CETA Tracker: Delays for the implementation of pharmaceutical patent reform

As we reported, the Canadian government has approved changes to Canada’s pharmaceutical patent regime, including the introduction of patent term restoration and the replacement of the current summary proceedings under the Patented Medicines (Notice of Compliance) Regulations with full actions.  The reforms were expected to come into force on July 1, 2017; however, media sources are now reporting a possible delay until Fall 2017.

Treaty/Act:        CETA/Bill C-30 (An Act to implement the Comprehensive Economic and Trade Agreement between Canada and the European Union and its Member States and to provide for certain other measures)

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

Links

Bill-30, Third Reading (House of Commons)

Text of the final Comprehensive Economic and Trade Agreement

Supreme Court dismisses leave to appeal regarding notice requirements under section 5 of the PM(NOC) Regulations

As we reported, Janssen Inc. et al. filed an application for leave to appeal with the Supreme Court of Canada on December 9, 2016 with respect to the Federal Court of Appeal’s decision addressing a generic manufacturer’s notice obligations when obtaining a notice of compliance (NOC) by way of a cross-referenced drug submission.

On June 22, 2017, the Supreme Court dismissed the application for leave.

Case: Janssen Inc, et al v Hospira Healthcare Corporation, et al (SCC Docket: 37342)

Drug: REMICADE® (infliximab)

Nature of case: Appeal of judicial review of a decision of the Minister of Health to not require notice under section 5 of the Patented Medicines (Notice of Compliance) Regulations (Regulations)

Successful party: Hospira Healthcare Corporation, et al (Hospira)

Date of decision: June 22, 2017

The Minister had issued NOCs for two generic products without requiring that the generics serve a notice of allegation. Because the submissions made reference to already approved generic drugs, the FCA found that the submissions did not give rise to a new or different basis for asserting that a particular product was infringing. Any potential infringement could be addressed in infringement proceedings.

Health Canada has provided notice that the FCA decision affects the application of section 5 of the Regulations with respect to administrative drug submissions (reported here).

Links:

Health Canada releases Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products

Health Canada recently released the Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products (GLPP Guide). The GLPP Guide was released as part of the Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) – more commonly known as the “Plain Language Labelling Regulations.”  As of June 13, 2017, the Plain Language Labelling Regulations are in force for non-prescription drugs. The GLPP Guide provides industry with guidance on how to comply with the new requirements set out as part of the  Plain Language Labelling Regulations, including the specifications for the Canadian Drug Facts Table (CDFT), which must be included on the outer labels of products.

Overview

As part of Health Canada’s Plain Language Labelling Initiative (reported here), Health Canada will require that for non-prescription drugs, any new drug identification number (DIN) applications or supplemental new drug submissions submitted on and after June 13, 2017, be in compliance with the Plain Language Labelling Regulations, which includes the CDFT requirements set out in the GLPP Guide. The June 13 compliance date applies to new products, or products with a label change that requires issuance of a new DIN or notice of compliance (NOC).

Currently marketed products must comply with the Plain Language Labelling Regulations, including the CDFT requirements, at the retail level by June 30, 2021.  The GLPP Guide notes that marketed products coming into compliance are not required to file a submission solely to comply with Plain Language Labelling Regulations, provided there no are label changes that would require a new DIN or NOC and that labels follow the standard CDFT format.

The bulk of the GLPP Guide provides information on current best practices in product label design and layout, the information contained on the label, and the design or choice of package.

Link:

Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products

For more information, please contact your IP/Life sciences or healthcare practice professional at Norton Rose Fulbright Canada LLP.

For a complete list of our IP team, click here. For a complete list of our Life sciences and healthcare team, click here.

