The 2010s saw many developments in Canadian patent law. Establishment of a trade agreement with the European Union, ratification of an international IP treaty, implementation of a national IP strategy, and other domestic initiatives resulted in numerous amendments to the Patent Act and associated regulations. Landmark court decisions affected central tenets of patent law, including subject-matter eligibility, novelty, obviousness, and utility. In this article, we provide a round-up of top patent law stories, including some of the most interesting Canadian patent cases, of the past decade.
Although we have identified what we feel to be the most interesting decisions from each year, many important cases are necessarily excluded. Indeed, there were numerous patent cases of significant commercial importance in the 2010s that are not discussed here. These cases have been selected as either deciding a central point of Canadian patent law or raising a unique or unusual issue.
Jump ahead to a round-up of:
| 2010 | |
2010
Legislation
Declaration of legal representative
Amendments to the Patent Rules came into force on October 1, 2010 to replace the complex requirement for a declaration of entitlement in a patent application with a simpler declaration of legal representative.
For more detail, please read our previous article here.
Interesting patent cases
Eli Lilly Canada Inc v Novopharm Ltd, 2010 FCA 197, rev’g 2009 FC 1018. A challenge directed to a determination that the conditions for a selection patent have not been met does not constitute an independent basis upon which to attack the validity of a patent. Rather, the conditions for a valid selection patent serve to characterize the patent and accordingly inform the analysis for the grounds of validity set out in the Patent Act—novelty, obviousness, sufficiency and utility.
Eli Lilly & Co v Apotex Inc, 2010 FCA 240, aff’g 2009 FC 991. It has been settled law in Canada for over a hundred years that, under the “Saccharin doctrine,” a process patent can be infringed by the importation, and use and sale in Canada, of a product manufactured abroad by another person using the patented process. The Saccharin doctrine may apply even apply if “material changes” are made to the article produced by the patented process prior to the importation of the ultimate product. It is necessary only that the patented process played an “important part” in the manufacture of the imported product.
Canadian Generic Pharmaceutical Association v Canada (Health), 2010 FCA 334. The constitutionality of the data protection provisions in the Food and Drug Regulations was upheld. The Food and Drugs Act was amended in 1996 to grant the Governor in Council authority to enact regulations for implementing data protection provisions of NAFTA and TRIPS. The Data Protection Regulation was properly delegated by Parliament to the Governor in Council and is intra vires the authority of the Governor in Council.
2011
Legislation
Accelerated examination
Amendments were made to the Patent Rules in 2011 to provide for accelerated examination of a patent application with no government fee if the application relates to a green technology.
For more detail, please read our previous article here.
Interesting patent cases
Celgene Corp v Canada (Attorney General), 2011 SCC 1, aff’g 2009 FCA 378. The Patented Medicines Prices Review Board (PMPRB) has jurisdiction to grant orders concerning excessive prices of patented medicines sold in Canada. The Supreme Court held that the PMPRB has jurisdiction over Celgene’s U.S.-based sales of THALOMID to Canadians pursuant to Health Canada’s Special Access Program. The PMPRB was correct and reasonable in interpreting the enabling provisions of the Patent Act as providing jurisdiction over sales made to consumers in Canada, notwithstanding that the locus of sale was outside Canada.
Corlac Inc v Weatherford Canada Inc, 2011 FCA 228, var’g 2010 FC 602. Paragraph 73(1)(a) of the Patent Act provides that a Canadian patent application shall be “deemed to be abandoned” if the applicant does not reply “in good faith” to an office action within the prescribed time. Patents have been attacked as allegedly invalid on the basis that the application was deemed to be abandoned for lack of a good faith response during prosecution and not reinstated. The Federal Court of Appeal rejected this argument, holding that the concept of abandonment in paragraph 73(1)(a) operates during the prosecution of the application for a patent. Its operation is extinguished once the patent issues.
