The following contribution to our gene patenting symposium comes from Andrew Torrance, Professor of Law at University of Kansas School of Law.
The Supreme Court may soon place its imprimatur on a principle that has been gathering force within patent law for several decades: human beings constitute unpatentable subject matter. In Association for Molecular Pathology v. Myriad Genetics, Inc., the Court will most likely answer its question – “Are human genes patentable?” – in the negative. Synthetic DNA sequences, designed by humans, may be excluded from this prohibition, but the invalidation of patents claiming human genes will wipe out vast amounts of private investment, and be a body blow to the biotechnology industry. However, this legal result will have been predictable through a careful reading of the entrails of judicial decisions, Congressional bills, and executive branch pronouncements about patents claiming human-related inventions, all of which have echoed the spirit of the Thirteenth Amendment by proscribing property rights – even intellectual property rights – in human beings. To understand how patent law has evolved towards this result, one may trace the legal treatment of patents claiming human embryonic stem cells (“hESCs”), chemical products of human physiology, human thought, and, yes, human genes. Woven together, these strands of evidence lead towards the likely rejection of human gene patents by the Supreme Court.
Origins of gene patents
When the Supreme Court first addressed the patentability of genes, their source was bacteria, rather than humans. In Diamond v. Chakrabarty (1980), a five-to-four Court ratified the patent eligibility of both transgenic microorganisms and DNA. This decision settled expectations that at least some biotechnological inventions were patent-eligible, and encouraged investment in such inventions. As Sheila Jasanoff suggested in her book, Designs on Nature,
extension of patents to the life sciences created new classes of property rights in things that were previously outside the realm of what could be owned, or even thought of as subject to ownership claims. As a result, these objects became commodities that could have value, be exchanged, circulate in markets, and foster productivity.
Soon, a large biotechnology industry formed, relying on patent portfolios to justify the long lag between inventions and commercial products. Liberal standards of patentability were eventually exported to the United States’ trading partners in Article 27 of the World Trade Organization Trade Related Aspects of Intellectual Property (“TRIPs”) agreement, which requires that member nations make patents available “for any inventions…in all fields of technology” (Article 27(1)), with exemptions allowed for inventions that threaten “ordre public or morality” (Article 27(2)) and for macroscopic “animals…and essentially biological processes” for making them (Article 27(3)). Patentable subject matter in biotechnology was at a high-water level, and appeared limited less by law than by the inventive imagination. However, human-related inventions such as hESCs, chemical products of human physiology, human thought, and human genes have been an exception to this rule, stubbornly defying patentability.
Human embryonic stem cells
In 1999, the European Patent Office (“EPO”) issued European Patent 0695351, entitled “Isolation, Selection, and Propagation of Animal Transgenic Stem Cells.” The claims, when interpreted in tandem with the patent specification, appeared to assert intellectual property rights that included a method of preparing a transgenic human. Public outrage was rapidly followed by the owner, the University of Edinburgh, amending the offending claims to remove the possibility they might be construed to cover a human being. Across the Pond, the Wisconsin Alumni Research Foundation (“WARF”) faced dogged opposition to its patents claiming aspects of hESCs and methods for their production. The United States Patent and Trademark Office (“USPTO”) granted WARF a series of fundamental hESC patents (e.g., U.S. Patent No. 6,200,806), and Geron Corp., in turn, secured potentially lucrative license rights it hoped to use to develop commercial WARF products. The USPTO elected to reexamine several of WARF’s patents, and found a number of serious flaws in them. Two major legal setbacks beset hESC patents in 2011: the European Court of Justice (“ECJ”) ruled hESCs unpatentable under Article 28(c) of the European Patent Convention (“EPC”) because their production necessarily results in the destruction of human embryos; and, the America Invents Act (“AIA”) made major changes to U.S. patent law, including a prohibition in Section 33 that “no patent may issue on a claim directed to or encompassing a human organism.” Emblematic of the hostile environment facing hESC patents, Geron announced its abandonment of hESC research in late 2011.
Chemical products of human physiology
When one substance, such as a chemical compound, is ingested or injected into the body of a living organism, it is often altered significantly by physiological or metabolic pathways inside that organism, and transformed into a second, distinct substance. This process is referred to as in vivo conversion (“IVC”). In the context of human medicine, the initial substance is a “prodrug” that is converted by the human body into a corresponding “drug.” Companies often pursue patent protection not only on prodrugs they produce, but also on drugs produced by the human body. The USPTO has been receptive to granting patents on such IVC products. Courts, by contrast, have almost uniformly found such patents invalid or refused to enforce them, with the rationales for their decisions usually suggesting that the products of human physiology should be ineligible for patent protection. The Court’s 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories also focused on products of human metabolism, and their use in diagnosis and treatment of disease. Here, the Court emphasized the unpatentability of inventions produced by the human body:
Prometheus’ patents set forth laws of nature—namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm…While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law. [Emphasis added.]
