High Court Strikes Down Patents On Breast And Ovarian Cancer Genes

The U.S. Supreme Court’s decision today to invalidate a Utah company’s long-held patents on genetic testing for breast and ovarian cancer is expected to result in the test being more accessible to women, at a lower cost, experts say.

 

The court’s 9-0 decision comes four years after the American Civil Liberties Union on behalf of 20 named plaintiffs, including Ellen Matloff, director, Cancer Genetic Counseling at the Yale Cancer Center, filed a lawsuit charging that the patents held by Myriad Genetics of Utah on the DNA of two genes, known as BRCA1 and BRCA2, is unconstitutional and should be ruled invalid.

The lawsuit also challenged Myriad’s right to set prices on their exclusive testing that critics said “locked out” some women from affording the life-saving test, which costs about $3,450.

“I am thrilled with the decision.  I think it’s been inhumane for one company to make the call on how much these important tests will cost,’’ said Marya DiPerna, of Naugatuck, whose own BRACAnalysis genetic test was negative a year ago.  The patent “made it unavailable to those whose insurance won’t pay for it and who cannot personally otherwise afford it,’’ added DiPerna, who applauded the decision.

“I was lucky that my husband’s insurance covered the cost because my sister, a deployed Marine’s wife, had breast cancer.  She had to fight for her test while she was sick and at first, she was denied,’’ added DiPerna.  Her sister could not afford to pay for the test while she was in treatment and raising her children alone as a military mom.   DiPerna’s sister recently received approval for a paid test and had a negative result.

Myriad has held the patents for 16 years and earned $405.5 million from BRCA testing in its last fiscal year.  The court, in it’s decision, allowed for synthetically  produced genetic material to be patented.

Sandra Park, senior staff attorney with the ACLU Women’s Rights Project, which brought the lawsuit in 2009, said, “Today, the court struck down a major barrier to patient care and medical innovation.  Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued.”

Matloff added, “It is a critical day in the history of medicine. Abolishing gene patents will make personalized medicine at an affordable price possible for the average citizen.  I know of companies that are prepared to immediately begin offering more comprehensive BRAC testing at lower rates.”

Matloff and others had argued that gene patents stifle medical research, second opinion availability and competitive test pricing.

In Connecticut, most health insurance plans, Medicare and Medicaid, cover the test called BRACAnalysis for those who have had breast or ovarian cancer – but co-pays, coinsurance and deductibles vary widely, so a test could cost hundreds of dollars.   The Affordable Care Act requires all newly-issued private insurance plans to cover the BRACAnalysis test and genetic counseling as a preventive service for asymptomatic women with a “qualifying family history.”

Approximately 7% of breast cancer and 11 to 15% of ovarian cancer cases are caused by mutations in the BRCA1 or BRCA2 genes.  For women, a positive BRACAnalysis test means an 87 percent risk of breast cancer and a 44 percent risk of ovarian cancer by age 70, including a significantly increased risk of developing a second primary cancer.   Men with the inherited mutation also have increased risks of breast and prostate cancers.

Often women elect to undergo a double mastectomy, as did actress and director Angelina Jolie, as well as a hysterectomy or oophorectomy.  Jolie’s public disclosure raised awareness about the importance of the BRACAnalysis test among those with familial connections to the diseases.

Myriad’s hold on the gene patents also raised issues about whether the test was comprehensive.   Two years ago, more than 140 researchers, doctors and clinicians affiliated with the Yale Cancer Center and from institutions all over the country, wrote to Myriad raising concerns that the BRAC test did not detect “a significant proportion of BRCA1 and BRCA2 mutations’’ and is not truly “comprehensive.’’

They said an additional analysis, known as BART, (BRAC Analysis Rearrangement Test), is necessary, but not always accessible – especially for Hispanics, who show in Myriad testing to be at high risk for the mutations.

In defense of its practice, Myriad states on their website that “there is, on average, a less than 1% chance that BART will identify a mutation in a patient who has already had a negative result from Comprehensive BRACAnalysis.”  The BART test, licensed by Myriad in 2006, costs $700, is still not widely approved by insurance companies, and is not automatic with a negative BRACAnalysis result.

Connecticut has the second-highest incidence of female breast cancer in the nation according to 2010 data from the U.S. Dept. of Health & Human Services.   According to that data, Connecticut ranks 34th in the nation for breast cancer mortality; 490 women in the state died from the disease in 2008, the latest figure available.

The American Cancer Society, in their 2013 Cancer Facts and Figures Report, predicts 3,050 new cases of female breast cancer and 460 female deaths this year in Connecticut.

Using the estimates that five to 10 percent of breast cancers are caused by these mutations, as many as 300 of the 3,050 cases would occur in people likely to have the BRCA 1/2 mutation.

An estimated 129,000 Connecticut women between the ages of 19 and 64 do not have health insurance, according to Kaiser health data.