Nearly a month after the U.S. Supreme Court ruled that genes cannot be patented, Penn and Myriad Genetics — the company which had its genetic patents overturned by the Court — have filed two lawsuits claiming that their breast cancer-related patents were infringed.
The two lawsuits, which were brought separately in early July against Ambry Genetics and Gene by Gene LTD, claim that a series of patents relating to breast cancer genes that are owned or exclusively licensed to Myriad are being violated. Two of the genetic patents in question are owned in part by Penn.
The two genes involved in the cases — BRCA1 and BRCA2 — are the same ones the Supreme Court cited in its June 13 ruling that products of nature, such as natural genes, cannot be patented.
The day the Supreme Court issued its ruling, Ambry and Gene by Gene separately announced that they would be offering BRCA1/2 analysis — which can help determine a person’s hereditary risk for breast and ovarian cancer.
“People jumped into the market after the Supreme Court made its decision,” said Richard Gold, a professor at McGill University’s Faculty of Law and the founding director of McGill’s Centre for Intellectual Property Policy.
While these companies claim that the Supreme Court ruling allowed them to begin offering tests for these genes, the plaintiffs claim their current patents are being infringed, causing them “irreparable injury.”
The plaintiffs, which also include the University of Utah Research Foundation and Endorecherche, Inc., are asking to be awarded “enhanced damages,” in addition to court costs and attorney fees, and are requesting that the defendants no longer be allowed to offer these tests.
Gold expects that Myriad will argue that all patents not struck down by the Supreme Court should still stand. He added that Ambry and Gene by Gene will presumably argue that “the same logic [employed in the Supreme Court’s decision] applies to these patent claims.”
Two suits, two Penn patents
While the lawsuit against Ambry involves 10 patents, and the one against Gene by Gene involves nine, only two of the patents in each case — No. 5,837,492 and No. 6,033,857 — are owned in part by Penn. Both Penn patents relate to the gene BRCA2.
The first patent deals with primers, strands which serve as the starting points for DNA synthesis, and the second concerns a “method for diagnosing a predisposition to breast cancer,” according to the patent.
Loyola Law School professor and 2002 Penn Law graduate Lee Petherbridge said that the primer patent’s claims will raise questions concerning the Supreme Court’s definition of “product of nature,” but “what this [patent] claim language means is presently legally unclear.”
He thought the Court’s recent decision will not greatly affect the claims made by the latter patent because he thinks that these patents deal with substances which are legally allowed to be patented.
“For that reason, I doubt it is impacted much by the Supreme Court’s recent Myriad opinion,” Petherbridge said.
‘A Matter of Law’
According to Senior Vice President of the University of Pennsylvania Health System Susan Phillips, Penn is taking part in the lawsuit because the co-owners of patents are legally required to be co-plaintiffs.
“It is a matter of law, not a matter of choice. We did not seek out this lawsuit,” she said. “You can call the Hospital of Sick Children in Toronto and they would feel the same way.”
However, according to McGill Law Professor Richard Gold, Penn’s March 1996 contract with Myriad mandates that Penn be named in any potential lawsuit.
Article 7.4 of the contract states, “In any action to enforce any of the JOINT PATENT RIGHTS, either party, at the request and expense of the other party shall cooperate to the fullest extent reasonably possible.”
According to Gold, “this was not an uncommon provision,” in similar contracts during the 1990s. Endorecherche’s contract with Myriad, also obtained from the SEC, includes a similar provision.
Penn is “being named [in the lawsuit] because they did not negotiate a very good contract,” he said. “They may or may not agree with Myriad.”
Petherbridge thinks that this case is “of considerable significance.”
This case “probably represents the first practical test of Myriad’s ability to exclude others from its BRCA testing technology,” Petherbridge said.
“If Myriad cannot prevail in these cases, then it may well have to accept competition in the marketplace,” he added.
Gold believes that this case will have a direct effect on the cost of BRCA tests. He said that the BRCA tests offered of Ambry and Gene by Gene were more affordable than those previously offered.
However, if competing companies — like Gene by Gene and Ambry — are prevented from joining the industry the price will increase again.
“If [Ambry and Gene by Gene] are proved wrong, and I think they will be, it will be at the expense of women who want to be tested,” Gold said. “It’s legal, but not ethical.”
Gold noted that within ten years, all of the patents in questions will run out and will not be eligible for renewal. At that point, he believes the price of testing will decreas.
Myriad, however, has argued that the cost of BRCA testing is widely exaggerated. “As of today, BRCA testing is widely covered by public and private insurance for the vast majority of at-risk patients, and their average out-of-pocket cost is less than $100,” Ronald Rogers, spokesman for Myriad, said in an email.
The University of Pennsylvania Health System advocated support for providing genetic testing to others.
“We support access to medically appropriate genetic testing and will be using royalties we receive as a result of [the University’s] co-ownership with Myriad of the gene sequencing patents to enhance genetic testing technology and to subsidize the cost of testing when needed,” Susan Phillips, senior vice president for UPHS, said in a statement.
Although Ambry also voiced support for widespread genetic testing, it said that it “intends to vigorously defend itself against the patent infringement lawsuit.”
“We have had an overwhelming response from our clients seeking an alternative laboratory to perform BRCA testing and Ambry is fully committed to supporting our clients and patients moving forward,” Ambry CEO Charles Dunlop said in a statement.
However, Myriad argued that the synthetic DNA and tests employed by Ambry and Gene by Gene are Myriad’s patented intellectual property.
The University of Utah Research Foundation deferred comment to Myriad. Gene by Gene did not respond to multiple requests for a comment. As of press time, Endorecherche has not responded to a request for an interview.
This is the second patent-related lawsuit Penn has filed this year. On March 22, Penn filed suit against St. Jude Children’s Research Hospital asking that a cancer research patent issued to St. Jude on March 19 be invalidated.