After years of varying decisions by lower courts regarding the patents held on a test for genetic mutations associated with breast cancer, the US Supreme Court has ruled that a segment of DNA in isolation is a natural product and not eligible for patent protection.
However, some of the patents held by the company on the defensive end of the case will still be eligible for legal protection because they involve composite DNA (cDNA), and the court ruled that the development of those products requires a great degree of human intervention.
The decision brings a close to the case of Association for Molecular Pathology v Myriad Genetics, Inc,
and officially overturns some previous decisions by lower-level courts ruling in favor of the patent protection. However, this decision may not have any immediate effects on the availability of the current test, or the ability of other manufacturers to bring similar tests to market.
At the center of this ruling is the BRACAnalysis test manufactured by Salt Lake City, Utah-based Myriad Genetics, a molecular diagnostic company that holds the patents on the BRCA1
genes, both of which are closely associated with a greater risk of development of breast and ovarian cancer. Since Myriad secured the patent on the two genes, all testing for the genes has had to be done with the company’s test, estimated to cost approximately $3340 before any insurance coverage. It’s the same test that recently determined that actress Angelina Jolie had mutations in the BRCA1
In the Supreme Court’s decision, the justices stated that “Myriad did not create or alter either the genetic information encoded in the BRCA1
genes or the genetic structure of the DNA,” and that extensive effort alone in the discovery of those genes is insufficient to meet patent eligibility. With regard to cDNA, the court stated that it is not a product of nature and is eligible for patent protection because “its creation results in an exons-only molecule, which is not naturally occurring” and “the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.”
The case did not involve any method claims or patents on any new applications of the knowledge about the BRCA1
genes, according to a statement from Justice Clarence Thomas on behalf of the court.
In a press briefing held after the decision was announced, representatives for the plaintiffs in the case expressed their approval of the decision.
The Association of Molecular Pathology (AMP) said in a statement that the organization was “very pleased” with the highest court’s decision. When the AMP filed its original lawsuit, the organization expressed concerns that patents on genes could lead to monopolies and allow companies to restrict access to databases containing genetic information acquired through tests like BRACAnalysis, thus preventing the medical community at large from using any of that information.
“The Court’s decision that human genes are not patentable is a great step forward for the field of molecular pathology, for genomic science, and most important for our patients,” the organization said in a statement posted on its website. “We look forward to exciting future advancements in diagnostic testing and therapeutics that will accrue to the benefit of our patients and our field.”
Roger D. Klein, MD, JD
Roger D. Klein, MD, JD, chair of the Professional Relations Committee for the AMP and a pathologist in the department of Molecular Pathology at the Cleveland Clinic, said that cDNA “really is not crucial for the performance of this work” and considered the decision a “major victory.”
Sandra Park, senior staff attorney with the American Civil Liberties Union Women's Rights Project and a co-counsel on the case, explained that the BRACAnalysis test is unable to detect mutations in very large rearrangements of DNA, and this is something that hopefully can be achieved now that research laboratories are free to test for BRCA1
in addition to other mutations all at once.
However, a statement from Myriad Genetics contends that the company is also pleased with the court’s decision, noting that after the opinion was rendered, “Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis test.”