Sections of Vanessa’s Law regulating drugs for urgent public health need come into force

On July 12, 2017, section 5 and subsections 6(3) and 6(4) of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) came into force. These sections amend the Food and Drugs Act to require healthcare institutions to report serious adverse drug reactions and permit the Governor in Council to make regulations that specify what this reporting will be and how it will be done. The amendments will also allow for the importation and sale of foreign drugs that have not been authorized for sale in Canada, but for which there is an urgent public health need.

Vanessa’s Law, which amended the Food and Drugs Act, came into force on November 6, 2014. While most of the act’s amendments came into force immediately, some required supporting regulations.

As we reported, the Government of Canada published draft regulations amending the Food and Drug Regulations on April 22, 2017. However, the draft regulations did not come into force at that time, as the necessary provisions in Vanessa’s Law were not yet in force.

These newly in force sections of Vanessa’s Law introduce those necessary provisions. They will allow the amendments to the Food and Drug Regulations that will (i) require healthcare institutions to report serious adverse drug reactions associated with foreign drugs sold for use regarding an urgent public health need, and (ii) permit the importation and sale of foreign drugs that have not been authorized for sale in Canada, but for which there is an urgent public health need.

This will be the first time that healthcare facilities will be required to report serious adverse drug reactions under the Food and Drugs Act. Currently, the manufacturer or importer of a drug authorized for sale in Canada is required to report. However, given that no authorization will be issued for foreign drugs imported in connection with an urgent public health need, responsibility for reporting has  been shifted to healthcare institutions, which will be best placed to identify serious adverse drug reactions that may be associated with the use of these foreign drugs in Canada.

Links:

Canada Gazette Part II, Vol. 151, No. 14 – July 12, 2017

Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) (S.C. 2014, c. 24)

Updated statistics on protection of patented and innovative drugs released in the Therapeutic Products Directorate Statistical Report for PM(NOC) Regulations and Data Protection

 

Innovators’ growing use of the Patent Register is highlighted in the annual statistical report on the Patented Medicines (Notice of Compliance) Regulations and Data Protection issued by the Therapeutic Products Directorate (TPD) on July 14, 2017. This report includes data up to the end of fiscal year (FY) 2016/2017, which ended March 31, 2017.

As we reported, significant changes are coming to the Regulations and Patent Act in connection with the Comprehensive Economic and Trade Agreement (CETA) with the European Union. As a result, FY 2016/2017 is likely to be the last complete period of data under the existing scheme.

Statistics on the Patent Register and Patented Medicines (Notice of Compliance) Regulations

The growing use of the Patent Register and historically low rates of patent list rejection are contrasted by shrinking numbers of generic submissions addressing patents or involved in prohibition applications in this year’s figures from the TPD.

  • Patent lists. More patent lists were added to the Patent Register in FY 2016/2017 than in any of the previous four periods. A total of 769 patent lists were added, including 430 patents that were not previously listed. The total number of patent lists received was similar to the last fiscal year, while there were fewer rejections.
  • Patent register. As of March 31, 2017, there were 1,070 patents listed against 1,451 drug identification numbers (DINs) representing 583 drugs. Forty-six per cent of the drugs had only one patent listed against them, while an additional 47% had two to four patents listed.
  • Prohibition proceedings.
    • Generic submissions addressing patents. FY 2016/2017 saw the lowest number of submissions containing Form V and notices of allegation (NOAs) of any of the last five periods. The 126 Form Vs and 105 NOAs received are similar in number to FY 2014/2015, but lower than FY 2015/2016, which saw 200 Form Vs and 176 NOAs.
    • Applications.  Thirty-two prohibition applications were commenced in FY 2016/2017, up from 18 in the previous period; 14 prohibition applications were pending as of March 31, 2017. Over the last several periods, prohibition applications have taken much of the available 24 months but none have exceeded this time since FY 2012/2013.

Data protection

Data protection under section C.08.004.1 of the Food and Drug Regulations continued to provide a means of protecting market exclusivity for innovative drugs with a minimum of litigation in FY 2016/2017.