Apotex files leave to appeal to SCC on damages against Health Canada for Apo-Trazodone

Apotex filed an application for leave to appeal the decision allowing its claim for damages for misfeasance of public office, negligence and breach of contract against Health Canada based on its review of Apotex’s drug submission for Apo-Trazodone. Apotex has appealed the 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. (Apotex)

Respondent: Her Majesty the Queen

Date: June 5, 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. The FCA found that Apotex was not required to mitigate its damages by providing Health Canada with evidence of bioavailability of Apo-Trazodone based on a comparison to a Canadian reference product. Apotex was entitled to specific performance to receive a Notice of Compliance based on a foreign reference product, and had a legitimate business interest in doing so.

The FCA 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, finding that Health Canada does not owe a prima facie duty of care to Apotex, or any other drug manufacturer, because 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. Apotex has filed leave to appeal to the Supreme Court of Canada on this question.

Links:

SCC Docket: 37593

FCA Decision: Apotex Inc v Her Majesty the Queen, 2017 FCA 73

Trial Decision: Apotex Inc v Canada (Minister of Health), 2014 FC 1087

Government of Canada opens NAFTA consultations: IP on agenda

The Canadian government is requesting feedback relating to the renegotiation of the North American Free Trade Agreement.  In particular, the government is asking for the public’s “views on the key areas in NAFTA that could be clarified or updated, and on any new areas that should form part of a modernized agreement.”

Treaty/Act:        North American Free Trade Agreement

Date:                Consultation period from June 3 – July 18, 2017  

Opportunity for pharmaceutical patent reform

The NAFTA consultation is an opportunity to address concerns with respect to Canada’s patent regime under the Intellectual Property chapter (Chapter 17).  The United States has placed both Canada and Mexico on its IP “Watch List” over the years.  Specific to Canada, the United States has expressed a number of serious concerns regarding Canada’s patent regime, including: (i) the lack of clarity in Canada’s “utility” standard, and the interpretation of the “promise doctrine”; and (ii) the availability of appeal rights from administrative regulatory decisions of pharmaceutical patents.

How to provide written submissions

Interested parties are invited to provide written submissions to Global Affairs Canada (NAFTA-Consultations-ALENA@international.gc.ca) by July 18, 2017.  Submissions should include: (i)  the contributor’s name/organization; (ii) the specific issue addressed; and (iii) precise information on the rationale for the positions taken, including any significant impact they may have on Canada’s domestic or international interests.  Any submissions will be considered as public information.

Links:

Consultation Notice:  Canada Gazette, Volume 151, No. 22

NAFTA Consultation Website:  Consulting Canadians on the renegotiation of the North American Free Trade Agreement with the United States and Mexico

Current Text of NAFTA

United States Trade Representative 2017 Special 301 Report

Supreme Court dismisses leave to appeal regarding patent validity and infringement in omeprazole case

On June 2, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal the decision finding that AstraZeneca’s Canadian Patent No. 1,292,693 was valid and infringed by Apotex’s manufacture, sale, and promotion of Apo-Omeprazole capsules.

Case:  Apotex Inc v AstraZeneca Canada Inc, et al (SCC Docket: 37478)

Drug:  LOSEC® (omeprazole)

Nature of case:  Appeal from validity and infringement action under the Patent Act, RSC 1985, c P-4 (Patent Act)

Appellant:  Apotex Inc. (Apotex)

Respondents:  AstraZeneca Canada Inc., AstraZeneca AB and Aktiebolaget Hässle (collectively AstraZeneca)

Date of decision: June 2, 2017

Federal Court of Appeal decision

As we reported, the Federal Court of Appeal agreed with the Federal Court’s findings on construction, validity and infringement, and affirmed that a patent need only describe a single method or process for making the claimed invention. However, the FCA overturned the Federal Court’s decision on the applicable limitation periods, and held that, as the 693 patent is covered by the pre-1989 Patent Act, provincial statutory limitations would apply to any “cause of action arising in that province” instead of the six-year federal limitation period. The FCA also dismissed AstraZeneca’s cross-appeal on punitive damages.