Canada (Attorney General) v Amazon.com, Inc, 2011 FCA 328, rev’g 2010 FC 1011. The determination of patentable subject-matter must be based on a “purposive” construction of the patent claims. A patentable art, which includes either a method or a process: i) must not be a disembodied idea but have a method of practical application; ii) must be a new and inventive method of applying skill and knowledge; and iii) must have a commercially useful result. A business method possibly could meet the requirements for patentable subject-matter. Patentable subject matter must be something with physical existence, or something that manifests a discernible effect or change. On redetermination, the Patent Office concluded that Amazon.com’s one-click shopping method was a patent-eligible invention.
2012
Interesting patent cases
Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60, rev’g 2010 FCA 242. The Supreme Court held that Pfizer’s patent for VIAGRA lacked sufficiency of disclosure for a claim specific to the use of sildenafil for treating erectile dysfunction. The utility of sildenafil in treating erectile dysfunction had been demonstrated before filing. The specification stated that one of the especially preferred compounds of the invention induces penile erection in impotent males but did not state whether this was sildenafil or another claimed compound. Determining which of two claims was directed to the specific compound that had been determined to work would have required “a minor research project,” rendering the description insufficient.
Wenzel Downhole Tools Ltd v National-Oilwell Canada Ltd, 2012 FCA 333, aff’g 2011 FC 1323. The subject-matter of a patent claim lacks novelty if it was disclosed by the applicant more than one year before the filing date “in such a manner that the subject-matter became available to the public in Canada or elsewhere.” The plaintiff invented a drill apparatus which was rented to customers more than one year prior to the plaintiff filing a patent application. During rental periods, the drill was encased in a box, and was not visible or easily accessible to renters. Additional information on the invention was available to renters upon request, but no request was received. Even with no evidence that the inner workings of the drill apparatus had been seen, or that the additional information relating thereto had been accessed, the trial and appeal judges found that the renters had an “opportunity to access” that was not circumscribed or prohibited by agreement. The trial and appeal judges decided that opportunity was sufficient to constitute disclosure of the invention and held the patent invalid.
2013
Interesting patent cases
Takeda Canada Inc v Canada (Health), 2013 FCA 13, aff’g 2011 FC 1444. The Federal Court of Appeal found dexlansoprazole ineligible for listing on the Register of Innovative Drugs. Dexlansoprazole is one of the enantiomers of the previously approved racemate lansoprazole, and was ineligible for listing on the Register because it was a variation that is specifically excluded from the definition of “innovative drug” in section C.08.004.1 of the Food and Drug Regulations, which reads: “innovative drug” means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph.
Sanofi-Aventis v Apotex Inc, 2013 FCA 186, rev’g 2011 FC 1486, var’d 2013 FCA 209. The Federal Court of Appeal overturned the Federal Court’s decision invalidating the patent that claims clopidogrel bisulphate (sanofi-aventis’s PLAVIX). When analyzing utility in the context of the promise doctrine (overturned by the Supreme Court in 2017 – see AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36, discussed below), the Court stated that the first step is to determine if a skilled person would understand the patent to contain an explicit promise of a specific result. If so, the inventor will be held to that promise; if not, a mere scintilla of utility will do. The Supreme Court granted Apotex leave to appeal this decision, but Apotex discontinued its appeal on November 3, 2014.
Had the proceedings gone forward, the Supreme Court would have considered the validity of the PLAVIX patent a second time, since it had previously been the subject of litigation under the Patented Medicines (Notice of Compliance) Regulations (the “PM(NOC) Regulations”), in which the Supreme Court upheld the Order of prohibition preventing the Minister of Health from issuing a notice of compliance to Apotex with respect to the PLAVIX patent: 2008 SCC 61.
Bell Helicopter Textron Canada Ltée v Eurocopter, 2013 FCA 219, aff’g 2012 FC 113. Claims to helicopter landing gear were held invalid for failure of the patentee to establish either by demonstration or sound prediction the promised utility of reducing ground resonance (potentially dangerous vibrations that can occur on landing). This was a rare application of the doctrines of sound prediction and promised utility outside the pharmaceutical field. The case is also notable for the award of punitive damages. The defendant was found to have misappropriated the invention as its own and an accounting of profits and compensatory damages were considered insufficient remedies. For the damages phase of this bifurcated case, see 2019 FCA 29, discussed below.
