The public health call for social distancing to help curb the COVID-19 pandemic has no doubt already affected how companies will be sharing information about pharmaceuticals and other licensed health products with healthcare professionals (HCPs), patients, and the public. As industry plays its part in keeping sales representatives and medical science liaisons (MSLs) home to help “flatten the curve”, many interactions between HCPs and companies are moving to the virtual world. At the same time, HCPs will look to the industry to provide timely and accurate information through their medical teams or patient support programs (PSPs) about how to manage … Continue Reading
On March 13, 2020, the Government passed Bill C-4 to implement the Canada-United States-Mexico Agreement (CUSMA). Canada will be the third and final party to ratify the treaty.
The Bill, sponsored by Deputy Prime Minister Freeland, was introduced on January 29, 2020. The Bill was recently expedited in order to ensure that it passed before both Houses adjourned at the end of the week over concerns regarding the spread of COVID-19.
In light of recent developments relating to the to the 2019 novel coronavirus (COVID-19), Health Canada recently sent a reminder to all Drug Establishment License (DEL) holders of their obligations under the Food and Drug Regulations (FDR) regarding reporting of events that could affect operations and lead to shortages or issues affecting quality, safety, and efficacy of products.
The bulletin reminded DEL holders of their obligations to notify or report to Health Canada any events that could have an impact on pharmaceutical operations. Specifically, a DEL holder should notify Health Canada within 15 days if an event occurs that could … Continue Reading
The Federal Court has invalidated Health Canada’s decision to disclose records pertaining to a veterinary pharmaceutical product, Fortekor Flavour Tabs (Fortekor), pursuant to the Access to Information Act (the Act). Health Canada defended its decision on the basis that the information contained in the records was “part of public domain information”. On judicial review, the Court agreed with the applicant, Elanco Canada Limited (Elanco), that Health Canada’s argument was based on unsubstantiated information, relating to different medications, with different compounds, in different jurisdictions.
Through the veterinary drug submission process, Elanco provided Health Canada with … Continue Reading
The Federal Court granted leave to the United States of America (USA), in its capacity as co-owner of a patent, to file its own pleading in an action under s 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations). The USA was permitted to respond to the defendant’s (Apotex Inc.) allegations of invalidity, including by making new and different allegations than those made by the plaintiff.
This decision arose in the context of Allergan Inc.’s (Allergan) action against Apotex under s 6(1) of the PM(NOC) Regulations concerning ulipristal acetate. Allergan licenses … Continue Reading
On December 18, 2019, Health Canada published a new Guidance Document Software as a Medical Device (SaMD): Definition and Classification (Guidance Document). The Guidance Document explains what products would be regulated as SaMD under the Food and Drugs Act (Act) and the Medical Devices Regulations (Regulations) as well as information on classification of SaMD.
What Constitutes SaMD
Not all software falls within the scope of the Act and Regulations. The Guidance Document provides current interpretations of what constitutes a “device” or “medical device” in the Act and Regulations (including by reference to the definition … Continue Reading
In this article, the Pharma in Brief team curated the most significant topics we covered during 2019.
The Canadian pharma and life sciences space saw many developments in 2019. These included major policy initiatives and regulatory changes affecting the industry, driven in part by three high-profile federal objectives: lowering drug prices to move towards national pharmacare, replacing the North American Free Trade Agreement (NAFTA), and changes to drug approval pathways.
There were few pharmaceutical patent decisions released in 2019 but plenty of activity in the Courts, as the first actions under the new Patented Medicines (Notice of Compliance) … Continue Reading
The Ontario Ministry of Health and Long-Term Care (the Ministry) introduced changes to regulations (collectively, the Regulations) made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). These changes will remove the financial caps on ordinary commercial term (OCT) payments made by drug manufacturers to pharmacies and allow private label products to be listed as benefits or be designated as “interchangeable”. The amendments to the Regulations come into force on January 1, 2020.
