As indicated below, Children’s Hospital of Eastern Ontario (CHEO) has started litigation against the University of Utah Research Foundation, Genzyme Genetics and Yale University. The litigation seeks a declaration of non-infringement and invalidity of certain patents relating to Long QT Syndrome genes, including on the basis of non-patentable subject matter.
The patents being challenged are:
- CA2,240,737 – A Long QT Syndrome Gene Which Encodes KYLQT1 and its Association with MinK
- CA2,336,236 – Mutations in and Genomic Structure of HERG – A Long QT Syndrome Gene
- CA2,337,491 – Human MinK Gene Mutations Associated with Arrhythmia
- CA2,369,812 – MinK-related Genes, Formation of Potassium Channels and Association with Cardiac Arrhythmia
- CA2,416,545 – Common Polymorphism in SCN5A Implicated In Drug-Induced Cardiac Arrhythmia
According to the pleading, Children’s Hospital cannot obtain approval to conduct genetic tests because of the patents. A copy of the Statement of Claim is available from Gilbert’s LLP’s Just Biotech blog.
The patents are challenged, including on the basis of unpatentable subject matter:
53. Naturally-occurring phenomena and discoveries thereof are not patentable. The isolation of the claimed nucleic acids from their natural environment requires trivial effort and does not constitute a sufficiently marked departure from the naturally-occurring unpatentable nucleic acids to warrant patentability under section 2. Isolated naturally-occurring nucleic acids are neither new compositions of matter nor improvements of compositions of matter.
Similar arguments were litigated in the United States in the Myriad proceeding to the United States Supreme Court which held that that isolated DNA is not patentable subject matter but cDNA is patentable in the United States.