2014
Interesting patent cases
Apotex Inc v Sanofi-Aventis, 2014 FCA 68, var’g 2012 FC 553, aff’d 2015 SCC 20. In this and the companion case Teva Canada Ltd v Sanofi-Aventis Canada Inc, 2014 FCA 67, var’g 2012 FC 552, the Federal Court of Appeal addressed the quantification of damages under section 8 of the PM(NOC) Regulations, the Federal Court decisions on appeal having been the first to consider this issue. While confirming that the correct approach is based on the principle of “but for” causation that is applicable to monetary remedies in general, the Federal Court of Appeal clarified some principles regarding the start and end date for the liability period, as well as the construction of the “but for” or hypothetical world in which no prohibition application had been brought. The Supreme Court unanimously dismissed Sanofi’s appeal “substantially for the reasons of the majority of the Court of Appeal.”
Bayer Inc v Apotex Inc, 2014 FC 436. The Federal Court considered a disclosure by prior use in clinical trials, finding that although it was theoretically possible that a tablet provided during the trials could have been kept and analyzed, it was nevertheless not an anticipating disclosure as an experimental use: “experimental use in order to bring the invention to perfection, does not constitute public use”, particularly where the experimental use must, of necessity, be conducted in public.
AbbVie Biotechnology Ltd v Canada (Attorney General), 2014 FC 1251. The Federal Court accepted the patentability of claims to the use of a known drug in a fixed dosage and a fixed interval, finding them not to cover methods of medical treatment. The Court found that the claimed dosage and bi-weekly interval is appropriate for all those to whom it is administered and is not expected to require adjustments that would require the exercise of a physician’s skill. While the physician must exercise skill and judgment to determine if the claimed use is appropriate for the patient, the physician decides to prescribe it as is or not at all, and if prescribed, the physician’s skill is not expected to be exercised within the claim.
2015
Interesting patent cases
Apotex Inc v Merck & Co, Inc, 2015 FCA 171, aff’g 2013 FC 751. Apotex was found liable for damages for infringement of a product-by-process patent for the anti-cholesterol drug lovastatin owned by Merck. Apotex argued that the damages owed should be reduced because it had available to it a non-infringing alternative (NIA) process for producing lovastatin that Apotex could and would have used had it not infringed. The Federal Court of Appeal held that the availability of a non-infringing alternative may be a relevant consideration when assessing damages for patent infringement. “Perfect compensation” requires consideration of: (i) what, if any, non-infringing product the defendant or any other competitors could and would have sold “but for” the infringement; and, (ii) the extent lawful competition would have reduced the patentee’s sales.
Canada (Attorney General) v Sandoz Canada Inc, 2015 FCA 249, rev’g 2014 FC 501, 2014 FC 502. The Federal Court of Appeal held that ratiopharm and Sandoz were “patentees” within the meaning of subsection 79(1) of the Patent Act and therefore subject to the jurisdiction of the PMPRB to review prices set by ratiopharm and Sandoz. ratio-salbutamol HFA sold by ratiopharm was manufactured and packaged by GlaxoSmithKline, which granted ratiopharm an exclusive licence to set the price of the product and sell it in Canada. Sandoz sold medicines covered by patents owned by its parent Novartis AG or one of its wholly owned subsidiaries. Each of the medicines at issue was obtained by way of a purchase order. No written licence agreements existed between Sandoz and Novartis relating to the sale of these medicines.
2016
Legislation
Privileged communications between agents and their clients
On June 24, 2016, amendments to the Patent Act and the Trademarks Act came into force, establishing privilege in communications between Canadian patent and trademark agents and their clients.
A communication is privileged if:
(a) It is between a Canadian patent or trademark agent and their client;
(b) It is intended to be confidential; and
(c) It is made for the purpose of seeking or giving advice with respect to any matter relating to the protection of an invention, trademark, geographic indication, or certain related rights.
