Myriad Genetics sues Aliso Viejo company Ambry Genetics over gene tests

Myriad Genetics, a biotech company, owns patents on the BRCA1 and BRCA2 genes, mutations of which help to increase the risk of certain breast and ovarian cancers. The Association for Molecular Pathology filed a suit against Myriad in 2009, claiming that the genes, which are naturally occurring segments of DNA, are not eligible for a patent. The American Civil Liberties Union, which also helped file the suit against Myriad, claimed that by having gene patents, testing for patients is monopolized since the company who owns the patents can then control who administers the tests, as well as how much the tests cost. The case was eventually brought before the United States Supreme Court.

One month ago, on June 13, 2013, the Supreme Court ruled unanimously against Myriad that isolated human genes do not qualify as patentable subject matter. While isolated human genes no longer have patent eligibility, products that have been synthetically altered may continue to be patented.

Immediately after this ruling, Ambry Genetics, a company located in Aliso Viejo, California, began offering tests for the BRCA1 and BRCA2 genes. According to its website, Ambry Genetics is the leader in “hereditary cancer diagnostics,” and with the addition of BRCA1 and BRCA2 tests, Ambry Genetics “now offers the most comprehensive germline cancer-testing menu in the industry, providing patients with the most accurate diagnosis currently available.”

On Tuesday, July 9, 2013, Myriad Genetics filed suit against Ambry Genetics, claiming that Ambry is infringing on 10 of Myriad’s patents. Other company’s that are also against Ambry in the lawsuit include the University of Utah Research Foundation, the Trustees of the University of Pennsylvania, HSC Research and Development LP, and Endorecherche Inc. Though the claims in Myriad’s patents about BRCA1 and BRCA2 genes are invalidated, techniques for testing remain patentable matter.

Ambry announced that it is determined to protect itself from Myriad’s patent infringement lawsuit, a sentiment expressed by Charles Dunlop, CEO of Ambry Genetics. “Ambry Genetics supports the Supreme Court’s decision and will vigorously defend its position,” said Dunlop. “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.”

Audrey Nicolson
Law Clerk at
JAFARI LAW GROUP®, INC.