Links to decisions:

SCC Decision: Apotex Inc v AstraZeneca Canada Inc et al, Supreme Court of Canada – Judgments in Leave Applications (37478)

FCA Decision: Apotex Inc v Astrazeneca Canada Inc, 2017 FCA 9

Trial Decision: Astrazeneca Canada Inc v Apotex Inc, 2015 FC 322 and Astrazeneca Canada Inc v Apotex Inc, 2015 FC 671 (amended judgment)

Health Canada publishes updated guidance document on data protection

Health Canada has released an updated version of Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations. According to Health Canada, the guidance document has been updated to reflect judicial consideration of “innovative drug” and current administrative practices, including requirements for submissions relying on third-party data, protection for products containing an innovative drug, biosimilars, and the six-month extension for data related to pediatric populations.

Revisions to the guidance document

Definition of innovative drug. The updated guidance document relies on the definition of innovative drug contained in the Food and Drug Regulations, i.e. a drug that contains a medicinal ingredient not previously approved by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph.

The guidance document sets out two requirements for data protection eligibility: (a) the drug must be a new chemical entity and (b) the data that supports the approval of the medicinal ingredient must have required considerable effort.

“Considerable effort” means that the approval is being sought on the basis of new and significant data (i.e. evidence to determine the safety, efficacy, properties and conditions of use of the drug, usually in the form of pivotal clinical trials).

The guidance document also states that where there is an “arguable variation” of a previously approved medicinal ingredient, but not a salt, ester, enantiomer, solvate or polymorph as specifically excluded from the definition of innovative drug in the Food and Drug Regulations, Health Canada will undertake an assessment of whether the variation is an innovative drug. Health Canada will then consider whether the data was generated with “considerable effort.”

Submissions relying on third-party data. The guidance document states that drugs reviewed on the basis of literature references, study reports of trials not conducted or sponsored by the applicant, books, consensus guidelines from professional bodies and/or market experience (i.e. third-party data) are not eligible for data protection. These amendments are likely being made further to Health Canada’s Guidance Document: Drug Submissions Relying on Third-Party Data, released in May 2015.

Drugs containing the same medicinal ingredient as an innovative drug. Where a drug contains one or more medicinal ingredients found in an innovative drug for which data protection is still in effect, the drug will benefit from the same period of data protection as the innovative drug. However, in order to benefit from the data protection term, there must be a relationship to the innovative drug. This does not apply to subsequent-entry drugs.

Biosimilars. The guidance document states that the six-year “no file” period prescribed by the Food and Drug Regulations (applicable to manufacturers seeking a notice of compliance on the basis of an indirect or direct comparison to an innovative drug) is intended to apply to biosimilar drugs. New drug submissions which are based on independent clinical trials and not on a comparison to an innovative drug are not captured by the six-year “no file” period.

Submissions that do not result in a subsequent-entry version of the innovative drug are not captured by the six-year “no file” period. For example, a submission for a drug indicated for use in combination with an innovative drug will not be prevented from filing.

Pediatric population extension. In order to be eligible for the additional six-month extension for drugs intended to treat pediatric populations, the innovator must provide the Minister with the description and results of clinical trials relating to the use of the innovative drug in pediatric populations in its first new drug submission or in any supplement to that submission filed within five years after the issuance of the first notice of compliance.

The clinical trials must be designed for the purpose of increasing knowledge of the use of the innovative drug in pediatric populations and this knowledge must provide a health benefit to the pediatric population.

Details of the study will be used to determine if the clinical trial was conducted for the purpose of increasing knowledge of use of the drug in pediatric populations. If the knowledge requirement is met, Health Canada will determine whether that knowledge is available to provide a health benefit. At minimum, the knowledge must be available to the public, e.g. through the approved labelling or Product Monograph.