Communications between a foreign patent or trademark agent and their client are also privileged if they would have been privileged under the above conditions had they been made with a Canadian agent.
This statutory privilege applies to communications made before June 24, 2016, provided they remained confidential at that date. However, it does not apply in respect of an action or proceeding commenced before June 24, 2016.
The Privacy Act and the Access to Information Act were amended effective December 13, 2018 to ensure that the agent privilege is treated no differently from solicitor-client privilege and prevent the disclosure of privileged intellectual property information.
For more detail, please read our previous article here.
Interesting patent cases
Brown v Canada, 2016 FCA 37, rev’g 2014 FC 831. Subsection 4(1) of the Canadian Public Servants Inventions Act requires that every public servant who makes an invention must notify the appropriate government minister and disclose in any patent application that the inventor is a public servant. Subsection 53(1) of the Patent Act provides that a “patent is void if any material allegation in the petition of the applicant in respect of the patent is untrue….” The Federal Court of Appeal held that the inventor’s failure to disclose his status as a public servant was not an untrue and material allegation as contemplated under subsection 53(1). Furthermore, the Patent Act stands as a complete statutory scheme in relation to patent rights.
Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc, 2016 FCA 119, aff’g 2015 FC 17. The Federal Court of Appeal emphasized that in the obviousness analysis for double-patenting, the claims of the first patent and the second patent are to be compared, to determine whether the claims of the second patent exhibit inventiveness over the first patent. As ordinary rules of claim construction apply in the comparison, if the claims of the first patent are unambiguous, it is improper to refer to the specification to vary the scope of the claims. The Court also considered the relevant date on which obviousness-type double-patenting should be assessed, but declined to definitively decide the issue in both this decision, and in Apotex Inc v Eli Lilly Canada Inc, 2016 FCA 267.
2017
Legislation
CETA
Amendments to the Patent Act and associated regulations came into force on September 21, 2017, giving effect to Canada's obligations under the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union. There were significant changes, particularly with respect to pharmaceutical patent law.
Certificates of Supplementary Protection (CSPs) were introduced, providing for restoration of patent term to account for marketing delays resulting from time required to obtain regulatory approval.
The CETA changes also comprehensively altered the regime that governed pharmaceutical patent litigation in Canada for nearly 25 years. The summary proceedings previously in place, in which an innovator seeks an order from the Federal Court, enjoining the Minister of Health from issuing marketing authorisation to a second person, were replaced by a full right of action, with accompanying procedural guarantees and discovery obligations. The new regime is intended to provide equivalent and effective rights of appeal to all litigants (the previous summary proceedings were moot once marketing authorisation was issued), and to end the practice of dual litigation, where a full patent infringement action followed summary proceedings.
For more detail, please read our previous articles here and here.
Interesting patent cases
AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36, rev’g 2015 FCA 158. In the most significant case of the decade, the Supreme Court of Canada rejected the “promise doctrine” and clarified the requirement for patent utility in Canada. The so-called “promise doctrine” developed by the Federal Courts in recent years had become the yardstick against which utility was measured. This had become a highly contentious issue as it resulted in the invalidity of numerous pharmaceutical patents. The Supreme Court fully rejected the doctrine as “incongruent with both the words and the scheme of the Patent Act”.
Apotex Inc v ADIR, 2017 FCA 23, rev’g in part 2015 FC 721. The Federal Court of Appeal held that a patentee should only receive that portion of the infringer’s profit that is causally attributable to the invention. The Court observed that in considering whether an alleged NIA was available, one enters a hypothetical world where the infringer did not infringe, and an infringer must establish that in this hypothetical world it “could have” and “would have” obtained and used the NIA. In this case, the Court of Appeal found that the Federal Court had erred in law by rejecting Apotex’s argument that the availability of NIAs reduced the profits to be disgorged. The question of whether an NIA was available on the facts was remitted to the Federal Court. The Court of Appeal upheld the Federal Court’s decision not to apportion Apotex’s foreign revenues between those received for perindopril and those allegedly received for non-infringing services.
