ACROSS CANADA
PATENTING GENES IN CANADA By: Carmela DeLuca, Micheline Gravelle and Amardeep Rana
With our neighbours to the south once again battling in the highest court of their land over whether or not “genes” should be patentable, it is interesting to consider the patent situation in Canada and assess what implications the U.S. situation may hold for Canadian enterprises relying on gene patents.
A
s most in the diagnostics industry are aware, the U.S. Supreme court is presently hearing a challenge to “gene patents” related to breast cancer-related genes, BRCA1 and BRCA2, owned or licensed to diagnostic giant Myriad Genetics. “Gene patents” can be described as generally falling into two categories: 1) patents that claim isolated nucleic acid molecules (e.g. “genes” which are specific nucleic acid sequences encoded in the form of DNA, RNA, or cDNA nucleic acid molecules); and 2) patents that claim methods using isolated nucleic acid molecules. The first category includes claims to “isolated DNA.” The second category encompasses methods for identifying a condition associated with a defective disease gene (i.e. diagnostic methods) and methods of identifying a therapeutic candidate substance to treat a disease related to a defective gene (i.e. screening methods). One or more of these types of patent claims can be found in a single patent. Although both categories of gene patents were at issue in the Myriad Genetics dispute, the sole question presently before the Supreme Court is whether or not human genes are patentable. The attack on the BRCA patents is being led by the American Civil Liberties Union (ACLU) and various other parties who argue that human genes cannot be patented because they are classic products of 22 BIOTECHNOLOGY FOCUS June 2013
nature, and that gene patents violate the First Amendment and stifle diagnostic testing and research. Little empirical evidence seems to support the stifling of diagnostic testing and research, but the argument has gained traction in the U.S. The initial suit was heard in the United States District Court for the Southern District of New York and a first decision, which found all of the contested claims invalid, was rendered on March 29, 2010. Claims to “isolated DNA” containing sequences found in nature were determined to be unpatentable subject matter, and methods involving the comparison of DNA sequences were considered to be abstract mental processes and thus not patent eligible. A drug screening claim was also found unpatentable for covering a “basic scientific principle.” Myriad appealed the decision to the Federal Circuit and the appeal was allowed in part, denying claims that involved merely “comparing DNA sequences” as patent eligible, but finding that Myriad’s isolated DNA claims were different than the DNA found in nature and that the screening claim was patent eligible as well. A first petition to the Supreme Court followed, which vacated the Federal Circuit decision and required the Federal Circuit to rehear the case in light of the U.S. Supreme Court’s decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 566 U. S. ____, 132 S. Ct. 1289. Prometheus, as reported in the October issue of Biotechnology Focus, has made patenting diagnostic methods that rely on a novel correlation much more difficult in the U.S. The Federal Circuit nonetheless held its ground and in August 2012, issued an almost identical decision to its first decision. Tenaciously, the ACLU filed a second appeal which is now being heard by the Supreme Court. The Court’s decision is expected by the end of June
