2019 Life Sciences Year in Review
The big news for Canadian Patent law in 2019 was the coming into force of numerous changes to the Patent Act and Patent Rules on October 30, 2019. Among these are changes relating to various filing requirements and deadlines. We have summarized many of these changes in A Practical Guide to the transition to Canada's new Patent Act and Rules. The most notable changes relate to the introduction of third party rights in relation to applications and patents for which maintenance fees are not paid within the prescribed time. One important change of interest to many life sciences innovators is that there are no longer excess page fees for sequence listings submitted in electronic format.
The courts have been busy too, releasing a number of decisions that highlight issues of claim construction and obviousness, overbreadth and obviousness, citability of art with respect to obviousness, and did we mention obviousness? The Federal Court also considered issues of timing with respect to listing a patent on the Patent Register. In July, the Federal Court indicated that it is willing to consider the possibility that so-called “use claims” could be directly infringed by drug manufacturers. The year ended with a final agreement on CUSMA/USMCA.
We summarize these developments below.
Claim Construction – What’s in a name?
Two cases highlight the importance of the language of the claims, underscoring the notion that the specific terms used in the claims can be a self-inflicted wound that can impact the scope of the claims, and potentially lead to invalidity.
The patent at issue in Tearlab Corporation v I-MED Pharma, 2019 FCA 179 (“Tearlab”), related to an invention used to measure the osmolarity of bodily fluids. The Federal Court found that the patent was invalid as being anticipated and obvious. The main issue on appeal was construction of the term “sample receiving chip”. The Federal Court construed the term broadly to comprise a substrate and a sample region of the substrate whereupon the properties of the sample are detected. On appeal, Tearlab argued that a purposive construction required that the sample receiving chip have certain properties such as rigidity, planarity, integrated electrodes, and volume independence (i.e. a microchip). The specification had some references to microchip but the claims only referred to “chip”, there was no mention of rigidity in the claims or specification and only a minor mention of planarity. The Federal Court of Appeal found that there was no error by the Federal Court in declining to add limitations that were not expressly included in the language of the claims.
The patent at issue in Les Laboratoires Servier v Apotex Inc, 2019 FC 616 (“Servier”), pertained to the drug perindopril arginine for treating hypertension and heart failure and claimed the arginine salt of perindopril. In construing the term “arginine”, the Court noted that the specification used the phrase “preferably L-arginine”, which was indicative of a broader construction of “arginine salt”. This broader construction included L-, D- and racemic mixtures. The issue of claim construction was central to this case since Servier had only ever made and tested the L-isomer, but not other isoforms or hydrates (which were also claimed but not tested). Ultimately, based on the broader construction of the term “arginine”, the Court held that the claims were broader than the invention disclosed.
Obviousness – If at first you don’t succeed…
Followers of pharmaceutical patent law are quite familiar with obviousness objections and will readily know the three-pronged “obvious to try” test set out in Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61, (“Sanofi”): 1) is it more or less evident that what is being tried ought to work? 2) what is the nature and amount of effort required? 3) is there motive in the prior art to achieve the invention?
In two companion cases, Teva Canada Limited v. Pfizer Canada Inc, 2019 FCA 15 and Apotex Inc v Pfizer Canada Inc, 2019 FCA 16, the Federal Court of Appeal reaffirmed that the “obvious to try” analysis can be a useful factor to consider in certain (but not all) circumstances, and should therefore be approached with caution. The Court reiterated that the “obvious to try” analysis is meant to supplement, not replace previous obviousness inquiries. It is one of a number of secondary considerations that form part of an expansive and flexible approach to the obviousness inquiry. The Court also pointed out that the Sanofi framework “expressly permits consideration of the course of conduct of those involved in the claimed invention” (2019 FCA 15 at para. 45). Thus, it is recommended to keep track of the time and effort involved in innovative endeavours.
The Sanofi test, including the obvious-to-try analysis, was also relevant in Servier. The arginine salt was considered obvious not only because the arginine salt had already been made by the inventors in 1984, but also because the prior art indicated that salt selection is routine, and it was more or less self-evident that the salt screening would have worked to identify a form that had greater stability than the erbumine salt.
Obviousness was also at issue in Tearlab. On appeal, Tearlab argued that the Federal Court had erred in not taking into account secondary indicia of obviousness such as “long-felt want or need” or commercial success. The Federal Court of Appeal dismissed the argument, finding that the Sanofi framework had been followed and reiterating that commercial success is never conclusive of obviousness “and is clearly not sufficient to save an obvious claim.” In practice, this means that inventors should not expect to rely on commercial success as an indicator of inventiveness, especially as it is difficult to establish that the commercial success of the product is related to the ingenuity of the claimed invention and not due to other factors, such as marketing or price.
