Canada: Patent Act Infringement Actions Cannot Be Joined To PM(NOC) Infringement Actions During NOC Prohibition Period

The Federal Court recently confirmed that an infringement action under the Patent Act cannot be joined with an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations) while the Regulations prohibit the Minister from granting a NOC. The Court stated that an infringement action under the Patent Act could instead be brought in a separate proceeding.

With cooperation between the parties and simultaneous scheduling of the trial of common issues, separate Patent Act and Regulations infringement proceedings could proceed efficiently without formal joinder. The Court's position is consistent with its recent decision in Bayer Inc. v Teva Canada Limited, 2019 FC 191 (Tabib P.).

Background: Pharmascience seeks to market a new dosage form

Teva markets glatiramer acetate in Canada under the brand name Copaxone in two dosage strengths: 20 mg/mL and 40 mg/mL. Copaxone is used in the treatment of multiple sclerosis. Teva listed Canadian Patent No. 2,702,437 (the 437 Patent) on the Patent Register in respect of 40 mg/mL Copaxone; however, no patents were listed against 20 mg/mL Copaxone.

Pharmascience obtained a Notice of Compliance (NOC) to market its own 20 mg/mL glatiramer acetate product, Glatect 20 mg, in August 2017. Pharmascience was not required to address the 437 Patent because it was not listed against the 20 mg/mL product.

In November 2018, Pharmascience filed a Supplementary New Drug Submission (SNDS) for approval to market Glatect 40 mg and was therefore required to address the 437 Patent, which it did by way of Notice of Allegation (NOA). Teva responded by filing an infringement action pursuant to subsection 6(1) of the Regulations, asserting that:

  • Pharmascience would infringe the 437 Patent by marketing Glatect 20 mg and Glatect 40 mg in accordance with the SNDS; and
  • Pharmascience was already infringing the 437 Patent through its past or current activities relating to Glatect 20 mg.

This decision concerns a motion by Pharmascience to strike Teva's pleadings relating to Glatect 20 mg.

Strict rule against joinder: the Court strikes Teva's infringement claim in part

The Federal Court struck Teva's infringement claim relating to Pharmascience's past or current activities relating to Glatect 20 mg because they were not done "in accordance with the submission or supplement" that precipitated the NOA underlying the proceeding, as required by subsection 6(1) of the Regulations. Rather, they were done pursuant to Pharmascience's earlier submission for Glatect 20 mg, which did not trigger the Regulations.

Having found that Teva's claim for past and current infringement could not be grounded in subsection 6(1) of the Regulations, the Court went on to consider whether it could be supported by subsection 55(1) of the Patent Act instead. The Court held that Teva was free to bring such a claim. In particular, the Court confirmed that such a claim would not be barred by section 6.01 of the Regulations because it could not have been brought pursuant to subsection 6(1).

However, the Court found that once properly constituted under subsection 55(1) of the Patent Act, Teva's claim for past and current infringement could not be joined with the subsection 6(1) action due to the rule against joinder in section 6.02 of the Regulations. The Court held that this provision strictly prohibits the combination of subsection 6(1) actions with any other rights under the Patent Act while the Minister is prohibited from granting a NOC by the statutory stay under subsection 7(1) of the Regulations. The Court found that this mandatory prohibition on joinder left no discretion to the Court, unlike the rule of joinder under the Federal Courts Rules.

Accordingly, Teva's infringement claim regarding Pharmascience's past or current activities marketing Glatect 20 mg was struck as failing to disclose a reasonable cause of action.

Pharmascience also argued that the balance of Teva's claim in respect of Glatect 20 mg should be struck on the basis that the SNDS in issue only pertained to Glatect 40 mg — as such, Pharmascience would not make, construct, use, or sell Glatect 20 mg in accordance with the SNDS even after it issued. The Court rejected this argument on the basis of Teva's pleading that Pharmascience's SNDS related to both Glatect 20 mg and Glatect 40 mg. In doing so, the Court refused to consider affidavit evidence filed by Pharmascience to contradict the pleading in the statement of claim, finding that it was required to take the pleading as true for the purpose of determining whether the pleading disclosed a reasonable cause of action.

The Court also dismissed Pharmascience's assertion that Teva's claim was frivolous, vexatious, or an abuse of process. In reaching its conclusion on this issue, the Court found that it was permitted to receive evidence, but stated that it had significant doubts as to the propriety of using such a motion as a means of adducing evidence that goes specifically to disproving the truth of an allegation of fact made in a pleading.

Teva Canada Innovation v Pharmascience Inc., 2019 FC 595 (Tabib P.)


About Norton Rose Fulbright Canada LLP

Norton Rose Fulbright is a global law firm. We provide the world's preeminent corporations and financial institutions with a full business law service. We have 3800 lawyers and other legal staff based in more than 50 cities across Europe, the United States, Canada, Latin America, Asia, Australia, Africa, the Middle East and Central Asia.

Recognized for our industry focus, we are strong across all the key industry sectors: financial institutions; energy; infrastructure, mining and commodities; transport; technology and innovation; and life sciences and healthcare.

Wherever we are, we operate in accordance with our global business principles of quality, unity and integrity. We aim to provide the highest possible standard of legal service in each of our offices and to maintain that level of quality at every point of contact.

For more information about Norton Rose Fulbright, see nortonrosefulbright.com/legal-notices.

Law around the world
nortonrosefulbright.com

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 Mondaq.com.

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

Authors
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
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