Bristol-Myers Squibb Canada Co v Teva Canada Ltd, 2017 FCA 76, aff’g 2016 FC 580. The Federal Court of Appeal dismissed Bristol-Myers Squibb’s appeal of the decision dismissing its prohibition application against Teva for atazanavir sulfate (Bristol-Myers Squibb’s REYATAZ). While the Court of Appeal held that the Federal Court erred in its identification of the inventive concept, it upheld the finding that the patent was obvious. The Court of Appeal held that the “inventive concept” was not “materially different” from “the solution taught by the patent”, which on the facts, was “atazanavir bisulfate, a salt of atazanavir which is pharmaceutically acceptable because it has equal or better bioavailability than the atazanavir free base.” The Federal Court of Appeal commented further on the inventive concept in Ciba Specialty Chemicals Water Treatments Limited v SNF Inc, 2017 FCA 225, where it noted that the uncertainty with respect to how to define the inventive concept “can be reduced by simply avoiding the inventive concept altogether and pursuing the alternate course of construing the claim.”
The Dow Chemical Company v Nova Chemical Corporation, 2017 FC 637. The Federal Court awarded a record amount in a patent infringement lawsuit involving polymers used in heavy plastic bags, pallet wrapping and food packaging. Dow, the successful plaintiff, elected to recover the defendant's infringing profits as opposed to damages from lost sales, as is often permitted in IP matters in Canada. In this case, the Court also awarded an amount for infringing activity that took place after the publication of the patent application but in advance of the patent issuing, and an amount representing the springboard profits enjoyed by the defendant following expiry of the patent as a result of the defendant's infringing activity prior to expiry. After a reference on quantification, Dow was awarded C$645 million, including pre-judgment interest which was calculated based on a profits-on-profits approach. The decision is under appeal.
2018
Legislation
Regulation of patent agents
Portions of the College of Patent Agents and Trademark Agents Act were enacted on December 13, 2018, establishing for the first time a distinct regulatory body governing the practice of the patent and trademark agent professions in the public interest.
For more detail, please read our previous article here.
National IP Strategy
In its 2017 budget, the government of Canada announced that it would develop a national IP Strategy designed to help Canadian companies and innovators to better understand, protect and leverage intellectual property. This was followed in the 2018 budget with a commitment to invest $85.3 million towards initiatives supporting IP Strategy over five years.
The Budget Implementation Act, 2018, No. 2 introduced the following amendments to the Patent Act to implement aspects of the IP Strategy. These came into force on December 13, 2018.
Demand letters
New Section 76.2 of the Patent Act provides a regulation-making authority for the establishment of requirements for written demands relating to patents (i.e. cease and desist letters).
Written demands received by a person in Canada, relating to an invention patented in Canada or elsewhere, or protected by a CSP or its equivalent, must comply with the prescribed requirements.
A person receiving a written demand that does not comply with the prescribed requirements, or a person “aggrieved” as a result of the receipt by another person of such a written demand, may seek relief in the Federal Court. Such relief may include recovery of damages, an injunction, a declaration, or an award of costs.
Regulations setting out the prescribed requirements will be needed before these provisions can be operative. The regulation-making authority under these new provisions extends to regulations respecting:
(a) what constitutes a “written demand” or “aggrievement;”
(b) the requirements with which a written demand must comply;
(c) the factors that the Federal Court may consider, must consider, or is not permitted to consider in granting a remedy; and
(d) the circumstances in which someone who issues a non-compliant written demand is not be found liable in the Federal Court.
