BRCA1 protein rendering.
On July, 29, 2011, a US appeals court sided with Myriad Genetics, Inc’s patents on the BRCA1 and BRCA2 genes. The court ruled 2-to-1 in favor of Myriad, citing that genes in isolation are not naturally occurring and are therefore allowed to be patented. Many researchers believe that any part of the human genome is naturally occurring and should not be patented.
The ruling overturned a decision made by a US district court in New York City in March 2010. In that case, Judge Robert W. Street and the court concluded that isolated DNA is a discovery, not an invention, because an isolated portion of DNA differs little from non-isolated DNA since it leaves the nucleotide sequence intact.
In this current decision, Judge Alan D. Lourie wrote that the appeals court reversed the district court’s decision “that Myriad’s composition claims to ‘isolated’ DNA molecules cover patent-ineligible products of nature…since the molecules as claimed do not exist in nature.”
With this decision, Myriad’s existing patents, along with thousands of other gene patents, are protected for the moment. Lourie wrote that “…the mere fact that the larger chromosomal polymer includes the same sequence of nucleotides as the smaller isolated DNA is not enough to make it per se a law of nature and remove it from the scope of patentable subject matter…Instead, the claimed isolated DNA molecules, which are truncations (with different ends) of the naturally occurring DNA found as part of the chromosome in nature, are not naturally produced without the intervention of man.”
The controversial case has divided the scientific research community. Biotechnology companies have been patenting gene sequences for years as a routine part of developing drugs, with more than 4000 genes already patented. The process also creates financial incentives, since companies are able to lay claim to those genes when developing new diagnostic techniques, genetic tests, and novel treatment options. However, many in the research community are of the mind that opportunities for using gene sequences for research are being restricted by the very same process.
BRCA2 protein rendering.
In 2009, the Association for Molecular Pathology (AMP), the American Civil Liberties Union (ACLU), and the Public Patent Foundation filed the lawsuit against the US Patent and Trademark Office and Myriad. They argued that the patents limit patient access to affordable, high-quality testing for BRCA1 and BRCA2mutations, which have been linked to breast cancer, ovarian cancer, and prostate cancer. Myriad not only manufactures the only test available in the United States to detect the patented BRCA mutations, but the company also restricts researchers’ access to the genes. However, those who sequence an entire human genome are not bound by these restrictions.
The court did make an additional exception for renowned scientist Harry Ostrer, MD, director of the Human Genetics Program at New York University. Because Ostrer, one of the plaintiffs in the case, has demonstrated a capability and desire to begin BCRA testing in his lab, he may challenge Myriad’s patent protection in order to continue his work with the genes. Two other researchers had expressed a desire to begin BCRA testing in their laboratories, but the court ruled that they did not have the same capabilities to perform the research as Ostrer had shown.
Many legal analysts predict that the case will eventually head to the US Supreme Court to be decided. The plaintiffs intend keep pursuing the case. The Obama Administration filed a friend-of-the-court brief in 2010 siding with the ACLU, one of the plaintiffs in the case. The administration agreed with the ACLU on the basis that isolating something that already exists in nature is not something that should be able to be patented and gain the rights offered by patent protection.
“Gene patents and exclusive licenses that confine molecular testing to a single provider are detrimental to the public interest by limiting patient access to testing,” said Timothy J. Leary, MD, PhD, president of the AMP, one of other the plaintiffs in this ongoing litigation. “Monopolies on gene testing make it impossible for patients to access alternate tests or get a second opinion about their results. AMP will continue to advocate until a resolution is found either in the courts or in legislation.”