Breast cancer gene case has another day in court

A three-judge federal appeals court heard arguments on Monday in a case that could decide the future of human gene patents.  The high-profile lawsuit was filed by the American Civil Liberties Union and the Public Patent Foundation on behalf of a number of researchers, patients, women’s health organizations and scientific organizations against Myriad Genetics and the University of Utah Research Foundation, holders of patents on genes known as BRCA1 and BRCA2 that are associated with elevated risk of breast cancer. The plaintiffs argue that the US Patent and Trade Office erred in granting these patents because genes are products of nature, not human inventions.

The panel heard Myriad’s appeal of a decision strongly favoring the plaintiffs that was issued in March 2010 by Federal District Court Judge Robert Sweet. Whatever is decided by the appeals court, many observers expect the case to continue on to the Supreme Court.

A few things stood out in Monday’s hearing. First, the judges were very interested in whether all the plaintiffs actually have standing in the case – that is, in whether they have actually been harmed by Myriad’s control of the genes. For example, University of Pennsylvania researchers whom Myriad stopped from conducting BRCA1/2 testing are now saying that if the patents on those genes are ruled invalid, they are unsure whether they will continue to screen for them. The judges focused on this account to the exclusion of statements filed by more than 150 other labs attesting to work that had been halted by the Myriad patents or by “cease and desist” letters from the company. The ACLU argued that University of Pennsylvania will, of course, screen for those two genes since their molecular pathologists screen for almost every other medically relevant gene on a daily basis. They asserted that these researchers’ reluctance to say so outright is due to past threats by Myriad.

If the appeals court judges wish to sidestep this high-profile and high-stakes case, they might use the question of standing to avoid making a decision. But that kind of dodge would likely make it seem that the Justices were unsympathetic to persons with breast cancer and other diseases that are correlated to particular genes.  This could help get more Members of Congress interested in fixing the gene patenting problem—something they have left up to the courts until now. 

A second notable aspect of Monday’s hearing was the extent to which the U.S. Solicitor General supported the plaintiffs’ key argument that genes are not patentable. This was in keeping with the Department of Justice’s surprise move last fall when it filed a “friend of the court” brief in support of the lawsuit against Myriad.  Unfortunately, the DOJ and the Solicitor General are saying that while genes cannot be patented, copies derived from them, known as cDNA (copy DNA), can be.  While creating cDNA is technically complex, for explanatory purposes, this is equivalent to saying that while one cannot patent a Picasso painting itself, patenting and selling a photocopy of the original is completely permissible.  While we disagree with the DOJ’s conclusion on cDNA, it was a big plus to have them arguing largely on the side of plaintiffs in the appeals court hearing.  A major aspect of the DoJ’s motivation in this case is to assure that patents on isolated genes do not prevent medical gene testing, including whole genome sequencing for multiple diseases, from proceeding.  

Perhaps the most striking moment of the day, however, came when Myriad’s lawyer unaccountably admitted that under the company’s legal theory, elements of the periodic table are in fact eligible for patents. Pressing the logic of this claim, the Solicitor General pointed out that lithium, a naturally occurring element that does not exist in isolated form in nature, was first isolated by a chemist in 1818, but that no one has ever claimed it is patentable. In response to questioning by the judges, Myriad’s lawyer said pretty much outright that yes, he does believe that isolated lithium is patentable material.  In his defense, he did note that he was an English major, not a scientist.

Barely addressed in the hearing was the important issue of DNA as carrier of information, despite the fact that Judge Sweet relied heavily on this idea in his reasoning about why DNA is different from other material compositions. In his ruling for the District Court, Sweet wrote:

The information encoded in DNA is not information about its own molecular structure incidental to its biological function, as is the case with adrenaline or other chemicals found in the body…this informational quality (of DNA) is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as ‘no different’ than other chemicals previously the subject   of patents….DNA, in particular the ordering of its nucleotides, therefore serves as the physical embodiment of laws of nature – those that define the construction of the human body…the preservation of this defining characteristic of DNA in its native and isolated forms mandates the conclusion that the challenged composition claims are to unpatentable products of nature.

Hopefully, the appeals court will consider this crucial piece of the puzzle when making its decision, since failing to do so will favor Myriad over the plantiffs. But expectations are not high, since this appeals court has in the past routinely upheld the views of patent holders.  How broadly it rules and what deference it gives to the Justice Department’s views will affect how and whether the case is accepted for a hearing at the Supreme Court.

Regardless of the outcomes in this case, it is likely that a true fix to the problem will only come if Congress steps in and declares naturally occurring DNA sequences as outside the scope of patentability. A similar statement was made by one of the judges on the panel for very different reasons, when he said that a ruling in the Myriad case could have “dramatic” consequences for the biotechnology industry and that the issue may be more appropriately addressed by Congress. It is time for Congress to reintroduce and pass the currently stalled “Genomic Research and Accessibility Act,” which would ban the patenting of genes and naturally occurring DNA sequences.

Eric Hoffman is biotechnology policy campaigner at Friends of the Earth. Jaydee Hanson is policy director for human genetics at the International Center for Technology Assessment.

Originally posted on the Biopolitical Times, a weblog of the Center for Genetics and Society.