Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (Part 2) – Contributory infringement

by FPA Patent Attorneys
Contact

[authors: James Cherry & Milena Dryza]

The scope of what conduct constitutes contributory infringement in Australia remains unclear but is now potentially broader as a result of this decision. Contributory infringement will always depend closely upon the facts, and, in this case, the Federal Court of Appeal in Australia had interpreted method of treatment claims as having an element of intention.1  In Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd - Claiming intent we dealt with the construction and novelty of the relevant claim. The focus of this article is the way the Federal Court of Appeal analysed the issue of contributory infringement under Australian law. This is particularly topical given the recent Federal Circuit decision in the US regarding inducement of patent infringement.

In this case, the issue was whether the sale of a generic leflunomide product by Apotex Pty Ltd for the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) would infringe the single claim of Sanofi-Aventis Deutschland GmbH’s Australian patent number 670491. The claim is:

A method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of a pharmaceutical composition containing as an active ingredient a compound of formula I or II…

The compound of formula I is the active leflunomide. As discussed in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd - Claiming intent, the trial judge found as facts that:

(i) a person suffering from RA may have or develop psoriasis;
(ii) a person suffering from PsA will almost always have psoriasis; and
(iii) by administering leflunomide to a person with RA and/or PsA (as taught in the prior art), any psoriasis that the patient may have or may develop would inevitably be prevented or treated.

The appeal judges construed the claim as being limited to the administration of leflunomide for the objective of preventing or treating psoriasis, regardless of whether other conditions (such as RA and/or PsA) may also be treated, or were sought to be treated, by its administration. In light of this claim construction, Apotex itself was found not to directly infringe the claim.

However, Apotex was still held to infringe the claim by way of contributory infringement by supplying leflunomide with a Product Information (PI) leaflet, which included a statement that this leflunomide product “is not indicated for the treatment of psoriasis when it is not associated with manifestations of arthritic disease”.

Contributory infringement

The legislative provision governing contributory infringement in Australia is s 117(1), which states:2

If the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent.

In cases such as Rescare Ltd v Anaesthetic Supplies Pty Ltd,3  this provision has been interpreted as being limited to only those situations where it is a product that is the subject of a patent claim (or a product resulting from the use of a patented method or process), and therefore it does not apply where the subject of a patent claim is a method or process of using a product. That is, where the patent involves a method or process claim, there must be a product resulting from an infringing use of the method or process for there to be contributory infringement under s 117(1). Other decisions have taken a less restrictive view (for example, Bristol-Myers Squibb Co v FH Faulding).4

Two questions in the present case were whether the supply of an input (ie Apotex’s generic leflunomide product) for use in a patented method of treatment was capable of attracting the operation of s 117(1), and, if so, whether the statement in the PI affected that operation.

In the present case, s 117(1) was considered to have a broader application – that is, it extended to method of treatment patents. The Court therefore concluded that, because psoriasis would inevitably be treated when Apotex’s generic leflunomide product was administered to a patient, Apotex, through its PI (which, as mentioned above, indicated use of the generic leflunomide product for the treatment of arthritic disease) was held to contravene s 117(2)(c).  In addition, it was held that Apotex had reason to believe that its generic leflunomide product would be used in a method of preventing or treating psoriasis (in contravention of s 117(2)(b)).5 Therefore, Apotex, by supplying pharmacists (who would then supply a patient) with its generic leflunomide product, was held to infringe the method of treatment claim by contributory infringement.

This decision highlights some of the vagaries of s 117 contributory infringement. It re-enforces the need to be aware of any rights that competitors may have in methods of using products (even in the absence of any patent rights to the products themselves) and that method claims may be infringed even when it is not intended that a claimed method be carried out.

1. Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2) [2012] FCAFC 102.
2. Patents Act 1990.
3. (1992) 25 IPR 119.
4. (2000) 46 IPR 553.
5. s 117(2) A reference in subsection (1) to the use of a product by a person is a reference to:

(b) if the product is not a staple commercial product – any use of the product, if the supplier had reason to believe that the person would put it to that use; or
(c) in any case – the use of the product in accordance with any instructions for the use of the product, or any inducement to use the product, given to the person by the supplier or contained in an advertisement published by or with the authority of the supplier.

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© FPA Patent Attorneys | Attorney Advertising

Written by:

FPA Patent Attorneys
Contact
more
less

FPA Patent Attorneys on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Privacy Policy (Updated: October 8, 2015):
hide

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.

Security

JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at info@jdsupra.com. In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at: info@jdsupra.com.

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
Feedback? Tell us what you think of the new jdsupra.com!