  • Human drugs. In FY 2016/2017, 31 human drugs were added to the Register of Innovative Drugs, nine with paediatric extensions. This trend is driven by a shrinking number of innovative pharmaceuticals (17); new biologics (12) and radiopharmaceuticals (2) are the highest that they have been in the past five periods.
  • Veterinary drugs. One innovative veterinary drug was added to the Register in FY 2016/2017.
  • Disputes. There were no judicial review applications concerning data protection in FY 2016/2017.

Submissions on IP Hold

Submissions on intellectual property (IP) Hold are those for which an NOC would be issuable, but for the operation of either the Regulations (“Patent Hold”) or data protection. The TPD reports these figures in the aggregate; it does not indicate what proportion of IP Holds are due to patents vs. data protection.

  • Submissions previously on IP Hold. In FY 2016/2017, 201 submissions received notices of compliance (NOCs) following expiry of IP Hold. This number has increased in each of the last three periods and is the highest since at least FY 2012/2013.
  • Time on IP Hold. For the 201 submissions that received NOCs in FY 2016/2017, the average length of the IP Hold was 271 days. This number has decreased in each of the last three periods and is the lowest since at least FY 2012/2013.
  • Submissions remaining on IP Hold. As of March 31, 2017, 14 submissions were on IP Hold. While lower than the peak reached at the end of FY 2015/2016, when 29 submissions were on IP Hold, more submissions were on hold at the end of FY 2016/2017 than in five of the last nine periods.

Links:

The Therapeutic Products Directorate Statistical Report 2016/2017 for the Patented Medicines (Notice of Compliance) Regulations and Data Protection can be found here.

 

CETA tracker: CETA Upends the Once-Delicate Balance

New CETA regulations impacting pharmaceuticals published but not yet in force

The Canadian government has published the proposed patent term restoration / Certificate of Supplementary Protection (CSP) and Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) under Bill C-30.  A 15-day consultation is open for interested parties to make submissions.

Since their first enactment, the PM(NOC) Regulations were intended to strike a “delicate balance” between the rights of patent holders and timely access to generic medicines. With the enactment of Bill C-30 that balance has been upended. Ironically, this sea-change in how patented medicines will be treated in Canada comes at the same time as the government has announced its intention to develop a new intellectual property strategy over the coming year purportedly “in recognition of the importance of a well-functioning intellectual property regime.”

Background

Canadian and European Union leaders signed the Comprehensive Economic and Trade Agreement (CETA) on October 30, 2016. CETA and Bill C-30 provide key reforms to the Patent Act affecting the pharmaceutical industry, including a so-called “single track” pharmaceutical patent litigation regime and up to two years of supplementary protection for patented pharmaceuticals.

Today, the government has provided additional details about the new regime affecting pharmaceuticals under Bill C-30.

Single Track Patent Litigation

The government has stated that replacing the current summary proceedings under the PM(NOC) Regulations with full actions (resulting in final determinations of patent infringement and validity) will provide all litigants with “equivalent and effective” rights of appeal and allow “for more robust scrutiny of issues and greater overall efficiency”  and “greater legal and market certainty.”

Key aspects of the new PM(NOC) Regulations include:

