[December 17, 2014]

Ambry Genetics Defeats Appeal by Myriad Genetics to Restrict Market for Breast-Ovarian Cancer Genetic Testing

Ambry Genetics defeated an appeal by Myriad Genetics to block competing DNA-based tests to determine hereditary risk for breast and ovarian cancer after a United States Court of Appeals for the Federal Circuit held today that claims from three of the patents covering DNA-based BRCA1 and BRCA2 tests Myriad is asserting against Ambry do not contain subject matter eligible for patent protection. "Myriad did not create or alter any of the genetic information encoded in the BRCA1 or BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them," the U.S. Court of Appeals for the Federal Circuit said in an opinion posted today on the court's docket. The Court of Appeals also relied on the 2013 Supreme Court opinion finding other of Myriad's claims patent-ineligible and observed, "As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible."

After learning of today's ruling Ambry Genetics Chief Executive Officer, Charles Dunlop, offered, "I knew intellectually that we were right, and our basic arguments were correct. I have cancer, and I could not believe - I found it offensive, actually - that somebody with cancer would not have options for genetic testing. Because we believed our position was correct under the law, we decided to move forward and defend Ambry from Myriad's claims."

In July 2013, Ambry Genetics announced it would vigorously defend itself against the patent infringement suit filed the day before in the United States District Court for the District of Utah by Myriad Genetics, the University of Utah Research Foundation, the Trustees of the University of Pennsylvania, HSC Research and Development LP, and Endorecherche, Inc. The complaint alleged Ambry Genetics infringed on certain Myriad BRCA1 and BRCA2 gene patents by offering diagnostic BRCA1 and BRCA2 genetic testing. Myriad has snce added to the lawsuit patents relating to MYH genetic testing.

Ambry Genetics began offering BRCA1 and BRCA2 diagnostic testing following the United States Supreme Court's landmark June 13, 2013 decision in AMP et al. v. Myriad Genetics, et al. A coalition of patients, physicians, and healthcare groups brought that lawsuit to challenge Myriad's patents directed at BRCA1 and BRCA2 genes. As alleged in that lawsuit, Myriad maintained a monopoly over diagnostic testing of the BRCA1 and BRCA2 genes under the Myriad patents, and threatened legal actions against entities that wished to provide BRCA1 and BRCA2 genetic testing to patients. Following a multi-year legal battle, the unanimous Supreme Court decision held that genomic sequences, whether isolated or not, may not be patented and declared invalid the Myriad BRCA1 and BRCA2 patent claims challenged in that suit. Myriad subsequently appealed this decision, and the U.S. Court of Appeals for the Federal Circuit has just rejected this.

Ambry Genetics Chief Medical Offer, Dr. Elizabeth Chao, felt, "As a geneticist, I am thrilled. This decision echoes what the Supreme Court unanimously stated 18 months ago. It's a win for patients, for practicing clinicians trying to access genetic testing for their patients, and for the industry overall. It's great not to have these patent claims holding back important research and progress in genetics. At Ambry, we will continue to offer our high-quality testing that has been very beneficial for families."

This is an important victory for Ambry Genetics, and this decision will resonate as other gene patents are asserted. Chief Commercial Officer and President of Ambry Genetics, James Dunlop, added, "The playing field is starting to be leveled. Now it will come down to service and expanding science, not gene patents."

For the complete United States Court of Appeals for the Federal Circuit opinion, please visit http://www.cafc.uscourts.gov/images/stories/opinions-orders/14-1361.Opinion.12-15-2014.1.PDF

Ambry Genetics was represented in the appeal by McDermott Will & Emery and is represented in the district court litigation by McDermott Will & Emery and TraskBritt.

ABOUT AMBRY GENETICS®

Ambry Genetics is a College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified commercial genetic diagnostics laboratory headquartered in Aliso Viejo, California. Ambry Genetics is a leader in clinical genetic diagnostics and offers the most comprehensive testing menu in the industry. Hereditary cancer menu highlights include multi-gene panels for breast cancer, ovarian cancer, colorectal cancer, renal cancer, pancreatic cancer, paraganglioma, pheochromocytoma, and more. Ambry Genetics was the first to offer clinical exome sequencing commercially, and has an extensive menu including hereditary cardiology and numerous general genetic testing options. Ambry has established a reputation for sharing data, unparalleled service, and responsibly applying new technologies to the clinical molecular diagnostics market. To learn more about services available through Ambry Genetics, visit www.ambrygen.com.

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