Role of prosecution history in claim construction
The Patent Act was amended to establish that the prosecution history of a Canadian patent may be relevant to claim construction. New section 53.1 of the act provides in part that:
In any action or proceeding respecting a patent, a written communication, or any part of such a communication, may be admitted into evidence to rebut any representation made by the patentee in the action or proceeding as to the construction of a claim in the patent if
(a) it is prepared in respect of:
(i) the prosecution of the application for the patent,
(ii) a disclaimer made in respect of the patent, or
(iii) a request for re-examination, or a re-examination proceeding, in respect of the patent; and
(b) it is between
(i) the applicant for the patent or the patentee; and
(ii) the Commissioner, an officer or employee of the patent office or a member of a re-examination board.
These provisions also apply to divisional applications filed after the relevant written communication was made in the parent application, to reissued patents and applications to reissue patents, and to CSPs.
These provisions apply in respect of any action or proceeding that had not been finally disposed of as of December 13, 2018.
For more detail, please read our previous article here.
Experimental use exception
New section 55.3 of the Patent Act enacts an exception from infringement for experimental use of patented technologies, providing that an act committed for the purpose of experimentation relating to the subject matter of a patent is not an infringement of the patent.
Regulations may be established in the future, concerning
(a) factors that the court may consider, must consider or is not permitted to consider in determining whether an act is, or is not, committed for the purpose of experimentation relating to the subject matter of a patent; and
(b) circumstances in which an act is, or is not, committed for the purpose of experimentation relating to the subject matter of a patent.
The experimental use exception from infringement also extends to infringement of a CSP issued for a patent. The new provisions apply in respect of any action or proceeding that has not been finally disposed of as of December 13, 2018.
Canadian courts have previously held that it is not an infringement to make or use a patented invention by way of experiment or testing only, without the intention to commercialise.
For more detail, please read our previous article here.
Prior user rights
Section 56 of the Patent Act concerning rights of prior users of patented technologies was amended.
Amended Section 56 applies to an action or proceeding in respect of a patent issued on the basis of an application whose filing date is on or after October 1, 1989 and that is commenced on or after October 29, 2018.
Unlike the predecessor provision, which limited prior user rights to the right to “use and sell to others the specific article, machine, manufacture or composition of matter patented and so purchased, constructed or acquired” before the claim
date (i.e. the priority date for a particular claim), the revised provision protects acts “that would otherwise constitute an infringement” if the act had been completed before the claim date, or if “serious and effective preparations
to commit such an act” were made before the claim date.
Having prior user rights apply to “an act that would otherwise constitute infringement” rather than a “specific article, machine, manufacture or composition
of matter” is significant, as it appears to clarify that prior user rights can be invoked for processes.
A “good faith” requirement and provisions providing that prior users cannot invoke the defence if they acquire the knowledge required to carry out the infringing act, directly or indirectly, from the patentee and know that the patentee is the source of the knowledge, have been added.
The new provisions also address the rights of purchasers of an article from a prior user, providing purchasers the rights to use and sell the article, and extending the exemption to the use of “an article that is substantially the same as the one used, for that use.” There are also exemptions for the use of a service or a service that is substantially the same as one previously used.
For more detail, please read our previous article here.
Standard-essential patents
New Section 52.1 of the Patent Act provides that a licensing commitment in respect of a standard-essential patent that binds the patentee, also binds any subsequent patentee (e.g. an assignee of the patent). The scope of what constitutes a “licensing commitment” or a “standard-essential patent” remains to be set by regulation. This provision applies in respect of any action or proceeding that had not been finally disposed of as of December 13, 2018.
For more detail, please read our previous article here.
IP licences in liquidation proceedings
In restructuring, IP licensees in good standing can continue to use the IP if the debtor disclaims the licence. The above-discussed Budget Implementation Act, 2018, No. 2 introduced amendments to the Bankruptcy and Insolvency Act and Companies’ Creditors Arrangement Act,which extend this right to liquidation proceedings. These amendments came into force the following year, on November 1, 2019.
