Molecular Pathology Vs. Myriad Genetics Case Study

Association for Molecular Pathology vs. Myriad Genetics The case of the Association for Molecular Pathology vs. Myriad Genetics was a case that challenged the validity of gene patents in the United States. It specifically challenged certain claims in issued patents owned or controlled by Myriad Genetics that cover isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences. Before this case occurred, the U.S. Patent Office accepted patents on isolated DNA sequences as a composition of matter. Diagnostic claims were already under question through the In re Bilski and Mayo v. Prometheus cases. Drug screening claims were not seriously questioned
In August of 1994, a man by the name of Mark Skolnick, and researchers at Myriad, along with colleagues at the University of Utah, the National Institutes of Health, and McGill University published the sequence of BRCA1, which they had isolated. In that same year, the first BRCA1 U.S. patent was filed by the University of Utah, National Institute of Environmental Health Scientists, and Myriad. Over the next year, Myriad, in collaboration with University of Utah, isolated and sequenced the BRCA2 gene, and the first BRCA2 patent was filed in the U.S. by the University of Utah and other institutions in 1995. In 1996, Myriad launched their BRACAnalysis product, which detects certain mutations in the BRCA1 and BRCA2 genes that put women at high risk for breast cancer and ovarian cancer. Myriad’s business model has been to exclusively offer diagnostic testing services for the BRCA genes. It was on the basis of the premium price that the patents would allow Myriad to set during the 20 year life of the patents, that investors put money into Myriad. These were the funds that allowed Myriad to rapidly sequence the BRCA2 gene and finalize a robust diagnostic test. The business model meant that Myriad would need to enforce its patents against competitors, which included diagnostic labs at universities, which function very much like for-profit businesses in addition to educating pathologists-in-training. The patents expire starting in 2014. In 2012, Myriad had employed about
The District Court ruled that “isolated DNA” containing sequences found in nature are unsustainable as a matter of law and are deemed unpatentable under 35 U.S.C. 101. As expected, Myriad appealed. The Federal Circuit court concluded that since Myriad’s patents describe DNA sequences that do not alone exist in nature, they are patent eligible. The case went as far as the supreme court and the supreme court ruled that “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring. I agree with the majority ruling and I believe that naturally occurring DNA or any natural genetic material should not be a patentable item, unless it is not naturally occurring or