meldrumPeter D. MeldrumThe Supreme Court has upheld patent claims by  Myriad Genetics Inc, Salt Lake City, on complementary DNA, or cDNA.

However, the Court ruled that five of Myriad’s claims covering isolated DNA were not patent-eligible. Following the Court’s decision, Myriad has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis® test, the company reports.

The Court noted that many of Myriad’s unchallenged claims are method claims applying knowledge about the BRCA 1 and BRCA 2 genes. While these method claims were not at issue in this case, the Court highlighted Federal Circuit Judge Bryson’s opinion that, “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications to that knowledge.”

“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,” says Peter D. Meldrum, president and CEO, Myriad Genetics. “More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall health care costs.”

BRACAnalysis is the leading genetic test worldwide to determine if a patient has an increased risk of hereditary breast and ovarian cancer and has been used by more than a million women to assess their risk of hereditary breast and ovarian cancer. BRACAnalysis testing is widely reimbursed by private insurance companies, Medicare and Medicaid. As a result of the Affordable Care Act, the vast majority of at-risk patients can receive BRACAnalysis testing with no out-of-pocket costs—meaning no copays or deductibles. Additionally, more than 35,000 at-risk patients in need have participated in Myriad’s patient assistance programs that provide free tests or other financial assistance.

“We are collaborating with the medical and scientific communities to improve patient access to genetic testing and facilitate research worldwide,” Meldrum says. “Already, more than 10,000 scientific papers have been published on the BRCA genes, ranking them among the most researched genes in history.

“We are committed to advancing scientific knowledge even further, and Myriad will continue to encourage and support academic research studies conducted on the BRCA genes,” Meldrum adds. “While we are confident that Myriad offers the highest quality genetic tests in the world, we also support patients’ rights to seek second opinion tests from any of the many laboratories conducting BRCA testing for the purpose of confirming the Myriad test result.”

The case is the Association for Molecular Pathology v. Myriad Genetics.

[Source: Myriad Genetics]