Are Human Genes Patentable?

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.

photo credit: iStockphoto/Martin McCarthy
photo credit: iStockphoto/Martin McCarthy

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.

Both sides have good arguments legally. AMP argues that gene sequences, while not complete genes, are nevertheless “naturally occurring articles” and thus should not be subject to patent under 35 USC §101.
On the other hand, Myriad argues that it is not the gene sequences themselves it is patenting, but rather the identification of those gene sequences and their subsequent use as they relate to diagnostic testing.  That is, Myriad claims it is only patenting its own processes and methods and not the physical substances themselves.

In a way, gene sequences that do not naturally occur in nature are no different from hybrid forms of many vegetables and fruits that are created from human (and thus “unnatural”) manipulation of their gene sequences, and these forms of products are fully patentable.  However, the decision on diagnostic methods and screening procedures may well turn on the issue raised in the Court of Appeals’ dissent: whether Myriad’s methods do “enough” to change the characteristic of the genes to be truly significant or “inventive” and thus patentable.   It is hard to argue that Myriad’s methods are innovative enough.
Given the recent history of SCOTUS on these issues (primarily Collaborative Services v. Prometheus Labs, Inc.), we expect the Supreme Court to hold that the gene sequences are patentable, but that neither the diagnostic methods nor the screening therapeutics are.  Given that the diagnostics and screening methodologies are the financial core of the case, it might be a bad day in court for Myriad.  And even if Myriad wins, the litigation sure to arise from enforcement and infringement actions will be long and expensive.

Jim Pikl is a trial and appellate lawyer. He is Board Certified by the Texas Board of Legal Specialization in Consumer and Commercial Law. His practice emphasizes a wide range of commercial and consumer litigation, including class actions and complex disputes involving multiple parties and claims. Mr. Pikl has extensive experience as lead counsel in dozens of bench and jury trials in state and federal court, as well as appeals all the way to the Texas Supreme Court and the United States Supreme Court.