A. The Association for Molecular Pathology, et al V. Myriad Genetics, Inc.
According to USPTO guidelines there are four categories of things that can be patented. They are a process, a machine, an article of manufacture and a composition of matter. (Title 35 U.S.C. 101). As an isolated DNA sequence Myriad genetics patents of BRCA1 and BRCA2 fall under the composition of matter category. It is against this backdrop that Myriad was sued along with the USPTO, concerning the validity of these patents and the harm that they produce in the area of genetic research. The case was argued in front of the United States District Court Southern District of New York.
Myriad’s argument was that there was a difference between DNA as merely bits of information that make up a gene, and isolated DNA fragments. They argued that when you isolated a specific DNA segment it is inherently different than the entire gene as a whole. Lastly Myriad argued that the USPTO has jurisdiction over what is patentable and what is not, and as such the entire suit should be dismissed.
The court found for the plaintiff in this case referencing an earlier U.S. Supreme Court ruling that stated “The laws of Nature, physical phenomena, and abstract ideas have not been held patentable” (Chakrabarty, 447 U.S. at 309 (1980)). The court also found that regardless of USPTO patent approvals, the courts have never in patent disputes affirmed that branch of the government as the sole arbiter of what is patentable and what is not. That distinctions falls on the courts to interpret the laws as they are written (The Association for Molecular Pathology, et al V. Myriad Genetics, Inc., 2010).
This ruling was then appealed by myriad to the United States Court of Appeals for the Federal Circuit. The appeals court overturned part of the previous decision based on the fact that the isolated DNA of BRCA1 was markedly different from the naturally occurring DNA sequences found in the human body. As such “isolated” DNA fragments broken from their nucleotide sequences are not naturally occurring in nature even though their original location was naturally occurring, i.e. the human genome. The only part that was not upheld is Myriad’s claims on exclusivity as to the process of finding the BRCA1 gene. This would in effect leave it open for another lab to recreate their research and come to the same conclusion as to the link between BRCA1 and breast cancer. The plaintiff in this case then appealed to the Supreme Court which sent the case back to the Court of Appeals. The Court of Appeals then reviewed the case and came to the same conclusion. The case was then remanded to the Supreme Court which has agreed to hear arguments. As of this writing there is no set date as to when the court will hear this case.