On March 30, 2019, the government published proposed amendments to the Food and Drug Regulations (FDR) intended to clarify whether a generic version of a drug can be approved using the abbreviated new drug submission (ANDS) pathway. These amendments affect how the FDR apply to a generic drug product if it contains a different medicinal ingredient than the Canadian reference product (CRP), but the same therapeutically active component. They also include changes to (i) labelling requirements and (ii) data protection eligibility for variations of previously-approved medicinal ingredients.
On March 8, 2019, the Federal Court issued a prohibition order against a generic version of GLUMETZA® (metformin hydrochloride extended-release tablets) proposed by Generic Partners Canada Inc. (Generic Partners) in an application under the pre-CETA Patented Medicines (Notice of Compliance) Regulations. GLUMETZA® is marketed in Canada by Valeant Canada LP/Valeant Canada SEC (Valeant), which asserted Canadian Patent No. 2,412,671 (671 Patent) against Generic Partners in the proceeding.
671 Patent and its Claims
The 671 Patent relates to oral water-swellable oral dosage forms for drugs (e.g., metformin) that may benefit … Continue Reading
On March 13, the Competition Bureau published a revised version of its IP Enforcement Guidelines (IPEGs). The IPEGs clarify the Bureau’s approach to conducting investigations of alleged anti-competitive activities that involve IP, including settlement of pharmaceutical patent litigation under the Patented Medicines (Notice of Compliance) Regulations (Regulations).
The revised IPEGs replace the earlier 2016 version. Sections 7.2 and 7.3 include a detailed explanation of the Bureau’s approach to litigation settlements under the Regulations, which can be summarized as follows:
- Entry-split agreements. An entry-split settlement pursuant to which the generic firm enters the market on or
The Federal Court of Appeal (“FCA”) upheld the validity of Canadian Patent 2,436,668 (“668 Patent”) which covers Form I ODV succinate (marketed as PRISTIQ) in two separate appeals by Apotex Inc. (“Apotex”) and Teva Canada Ltd (“Teva”), finding that the claims were novel and inventive.
The FCA began be reiterating key points of the obviousness analysis:
- The Sanofi test is flexible and expansive and can include consideration of the invention story as a whole;
- The “obvious to try” test is only one part of the obviousness analysis and does not displace
Last year ushered in a number of changes to the Canadian pharmaceutical and life sciences sector. 2018 also served as a year to explore the impacts of major intellectual property decisions and regulatory changes from 2017 including the impact of the Supreme Court’s decision in NEXIUM striking down the Promise Doctrine and the implementation of CETA on single-track patent litigation under the newly amended Patented Medicines (Notice of Compliance) Regulations. Further, a number of IP and regulatory developments arose, such as: the potential for a national pharmacare program, advances to the self-care products framework for non-prescription drugs, natural health … Continue Reading
The Federal Court of Appeal (“FCA”) confirmed that in assessing the availability of a non-infringing alternative (“NIA”) defence, the NIA must be legal and cannot infringe any patent, and its economic viability must be considered objectively. The FCA upheld an award for damages for patent infringement by the Federal Court (“FC”) but remitted the issue of prejudgment interest back for redetermination.
This case arises from a dispute between Apotex Inc. (“Apotex”) and Eli Lilly and Company and Eli Lilly Canada Inc. (together, “Lilly”) regarding eight of Lilly’s process patents … Continue Reading
Canada’s core IP statutes have been amended by Bill C-86, which received Royal Assent as the Budget Implementation Act, 2018, No. 2, SC 2018, c 27 on December 14, 2018. The final version of the legislation includes amendments to the Patent Act that are substantially identical to the version that received first reading 46 days ago, on October 29, 2018. The patent-law changes in Bill C-86 are not specifically directed at pharmaceutical patentees, but have the potential to affect this area of litigation.
As we reported following first reading, the changes to the Patent Act include:
- Patent prosecution history
The Federal Court has ordered that the trial of two actions brought under the post-CETA Patented Medicines (Notice of Compliance) Regulations (the Regulations), against two separate generics, be heard concurrently, on issues of invalidity. This decision highlights the Federal Court’s push to streamline section 6 actions. The court rejected the defendant Taro’s arguments that the common hearing of issues reduces the likelihood that Taro will benefit from any “first to market” advantage.
