Experts Look At The Meaning Of Myriad Case, One Year Later

IRVINE, CALIFORNIA – Experts gathered here last week addressed the question of – one year later – what does the United States Supreme Court’s decision on human gene patents mean for scientific research and patent policy?

At issue was the US Supreme Court decision to invalidate some of Myriad Genetics’ patents on human BRCA1 and BRCA2 genes, which are used in screening for breast and ovarian cancer.

The Meaning of Myriad Conference was held on 12 September at the University of California, Irvine School of Law.

Experts from the legal and research science fields presented their views on patent eligibility and discussed the significance of the decision for the patent system and for scientific research. The event was organised by Irvine law school professor Dan Burk.

In June 2013, the Supreme Court addressed the issue of patent eligibility of human genes. Instead of ruling that all genetic information was ineligible, the Court chose to distinguish genomic DNA (gDNA) from complementary DNA (cDNA). It viewed the former as being a mere product of nature and unpatentable, while the latter was deemed not naturally occurring and therefore patentable.

Patentable Subject Matter

The first speaker of the day, Mark Janis, law professor at the University of Indiana, Bloomington, took a step back from the traditional view of eligibility. Instead, Janis analysed Myriad through the lens of “expressive eligibility.” From this perspective, he said, the Supreme Court’s decision could be understood as a political move to situate itself as a “moderate player” in the patent system, rather than a move to draw lines between what is patentable and what is not.

The science at issue in Myriad is relatively simple, compared to more complex issues in genetics such as genetic modification and activation. Thus, the remarkable thing about Myriad is that the facts are wholly unremarkable.

Amelia Rinehart, law professor at the University of Utah, explained that what garnered so much public interest in this case was not Myriad Genetics’ actions. Rather, it was the fact that the company acted well within the bounds of the patent system and yet could have widespread and negative repercussions.

Rinehart said the Myriad case made ordinary people, not just patent scholars, consider the purpose of the patent system, and prompted the public to question the trade-off between innovation and access, as well as question the assumption that the benefits of the patent system outweigh the costs. Rinehart described Myriad as a “worst-case scenario” for patent law, and suggested that when doctrines such as eligibility are adopted, the broader policy impact should also be considered.

Implications for Scientific Research

Emphasising the importance of data, Anna Laackman, a law professor at Lewis and Clark University (US), cautioned that restrictions on eligibility could restrict information flows, and make it more onerous for researchers to obtain access to patent ineligible discoveries. Laackman proposed that the US Food and Drug Administration (FDA) act as an “information intermediary” by leveraging its gatekeeping authority to increase data sharing. In this framework, the FDA would use its licensing approval authority in exchange for disclosure of patent-ineligible genetic information by way of a “genomic semi-commons”. Laackman said that without structured commitments to standardise and deposit data into a centralised repository, a “potential treasure trove of information” could be privatized into siloes.

Peter Lee, law professor at the University of California, Davis, pointed out that despite losing its claims on gDNA, Myriad Genetics still maintains its rights over its cDNA claims, its method patents, and perhaps most importantly, its data. Because of this, the meaning of Myriad does not pertain to eligibility alone: Lee suggested that the real legacy of the case is “policy-oriented pragmatism” framed in both doctrine and science.

Lee noted that accelerating genetic research requires access to proprietary data, and that patent eligibility is just one piece of the larger policy puzzle. There are other policy levers, both within and beyond the patent system, which can shape the trajectory of innovation in the US. Adapting the non-obviousness doctrine or the scheme of federal funding for research can also influence how research is done. For example, the US enacted the Bayh-Dole Act in 1980 to allow non-profit organisations to retain rights to inventions made with federally-funded research.

Non-patent Innovation Incentives

It is important not to approach innovation policy with “patent blinders,” as Lisa Ouellette, a professor at Stanford Law School, said. Ouellette said that too often, issues like those brought up in Myriad are viewed as “patents-or-nothing” and that this is not the right perspective. Ouellette echoed Lee in emphasising other ways to incentivise innovation, such as direct federal spending on grants and national labs, prizes, R&D tax incentives, or other patent-like exclusivity provisions.

These types of incentive structures accomplish the same goal as the patent system: transferring rewards to innovators. Ouellette said that using the judicial system to establish eligibility standards seemed like a “poor tool” for optimising innovation policy, because even if patents are eliminated, other barriers remain. The government already provides non-patent innovation incentives, and perhaps Myriad provides an opportunity to consider whether or not the government should do more.

The Legacy of Myriad

Mark Lemley, also a professor at Stanford Law School, placed Myriad in the context of patent eligibility Supreme Court cases by reviewing the holdings from Myriad’s predecessor and successor. Prior to Myriad, the US Supreme Court held in Mayo v. Prometheus that “‘laws of nature, natural phenomena, and abstract ideas’ are not patentable…. [T]o transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it.’” Lemley said that in Mayo, the Court implied that patentability required an inventive step in addition to a mere discovery made about the world.

Some people felt that the Court’s holding in Myriad effectively overruled Mayo, but this year’s decision in Alice Corp. v. CLS Bank“reaffirmed Mayo on its facts,” said Lemley.

Lemley said that the Supreme Court is distinguishing between “making things and finding things,” and isemphasising thatpatent law should be about things that are made, designed, and that required human ingenuity. Lemley further said that the Supreme Court’s intent in Myriad was consistent with the other two cases, by ruling thatMyriad did not actually create anything, but the court “miffed it” by drawing a distinction between cDNA and gDNA.

International Context

The US policy on patentability arising from Myriad differs somewhat from policies in the international landscape. For example, the European Commission has a directive that codifies and defines patent eligibility in biotechnology. Jessica Lai, postdoctoral researcher at the University of Lucerne, said that because of the way the directive was written, little thinking is involved when it comes to patentable subject matter in the European Union.

Brad Sherman, professor of law at Griffith University (Australia), explained how the Federal Court of Australia’s recent ruling on a case involving Myriad Genetics and patents on BRCA1 read like an appeal to the US Supreme Court’s decision in Myriad. The characterisation of the alleged invention in the Australian case differed from the American characterisation, and Australia came out with the opposite result, given virtually the same facts.

The main message from the day’s discussion was that innovation policy is multifaceted and that eligibility standards comprise but one aspect of the framework. Looking forward, the challenge of the US Supreme Court’s decision to draw a line between naturally and non-naturally occurring subject matter is that it is not always easy to discern where nature begins and ends. As technology advances we are able to make finer and more subtle distinctions, and applying a simple doctrine to a complex concept might not yield optimal or even correct results.

The papers presented at this conference will be published in the forthcoming issue of the UC Irvine Law Review.

Brittany Ngo is completing her J.D. at the University of California, Irvine School of Law. She holds an M.P.H. from Yale University and a B.A. in Economics from Georgetown University. Brittany previously interned at Intellectual Property Watch in Geneva, Switzerland, covering health-related IP issues.