Federal Court of Appeal affirms that the Patent Act’s price control provisions over patented medicines were validly enacted

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.

Background

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.

Alexion’s judicial review application was struck on a motion by the Attorney General on the grounds that the Federal Court of Appeal had already ruled that the excessive price provisions were constitutional in the Sandoz decision.  The Federal Court upheld the decision.  Alexion appealed to the Federal Court of Appeal.

Sandoz is dispositive of the constitutional issue

The Court of Appeal held that the Sandoz Court found the relevant portions of the Patent Act had been validly enacted by Parliament: the price control provisions are within Parliament’s jurisdiction under subsection 91(22) of the Constitution Act, 1867 (“Patents of Invention and Discovery”) and do not impermissibly intrude on provincial authority under subsection 92(13) (“Property and Civil Rights in the Province”).  Although the Sandoz Court addressed whether the price control provisions validly applied to non-patent holders or owners, the Court first addressed the question of whether the provisions were constitutionally supported as they applied to patent-holders.  Thus, Alexion’s constitutional challenge had already been decided on the basis of stare decisis.

Links to Decisions:

Supreme Court dismisses leave to appeal on damages against Health Canada for Apo-Trazodone

On December 14, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal the decision finding that Health Canada does not owe a duty of care to drug manufacturers in reviewing drug submissions.

Case: Apotex Inc v Canada (Minister of Health) (SCC Docket: 37593)

Drug: Apo-Trazodone

Nature of case: Application for leave to appeal related to action for damages in tort and breach of contract

Appellant: Apotex Inc.

Respondent: Her Majesty the Queen

Date of decision: December 14, 2017

Federal Court of Appeal decision

As we reported, the Federal Court of Appeal (FCA) allowed Apotex’s appeal, in part, from the Federal Court decision that found Apotex was entitled to damages for misfeasance of public office based on Health Canada’s review of Apotex’s drug submission for Apo-Trazodone.

The FCA, however, dismissed Apotex’s claim that the Federal Court erred in failing to conduct an analysis of negligence outside of Health Canada’s liability arising from the settlement agreement between the parties. The FCA found that Health Canada does not owe a prima facie duty of care to Apotex, or any other drug manufacturer, since this duty would conflict with the intent of the Food and Drugs Act and Regulations, which is directed to public health and safety through regulation of drug manufacturers.

Links:

CETA tracker: First CETA PM(NOC) action has been commenced in Federal Court

The first court action under the newly amended Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) was commenced on December 11, 2017.  Genentech, Inc. and Hoffmann-La Roche Limited v Amgen Canada Inc. (T-1921-17) addresses allegations of infringement with respect to Canadian Patent Nos. 2,376,596; 2,596,133; 2,407,556 and 2,540,547 and a biosimilar new drug submission for trastuzumab.  Trastuzumab is marketed by Hoffmann-La Roche Limited under the brand name PrHERCEPTIN®.

Norton Rose Fulbright Canada LLP is representing the innovator plaintiffs.

Background

As we reported, the Canada–European Union Comprehensive Economic and Trade Agreement Implementation Act (CETA Act) and accompanying regulations came into force on September 21, 2017.  The CETA amendments provide key reforms to the Patent Act affecting the pharmaceutical industry, including a new pharmaceutical patent litigation regime under the PM(NOC) Regulations.  Proceedings previously conducted as summary applications will now proceed as actions while the confines of the 24-month statutory stay remain unchanged.

The new PM(NOC) Regulations apply to matters where a notice of allegation is served on or after September 21, 2017.

Link:

Are you CETA ready? Contact Norton Rose Fulbright with all your CETA questions

Ontario legislation requiring disclosure of payments to physicians receives Royal Assent

On December 12, 2017, Bill 160 passed third reading and received Royal Assent.  Included in Bill 160 is the Health Sector Payment Transparency Act (the “Act”). This Act will come into force at a later date to be determined by the government.

The stated purpose of the Act is to require the reporting of information about financial relationships in the Ontario healthcare system.  It enables the collection, analysis and publication of that information in order to increase transparency, provide patients with information that may assist in making healthcare decisions, and provide information for research, evaluation, planning and policy analysis.  The Act provides for broad reporting obligations, and many details (discussed further below) are left to be prescribed by regulation, copies of which are not yet available.