Removal of OCT benefit financial cap
OCT benefits are payments made between … Continue Reading
On December 10, 2019, Canada, the United States, and Mexico agreed to amend the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA) as the trade agreement proceeds toward ratification in each country. Among other changes, the amended CUSMA no longer requires Canada to extend data protection for biologics to 10 years from the 8 years currently provided under Canadian law.
Changes to the CUSMA
As we reported, the previous version of CUSMA required two notable changes to Canadian law concerning pharmaceuticals and biologics:
- Extended data protection for biologics. CUSMA previously required Canada to provide a
The Patented Medicine Prices Review aboard (PMPRB) has extended the deadline for written submissions on new Draft Guidelines until January 31, 2020. Originally, the consultation was scheduled to run until January 20, 2020.
As we reported, the Board proposed Draft Guidelines to replace its existing price-review practices, including the Compendium of Policies, Guidelines and Procedures. The changes are intended to implement the recent amendments to the Patented Medicines Regulations, which come into force on July 1, 2020. The PMPRB released the Draft Guidelines on November 21, 2019.
According to a December 10, … Continue Reading
The Federal Court dismissed Pharmascience Inc.’s (Pharmascience) motion to determine a question of law on the issue of whether a first person can commence an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) for a drug for which there are no patents listed on the patent register. The Court held that the facts required to determine the motion were contested so answering the question of law would not determine the dispute as between the parties. It also stated that, in the context of the PM(NOC) Regulations, such motions may … Continue Reading
The Federal Court has denied a motion by Dr. Reddy’s Laboratories’ (Dr. Reddy’s) seeking to participate in a common validity issues trial in actions concerning four other generic versions of the same drug under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations).
As we reported, the Federal Court has made a number of orders concerning common validity trials in actions commenced by Bayer Inc. (Bayer) under the PM(NOC) Regulations in respect of generic versions of XARELTO (rivaroxaban). The common validity issues in these earlier actions against Apotex Inc., Teva Canada Limited, … Continue Reading
Today, the PMPRB launched a consultation on Draft Guidelines intended to implement recent amendments to the Patented Medicines Regulations. The PMPRB also released a Q&A-style Consultation Backgrounder. Interested parties have 60 days, until January 20, 2020, to make submissions on the Draft Guidelines.
As we reported, the Government released final amendments to the Patented Medicines Regulations on August 9, 2019. These amendments are scheduled to come into force on July 1, 2020 and are intended to lower the prices of patented medicines in Canada. They include: (1) new factors for assessing excessive pricing, (2) new … Continue Reading
The Federal Court has granted an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex Inc. for a generic version of ZYTIGA (abiraterone acetate). It held that the use of the combination of abiraterone acetate and prednisone claimed by Janssen Inc.’s patent was patentable subject matter, and that the patent’s claims were non-obvious and possessed at least a scintilla of demonstrated utility. The Court also held that Apotex would induce infringement of Janssen’s patent with the product monograph for its proposed generic. This will likely be one of the last cases decided under the pre-September … Continue Reading
The Federal Court of Appeal has provided a detailed review of the proper approach to identifying palpable and overriding errors of fact or mixed fact and law in an appeal concerning the obviousness of two patents. The Court of Appeal concluded that when viewed as a whole, there was no reviewable error in the judgment and dismissed the appeal.
The underlying action concerned a claim by Teva Canada Limited (Teva) for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations) concerning a generic version of VELCADE (bortezomib). The defendants, Janssen Inc. … Continue Reading
The Ontario Ministry of Health and Long-Term Care (the Ministry) has proposed draft amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Ontario Drug Interchangeability and Dispensing Fee Act. The proposed changes are intended to reduce technical requirements for listing a product on the Ontario formulary and align policies with industry standards and other provinces. The consultation period will close on November 27, 2019.
The proposed changes
Key changes to the Regulations include:
- Remove the requirement for the Drug Notification Form (DNF) from formulary drug submissions. A DNF is a form submitted
The Federal Court has ordered that two additional generic defendants (Taro Pharmaceuticals Inc., Sandoz Canada Inc.) be added to a trial of common issues currently set for Bayer Inc.’s claims against Teva Canada Limited and Apotex Inc. concerning generic versions of XARELTO® (rivaroxaban) under the Patented Medicines (Notice of Compliance) Regulations (the Regulations).
