The Legal Battle Over Genetic Testing For Breast Cancer

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Supreme Court unlocks the chains of patent protection for BRCA1 and BRCA2 DNA sequencing in a ruling which can widen access to testing for predisposition to breast cancer and ovarian cancer

Breast cancer and ovarian cancer can have devastating effects for women and their families.  Through science and ingenuity, mankind has developed tests which earlier identify women whose risk of acquiring breast or ovarian cancer drastically exceeds that of the general population.  But, some women are simply unable to afford testing which can help spot mutations in genes that predispose a woman to breast cancer and ovarian cancer.

Change may be on the horizon.  A recent opinion by the United States Supreme Court clears the way for competition in the market for genetic testing that identifies women with an elevated risk of breast and ovarian cancer.  In Association for Molecular Biology, Inc., et al. v. Myriad Genetics, Inc., et al. 133 S. Ct. 2107(2013), Justice Clarence Thomas held that by merely isolating gene sequences of DNA known as BRAC1 and BRAC2, Myriad Genetics did not create or invent “any new and useful…composition of matter” eligible for patent protection under section 101 of the Patent Act, 35 U.S.C 101.  Some industry observers are optimistic more women will soon have access to genetic testing often not covered by health insurance and until now available exclusively through Myriad for around $4,000.

Women who have mutations of the BRCA1 and BRCA2 genes are at a greatly increased risk for developing breast or ovarian cancer.  In fact, the risk of breast cancer among women in the general population is 12%, but the risk of breast cancer in women with an inherited mutation of the BRCA1 or BRCA2 genes is 60% – an increase of five-fold.  The risk of ovarian cancer for women in the general population is 1.4%.  But, the risk of ovarian cancer increases to 39% for women age 70 or younger who inherit a mutation of the BRCA1 gene and between 11 and 17% for women who inherit a BRCA2 gene mutation.   An estimated 5 to 10% of breast cancer cases and 10-15% of ovarian cancer are associated with mutations of the BRCA1 or BRCA2 genes.

According to the opinion, Myriad identified groups of relatives with a history of breast cancer and compared their chromosomes for shared genetic abnormalities.   By this process Myriad discovered the cancer predisposing genes were located on two of the 23 pairs of human chromosomes – chromosomes 17 and 13.  Isolation of the BRAC1 and BRAC2 genes opened the door for Myriad to determine the typical sequence of DNA nucleotides within those genes.   The DNA nucleotide sequence contains the information necessary for the formation of amino acids, and in turn, proteins.  Equipped with knowledge of the typical nucleotide sequence for BRCA1 and BRCA2, Myriad developed tests to detect mutations in the genes and asses the increased risk of cancer.

Regrettably, the benefits of Myriad’s important discovery were masked by lack of competition.  Myriad obtained several patents related to its discovery.  Some of those patents, including three at issue before the Supreme Court, gave Myriad the exclusive rights to conduct genetic testing for BRCA1 and BRCA2.  In the United States, Myriad used the power of its exclusive patent to stop other laboratories from testing patients for the genes.  Soon, Myriad was the only entity performing BRCA testing.

Eventually, physicians, patients, and advocacy groups joined with the American Civil Liberties Union to file a lawsuit asking a federal district court to declare Myriad’s patents invalid.  Ultimately, a federal circuit court held that the isolated DNA, as well as a synthetic version of the DNA, was patent eligible under section 101.  That decision was appealed and accepted by the U.S. Supreme Court.

The Supreme Court identified the legal standard for patent protection as a “delicate balance between creating “‘incentives that lead to creation, invention, and discovery'” and “‘impeding the flow of information that permit, indeed spur, invention.'”  Judge Thomas recognized without hesitation Myriad did not create or alter the BRCA1 and BRCA2 genes.  The location of the nucleotides existed in nature before discovery by Myriad.  For Justice Thomas, discovery itself, no matter how “groundbreaking, innovative or even brilliant” does not suffice for patent protection.

Myriad also claimed that by isolating the DNA from the remainder of the human genome, it somehow created a non-naturally occurring molecule eligible for patent protection.  The Court rejected this argument, finding the patents in question focused on the unique genetic information naturally encoded in the BRCA 1 and BRCA2 genes, not on any chemical changes resulting from the isolation of a particular section of DNA.

Until this important victory, Myriad’s exclusive rights to BRCA1 and BRCA2 testing stood in the way of important genetic testing which could have helped women decide whether to undergo preventative measures like mastectomy or removal of the ovaries (oophorectomy).  The full impact of the Myriad decision on the market for BRCA1/BRCA2 testing may play out in the months to come.  Already, only hours after the Court’s decision, the Wall Street Journal online reported that DNATraits, a division of Gene by Gene, Ltd., announced it would offer BRCA1/BRCA2 analysis for only $995.00 – a significant savings for testing which cost approximately $4,000 before the Court’s ruling.

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