U.S. Court Puts Gene Patents Under a 'Magic Microscope'

The Court of Appeals for the Federal Circuit in Washington, D.C., heard oral arguments today in a case that could rewrite or invalidate much of biotechnology patent law in the United States. The controversial nature of the patents in dispute has attracted a lot of public attention, and the arguments reveal deep rifts even within the federal government itself over the issues involved.

The case, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., concerns a number of genes related to breast and ovarian cancer whose patent rights are owned by Myriad Genetics of Salt Lake City. Myriad has had exclusive rights to test for BRCA1 and BRCA2 in patients for years, but a lower court decision in March 2010, in New York, struck down the patents.

In one sense, the controversy hinges on issues as old as the granting of patents. The plaintiffs (those opposing the Myriad patents) have argued that Myriad's exclusive rights have hindered competition and don't give patients other options for seeking genetic testing. Myriad, meanwhile, argues that without a window of exclusivity and the big revenues it brings, companies like it would never invest the time and money to locate the genes associated with cancer and develop reliable tests.

But in another sense, the case is unique because it has become—at least in the public's eye—question about whether biotech companies can patent parts of a human being. For those reasons, people have been watching every twist and turn in the case for months and speculating over which three judges would sit on the panel that will decide the case. The plaintiffs had even filed a motion asking that the chief judge of the court, Randall R. Rader, not sit on the panel because of public comments he had made that, they argued, seemed to reveal he had made up his mind already.

The panel membership was kept confidential until this morning, when the court revealed that William C. Bryson, Kimberly A. Moore, and Alan D. Lourie will judge the case. Lourie has a Ph.D. in chemistry, a background highly relevant to some of the issues involved about isolating genes and gene fragments within cells. (Moore has a background in electrical engineering. Bryson's official bio indicates nothing about his scientific background, if any.) These three justices will decide the case over the next few weeks to months, and, no matter the outcome, the losing side will almost certainly appeal to the Supreme Court.

The arguments today contained an unusual twist. One of the defendants in the case is the U.S. Patent and Trademark Office (PTO). But the Department of Justice (DOJ), another federal agency, actually stood up and argued for the plaintiffs. This reveals "a profound disparity, a profound conflict between the two agencies," says William Simmons, an attorney who attended the arguments today. Simmons specializes in biotechnology law at the firm Sughrue Mion, and he did graduate and postgraduate work in molecular biology and genetic engineering.

To explain DOJ's position, federal attorneys have invoked what both judges and lawyers have taken to calling the "magic microscope" test. The magic microscope can look deep inside cells and find any natural molecule in them. And any natural molecules that it can find should be excluded from patent protection, argues DOJ, since "products of nature" have never been patentable. If applied consistently, DOJ's criterion could exclude patents not only on genes like BRCA1 and BRCA2 but also on any naturally occurring protein, polypeptide, or other fragment that a scientist can find in plants, viruses, bacteria, or other forms of life.

However, Myriad was granted patents on isolated forms of BRCA1 and BRCA2 that are not found in cells. (In nature they are embedded, along with many other genes, in chromosomes.) At one point, Moore referred to the magic microscope analogy as "kitschy," which Simmons took as a sign she wasn't impressed.

Simmons added that the seeming conflict between DOJ and PTO—which continues to issue patents similar to the Myriad ones—puts researchers in a real bind. Today's arguments, and the uncertainty over how the judges will rule, leave "people really at sea" over what to do with their biological discoveries, he says. "From a researcher's perspective, I don't know how they can make sense of it."

The federal court is expected to make the oral arguments available online soon.

Posted in Health