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Children’s Hospital of Eastern Ontario (CHEO) seeks declaration of invalidity and non-infringement of Long QT syndrome gene patents

By Statement of Claim issued November 3, 2014 ("Claim"), the Children’s Hospital of Eastern Ontario (“CHEO”) seeks a declaration of invalidity and non-infringement of five Canadian patents relating to nucleotide and amino acid sequences of genes and proteins implicated in Long QT syndrome (“Long QT”), an inherited cardiac disorder. The patents at issue are owned by one or more of the defendants University of Utah Research Foundation, Genzyme Genetics, and Yale University.

According to the Claim, Long QT is known to be associated with mutations of 13 human genes, five of which are covered by the patents at issue (the Long QT patents). These patented genes encode for human proteins involved in cardiac ion channel function, a disruption of which can lead to symptoms of Long QT.

In its Claim, CHEO states that “the Long QT Patents are preventing [CHEO] from offering genetic screening for Long QT” and that it “wishes to conduct genetic testing for Long QT syndrome among its patient population for public, non-commercial purposes,” and to this end has sought a declaration that its proposed process to diagnose and/or assess the risk of Long QT syndrome is non-infringing.

CHEO also seeks a declaration that the patents are invalid, alleging that the isolated nucleic acid claims, as naturally-occurring phenomena, do not constitute patentable subject-matter. CHEO claims that isolation of the claimed nucleic acids from their natural environment “requires trivial effort and does not constitute a sufficient marked departure from the naturally-occurring unpatentable nucleic acids to warrant patentability under section 2.” CHEO also pleads invalidity on the bases of lack of novelty, obviousness, and lack of sufficiency.

This case raises similar issues to those in Association for Molecular Pathology et al v Myriad Genetics, Inc et al, 569 U.S. 12-398 (2013) reported in the Smart & Biggar article dated June 13, 2013, in which the United States Supreme Court held that genomic DNA, isolated from the human genome by the breaking of chemical bonds, is not eligible for patent protection, but that complementary DNA (“cDNA”), having sequences different from those occurring in nature, is patentable subject-matter.

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