All four proceedings are patent infringement actions brought by Bayer under the Regulations. The actions were launched in response to each defendant’s Notice of Allegation (NOA) for their respective generic versions of XARELTO® and one or more Bayer patents.
Earlier this … Continue Reading
The Federal Court has found that it is reasonably arguable that a claim for “a composition for use in the treatment of a disorder” may be directly infringed through the importation, manufacture and stockpiling of the composition. The Court distinguished these claims from pure “use of a composition for a treatment” claims, which can only be infringed by a generic manufacturer through inducing infringement.
The Court’s decision concerns a pleadings amendment motion by Eli Lilly Canada Inc. and its co-plaintiffs (collectively, Lilly) in patent infringement actions against: (1) Apotex Inc.; (2) Mylan Pharmaceuticals ULC; (3) Teva Canada Limited; … Continue Reading
On a motion for leave to file reply expert reports, the Federal Court has reinforced the rule against case splitting and outlined the circumstances under which reply expert reports are permissible under the Federal Courts Rules. The Court concluded that none of the proposed reply reports put forward by Teva Canada Limited (Teva) in respect of patent validity issues were proper and dismissed the motion.
This motion arose in the context of an action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, relating to the drug INVEGA SUSTENNA (paliperidone). The plaintiffs, … Continue Reading
The Government is moving forward with changes to the PMPRB intended to lower the prices of patented medicines in Canada in order to lay the foundation for National Pharmacare. The changes are set out in final amendments to the Patented Medicines Regulations that were released on Friday, August 9, 2019. The amendments will come into force on July 1, 2020.
Once the amendments come into force, the PMPRB will use a different basket of price comparator countries. Significantly, the new basket excludes the US. The PMPRB will also consider new pharmacoeconomic market size, and gross domestic product (GDP)-based … Continue Reading
The Competition Bureau (Bureau) recently conducted a preliminary investigation into possible competition concerns arising from a proposal to include a clause in a procurement contract that would restrict off-label use of a vaccine. The Bureau concluded that there was no abuse of dominance as the provision was not included in the procurement contract; however, it issued a statement providing guidance on off-label use of vaccinations.
After outlining vaccine approval and reimbursement, and administration of immunization programs in Canada, the statement indicates that, while manufacturers are prohibited from selling or advertising vaccines for off-label use, off-label use can and … Continue Reading
As we reported, the Budget Implementation Act, 2019 (BIA) paved the way for changes to the regulation of clinical trials and created a new class of “advanced therapeutic products” (ATPs) regulated by Health Canada. Health Canada is consulting on what it should consider in developing regulations for clinical trials and implementing the approval pathway for ATPs until August 30, 2019.
The BIA received Royal Assent on June 21, 2019. The changes to clinical trial regulation will come into force once new regulations are developed and implemented. While the ATP provisions from the BIA are … Continue Reading
Health Canada is consulting on a draft guidance document entitled The Distinction Between Promotional and Non-promotional Messages and Activities for Health Products (Draft Guidance), which is intended to replace the current 1996 policy entitled The Distinction Between Advertising and Other Activities (Current Policy). Copies of the Draft Guidance are available from Health Canada on request; comments can be submitted until September 3, 2019.
As with the Current Policy, the Draft Guidance is intended to outline the factors that contribute to rendering a message or activity non-promotional, in order to determine if it is subject … Continue Reading
The Federal Court of Appeal has provided new guidance on the proper approach to the “patent pertaining” analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the invention of the patent, in a case concerning Differin®. Having provided this guidance, the Court of Appeal set aside the judgment under appeal and remanded the final determination of whether or not the patent in question pertains to Differin® to the Board.
This case concerns Canadian Patent No. 2,478,237 (the 237 Patent), which relates to … Continue Reading