Interesting patent cases
Apotex Inc v Eli Lilly and Company, 2018 FCA 217, aff’g 2014 FC 1254. The Federal Court of Appeal clarified that the objective of the non-infringing alternative defence “is to help ascertain the real value of inventions for which a patentee […] was granted a monopoly. […] Thus, the goal is not to enable an infringer to breach the bargain made on behalf of the Canadian public when a patent is issued. Nor is the defence a means by which one can infringe at the lowest possible cost.” The Court also held that a loss of interest must be proved in the same way as any other form of loss or damage.
2019
Legislation
Global harmonization
Canada ratified the Patent Law Treaty on July 30, 2019, which harmonizes several formal procedures in respect of national and regional patent applications and patents, aiming to make such procedures more user-friendly. Related amendments to Patent Act and Patent Rules came into force on October 30, 2019. Particularly significant changes include the following:
Late PCT national phase entry – For an application having a Patent Cooperation Treaty (PCT) international filing date on or after October 30, 2019, if the applicant fails to enter the national phase within 30 months from the earliest priority date, it is still possible to do this within 42 months of the priority date, but only upon submitting a request that the rights of the applicant be reinstated and a statement that the failure to meet the 30-month deadline was unintentional.
Restoration of priority – Restoration of priority will be available on an “unintentional” standard in Canadian patent applications filed on or after October 30, 2019, and in the Canadian national phase if the PCT international filing date is on or after October 30, 2019.
Certified copies of priority documents – Certified copies of priority documents must be filed (or made available from the WIPO Digital Access Service) in Canadian patent applications filed on or after October 30, 2019, or in the national phase of PCT applications having an international filing date on or after October 30, 2019 if a certified copy was not filed in the international phase.
24/7/365 filing – It is now possible to obtain a filing date on a weekend, holiday, or other day when the Patent Office is closed to the public, by filing the application electronically.
Maintenance fees – Anyone, not only Canadian patent agents, can now pay a maintenance fee on a pending application. If the original maintenance fee deadline is missed, the Patent Office will issue a late notice. The application will be abandoned if the missed maintenance fee and a late fee of CAD $150 are not paid within the later of two months from the late notice and six months from the original deadline. Reinstatement of an application abandoned for failure to pay a maintenance fee is possible only on a “due care” standard, and third party rights to practice the invention may arise. Similar provisions apply to maintenance fees payable on issued patents.
Examination request – If the examination request and fee are not submitted by the original deadline, the Patent Office will issue a late notice. If the examination request, examination fee, and a late fee are not submitted within two months from the date of the notice, the application will be abandoned. Reinstatement of an application abandoned for failure to request examination may only be possible on a “due care” standard, and third party rights to practice the invention may arise.
Shortened prosecution deadlines – The new Rules aim to reduce application pendency. The deadline for requesting examination is reduced from five years to four years from the filing date for an application with a filing date on or after October 30, 2019. The term for responding to an Examiner’s Report is reduced from six months to four, and the term for paying the final fee upon allowance is reduced from six months to four.
Amending an allowed application – The procedure for amending an allowed application has been simplified. Prosecution can be re-opened upon request for withdrawal of the notice of allowance and payment of a CAD $400 government fee prior to payment of the final fee. But if the application becomes abandoned for non-payment of the final fee and is subsequently reinstated, only limited amendments to correct “obvious” errors are permitted, and such an amendment must be submitted no later than when reinstating and paying the final fee.
Correction of errors – Under the new Rules, the broad general procedure for correcting clerical errors is replaced with a new regime establishing deadlines for correcting only particular errors. If a deadline for correcting an error is missed, correction may not be possible.
For more detail, please read our previous article here.
Interesting patent cases
Airbus Helicopters SAS v Bell Helicopter Textron Canada Limitée, 2019 FCA 29, aff’g 2017 FC 170. In the second phase of a bifurcated patent infringement case (for the first phase, see 2013 FCA 219, discussed above) about helicopter landing gear, the Federal Court of Appeal upheld an award of $1 million in punitive damages based on "deliberate and outrageous" conduct of the defendant in wilfully infringing the plaintiff's patent. The punitive damage award was particularly notable because it tripled the total damages award, the Federal Court having found that only C$500,000 should be awarded as compensatory damages based on a hypothetical royalty between the parties.
