
Tuesday, Oct 06, 2015

Supreme Court and DNA: No one can own a gene

Los Angeles Times


For the past 60 years, we have been learning a new language. Ever since the double-helix structure of DNA was uncovered in 1953, the vocabulary of genetics has been creeping into our lives, becoming over time a full and rich lexicon. Last week's Supreme Court ruling against patents for two genes implicated in cancer is a step toward ensuring that this language remains one of science and humanity rather than profit.

The landmark ruling centered on patents for two genes - BRCA1 and BRCA2 - held by Myriad Genetics, a diagnostic testing company based in Utah. Hundreds of mutated forms of these genes have been identified, several of which are associated with an increased risk of breast and ovarian cancers. In the United States, a woman's risk of getting breast cancer is about 12 percent to 13 percent; certain BRCA1 and BRCA2 mutations increase that risk to 50 percent to 80 percent. For ovarian cancer, the risk moves from about 2 percent with the normal genes to 20 percent to 50 percent with certain mutations.

Research in the 1990s, conducted in part by scientists who formed Myriad, led to the discovery of the exact chromosomal location and sequence of these two genes. The company then sought a patent for the isolated DNA; that is, the lengthy sequence of nucleotides - the chemicals, symbolized as A, G, T and C, that serve as the "alphabet" for genetically encoded information - that make up the BRCA (pronounced "braca") genes.

The company also filed for patent rights on any series of 15 nucleotides present in the complete sequence. Essentially, Myriad would own any possible permutation of the genes. The patents were granted in the late 1990s.

That decision by the U.S. patent office had far-reaching consequences.

After Myriad launched a diagnostic test for the BRCA genes in 1996, the company began preventing academic institutions and companies from providing genetic testing for BRCA1 and BRCA2. If a woman wanted her DNA tested for the presence of these risky mutations, she had to go to Myriad, which charged about $3,000 per test, one that often required a second opinion. Many insurance providers covered the test for women with a family history of breast cancer, but not for all customers. A lucky few could get financial assistance directly from Myriad. An unlucky many didn't get tested. Researchers were likewise prevented from investigating BRCA1 and BRCA2 in the laboratory without paying Myriad a licensing fee.

This, despite the fact that knowing one's BRCA1 and BRCA2 mutation could be life saving. For women who test positive, undergoing a mastectomy and oopherectomy (ovary removal) can completely eliminate the risk of getting cancer.

The monopoly on BRCA testing was also granted despite the fact that portions of the research had been funded by federal research grants. In 2012, BRAC Analysis revenue totaled $405.5 million, more than 80 percent of the company's total revenue for that year.

The protest against Myriad's patent first entered the courtroom in 2009. Harry Ostrer, a doctor and researcher at New York University School of Medicine, had been sending patients' DNA samples to the Genetic Diagnostic Laboratory at the University of Pennsylvania for BRCA testing. Myriad cried patent infringement and the laboratory agreed to stop testing.

But Ostrer and a group of patients, advocates and doctors filed a lawsuit against Myriad. In 2009, a federal court upheld Myriad's patent claim. The plaintiff (the Association for Molecular Pathology) petitioned for the Supreme Court to hear the case.

On June 13, the Supreme Court voted unanimously to reverse a crucial part of the lower court decision, holding that genes are natural and therefore can't be patented. Myriad argued that its isolation of the BRCA1 and BRCA2 sequences outside of the body rendered them patentable; isolated DNA isn't a natural phenomenon we stumble upon during a forest walk, but rather is a laboratory-created substance. In a decision that could save lives, the court disagreed, asserting that the labor and technology used to isolate the DNA did not render the DNA into an invention. "The location and order of the nucleotides existed in nature before Myriad found them," read the opinion of the court, delivered by Justice Clarence Thomas.

The court did rule in favor of patents on complementary DNA, or cDNA, essentially strands of DNA synthesized in a laboratory as part of genetic research. That decision protects genuine innovations stemming from genetic research.

The privatizing of the human genome - Myriad's patents were just two of many - is an alarming development in the search for links between DNA and disease. Claiming a patent on an isolated sequence of DNA goes against the legacy of publicly funded research that made such discoveries possible, including that of the BRCA1 and BRCA2 genes. And even within our for-profit health care structure, there has to be a limit on what can be capitalized on. A test for a deadly genetic mutation exceeds that limit.

The ruling also helps ensure that the science of genetics will remain accessible to all, and not restricted to boardrooms and bank accounts.

Jessica Wapner is the author of "The Philadelphia Chromosome - A Mutant Gene and the Quest to Cure Cancer at the Genetic Level." She wrote this for the LA Times.

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