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Pharma in Brief: The 2019 Year in Review

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

Ontario reduces restrictions on ordinary commercial term benefits and private label products

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

Amended CUSMA no longer extends data protection for biologics

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
Continue Reading

PMPRB extends consultation on new Draft Guidelines implementing amendments to the Patented Medicines Regulations

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.

Background

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.

Consultation update

According to a December 10, … Continue Reading

Federal Court refuses to allow fifth generic to join common trial on validity

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).

Background

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

PMPRB launches 60-day consultation on new Draft Guidelines following amendments to the Patented Medicines Regulations

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.

Background

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

Apotex held to induce infringement in one of the last applications under the old PM(NOC) Regulations

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

Federal Court of Appeal applies holistic approach to the “palpable and overriding error” standard of review

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.

Background

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

Ontario consults on changes to streamline drug formulary listing and reduce government payments to pharmacies

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
Continue Reading

Federal Court rejects the concept of “first mover advantage” for generics in PM(NOC) infringement actions

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

Stockpiling generic manufacturers may be liable for direct infringement of “composition for a use” claims

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.

Background

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

Federal Court refuses to permit reply evidence on validity issues in action under the PM(NOC) Regulations

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.

Background

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

Government releases final amendments to the PMPRB’s Patented Medicines Regulations to lower the prices of patented medicines

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

Competition Bureau issues statement regarding off-label use of vaccines

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

Health Canada consulting on clinical trial requirements and “new class” of advanced therapeutic products

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.

Background

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 consulting on draft guidance distinguishing promotional and non-promotional activities for health products

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.

Background

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

Federal Court of Appeal agrees that the PMPRB incorrectly applied the patent-pertaining analysis

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.

Background

This case concerns Canadian Patent No. 2,478,237 (the 237 Patent), which relates to … Continue Reading

Patent Act Infringement Actions Cannot be Joined to PM(NOC) Infringement Actions During NOC Prohibition Period

The Federal Court recently confirmed that an infringement action under the Patent Act cannot be joined with an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations) while the Regulations prohibit the Minister from granting a NOC. The Court stated that an infringement action under the Patent Act could instead be brought in a separate proceeding.

With cooperation between the parties and simultaneous scheduling of the trial of common issues, separate Patent Act and Regulations infringement proceedings could proceed efficiently without formal joinder. The Court’s position is consistent with its recent decision in Bayer Inc. v Continue Reading

Health Canada proposes updates relating to sale of unapproved drugs for emergency treatment

Amendments have been proposed to the Food and Drug Regulations that relate to the sale of drugs that have not been approved in Canada for emergency treatment. These amendments update the Special Access Program (SAP) and create a mechanism whereby drugs can be purchased for immediate use or stockpiled for public health or Canadian Armed Forces (CAF) emergencies.

I.  Changes to the SAP

The proposed amendments are intended to streamline the application process for practitioners in respect of previously approved drugs and clarify when a manufacturer can have an unapproved drug warehoused in Canada in advance … Continue Reading

CUSMA Implementation Bill Introduced

On May 29, 2019, the federal government introduced Bill C‑100 to implement the new trilateral trade deal known as the Canada-United States-Mexico Agreement (CUSMA, also referred to as USMCA), making Canada the first of the three member countries to introduce legislation that would ratify the treaty.

CUSMA provides more protections for biologic and innovative pharmaceuticals under Canadian law. However, the treaty does not require the immediate adoption of these new protections and none of them are directly implemented by Bill C‑100.

As we reported, full implementation of CUSMA will require Canadian law to include:

  • Extended data protection
Continue Reading

Quebec Court of Appeal confirms CPA does not apply to the sale of prescription drugs

In a May 8 decision, the Quebec Court of Appeal confirmed that the Quebec Consumer Protection Act (CPA) does not apply to the sale of prescription drugs. The decision, Brousseau v Laboratoires Abbott limitée, 2019 QCCA 801 provides critical guidance on the liability regime in Quebec for manufacturers of pharmaceutical products facing product liability claims.

A French version of this post follows.

Relevant facts

Abbott Laboratories manufactured a drug commercialized under the name Biaxin®. Abbott was named as a defendant in a class action where the plaintiff alleged the use of the drug causes side effects that had not … Continue Reading

Federal Court of Appeal affirms cancellation of reconsideration of ANDS for Apo-omeprazole

The Federal Court of Appeal has dismissed an appeal by Apotex Inc. (Apotex) in its unsuccessful application for judicial review of a decision by the Minister of Health (the Minister) to cancel the reconsideration of approval for Apo-omeprazole.

Background

As we reported, the Minister revoked Apotex’s Notice of Compliance (NOC) for Apo-omeprazole and declined to issue the NOC again in 2013 due to inadequate evidence of bioequivalence in its Abbreviated New Drug Submission. Apotex sought reconsideration of the Minister’s decision by an external expert panel on the basis of safety and efficacy. The Minister … Continue Reading

Proposed amendments to Food and Drugs Act introduced in omnibus budget bill

The federal government has proposed changes to the Food and Drugs Act (FDA) that would allow the Minister of Health (Minister) to classify products as foods, drugs, cosmetics, devices, or “advanced therapeutic products”; require authorizations to conduct clinical trials; and modify Health Canada’s inspection powers.

These changes are included in an omnibus budget bill, the Budget Implementation Act, 2019, No 1 (Bill C-97). Bill C-97 was introduced and received its first reading in the House of Commons on April 8, 2019. Second reading in the House commenced on April 10, 2019.

Classification of productsContinue Reading

Regulatory changes for generics proposed to clarify ANDS pathway eligibility

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.

The proposed amendments follow a consultation on … Continue Reading

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