Canada: Galderma Successful In Judicial Review Of PMPRB Decision On Differin

Last Updated: November 17 2017
Article by Andrew Shaughnessy, Teresa A. Reguly and Zhonghui (Sue) Fei

On November 9, the Federal Court issued its ruling on the judicial review of a decision by the Patented Medicine Prices Review Board (PMPRB) regarding the drug product Differin (adapalene), marketed by Galderma Canada Inc (Galderma). 1 The Court reaffirmed the correct approach to determining whether PMPRB has jurisdiction over the price of a drug and, in particular, whether an invention "pertains" to a medicine.

What You Need To Know

  • In determining whether PMPRB has jurisdiction over the price of a medicine, the question is whether the invention described in a patent is intended or capable of being used for that medicine. The PMPRB erred in its analysis by neglecting to determine the invention of the patent in question.
  • The Court reaffirmed that while a high level review of the "face of the patent" is the proper analysis, the correct approach is to read the patent as a whole to determine the invention. The Court emphasized it would be unreasonable to fail to review the patent's claims and description in ascertaining the scope of the invention. Put differently, the court reiterated the importance of reviewing a patent holistically.
  • Importantly, the Court noted that, within the relevant context of standard of review, significant deference will be paid to the Board's decisions, but the decision of whether a patented invention pertains to a medicine is not a discretionary exercise.
  • The Court affirmed the appropriate standard of review for each of the three questions raised by the decision:

    • Matters of natural justice or procedural fairness: correctness standard;
    • PMPRB decision on whether an invention "pertains" to a patent: reasonableness standard; and
    • PMPRB's interpretation of general terms in the Patent Act or principles of general patent law: correctness standard.
  • The Court found it was unreasonable for PMPRB to conclude that a separate invention to a higher concentration, extended release technology was "capable" of being used for the original lower concentration, immediate release formulation of adapalene and quashed the Board's decision on its rule.


The facts of this case relate to two medicines, Differin (a formulation of adapalene in a concentration of 0.1%) and Differin XP (a sustained release 0.3% formulation). Patents on Differin had been duly reported to the PMPRB Staff. They expired in 2009. A different patent had been reported in respect of Differin XP, which expired in 2016. The issue was whether the later patent (to the 0.3% formulation) should have been reported in the post-2009 period for Differin (presumably because, although Differin XP was still under price control, Differin was no longer under the price control jurisdiction of the Board.)

Despite not having taken any steps, in respect of Galderma's alleged failure to report the later patent against Differin, for seven years, The Board staff alleged Galderma had failed to provide the pricing and sales information in relation to the medicines Differin and Differin XP as required by "patentees" under the Act. After a hearing was conducted, the Board concluded the later patent pertained to the medicine Differin and ought to have been reported, meaning that from post-2009 to 2016, Differin would have been under price control.


On judicial review, Phelan J. held that PMPRB made two critical errors in its decision.

First, the Court found errors in the Board's approach to determine whether the later patent pertained to the earlier medicine. The Board noted that the jurisprudence allowed it to assert jurisdiction where the "merest slender thread" of pertinence could be found between a patent and a medicine and argued that this was a matter of deference. The Court ruled, rightly, that the focus of the analysis on whether a patent "pertains" should be a determination of whether the invention in the patent pertains to the medicine. While the Court noted that the Board is entitled to deference on the scope of the word "pertains", that deference applied (on the reasonableness standard) only as the Board asks the right question and "does not stretch the application of 'pertains' such that it strays into constitutionally impermissible grounds"—those grounds being limited to an "invention" that pertains to a medicine.

The court observed that since the PMPRB had used the terms "patent" and "invention" interchangeably in its decision, it was not clear to the Court that the Board was aware that these terms, often used synonymously as a form of short hand, were different under the scheme of the Act with important and distinct meanings.

The court ruled the PMPRB did not identify the invention in the later patent and failed to consider whether the 0.3% extended release formulation disclosed in the later patent was intended or capable of being used for the original 0.1% Differin medicine. Thus, PMPRB wrongly focused on considerations other than the actual invention disclosed in the patent.

Second, while the court agreed with PMPRB that the proper analysis is to review the "face of the patent" when deciding whether an invention pertains to a medicine, this facial review requires that patent be reviewed as a whole. This would include the claims, description, and scope of the invention. The court found that PMPRB failed to review the later patent "holistically" and therefore erred in concluding that the later patent covered more than the 0.3% extended release formulation based on the whole patent, and particularly its claims.

Taken together, it was unreasonable for PMPRB to conclude that on its face the later patent pertained to Differin.


This decision effectively adds significant meaning to jurisprudence and shows that, while the "merest slender thread" of nexus between a patent and a medicine will be required, the analysis must be based on the language of the statute.

While the Board Staff in this, and other cases, has taken the position that a patent containing the active ingredient of a medicine may pertain to the medicine even if it covers a different formulation or dosage format, that practice will have to be reconsidered in light of this decision. In a very clear decision, Phelan J. has clarified that the focus of the analysis has to be whether the invention of the patent pertains to the medicine. This elevates the threshold required in establishing a nexus and in, this case, snapped the thread of pertinence relied on by the Board.


1 See:

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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

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

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
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 (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

To Use 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.


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.


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