Yesterday, the U.S. Supreme Court heard oral arguments in the much-publicized gene patenting case AMP v. Myriad Genetics. Myriad and the University of Utah own several patents directed to isolated gene sequences for mutations in the BRCA-1 and BRCA-2 genes, as well as methods of using the same for predicting risk of breast cancer. AMP is seeking to invalidate these patents for claiming inventions that are not patentable subject matter, i.e. merely products of nature, which should not be restricted from widespread use. Myriad maintains that since the patents are for isolated gene sequences, they do not cover genes as naturally occurring within the body, and therefore are not overly restrictive and should properly be the subject of patent protection.
The Supreme Court heard from both sides yesterday. AMP argued that the invention discovered by Myriad was that particular mutations in certain genes led to an increased risk for breast cancer, but that this is a result of nature, not the product of man, and therefore should not be patentable. Myriad countered that knowing where to cut to excise the isolated gene sequence from the chromosomal DNA in which it exists naturally made it a new thing which does not exist in nature, and therefore should be patentable. The U.S. government also weighed in on the debate, proffering that lab-made cDNA, created by complementing mRNA with DNA nucleotides, is not done in nature and therefore is man-made and patentable, but that isolated gene sequences merely taken from naturally occurring genes are not patentable.
The questions posed by the Justices revealed they were very interested in this case, and that their minds were clearly not made up. They seemed to struggle with the broad question before the Court “[a]re human genes patentable?” For example, they asked pointed questions about the distinction between isolated DNA and DNA as it exists in nature, acknowledging that though the chemical composition or sequence may be the same, they are clearly different in form. They also queried how best to protect investments if isolated gene sequences were not permitted patent protection, as is critical to the biotechnology industry. When AMP’s arguments ventured into the realm of obviousness, which has happened repeatedly at each round of the Courts leading up to the Supreme Court, the Justices were quick to note the difference between subject matter patentability, which is a threshold question and what is being challenged here, and obviousness which is an approach meant to narrow what is already deemed the proper subject matter. Acknowledging that AMP may have very strong arguments on obviousness grounds, the Justices noted that was not what was raised, but that the case was structured to bring the broadest possible grounds before the Court. Though it is always folly to try and predict the outcome of Supreme Court cases, I would not be surprised if the Court split the baby here and found cDNA sequences to be patentable, but not gene sequences merely isolated from a natural source, particularly in view of the very broad nature of the question before them and their obvious concern for protecting biotechnology investment. Their opinion should surface around June.