Canada: 2018 Highlights In Canadian Life Sciences IP

Last Updated: January 10 2019
Article by Nancy Pei

In 2018 we reported on a number of developments in life sciences IP and regulatory law. Our most-read articles were: #1 a June update on biosimilars (authored by Urszula Wojtyra); #2 a "live" summary chart of Vanessa's Law developments (authored by Katie Lee); and #3 an article reporting on a decision that a use patent for infliximab was valid and infringed by Hospira's biosimilar INFLECTRA (authored by Katie Lee and Urszula Wojtyra).  We review these and other top developments below. 

Decisions under appeal are noted with an *.

1.  Biosimilars Update: Consultation on naming approaches; Janssen patent valid and infringed by INFLECTRA; CADTH environmental scans

Our most-read article this year was our mid-year update on biosimilars, including on 2018 biosimilar marketing approvals (there were four by year-end, with a December approval of BGP Pharma's FULPHILA (pegfilgrastim), a biosimilar of NEULASTA) and ongoing litigation matters. There was a  consultation on naming (January) and the Canadian Agency for Drugs and Technologies in Health (CADTH) revised its  biosimilar review process (February). In March, our third most-read article reported on the Federal Court's  finding* that a patent for a use of infliximab (Janssen's  REMICADE) was valid and infringed by Hospira's biosimilar INFLECTRA (approved in 2014). CADTH released two environmental scans relating to biosimilars: Biosimilars — Regulatory, Health Technology Assessment, Reimbursement Trends, and Market Outlook (January) and International Policies on the Appropriate Use of Biosimilar Drugs (October).  A reminder that Health Canada's listing of submissions under review includes biosimilars, which now includes sponsor names for new entries.

2.  Proposed PMPRB amendments still under consideration; litigation matters pending

Proposed Regulations Amending the Patented Medicines Regulations remain under consideration; they were not finalized and in force on January 1, 2019, as originally planned. Potential changes to the Patented Medicine Prices Review Board (PMPRB)'s pricing criteria include expanding the list of comparator countries, but excluding the U.S. and Switzerland, and taking into account pharmacoeconomic value. The proposed amendments contributed to Canada's appearance on the Office of the U.S. Trade Representative's 2018 Priority Watch List. A steering committee on proposed reform and associated guidelines had its first meeting in June. Its work, and that of a technical working group, is ongoing (see latest status here).

Alexion's application for leave to appeal a decision dismissing its challenge to the constitutionality of certain PMPBR provisions of the Patent Act was dismissed in June. Two other court cases are pending: (i) Alexion's judicial review application of the  Board's SOLIRIS decision on use of the Board's Guidelines was heard; a decision is pending and (ii) the  PMPRB's appeal relating to Galderma's DIFFERIN on the jurisdictional issue of whether an invention "pertains to" a medicine is scheduled to be heard by the Federal Court of Appeal (FCA) on January 17, 2019.

The PMPRB's 2017 Annual Report was released in August 2018.

3.  Certificates of supplementary protection

Certificates of supplementary protection (CSPs) provide an additional patent-like protection term of up to two years, and are intended to partly compensate for the time required to obtain Canadian regulatory approval. Canada's regime  came into force on September 21, 2017. We published a  chart comparing CSPs to European Supplementary Protection Certificates and a first anniversary update, which provides a summary of the elements of the regime (including key deadlines) and the nature of the rejections to that date. GlaxoSmithKline's application for judicial review of the rejection of a SHINGRIX CSP application remains pending.

4.  Amended PMNOC Regulations: Early procedural decisions, updated Health Canada guidance

Substantial amendments to the Patented Medicines (Notice of Compliance) Regulations  (PMNOC Regulations) came into force on September 21, 2017 (see our comparison to the Hatch-Waxman regime). On May 11, Health Canada issued  updated Guidance on matters including Patent Register eligibility of CSPs. In July, Health Canada released the Therapeutic Products Directorate Statistical Report 2017/2018 providing an overview of its administration of the PMNOC Regulations and the data protection regime for the year ending March 31, including court activity under both regimes. We provided a first anniversary update with a summary of the various procedural decisions within the first year. Further procedural decisions include: (i) an innovator was not precluded from asserting a patent under the amended PMNOC Regulations after being unsuccessful on an invalidity allegation under the pre-amended PMNOC Regulations; (ii) a concurrent trial on common invalidity issues involving two generic manufacturers was ordered; and (iii) claims for damages and profits were not struck. By November 2019, barring any extensions of the statutory stay, all applications under the pre-amended PMNOC Regulations will be concluded, marking the end of a 26.5-year era.

