For nearly two decades, Myriad Genetics has held the exclusive right to test genes BRCA1 and BRCA2 — genes that, if mutated, hugely increase the risk for breast and ovarian cancers.
This past week the Supreme Court ruled on Association for Molecular Pathology v. Myriad Genetics, a much-anticipated case, saying naturally occurring DNA cannot be patented while affirming the patentability of complementary DNA.
Price Heneveld patent attorneys Aaron Wong, senior associate, and Steve Underwood, partner, explained that statute 35 USC 101 determines whether or not something is patent eligible. Included in the statute is “composition of matter,” which was the issue being examined in this particular case.
“The Supreme Court was asked to decide whether or not DNA discoveries and related applications would be patentable,” Underwood said.
“Essentially, what their decision came down to was that DNA that is naturally occurring in the body is not patent eligible even if that DNA is isolated using laboratory techniques or a significant amount of effort,” said Wong.
“Unlike isolated DNA, which consists of introns and exons as they occur in nature, the Supreme Court found that cDNA (complementary DNA) is not naturally occurring since it consists of exons-only molecules. The petitioners — the group opposing Myriad’s patents — contended that cDNA should also be found ineligible since its structure is ‘dictated by nature,’ even if it may not be found in nature. However, the Supreme Court pointed out that a lab technician ‘unquestionably creates something new’ when cDNA is made.”
The most direct impact of this case is it now opens the door for many other companies to begin testing on genes that were previously patented, including BRCA1 and BRCA2. It is anticipated the ruling will lead to an increase in genetic testing and a decrease in cost due to greater competition.
Myriad Genetics has charged nearly $4,000 for BRCA1 and BRCA2 testing, making it difficult for some patients to obtain and leaving some medical professionals reluctant to recommend the testing. It has been suggested that costs could eventually decrease to as little as $1,000.
“It also allows other researchers to get into the experimentation and research of those strands without having to first seek some type of license to do so,” Wong added.
As to whether or not the decision could negatively impact future work in genetic research and treatments that might come from that, Wong and Underwood do not think that scenario is likely.
“I would say, in light of this decision, invention is highly encouraged, but this decision is just saying if it’s purely naturally occurring — even if you isolate it and take it out of its natural environment — the molecule itself is not patentable,” Wong said.
“I think they are still going to go to the patent office, they are still going to publish all this information, but I think they will be a little more reluctant to disclose the isolation of the gene initially until they are further down the research path,” Underwood added.
The decision is an interesting one for patent law and follows a trend for greater scrutiny of patentability, particularly in the areas of medical research and technology.
“I think there is, in recent years, a real shift in the way the courts are looking at these types of patents,” Underwood said.
He noted a case from May that came in front of the U.S. Court of Appeals Federal Circuit, which has exclusive jurisdiction on patent cases and falls just below the Supreme Court: CLS Bank International v. Alice Corp.
“The question there was the patentability of computer-related patents,” Underwood said. “It was an en banc decision … where all of the judges of the Federal Circuit will sit and hear the case. They were split all over the board. There were five separate opinions that came down. The lower court’s decision was affirmed as a consequence of the fact that they couldn’t get a majority to reverse.
“This was a system on how to manage risk, and they had a claim that covered basically having a third party hold the risk between two individuals involved in the transaction and they had a patent on that, a so-called business method patent. I fully expect and would be surprised if this case did not go up to the Supreme Court, as well.”
In fact, there will likely be other patent cases in front of the Supreme Court in the near future.
“One of the things to take away from (the) decision is how narrow it was,” Underwood said. “It only applies to the question of isolating the DNA strands and of artificially created DNA strands.
“The Supreme Court expressly stated that this decision should not be interpreted to address questions as to whether method claims dealing with this technology would be patent eligible, whether or not development of new applications of knowledge about using isolated DNA would be patent eligible, or whether or not altering the sequence of naturally occurring DNA strands would be patent eligible. They expressly put that decision off for another day. The decision is important, but it leaves several questions unanswered.”