As we reported, Bill 160 was introduced on September 27, 2017.  As we also reported, it was referred to committee where consultation occurred.  The only change made to the Act since it was introduced is a change to the definition of “personal information” which now excludes personal health information.  The Act provides that the Minister may collect personal information, which now excludes personal health information as defined in the Personal Health Information Protection Act.

Summary of the Act

The Act provides for the reporting of transfers of value.

What must be reported? 

Any transfer of value provided directly or indirectly by a “payor” to a “recipient” must be reported to the Minister unless the transfer is exempt by regulations, due to a low dollar value or otherwise.  If required by the Minister, intermediaries or affiliates involved in the transaction may also be required to report transfers.

Who is a Payor?

Payor is defined as any person who provides a transfer of value to a recipient and is:

  • a manufacturer selling a medical product (drug, device, or any other prescribed product) whether under its own name or a name or mark that is owned or controlled by it;
  • a person who fabricates, produces, processes, assembles, packages, or labels a medical product on behalf of a manufacturer;
  • a wholesaler, distributor, importer, or broker of a medical product;
  • a marketing firm or person who markets or promotes a medical product;
  • a person who organizes continuing education on behalf of a manufacturer; or
  • a person otherwise prescribed in regulation.

Who is a Recipient?

A recipient is a person, prescribed by regulation, who receives a transfer of value.  As we noted above, regulations are not yet available and the types of persons who will be considered recipients remains unknown.

What information must be reported?

The following information must be reported:

  • the name and address of each party to the transaction (party includes the payor, the recipient, and any intermediary);
  • the source of the transfer if it is reported by an intermediary or affiliate;
  • the date of the transfer;
  • the dollar value or, in the case of non-monetary transfers, the approximate dollar value;
  • a description of the transfer including the reason for it; and
  • any other prescribed information.

The payor is responsible for collecting any necessary information from the recipient in order to report to the Minister.

How must transfers of value be reported?

This has yet to be announced.  The frequency and method of reporting are to be prescribed by regulation, and records must be kept for a length of time to be prescribed by regulation.

What will the Government do with the Information? 

The Act provides that the Minister shall disclose the information (including personal information) on a website, analyse the information and, if appropriate, publish the result of any analysis.

How will it be Enforced?

The Act provides for enforcement and offences including considerable inspection powers that would allow inspectors to enter premises without a warrant at any reasonable time should they believe that a record relating to a transaction may be located there in order to determine compliance.

If the Minister or an inspector has grounds to believe that a person has failed to comply with the Act or regulations, they may serve a compliance order requiring the person to take actions in order to comply with the legislation.  A person served with a compliance order has 14 days to make submissions, otherwise they must comply with the order.  If no submissions are made within 14 days or the Minister confirms the order following review of submissions, the name of the person and a description of non-compliance will be published on a website.

What else does the Act cover?

The Act also provides details as to the ability to correct information and notice requirements pursuant to the Freedom of Information and Protection of Privacy Act.

Link:

Bill 160

PMPRB responds to proposed amendments to the Patented Medicines Regulations with Guidelines Scoping Paper

On Monday, December 11, 2017, the Patented Medicine Prices Review Board (PMPRB) released a scoping paper providing a high-level overview of how a new, risk-based approach to its mandate could function under revised Guidelines following forthcoming amendments to the Patented Medicines Regulations. This previews an official consultation on a revised set of proposed Guidelines that the PMPRB intends to hold in the spring of 2018.

Background

As we reported, the government pre-published amendments to the Patented Medicines Regulations on December 2, 2017. The proposed amendments aim to empower the PMPRB to:

(i) consider new pharmacoeconomic information as part of determining excessive pricing;

(ii) require broader disclosure of price adjustments, such as third-party rebates under formulary listing agreements with the provinces;

(iii) provide reduced reporting obligations for patented medicines perceived to be at low risk of excessive pricing; and

(iv) address a new and expanded schedule of international comparator countries (the PMPRB12) that, notably, excludes the United States and Switzerland.

Highlights

The scoping document describes a five-part proposal for revisions to the price review process.

