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20 www.lexpert.ca Feature Judicial decisions Although the Supreme Court of Canada struck down the so-called promise doctrine in December 2017 in AstraZeneca Canada Inc. v. Apotex Inc., other grounds for attacking patents have emerged, says Richard. For example, parties have chal- lenged the validity of patents based on "overbreadth," which is generally framed as an allegation that the patent claims are broader than the invention disclosed. Another ground for attacking patents is "double patenting," meaning a second patent for the same or similar invention claimed in an earlier patent. Double patenting has become a common challenge to patent validity in Canada since the Supreme Court of Canada's decision in Whirlpool Corp. v Camco Inc. in 2000, Smart & Biggar wrote in a July 2020 bulletin. e "Canadian double-patenting doctrine is similar to the U.S. double-patenting doctrine, but subtle differences between the two can lead to a fatal double-patenting issue for a Canadian patent that would otherwise be easily resolved for its U.S. counterpart under U.S. practice." In March, the Federal Court of Appeal handed down its decision regarding the drug Vyvanse. is drug can treat inattention and hyperactivity/impulsivity, including binge-eating disorder. In Apotex Inc. v Shire LLC, 2021 FCA 52, the court clarified how to apply the test for obviousness for patents and concluded that the claims at issue were not obvious. Lainson is also seeing "some very strong pro-patent-type decisions that are more consistent with what we saw a few years ago . . . Overall, I think we're in a very good space in terms of patenting, and the types of patents we're seeing in health care." For some time, biotech was struggling in the U.S. and diagnostics as well, she says. "And now that there is more of a return to normal or a better understanding of how to secure valid IP rights, I think we're seeing a bounce-back — a little delayed behind the U.S., but we are seeing , I think, more innovation in the diagnostic and the biotech space." then dropped by 40 per cent, despite the number of global launches rising during the year. And by mid-2020, the IQVIA report found, Canada benefitted from less than half of the new therapies launched globally in 2018. e ever-changing date for the new regulations coming into force will also affect what pharma companies charge for their drugs when they reach the market, says Lainson. Companies will also want to know how judicial decisions will affect the regulations. A federal election and change of govern- ment could also affect intellectual property laws, Lainson says. e past few years have brought significant changes to Canada's Trademarks Act, Patent Act and Industrial Design Act and their regulations, she adds. Although changes in government have not historically brought significant changes to IP law, "it's hard to say what the future will hold." As a lawyer working for innovator compa- nies in the patent space, though, "I feel that Canada is a bit out of step with other coun- tries," she adds. "We seem to keep creating anti-pharma sentiment in Canada that's not going to make Big Pharma want to do business here," says Gravelle. "at's my concern," including that Canadians may not have access to drugs they would otherwise because phar- maceutical companies are not interested in launching in Canada. Aer Canada entered into the Comprehensive Economic and Trade Agreement with Europe in August 2014, Canada started allowing patent extensions aer patents were granted. She says the extension was only two years, unlike the five years given in most European countries. "All these various pieces together create a climate that isn't really pharma-friendly. I agree you want to get medicines to Canadians at a reasonable cost, but these new changes might be going too far" and discourage pharmaceutical companies from wanting to do business in Canada, Gravelle adds. "We seem to keep creating anti-pharma sentiment in Canada that's not going to make Big Pharma want to do business here." Micheline Gravelle BERESKIN & PARR LLP "Because of the speed at which these products are being brought to market and the types of product . . . it's more of a challenge to fit within how our laws are structured." Marc Richard GOWLING WLG (CANADA) LLP

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