Legal controversy over BRCA patent rights spreads deeper into cancer care.

The legal controversy over BRCA patent rights spreads deeper into cancer care

It has long been known that the BRCA1 and BRCA2 tumor-suppressor genes can harbor mutations that greatly boost risks for breast, ovarian, and other cancers. Now clinical investigators are learning about a tricky legal issue when it comes to BRCA1 and BRCA2 test results that increasingly will affect standard patient care.

Researchers technically can’t convey BRCA mutation status to study participants without infringing on the intellectual property of Myriad Genetics, of Salt Lake City, UT. Given that the company owns patents on detection and isolation of the 2 genes, Myriad’s position is that the mutations should be analyzed in the company’s own facilities, via PCR and Sanger sequencing at a cost of $3,340 per test.

However, Myriad generally doesn’t expect payment for the communication of BRCA results obtained by hospital laboratories during research, as long as the patient isn’t charged for data analysis or re-analysis, says spokesperson Rebecca Chambers. “We encourage research and wouldn’t want to hinder it with our intellectual property,” she says.

Today, though, next-generation sequencing (NGS) gathers genomic information dramatically more cost-effectively than does the earlier technique employed by Myriad. As NGS tests reporting on many genes start to enter the standard workup for newly diagnosed cancer patients, Myriad’s legal lockdown on the BRCA genes is becoming a greater clinical concern.

“We’re designing gene panels to guide therapy now and if we exclude BRCA1 and BRCA2 then that’s a medical disservice,” says Leif Ellisen, MD, PhD, an associate physician and clinical director for breast and ovarian cancer genetics at the Massachusetts General Hospital Cancer Center in Boston, MA.

Ellisen points out that the clinical panels under development now do not include BRCA genes because of Myriad’s restrictions.

Chambers says this process is appropriate since clinicians may not have an up-to-date grasp on which of the thousands of BRCA mutations are deleterious.

Questions in Sequence

Next-generation sequencing platforms used to screen routinely for somatic mutations in patients’ cancer cells are already entering major cancer centers.

Those tools, Ellisen says, will also increasingly reveal germline mutations, including BRCA variations detected in tumors from patients with breast, ovarian, and other cancers linked to the genes.

Such findings have important clinical implications. Among them, women with BRCA-mutated breast cancer may be candidates for prophylactic mastectomy or contralateral mastectomy. Researchers are also examining potential ways to better treat these patients, such as with targeted therapies like poly(ADP-ribose) polymerase (PARP) inhibitors.

Myriad Genetics has offered tests to spot mutations in BRCA1 (whose protein structure is shown here) and BRCA2 since the 1990s.

Myriad Genetics has offered tests to spot mutations in BRCA1 (whose protein structure is shown here) and BRCA2 since the 1990s.

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Moreover, the cost of analyses of sequenced genes will amount to far less than what Myriad charges for a single BRCA mutation test, points out Edith Perez, MD, deputy director-at-large for the Mayo Clinic Cancer Center in Rochester, MN. “So why are we paying more than $3,000 for a test that can be done cheaply by other laboratories and that piles on costs to the healthcare system and ultimately the patient?” Perez asks.

In Ellisen’s view, Myriad’s patents apply solely in terms of inherited risk—not treatment. Furthermore, broad assays that sequence hundreds of genes, including BRCA, to guide treatment might not be addressed by the company’s intellectual property, he asserts.

Chambers responds that Myriad doesn’t distinguish between whether the test is used for assessing risk or for clinical decision making. Either way the costs of its analyses are justified, she says, by the quality of Myriad’s results and the speed of its analytical turnaround. —Charles Schmidt

Patently Unclear

In the United States, Myriad’s BRCA patents hang in the balance following a March 20 decision by the Supreme Court in the case of Mayo Collaborative v. Prometheus Laboratories. In that suit, the court ruled that correlations between drug dosage and metabolite levels in the body comprise a “law of nature” that can’t be claimed as intellectual property.

Given that finding, the courts must now reassess Myriad’s core legal position that isolated DNA is not a product of nature, because it was discovered through human ingenuity.

The case upon which the Myriad position rests—Association for Molecular Pathology v. Myriad Genetics—had been scheduled for Supreme Court review but now has been sent back to the Court of Appeals for the Federal Circuit.

“You can argue that the cases cover different claims, in that one is a method and the other is a substance,” says Konstantin Linnik, PhD, a partner in the law firm Nutter, McClennen, and Fish in Boston, MA. “The real question is whether isolated DNA is sufficiently distinguishable from what occurs in nature.”

Linnik predicts that the Federal Circuit will uphold its 2011 ruling that isolated DNA is patentable. But he adds there’s no guarantee that the Supreme Court won’t reverse that decision.

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