  • Part I: Interim international price reference test. The list price of all new drugs in Canada would be compared to the list price in the PMPRB12 countries. The Canadian list price would be considered potentially excessive if it exceeds the median of the PMPRB12 list prices.
  • Part II: Screening. A variety of factors would be used to classify new drugs as either “high” or “low” priority based on their impact on Canadian consumers (patients and payers). In general, high priority drugs would include breakthrough drugs, high-cost drugs, and drugs addressing large patient populations or unmet needs. High-priority drugs would be subject to automatic investigation and a comprehensive review.
  • Part III: High-priority drugs. The price of high-priority drugs would then be subjected to a two-part test:

First, the incremental cost per quality-adjusted life year (QALY) of the drug would be assessed, as determined by CADTH, against an explicit cost-effectiveness threshold.

Second, for drugs that meet the cost-effectiveness threshold, the potential for a further price adjustment would be assessed based on expected impact on payers within the first three to five years of launch.

If the price fails this two-part test, the patentee would be given an opportunity to explain why the price is not excessive, including using confidential commercial information (costs of making and marketing, “true” PMPRB12 prices, proposed rebates and discounts). If the price is found to be potentially excessive, the public ceiling price would continue to be set by international price referencing but the ceiling price resulting from application of the two-part test would remain confidential.

  • Part IV: Medium and low-priority drugs.
    • Medium-priority drugs (those with a minimum number of therapeutic alternatives and little-or-no therapeutic improvement over standard of care) would be subject to the same initial price test as high-priority drugs, and might also be required to meet a revised therapeutic class comparison test that requires each successive entrant to reduce its price relative to the price of the drug that preceded it.
    • Low-priority drugs (those with a significant number of therapeutic alternatives and/or generic competition) would not be subject to an introductory or ongoing section 85 analysis, and would be investigated on a complaints basis only.
  • Part V: Re-benching. The re-benching process, which is not described in detail, would ensure that previous determinations of potential excessive pricing and/or price ceilings remain relevant in light of a variety of factors (new indications, changes in market conditions), and might result in increases or decreases in ceiling price.

Next steps

The PMPRB is not currently seeking feedback on the scoping document, but encourages stakeholders to reflect upon it in the lead-up to an expected first draft of the new Guidelines in the spring of 2018. The PMPRB expects to consult on the draft with a view to having new Guidelines in place by early 2019.

Links

  • The PMPRB’s Guidelines Scoping Paper can be found here.
  • An HTML version of the proposed amendments to the Patented Medicines Regulations and associated RIAS can be found here.
  • An official copy of the Canada Gazette, Part I, Vol. 151, No. 48, setting out the proposed amendments to the Patented Medicines Regulations and associated RIAS can be found here.
  • Health Canada’s portal for consultation on the proposed amendments to the Patented Medicines Regulations can be found here.

PAAB Announces New Code of Advertising Acceptance

The Pharmaceutical Advertising Advisory Board (PAAB) has announced an updated Code of Advertising Acceptance (Code).  The new Code will be implemented beginning on January 1, 2018.

The primary change is to the Code’s format.  It will only be available online and will allow keyword searching and filtering code provisions by core principle.  Other changes include language streamlining for clarity, the addition of some definitions, and the reorganization of provisions.  Sections that did not relate to advertising standards have also been removed.

Link:

The PAAB Code

Federal Court of Appeal Provides Further Guidance on Inventive Concept

The Federal Court of Appeal has provided additional guidance on the framework for analyzing obviousness. In dismissing an appeal from the Federal Court, the Court of Appeal identified the search for an inventive concept as an “unnecessary satellite debate” and held that a more useful approach would be to construe the claims.

Case:  CIBA Specialty Chemicals Water Treatments Limited v SNF Inc, 2017 FCA 225

Nature of case: Action for a declaration that Canadian Patent 2,515,581 (the 581 Patent) was invalid

Successful party: SNF Inc.

Date of public reasons: November 17, 2017

Background

The 581 Patent relates to processes for treating aqueous waste material from mining operations. The claimed processes involve treating the aqueous waste material with a water-soluble polymer that causes particulate matter in the waste material to aggregate. The processes allow the waste material to be transferred as a liquid, but also allow the particulate matter to solidify upon reaching a deposition area.

