Julie Desrosiers began her legal career at Fasken Martineau DuMoulin over 25 years ago, after studying philosophy as an undergraduate. Though she enjoyed the subject, she felt “it was too passive” and wanted to study something with “more influence in society”, which led her to study law. Eventually, she would became global leader of the firm’s IP and technology group. Desrosiers says: “Early on, it was clear that I wanted to be a litigator, so I started in the commercial litigation group.” At the time, Fasken Martineau’s IP team was in its early form. When one of the leading IP partners was appointed to the bench, the opportunity arose for Desrosiers to take on additional work in IP litigation: “I had been practising commercial litigation for about 10 years at that point and I was really open to that change.”
The utility test
Desrosiers was drawn to the international nature of IP work, particularly patent litigation: “It’s connected to all of the innovations in the world. I’ve been doing this for 15 years with pleasure!”
In one of her career highlights, her first patent case before Supreme Court of Canada, Desrosiers was at the forefront of arguments connected to the test for patent utility. Last year, these discussions culminated with the AstraZeneca Canada appeal: “It completely changed the test in Canada for utility. It came back to what it was maybe 10 years ago, which is more aligned to what it is in the UK and US,” Desrosiers says.
“So, if an invention is capable of some practical application then it should be useful. Judges are considering what the promise is, instead of just considering what the invention is and what it does. Patentees were really struggling with the test as it was, but thanks to the Supreme Court, now that’s been changed.”
As a result of the same judgment, the promise doctrine – a scheme from Canada’s 1985 Patent Act for determining the validity of utility claims – was removed. According to Desrosiers, this is a good change: “The promise doctrine as it was applied by the Federal Court led to the invalidity of many patents for blockbuster drugs, for instance. A drug would be beneficial for tonnes of people around the world, yet it would be decided that the patent for the drug was not be useful.”
“Now, Canada is more aligned with the rest of the world. I think it reassures patentees that Canada will comply with international obligations.”
International pharma patents
For foreign patent owners, Desrosiers highlights a common issue: “There would never be a challenge in any other jurisdiction and when you go into Canada, many patents were found notto be useful. That was a problem especially for international companies who file a patent on two PCT applications in foreign countries with the expectation that when the patent is filed in Canada, it would be valid in Canada and this was not the case.”
Recently, market commentators have been said that the decision has lowered the bar for receiving patents, thus favouring foreign multinational companies over Canadian patent owners. Desrosiers says: “I would not say that it favours international patent owners over Canadian patent owners. I think the approach of Canadian courts to utility is more aligned with foreign jurisdictions, so now the test is probably more similar to those applied in the US, the UK and other common law countries like Australia. It’s easier for a patentee to know what to expect when they file a patent and go into litigation in Canada.”
On the other hand, while the utility test is simpler, Desrosiers identifies an issue for Canadian and international patent owners: “You don’t have a promise. It could be different, depending on who the judge is - one judge could see a promise here and another judge will see a promise there.”
Now, as the promise does not have to be part of the claim, Desrosiers says patent files face greater scrutiny: “It always depends on how you construe some words in the specification. It’s difficult for clients because it creates some insecurity. You do not know what the judge will decide. The question is: Does this invention have some utility in a practical sense?”
Free trade agreement drives patent change
In Canada’s impending implementation of The Comprehensive Economic and Trade Agreement (CETA), a free trade agreement with Europe, Desrosiers identifies a number of concerns for the pharma industry.
Among these are the “proposed amendments to a variety of regulations to implement CETA”, including the “patent term extension that Canada and Europe agreed to extend in Canada”. She adds: “Another concern is the right of appeal of the innovators if ever they are unsuccessful throughout PM(NOC) regulations – the Canadian equivalent of the Orange Book in the US”. In response to CETA plans, proposed amendments to the Patented Medicines (Notice of Compliance) Regulations [PM(NOC)] included a pledge for right of appeal for all parties in patent litigation.
At the heart of these amendments is the way “brands and generics will litigate their entry into the market, a generic version of the brand drug that is approved”.
In Canada, such issues call for litigation whereas in the US, Desrosiers explains: “There is an automatic stay at the beginning to prevent the generic from entering the market. This stay is for 24 months, so the court needs to issue a ruling before then. If not, the generic can enter the market and the only thing that is left is an action for patent infringement.”
Patent Act proposals
In addition, Canada is making substantial changes to the way these litigations are addressed: “In the past, it used to be summary proceedings where all the witnesses were cross-examined out of court. When you go and argue these cases, it’s really based on paper material with no witnesses”.
“Now, Canada is suggesting that this should change. They want to address these litigations as usual trials where you will go to court with your expert and witnesses to consider the validity and infringement of a patent.”
In August, the Canadian government opened a public consultation about all proposed amendments to the Patent Act. It is thought that the rules could be in force in 2019. According to Desrosiers, there is no time like the present to revise “the whole litigation of patents” in Canada: “In pharma patent litigation, because proceedings were done out of court, because judges who decided whether the patent was invalid or infringed had not heard from any experts, this led to some changes that were surprising.”
“These proceedings have been highly criticised both by generics, brands, practitioners and the court. I hope that these changes Canada intends to make to the regulation will help Canada to be more aligned with its international partners.”
Biologic patents
In pharma innovation, Desrosiers notices increasing approval of biologic patents: “The years to come will be very interesting in terms of patents in Canada, pharmaceuticals, the way governments address drugs and the way they are marketed.” Despite the growing interest in biologic patents, Desrosiers says: “Canada is slower than other jurisdictions to approve them because as there are maybe 20 different biologic drugs approved in Europe and there are maybe five of six in Canada, but it’s moving up. Litigation with these products will be interesting because in terms of how it can be protected, it’s different from making a molecule with a chemistry process in a lab, different than making protein or isolating a DNA sequence. Is it patentable or not?”
“Sometimes, with these inventions, the big thing is the process to make them instead of the composition itself, which sometimes cannot be patented. We see that a lot in the US and will see that in Canada in the years to come, which will be interesting for patent litigators like me.”
An additional inconvenience in processing biologic patents, is the unusual delay: “I think they take so long to process because it is new. It is likely that the companies who develop them went to the bigger jurisdictions to complete all the tests for approval. They are protected, but then you have to go through all of the regulatory processes in order to get approval.”
“Health Canada might be pickier than other jurisdictions for some things, because these products are new and different.”
Staying motivated
After more than 25 years in the profession, Desrosiers’ practice has benefitted from dynamic experience in patent litigation and technology. While Desrosiers has come to expect change in every aspect of the market, legislation and her professional environment, her passion for IP remains the same. She describes being asked to be the first woman from the Montreal region to sit on the international board of Fasken Martineau as one of her happiest moments.
Desrosiers says, organisation and focus are keys to her success: “Work when you’re working, work. When you’re doing something else, do something else.”
Another key to success, she says, is to be surrounded by a devoted team: “I’m someone who really likes to work as a team and I delegate a lot – the young lawyers I work with really get involved and deliver on what they commit to.”
For Desrosiers, team work extends beyond the workplace: “I have three kids – I’m a mum! I delegate at home too. I have help at home, otherwise I would not be able to do it. Working together is always a plus, you get to have the impact of other brilliant people.”