Myriad Genetics, the biotechnology company that in a recent Supreme Court ruling lost exclusive rights to isolated human genes, has filed patent infringement lawsuits against companies that launched competing versions of BRCA tests.
After the high court’s ruling June 13, several companies announced plans to accept and analyze samples of BRCA1 and BRCA2, isolated genes associated with breast and ovarian cancer.
Ambry Genetics of Aliso Viejo, Calif. launched BRCA tests at $2,200, undercutting Myriad’s $4,040 integrated BRACAnalysis test by nearly half. Gene By Gene Ltd. of Houston offered its version of the test at an even lower price: $995.
But by being the first to hit the market, these companies came under Myriad’s fire.
Myriad adopted a classic strategy that originates with innovator drug companies: When you lose the principal claim to exclusivity—such as a composition of matter patent—claim infringement of provisions that cover methods of use, special know-how associated with using the products.
Frequently, pharmaceutical companies use this strategy as a delay tactic which allows them to hang on to monopoly profits for the duration of the legal battle.
The Myriad lawsuits, filed July 9 and 10 in the District Court for the District of Utah, Central Division, are posted on The Cancer Letter website.
“We think that they are infringing on our intellectual property and our patents, and we’ll demonstrate that in court,” Myriad spokesman Ron Rogers said to The Cancer Letter. “The vast majority of the patent claims remain valid and enforceable.
“The patent owners are going to demonstrate in these lawsuits that the testing process employed by both Ambry and Gene By Gene infringe ten patents covering synthetic primers, probes and arrays, as well as methods of testing related to BRCA,” Rogers said.
The BRCA genes were discovered by Myriad, which said it invested more than $500 million in researching the genes and commercializing testing products (The Cancer Letter, April 19).
Myriad isn’t alone in this phase of the legal battle. A group of co-owners of the BRCA patents joined the company’s lawsuits.
The other plaintiffs are: the University of Utah; the University of Pennsylvania; the Hospital for Sick Children; and Endorecherche, a Canadian medical research corporation.
A Classic Patent Dispute
“I think they are basically trying to stave off competition by making Ambry an example, and forcing Ambry to spend a lot of money and hire a bunch of lawyers to accompany their entry into the market,” said Robert Cook-Deegan, director of the Center for Genome Ethics, Law and Policy at the Duke University Institute for Genome Sciences and Policy.
Cook-Deegan’s guest editorials on the oral arguments in the Myriad Supreme Court Case and the ruling appeared in the April 19 and June 14 issues of The Cancer Letter.
Only two competitors have been sued so far. Others that have announced plans to launch BRCA tests—GeneDx, Pathway Genomics, Quest Diagnostics—appear to be holding back, presumably until the lawsuits blow over.
“I think it’s probably, as much as anything, a delaying tactic, and it worked, because Myriad’s stocks are back up,” Cook-Deegan said.