Last month, BioNews Texas‘ Science Editor Charles Moore reported on how the U.S. Supreme Court’s Landmark Decision On Gene Patentability Opened Door To Market Competition (And Lower Prices) For Breast Cancer Testing, citing Houston-based Gene By Gene Ltd. as a prime example of a DNA testing company that would benefit greatly from the court’s ruling. Now, in the wake of that decision, Myriad Genetics, the defendant in the case and once sole-holder of the patent for the BRCA1 and BRCA2 DNA tests, is suing both Gene-By-Gene and another competitor (Ambry Genetics of Aliso Viejo, California) for violating a type of synthetic DNA patent that Myriad feels the U.S. Supreme Court clearly upheld in their decision.
Both Ambry and DNATraits, a division of Gene By Gene, are currently offering the BRCA1 and 2 tests for considerably less money than what Myriad had been able to garner from customers prior to the Supreme Court decision. According to their website, Gene By Gene, offers testing for theBRCA1 and BRCA2 genes in the United States for $995, while Ambry’s testing reportedly costs $2280. Myriad’s testing costs $4,000.
While the Myriad lawsuit is not contesting Gene by Gene or Ambry on the basis of the Supreme Court ruling on natural DNA, Myriad is asserting that so-called “synthetic DNA,” or cDNA, “were not affected by the Court’s decision and remain valid and enforceable.” Coverage of the Supreme Court’s ruling in June focused less on the issue of cDNA, however, it is generally agreed that cDNA can indeed be patented, due to the fact that it is developed via “physical, transformative steps” in the laboratory.
Peter D. Meldrum, president and CEO of Myriad, said in June: “We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward.”
Myriad is not alone in its lawsuit; it is joined by the University of Utah Research Foundation, the University of Pennsylvania, HSC Research and Development LP, and Endorecherche, Inc. all as coplaintiffs.
For their part, Ambry has already stated that it will “vigorously defend itself” in the suit, while Gene By Gene has yet to comment. In any case, it is clear that all of the parties involved anticipated this legal gambit, which will undoubtedly lead to further legal wrangling in the months and years to come.