Did You Miss Them? - Four Important Patent Cases In 2013

by FPA Patent Attorneys

This article outlines the main findings in Apotex v Sanofi-Aventis1, Cancer Voices Australia v Myriad Genetics2, Research Affiliates3 and RPL Central4 each of which have important implications for patent law in Australia.

Apotex v Sanofi Aventis - Methods of Medical Treatment

The highest court of Australia confirmed the patentability of methods of medical treatment of humans in Apotex v Sanofi-Aventis5.

In this case, Apotex appealed to the High Court on the basis that the Sanofi-Aventis patent claims a method of medical treatment and was therefore not patentable subject matter. Sanofi-Aventis claimed a method for preventing or treating psoriasis by administrating an effective amount of leflunomide. Leflunomide was already known and registered for use in the treatment of rheumatoid arthritis (RA) and psoriatic arthritis (PsA). It was held (by a 4:1 majority) that a patent for administration of a pharmaceutical substance (with prior therapeutic uses) for a hitherto unknown therapeutic use was patentable subject matter.

For more information see our article; Pharmaceutical companies breathe a sigh of relief: Australia’s highest court confirms that methods of medical treatment are patentable.

Apotex v Sanofi Aventis - Contributory Infringement

The High Court decision in Apotex v Sanofi-Aventis6 is also important for its finding on indirect or contributory infringement. Sanofi-Aventis had sought an injunction against Apotex to prevent them from supplying Apo-Leflunomide. Apotex planned to market leflunomide only for its known uses, namely RA and PsA. Their proposed product information included the statement “Apo-Leflunomide is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease.” The High Court of Australia held that :

  • the product information amounted to an emphatic instruction to recipients of Apo-Leflunomide from Apotex to restrict use of the product to uses other than use in accordance with the patented method; and
  • Apotex had no reason to believe that the unpatented pharmaceutical substance would be used by recipients in accordance with the patented method, contrary to the indications in Apotex's approved product information document.

In doing so, the High Court overturned the lower court’s finding of indirect infringement. This decision indicates that carve outs in product information leaflets are a legitimate way of avoiding indirect infringement. For more information see our article; Australia’s highest court takes a knife to indirect infringement: “carve-outs” in product information leaflets are a legitimate way of avoiding indirect infringement”.

Cancer Voices Australia v Myriad Genetics - Gene patenting

In Cancer Voices Australia v Myriad Genetics7, the court considered for the first time whether an isolated nucleic acid is patentable subject matter.

Myriad Genetics’ claims are directed to an “isolated nucleic acid” encompassing both DNA and RNA. In particular, the patent covers the mutations in the breast cancer gene BRCA1 associated with an increased risk of breast cancer.  The Federal Court of Australia held that any nucleic acid found in cells, whether it be DNA or RNA, that has been removed from the cellular environment in which it naturally exists (i.e. that has been isolated), is patentable.

An appeal has already been heard by the Full Federal Court and we now await its decision. For more information see our article; Isolated nucleic acids are patentable – what does the “Myriad” decision in Australia mean for patent applicants?

Research Affiliates and RPL Central - Computer Implemented Inventions

There were two contrasting lower court decisions handed down in 2013 relating to the patentability of computer implemented inventions. Both decisions dealt with patents directed to a computer implemented method involving retrieval and processing of information. Whereas in the first decision, Research Affiliates8, the judge found that the method was not patentable subject matter, in the latter decision, RPL Central9, the method was found to be patentable.

In Australia, a current test for patentable subject matter is whether a physical effect, in the sense of a concrete effect, phenomenon, manifestation or transformation, is provided. In Research Affiliates, Justice Emmett’s main consideration was whether the output of the invention, namely, an index produced by the claimed method, gave rise to the required physical effect. He held that the index is nothing more than information and that information is not, of itself, patentable. He also stated that using a computer to implement a scheme or method does not automatically confer patentability if the substance of the invention was an unpatentable scheme or method. In contrast, in RPL Central, Justice Middleton found that the computing steps did not need to be a central or substantial part of the invention and that claimed computing steps are to be taken into account when considering patentable subject matter. He also held that computer implemented operations, such as retrieving, processing, and/or presenting information were patentable, as each of the steps gives rise to a change in state or information in a part of a machine, and therefore produces the required physical effect.

Both decisions are currently under appeal. We are keenly awaiting judgement in relation to the Research Affiliates appeal which was heard in November last year.

More information on Research Affiliates see our article; Australian Federal Court clarifies patentability of computer inventions.

More information on RPL Central see our article; Encouraging developments for computer implemented inventions in Australia
Our comments on the Research Affiliates appeal hearing are mentioned in; Computer implemented inventions in Australia: the saga continues

1 Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 (4 December 2013)
2 Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65
3 Research Affiliates LLC v Commissioner of Patents [2013] FCA 71 (13 February 2013)
4 RPL Central Pty Ltd v Commissioner of Patents [2013] FCA 871 (30 August 2013)
5 Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 (4 December 2013)
6 Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 (4 December 2013)
7 Cancer Voices Australia v Myriad Genetics Inc [2013] FCA 65
8 Research Affiliates LLC v Commissioner of Patents [2013] FCA 71 (13 February 2013)
9 RPL Central Pty Ltd v Commissioner of Patents [2013] FCA 871 (30 August 2013)

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

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):

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.


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.