sequenced DNA for which only generic uses were known.  But the USPTO’s approach still permitted the patenting of isolated genetic sequences like those in Myriad’s patents, which were known predictors of predisposition to a particular disease.

One of the twentieth century’s most esteemed judges, Learned Hand, pioneered the distinction between isolated and naturally occurring substances in a way that foreshadowed recent USPTO practice.  In a 1911 decision, Hand ruled that certain purified forms of adrenaline were patentable.  According to Hand, even if such purified adrenaline were “merely an extracted product without change,” it was far more useful and feasible as a means of medical treatment than significantly less pure forms of adrenaline and thus “for every practical purpose a new thing commercially and therapeutically.”  Hand’s opinion can be understood to mean that whenever, for some purpose, an isolated or purified version of a substance is substantially more useful than the naturally occurring form, the isolated or purified version may be patented.  Arguably, the USPTO’s 2001 guidelines applied but also simplified Hand’s analysis by indicating that isolation and purification alone, without evidence of substantially greater usefulness, could render a substance patentable.

The Trial Court’s Opinion

The trial judge in Myriad, Robert Sweet, questioned the breadth of Hand’s opinion and even the soundness of the great man’s reasoning.  He may have been partly motivated—or at least mentally emancipated—to do so by a longstanding grudge.  Sweet’s opinion quotes an “oft repeated adage” that Hand’s analyses were more rhetorically beautiful than substantively correct.  The opinion even more gratuitously informs readers that Hand “once turned his back on the author” during an oral argument in which Sweet was appearing for the Government.

Sweet found legal support for his conclusion in Supreme Court precedent suggesting that, to be patentable, a claimed invention needs to be “markedly different” from an associated natural substance.  Because DNA’s informational content is central to its nature and because this informational content is unchanged by isolation, Sweet ruled that isolated DNA is not “markedly different.”  Sweet claimed that his ruling was essentially DNA-specific and thus would not threaten patents on other isolated and purified substances that are widespread in the biotechnology and pharmaceutical industries.

A Divided Appellate Court

On appeal, a fractured panel of three Federal Circuit judges reversed Sweet’s holding.  Judge Alan Lourie, a former patent lawyer who holds a Ph.D. in chemistry, concluded that isolated DNA is patentable subject matter because it is not merely purified—i.e., “removed from its native cellular and chromosomal environment”— but is also separated from other DNA to which it would be covalently bonded in nature.  Judge Kimberly Moore, a former law professor and electrical engineer, agreed that all the DNA at issue was patentable but differed in her reasoning.  In her view, complementary DNA (cDNA), which corresponds only to actively coding nucleotides, is patentable because cDNA sequences (1) lack naturally occurring non-coding nucleotides, (2) have substantial chemical differences from the messenger RNA from which humans construct them, and (3) have distinctively useful features such as “greater stability.”

Likewise, Judge Moore concluded that “short isolated sequences” of DNA are patentable because they have “new and distinct” uses as, for example, “primers to synthesize DNA” or probes to detect a genetic mutation.  Although “longer strands of DNA” lack such uses, Judge Moore nonetheless concluded that longer sequences should also be considered patentable because of (1) the USPTO’s long and deliberately considered practice of issuing patents, (2) congressional acquiescence in that practice, (3) “settled expectations of the biotechnology industry,” and (4) “the complicated technology and conflicting incentives at issue.”

On the issue of acquiescence, meaning Congress’ failure to change an interpretation of which it was well aware, Judge Moore pointed specifically to the legislative history of a congressional prohibition on issuing patents “encompassing a human organism.”  This prohibition was repeatedly approved in appropriations bills and in 2011 enacted into more permanent substantive law.  In a 2004 discussion on the floor of the House of Representatives, the congressman after whom the appropriations rider was named explicitly reassured his colleagues that the provision had “no bearing on stem cell research and patenting genes” and “would not affect any of those current existing patents.”

The third Federal Circuit judge, Judge William Bryson, disagreed about the patentability of merely isolated DNA.  Judge Bryson, a graduate of the University of Texas School of Law (a point of interest to this post’s authors!), worked for many years in the U.S. Department of Justice (DOJ) before his appointment to the bench.  In Myriad, DOJ argued to the Federal Circuit that cDNA should be considered patentable but that merely isolated DNA should not be.  Judge Bryson agreed, characterizing the structural changes to genetic sequences made through isolation as “necessarily incidental to [their] extraction” and irrelevant to their utility.

What Will The Court Decide?

Given Myriad’s high stakes and the differences in views on the intermediate appellate court, the Supreme Court’s decision to hear the case is unsurprising.  But how will the Justices rule?  All things being equal, one might speculate that the Justices will react most like their biographical peers, who are more to be found among Judge Sweet, Judge Bryson, and DOJ than among more “technical types” like Judges Lourie and Moore.  Thus, a plausible guess is that the Court will, like Judge Bryson, find cDNA to be patentable but merely isolated DNA to be unpatentable.  Permitting the continued patenting of cDNA might be particularly attractive as it will lessen the overall effect of the ruling on patentee expectations.

Whatever the outcome, the case highlights a point about patent law made by Judge Hand a century ago: “the extraordinary condition of the law which makes it possible for a man without any knowledge of even the rudiments of chemistry to pass upon such questions.”  Even at the Federal Circuit, a semi-specialized court that considers hundreds of patent appeals each year, the three judges who heard the Myriad case lacked substantial backgrounds in the specific form of technology at issue.  With a Ph.D. in chemistry, Judge Lourie has the most relevant technological background, but he was only one judge among three.  Moreover, some have suggested that, in the “large molecule” domains of biochemistry and molecular biology, Judge Lourie’s experience in pharmaceutical chemistry might tilt the Circuit’s thinking in inapt directions.

At the Supreme Court, the ultimate arbiter, scientific training and experience are seldom to be found.  The Justices who will decide Myriad generally lack expertise in chemistry, biology, or economics.  Without fact-finding hearings and after an oral argument likely to last no more than one hour, they will rule on the means for developing and commercializing some of our most advanced biomedical technologies.  We seem a long way from heeding another of Judge Hand’s suggestions—to submit such questions to panels of “technical judges … who can intelligently pass upon [them] without blindly groping among testimony upon matters wholly out of their ken.”

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    December 7th, 2012 at 9:44 pm

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