By Turna Ray
Following US District Court Judge Robert Sweet's decision earlier this month to not rule from the bench as to whether Myriad Genetics' BRCA gene patents are legally and constitutionally valid, it is anyone's guess as to when the judge may issue a determination on the case. Nevertheless, some legal experts predict that the judge may be waiting to decide the American Civil Liberties Union's anti-gene patenting case in order to see how the Supreme Court handles the method claims in Bilski v. Kappos.
In Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al. — filed in May by the American Civil Liberties Union and the Public Patent Foundation on behalf of scientific organizations representing numerous medical professionals, researchers, women's health groups, and individual women — it is alleged that the BRCA gene patents held by the University of Utah Research Foundation and exclusively licensed to Myriad "stifle research that could lead to cures and limit women's options regarding their medical care." Specifically, the lawsuit challenges the patentability and constitutionality of Myriad's patents on the BRCA1 and BRCA2 genes, linked to increased hereditary risk for breast and ovarian cancer [see PGx Reporter 05-13-2009].
At a Feb. 2 hearing at the New York Southern District Court, the ACLU and Myriad both argued for summary judgment. Both sides are asserting that there are undisputed facts in the case and that summary judgment is appropriate because the case rests on legal questions, such as whether Myriad's exercise of its exclusive licenses to certain BRCA gene mutations restricts research, limits thought, and violates the First Amendment. Concurrently, the USPTO argued that the judge should dismiss the ACLU's charges against it on the basis of "constitutional avoidance," which recommends courts to attempt to decide a case on statutory grounds first before interpreting the Constitution [see PGx Reporter 01-20-2010].
During the hearing, lawyers representing the plaintiffs and defendants stuck to the arguments made in their memo briefs. While it was no surprise to most in the courtroom that Judge Sweet didn't rule from the bench, given the complexity of the case, he also didn't drop any signs as to which way he was leaning during the hearing.
"The judge, I'd say, was pretty poker faced throughout … He did ask some questions here and there but it was really hard to get a read with regard to which way he was leaning," Jennifer Gordon, partner in the intellectual property practice at Baker Botts, told Pharmacogenomics Reporter recently.
"The ACLU was trying to make it sound like isolating a gene is pretty much the same as plucking a grape off of a bunch of grapes," said Gordon, who along with several other Baker Botts lawyers crafted an amicus brief on behalf of the Biotechnology Industry Organization in support of Myriad's opposition to the ACLU's motion for summary judgment.
On the other hand, "Myriad's lawyer, at least in my way of thinking, was at least more faithful to the actual technical feat of isolating a gene, which is still a lot of work," Gordon added. "A lot of work goes into identifying a meaningful stretch of DNA that might have diagnostic ramifications."
The two parties had different views of the first hearing, however.
Daniel Ravicher, executive director of the Public Patent Foundation, which along with the ACLU represents the plaintiffs, said he felt the hearing was "entertaining" but not "very substantive."
Part of the "entertainment" during the hearing may have been the creative metaphors being thrown around in an effort to differentiate isolated DNA from naturally occurring DNA. The judge must ultimately decide whether isolated DNA markedly differs from naturally occurring DNA, thus making it patentable subject matter [see PGx Reporter 02-03-2010].
For example, ACLU lawyer Chris Hansen explained isolated DNA by describing naturally occurring DNA as the blood inside one's body, and the blood that would spill as a result of cutting one's hand as isolated DNA.
Likewise, Brian Poissant, counsel for Myriad Genetics, tried to explain the difficulty of locating a meaningful stretch of DNA of diagnostic significance by likening the search to looking for a string inside an egg.
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In an interview with Pharmacogenomics Reporter about the hearing and the future of the case, Ravicher left out the metaphors and attempted to clarify the plaintiffs' stance on isolated genes. "In our lawsuit [we point out that] Myriad's patents are on isolated genes that are only valuable to the company and the rest of society because they are not different than what exists in our body," Ravicher said. "If the genes in our bodies were different than screening those isolated genes for mutations, then they wouldn't tell us anything about what's going on in our bodies. They are only valuable as a diagnostic technique because they are not markedly different from what exists in our body.
"No one on the other side can respond to that and they haven't responded to that," Ravicher asserted. "Their only response is to try to obfuscate the issues."
The ACLU and PUBPAT are challenging method and composition claims on seven BRCA patents belonging to Myriad. Gene patents grant exclusivity to the patent holder for 20 years. Based on the filing dates for the patents at issue, June 2015 is when the first of Myriad's challenged patents are slated to expire. However, a patent holder can be held liable for infringement up to six years after a patent expires.
Guessing at a Pokerface
Despite the colorful descriptions of isolated DNA, the Judge didn't seem to let on how much or how little he understood the issues at hand. Industry observers have guessed that the judge may take anywhere between a few months to several years to come back.
"I was in a case once where a judge never came back with a decision on summary judgment. It can stretch out," Gordon said.
