The ACLU has just petitioned the US Supreme Court to review a Federal Circuit Court’s decision in the landmark Myriad Genetics gene patent case. The lawsuit, which seeks to invalidate patents for two genes associated with hereditary forms of breast and ovarian cancer, was filed in 2009 on behalf of plaintiffs who include women’s health groups, medical research organizations and breast cancer patients. The outcome is likely to have significant implications for scientific research and access to medical care.
The ACLU’s request was expected after Judge Alan Lourie ruled again that an isolated DNA sequence is a “composition of matter” that is eligible to be patented under federal law. The ACLU contends that the Federal Circuit Court decision did not adequately incorporate the Supreme Court’s recent ruling in Mayo v. Prometheus into its analysis. But Judge Lourie simply stated that the Mayo case isn’t controlling in the gene patent context. He found that the issue at hand is “solely whether the claims to isolated BRCA DNA [the genes in contention], to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics meet the threshold test for patent-eligible subject matter” and that “Mayo does not control the question of patent-eligibility of such claims.” Plain and simple, according to Judge Lourie, the claims pertaining to isolated DNA molecules are composition-of matter-claims that are expressly authorized under federal law.
If it’s so plain and simple, then why have the ACLU and dozens of professional and public interest organizations (including the Center for Genetics and Society, which has signed several amicus briefs in the case[1, 2]) invested time and money in this fight?
Because the United States Constitution gives to Congress the power to “promote the Progress of Science and useful Arts, by securing for limited Times to...Inventors the exclusive Right to their...Discoveries.” Patents incentivize investment in research and development by guaranteeing an exclusive right (for a finite period of time) to profit from hard work, innovation and investment. And patents make possible future improvements in technology. Patents holders have to fully disclose their inventions to the Patent and Trademark Office in order to get that profit monopoly, so once the patent expires, new folks can come in and build a bigger and better version of the invention.
Sounds good, right? But there’s a catch. People can’t patent something (a “composition of matter”) that occurs naturally. To do so would be to undermine the whole point of patents by rewarding someone who didn’t put in any work and by making new innovation nearly impossible since the basic building blocks provided by nature would be off limits to those looking to make improvements later on. In Mayo, the Supreme Court drew a line in the sand to separate the natural from the human-made, but Judge Lourie said that line is on a different beach. See what you think:
Prometheus Lab’s first patent, which the Supreme Court invalidated on March 20, 2012, simply describes the result of an entirely natural process—the body’s metabolization of ingested drugs. Its claim set forth a relationship between the concentration of a certain metabolite in the blood and the effectiveness of a dosage of a drug; if the concentration of the metabolite was below a certain specified range, the drug would be ineffective, and if the concentration was higher, the drug would likely cause harm to the patient. The Court found that the relation between the concentration of the drug in the bloodstream and the drug’s efficacy was an entirely natural phenomenon, and therefore unpatentable.
As the Court summarized it, Prometheus’s first claim
simply tells doctors to . . . measure (somehow) the current level of the relevant metabolite” and the other claims go on to tell doctors to “use particular (unpatentable) laws of nature . . . to calculate the current toxicity/inefficacy limits, and [then] reconsider the drug dosage in light of the law.
Judge Lourie found the claims in Mayo to be entirely distinct from those in Myriad. The supposed “natural phenomenon” in the Mayo case was the concentration of metabolites in the blood, but in the Myriad case it is isolated DNA. And like it or not, “isolated DNA molecules . . . are not found in nature.” They are “prepared from products of nature, [but] so is every other composition of matter.”
Comparing isolated DNA molecules to manufactured plastic products and modern medicines, Judge Lourie landed on one side of a fine line the federal courts have been trying to draw for decades. Natural phenomena have long been deemed unpatentable, but too broad of an interpretation of what counts as a natural phenomenon could eviscerate patent law because all innovations at some level use laws of nature. As Judge Lourie put it, “patents on life-saving material and processes, involving large amounts of risky investment, would seem to be precisely the types of subject matter that should be subject to the incentives of exclusive rights.”
In what appeared to be a nod to the multitude of amicus briefs and expert opinions that have addressed the undesirable practical implications of permitting such patents, Judge Lourie specifically noted several examples of what the legal issues in the Myriad case do not include. First, he wrote, the legal issue “is not about whether individuals suspected of having an increased risk of developing breast cancer are entitled to a second opinion.” Next, it is not about “whether it is desirable for one company to hold a patent or license covering a test that may save people’s lives.” Additionally, it does not address “whether the claims at issue are novel or nonobvious or too broad.” More to the point, Judge Lourie opined that “disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress.”
But the ACLU disagrees, for good reason. Policy is embedded in the very fabric of the Constitution’s Patent Clause and lies behind all the best judicial decisions—patent-related or not.
This most recent ruling by Judge Lourie was a narrow one. The issue was patent eligibility only. Despite the fact isolated DNA sequences are, for now, considered patentable compositions of matter, each proposed patent will have to meet all the criteria of patentability including novelty, non-obviousness, and utility. But there’s still a possibility that Congress could, as Judge Lourie noted, decide to revise current statutory law and specifically exclude isolated DNA as patentable subject matter for policy reasons. There’s also the possibility that the Supreme Court will do it…rumor is they’ve made a policy decision once or twice before.
Previously on Biopolitical Times:
Posted in Biotech & Pharma, Emily Stehr's Blog Posts, Patents & Other IP, Sequencing & Genomics, US Federal
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