Monsanto and Myriad: Is the Supreme Court Rendering Consistent Decisions When it Comes to Human Versus Non-human Gene Patentability?

• Publication year: 2014
• Author: Dana Tykocinski

Monsanto and Myriad: Is the Supreme Court Rendering Consistent Decisions When it Comes to Human Versus Non-Human Gene Patentability?

Dana Tykocinski

Liner LLP

As Watson and Crick's discovery of the biological code of life has spiraled into the subsequent mapping of nearly the entire genetic code of numerous plants and animals, rapid advances in genomic technologies and next generation sequencing have made the control of whole genomes a reality. These advances should help to elucidate genetic factors underlying diseases and physical characteristics and traits. Human genome patentability has recently pushed to the forefront of legal debates due to these advances. The implications of this sort of revision "Mother Nature's" work (or at least more personal subject matter) have only recently become an issue and have led to contradictory decisions. The most recent Supreme Court decision in the area of human genome patentability, Ass'n for Molecular Pathology v. Myriad Genetics, Inc. ("Myriad"),¹ compared to one of the more recent non-human genome patent cases, Bowman v. Monsanto Co. ("Monsanto"),² demonstrates the Court's ambivalent and possibly inconsistent approach towards human versus non-human genome patentability.

In a very basic sense, the Myriad decision does not correspond with the Supreme Court's proclivity towards expanding biotechnology patents that was demonstrated in Monsanto. Myriad decreases patent rights while Monsanto safeguards them. In Monsanto, the court upheld a decision preventing a farmer from reproducing patent-protected soybeans for subsequent plantings. In Myriad, the Court ruled that DNA as it exists in living organisms is not patentable. However, more significant than the result is the different reasoning that the Supreme Court seems to apply in the two cases. It applied a more calculated, economically motivated cost-benefit analysis approach in Monsanto (the non-human genome case) and a morally-motivated assessment harping on the extent to which man may control or own "nature" in Myriad (the human genome case).

The U.S. Supreme Court sought to solve the human genome technology debate under the same framework it has been developing and applying for the past 150 years for other patent law questions, consistently holding that products of nature, laws of nature, physical phenomena and abstract ideas are not patentable subject matter. The Court's decision in Myriad followed this pattern, hinging its decisions on defining what are products of or laws of "nature."³ But since the inception of the line of patent eligible subject matter cases, the Supreme Court has never provided a concrete definition or a legal test for what makes a natural "law," "phenomenon," or "product." In 1948, however, the Supreme Court, in Funk Brothers Seed Co. v. Kalo Inoculant Co., proscribed patents on "laws of nature" or "natural phenomena."⁴ At around the same time, courts also began to incorporate patent law's long-standing ban on patenting "products of nature" into this reimagined doctrine of patent eligibility.⁵

Thus, the current doctrine of patent eligibility, which involves a two-step process for determining subject matter eligibility,⁶ equates all "laws of nature," "natural phenomena," and "products of nature," irrespective of their individual content and any patent encompassing any of these qualities without more is deemed ineligible.⁷

MYRIAD

The Myriad case involved Myriad's patents on the human breast cancer genes known as BRCA1 and BRCA2. The patents at issue claimed naturally occurring gene sequences—and some of these claims made your genes Myriad's property once they were removed from your body in isolated form separate from the chromosomes in which they are found in nature. The patentee (Myriad) had identified the location of these genes in the human genome, where a heritable mutation can confer an increased susceptibility to developing breast cancer. By patenting the sequences, the company could control all uses of the naturally occurring gene sequences, including any uses for diagnostic testing or research.

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Several plaintiffs sued Myriad in the Southern District of New York seeking a declaration that the claims are invalid. Among their contentions was that DNA sequences that can be found in nature, such as within human genes, should be excluded from patent eligibility because they are products of nature. Myriad disagreed, contending that because it specifically claimed "isolated" DNA, in keeping with USPTO guidelines, the claimed subject matter was not a product of nature because such molecules do not naturally exist in an isolated form. The district court held for the plaintiffs, finding the claims invalid as being impermissibly drawn to patent-ineligible subject matter.⁸

The central issue discussed in the Myriad case was whether the act of isolating a DNA sequence, i.e., separating a sequence of nucleotides from the rest of the chromosome, is an inventive act that entitles the first person to do it 'to a patent.' The Supreme Court in Myriad held that "[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated."⁹ This rule invalidated some (but not all) patent claims held by Salt Lake City firm Myriad Genetics, which has held a near-monopoly on BRCA1 and BRCA2 testing through its Sanger sequencing-based BRACA analysis test. But more generally, the ruling invalidates all such claims on natural human gene sequences.

The Myriad Court's analysis began with the patent statute, which states that "whoever invents or discovers any new and useful...composition of matter, or any new and useful improvement thereof, may obtain a patent therefor."¹⁰ The statute has consistently been interpreted to preclude the issuance of patents claiming laws of nature, abstract ideas, and natural phenomena, since such discoveries, however important, are not actual inventions, i.e., they encompass the "something more" which renders it subject matter ineligible.¹¹ However, the distinction can often be ambiguous, and Justice Thomas (who wrote the decision for the Court) recognized that "patent protection strikes a delicate balance between creating 'incentives that lead to creation, invention, and discovery' and 'imped[ing] the flow of information that might permit, indeed spur, invention.'"¹²

Myriad argued that isolating the BRCA1 and BRCA2 genes required the severing of chemical bonds, and therefore the creation, rather than the discovery, of a substance that doesn't occur naturally. The Court did not agree with this argument, but instead found that "Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from...