5.  Decisions on the merits: PMNOC applications and actions

There were only three PMNOC decisions on the merits in 2018: (i) Shire was successful* against Apotex in a consolidated prohibition application and impeachment action relating to its patent for lisdexamfetamine (a prodrug of amphetamine, VYVANSE); (ii) Apotex was successful in its obviousness allegation relating to Eli Lilly's patent for use of prasugrel (EFFIENT) in combination with aspirin in diseases caused by thrombus or embolus; and (iii) Ranbaxy was successful  in its non-infringement allegation relating to Valeant's modified-release tablet formulation patent covering its bupropion extended-release tablets (WELLBUTRIN XL). 

There were also three decisions on the merits in impeachment/infringement actions: (i) Janssen was successful* in infliximab (see #1 Biosimilars, above) on infringement and validity of a patent relating to the use of infliximab in combination with methotrexate for the treatment of rheumatoid arthritis, including on the issue of obviousness (the quantification stage is ongoing); (ii) Shire was successful* in lisdexamfetamine (consolidated with the PMNOC application noted above); and (iii) Teva was successful* in responding to Janssen's counterclaim for infringement of three patents relating to bortezomib (see #6 Section 8 damages, below); the compound patent and a formulation patent were found obvious and a process patent was found not infringed. The Federal Court separately held that AstraZeneca was  entitled to a declaration of infringement in AstraZeneca's esomeprazole (NEXIUM) infringement action against Apotex (following the Supreme Court of Canada decision striking down the promise doctrine).

There were no appeal decisions on the merits in PMNOC applications or liability-phase decisions in infringement/impeachment actions, although the FCA did confirm that an infringer does not have the right to elect a patentee's remedy.

6.  Section 8 and other claims following failed PMNOC Regulations proceedings: No section 8 liability for valid and infringed patent in NEXIUM proceedings; Teva succeeds in olanzapine section 8 appeal and bortezomib section 8 action

There were three decisions on the merits (including one appeal) regarding claims under pre-amended section 8: (i) AstraZeneca was found not liable to Apotex for any section 8 damages relating to its esomeprazole magnesium product (a generic version of AstraZeneca's NEXIUM), as Apotex's claim would be fully offset by its liability for patent infringement in the but-for world; (ii) the FCA  dismissed Eli Lilly's appeal of a decision awarding $70 million in section 8 damages to Teva, relating to its lost olanzapine sales (a generic version of Eli Lilly's ZYPREXA), but granted Teva's cross-appeal seeking lost pipefill sales and an adjustment for under-reporting of sales (Eli Lilly's subsequent application for leave to appeal was dismissed); and (iii) the Federal Court granted* Teva's section 8 claim relating to bortezomib (Janssen's VELCADE), rejecting the defence of infringement and dismissing the counterclaim for infringement (see #5 Decisions on the merits, above). 

Separately, in November, in an action by Apotex for compensation from Sanofi and Schering under the Ontario Statute of Monopolies, U.K. Statute of Monopolies (premised on the assertion of an invalid patent) and the Trade-marks Act, the Ontario Court of Appeal granted Sanofi and Schering leave to amend their defences to plead that the Federal Court relied on wrong legal principles in finding the patent at issue invalid in light of special circumstances arising from the subsequent Supreme Court of Canada's NEXIUM decision striking down the promise doctrine. 

7.  Damages and accounting references: Teva's $19 million levofloxacin damages appeal dismissed; $61 million perindopril profits award against Apotex stands; $75 million cefaclor prejudgment damages interest award against Apotex remitted for reconsideration

The FCA  dismissed Teva's appeal relating to Janssen's damages ($19 million) for infringement of Janssen's patent for levofloxacin (LEVAQUIN) and affirmed that Janssen U.S. had standing to make a claim, i.e., it was not required to demonstrate that it had engaged in conduct in Canada that would otherwise amount to infringement. Teva's subsequent application for leave to appeal was dismissed.

Servier and ADIR were  successful* in the redetermination of the profits reference relating to perindopril (Servier's  COVERSYL): the Federal Court again dismissed Apotex's non-infringing alternative (NIA) defence, finding that Apotex would not have called on foreign third parties to manufacture perindopril to supply Apotex affiliates in the U.K. and Australia. The original $61 million profits award against Apotex was therefore re-affirmed.

The FCA allowed in part Apotex's appeal of a decision awarding Eli Lilly over $100 million for Apotex's infringement of patents related to cefaclor. The Federal Court had awarded Eli Lilly $75 million in prejudgment interest as damages for the lost time value of its lost profits. The FCA remitted the decision to the Federal Court for reconsideration solely on the issue of interest. The Court also provided guidance regarding the application and objective of the NIA defence.