SNF Inc.’s action for a declaration of invalidity was brought on the basis of obviousness, anticipation, insufficiency, overbreadth and the presence of false and misleading statements in the application for the patent. The only successful ground of invalidity was obviousness.

Construing Claims Reduces Uncertainty Surrounding the Inventive Concept

As we reported, the Federal Court of Appeal recently addressed whether “inventive concept” was intended to change the definition of obviousness. Justice Pelletier was unwilling to find that the Supreme Court changed substantive law by implication to make inventiveness more or less likely and concluded that the “inventive concept” is not materially different from “the solution taught by the patent,” which has often been treated as synonymous with “what is claimed” or simply “the invention.”

In this case, Justice Pelletier stated that the “inventive concept” remains undefined and the search for it has brought considerable confusion into the law of obviousness. He observed that it may more prudent to avoid the “inventive concept” altogether. As the analysis requires determining the differences between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed, construing the claim may be more useful than engaging in an “unnecessary satellite debate” to determine the inventive concept.

Inventive Concept or Claim as Construed to be Compared to the Prior Art

The Court of Appeal also commented on the correct comparison for identification of the differences between the inventive concept (or the claim as construed). Several recent decisions had compared the inventive concept to the common general knowledge; however, the Court of Appeal confirmed that the correct comparison is between the inventive concept (or the claim as construed) and the prior art relied upon by the person alleging obviousness.

Common general knowledge is relevant when deciding whether the difference between the inventive concept (or the claim as construed) and the prior art can be bridged by the skilled person, as the skilled person can have recourse to his or her common general knowledge supplemented by those pieces of prior art that could be discovered by a reasonably diligent search.

Remaining Grounds

The Federal Court of Appeal found that, despite the Federal Court’s error in the articulation and application of the obviousness analysis, it had arrived at the correct conclusion on the question of obviousness and that the claims at issue were invalid on the grounds of obviousness. The Federal Court of Appeal dismissed the appeal without addressing the other grounds of invalidity.

Links to Decisions:

Amendments to the Patented Medicines Regulations are coming: Health Canada proposes new powers for the PMPRB to lower prices of patented medicines in Canada

On Friday, December 1, 2017, the government revealed proposed amendments to the Patented Medicines Regulations (the Regulations) conferring new powers on the Patented Medicine Prices Review Board (PMPRB) and setting the stage for revised Guidelines from the Board. Interested stakeholders have until February 14, 2018 to provide comments to the government. A definitive version of the amendments is expected to take effect on January 1, 2019.

The proposed amendments aim to empower the PMPRB to: (i) consider new pharmacoeconomic information as part of determining excessive pricing; (ii) require broader disclosure of price adjustments, such as third-party rebates under formulary listing agreements with the provinces; (iii) provide reduced reporting obligations for patented medicines perceived to be at low risk of excessive pricing; and (iv) address a new and expanded schedule of international comparator countries that, notably, excludes the United States and Switzerland.

Background

The proposed amendments are driven by the modernisation initiative that began with the PMPRB in June 2016, when the Board published a consultation paper called Rethinking the Guidelines.  In May 2017, the PMPRB announced that it had put its Guidelines consultation on hold and passed the baton to Health Canada, which published a consultation paper called Protecting Canadians from Excessive Drug Prices: Consulting on Proposed Amendments to the Patented Medicines Regulations. This paper addressed many of the same themes as the PMPRB’s consultation, but proposed to deal with them by amending the Regulations with the expectation that the PMPRB would then be better-equipped to rethink its Guidelines. Health Canada’s consultation on the paper concluded on June 28, 2017 and led to the proposed amendments.

The government states in the accompanying Regulatory Impact Analysis Statement (RIAS) that the objective of the proposed amendments is to “lead to lower prices for patented medicines in Canada that are more closely aligned with their value to patients and the health care system, and Canadians’ willingness and ability to pay.”

