Ariosa Diagnostics has crucially secured a New York State certification for their Harmony™ noninvasive prenatal genetic diagnostic test. Having already gained acceptance as a key provider of prenatal diagnostics in California and abroad, this is good news for both the company and for women carrying pregnancies at high risk for genetic defects. Ariosa competitor Sequenom, Inc. is continuing with sales of its MaterniT21™ prenatal diagnostic test, expanding their reach by licensing their test through Mayo Medical Laboratories.
Technologically, this is exciting news: by making use of the fact that fetal DNA can be isolated from the maternal bloodstream, it is possible to pre-screen high risk pregnancies for genetic defects with a simple maternal blood sample, rather than having to subject patients to riskier (and considerably more painful) procedures such as amniocentesis. Also, as sequencing-based diagnostic technologies, these tests can offer extremely high resolution in identifying risk factors and guiding medical decisions.
For patent watchers, there have been some interesting twists to this story. Recent Supreme Court cases have not been kind to the field of medical diagnostics: in Mayo v. Prometheus (involving the same Mayo lab that is now distributing the Sequenom test) the Court held that a method of examining a physiological state in order to guide medical decision-making was unpatentable subject matter, and in Association for Molecular Pathology v. Myriad Genetics, genomic DNA sequences like the ones examined here, were themselves found not to be not patentable. The prenatal diagnostic tests that Ariosa and Sequenom are selling were the subject of the first genetic diagnostics case to find its way to the federal courts in the post-Myriad era. In Ariosa v. Sequenom (N.D. Cal., Oct. 30, 2013), the Northern District of California followed Myriad and held that circulating fetal DNA is not patentable subject matter, granting summary judgment of invalidity of Sequenom’s patent on circulating fetal DNA. Thus, while both companies are now free to move forward, they are without patent protection for the broadest elements of their underlying technology.
While it is good news for patients, there is a point to be made about the role of gene patents here. Despite the turmoil in the courts and the dire predictions of some in the biotechnology industry about the consequences of the loss of patentability of genomic sequences, these companies are moving ahead despite drastic changes in their patent positions, and they have been successful. The Supreme Court diagnostics cases may have complicated things, but so far the sky has not fallen and the field of genetic diagnostics continues to advance.