  • Patent Register. Patent list eligibility criteria are unchanged. The Minister of Health (Minister), however, is required to add and delete patents from the register, in certain circumstances. Discretionary reviews of the register to assess eligibility are also permitted, upon notice to patentees.
  • Generic Notice of Allegation. The NOA must address each claim of the listed patent. Patent list ineligibility may be addressed in the NOA, but can no longer result in dismissal of the proceeding. The NOA is still required to be a detailed legal and factual basis of the invalidity allegation, but the generic/second person is no longer bound by it since the action will be governed by pleadings.
  • New Production Obligations. Generics are now required to serve relevant ANDS information and prior art with the NOA. Generics may also request in the NOA that innovators provide: (i) inventor contact information; and (ii) “any laboratory notebook, research report or other document that may be relevant to determine whether a particular property, advantage, or use asserted by the second person to be part of the invention was established as of the filing date of the application for the patent” (i.e., invention information). The generic must make specific allegations on the latter, including by identifying the relevant portions of the patent. Innovators must either serve the requested information upon commencing the action or advise of steps taken to respond.  Litigants may each impose reasonable confidentiality terms on their respective production obligations, subject to review by motion or the Federal Court.
  • The Proceeding. A first person still has 45 days to start what will now be an action seeking a declaration of infringement in response to an NOA. However, the first person can now assert all claims of any listed patent and the court may order any remedy at law or equity. Like any other action, the proceeding will include full pleadings, discovery and viva voce evidence at trial. The Minister is no longer a party to the proceeding. Parties have a duty to act diligently and reasonably cooperate.
  • Where a first person/patentee, having received an NOA, does not start a proceeding within 45 days, they are thereafter prohibited from bringing a subsequent infringement action against the second person, unless they can later establish they lacked a “reasonable basis” for bringing the action at the time.
  • The statutory stay prohibiting generic market entry remains capped at 24 months, despite the adoption of more procedural complexity by way of action. Key differences between the current and new regimes are: (i) the first person now has the ability to renounce the stay at the outset (thereby opting out of s. 8 liability); (ii) the stay will be lifted for ineligible patents, but the action itself will not be dismissed on this basis; and (iii) the stay may no longer be shortened or extended on the consent of the parties.
  • Motions. Motion rights are provided: (i) for litigants to compel ANDS/ “invention information”; (ii) for litigants on confidentiality of ANDS/“invention information”; (iii) for generics to challenge patent/CSP eligibility for listing on the Patent Register (whereby the Minister will have automatic rights to intervene); (iv) for generics to seek to dismiss action in whole/part for abuse of process (however parties also retain access to Rule 221 motions to strike). Leave to appeal interlocutory orders may be sought with leave to the Federal Court of Appeal in accordance with the Federal Courts Rules.
  • Section 8. Generics maintain a right of action under section 8, but under new parameters. The innovator’s liability start date is now stated as the later of (i) date of NOA service; or (ii) date of generic approvability (i.e., “patent hold” date). Start date also remains subject to the court’s discretion. The innovator’s liability end date is no longer stated as “any loss suffered during the period”, but to “any loss suffered after” the start date.  The Regulatory Impact Analysis Statement (RIAS) states that generics may “seek compensation for any loss suffered as a result of delayed market entry after the date specified in the proposed Regulations. It would be left to the Court to determine whether the loss is properly recoverable.” Joint and several liability of defendants is also provided for.
  • Related rights of action. Innovators also have a new right of action to assert unlisted patents based on NOA service (i.e., quia timet). However, such an action cannot be joined to a listed patent proceeding under the PM(NOC) Regulations until the 24-month stay expires. Generics, having filed an ANDS, are also deemed an “interested person” for purposes of a related patent invalidity action.
  • Once in force, the new PM(NOC) Regulations will apply immediately to any matters for which an NOA is served after the coming into force date. The current summary regime will continue to apply to any matter that relates to an NOA served before the coming into force date.

Certificates of Supplementary Protection (“CSP”)

As stated in the RIAS, 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 the patent. Like a patent, a CSP is subject to the jurisdiction of the Patented Medicine Prices Review Board and can be listed on the Patent Register.

As we reported, many CSP regime details have been available in Bill C-30, including the following:

  • Applicability. Only new drugs issued Notices of Compliance (NOC) after Bill C-30 is in force can be CSP-eligible.
  • Term. The term of the CSP will be calculated as the difference between the filing date of the patent application and the date of NOC issuance, minus five years, capped at a maximum of two years.
  • Different Medicinal Ingredients. Medicinal ingredients for human use will be treated as “different” medicinal ingredients eligible for CSP than when approved for veterinary uses. A first approval of a combination of medicinal ingredients will be treated as a “different” medicinal ingredient eligible for CSP.
  • Actions for infringement and impeachment of a CSP: Actions may be brought in the same manner as an action for the infringement or impeachment of a patent.
  • Export exemption: It is not an infringement of a CSP to make, construct, use or sell for the purpose of export from Canada.

