An distinguished professor of patent law travelled from California to present on March 5 The University of Akron School of Law’s annual Albert and Vern Oldham Intellectual Property Law lecture on an imminent and potentially groundbreaking case.
Professor Dan L. Burk from the young University of California, Irvine School of Law spoke on Association for Molecular Pathology v. Myriad Genetics Inc.######, a case set to be argued for the second time before the United States Supreme Court concerning the patent eligibility of human genes. He lectured the day after UA Law’s 15th annual Richard C. Sughrue Symposium on Intellectual Property Law and Policy at the John S. Knight Center.
“I’ve heard many things about the program here and the faculty here, and it’s a real honor to be here,” Burk said of his first visit to the Rubber City.
After the quick pleasantries, Burk quickly tore into the meat of the case, a philosophical question that revisits the core of intellectual property law: can something that has already existed in nature be patented?
In 1995, researchers at the University of Utah and Myriad Genetics, then a small startup company with roots at the school, obtained patents for the sequences of BRCA1 and BRCA2, human genes associated with breast and ovarian cancers in women. Myriad quickly grew, offering an exclusive diagnostic test for the genes at a high price. In 1998, Myriad attorneys demanded that researchers at the University of Pennsylvania stop testing patients for the BRCA genes, threatening lawsuits over patent infringement.
The Association for Molecular Pathology, which had long lobbied against patent eligibility for human genes, sued Myriad, the trustees of the University of Utah and the U.S. Patent and Trademark Office. Other plaintiffs included individual patients, advocacy groups and premier academic research institutions. The Public Patent Foundation and the American Civil Liberties Union represented the plaintiffs and Jones Day defended Myriad.
The plaintiffs challenged seven of Myriad’s 23 patents relating to the genes. The patents boiled down to three inventions, according to Burk: isolated genomic DNA (gDNA) sequences as found in the body, copied DNA (cDNA) usually not found in the body but manipulated for use in diagnostics and the method claims to use them in breast cancer diagnostics.
Of the four requisite steps leading toward patentability, the majority of the case remained on the first: subject matter. The spotlight quickly turned to the isolated gDNA, which held many of the same traits as the genes in their natural environment. The manufactured, copied DNA (cDNA) poses less of a problem for legal scholars, according to Burk.
“Those are clearly man-made, because that’s not how things happen in cells,” he said.
In March 2010, however, the U.S. District Court for the Southern District of New York found all the contested claims invalid in a 152-page opinion that held that isolated genes retain the “fundamental quality of DNA as it exists in the body.”
On appeal, the U.S. Court of Appeals for the Federal Circuit affirmed most of the lower court’s ruling. Judge Alan Lourie, who wrote the majority opinion, held that isolated DNA sequences are “markedly different” from their natural state. This test came from Diamond v. Chakrabarty###, a landmark 1980 case which found genetically-modified bacteria used for consuming oil spills to be patent-eligible. Judge Kimberly Moore concurred, holding that the different uses of the isolated genes proved sufficient. Judge William Bryson found the differences between the isolated gene and its form in the body to be insufficient for patent eligibility.
The Supreme Court then granted the plaintiffs’ writ of certiorari, but revoked the previous judgment and remanded in light of its recent ruling in ######Mayo Collaborative Services v. Prometheus Laboratories, Inc. In that case, also surrounding medical diagnostic technology, the high court found that some types of claims that include natural phenomena could not receive a patent.
After the federal appellate court reiterated its stance, the Supreme Court again granted certiorari and set oral arguments for April 15.
Burk said the eventual decision in Myriad### could invalidate 30 years of gene patenting and upturn the relevant research industry’s financing model. Over 20 percent of human genes are patented, according to a 2005 study in the journal Science.###
Burk focused the majority of his lecture on arguments made against the manufactured cDNA genes. He argued that genes are simply arbitrary distinctions of parts of molecules that exist solely to carry information.
“A key is a mechanical instantiation of information the same way that nucleotide sequences is a chemical or physical instantiation of information,” Burk said.
“I think keys are patentable, and I think locks are patentable, even if they accomplish the same purpose of locking the door.”
Some of the plaintiffs’ other claims against cDNA’s patent eligibility held that, given the vast number of cells and virus that cause mutations, exact copies of the patented cDNA must exist somewhere at some time. He said these “disturbing arguments” had already been settled by landmark cases #####In re Seaborg and Tilghman v. Proctor. At any rate, he argued, they should be considered when arguing an invention’s novelty instead of subject matter, which always comes first and rarely poses more than a drafting problem.
“Section 101 [the patentable subject matter statute] is very easy,” he said. “Is it a composition of matter, a process, a machine or an article of manufacture?”
“It’s an easy statute – just read those things and move on. You don’t have to sit and philosophize about whether laws of nature are created by humans.”
Burk said that judges without sophisticated intellectual property experience find it easier to philosophize about Section 101 than the complex latter sections. He predicted that the Supreme Court would try and “finesse” Section 101, complicating the usually straightforward section: “I fear they’re going to leave more of a mess when they’re done.”
A brief question and answer period followed Burk’s lecture and drew queries from local patent attorneys, law professors and students.
Burk is a founding faculty member of UC Irvine School of Law, a currently unaccredited school that many expect to crack the top 20 in its inaugural U.S. News and World Report## ranking. He holds a master’s degree in molecular biology and biochemistry from Northwestern University and a juris doctorate from Arizona State University. Before joining UC Irvine, Burk taught at the University of Minnesota. Two years ago, he testified before Congress about the America Invents Act.
The lecture followed UA Law’s annual IP symposium, which featured a keynote address from Teresa Rea, deputy director of the United States Patent and Trademark Office. Several prominent patent attorneys and academics spoke along with UA president Dr. Luis Proenza and former Ohio State football coach Jim Tressel, who now works for UA as vice president of strategic engagement.