Taro and Apotex are both seeking to market a generic version of Biogen’s FAMPYRA (fampidrine) product in Canada. Both generics served Notices of Allegations (… Continue Reading
This decision of the Ontario Court of Appeal (ONCA) arises in the context of a novel action brought by Apotex seeking damages for the delayed market entry of its generic version of Sanofi’s blockbuster ramipril drug.
Apotex’s claims in this action are linked to the invalidity of Canadian Patent No. 1,341,206 (206 Patent). The 206 Patent had previously been invalidated based on the application of the “promise doctrine”. In June 2017, the Supreme Court of Canada (SCC) held that the invocation of the “promise doctrine” was an error in law and abolished the doctrine … Continue Reading
The Ontario Superior Court of Justice (ONSC) recently denied Apotex’s attempt to repackage the now defunct “promise of the patent” doctrine (the Promise Doctrine). Apotex sought to amend its pleadings to reintroduce the Promise Doctrine under the guise of invalidity allegations of over-breadth, insufficiency, and willful misrepresentation pursuant to sections 27 and 53 of the Patent Act.
The motion was heard in the broader context of the quantum phase of an action for damages by Apotex pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations). Abbott and Takeda counterclaimed for … Continue Reading
The federal government’s recent omnibus budget bill, Bill C-86 tabled October 29th, 2018, proposes significant changes to Canada’s IP laws. Division 7 of the Bill is intended to implement many aspects of the government’s IP strategy, announced in April 2018. The Bill targets the Patent Act, the Trade-marks Act, and Copyright Act; provides for a new College of Patent Agents and Trade-mark Agents Act; and effects changes to diverse legislative schemes impacting the IP regime, including privacy and bankruptcy.
Below, we have outlined some of the most significant changes likely to affect the patent-intensive … Continue Reading
As we reported, Canada has joined a new trilateral trade deal called the United States-Mexico-Canada Agreement (USMCA). The USMCA contains important new protections for biologic and other pharmaceutical innovation. Chief among them, Canada will introduce an extended ten-year period of data protection for biologics and patent-term restoration (PTR) for delays in the patent office.
The USMCA, which replaces the North American Free Trade Agreement (NAFTA), will come into force after it has been signed and ratified by the member states. It is anticipated that the USMCA will be signed before the end of … Continue Reading
On July 6, 2018, the Federal Court dismissed the first motion brought under section 6.08 of the newly-amended Patented Medicines (Notice of Compliance) Regulations (the Regulations). The Court’s public reasons were released July 30, 2018. The moving party, Amgen Canada Inc. (Amgen), was seeking an order dismissing the Plaintiffs’ action in respect of two of the patents in suit on the ground that the action is redundant, scandalous, frivolous or vexatious or is otherwise an abuse of process. Amgen contended that it was plain and obvious that the Plaintiffs’ infringement allegations had no chance of success.
Norton … Continue Reading
As we reported, Canada implemented a single-track pharmaceutical patent litigation regime through amendments to the Patented Medicines (Notice of Compliance) Regulations (the Regulations) on September 21, 2017. Below, we provide an update on new actions and decisions under the amended Regulations.
New actions under the amended Regulations
Nearly seven months after the amended Regulations came into force, litigation is gathering steam. As we reported, the first action under the new regime was commenced by Norton Rose Fulbright Canada LLP on behalf of Genentech, Inc. and Hoffmann-La Roche Limited (collectively, Genentech) in respect of trastuzumab biosimilars on … Continue Reading
The Federal Court dismissed Apotex’s motion to re-open the validity phase of the patent infringement action relating to esomeprazole (AstraZeneca’s NEXIUM®). Apotex had moved to re-open validity to allow the Court to adjudicate the issue of “overpromising” in light of the Supreme Court of Canada’s decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 , which related to the same patent.
As we reported, the only issue before the SCC was utility. The court allowed AstraZeneca’s appeal and struck down the Promise Doctrine as an error of law. After the SCC released its decision, … Continue Reading
As we reported, Abbott Laboratories Limited, Takeda Pharmaceuticals Company Limited and Takeda Pharmaceuticals America Inc. sought dismissal of Apotex’s action for s. 8 damages in the Ontario Superior Court by summary judgment. The Ontario Court of Appeal (ONCA) affirmed the lower court’s finding that a real-world notice of non-compliance – withdrawal (NON-W) issued by Health Canada did not operate to void the patent hold letter ab initio. The ONCA held it was open to the motions judge to accept “essentially unrefuted” expert evidence that in the hypothetical but-for world Health Canada would have issued … Continue Reading
On redetermination of an accounting of profits, the Federal Court (FC) rejected Apotex’s claim that the profits awarded to Servier due to Apotex’s manufacture and sale of infringing perindopril should be reduced based on alleged non-infringing alternatives (NIAs).