Additional details relating to CSP eligibility are provided in the new CSP Regulations.

  • Timing of CSP application. CSP applications must be filed before the end of 120 days, which begins on (a) the day the NOC is issued, if the patent is granted on or before that day; or (b) if the patent is granted after the day on which the NOC is issued, the day on which the patent is granted. No CSP application can be filed within two years preceding patent expiry. CSP applications are subject to a fee of $9,011.00 CAD.
  • Same Medicinal Ingredients. Esters, salts, complexes, chelates, clathrates or any non-covalent derivative, enantiomers or mixture of enantiomers, solvates or polymorphs and in vivo or in vitro post-translational modification of a medicinal ingredient will be treated as the “same” medicinal ingredient. Combinations of medicinal ingredients that only differ with respect to the ratio between those ingredients will be treated as the “same” combination.
  • “Timely submission requirement”. To be CSP-eligible, the Canadian NDS for the drug in question must be filed within 18 months of any first international drug submission filing for the same drug in the European Union, United States, Australia, Switzerland or Japan. This period decreases to one year at the one-year anniversary of CETA being in force. According to the RIAS, this requirement is intended “to incentivize the early introduction of innovative drugs into the Canadian market”.
  • Eligible patents: To be eligible, a patent claim must pertain to the “same” medicinal ingredient or a combination of “same” medicinal ingredients, which requires at least one claim for: (i) the “same” medicinal ingredient or combination; (ii) use of the “same” medicinal ingredient; or (iii) a product-by process claim for the “same” medicinal ingredient.

Our team has in-depth innovator pharmaceutical industry expertise at all stages of product life cycle, including patent prosecution, regulatory advice and litigation services. Our litigation group focusses on pharmaceutical patent infringement/validity, damages and section 8 actions. Most significantly for CETA purposes – Norton Rose Fulbright is experienced in expedited trial procedure, having been successful counsel on one of the very few pharmaceutical patent actions taken to trial and decided within 24-months.

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

Innovator must be named as respondent when PM(NOC) Regulations engaged

The applicant brought a judicial review application regarding the Minister of Health’s determination that it compared its product to a product with listed patents and was therefore required to address the listed patents. The Federal Court determined that the third-party innovator of the product with listed patents is a person “directly affected” by the application and ought to have been named as a respondent.

Case: Innovator Company v Canada (Attorney General), 2017 FC 548 (Court File No. T-485-17)

Nature of case: Motion for a confidentiality order in the context of an application for judicial review of a decision from the Minister of Health pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations).

Successful party: Attorney General of Canada

Date of decision: June 5, 2017

Background

The applicant, an innovative pharmaceutical company, filed a new drug submission (NDS) with Health Canada. Both the applicant’s and drug’s identities were undisclosed in the decision.

The Minister of Health determined that the applicant’s NDS makes a direct or an indirect comparison to a product for which another innovator has one or more patents listed on the patent register. The other innovator’s identity is also undisclosed. Section 5 of the Regulations is therefore triggered and the applicant is required to address the patents listed against the other innovator’s product.

The applicant sought judicial review of the minister’s decision and also brought a motion for a confidentiality order in respect of its own identity, the identity of its drug product, the entire content of its NDS and any information it provided to the minister in support of its NDS.

The other innovator is not named as a respondent to the judicial review and was therefore not served with or notified of either the notice of application for judicial review or the motion for a confidentiality order.

Regulations confer a “direct benefit” to the innovator

Following prior decisions of the Federal Court, the court concluded that once the minister decides the Regulations are engaged in favour of an innovator, “a direct commercial benefit is conferred on that innovator,” sufficient to provide standing.

The court noted the circumstances of this case are indistinguishable from those in Apotex Inc v Canada (Minister of Health), 2006 FC 846.

The court also considered the decisions in Forest Ethics Advocacy Association v Canada (National Energy Board), 2013 FCA 236 and Hospira Healthcare Corporation v Canada (Health), 2014 FC 179, upheld 2014 FC 235 and 2014 FCA 194 , which held that a proceeding seeking to set aside a decision by the minister that a patent listed on the register must be addressed directly affects the innovator who listed the patent against the referenced product. In Forest, the Court of Appeal clarified that a party has a direct interest not only when its legal rights are affected or legal obligations are imposed on it, but also when “it is prejudicially affected in some direct way.”

