Canada: HERCEPTIN Patents Survive Preliminary Non-Infringement Challenge In The First Motion Under Section 6.08 Of The Patented Medicines (Notice Of Compliance) Regulations

In one of the first actions brought under the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”), Genentech and Roche sued Amgen for infringement over its KANJINTI product, a biosimilar of Roche’s trastuzumab (HERCEPTIN) product. Amgen recently brought a motion under section 6.08 of the Regulations (the first one under this section) to dismiss the action with respect to Canadian Patent Nos. 2,376,596 and 2,407,556 (there are also two other patents at issue in the action). This section permits the Court to dismiss a patent infringement action brought under the Regulations if it is redundant, scandalous, frivolous, or vexatious, or is otherwise an abuse of process. Prothontary Aylen dismissed Amgen’s motion (reported at 2018 FC 694), finding that it was not plain and obvious that Genentech’s infringement claim with respect to the 596 and 556 Patents would fail. 

As background, section 6.08 came into force in September 2017 as part of a significant overhaul to the Regulations. Prior to the amendments, proceedings under the former Regulations were summary applications. They determined only whether to prohibit the Minister of Health from issuing marketing authorization of a medicine to a generic (the “second person” under the Regulations), based on the generic’s allegations of patent non-infringement or invalidity. They were not determinative of the parties’ substantive rights. This scheme frequently resulted in a multiplicity of proceedings (applications under the Regulations, followed by full patent impeachment or infringement actions). Since the amendments came into force, proceedings under the Regulations are now full actions, with discovery and a trial. They are determinative of patent infringement and validity.

The Court noted that the language of section 6.08 is essentially the same as former section 6(5)(b) of the Regulations, and the jurisprudence of that section applies. The threshold to succeed is high, and the moving party bears the onus of demonstrating that the claim is so clearly futile that it does not have the slightest chance of success. In other words, it must be plain and obvious that the claim has no chance of succeeding. The Court noted that in theory it should be easier for a plaintiff to resist a section 6.08 motion, because the plaintiff is now entitled to discovery of the defendant (which it was not under the former Regulations). 

Importantly, the Court observed that the consequences of granting a motion under section 6.08 are more significant than under former section 6(5)(b). This is because if it strikes the claim, section 6.01 precludes the plaintiff from subsequently commencing an action for infringement (which was open to it under the former Regulations). Therefore, the Court should have a heightened level of caution in striking claims under section 6.08, and it should grant such motions only in the clearest of cases. 

The Court also noted that its role on this type of motion is simply to determine whether the plaintiff raises an arguable case such that it is not plain and obvious that the action will fail. It is not a hearing on the merits, and generally, substantive arguments regarding claim construction and non-infringement should be addressed at trial.   

There were two patents at issue on Amgen’s motion – the 596 Patent and the 556 Patent. The 596 Patent relates to the biologic drug pertuzumab (marketed by Roche under the name PERJETA). Several claims relate to the use of pertuzumab in combination with trastuzmab. 

The 556 Patent relates to the use of trastuzumab in a patient whose her2 gene in tumour cells has been found to be amplified (for example as measured by fluorescent in situ hydridization or “ISH”), and whose tumour cells have HER2 expression level of 0 or 1+ as determined by immunohistochemistry (“IHC”).

Amgen moved to dismiss the action on the basis that it would not infringe the 596 or 556 Patents.  Regarding the 596 Patent, Amgen argued that it was not seeking approval for the use of KANJINTI in combination with PERJETA, and it expressly carved out such combination therapy from its draft product monograph which makes no mention of it. Any physicians who prescribe KANJINTI in combination with PERJETA would be doing so simply in furtherance of the current standard of care, not because of Amgen’s influence. Amgen argued that it was not doing “something more” than selling the product, for an old use (monotherapy). It must do “something more” to induce infringement.

Genentech argued that KANJINTI would be publicly funded for use in combination with PERJETA. Also, there is a factual dispute whether prescribing KANJINTI in combination with PERJETA would be an off-label use, or whether it is consistent with its overall metastatic breast cancer indication. Even if physicians prescribe KANJINTI in combination with PERJETA in accordance with the current standard of care and not the product monograph, it may still be the “something more” required to find inducement. Amgen’s express failure to prohibit combination therapy in its product monograph, together with the other outlined factors, supports a finding of inducement. The trial judge must determine these contested matters.

The Court found that given these contentious matters, the plaintiffs have at least an arguable case of inducing infringement in relation to the 596 Patent, and it was not plain and obvious that they could not succeed at trial.

Regarding the 556 Patent, Amgen argued that it would not induce infringement because the manner in which the patient’s HER2 status is determined will not play any role in Amgen’s marketing plans. The product monograph directs third parties to test HER2 status by either immunohistochemistry or in situ hybridization. Therefore, it would not induce any physician or patient to use both tests. Amgen also argued that the meaning of the patent claims was clear and no claims construction analysis is required.  The claims relate to a new way of identifying patients who would benefit from HERCEPTIN treatment.

Genentech argued that the claims are not about identifying patients. Rather, they relate to treating patients with HERCEPTIN if they fall within the specific patient population of those having her2 gene amplification and who are IHC 0 or 1+. Amgen made the deliberate decision to refer to ISH testing in its product monograph. It could have referred only to IHC testing, like the original product monograph for HERCEPTIN. This shows Amgen’s intent to influence physicians to use both IHC and ISH testing. Amgen cannot seriously dispute that its intention is to treat the 556 Patent patient population, and it cannot simply ignore the inevitable infringement that it puts in motion.

After reviewing the evidence and submissions, the Court found that there was a debatable issue about the meaning of the 556 Patent’s claims. Because of this, and the evidence on the motion, the Court held that it was not plain and obvious that the plaintiffs’ claim for infringement by inducement could not succeed. 

Accordingly, Prothonotary Aylen dismissed Amgen’s motion with costs.

While most of the Court’s decision turned on facts and arguments specific to the case at hand, of specific note was the Court’s rationale that defendants should be held to a higher standard when moving to dismiss an action under section 6.08 than under the former section 6(5)(b). Given the Court’s cautionary warning, it will be interesting to see how law develops under section 6.08, and in particular, under what circumstances a defendant will be able to establish the necessary facts to meet such a high threshold.

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
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must 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