Case law in federal district and appeals courts had already rejected the patentability of human IVC products. Mayo v. Prometheus added the Supreme Court’s voice to the chorus. Furthermore, as the judicial decision that the Court asked the Federal Circuit to bear in mind as it was ordered to consider Myriad Genetics v. Association for Molecular Pathology for the second time, Prometheus, with its rejection of patent claims covering human-related inventions, is a likely harbinger of the Court’s decision in Myriad.
The “mental steps” doctrine limits the patentability of methods that are overly dependent on processes of human thought. The Court of Customs and Patent Appeals (“CCPA”), the predecessor court of the Federal Circuit, stated in In re Abrams (1951) that “[i]t is self-evident that thought is not patentable.” Three decades later, the Supreme Court warned, in Diamond v. Diehr (1981), that “mental processes and abstract intellectual concepts” are not patent-eligible. Most recently, in Bilski v. Kappos (2010), the Supreme Court reconfirmed the vitality of prior precedents banning the patentability of abstract human thoughts. Regardless of whether one conceives of human thought in the abstract or as a result of human neuronal processes, if a human mind is capable of carrying out the steps in a method, that method is not patent-eligible. As with human ESCs and IVC products of the human body, the association of property-like patent rights with the “human” in human thought has troubled and motivated the courts.
Over the past century, genes have been conceived of as particles, sequences of DNA, information storage units, computer programs, and, most recently, as metaphorical pieces of lego, or BioBricks. Since Diamond v. Chakrabarty was decided, methods of determining specific nucleotide sequences of genes have improved rapidly, leading to a “gene rush” of patents during the 1990s and 2000s. Patent applications claiming human genes, or fragments thereof, soared, peaking around 2000, and then gradually declining thereafter. This flood of human gene patent applications, followed by issued human gene patents, inspired considerable opposition from many quarters. One prominent example was an alarum by author Michael Crichton, in The New York Times in 2007, warning that “YOU, or someone you love, may die because of a gene patent.” Action to limit gene patents had already been gaining momentum. The Federal Circuit’s decision in In re Fisher (2005) announced a tough judicial stance on the patentability of fragments of genes, Congressman Xavier Becerra introduced the “Genomic Research and Accessibility Act of 2007,” calling for a ban on human gene patents, and Section 33 of the AIA became law in 2011. Remarkably, although the USPTO was initially a defendant in the Myriad case, the Department of Justice broke with traditional patent policy in October 2010, by announcing its formal opposition to patents claiming “isolated but otherwise unmodified genomic DNA.” After having reached the Federal Circuit twice, Myriad is now in the hands of the Supreme Court, marking the arrival of the human gene patenting issue on the highest judicial stage. The Court has the power to declare human genes ineligible for patent protection. It is likely to do just that.
The unpatentable human being
With Myriad, the Court stands on the verge of endorsing a venerable principle in biotechnology patent law: human beings are improper subject matter for patenting. Under U.S. law, humans may not be property. Even human body parts, such asorgans, may usually not be owned and sold as property, whether from the living or the dead. The evidence from attempts to maintain patent rights covering hESCs, IVC products, human thought, and human genes are in accord: intellectual property may not confer ownership over human beings or human-related inventions. Add to this the force of AIA Section 33, banning patent claims “directed to or encompassing a human organism,” and it is likely the Supreme Court will answer its question on appeal in the negative: human genes are not patentable. Such a result will roil the biotechnology industry, while delighting the many critics of patents claiming human genes. However, the full effect on biotechnology may be modest because synthetic genes are quite likely to remain patentable. ven if the Court were to end the patentability of all genes, both natural-source and synthetic, copyright protection for DNA sequences may be waiting in the wings, and reliance on trade secrecy may become greater. One benefit that would flow from a decisive Supreme Court rejection of human gene patents would be the repose that legal certainty could bring. Evolving legal standards for the patentability of biological inventions have made it difficult for researchers and industry to maintain settled expectations of their and others’ legal rights. By holding in Myriad that human genes cannot be patented, the Supreme Court would hand non-commercial researchers and critics of human gene patents a valuable gift. However, even a negative outcome for human gene patents holds the potential to establish more predictable legal standards for the biotechnology industry, allowing it to forge its future path in an atmosphere of greater certainty. In any case, if the law’s prior treatment of human-related inventions is a reliable guide, it is likely that human gene patents will soon be history.