Canada has joined the gene patenting debate. Children’s Hospital of Eastern Ontario (“Children’s”) sued the University of Utah Research Foundation, Genzyme Genetics, and Yale University (“Defendants”) in Canada’s Federal Court asserting that 5 patents[1] assigned to Defendants (collectively the “Long QT Patents”) for compositions and methods useful in the diagnosis and/or assessment of Long QT syndrome (“Long QT”) in human patients are invalid and/or unenforceable.

Diagnosis of Long QT Syndrome

Children’s complaint describes Long QT as an inherited cardiac disorder. Patients suffering from Long QT may experience seizures, cardiac arrest or sudden death. Symptoms of the disease can present at any time. Sudden death is the first sign of the disease in 10-15 percent of affected individuals. While symptoms of the disease are severe, treatments are available for those who are timely diagnosed with the disease.

Long QT is associated with mutations in 13 human genes. Five of the 13 mutated genes are the subject of Defendant’s Long QT Patents. Children’s asserts that no laboratory in Ontario has obtained approval from the Ontario Government to conduct on site genetic testing for Long QT because the Long QT Patents prevent such testing. Complaint at page 5. Ontario hospitals and physicians that wish to offer these tests must obtain Ontario government funding to purchase testing services from genetic testing services outside of Canada. Id.

Children’s currently provides genetic testing, but not for Long QT. Children’s would like to offer these tests using next-generation sequencing technology. The complaint states that implementation of the Long QT tests would enable Children’s to build the first repository of Long QT genetic information in Canada, with the hope of improving diagnosis and therapy.

The Long QT Patents

Children’s complaint states that the Long QT Patents collectively cover the identification of the molecular basis for Long QT, including the identification of genetic mutations that cause Long QT in five Long QT genes: KCNQ1, KCNH2, KCNE1, KCNE2, and SCN5A. The patents claim isolated nucleic acid sequences, nucleic acid probes and methods for identifying Long QT mutations.

The complaint notes that Children’s proposed claims will not infringe the Long QT Patents because the use of next generation sequencing does not require isolation or amplification of gene sequences. The method claims also are alleged not to infringe the Long QT Patents because diagnosis and/or assessment of the disease will require the clinical judgment of a clinical professional and will not be possible based on identification of mutations alone. Complaint at page 10.

Joining an International Debate

With Children’s suit, Canada has entered the gene patenting debate and provides the Canadian court the opportunity to re-evaluate patent-eligible subject matter. According to a blog posting by Children’s counsel, the Canadian definition of patentable subject matter is derived from the U.S. definition but the concepts are not similarly applied differently in Canada. (See, “Gene Patents in Canada: A Myriad of Possibilities”). At the same time, the U.S. debate may be culminating in the soon to be released revised USPTO patent-eligibility guidelines that are anticipated to be more favorable to patenting natural products than the previously issued March Guidance. (SeeUSPTO Official Says New Eligibility Rules Will Quell Fears” posted by Law360 on Friday, November 21, 2014).

The Personalized Medicine Bulletin will continue to track this case as the law regarding patent-eligibility continues to evolve in the U.S. and internationally.

Children’s complaint is attached here.