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Myriad Expands IP Portfolio with Exclusive License for Pancreatic Cancer Gene Patents

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By Turna Ray

Myriad Genetics is planning to launch a new diagnostic test for early detection of pancreatic cancer next year based on the assessment of PALB2 gene mutations, as well as mutations in the BRCA2 gene and p16 genes.

Myriad said last week that it has obtained from Johns Hopkins University an exclusive, worldwide license to patents covering mutations in the PALB2 gene, which have been shown to confer an increased risk for pancreatic cancer in those who carry the gene variants.

The PALB2 gene mutations and their association with pancreatic cancer susceptibility were identified by researchers at Hopkins' Sol Goldman Pancreatic Cancer Research Center. Myriad also holds exclusive rights under 10 issued US patents covering p16 and BRCA2 gene mutations linked to pancreatic cancer.

In a paper published in the April 10 issue of Science by JHU researchers, 1,084 cancer-free patients were found to have no mutations in PALB2. However 3 percent of 96 familial pancreatic cancer patients "had protein truncating mutations that would have compromised PALB2's ability to perform its tumor suppressor function."

According to the Pancreatic Cancer Alliance, genetic factors are the cause of between 5 percent and 10 percent of the 200,000 pancreatic cancer cases globally. According to Myriad, a mutation in the BRCA2, PALB2, or p16 genes confers between 10 to 20 times greater risk of developing pancreatic cancer for those aged 70 and over.

JHU in 1994 launched the National Familial Pancreas Tumor Registry, through which researchers have identified several promising candidate genes associated with disease susceptibility, including PALB2.

The PALB2 gene is a tumor suppressor gene that binds with BRCA2 to repair DNA damage. Mutations in the PALB2 gene debilitate its ability to keep cells from growing rapidly and turning cancerous.

"A molecular diagnostic test that could assess an individual's risk of developing pancreatic cancer later in life would enable a physician to better manage a patient's healthcare by increasing surveillance to catch the cancer at an earlier stage when it is more treatable and the prognosis is more favorable," Myriad said in a statement "The information provided by such a test also may guide therapy."

Information provided by the Pancreatic Cancer Alliance suggests that "the lifetime risk of pancreatic cancer [associated with BRCA2 gene mutations] is … expected to be low (less than 5 percent)." Also, while one study found a 17 percent risk of pancreatic cancer by age 75 for those who have mutations in the p16 gene, two other studies reported no increased risk of pancreatic cancer over the general population.

JHU's technology transfer office would not comment on the strategy of assessing mutations in BRCA2, PALB2, and p16 to detect pancreatic cancer risk, and declined to discuss the university's decision to exclusively license its PALB2 patents to Myriad.

Myriad's announcement comes amid its involvement in a highly publicized pending anti-gene patenting lawsuit and a government advisory group's report discouraging gene-association patents, indicating that the company is not looking to modify its strategy of exclusively licensing gene patents that will allow it to be the sole provider of new genetic tests.

In May, the American Civil Liberties Union filed a lawsuit on behalf of four scientific organizations — representing more than 150,000 medical professionals, researchers, women's health groups, and individual women — alleging that the BRCA gene patents held by the University of Utah Research Foundation and exclusively licensed to Myriad "stifle research that could lead to cures and limit women's options regarding their medical care." Furthermore, the lawsuit asserts that Myriad's exclusive license on the BRCA1 and BRCA2 genes, linked to increased hereditary risk for breast and ovarian cancer, violates the First Amendment by restricting research and knowledge [see PGx Reporter 05-13-2009].

Meanwhile, the HHS Secretary's Advisory Committee on Genetics, Health, and Society presented draft recommendations last week urging the HHS Secretary to support and work with the Secretary of Commerce to promote statutory changes that would exempt from infringement liability anyone developing or selling a test based on patent claims on genes for patient care or for research [see PGx Reporter 10-14-2009].

The recommendations were met with resistance from several committee members, as well as from a biotechnology industry representative and a university technology transfer official, who criticized the recommendations as inactionable for the HHS Secretary, charged that the task force had paltry evidence to support its recommendations, and warned that the recommendations were so broad they would be disruptive to the entire US patent system.

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