Canada (Attorney General) v Galderma Canada Inc, 2019 FCA 196, rev’g 2017 FC 1023. The Federal Court of Appeal granted the appeal of the PMPRB and returned to it the matter of whether the invention of Patent No. 2,478,237 – which the Court of Appeal found was the use of a 0.3% concentration of adapalene for the treatment of dermatological disorders – ‘pertained’ to Galderma’s DIFFERIN (0.1% adapalene). In determining whether “an invention pertains to the medicine”, the Court held that the phrases “rational connection or nexus” or “merest slender thread” cannot supplant the statutory language, which requires that “the invention is intended or capable of being used for the medicine.”
Aux Sable Liquid Products LP v JL Energy Transportation Inc, 2019 FC 581. The Federal Court found that claims to a gas mixture for use in a pipeline were invalid for “overbreadth” as an independent basis from sufficiency of disclosure, because they omitted essential limitations that were disclosed as part of the invention. The Court also held that a prior art reference which was disclosed to the public prior to the applicable date forms part of the prior art for purposes of an obviousness analysis, regardless of whether the reference would have been locatable through a reasonably diligent search.
Canmar Foods Ltd v TA Foods Ltd, 2019 FC 1233. The Federal Court held that representations made by a patentee during prosecution of a foreign patent application constituted admissible evidence under new section 53.1 of the Patent Act. The Court recognized that section 53.1 only specifies using Canadian prosecution file histories to rebut positions taken on claim construction and makes no reference to prosecution histories from other jurisdictions. Notwithstanding, the Court found that it could consider the U.S. Application prosecution history as part of a purposive construction of the claims in issue, based on the “extraordinary circumstances” identified by the Court in the case. This decision is under appeal.
Looking forward
2020 is off to a quick start, with further legislative amendments on the horizon.
USMCA
On December 10, 2019, Canada, the United States and Mexico signed the Protocol of Amendment to the Agreement between the United States of America, the United Mexican States and Canada, commonly referred to as the USMCA.
The USMCA specifies that a Party shall provide adjustment of the term of a patent to compensate for Patent Office delays in issuing patents. Patent term adjustment may accrue if a patent issues more than five years from the date the application is filed, or three years after examination is requested, whichever is later.
The United States has had such provisions in its patent laws for some 20 years, but patent term adjustment to compensate for Patent Office delay will be entirely new to Canadian patent law.
Canada must implement its obligations under this provision within 4.5 years of the date the USMCA enters into force.
Bill C-4 was introduced in the Canadian Parliament on January 29, 2020, a necessary step towards ratification of the USMCA.
For more detail, please read our previous article here.
Patented Medicines Regulations
Together with the Patent Act, the Patented Medicines Regulations provide the framework and authority by which the Government of Canada, through the Patented Medicine Prices Review Board (“PMPRB”), regulates the prices of patented medicines in Canada to avoid excessive prices. Amendments to the Patented Medicines Regulations will come into force on July 1, 2020. Noteworthy changes include:
For drugs that received marketing approval (i.e., that have been assigned a Drug Identification Number, or “DIN”) before August 21, 2019 or on or after August 21, 2019,
- An updated list of reference countries, notably excluding the United States and Switzerland;
- Reporting of price and revenue net of adjustments including third party price rebates; and
- Reduced reporting requirements for drugs considered at low risk of excessive pricing.
In addition, for drugs that received a DIN on or after August 21, 2019 only,
- Three new price regulatory factors: pharmacoeconomic value, market size, and gross domestic product (GDP) in Canada and GDP per capita in Canada; and
- Added reporting requirements relating to the new price regulatory factors.
For more detail, please read our previous articles here, here and here.
The amendments to the Patented Medicines Regulations have been the subject of two court challenges launched by groups of innovative pharmaceutical companies (22 companies in total), one in the Quebec Superior Court and the other in the Federal Court. For more detail, please read our previous article here.
For more information, please contact a member of our patents groups.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.