As the motion for a confidentiality order “cannot be isolated from the question of whether all of the necessary parties have been properly served notice of the underlying application,” the court adjourned the motion, holding that the motion could not go forward without giving the other innovator an opportunity to be heard. The court ordered that the motion materials be served on the other innovator.

Link:

Innovator Company v Canada (Attorney General), 2017 FC 548

CETA Tracker: Pharmaceutical patent reform to be provisionally implemented in September 2017

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 originally scheduled to come into force on July 1, 2017; however, the Government is now reporting a provisional application date of September 21, 2017.

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

Health Canada consults on changes to broaden access to generic drug equivalence

Health Canada is seeking input on potential changes to the Food and Drug Regulations affecting which drug products would be approvable by way of an abbreviated new drug submission (ANDS) and thus be designated therapeutically equivalent. Comments can be provided until October 13, 2017. This is the first in a series of consultations on the topic.

The proposed changes

Generic drug products can be approved via the ANDS pathway by making reference to a Canadian reference product (CRP), provided the manufacturer can demonstrate that its product is pharmaceutically equivalent and bioequivalent to the CRP, it has the same route of administration, and the conditions of use fall within those of the CRP. Approval through the ANDS pathway constitutes a declaration of “therapeutic equivalence.”

Products with the same medicinal ingredient in the same dosage form are currently considered “pharmaceutical equivalents.”  The proposed changes would allow drug products with different salts, esters, or complexes of the medicinal ingredient, and/or generic drug products with different but comparable dosage forms to the CRP to be considered “pharmaceutical alternatives.” Both pharmaceutical equivalents and pharmaceutical alternatives would be viewed as therapeutically equivalent, provided bioequivalence with the CRP has been demonstrated and the product has the same route of administration and the same safety and effectiveness.

Further, Health Canada is proposing a new definition for “medicinal ingredient” that would change when “sameness” between the generic product and its CRP is determined. Currently, the input material (i.e., the active pharmaceutical ingredient that goes into the manufacture of the drug product) is considered the medicinal ingredient. Health Canada is proposing to “add a definition of medicinal ingredient as the active substance that contains the therapeutic moiety in the drug product that is administered to or consumed by Canadians.”

Link:

Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology

“Promise Doctrine” rejected as a basis for invalidating patents for lack of utility in landmark Supreme Court of Canada ruling

The “Promise Doctrine” has been conclusively rejected by Canada’s highest court as a basis for invalidating a Canadian patent. In a judgment that reverses years of jurisprudence in the lower courts, the Supreme Court of Canada today held that the level of utility required of a Canadian patent must not be measured by statements in the specification. This judgment brings Canadian law more closely in line with that of our international trading partners and is a significant win for patentees and pharmaceutical innovation in Canada.

Case: AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 (SCC File No. 36654), rev’g 2015 FCA 158 (Court File No. A‑420‑14), aff’g 2014 FC 638 (Court File No. T-1668-10)

Drug: NEXIUM® (esomeprazole)

Nature of case: Appeal from declaration of invalidity in infringement/impeachment action under the Patent Act, RSC 1985, c P-4

Successful party: AstraZeneca Canada Inc., AstraZeneca Aktiebolag, and AstraZeneca UK Limited (AstraZeneca)

Date of decision: June 30, 2017

Background

The Supreme Court’s holding comes in the context of a dispute regarding the validity of a patent for esomeprazole, which has been litigated extensively in the Federal Courts. Esomeprazole is a proton-pump inhibitor (PPI) used in the reduction of gastric acid, reflux esophagitis, and related maladies. AstraZeneca Canada Inc. markets esomeprazole in Canada as NEXIUM®, which is claimed in Canadian Patent No. 2,139,653 (the 653 Patent).

