In a decision that seemed designed to carve out a middle ground in the legal battle over whether companies can hold exclusive rights in the use of biological material, the U.S. Supreme Court ruled Thursday that isolated human genes are not patentable, but synthetically created genetic material may be patented.
The result of the ruling in Association for Molecular Pathology v. Myriad Genetics, Inc. could be immediate for both patients and companies asserting or challenging patent ownership rights.
Biological testing based on the detection of genetic material “will become much cheaper and more readily available,” said Charles A. Rothfeld, special counsel in the Washington office of Mayer Brown LLP. “The broader result is that it will become much more difficult for individual companies to claim a monopoly on biological and biotechnical products.”
But the limited scope of the justices’ decision, which affects only the patentability of human genetic material, could prevent it from being the blockbuster that some in the biotech industry expected. Broader questions about the patentability of other quasi-natural materials — from genetically modified foods to medications created from naturally occurring bacteria and fungi — remain unanswered by the ruling.
“I think the impact will be pretty small,” said Thomas J. Engellenner, a partner in the Boston office of Pepper Hamilton LLP, noting that the entire human genome has already been mapped. “Gene patents reached their heyday in the 1990s. Most have expired or will soon expire. The ruling itself is very limited.”
Isolating the issue
The case stemmed from the BRACAnalysis test, created by Utah-based company Myriad Genetics to detect the presence of two human gene mutations (BRCA1 and BRCA2), which have been shown to dramatically increase the risk of breast and ovarian cancers. (Actress Angelina Jolie recently made headlines when she revealed she had one of the gene mutations and decided to voluntarily undergo a double mastectomy and have her ovaries removed.)
After securing a host of patents on every aspect of the testing process, including patents on the isolated DNA material as well synthetically created composite genetic material known as cDNA, Myriad began demanding that other entities performing BRCA testing cease to do so, and brought patent infringement claims against those who refused.
The Association for Molecular Pathology, a Bethesda, Md.-based national membership organization of doctors, researchers, health care organizations and others in the genomic science industry, brought suit to declare the patent invalid. The lawsuit was filed on the organization’s behalf by the ACLU and the Public Patent Foundation.
A federal district court granted summary judgment to the plaintiffs, declaring Myriad’s patents on DNA and cDNA material invalid under 35 U. S. C. §101, the section of the Patent Act excepting products of nature.
But the Federal Circuit reversed, finding both DNA and cDNA patent-eligible.
The Supreme Court reversed the Federal Circuit ruling with respect to DNA, and affirmed the conclusion as to cDNA. Unlike synthetically created genetic material, DNA cannot be subject to a patent just because it has been located and isolated, the court held.
“It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes,” Justice Clarence Thomas wrote for the unanimous court. “The location and order of the nucleotides existed in nature before Myriad found them.”
But Thomas stressed what the ruling did not address: the patentability of methods for isolating or manipulating genes, claims involving new applications for genetic material, and the patentability of DNA containing components that have been altered.
“We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material,” Thomas wrote.
Greater access vs. stifled innovation
Matthew S. Gibson, an intellectual property associate in the Oklahoma City office of McAfee & Taft PC, said the ruling could stifle creation of biotech products because even patentable methods and processes can only be found through the isolation and use of DNA materials over which companies can no longer assert ownership claims after the court’s ruling. Companies may not invest in expensive innovation if they can’t fully protect the process from competitors, he said.
“The bottom line is cost,” Gibson said. “It’s a massive investment and it takes a lot of time.”
The court’s middle-ground approach led both sides in the case to claim victory.
“Myriad did not invent the BRCA genes and should not control them,” said Sandra Park, a senior staff attorney with the ACLU Women’s Rights Project in New York. “Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued.”
In a statement, Myriad Genetics said that its BRACAnalysis test still enjoys “strong patent protection” based on the 500 valid and enforceable claims in 24 different patents that remain intact after the court’s ruling.
“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 president and CEO Peter D. Meldrum in a statement. “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.”