In 2008, the FC found that Servier’s patent claiming perindopril was valid and infringed by Apotex, and subsequently ordered Apotex to pay a combined total of $CAD 61 million plus interest, representing Apotex’s profits from its Canadian and export sales. Among other things, the trial judge rejected Apotex’s defence that it could and would have sold non-infringing … Continue Reading
The Federal Court of Appeal (FCA) has refused to apply the “special circumstances” exception to issue estoppel in view of a change in law arising from the rejection of the “promise doctrine” in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 (NEXIUM, reported here). Noting any injustice to Lilly is “entirely commercial in nature” as well as a concern of Teva being ‟twice vexed,” the court rejected Lilly’s argument that the NEXIUM decision should be considered as a factor in determining damages pursuant to section 8 of the Regulations.
Teva sought damages … Continue Reading
As we reported, on September 21, 2017 the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act and accompanying regulations came into force. The legislation provided key reforms to the Patent Act affecting the pharmaceutical industry, including up to two years of patent term restoration for patented pharmaceuticals under the Certificate of Supplementary Protection Regulations (CSP).
The protection given under a CSP is intended to “partly compensate for time spent in research and obtaining marketing authorization.” A CSP provides “patent-like rights” that take effect after patent expiry, and is subject to the “same limitations and exceptions” as … Continue Reading
The Federal Court denied Apotex’s section 8 claim relating to esomeprazole on the basis that its product would have infringed a valid AstraZeneca patent. This aligns with a previous decision of the court that placed significant weight on patent infringement in the context of section 8 damages (reported here). There was no dispute that Apotex’s Apo-esomeprazole product infringed, and the court’s interpretation of the Supreme Court of Canada’s (SCC) decision in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 that the same patent was valid was central to the decision.
Following the Federal Court’s decision that Bayer’s patent relating to YAZ and YASMIN (both containing drospirenone and ethinyl estradiol) was valid and infringed by Apotex and Cobalt, Apotex argued that it, rather than Bayer, should be entitled to elect between damages and an accounting of profits. As we reported, the court disagreed, and ordered that Bayer has the right to elect.
Apotex appealed and asked that the court choose an accounting of profits. The Federal Court of Appeal (FCA) dismissed Apotex’s appeal, finding that the Federal Court did not err in its interpretation of the Patent Act… Continue Reading
As we reported, Federal Court jurisprudence is being continually reshaped by the Supreme Court’s decision in AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36 (NEXIUM Decision). In Apotex v. Schering Corporation, 2018 ONSC 903, the Ontario Superior Court has now considered the impact of the NEXIUM Decision in the context of Apotex’s action for damages against Schering relating to ramipril.
This action arises from Apotex’s success both in litigation under the Patented Medicines (Notice of Compliance) Regulations (Regulations) and in a subsequent action to impeach Schering’s patent relating to ramipril (… Continue Reading
Happy New Year from Pharma in Brief!
Reflecting back on 2017, the only constant over the last year was change, with the implementation of CETA, the rejection of the Promise Doctrine and proposals for reform of various regulatory regimes. We have compiled our list of top headlines below.
- Major changes to regulatory framework for pharmaceutical industry. The implementation of the Comprehensive Economic and Trade Agreement Act on September 21, 2017 brought two major changes to industry: a single-track pharmaceutical patent litigation regime under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC)) and up to two years of patent
The Federal Court of Appeal has reaffirmed the constitutionality of the excessive price provisions of the Patent Act that ground the jurisdiction of the Patented Medicine Prices Review Board (PMPRB) over patented medicines.
In 2015, the PMPRB commenced a proceeding against Alexion alleging that the price of Alexion’s drug SOLIRIS® (eculizumab) was excessive. In response, Alexion brought a judicial review in the Federal Court seeking a declaration that the excessive price provisions of the Patent Act were unconstitutional.