Since May 2009, the ACLU and Public Patent Foundation (PUBPAT) have been litigating a case involving the patent eligibility of two human genes, BRCA1 and BRCA2, associated with ovarian and breast cancer. ACLU and PUBPAT, representing the petitioners, Association for Molecular Pathology, among others, have argued that human genes are not patentable and that patents on such objects stifle diagnostic testing and further research.
It has been estimated that 1 out of every 8 women in the United States will develop invasive breast cancer at some point in her life and although a diagnostic test exists to identify mutations on BRCA1 and BRCA2, many women do not have the testing done because of the high monopoly price. Those that do have the test cannot receive a second opinion and other scientists or researchers cannot improve upon the test–even when it was shown that Myriad’s test was flawed and failed to identify all known mutations, particularly for minority women. The legal issues, however, go far beyond the immediate question of the breast cancer gene patents, and depending upon how the case is decided, the courts may make it more difficult to obtain certain patents on human genes. One issue involves the patentability of isolated DNA and whether isolation of a naturally occurring product can receive patent protection; at the Federal Circuit level, the Solicitor General intervened arguing against patent eligibility for isolated DNA. This issue also involves a question of whether isolated DNA is “markedly different” from that found in nature. Other issues include the patent eligibility of cDNA, how broadly such claims can be drawn if patent eligible, and whether fragments of genes are patent eligible. If the Solicitor General recommends certiorari in this case, it may do so only the issue of isolated DNA.
Previously, a District Court Judge Sweet ruled in favor of the plaintiffs and held the claims-at-issue were not patent eligible because they were directed toward products of nature. Subsequently, the defendants in the case appealed to the Federal Circuit where a three judge panel had a three-way split in reasoning, but ultimately held by a narrow 2-1 decision that isolated DNA could receive patent protection. Prior KEI coverage on the case is available here (Judge Sweet on non-patentability of genes and TRIPS), here (recapping oral arguments at the Federal Circuit) and here (on the Federal Circuit opinion).
After the Federal Circuit ruling and subsequent refusal for rehearing, a petition for writ of certiorari to the Supreme Court of the United States, filed by the ACLU on December 7, 2011 and docketed December 14, 2011 is available here. Myriad’s opposition to the petition for writ of certiorari was filed on January 13, 2012.
On Friday, January 13, 2012, KEI filed an amicus brief to the Supreme Court of the United States in the case, Association for Molecular Pathology, et. al. v. Myriad Genetics, Inc., et. al., Docket No. 11-725. This brief supports the Plaintiffs-Petitioners’ petition for writ of certiorari.
KEI’s amicus brief notes that the question of whether isolated human genes are patentable will impact the future of patent law and have impacts on public health. Like the petition for writ of certiorari, KEI notes the lower court decision resulted in a fractured opinion and that even the Executive Branch appears divided over the issue. KEI argues the grant of such patents contravenes the Constitutional obligation to “promote the Progress of Science and useful Arts,” and in its final section KEI explains that where patents are inappropriate, unnecessary, insufficient or burdensome, non-patent mechanisms can be used to stimulate, subsidize and reward investments in new science and product development relating to human genes. Among the non-patent mechanisms that are available are innovation inducement prizes.
The table of contents to KEI’s brief, with respect to the argument section, is reprinted below:
I. THE QUESTION OF WHETHER HUMAN GENES ARE PATENTABLE RAISES FUNDAMENTALLY IMPORTANT CONSEQUENCES FOR THE FUTURE OF PATENT LAW.A. The Legal Community Needs Guidance With Regard to the Applicability of Section 101 to DNA
B. Even the Executive Branch is Fragmented and Divided With Regard to Patentablity of Genes
C. The question as to whether human genes or isolated DNA is patent eligible will have far reaching effects on genetic research, medical innovations, the future of patent law and public healthII. THE GOAL OF THE PATENT SYSTEM IS TO ENCOURAGE PROGRESS AND THE IMPACT OF THE PATENT ELIGIBILITY OF HUMAN GENES IS CRITICAL TO THE PROGRESS OF SCIENCE AND USEFUL ARTS AND TO THE PUBLIC HEALTH
A. Where Patent Protection Improperly Preempts All Other Uses, Progress of Science Is Hindered
B. Products of Nature, Laws of Nature and Natural Phenomena, Such as the Claims-At-Issue Are Not Patent EligibleIII. NONPATENT MECHANISMS CAN AND SHOULD ENCOURAGE PROGRESS WHERE PATENTS ARE AN INAPPROPRIATE, UNNECESSARY, INSUFFICIENT, OR BURDENSOME REWARD