"I've seen judges rule in a day; I've seen judges rule in three months and put the case on stay," Ravicher said. "There is no limit on what the judge can do and no one can predict what he's going to do."
It would not be unreasonable, however, were Judge Sweet to wait for the Supreme Court to issue a determination on Bilski v. Kappos before deciding the ACLU's gene patenting suit, even though Bilski wouldn't guide the judge on the composition claims challenged in Myriad's patents.
In the pending Supreme Court case Bilski, justices are deciding to what extent they will uphold or overturn a Federal Circuit Court's decision that a so-called machine-or-transformation test is necessary for a process to be patentable. The Justices' comments during a November hearing suggest they are struggling to narrowly uphold a lower court's machine-or-transformation test and minimize the impact to other sectors, mainly the technology and medical device industries [see PGx Reporter 11-18-2009]. Word in Washington, DC, is that the Justices will issue a ruling in the next few weeks.
"With the Bilski decision we might get some guidance as to some of the method claims … and I believe the judge is going to wait for that decision from the Supreme Court," Gordon said.
Another case that might inform the method claims at play in the Myriad case is Prometheus v. Mayo. The Federal Circuit court's decision last year in Prometheus found that diagnostic claims using a correlation occurring in nature — in this case involving methods for identifying metabolites of a drug for gastrointestinal disorders — were patentable.
Mayo has filed a petition for a writ of certiorari asking the Supreme Court to hear the case. According to Ravicher, the petition is being held until the Bilski decision, as well.
"If certiorari got granted in that case, then I could see why a district court may want to delay its decision until it got even more guidance from the Supreme Court," Gordon observed.
'Reason Will Prevail'
Sharon Terry, president of Genetic Alliance, spoke to Pharmacogenomics Reporter about the organization's hope "that reason prevails" in the ACLU's anti-gene patenting case. Genetic Alliance filed an amicus brief against the ACLU's motion for summary judgment, urging for a lesser measure than abolishing gene patenting to urge industry innovation and allow academic research.
"Patients really need treatments and tests to go forward, and to do that we need a system in which companies are incentivized," Terry said. "We'd like to see the heat and energy that's being put in to this kind of [legal] activity be focused on real solutions."
Genetic Alliance, a non-profit genetics health advocacy organization, feels that measures such as a more formalized research exemption for gene patents might be one such solution. "Some sort of research exemption that is formalized is probably a good idea … but would depend on how it was written," Terry said. "Another thing we need to pay more careful attention to is licensing."
According to Terry, most critics of gene patenting are too quick to want to abolish the practice, when the majority of problems that critics cite are actually related to companies' exclusive licensing practices. "When we know that a treatment is being impeded, there should be some way for the conversation about licensing to happen," Terry said. "People leap right to patenting, when most of the time if, it's a problem, it's a licensing problem."
Furthermore, she questioned, as many have, whether there is sufficient evidence to claim gene patenting restricts research on certain genes. Indeed there has been some disagreement within the HHS Secretary's Advisory Group on Genetics, Health, and Society about whether there is sufficient data to support the group's recommendation to limit gene associations patents [see PGx Reporter 10-14-2009].
"I know there are some women who have a really good case [about not getting access to tests], but that's not about the patent," Terry said. "Their case is against the horrible healthcare system that doesn't reimburse for certain tests. And again, whether these women need the test is a medical and clinical question, and it can't be decided by a court around a patent." Genetic Alliance represents a network of 1,000 disease-specific advocacy organizations, as well as thousands of universities, private companies, government agencies, and public policy organizations.
Ravicher is aghast at the claim by those like Myriad, BIO, and Genetic Alliance, who suggest there is not enough evidence to prove that research has been harmed by Myriad's patents.
"We represent researchers in this case that are our clients saying these patents have stopped them from doing research," Ravicher said. "We represent some of the leading geneticists in the world that are saying, 'I'm researching X, Y, and Z disease, but not BRCA or other breast cancer diseases because of these patents. I don't know how people can say there is no evidence."
In Ravicher's view, just because the USPTO has issued a number of patents to Myriad doesn't automatically mean that the patent office has abided by the law. According to Patstats, a web service from the University of Houston Law Center that provides quarterly and annual statistics for rulings on major patent cases, 40 percent of all patents challenged in court were found invalid in 2008.
"The problem we have with the patent office is that we basically have a patent office that is a rubber stamp," Ravicher said. "It's willing to grant them to anyone who is willing to pay the fees."
He added that the plaintiffs are in line with legal precedent. "We're saying this is where the line is drawn by the Supreme Court in Diamond v. Chakrabarty," a 1980 Supreme Court decision that held genetically modified micro-organisms to be patentable, Ravicher said. "We're asking for a very moderate, very reasonable, and very consistent with precedent ruling with the judge.
"For the people on the other side to say what we're asking for is crazy and ludicrous, and is going to ruin the entire world is ridiculous."
— Meredith Salisbury contributed reporting for this article.