Looking Back at Myriad: A User’s Guide

MyriadThe Genomics Law Report has provided ample coverage throughout the litigation over Myriad Genetics’ BRCA1/2 patents. The saga had a rather lengthy procedural history, so a timeline of key landmarks with hyperlinks to GLR coverage as appropriate (in the “where” column) may be useful.

When Where Action Citation
1997 USPTO US Patent 5693473 issued to Myriad Genetics Inc.
March 2010 SDNY US Patent 5693473 invalidated AMP v. USPTO, 702 F.Supp.2d 181
July 2011 Fed Cir NY SDNY decision affirmed in part, reversed in part AMP v. USPTO, 653 F.3d 1329.
March 2012 SCOTUS Certiorari granted, Fed Cir NY judgment vacated, case remanded to Fed Cir NY AMP v. Myriad, 132 S.Ct. 1794
August 2012 FedCir NY Subsequent determination made (in light of Mayo v. Prometheus) AMP v. USPTO, 689 F.3d 1303
November 2012 SCOTUS Certiorari granted AMP v. Myriad, 133 S.Ct. 694
April 2013 SCOTUS Heard oral arguments
June 2013 SCOTUS Fed Cir decision affirmed in part, reversed in part AMP v. Myriad, 569 US —

To understand the Supreme Court’s decision in AMP v. Myriad, announced on June 13, 2013, it’s important to keep in mind what question was before the Court. For a valid patent to issue, the following requirements must be met:
• 35 USCA §101 – patentable subject matter
• 35 USCA §102 – novelty
• 35 USCA §103 – non-obviousness
• 35 USCA §112 – adequate, explicit description

The only question before the Supreme Court was whether human genes are patentable. (The Court left the methods patent decisions of the Federal Circuit unaffected. In other words, Myriad’s diagnostic method patents are invalid but its therapeutic screening method patent is valid.) Basically, in answering this question, the Supreme Court would decide whether the patents held by Myriad met the first requirement of patentable subject matter (35 USCA §101).

The SCOTUS decision
The Court unanimously (9-0) answered that isolated DNA is not patentable subject matter but cDNA is patentable subject matter. Justice Thomas wrote the opinion. Justice Scalia wrote a succinct concurring opinion indicating he joined the judgment and all Parts except Part I-A (the scientific discussion).

Justice Thomas wrote:

…In this case, by contrast [to the facts of Diamond v. Chakrabarty, 447 US 303], Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. ¶Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.

The Court rejected the idea that a products patent (like the isolated DNA patent issued to Myriad) meets §101 by virtue of the extensive research efforts required to isolate the DNA of BRCA1 and BRCA2, that bonds are severed in the process of isolating the DNA from the surrounding genetic material, and of necessary deference to the USPTO practice of granting gene patents of this sort in the past. This last argument was rejected primarily because Congress had not endorsed the USPTO’s practice (in contrast to the example provided by Myriad, i.e., new plant breeds were held patentable as Congress endorsed the practice via its Patent Act amendment).

Justice Thomas continued:

…the lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a ‘product of nature’ and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.

What does the SCOTUS decision mean?
John Conley provided analysis of the decision for the GLR here. Robert Cook-Deegan called the recent ruling a “sensible decision” and explained the case highlights Myriad’s mismanagement of its patent portfolio, because cDNAs are useless for diagnostics but invaluable for protein therapeutics. He noted the Court seems to be concerned about the effects of patents on research and will, accordingly, narrowly interpret §101 regarding “compositions of matter” claims until a statutory exemption protects researchers from patent infringement liability. Chris Gunter interpreted the decision as a win for consumers, as it signals a slash in prices is on the horizon, driven by increased competition and removal of the price point dictated by Myriad. Ambry Genetics announced its BRCA1/2 testing, and Quest Diagnostics reportedly indicated its tests will be available by end of the year. But the value of Myriad’s patents was not just in the monopoly it gave them for testing revenue but also the monopoly it provided on the resulting data generated. The launch of the “Free the Data Initiative” (see also here) by the Genetic Alliance and other partners on the same day as the Supreme Court’s ruling recognized the public benefit of those data for research and provided a means for individuals who have had testing from Myriad to release those data from Myriad’s proprietary stronghold. Myriad’s proprietary database may help continue the company’s competitive advantage in spite of the hits the ruling delivers to Myriad’s patent portfolio (see, e.g., Cook-Deegan, Conley, Evans, and Vorhaus, “The next controversy in genetic testing: clinical data as trade secrets?” European Journal of Human Genetics 2013; 21: 585–588; doi:10.1038/ejhg.2012.217; published online 14 November 2012).

Others, however, have not been as flattering of the decision. Some patent attorneys have expressed that opponents of patents are inadvertent supporters of trade secrets. Moreover, Paul Cole explained the ruling is disharmonious with international opinion, particularly in its contradictions to the European Biotechnology Directive of 6 July 1998, [1998] OJL 175/1 and to the Australian decision of Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65 (15 February 2013). Cole lamented:

What a shame that nobody told the Supreme Court of this body of opinion and legislation in Europe and Australia, which is believed consistent with the opinions and legislation existing in most other countries of the industrialised world, or that if it was aware of this position elsewhere the Court decided to ignore it in favour of a judge-made exception to the express provisions of 35 USC 101!

The SCOTUS decision may have brought an end to the §101 challenges to gene patents (at least as far as Myriad is concerned), but it likely indicates only the beginning to challenges of gene patents on other grounds (namely, §102 requirement of novelty and §103 requirement of non-obviousness).

Filed under: Badges, Genomics & Medicine, Legal & Regulatory, Myriad Gene Patent Litigation, Patent Litigation
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