On August 16, 2012, the United States Court of Appeals for the Federal Circuit upheld a patent claim on the BRCA1 and BRCA2 mutations. Numerous patient and provider groups—including the Ovarian Cancer National Alliance—supported the case, which was led the American Civil Liberties Union (ACLU). Myriad Genetics owns the patent to the BRCA1 and BRCA2 genetic mutations, and sells a test for those mutations called BRCAnalysis that costs approximately $3,300.
The BRCA1 and BRCA2 mutations are heritable mutations, meaning that a person may inherit them through their mother or father. These genetic mutations can increase a woman’s risk of developing ovarian cancer between 10 and 60 percent.
The case hinged on the difference between nature and invention. The Alliance believes that since these genetic mutations are naturally occurring they should not be patentable; the court, however, ruled that the isolated DNA examined by Myriad is not found in nature. The court specifically stated that these genetic sequences are “prepared from the products of nature [but] so is every other composition of matter” (AMP v. PTO at 39).
The court ruled that isolated DNA is different from naturally occurring DNA, even when it contains the same information, as is the case with the BRCAnalysis test. The Court ruled that “isolated DNA is a tangible, man-made composition of matter defined and distinguished by its objectively discernible chemical structure” (AMP. PTO at 49) and therefore is eligible for a patent.
Sandra Park, staff attorney with the ACLU Women’s Rights Project, argued this case before the Federal Circuit Court. “This is a devastating decision for a woman’s health,” she said. “Patients facing life-changing medical decisions deserve the best quality care and research available. They should not be blocked from getting that care because a company owns the exclusive right to access their genes.”
The Alliance submitted amicus briefs on the case and was present at both Federal Circuit Court oral arguments. Our staff will continue to work with policy makers and payers to ensure that genetic counseling and testing are available as part of the implementation of evidence based guidelines. The Alliance is also working with regulators and industry to ensure that the results of all laboratory tests are accurate and clinically useful.
The case has been contentious, with the Patent and Trademark Office officially being sued for having wrongly granted the patent, and the Solicitor General’s office providing a legal opinion that unmodified DNA is not patent eligible but that DNA that is human engineered is patent eligible. It is highly uncommon for two government agencies to take different public positions on legal proceedings. The case has ramifications for many companies: the Patent and Trademark Office has issued 2,645 patents for isolated DNA in the past 29 years and at least 40,000 patents related to genes in the human genome (AMP v. PTO at 54)
Myriad’s patents on the BRCA1 and BRCA2 mutations expire on December 18, 2015. The ACLU can appeal to the Supreme Court; it has until mid-November to do so.