Thanks to a unanimous ruling by the U.S. Supreme Court, yesterday was a good day for persons opposed to gene patents. Specifically, many are opposed to gene patents because it’s obvious patent thickets will slow disease research as financiers and patent trolls seek to use patent claims and litigators to garner revenues for using now-routine science to read and report on the amino acid sequences which are the substance of genes.
Happily, yesterday’s unanimous ruling in Prometheus strongly suggests that gene patents will fail. Why? Because the Supreme Court knocked out Prometheus’ claim to a patent for describing a law of nature. And, it reversed after giving the Federal Circuit two chances to get it right, but the Federal Circuit failed both times. In short, Prometheus had claimed a patent for describing the levels at which drug metabolites would work safely, or not. Yesterday’s opinion shreds the rationale of the Federal Circuit’s narrow "patent-think" approach.
As a result, big pharma groups and their lawyers were already complaining as of yesterday afternoon. Meanwhile, numerous medical associations had opposed the patents and are no doubt celebrating the ruling. According to Patent Docs, the patent claims of Prometheus had been opposed by the American Medical Association, “the American College of Medical Genetics, the American Hospital Association, the American Society of Human Genetics, the Association of American Medical Colleges, the Association for Molecular Pathology, the Association of Professors of Human and medical Genetics, the College of American Pathologists, the Florida Hospital Association, the Minnesota Hospital Association, and the Minnesota Medical Association, [and to that end,] submitted an [amicus brief]" opposing the patent claims.
The next question is what happens with the case commonly known as Myriad Genetics. The case involves patent claim for two of the breast cancer genes – BRCA1 and BRCA2. Previously, a federal trial judge struck down Myriad’s patent claims. The Federal Circuit reversed in a 2-1, narrow opinion that could be loved only by patent lawyers lacking a world view and financiers hoping to profit from patenting scientific truths regarding gene sequences and disease. Some suggest that the Court will direct the Federal Circuit to reconsider its opinion in Myriad.
Patents and profits can and should follow for work that creates new cures for disease, but not for reporting on conditions inside human bodies. Indeed, patent claims to gene sequences raise significant constitutional issues as they involve a government-sponsored "taking" of the right to have tests performed on subparts of one’s body.
Some in pharma claim gene patents are required to incentivize people to find genes. That’s nonsense. Indeed, there was a massive race as various talented researchers sought to find BRCA1 and then BRCA2. The story of the search for BRCA1 is told well in Breakthrough – The Race to Find the Breast Cancer Gene. Simply put, the patent holders at Myriad happened to be the first to find it, and Mark Skolnick and others did some great work. But several groups were closing in and doing their own great work, including groups led by brilliant researchers such as Mary-Claire King and Francis Collins.
One more note. Kudos to Justice Breyer for selling stock that might have kept him from hearing the Prometheus case.