The ability to synthesize DNA through chemical processes is undoubtedly a marvel among modern technological advances and figures into a wide array of industry sectors… This Tuesday, July 3rd, marks the 34th anniversary of the issue of one of the seminal patents in the field of DNA synthesis. The lead inventor, Marvin Caruthers, is a member of the 2018 class of inductees into the National Inventors Hall of Fame.
On Friday, May 11th, Mountain View, CA-based personal genetics testing company 23AndMe filed a lawsuit alleging patent infringement claims against Lehi, UT-based genealogy firm Ancestry.com. The suit, filed in the Northern District of California, targets Ancestry’s use of a DNA testing kit, which allegedly infringes upon a genetic testing patent held by 23AndMe.
The law of patent eligibility is created by the nine least qualified people to make such a determination; the Justices of Supreme Court of the United States. The Supreme Court arbitrarily chooses which of its own prior decisions to follow and ignore, refuses to read and enforce the laws passed by Congress even when the statue is but a single sentence (as is 101), and they openly legislates from the bench by creating judicial exceptions to patent eligibility where no such statutory prerogative exists. If the Federal Circuit will not step up and do the right thing and limit the lawless Mayo decision, which instructs lower courts to ignore the patent statute and drive 100% of the analysis into 101, the U.S. will forfeit our lead in the biotechnology and medical device industries. That will be bad for the economy, but far worse for public health.
There have been signs that Samsung is trying to wind down its operations in its medical device businesses, but we found plenty of patent applications filed with the USPTO indicating that healthcare innovation is still very important to this corporation. A technique for the genetic analysis of human subjects to test for diagnosing certain leukemias is featured by U.S. Patent Application No. 20150038360, titled Method for Multiplex-Detecting Chronic Myelogenous Leukemia Gene Using Cleavable Probe. The kit for detecting an e19a2 breakpoint of a BCR-ABL fusion gene claimed here contains five primer sets, each having a primer comprised of a specific nucleic acid. This kit provides for the early detection of chronic myelogenous leukemia, or CML, including rarer varieties of the disease.
The Supreme Court quite directly contradicts the reasoning of Chakrabarty in Myriad. Thomas explains that it is a fact that isolated DNA is nonnaturally occurring, but still nevertheless not patent eligible. Whether we like it or not, the very foundation of the Supreme Court’s decision in Chakrabarty has been overruled, or at the very least significantly cut back. Arguments to the contrary are simply wishful thinking and ignore the explicit language of the Myriad decision.
Widely divergent views have formed in the wake of the Supreme Court’s decision in Association of Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, slip. op. (U.S. Jun. 13, 2013). Some commentators have reacted with dire predictions for the biotech industry, suggesting that the Court’s holding has unduly narrowed patent protection traditionally granted to DNA technology and has disincentivized researchers in the field, particularly those from small start-ups. Other commentators suggest that the Supreme Court’s decision in Myriad will actually benefit genetic research, particularly researchers at the start-up level. The authors of this post tend to agree with this latter view.