Earlier this year, in Association for Molecular Pathology v. Myriad Genetics (13 June 2013), the Supreme Court ruled that the process of isolating naturally occurring DNA is insufficient to transform the natural phenomenon into a patentable invention. At the same time, the court ruled that a man-made cDNA version of naturally occurring human DNA is patentable.
Within hours of that Supreme Court ruling, Ambry Genetics (“Ambry”), a closely held company in Aliso Viejo, California, announced that it would begin offering genetic testing for the BRCA1/BRCA2 mutations at a significantly reduced rate.
On 9 July 2013, Myriad Genetics (“Myriad”) filed a lawsuit against Ambry alleging that the Ambry tests infringe ten patents, that Myriad either owns or licenses, on the screening process. The other owners of the patents, comprising the University of Utah and University of Pennsylvania, Ontario’s Hospital for Sick Children and Endorecherche Inc., also joined in the suit against Ambry.
In their lawsuit, Myriad held that the patent owners “have been damaged and have suffered irreparable injury due to the defendant’s acts of infringement, and will continue to suffer irreparable injury” unless stopped by the court.
Myriad also said that it has invested more than US$500 million to create a diagnostic test for hereditary breast and ovarian cancer cases related to the genes it discovered, which are known as BRCA1 and BRCA2. The efforts “have revolutionized patient care and provided medical diagnosis and treatment options never thought possible”.
Ambry’s rival test will cause a loss of revenue from its tests, which in turn will mean lower royalty payments for the patent owners, according to the complaint. Hence, the plaintiffs are seeking compensation and an order that Ambry provide to the patent owners, including Myriad, all products that infringe the patents so they can be destroyed.
Although it appears that Myriad has a very strong case here, it may depend on whether the district court will entertain arguments that the public’s need for access to multiple sources of cancer diagnostic tools weighs heavily against injunctive relief.
The case is University of Utah Research Foundation et al. v. Ambry Genetics, 13-640, U.S. District Court for the District of Utah.