In each of the previous judgments on the validity of the 653 Patent, claims were declared invalid for failure to demonstrate or soundly predict “promises” of utility found in the specification. The main issue before the Court was whether, under the Promise Doctrine, these “promises” determined the standard against which utility should be measured.

Appeal allowed: The Promise Doctrine is an error of law

In unanimous reasons, the Supreme Court allowed AstraZeneca’s appeal and struck down the Promise Doctrine as an error of law.

Writing for the Court, Rowe J. emphasised the connection between utility and the subject-matter of the invention:

For the subject-matter to function as an inventive solution to a practical problem, the invention must be capable of an actual relevant use and not be devoid of utility.

With this in mind, Rowe J. held that utility must instead be assessed using the following two-step test:

First, courts must identify the subject-matter of the invention as claimed in the patent. Second, courts must ask whether that subject-matter is useful — is it capable of a practical purpose (i.e. an actual result)?

This new test is driven by the claims of the patent, rather than the description.

Justice Rowe also confirmed that there is a single, low bar for proof of utility, restoring the “scintilla” standard as the focus of the analysis:

The Act does not prescribe the degree or quantum of usefulness required, or that every potential use be realized — a scintilla of utility will do. A single use related to the nature of the subject-matter is sufficient, and the utility must be established by either demonstration or sound prediction as of the filing date[…].

In reaching this conclusion, the Court recognised that the Promise Doctrine was excessively onerous and inconsistent with the scheme of the Patent Act. By wrongly conflating the utility requirement in section 2 with the disclosure requirement in subsection 27(3), the Promise Doctrine had the potential to punish patentees for attempting to fulfill their part of the patent bargain by fully describing the invention and its use.

Declaration of invalidity reversed: The 653 Patent does not lack utility

Applying the correct test for utility, the Supreme Court held that the 653 Patent was valid and reversed the Courts below.

In the Federal Court, Rennie J. had held that the subject-matter of the 653 Patent was “optically pure salts of the enantiomer of omeprazole”. He had also held that one of the utilities identified under the promise doctrine — that these salts would be useful as PPIs to reduce the production of gastric acid — had been soundly predicted by the relevant date.

These holdings were sufficient to support the utility of the 653 Patent: the other promises the lower courts had found in the specification were irrelevant to the utility analysis.

Procedural history

Following the dismissal by Hughes J. of a prohibition application by AstraZeneca under the Patented Medicines (Notice of Compliance) Regulations in 2010, Apotex launched a competing esomeprazole product in Canada. This formed a basis for the underlying action, in which AstraZeneca sued Apotex Inc. and Apotex Pharmachem Inc. (Apotex) for infringement of the 653 Patent.

Apotex defended the action in part by counterclaiming for a declaration of invalidity. In 2014, Rennie J. (as he then was) found the 653 Patent invalid and dismissed AstraZeneca’s action for infringement. Although Rennie J. agreed with AstraZeneca that the claims of the 653 Patent were novel and non-obvious, he found that they were invalid for failure to demonstrate or soundly predict the promised utility of the patent.

As reported here, AstraZeneca appealed from the Court’s declaration of invalidity on the basis that the utility analysis contained a number of legal errors. Writing for a unanimous panel of the Court of Appeal in 2015, Dawson J.A. concluded that Rennie J. had correctly construed the promised utility of the claims in issue and dismissed the appeal. Today’s judgment is rendered on further appeal by AstraZeneca to the Supreme Court of Canada.

On the appeal, the Supreme Court heard oral argument from AstraZeneca and Apotex, as well as the following interveners: Innovative Medicines Canada and BIOTECanada (jointly); the Centre for Intellectual Property Policy; and the Fédération internationale des conseils en propriété intellectuelle. The Court also received written submissions from the Canadian Generic Pharmaceutical Association, the Intellectual Property Owners Association, and the Intellectual Property Institute of Canada.

Innovative Medicines Canada and BIOTECanada were represented on the appeal by Norton Rose Fulbright Canada LLP.

Links

  • The Supreme Court’s decision can be found here.
  • The Federal Court of Appeal Decision can be found here; our summary of the Federal Court of Appeal decision may be found here.
  • The Federal Court decision may be found here.

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.

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