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Apr 22, 2013
 |  BioCentury  |  Politics, Policy & Law

Myriad middle ground

Myriad arguments suggest SCOTUS looking to limit fallout on biotech innovation

All of the parties who participated in last week's Supreme Court oral arguments about the patentability of human genes - the justices, the Department of Justice, Myriad Genetics Inc., and the American Civil Liberties Union - seem to be looking for ways to limit the fallout from the case to prevent it from inflicting broad damage to biotech innovation.

Regardless of how the court rules in the case, it may take a long time to assess the consequences, intended and especially unintended, on the IP landscape.

In a discussion with BioCentury This Week television, Gregory Castanias, a partner at Jones Day who argued the case for Myriad at the Supreme Court, said critics who say the company is seeking to carve out sections of the human genome for its exclusive use are overstating its claims. Myriad does not believe its patents preclude using whole genome sequencing to test for the BRCA1 (breast cancer 1 early onset) or BRCA2 mutations and it would not seek to prevent this kind of activity, Castanias said (see BioCentury This Week, April 21).

Sandra Park, an ACLU attorney who was co-counsel in the case, rejected warnings that the case represents the start of a slippery slope that could lead to invalidation of a broad range of biomedical patents.

A decision in the ACLU's favor would be limited to patents on human genes, and assertions that the ACLU's legal argument could lead to invalidation of patents on recombinant proteins and a broad range of biotechnology products are overblown, Park said on BioCentury This Week.

In oral arguments, Solicitor General Donald Verrilli, Jr., representing the Department of Justice, suggested a middle ground between Myriad and the plaintiffs that would make isolated DNA ineligible for patent protection but would allow patents on cDNA.

Several of the justices expressed support for DOJ's position.

The justices also made it clear that although Association for Molecular Pathology, et al. vs. Myriad Genetics, Inc., et al., ostensibly involves an obscure aspect of patent law, they are concerned about broad public policy issues such as encouraging innovation.

The oral arguments were difficult to parse, in part because the justices interrupted the attorneys with hypothetical questions and fanciful analogies to trees, sap and chocolate chip cookies. In the process, the justices make it clear that they do not understand the basic scientific concepts at the heart of the case (see "Of Genes and Baseball Bats," A8).

Rollercoaster case

Last week's oral arguments are the culmination of a lawsuit the ACLU filed against Myriad in May 2009 asserting that the company's patents on BRCA1 and BRCA2 should not have been granted because human genes are "products of nature."

The suit asserts that claims for gene patents should not be allowed to pass through the first gateway to patentability, Section 101 of the Patent Act. Section 101 establishes four categories of patents: process, machine, manufacture, or composition of matter.

By challenging Myriad's patents under Section 101, rather than on the basis of novelty or obviousness, the plaintiffs hoped to invalidate all existing gene patents, prevent the future issuance of patents claiming human genes, and thus eliminate barriers to competition for genetic tests, the ACLU told BioCentury in 2010 (see BioCentury, Feb. 8, 2010).

The case has ridden a rollercoaster through the federal courts. The U.S. District Court for the Southern District of New York ruled against Myriad in April 2010. That was followed in July 2011 by a U.S. Court of Appeals for the Federal Circuit (CAFC) ruling that the company's composition of matter claims on two genes are valid, while its method claims for analyzing DNA sequences are unpatentable.

In March 2012 the Supreme Court vacated the CAFC's decision and ordered the appeals panel to reconsider the case taking into consideration the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories Inc. In...

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