Judge Rules Myriad Cannot Patent BRCA1 and BRCA2-Genes

BRCA1 protein rendering.

A US district court invalidated 7 of 23 of Myriad Genetics, Inc’s patents on the BRCA1 and BRCA2 genes, which confer an increased risk of developing breast, ovarian, and prostate cancers. If upheld, the decision by Judge Robert W. Sweet would threaten existing patents on thousands of genes and curtail the rights of an individual or organization to patent a gene. Biotechnology industry analysts predict that prohibiting gene patenting will stall advances in genetic research by diminishing financial incentives. Several research professionals disagree and believe restricting gene patenting expands genetic research opportunities.

The Association for Molecular Pathology, the American Civil Liberties Union (ACLU), and the Public Patent Foundation filed the lawsuit against the US Patent and Trademark Office and Myriad last year. They argued that the patents limit patient access to affordable, high quality testing for cancer-causing BRCA1 and BRCA2mutations. Myriad manufactures the only test available in the United States to detect the patented BRCA mutations, and each analysis costs more than $3000. Its patents make it virtually impossible for another company to develop a diagnostic test for the cancer-causing mutations. The plaintiffs’ other complaint is that the gene patents stymie progress in finding cures for cancer because Myriad restricts researchers’ access to the genes, and there is no workaround when investigating BRCA-related cancers.

Sweet agreed with the plaintiffs’ primary argument—that genes are products of nature and cannot be patented. Myriad countered that because the genes had been isolated from the DNA, they were no longer in their natural state. The judge disagreed and said the genetic sequences did not meet the Supreme Court precedent of having “markedly different characteristics” from their natural state, nor did they possess a “new or distinctive, form, quality, or property.” He compared it to a case in which the court ruled that refined cellulose—purified pulp obtained from wood or vegetable matter—could not be patented because, while the process to obtain it might be “the creature of invention,” the extracted material was still cellulose, a naturally occurring substance. While the Supreme Court has held that genetically altered microorganisms can be patented, Sweet said this is because these microorganisms do not occur in nature. In summary, Sweet concluded that isolated DNA differs little from non-isolated DNA because it leaves the nucleotide sequence intact and is therefore a discovery, not an invention.

Some of the contested patents gave Myriad the exclusive right to analyze BRCA1and BRCA2nucleotide sequences for mutations or compare them against a reference sequence. Another patent prohibited anyone from assessing the growth rate of recombinant cells containing the BRCA1and BRCA2genes in response to therapeutic treatments. Sweet said none of these process patents were valid because the methods involved an abstract mental process that did not involve transforming the genetic material in any way.

BRCA2 protein rendering.

Sweet’s decision surprised intellectual property law experts. The US Patent and Trademark Office has been granting gene patents for years, and they expected the judge to dismiss the lawsuit. Some expect portions of Sweet’s ruling to be overturned on appeal. Myriad has already indicated it will appeal the decision to the 2^nd US Circuit Court of Appeals in Manhattan. Given the significant ramifications of the findings on the field of research and diagnostics, either party will undoubtedly appeal to the Supreme Court in the event of an adverse ruling.

The National Institutes of Health estimates that nearly 20% of the human genome has been patented, with many of the genes linked to diseases like Alzheimer’s, cancer, and muscular dystrophy. Universities hold some of these patents, whereas others are held by diagnostic and biotechnology companies. In some cases, the discovery of a gene becomes the foundation for a new venture. This was the case with Myriad; Mark Skolnick, the University of Utah researcher who discovered the gene, went on to found the company.

Critics of gene patents have long maintained the patents create corporate monopolies that restrict genetic research and eliminate open competition that could yield better and cheaper tests. They view the ruling as a major breakthrough, and believe the decision will transform the established paradigm governing the field of genetic testing if it is not overturned. ACLU staff lawyer Chris Hansen, who helped argue the case, said, “The human genome, like the structure of blood, air or water, was discovered, not created. There is an endless amount of information on genes that begs for further discovery, and gene patents put up unacceptable barriers to the free exchange of ideas.”

In a statement on the ACLU’s Website, Selene Kaye of the ACLU’s Women’s Rights Project called the decision “a huge victory for women’s health and scientific freedom.” She cautioned that the fight was not over, however. Myriad points to the large number of studies involving BRCA1and BRCA2genes as proof that its patents have not stifled research. The company said that, in addition to making the information available for research, it publicizes data from its own research involving the genes. “We are very confident that the Court of Appeals for the Federal Circuit will reverse this decision and uphold the patent claims being challenged in this litigation,” Peter Meldrum, Myriad’s president and CEO, said in a statement.