Donald Zuhn - -
On Monday, the District Court for the Southern District of New York ruled in favor of the plaintiffs in Association of Molecular Pathology v. U.S. Patent and Trademark Office, finding the claims of several patents directed to the BRCA1 and BRCA2 genes invalid as encompassing non-statutory subject matter (see "Round One Goes to the ACLU"). So what are the parties saying about Monday's decision?
The originally named defendants in the case included the U.S. Patent and Trademark Office, Myriad Genetics, and the Directors of the University of Utah Research Foundation. The District Court's dismissal of claims against the USPTO left Myriad Genetics and the University of Utah Research Foundation as the remaining defendants.
While the University of Utah Research Foundation has not issued a statement regarding the decision, Myriad Genetics released a statement on Tuesday in which the molecular diagnostic company announced that it will appeal the decision to the Federal Circuit and "will continue to vigorously defend this litigation." Myriad President and CEO Peter Meldrum said that "[w]hile we are disappointed that Judge Sweet did not follow prior judicial precedent or Congress's intent that the Patent Act be broadly construed and applied, we are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation." Mr. Meldrum added that "[m]ore importantly, we do not believe that the final outcome of this litigation will have a material impact on Myriad's operations due to the patent protection afforded Myriad by its remaining patents." Myriad noted that while the District Court invalidated 15 claims in seven BRCA patents that the company owns or exclusively licenses, there are 164 remaining claims in those seven patents and an additional 16 patents covering Myriad's BRCA tests that were not challenged in the case.
Among the organizational plaintiffs and their counsel, the Association for Molecular Pathology, American College of Medical Genetics, American Society for Clinical Pathology, American Civil Liberties Union (ACLU), and Public Patent Foundation (PUBPAT) all issued statements regarding the decision (the College of American Pathologists, Breast Cancer Action, and Boston Women's Health Book Collective did not issue any statements on their respective websites).
In its press release, the ACLU noted that "[t]he precedent-setting ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes." ACLU First Amendment Working Group staff attorney Chris Hansen said the decision was "a victory for the free flow of ideas in scientific research," adding that "[t]he human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas." With respect to the USPTO's dismissal, the ACLU asserted that "[t]he court found that it was unnecessary to reach the First Amendment claims against the USPTO because it had already ruled in favor of the plaintiffs." The ACLU release also suggested that "[b]ecause the ACLU's lawsuit challenges the whole notion of gene patenting, its outcome could have far-reaching effects beyond the patents on the BRCA genes." ACLU Women's Rights Project staff attorney Sandra Park predicted that the decision was "the beginning of the end to patents that restrict women's access to their own genetic information and interfere with their medical care."
In a statement issued by PUBPAT, Executive Director Daniel Ravicher said that "[t]he court correctly saw that companies should not be able to own the rights to a piece of the human genome." Mr. Ravicher added that "[n]o one invented genes. Inventions are specific tests or drugs, which can be patented, but genes are not inventions."
The Association for Molecular Pathology (AMP) applauded the decision in its release. AMP President Dr. Karen Mann called the outcome "a landmark decision that has the potential to dramatically improve patient access to genetic testing." Dr. Mann suggested that the decision would also be "a boon to personalized medicine in the purest sense as nothing is more personal than one's genetic makeup." The AMP noted that it had adopted a Policy Statement on gene patenting in 2008 that "urged an end to the practice of granting patents on single genes, sequences of the genome or correlations between genetic variations and biological states," and "encouraged groups that currently hold gene patents, including higher educational and research institutions, not to grant exclusive licenses to access those patents." The AMP release contends that the decision is a "significant step forward to eliminating future DNA patents and calls into question the appropriateness of those already in existence."
In its statement, the American College of Medical Genetics (ACMG) "celebrated the US District Court ruling [on Monday] that genes are 'unpatentable.'" The group's release states that "[t]he outcome of this case is likely to have far-reaching positive implications for physicians, researchers and patients." ACMG executive director Dr. Michael Watson contended that "[t]he invalidation of gene patents will allow patients to get second opinions on test results, encourage quality improvement of current testing, allow researchers to develop new and better methods of testing and decrease costs of laboratory testing." ACMG President Dr. Bruce Korn added that "[t]he successful outcome will pave the way towards genome-wide testing, avoiding an obstacle course of patent protection of individual genes that will prevent reporting of a complete set of results." The group's release notes that the ACMG was the first professional medical association to establish a position against gene patenting (which it did in 1999).
The American Society for Clinical Pathology's (ASCP) release "hailed" the District Court's decision. ASCP President Dr. Mark Stoler said the ruling "gives patients the right to choose who will perform the test that determines whether they are at greater risk for breast cancer -- a right they never should have been denied." He added that as a result of the court's decision, "[w]e have won back our natural right to own our own genes."