Patenting Genes: What Does Association for Molecular Pathology V. Myriad Genetics Mean for Genetic Testing and Research?

Abstract

How the law addresses major policy issues in genetic testing and treatment represents one of the most important issues in public health, science, and law. This installment of Law and the Public's Health examines the critical relationship between patent law and genetic testing, as well as the implications of the U.S. Supreme Court's decision on access to genetic tests that can improve health.

Human stem cells patents—Emerging issues and challenges in Europe, United States, China, and Japan

“…This second point as well as the public impact as a result of the suppression of competition by patents can be illustrated by the well‐known story of Myriad. Before the Supreme Court decision which invalidated Myriad's claims over the natural BRCA genes, genetic tests for breast cancer which based on the evaluation of BRCA1 and BRCA2 genes costed about $3,000–4,000 in the U.S. (Cartwright‐Smith, ). Holding the patents which claimed the natural sequence of BRCA genes, Myriad was the sole company that could administer the BRCA1/2 tests.…”

“…Laboratories which provided BRCA tests were forced to terminate their services after Myriad alleged them for patent infringement, thereby barring patients from obtaining a second diagnostic opinion from an independent laboratory. The cost of the BRCA tests soon fell to around $1,000–2,300 after the Supreme Court decision (Cartwright‐Smith, ).…”

“…thereby barring patients from obtaining a second diagnostic opinion from an independent laboratory. The cost of the BRCA tests soon fell to around $1,000-2,300 after the Supreme Court decision (Cartwright-Smith, 2014).…”

Molecular Testing in Breast Cancer: A Guide to Current Practices

“…Until 2013, this test was offered in a single laboratory under patent protection. 126 This laboratory amassed during the course of 20 years a rich, proprietary database of variants with correlative clinical data, making it possible to determine which variants were associated with disease. 127 In Association for Molecular Pathology vs.…”

“…Myriad Genetics, the Supreme Court of the United States ruled that naturally occurring DNA sequences cannot be patented. 126,128 That decision opened the door to BRCA1/BRCA2 testing in numerous laboratories, but it did not place the variant database into the public domain. Collaborative platforms have now been established to aid in the interpretation of variants in BRCA1/ BRCA2 and other genes associated with hereditary breast cancer, 129,130 but even with data sharing, consistent interpretation remains a challenge.…”