The federal agency that grants patents has stopped extending them to diagnostic tests in which researchers discover links between a previously known element or compound in the human body and a specific disease.
Patent lawyers, other experts, and even some members of the Canadian Intellectual Property Office (CIPO) itself, say the patent office’s policy prevents new and potentially life-saving diagnostics from being developed in this country and becoming available to Canadian patients.
“Without a patent, they [the researchers] won’t have the investment or the interest from a corporate partner that they really need to go all the way,” says Kathleen Marsman, a patent agent at the law offices of Borden Ladner Gervais in Ottawa. “Fantastic Canadian development that was supported by Canadian grants and CIHR [Canadian Institutes of Health Research] and taxpayers’ dollars is just really going to fall on the cutting-room floor.”
In 2012, the CIPO quietly stopped assessing patent requests for certain types of diagnostic tests and, over the next three years, put about 300 applications on hold. Then, in 2015, it came out with a new set of “examination guidelines” to dictate what would be subject to diagnostic patents going forward.
If a marker is discovered in the blood that was previously unknown to science, and that marker, or “analyte,” can be traced to a specific disease, such as thyroid or breast or ovarian cancer, that discovery can be patented and the process of human trials and federal approvals can begin to create a test that is accessible to patients.
But, if a researcher makes a new connection between a disease and a previously known analyte, the CIPO considers that to be “common general knowledge” and will not give the researchers exclusive rights to develop a diagnostic process.
As a result of the new policy, Ms. Marsman said Canadian researchers who link known body chemicals to specific disease are not even trying to develop the diagnostic tests that would naturally flow from their discoveries. And, she said, researchers from outside of the country who make similar types of connections are no longer bothering to have their work patented in Canada.
Finding a new link between a known biological compound and a disease “is a long, long way from taking it through clinical trials, getting approvals and that kind of stuff,” says Norman Siebrasse, a professor of patent law at the University of New Brunswick.
“The patent protection is needed for the whole process,” Prof. Siebrasse said. “It’s to encourage you to come up with the idea and to take it all the way to commercialization. And without the patent, we won’t have the incentive for either.”
The office of Navdeep Bains, the Minister of Innovation, Science and Economic Development, which is responsible for the patent office, said in an e-mail that CIPO’s guidelines were drafted to conform to court decisions.
But patent lawyers, including Prof. Seibrasse, argue CIPO has misinterpreted the law, a position that appears to be shared by at least one senior employee in the patent office.
In a February, 2014, e-mail that was obtained under Access to Information and posted anonymously online, Michael Gillen, the chief of biotechnology for CIPO, says: “There is absolutely no basis in law for this and no reason why CIPO should take this approach. It is unexplainable, unsustainable and contrary to the decision of the Supreme Court in Shell [Oil.].”
The Supreme Court determined in 1982 that Shell could patent previously known chemical compounds for new uses as regulators in plant growth.
If a new diagnostic method relates to improving the measurement or detection of an analyte, the CIPO considers that to be solving a “data acquisition” problem that can be patented, said Carmela De Luca, a lawyer and patent agent with Bereskin and Parr in Montreal. If, on the other hand, the diagnostic method is related solely to the new correlation, Ms. De Luca said, the claim is seen as solving a “data analysis” problem and is likely not patentable.
But, she said, “it would seem there is no basis in law for applying the ‘data analysis’ versus ‘data acquisition’ framework for medical diagnostic inventions.”