• Breast cancer is one of the leading causes of death among women. Approximately 5-10% of the women who develop breast cancer are likely to have a mutation, inherited from one of their parents, along their BRCA1 or BRCA2 genes, that predisposes them to an increased risk of breast and/or ovarian cancer.
   
• Women with one of these significant gene mutations along the BRCA1 or BRCA2 gene have an approximately 40-85% lifetime risk of developing breast cancer. Inherited mutations on the BRCA1 and BRCA2 genes also increase the risk of ovarian cancer.
   
• A BRCA1/BRCA2 genetic test result that is positive for one of these mutations can have a substantial impact on a woman’s medical decisions and health. It can also have an impact on that woman’s relatives. Many women will obtain earlier and more vigilant screening for breast and/or ovarian cancers, and some women may choose to have prophylactic surgery to remove their breasts and/or ovaries in order to reduce the risk of future cancers.
   
• In the 1990’s, a number of genetic researchers around the world began looking for a human gene that correlated with an increased risk of breast and/or ovarian cancer. Many of those researchers, including the researchers who ultimately formed Myriad, were funded, at least in part, by the federal government.
   
• Researchers, using techniques widely available in the profession, determined in 1990 that one gene that correlated with an increased risk of breast and/or ovarian cancer was located in the body on chromosome 17.
   
• Another researcher team, eventually associated with Myriad, also using techniques widely available in the profession, sequenced the precise BRCA1 gene. They subsequently formed Myriad. They sought, and ultimately obtained, several patents on this human BRCA1 gene.
   
• Scientists knew that BRCA1 was not the only gene that predisposed women to an increased risk of inherited breast and/or ovarian cancer. Researchers from all over the world began looking for other similar genes, again using techniques widely available in the profession.
   
• Myriad, using techniques widely available in the profession, filed patents over the BRCA2 gene. Myriad ultimately obtained a series of patents over the human BRCA2 gene.
   
• Myriad did not invent, create or in any way construct or engineer the human BRCA1 and BRCA 2 genes. These genes are existing products of nature, naturally occurring within the human body. Myriad located them in nature and merely described their informational content as it exists and functions in nature.
   
• Myriad did not invent, create or in any way construct the differences found when genes are compared or the correlations between certain mutations and an increased risk of breast and/or ovarian cancer. Nature did that. Myriad identified nature’s laws.
   
• As a result of the breadth of its patents, Myriad has the right to control all genetic testing on BRCA1 or BRCA2. Researchers and clinicians cannot develop or implement new tests for mutations on BRCA1 or BRCA2 linked to breast/ovarian cancer. Women cannot obtain a second opinion about their test results from other researchers or clinicians. The effect is to infringe on quality medical practice and to compromise quality assurance and improvement of testing.
   
• Myriad has enforced its patent rights over BRCA1 and BRCA2 genes at least nine (9) times.
   
• Myriad obtained its patents from the U.S. Patent and Trade Office (PTO) pursuant to a formal written policy by the PTO which provides that naturally occurring genes can be patented if they are “isolated from their natural state and purified.”
   
• An “isolated and purified” human gene performs the exact same function as a non-isolated and purified human gene in a person’s body. The information dictated by the gene is identical whether it is inside or outside of the body. According to the PTO policy, an “isolated and purified” gene includes one that is simply removed from the body and removed from other content of the cell. Removing a product of nature from its natural location does not make it any less a product of nature.
   
• Myriad utilizes its patents by offering a test to determine if an individual has any mutations in the human BRCA1 or BRCA2 genes. The test consists of sequencing a person’s gene, comparing it to either another gene in that person’s body or one from another person, and reaching a conclusion about whether nature has caused a variant that increases that person’s risk of breast and/or ovarian cancer.
   
• Thousands of doctors and scientists, including molecular pathologists, geneticists, and researchers, around the country, have the technical ability to look at human genes and who do so on a daily basis. The only thing that prevents those doctors and scientists from looking at the human BRCA1 and BRCA2 genes is Myriad’s patents.
   
• One of the conditions for receiving a patent is to disclose publicly all information about the patented thing. The purpose of that requirement is to enable others to “invent around” and build upon and improve the patented thing, thereby fostering scientific progress. Unlike most things that are granted patents, it is not possible to invent around the patented human BRCA1 and BRCA2 genes or correlations. These genes, their effects, and the correlations between the genes and disease were created by nature and exist in nature. They are pure information, and in order to build upon them, one needs to utilize the patented sequences, which is not permissible under the patents.
   
• Because of its patents, Myriad maintains a monopoly over any genetic testing to determine the presence or absence of mutations on the human BRCA1 or BRCA2 genes. Thus, although others, including members of ASCP, have the technical ability to determine if a person has a mutation, and are willing to do so using non-patented methods, they can be prohibited from doing so because of the patents on the BRCA1 and BRCA2 genes and is they did perform the test they couldn’t tell any patient the results because of Myriad’s enforcement of its patents.
   
• Because Myriad maintains a monopoly on clinical testing to determine the presence or absence of mutations on the human BRCA1 and BRCA2 genes, the only types of tests that are offered to patients and the only mutations examined are those dictated by Myriad.
   
• Myriad maintains the largest database of BRCA1 and BRCA2 data. It does not share the information in that database with the Breast Cancer Mutation Database set up by the National Institutes of Health to ensure the widest possible distribution of information about genes and breast cancer.
   
• Gene patents can serve as a disincentive to innovation in molecular testing because they deny access to a vital baseline of genomic information that cannot be invented around. Moreover, threat of enforcement from a patent holder and ensuing litigation costs lead to a chilling effect as clinical laboratories are reluctant to develop new tests, even when new tests could directly benefit patients.
   
• For at least some portions of the life of the patents, Myriad did not perform certain tests that were known to reveal additional mutations that increased the risk of breast and/or ovarian cancer. Myriad prohibited anyone else from offering those tests to patients even though it knew that they would provide women with essential information about their risk of developing life-threatening cancer. Eventually, Myriad began to offer this additional testing, but chose to package it separately from its standard test.
   
• Because of its patents on the BRCA genes, Myriad has the power to bar patients from obtaining testing other than through its laboratory.

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