Canada: Ethinylestradiol/Drospirenone Formulation Patent Valid And Infringed

Last Updated: October 21 2016
Article by Scott Beeser

On September 7, 2016, Justice Fothergill released his public Reasons and Judgement in consolidated patent infringement/impeachment actions brought by Bayer against Apotex and Cobalt in relation to their various drospirenone/ethinylestradiol products.The patent at issue, Canadian Patent No. 2,382,426, relates to an oral formulation comprising ethinylestradiol and drospirenone particles having a specific dissolution profile. The only asserted independent claim reads:

31. A pharmaceutical composition comprising:

from about 2 mg to about 4 mg of drospirenone particles, wherein the drospirenone is in a form, which when provided in a tablet containing 3 mg of drospirenone, has a dissolution such that at least 70% of said drospirenone is dissolved in 900 ml of water at 37° C. (±0.5° C) within 30 minutes, as determined by USP XXIII Paddle Method using a USP dissolution test apparatus 2 at a stirring rate of 50 rpm, including 6 covered glass vessels and 6 paddles;

about 0.01 mg to about 0.05 mg of 17α-ethinylestradiol; and one or more pharmaceutically acceptable carriers; the composition being in an oral dose form, and the composition being effective for oral contraception in a human female.

Previous proceedings

This is not the first time that the Court has considered the 426 Patent. In a previous prohibition application involving Cobalt under the PM(NOC) Regulations, Justice Hughes rejected Cobalt's allegation that the relevant claim was limited to micronized drospirenone particles. Justice Hughes also rejected all of Cobalt's allegations of invalidity and accordingly granted Bayer's prohibition application in respect of the 426 Patent. Cobalt's appeal of Justice Hughes Judgment in respect of the 426 Patent was subsequently dismissed by the Court of Appeal, which held that the claim covered all drospirenone particles, micronized or not, that met the claimed dissolution criteria.

In a separate prohibition application under the PM(NOC) Regulations against Apotex, Justice Hughes concluded that while Apotex' allegations of invalidity were not justified, based on his construction that drospirenone praticles do not include Bayer had failed to demonstrate that Apotex's allegation of non-infringement was not justified.Justice Hughes accordingly dismissed Bayer's prohibition application in respect against Apotex.

Stare Decisis

In affirming Justice Hughes in the Cobalt PM(NOC) proceedings, the Court of Appeal concluded that Justice Hughes had not erred in his construction of the relevant claim. Before Justice Fothergill the parties raised the issue of whether this construction was binding given that the construction, while a question of law, is heavily dependent on expert evidence. Justice Fothergill held that he was bound to follow the Court of Appeal's construction, inventive concept, and promise of the patent, unless a party provides a good reason not to:

[53] To the extent that this Court may have discretion to follow or depart from the  previous construction adopted in the NOC proceedings, I consider the Federal Court of Appeal's prior construction to be prima facie binding, but acknowledge that it may be revisited if warranted by the evidence. In other words, I will adhere to the construction given to the '426 patent by Justice Hughes and by the Federal Court of Appeal unless a party provides good reason not to. The same holds true when defining the "inventive concept" of the patent and determining the "promise" of the patent, both of which are aspects of claim construction and are therefore questions of law (Sanofi-Synthelabo Canada Inc v Apotex Inc, 2008 SCC 61 at para 67 [Sanofi-Synthelabo]; Weatherford Canada Ltd v Corlac Inc, 2011 FCA 228 at para 24, leave to appeal to SCC refused [Weatherford]; Astrazeneca Canada Inc v Mylan Pharmaceuticals ULC, 2011 FC 1023 at para 87, aff'd on other grounds 2012 FCA 109 [Astrazeneca Canada]).

In application, Justice Fothergill held that was there were no good reasons to depart from the Court of Appeal's previous construction or determination of the inventive concept or promise of the relevant claims. With respect to anticipation, Justice Fothergill held that several phase III clinical trial conducted prior to claim date wherein study subjects had not signed a non-disclosure agreement, was not enabling disclosure. While it was possible that one or more tablets may have found their way in to the hands of the public, this would not enable the skilled person to discover and reverse-engineer the invention without inventive insight. Alternatively, if the distribution of tablets to patients in the phase III trials was enabling, this disclosure fell within the common law experimental use exception.

Justice Fothergill also rejected the other grounds of invalidity:

[188] Based on the preceding analysis, I find claims 31, 48 and 49 of the '426 patent are not invalid based on the asserted grounds of: (i) obviousness; (ii) anticipation; (iii) overbreadth; (iv) insufficiency or ambiguity of the specification; or (v) inutility

Apotex non-infringement – "particles"

Apotex asserted non-infringement on the basis that its tablets did not contain drospirenone particles, but instead contained a "molecular dispersion" that is not in the form of particles. On the basis of substantial competing analytical testing adduced by the parties, Justice Fothergill concluded that at least 90% of the drospirenone in Apotex' tablets is present in the form of particles, such that Bayer had discharged its burden of demonstrating infringement.

Cobalt non-infringement  – admission in pleadings

Cobalt's Statement of Defence and Counterclaim stated:

The Cobalt Product is made by dissolving drospirenone into solution and then spraying this solution onto inert carrier particles. The drospirenone particles that crystallize out once the solution is sprayed on in the Cobalt Product may or may not be in the micron range as per the standard sieve measurement ...

Prior to the hearing, Cobalt unsuccessfully tried to amend its pleading to remove the above passage and brought a second motion to amend supported by additional evidence. Since Cobalt later abandoned both its appeal and its second motion to amend, Justice Fothergill concluded that Cobalt's admission that its product contains some drospirenone particles must be taken as final. Although Cobalt was precluded by its admission from arguing that its product does not contain any drospirenone particles, it was allowed to argue that its tablets did not contain at least 2 mg of drospirenone particles as required by the asserted claims. However, based on the extensive analytical testing adduced by both parties, Justice Fothergill held that Bayer had discharged its burden of showing that Cobalt's tablets infringe each of the asserted claims.

A copy of Justice Fothergill's Judgment may be found here.

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