Myriad Genetics, which had been aggressively pursuing litigation related to molecular tests for breast and ovarian cancer risk, has pulled back after losing three sequencing patents in federal court late last year. The U.S. Appeals Court for the Federal Circuit ruled on Dec. 17 that three patents Myriad had held for forms of BRCA testing should not have been granted. As a result, the Salt Lake City-based Myriad has settled suits in recent weeks with two other laboratories in Southern California it had sued over their offering of testing of the BRCA gene or its variants. It settled a suit with San Diego-based Pathway Genomics on Jan. 23 and another case with Aliso Viejo-based Ambry Genetics on Feb. 2. Although the exact terms of the settlements were not released, all of the sides agreed to dismiss their claims and counterclaims with prejudice, meaning the litigation cannot be reinstated at a later time. “We are very pleased to close this chapter and continue our focus on providing innovative cancer risk testing to patients around the world,” said Pathway Genomics Chief Executive Officer Jim Plante in a statement. Myriad, which is a spinoff business from the University of Utah, had held a […]
Myriad Genetics, which had been aggressively pursuing litigation related to molecular tests for breast and ovarian cancer risk, has pulled back after losing three sequencing patents in federal court late last year.
The U.S. Appeals Court for the Federal Circuit ruled on Dec. 17 that three patents Myriad had held for forms of BRCA testing should not have been granted.
As a result, the Salt Lake City-based Myriad has settled suits in recent weeks with two other laboratories in Southern California it had sued over their offering of testing of the BRCA gene or its variants. It settled a suit with San Diego-based Pathway Genomics on Jan. 23 and another case with Aliso Viejo-based Ambry Genetics on Feb. 2.
Although the exact terms of the settlements were not released, all of the sides agreed to dismiss their claims and counterclaims with prejudice, meaning the litigation cannot be reinstated at a later time.
“We are very pleased to close this chapter and continue our focus on providing innovative cancer risk testing to patients around the world,” said Pathway Genomics Chief Executive Officer Jim Plante in a statement.
Myriad, which is a spinoff business from the University of Utah, had held a virtual monopoly on BRCA testing through an assay marketed as BRACAnalysis until the U.S. Supreme Court ruled in 2013 that a single gene was essentially simple human tissue and therefore could not be patentable. That opened the door to other laboratories to begin to offer forms of BRCA testing, with many offered at price points well below Myriad’s, which charged more than $3,000 for such a test.
Myriad had sued Ambry and Pathway, claiming the techniques they used to perform their assays were similar to a gene sequencing technique it had already patented.
As part of the litigation, Ambry had won a lower court ruling that the technique itself wasn’t patentable, a decision upheld when Myriad appealed.
In its opinion, the appeals court had decided that the sequencing techniques did not create genetic material considerably different than what appears in nature, meaning that it could not be patented.
The rise of competitors in the BRCA space has stopped Myriad’s growth and hit its bottom line. For the second fiscal 2015 quarter ending Dec. 31, the company reported net income of $24 million on revenue of $184.4 million. For the second quarter of fiscal 2014, its net income was $50.4 million on revenue of $196.2 million. For the first six months of fiscal 2015, its net income was $40 million on revenue of $343.7 million. For the first half of fiscal 2014, its net income was $62.1 million on revenue of $406.5 million.
Myriad has developed a variety of other assays that assess oncologic risks, including prostate, colorectal, pancreatic and lung cancers. It noted in its most recent filing with the Securities and Exchange Commission that sales of its recently introduced myRisk cancer panel have been brisk. The assay tests 25 genes for a patient’s risk of developing eight types of cancer. Myriad said myRisk testing now represents “more than 50 percent of all hereditary cancer samples received.” That has prompted the company to hire more staff and purchase more equipment to process those tests.
Takeaway: Myriad Genetics appears to be turning a new page in the BRCA saga, and likely will spend less time on litigation in the future.
