The Myriad Case has gone back to the courts. To recap, here is my non-expert-in-law timeline review:
- During the 1990s, Myriad Genetics had filed and received various patents on the isolation of, identification of several mutations of and methods of detection of the BRCA1 gene with United States Patent and Trademark Office. The gene is associated with an elevated risk of breast and ovarian cancer. Myriad was also able to secure similar patents for the a second, related gene, BRCA2. The patents provided Myriad the monopoly to market and license several tests for screening mutations of these genes in patients.
- In May 2009, complaint was brought against The USPTO and Myriad by a collection of foundations, scientists, health practitioners and patients in the U.S. District Court, Southern District of New York, alleging violations the U.S. Code (35 U.S.C. 101) and the Constitution (Aritcle I, Section 8, Clause 8; First Amm.; 14th Amm.). It is of course the purpose of the court system to interpret the intent of these documents, using previous decisions as a guide. The essence was that the claims in the disputed patents were for acts or processes which were not fit for patent; that the act of isolating or purifying the gene from the entire genetic sequence did not change the information it contained and the the isolated gene was not itself a new and novel material as it already existed in nature (see U.S.C.). Further, that this therefore prevented some innovative use of this gene (under methods and claims defined in the patents), violating the Constitution (see above reference to cited clause).
- In March 2010, Hon. Robert Sweet, presiding Judge for the U.S. District Court, ruled in partial favor of the plaintiffs. The reasoning was that genes being isolated from their naturally occurring state were not “markedly different” from the native DNA that is a product of nature. Therefore, the methods claims for “analyzing” and “comparing” the DNA sequences were not sufficient for patenting of the gene itself and violated U.S.C. 101 (quotations taken directly from context in the Table of Contents for the ruling). Further, Judge Sweet dismissed the claims on Constitutional violations.
- In April 2010, Myriad files for appeal with U.S. Court of Appeals. At issue was how Myriad’s specific patents were under question, considering the USPTO’s decades-long practice of issuing patents on genes and whether the patent claims actually violate 35 U.S.C. 101.
- On April 4, 2011, oral arguments were heard in the appeals case No. 2010-1406. The mp3 is available for download from the court’s website.
So this is all pretty interesting, but not being of the law background it can become a bit daunting to follow the specific arguments of a case, as it moves through the court system. Within FOSEP we have been discussing this case as well as genetic patents in general, from our Book Club on Who Owns You. After listening to the oral arguments, but without having read the full district court decision or any of the previous arguments, it seems that there is still a bit of confusion on exactly how to handle these genes. I think Koepsell (Who Owns You) attempted to lay the framework for considering these issues. In the arguments, much breath is spent attempting to put the genes, patent’s methods and the use of these genes into analogy with situations that are more familiar. It was cautioned in Who Owns You about defining the actual subject matter for which one wishes to analogize, a gene can be rather abstract; is it the genetic sequence itself we are concerned with (the chemical makeup of the gene), the information for which it includes (instructions for production of certain proteins), something else, or some combination.
It will be interesting to see this appeals case (and potentially further proceedings) unfold. I am perhaps more interested in how the courts and the general public respond to the idea of the genes themselves than of the patenting of them.