Links:

Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations

 

Health Canada seeks feedback on proposed regulatory amendments to PMPRB pricing regime of patented medicines

On May 16, 2017, Health Canada published a consulting paper titled “Protecting Canadians from Excessive Drug Prices.”  The paper describes five proposed amendments to the Patented Medicines Regulations that are meant to help better assess whether the price of a patented drug is excessive.

Stakeholders can provide feedback on the proposed amendments by June 28, 2017.

Proposed amendments

Further to the PMPRB’s initial consultation on guidelines modernization (as reported here), the proposed amendments are meant to “provide the PMPRB with new regulatory tools and information to better protect Canadian consumers from excessive prices while reducing regulatory burden on patentees.”  Further consultations on the PMPRB guidelines will follow from the regulatory amendments.  The proposed regulatory amendments are as follows:

(1)  Introduce new “pricing factors.”  The current framework for assessing whether the price of a new patented drug is excessive is largely based on three factors: (1) the degree of therapeutic benefit of the drug relative to existing drugs on the market; (2) the price of that same drug in seven comparator countries (PMPRB7); and (3) the highest priced drug in Canada in the same therapeutic class.  Under the proposed amendments, three new factors would be added: (i) the pharmacoeconomic evaluation for the medicine; (ii) the size of the market for the medicine; and (iii) the gross domestic product in Canada.

(2)  Update the list of countries used for price comparison.  The proposed amendments suggest revising the list of comparator countries to those that are “more aligned with Canada economically and from a consumer protection standpoint.”  The proposed revised list would remove the United States and Switzerland from the list of comparator countries, and add Australia, Belgium, Japan, Netherlands, Norway, South Korea and Spain.      

(3) Formalize a move to a complaints-based system for generic drugs.  Under the proposed amendments, patentees of generic drugs (e.g., drugs that have obtained approval based on an ANDS), would only be required to report the identity and price information in the event of a complaint or at the board’s request (as reported here).

(4) Detail the new pricing information required from patentees. To facilitate the use of the “new pricing factors” by the board, patentees would be required to submit additional information to the board, where available, including: (i) a cost utility analysis by approved indication of the medicine; and (ii) information on the estimated market uptake of the medicine.

(5) Require patentees to provide rebates and discounts information.  To more accurately determine the true market price of a drug, the board proposes that patentees be required to report all indirect price reductions to the Board (e.g., promotions, rebates, discounts, refunds, free goods, free services, gifts or any other benefit).

Links:

Consulting Paper:  Protecting Canadians from Excessive Drug Prices – Consulting on Proposed Amendments to the Patented Medicines Regulations

Call for Feedback: Consulting on Proposed Amendments to the Patented Medicines Regulations

Federal Court releases new trial management guidelines for actions and discusses impact of proposed regulations

On April 28 the Federal Court issued a Notice to the Parties and the Profession containing new guidelines for the trial management of actions. Among other things, they set new deadlines for various pre-trial steps and for the filing of motions, provide guidance regarding the scheduling and agenda of trial management conferences and streamline the handling of expert witnesses. The guidelines follow the court’s previous recommendations from June 24, 2015 (reported here) to increase proportionality in complex litigation and streamline practice and procedure, and are intended to ensure the most efficient, expedient and proportionally fair use of trial time for actions. The guidelines are effective immediately and apply to all actions scheduled for five or more days in Federal Court.

Instrument:                          Trial Management Guidelines

       Date released:                      April 28, 2017

The new guidelines were discussed at the Canadian Bar Association’s 2017 IP Day Town Hall Meeting, held on May 11, 2017. At the Town Hall, the court also indicated it was preparing for the upcoming changes to the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations), that will result from implementation of the Comprehensive Economic and Trade Agreement between Canada and the European Union (see our report here for the latest on the implementation of CETA). As we reported, the new PM(NOC) Regulations will replace the current summary proceedings with full actions. Although the details of the new single-track regime have yet to be published, the Federal Court appears to be turning its mind to the challenges of hearing PM(NOC) proceedings as actions within the same 24-month stay period.

