Genes safe from patents, but industry finds hope in ruling

Washington In a ruling that observers said will have major implications for the future of medical research and personalized care, the U.S. Supreme Court ruled that a biomedical testing company cannot hold claim to patents on a pair of human genes linked to certain kinds of cancer.

In a unanimous decision issued June 13, the high court justices unanimously held that Myriad Genetics of Salt Lake City does not hold a valid right to patents on the BRCA1 and BRCA2 genes. Mutations in those genes have been associated with breast, ovarian and other types of cancer. Myriad had used its patent protections to claim exclusivity over a screening test that could determine if a patient was at heightened risk for developing these diseases.

The key question in the case came down to whether the company could claim a patent on the gene itself by discovering its precise location on the corresponding human chromosome and removing that section of DNA for research and testing purposes. The justices concluded that “genes and the information they encode are not patent-eligible under [the federal Patent Act] simply because they have been isolated from the surrounding genetic material.” The justices concluded that Myriad’s discovery of the precise location of the genes does not alter the fact that the sequences are products of nature that cannot be patented.

Medical organizations, scientific researchers and patient advocates widely hailed the ruling as a major victory for the health care system. The groups had complained that Myriad’s patents allowed the company to exercise a monopoly over BRCA1 and BRCA2 testing that forced women to pay $3,000 or more to receive the screenings that their doctors said they needed. Medical researchers had said allowing patents on naturally occurring gene sequences hamstrung scientists trying to develop newer and better testing methods for a whole host of diseases.

The Litigation Center of the American Medical Association and the State Medical Societies had joined other health organizations in a friend-of-the-court brief urging rejection of the gene patents in question.

“The AMA is pleased that the justices saw through the flawed premise that resulted in Myriad’s exclusive patent awards and affirmed that human genes are products of nature and not patent-eligible,” said then-AMA President Jeremy A. Lazarus, MD, in a statement. “Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights.”

Research organizations predicted that the decision would mean significantly lower screening costs and more testing options for patients. The Assn. for Molecular Pathology was among the plaintiffs in the case that sued Myriad to overturn the gene patents and force a Supreme Court ruling on the practice.

“We believe the high court today removed a significant barrier to innovation in molecular pathology testing, and we look forward to future advancements in clinical diagnostics and therapeutics that will accrue to the benefit of our patients and our field,” said Roger D. Klein, MD, chair of the association’s professional relations committee.

Many patent possibilities remain

The decision was not a total loss for Myriad and companies like it, however.

“It is important to note what is not implicated by this decision,” the court stated in its opinion. It does not necessarily rule out patents on novel methods of manipulating genes, on new applications of knowledge about genes or on DNA sequences in which the order of nucleotides has been altered artificially. Many existing patents involving genes concern not the genes themselves, but the methods used to alter or apply them.

The court also rejected calls by the plaintiffs to prohibit patents on complementary DNA, or cDNA, which are certain types of genetic sequences created in the laboratory that do not exist on their own in nature. That split decision still leaves protections and opportunities in place for firms that use cDNA in the products they market to consumers, including Myriad’s BRACAnalysis test on the BRCA1 and BRCA2 genes. Myriad said it still had more than 500 enforceable claims on 24 patents related to the screening.

“We believe the court appropriately upheld our claims on cDNA and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward,” said Peter D. Meldrum, Myriad’s president and CEO. “More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall health care costs.”

The conservative Assn. of American Physicians and Surgeons, which issued a friend-of-the-court brief in defense of private property rights as a vital part of medical innovation, applauded the court for issuing what it said was a narrow ruling.

“Millions of women have benefited from the work of Myriad Genetics, the defendant in this case,” the association said in a statement. “While some complain about the high cost of testing for these genes, more encouragement of investment by protecting private property for innovative work — and reduction of the role of third-party payers — are the best ways to bring costs down.”