On April 15, 2013, the United States Supreme Court will hear arguments for Association of Molecular Pathology v. Myriad Genetics, Case No. 11-725. The case involves U.S. patents issued to Myriad that concern isolated DNA gene sequences that could be used to predict cancer susceptibility in patients, as well as diagnostic methods using the sequences and screening therapeutics associated therewith. AMP is challenging the patents, claiming in part that the gene-sequence patents are basically patents relating to human DNA and thus are not patentable, and the diagnostic methods and screening protocols are merely “human thought” and add nothing to standard science. The trial court found the patent claims not patentable, ruling contrary to a long line of cases in which genetic mutations have been found patentable.
The Court of Appeals for the Federal Circuit (the court responsible for hearing appeals in patent litigation) reversed, ruling that DNA which does not exist in nature (i.e., isolated DNA sequences) along with the drug screening claims are, in fact, patentable (the appellate court held the diagnostic claims unpatentable). As with all patents, the proponents make the financial argument that patents incentivize investment for R&D, and unless processes can be patented, the financial incentive for conducting research and development is thwarted. Here, Myriad adds to the financial argument an emotional, slippery-slope one: that we may have finally found a cure for cancer, and if the courts do not allow a patent, then the cure (and subsequent DNA-based cures) will be less likely to come about.
AMP and other opponents of patents in this area have their own arguments, primarily that issuing patents restricts research to only a few companies, keeps the technology a “secret,” and thus stifles innovation and the marketplace incentives that go along with it. Of course, hiding within such arguments is the economics involved: if the opponents want to conduct such research, they can always obtain/pay for a license from the patent holder to allow them to do so.