New guidelines

The Notice contains 21 guidelines. Some set new deadlines for pre-trial steps and the filing of motions as well as introduce various requirements. Others encourage, without strictly requiring, parties to collaborate on issues such as factual statements, documents filing and presenting evidence at trial. The new guidelines include:

  • Motions. No motion may be brought within 60 days of trial without leave of the case management judge or the trial judge. While motions may be necessary during trial, contested motions at trial are discouraged.
  • Trial management conference. Parties shall requisition a trial management conference to take place at least two months before trial, subject to an extension or abridgement of time granted by the trial judge and are to include in the requisition a proposed agenda and timing of any motions that may need to be brought before the court.
  • Experts. The guidelines include several recommendations for dealing with experts, including that any objections to expert reports must be made within 30 days of service and no later than 30 days before trial, expert reports to be relied on at trial must be submitted at least two weeks before trial, and by submitting the report of an expert to the court, the party is undertaking to call this expert at trial; examinations in chief of experts should be concise and limited to the key relevant issues.
  • Science primer. Parties are encouraged to prepare and deliver a joint primer on the relevant technology and scientific principles in advance of trial on a date determined by the trial judge.
  • Joint statements of issues and facts, book of documents. Parties are encouraged to submit a joint statement of issues two weeks before trial. Parties are also encouraged to submit an agreed statement of facts and book of documents, including admissions on authenticity, at least one week before trial.
  • Proposed trial schedule and list of witnesses. Parties shall submit a proposed schedule for trial proceedings at least two weeks before trial, with any disagreements regarding the schedule to be determined at the judge’s discretion. Parties shall exchange a brief description of the proposed areas of testimony of fact witnesses at least two weeks before trial and are encouraged to discuss the use of witness statements and fact stipulations where cross-examination is not necessary.
  • Compendia and written arguments. Parties shall provide to the trial judge compendia, in paper and electronic format, including only the relevant excerpts they will rely on at trial. Parties are encouraged to submit joint compendia. Absent a contrary direction, parties shall submit written arguments at the end of trial in electronic and paper format and are encouraged to keep the written arguments to no more than 50 pages.

Links:

Notice to the Parties and Profession (April 2017): Trial Management Guidelines

Notice to the Parties and the Profession (June 24, 2015): Case Management: Increased Proportionality in Complex Litigation before the Federal Court

CETA tracker: CETA Bill C-30 receives royal assent to implement pharmaceutical patent reform

It’s official – the Canadian government has approved the changes to Canada’s pharmaceutical patent regime. On May 16, 2017, Bill C-30 (the act intended to implement CETA into Canadian law) received royal assent, the final stage of the legislative process.

Treaty/Act:        CETA/Bill C-30 (An Act to implement the Comprehensive Economic and Trade Agreement between Canada and the European Union and its Member States and to provide for certain other measures)

Date:                May 16, 2017 – Bill C-30 receives Royal Assent

What are the changes? As we reported, CETA and Bill C-30 provide key reforms to the Patent Act affecting the pharmaceutical industry, including:

  • Patent term restoration (i.e., certificates of supplementary protection or CSPs) capped at a maximum of two years for eligible patents covering eligible products; and
  • Replacement of the current summary proceedings under the Patented Medicines (Notice of Compliance) Regulations with full actions resulting in a final determination of patent infringement and validity. Equal access to effective appeal rights will also be provided.

When will the changes come into force? Section 138 of Bill C-30 provides that most of the act comes into force on a day to be fixed by order of the Governor in Council. Under CETA, Article 30.7 – “Entry into force and provisional application” – we anticipate that Canada may provisionally implement the changes as early as June 1, 2017. It is expected that CETA will enter into full force on July 1, 2017. The regulations accompanying these reforms are expected to be published shortly.

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

Links

Bill C-30, Third Reading (House of Commons)

Text of the final Comprehensive Economic and Trade Agreement

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