TORONTO – Dishing out hundreds of millions of dollars for new COVID-19 fighting ventilators, test kits and antibody detection platforms Ottawa has another vital gap to close: the time it takes to approve these technologies for the marketplace. A new Canadian pilot program could significantly reduce the amount of time it takes to determine if these technologies are ready for prime time.
“It can take a number of years before a patent is granted depending upon how far apart the applicant and the Canadian Intellectual Property Office (CIPO) are as to what can be protected,” said David Schwartz, a partner at the Ottawa office of Smart and Biggar LLP and a patent and trademark agent. “If you’re filing a patent that relates to COVID-19 technology that is innovative and has to be approved by Health Canada, you can benefit from this.”
Jumping the queue
The pilot project is aimed at med-tech companies that have filed a new or existing patent application for an invention supporting the health-related response to COVID-19 and with fewer than than 50 employees. A case in point: Orpheus Medica Inc., a Mississauga, Ontario-based biotech company with 12 experts busy developing a rapid saliva test for detecting the SARS-CoV-2 strain that causes the COVID-19 virus. Investors as well as small- and medium-sized enterprises (SMEs) are paying attention.
“The first thing an investor will ask about your technology is ‘Do you have a patent on it?’” Orpheus Medica chairman and CEO Saeid Babaei told BioWorld. “So with an accelerated process of review, that provides a lot more assurance for SMEs anxious to track their investments.”
Now the 14 months it typically takes CIPO to get back to companies about their application has been cut down to three months if it is COVID-19 related technology. The criteria for the kinds of applications range from a basic medical device license and investigational testing authorization to authorized clinical trials for medical devices and drugs relating to COVID-19.
“That’s all good for those things that are clearly designed to help innovative companies move more rapidly at a time when solutions from those companies are required in the markets,” John Ralston, CEO of Menlo Park, Calif.- and Calgary, Alberta-based Protxx Inc. told BioWorld. The idea of wearable medical devices like his wearable sensors platform for remote patient monitoring got a boost after the pandemic triggered health care lockdowns.
CIPO is also waiving a current provision barring companies from obtaining an extension of time after missing a deadline or that obtains an extension of time prior to requesting an accelerated examination. “It’s probably a little more loosely written than if they had been writing patent regulations,” Schwartz told BioWorld, “but that’s the way I read it.”
Added Ralston, “Anything that reduces the cost and time to get a patent reviewed and issued is good. Absolutely.”
Lose the filing fee, please
The biggest beneficiaries of the pilot project, said Babaei, could be underfunded academics who struggle to make every penny count. They’re likely to jump at CIPO’s decision to waive the CA$500 (US$350) fee required for an accelerated patent application, he said.
“Professors who own the intellectual property rights of an invention may hesitate to use their own personal funding to protect the IP. They’re also reluctant to patent an invention until the proof of concept has been achieved.” Babaei’s own company is waiting for enough data to be collected for its rapid saliva test before filing its patent application.
“We want to be responsible. We want to be sure about what we’re filing and then prevent other companies from using the kind of antibody and peptide that we have developed.”
The pilot project is fairly straightforward, Schwartz noted, and any company would likely have consulted their own advisers. They understand “everyone wants something done yesterday,” and can tell you, “Here’s the way to do it,” said Schwartz. He believes the changes could have a major impact on SMEs, “especially with the urgency that we’re faced with now around COVID-19.”
https://www.bioworld.com/articles/496431-canadas-patent-office-speeding-examination-of-covid-19-med-tech-applications-cutting-company-costs