8.  Treaty/Legislative Updates: CUSMA, proposed amendments to Patent Rules, Patent Act amendments

The United States-Mexico-Canada Agreement (CUSMA or USMCA), which (if ratified) will replace the North America Free Trade Agreement (NAFTA), was signed on November 30. CUSMA's required changes include: (i) an extension of the data protection term for biologics from eight to ten years, which must be implemented within five years of CUSMA entering into force and (ii) patent term adjustment to compensate for Patent Office delays. 

Significant proposed amendments to the Patent Rules (mainly to implement the Patent Law Treaty) were released on December 1. See our IP Update for twelve notable proposed changes and tips. The amendments are expected to come into force in 2019.

Amendments to the Patent Act (Bill C-86, Budget Implementation Act, 2018, No. 2) came into force on December 13 and include: (i) admissibility of prosecution histories to rebut patentee's representations as to patent construction; (ii) codification of an experimental use exception to infringement; and (iii) expansion of the scope of prior user rights.

9.  Health Canada: Strengthening post-marketing oversight, aligned reviews with health technology assessment organizations (HTAs), generic submissions under review now public

The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), which was approved on November 6, 2014, amended the Food and Drugs Act and granted the Minister of Health new post-marketing oversight powers over therapeutic products. See our summary chart (our second most-read article) of the related developments to date including those reported in our mid-year update (#9), a guidance document on notifying Health Canada of foreign actions and revised guidance documents on post-notice of compliance changes. In July, the Federal Court ordered Health Canada to release requested copies of all sections of all clinical study reports and all electronic datasets from certain clinical trials under the confidential business information provision.

As of June 22, Health Canada permitted biological (including biosimilar) and pharmaceutical new drug submission sponsors to seek aligned reviews between Health Canada and CADTH and l'Institut national d'excellence en santé et en services sociaux (collectively, the HTAs).

Health Canada's Drug Submission Performance Annual Reports for the year ending March 31, 2018 report on review activity including approval times. A Drug and Medical Device Highlights 2017 report from July 2018 includes numbers on new drugs and medical devices approved, brief details of approvals, post-market surveillance, and 2017 accomplishments.

In August, the Minister of Health made an  interim order permitting the importation and sale of FDA-approved epinephrine auto-injectors, AUVI-Q, for use in emergency treatment of life-threatening allergic reactions, to address the shortage of EpiPen products.

Beginning October 1, Health Canada expanded its Submissions Under Review list (accessible here), including to extend to abbreviated new drug submissions (submissions for generic products)(see Generic Submissions Under Review (GSUR) List) and to add sponsor names to new drug submissions and supplemental new drugs submissions.  Health Canada also expanded its Regulatory Decision Summaries (accessible here) to extend to final positive and negative decisions for ANDSs and supplemental ANDSs that may be of interest, including where it deviated from guidance.  In December, Health Canada released a helpful comprehensive list of its drug and medical device databases, including the above.

Also in December, Health Canada released an action plan for medical device reform.

10.  Consultation on National Pharmacare

On February 27, the creation of an Advisory Council on the Implementation of National Pharmacare (Council) was  announced and on April 19, the Standing Committee on Health  released a report advocating for a national pharmacare program, specifically, a single payer universal publicly funded prescription drug coverage program for all Canadians. On June 20, the Council was launched, together with release of a Discussion Paper and the opening of a http://www.smart-biggar.ca/newsletters/RxIPUpdate_August2018.html#story7public consultation, which closed on September 28.

11.  Other litigation: Apotex succeeds in claim against CRO; FCA dismisses Apotex's appeal in judicial review of Health Canada decision seeking further information from facilities in India 

Released in December 2017 but as we reported in January, the Ontario Superior Court of Justice held that Apotex was entitled to over $11million, plus interest, for losses flowing from delays in the U.S. Food and Drug Administration (FDA)'s approval of Apotex's amoxicillin-clavulanic  acid and levodopa-carbidopa products caused by the contractual breaches and negligence by MDS Pharma Services, a contract research organization (CRO). 

In August, the FCA dismissed Apotex's appeal of the dismissal of its application for review of Health Canada's decision to require Apotex to submit additional information for products manufactured or tested in Apotex's facilities in India. Apotex has sought leave to appeal.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
Similar Articles
Relevancy Powered by MondaqAI
Norton Rose Fulbright Canada LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Norton Rose Fulbright Canada LLP
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions