Canada: Pharmacapsules @ Gowlings - August 21, 2009

Last Updated: August 31 2009


  • FDA To Speed Up Inspection And Warning Process
  • U.S. Patients Receive Greater Access to Unapproved Medications
  • Recent Cases

FDA To Speed Up Inspection And Warning Process
Isabel Raasch

On August 6, 2009, the USFDA's top official Margaret Hamburg vowed to speed up the reporting of warnings related to problems found during inspections and to act more aggressively in serious cases that could harm consumers and patients. The announcement follows criticism of the delays caused by the agency's previous requirement that all warning letters be reviewed by the agency's top lawyer before being sent to manufacturers. This procedure will now only be used for certain legally complex cases. Under the new policy, the agency will strive to send warning letters promptly, whereupon companies will have up to 15 working days to respond before the agency takes further action. Ms. Hamburg also stated that the agency will move quickly to close cases after problems found during inspections have been resolved and that it would make such information public.

For more information, please see:

U.S. Patients Receive Greater Access to Unapproved Medications
John Norman

Seriously ill patients will have greater and easier access to unapproved medicines due to new USFDA regulations. The new rules establish who is eligible for these new experimental drugs and when manufacturers can charge for them. The FDA predicts a 50% increase in individual applications, and a 25-50% increase in applications from groups of patients. It is also hoped these new rules will encourage companies to provide experimental medicines outside of clinical trials.

For more information, please see:

Recent Cases
By: Beverley Moore

Purdue v. Pharmascience; merits of a 55.2 proceeding; 2009 FC 726; oxycodone; July 16, 2009

The Court granted an order of prohibition to Purdue in the face of Pharmascience's allegations that the patent was invalid.

Regarding the anticipation allegation, the Court found that none of the alleged documents met the disclosure requirement. In considering obviousness, the Court applied the Supreme Court's test in Sanofi and looked at testimony from the inventors as well as the experts. The Court then went on to hold that a considerable amount of work had been required in order to achieve the invention. Furthermore, the trials of the inventors were not routine and it was not self-evident that what was being tried ought to work. Thus, the work was inventive. The Court also found in favour of Purdue regarding the allegations of inutility and overbreadth.

The full text of the decision can be found at:

Apotex v. Lilly; interlocutory motion in a section 8 proceeding; 2009 FC 693; raloxifene; July 3, 2009

Apotex brought an actionpursuant to section 8 of the NOC Regulations and as part of its relief, Apotex claimed that it should be compensated by a disgorgement of Lilly's revenues through an application of the principles of unjust enrichment. Lilly brought a motion to strike that part of the claim. The Court granted the motion to strike.

The Court held that as there has been a judicial determination of the available remedies under section 8 in the context of a full trial, it can now make preliminary determinations on motions to strike. The Court held that it was bound by the Court of Appeal in Merck which held that the only remedies included in section 8 are those that would compensate the generic company for the losses it had suffered. An accounting of profits has the same remedial aim as unjust enrichment, in that it would return to the plaintiff what rightly belongs to it, namely the revenues earned by infringing use of its intellectual property. As the generic company is not a patentee, it cannot claim these remedies. The Court further found that a private cause of action entirely based on unjust enrichment is outside the jurisdiction of the Federal Court.

By motion, Lilly had also requested a stay of the section 8 proceeding pending its motion for leave to appeal the underlying Court of Appeal decision to the Supreme Court. The stay was declined.

The full text of the decision can be found at:

Abbott v. Sandoz; merits of a 55.2 proceeding; 2009 FC 648; clarithromycin; July 7, 2009

The application involved two patents. The Court granted prohibition on the basis of one of the patents, but not the other. Both patents related to extended release formulations.

The Court addressed obviousness allegations against both patents but found that neither allegation was justified. The Court also found in favour of Abbott on the inutility claims of one of the patents.

However, the allegations of double patenting were found justified in part. In particular, double patenting was asserted in respect of two patents. In respect of the first, the Court did not find double patenting on the basis that it was a forced divisional. However, in respect of a second patent, the Court held there was double patenting and refused to consider the dedication to the public, because the dedication occurred after the NOA. The Court held that a patent's claims should be construed as of the date of the NOA. Thus, no effect could be given to a dedication that occurred after the NOA. The Court found that this patent in the proceeding was not patentably distinct over the dedicated patent.

The full text of the decision can be found at:

ratiopharm v. Pfizer; impeachment decision; amlodipine; July 8, 2009

The Court found the patent invalid on all five grounds alleged in final argument, namely obviousness, improper selection, utility, sufficiency and section 53 of the Patent Act.

During the course of the trial, the court considered a single claim which was specific to the besylate salt of amlodipine. Once construed, it was found to be unrestricted as to any particular use or form of the compound. The Court considered a number of factual witnesses detailing the background of the invention and the drafting of the patent. The Court also considered the number of expert witnesses from both sides.

In addressing the obviousness allegations, the Court found that the besylate salt was found through routine salt screening tests. Furthermore, the Court held that it was not clearly superior to the other salts screened and that it was chosen as a reasonable compromise. Thus, the patent was found invalid for obviousness. The Court then addressed the selection patents, indicating that this should really be a question of obviousness. Considering the language used in the patent, the Court held that superlatives in the patent cannot create a selection patent where none in fact exists. As, on the face of the evidence, the Court found that there was nothing unique or outstanding about the besylate salt, the patent was invalid as a selection patent.

The Court then found that the promise of the patent was that the besylate salt would be unique and outstanding. When the evidence was considered, the Court held that this was not the case. Thus, the promise was not fulfilled and the patent was invalid for inutility. Furthermore, the Court found that there were a number of serious errors, omissions and insertions in the patent as well as general departures in comparison to what the inventors had contemplated. Thus, the patent was invalid for insufficiency.

Finally, the Court considered section 53 of the Patent Act and due to those same errors and omissions, the Court found that there were misstatements in the patent, they were misleading and there was sufficient intent to make those misleading statements. Thus, the patent was invalid under section 53 of the Patent Act.

This decision has been appealed.

The full text of the decision can be found at:

Canada Research-Based Pharmaceutical Companies (Rx&D) et al. v. Canada; Judicial Review of PMPRB decision; July 10, 2009

In this decision, the innovators were successful in overturning the PMPRB's requirement for reporting of third party payments. A full summary of this decision can be found in Gowlings' recent Drug Pricing and Reimbursement newsletter here.

The Full text of the decision can be found at:

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.

In association with
Related Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
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 (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