Judge Robert W. Sweet, US District Court of Southern District of New York, invalidated several gene patents held by Universty of Utah Research Foundation and licensed to Myriad Genetics (MYGN) covering BRCA1 and BRCA2. These genes serve as the basis of a Myriad diagnostic test service use to predict whether a woman is at high risk of getting breast or ovarian cancer. Myriad will appeal the ruling.
The ACLU and the Public Patent Foundation (PUBPAT) brought the suit on behalf of patients, joined by several medical groups, who claimed the gene patents were illegal and restrict both scientific research and patient's access to medical care. The gene testing service in question costs about $3000.
Judge Sweet ruled the patents were improperly granted as they dealt with genes which are "products of nature" and therefore not eligible to be patented. The genes may qualify as discoveries but cannot be subject to patents. Sweet assailed the logic which allow patenting gene sequences isolated from the body (versus direct patenting of a sequence in the body) as a "lawyers trick". He wrote "isolated DNA "is not markedly different from native DNA as it exists in nature." He further indicated that the ruling would NOT decimate the industry. Sweet explicitly avoided any ruling on whether the US Patent Office should be granting gene patents in the first place or ruling on First Amendment questions raised by plaintiffs - merely indicating that the case could be decided on the basis of existing patent law.
Despite headlines seeming to indicate widespread impact for this ruling, it is really narrow in scope at present. The ruling applies only to the 11 patents associated with the BRAC1 and BRAC2 genes being considered in this case, and is only applicable to the Southern District of NY. To take on any real weight or precedent value, the Federal Circuit Court or the Supreme Court would have to affirm it. Then it would be binding on issued gene patents and those pending. There are more than 2000 gene patents pertaining to approximately 20% of the human genome.
Most legal experts expect the ruling to be overturned on appeal - although most did not expect the ruling to be issued. Even under a doomsday scenario (from gene patent backer's point of view), upholding of the ruling would take years to have a significant effect. Critics of the ruling believe the judge misread the law and engaged in "activist jurisprudence". Industry experts believe the ruling may have a short term negative effect on funding in this area - particularly for genetic diagnostic companies (e.g. Myriad and Athena type companies) and some engaged in personalized medicine efforts. The ruling is unlikley to have any impact on drugs themselves as these tend to be protected by patents on their own composition. Myriad lawyers noted "Without [gene] patents who is going to do the work and spend money to make the product accessible to people?" Peter Meldrum, Myriad CEO, told investors that the outcome of suit will not have a material adverse effect on the company or its future revenues. So why complain so vehemently?
Groups supportive of the ruling called it historic. "Today's ruling is a victory for the free flow of ideas in scientific research" said ACLU lawyer Chris Hansen. "The court correctly saw that companies should not be able to own the rights to a piece of the human genome" concluded PUBPAT's Daniel Ravicher.
Other commentators, like David Duncan of Fortune, have suggested that this is a wake up call for the industry to look at "better more collaborative ways to protect and share findings". He further observes that "arguably the endless controversies [over gene patents] have actually slowed innovation" as uncertainty of ownership scares investors. Can IP be created and protected in other ways besides patents?
He floats the novel idea (to me anyway) of comparing genomic information to the electromagnetic spectrum. Radio, GPS and cell phone frequencies are publicly owned and government licensed to users. Licensees are required to follow certain rules or potentially lose their license. Clifford Mintz suggests on his BioJobBlog that the diagnostic industry would be better served to go to an open source business model similar to that followed by software developers - that could stimulate creativity and development of new products and commercial applications.
The industry has a couple years to ponder and act on this advice (or not) before the case will make its way through the appellate system.
Posted by Bruce Lehr April 2nd 2010.