Availability of Prior Art – Anything goes
A non-life sciences decision, Aux Sable Liquid Products LP et al v. JL Energy Transportation Inc., 2019 FC 581, will have significant implications for life sciences patents. In this case, the Federal Court considered how “available” prior art or information must be to render an invention obvious. One line of previous cases suggested that the type of art that could be used was limited to that which could be found by a “reasonably diligent search”. However, other cases suggested that, so long as the public had an opportunity to access the information, it was “available to the public”. The Federal Court concluded that the latter line of cases was in keeping with the Patent Act, noting that the only limitation imposed by the Act is that the information be disclosed “… in such a manner that the information became available to the public in Canada or elsewhere” prior to the relevant date. Or if you prefer to quote Douglas Adams, even information “on display in the bottom of a locked filing cabinet stuck in a disused lavatory with a sign on the door saying ‘Beware of the Leopard’” would be considered “on display” for the purposes of an obviousness analysis.
Patent Listing – Timing is everything
Under s. 4(6) of the PM(NOC) Regulations a patent cannot be listed on the Patent Register unless it is filed before the corresponding New Drug Submission (NDS) is filed. On June 21, 2011 Elanco filed an NDS, and then filed additional materials relating to the submission in 2012 and 2013. The patent relating to the submission was filed on September 22, 2011. The Minister of Health found that the NDS was administratively complete on the filing date of June 21, 2011 and refused to list the patent on the Patent register on the basis that it did not meet the timing requirements under the Regulations.
Elanco appealed the Minister’s decision in Elanco v Canada (Attorney General), 2019 FC 5. The Federal Court dismissed Elanco’s application on the basis that the legislative provisions do not define the date of filing, and it was therefore open to the Minister to allocate a filing date for submissions. Going forward it will be important to ensure that any patent applications relating to a new drug have been filed before submitting any documents relating to an NDS.
Pharmaceutical Use Claims
Eli Lilly Canada Inc v Apotex Inc, 2019 FC 884, relates to independent infringement actions against Defendants Apotex, Mylan, Teva, and Pharmascience. The proceeding was a motion for leave to amend in order to introduce a new claim against each defendant: that the defendants had infringed Lilly’s ‘784 patent relating to the use of tadalafil for the treatment of erectile dysfunction (ED).
Since methods of treatment are not patentable in Canada, pharmaceutical patents are drafted to claim uses of the compound. There are three common styles of use claims: 1) compound X for use in the treatment of Y; 2) use of compound X for the treatment of Y; and 3) use of compound X for the manufacture of a medicament for the treatment of Y. If the compound itself is new, the patent will also contain claims to the compound itself.
The ‘784 patent contains each of the three styles of use claim, but no claims to tadafil itself because the compound was already known. The issue before the Court was whether there can be direct infringement of the ‘784 patent by manufacturing and/or importing tadafil, even though the product was not sold (and therefore not actually used by patients), prior to the expiry of the ‘784 patent.
In deciding to grant leave to amend, the Court did not accept the Defendants’ arguments that a finding of infringement required that there be actual use of the compound by patients during the period of validity of the patent. Rather, the Court found that the jurisprudence recognizes a difference between claims drafted as “use of a composition for the treatment of” and those drafted as “composition for use in the treatment of”. Further the Court noted that “these cases also do recognize that claims drafted as “a composition for use in the treatment of” can be construed as claiming a specific product, and are therefore susceptible of direct infringement by a maker of generic medicines.” These cases will be interesting to watch as they progress through the Court, but they highlight the importance of including a variety of styles of “use” claims to ensure full protection.
CUSMA/USMCA Update
A final trade agreement between Canada, the United States, and Mexico was reached at the end of 2019. The final agreement requires very few changes to Canada’s current Patent and pharmaceutical IP framework. The agreement includes an obligation that Canada provide a patent term adjustment to compensate patentees for “unreasonable delays” in patent application processing at the Canadian Patent Office. However, most notably the agreement does not require any changes to either the Certificate of Supplementary Protection or the regulatory data protection regimes. This allows Canada to maintain its current term of 8 years of regulatory data protection for both small molecule and biologic drugs, and up to 2 years of supplemental patent-like protection for innovative new drugs.
The Bereskin & Parr team will continue to bring you timely and comprehensive updates to new developments in the life sciences and patent space. 2020 is shaping up to be an exciting year as we adapt to the new patent regime, watch for new insight into pharmaceutical use claims, and await the usual obviousness cases in the life sciences realm.