Highlights

The proposed amendments would implement five policy changes:

  • New factors for assessing excessive pricing. The PMPRB will be directed to consider three new factors when assessing excessive prices:
    • Pharmacoeconomic value, as assessed by cost-utility analyses that measure cost per quality-adjusted life years (QALY). Patentees will not be required to prepare such analyses, but will be required to report them to the PMPRB within 30 days of publication by a publicly-funded Canadian organisation such as the Canadian Agency for Drugs and Technology in Health (CADTH) and the Institut national d’excellence en santé et services sociaux (INESSS).
    • Market size for the drug in Canada, expressed as estimated maximum usage by quantity of the medicine sold in final dosage form. It is expected that patentees already prepare such analyses and will be required to keep them up to date with the PMPRB.
    • Gross domestic product and per capita gross domestic product for Canada. These data will be obtained by the PMPRB from Statistics Canada.
  • New powers to collect information regarding the pharmacoeconomic factors. The proposed amendments contain specific guidance regarding the triggers and timing for reporting cost-utility analyses and market size information, including special provisions for drugs that are already on the market.
  • New obligations to report price adjustments. The proposed amendments expand the information required to be included when calculating average price per package and net revenue from sales for reporting in Form 2. These calculations will be required to factor in any price “adjustments that are made by the patentee or any party that directly or indirectly purchases or reimburses for the purchase of the medicine”. This is intended to include confidential third-party rebates paid to insurers under formulary listing agreements.
  • More medicines to benefit from reduced risk-based reporting. The proposed amendments expand the existing categories of medicine that benefit from reduced reporting requirements because they are considered to be at a low risk of excessive pricing. The list now includes all non-prescription/over-the-counter drugs (including those containing controlled substances), veterinary medicines, and generic drugs (defined as those that were approved on the basis of an abbreviated new drug submission).
  • Revised international comparators. The list of international comparator countries (previously known as the “PMPRB7”) is modified, deleting the United States and Switzerland while adding Australia, Belgium, Japan, the Netherlands, Norway, the Republic of Korea, and Spain. France, Germany, Italy, Sweden, and the United Kingdom remain on the list, which is now being referred to as the “PMPRB12”.

The RIAS accompanying the proposed amendments indicates that the new reporting obligations will apply to all patented medicines marketed on or after January 1, 2019, but only in respect of sales on or after that date. As with the current version of the Regulations, the proposed amendments assume that the PMPRB will fill in specific details regarding implementation through amendments to its Guidelines, which are expressed in the Compendium of Policies, Guidelines and Procedures and the Patentee’s Guide to Reporting.

Links

  • An HTML version of the proposed amendments and associated RIAS can be found here.
  • An official copy of the Canada Gazette, Part I, Vol. 151, No. 48, setting out the proposed amendments and associated RIAS can be found here.
  • Health Canada’s portal for consultation on the proposed amendments can be found here.
The OBA is hosting a timely panel discussion on Navigating the Patented Medicine Prices Review Board: From Scientific Review to Hearing, on December 7 – click here to view the agenda and register.

PMPRB update: new developments in eculizumab and adapalene cases

We provide an update of developments in recent PMPRB cases below. Notably, the PMPRB has ordered Alexion Pharmaceuticals Inc. to pay $4,245,329.60 in excess revenues earned on sales of SOLIRIS (eculizumab) to Her Majesty in right of Canada and has also appealed the Federal Court’s judgment against it in the Galderma case regarding DIFFERIN.

Updates in the SOLIRIS case

Background.  As we reported, a PMPRB panel found Alexion liable for excessive pricing on SOLIRIS and ordered the parties to submit their calculations by October 20, 2017, on the amount of excess revenues owed to the Crown in accordance with the highest international price comparison (HIPC) test.Submissions and decision.  Alexion and the board staff disagreed regarding the amount owed by Alexion to the Crown because of differing assumptions about which international prices were relevant to the analysis. Following a clarification issued by the panel on October 25, the parties agreed to a calculation of Alexion’s liability made using the  median international price comparison  test for 2009 and the HIPC test for 2010–2017, using Alexion’s final revised Block 5 reported prices. The panel approved this amount on November 8 and required Alexion to pay the balance ($4,245,329.60) on or before December 8, 2017.

Alexion’s judicial review.  On October 20, 2017, Alexion filed an application for judicial review of the panel’s decision on the merits in Federal Court File No. T-1596-17. We will monitor the proceeding and report on developments as they arise.

