This week, we are celebrating the tenth anniversary of the Supreme Court’s decision, Association of Molecular Pathology versus Myriad Genetics (“Myriad") that overturned the validity of gene patents. The case was successful, because of some remarkable contingencies, first the conceptualization by ACLU lawyer Chris Hansen and his advisor Tania Simoncelli and second the selection of Robert Sweet of the Southern District of New York as the presiding judge. Chris and Tania’s collective genius was to formulate that not only was this a case about nature product law (“Can’t patent a product of Nature”), but also that it was a case about free speech, our most favorite right (“Keep your hands off my genes”). Judge Sweet, a very experienced jurist, decided that the case had merit and that one plaintiff should have standing to see the case through. My standing was based on my receiving a cease and desist letter that took hours for me to find and on my stating in my deposition that I would initiate testing for the BRCA1 and 2 genes in my laboratory at New York University Medical Center should the patents be lifted. What was most surprising about Judge Sweet’s decision was how expertly it was drafted with clear insight into the details of genetic testing. The draftsman was Herman Yue, a lawyer who had received his Ph.D. in molecular genetics at Berkeley prior to going to law school and becoming Judge Sweet’s clerk. In 2011, I saw Judge Sweet again, this time at a symposium about gene patenting sponsored by the American Society of Human Genetics. When he asked me about his opinion, I replied, “Well, I like it just fine, Your Honor.”
But we still had 2 years to go with two trips to the appellate court and other Supreme Court rulings about patents before our case prevailed. When it occurred, their decision was transformative Without the barrier of gene patents, several laboratories started the very next day to offer gene panel testing for breast and ovarian cancer risks. Other gene panels readily followed and the notion of sequencing our genomes to learn about our undiagnosed disease, genetic predispositions, and potential responses to therapy became a reality without the threat of cease and desist letters. Sometimes contingencies line up in favorable ways. As I told Chris and Tania early on, the lawsuit was either foolhardy or wise.
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