Updates in the DIFFERIN case

Background.  As we reported, the Federal Court found that the PMPRB wrongly asserted jurisdiction over Differin® pricing based on an incorrect application of the patent-pertaining analysis. The court allowed a judicial review application from the PMPRB’s failure-to-file decision, holding that the PMPRB had failed to consider the entirety of Galderma Canada Inc.’s patent when determining whether it pertained to Differin®.

PMPRB’s appeal.  On November 21, 2017, the PMPRB filed an appeal from the Federal Court’s judgment in Court File No A-385-17. The PMPRB alleged the Federal Court committed a range of factual and legal errors, including:

  • finding that the “medicines” at issue were the consumer end products — Differin® and Differin XP® — rather than adapalene (the same, sole active ingredient of both end products);
  • misapplying the ICN test and elevating the very low threshold necessary for the board’s jurisdiction under the “merest slender thread” test;
  • interpreting the relevant provisions of the Patent Act with a focus on those in a position to cause mischief rather than those in need of protection from such mischief, i.e., consumers;
  • failing to properly apply the “reasonableness” standard of review; and
  • conflating the concepts of “claim” and “pertain.”

We will monitor the proceeding and report on developments as they arise.

Links

  • The PMPRB’s decision on quantum of liability in the SOLIRIS (eculizumab) case can be found here.
  • The PMPRB’s decision on the merits in the SOLIRIS (eculizumab) case can be found here.
  • The PMPRB’s Notice of Appeal in the Galderma case can be found here.

Federal Court finds that the PMPRB incorrectly applied patent-pertaining analysis in Galderma judicial review

The Federal Court found that the PMPRB wrongly asserted jurisdiction over Differin® pricing based on an incorrect application of the patent-pertaining analysis. The Court allowed an application for judicial review by Galderma Canada Inc. (Galderma) from the PMPRB’s failure-to-file decision, holding that the PMPRB had failed to consider the entirety of Galderma’s patent when determining whether it pertained to Differin®.

Case: Galderma Canada Inc. v Canada (Attorney General), 2017 FC 1023 (Court File No. T-83-17)

Nature of case: Application for judicial review of a PMPRB Board Decision on the merits

Drugs: Differin® (adapalene 0.1% w/w) & Differin XPTM (adapalene 0.3% w/w)

Date of decision: November 9, 2017

Background

Canadian Patent No. 2,478,237 (the 237 Patent) relates to the use of adapalene to treat dermatological disorders. Galderma markets two adapalene products:

  • Differin® contains 0.1% adapalene.
  • Differin XPTM contains a higher concentration of adapalene — 0.3%.

As we reported, in an application before a hearing Panel of the PMPRB, the Board staff successfully argued that the 237 Patent pertained to Differin®. Galderma argued that the 237 Patent is not intended or capable of being used to make Differin® — a 0.1% adapalene formulation — because on its face, the patent is specific to 0.3% adapalene formulations (such as Differin XPTM). The Panel did not accept that argument.

The PMPRB applied the wrong test

The Federal Court held that the central question the PMPRB had to address was whether the invention in the 237 Patent pertains to Differin®.

The Court held that the PMPRB misapprehended the question and engaged in an unreasonable analysis. In particular, the PMPRB did not consider the entire patent in its analysis and did not determine what the invention was. Instead, it incorrectly focussed on the commonality of medicinal ingredients between the drugs. This analysis was unsupported: there was no evidence that the invention of the 0.3% adapalene in the 237 Patent could be used for 0.1% adapalene formulation of Differin®.

In reviewing the PMPRB’s decision, Phelan J. held that “[t]he Board is entitled to deference on the scope of “pertains” so long as it asks the right question, and does not so stretch the application of “pertains” such that it strays into constitutionally impermissible grounds to regulate drug prices which are not sufficiently connected to a federal field of jurisdiction (i.e. patents).” Although the patent-pertaining analysis does not include claims construction, the PMPRB is nonetheless required to consider the entire patent, including the claims. While a holistic analysis is potentially reasonable, the Court rejected the PMPRB’s finding that the “patents pertaining” analysis is discretionary.

The Court also rejected an argument by Galderma that the PMPRB had denied it procedural fairness by deciding the matter on grounds that were not argued by either party.

Links

  • The Federal Court’s decision can be found here.
  • The PMPRB’s Board Order can be found here.
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