Australia: Generics win the battle for CRESTOR, but lose the war over inventive step

Last Updated: 25 August 2014

While the Full Court's decision represents a loss for AstraZeneca, it places innovators at a significant advantage over generic companies in respect of follow-on inventions (such as formulations and dosage regimes). Where an innovator is familiar with a particular compound the innovator will effectively have a "head-start" over other companies.

The Full Court's finding that the generics would have contravened the 'infringement by supply' provisions in s117 coupled with the Court's comments that it may not have been appropriate to grant an injunction raises further uncertainty about the operation of those provisions.

An enlarged Full Federal Court (Besanko, Jessup, Foster, Nicholas and Yates JJ) in AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99 has upheld a decision by Justice Jagot finding that two AstraZeneca patents protecting the blockbuster product CRESTOR (rosuvastatin) were invalid. The patents where challenged by three generic pharmaceutical companies: Apotex, Watson and Ascent Pharma.

The key issue in the appeal was identifying the proper "starting point" for assessing inventive step and, in particular, whether the problem set out in a patent speciation necessarily forms part of the "common general knowledge". The Full Court overturned Justice Jagot's finding that knowledge of rosuvastatin can be taken as the "starting point" as the common general knowledge must be assessed objectively.

Nevertheless, in the present case the Full Court upheld the findings that the patents were invalid on other grounds. This article only addresses the Full Court's findings with respect to inventive step (Cation Patent), the priority date (Cation Patent), entitlement (Low Dose Patent) and novelty (Low Dose Patent).

This article also addresses the Full Court's findings with respect to allegations that the generics would infringe the Low Dose Patent by supplying 20mg and 40mg tablets with the knowledge they would be split. The Full Court held that, had the patent been valid, the generics would have infringed under s117 of the Act, which prohibits supplying a product with reason to believe it will be put to an infringing use or directions to put the product to such a use. The Court commented that, in circumstances where only a small proportion of use would be infringing it may not be appropriate to grant an injunction. This raises further questions about the operation of the provision and the Court's approach may be questioned on the basis that the Act deems the supply to be infringing.


While the Court upheld Justice Jagot's finding that the Cation Patent was invalid, it overturned the key finding in relation to the proper "starting point" for assessing inventive step.

At first instance, Justice Jagot found that the statement of the problem, which pre-supposed knowledge of rosuvastatin, should be taken into account as part of the common general knowledge, otherwise the invention (which claims a pharmaceutical composition) would be transformed "into something which includes the discovery of rosuvastatin". Accordingly, Her Honour found that the starting point was the problem identified in the Cation Patent namely, how to create a composition with containing rosuvastatin with improved stability characteristics.

However, the Full Court found that the problem that is addressed in a patent specification does not necessarily form part of the "common general knowledge" against which inventive step is to be assessed. The Court cited the following key reasons in support of this conclusion.

  • It is not necessarily the case that the "starting point" outlined in the patent would have been apparent to the skilled person.
  • There is no requirement to describe the starting point in the specification.
  • Otherwise, information that was not public might be taken to form part of the common general knowledge which is contrary to the basic principles of patent law.

The Full Court's reasoning is persuasive. Otherwise a patent claiming an invention might lack inventive step where the inventor's understanding of the problem is disclosed, but be valid if the inventor did not describe the problem in the patent.

While the Full Court's approach favours consistency and objectivity, it may be seen to provide a "head-start" for innovators who have particular knowledge about a substance when compared to others in the field. Indeed, it will not always be apparent to those in the relevant field that there is a particular problem that needs to be overcome.

This finding places innovators at an advantage with respect to follow-on patents where the active compound has not yet been marketed. Follow-on patents, such as patents for formulations, which may have been "obvious" to those with knowledge of the compound in question are nevertheless likely to be valid when tested against the lower level of knowledge of other skilled persons in the field.


In order to defeat the challenge to the validity of the Cation Patent, AstraZeneca also needed to persuade the Full Court to overturn Justice Jagot's finding that the priority date of the Cation Patent was in August 2000 rather than the date the patent was amended in January 2005. AstraZeneca accepted that if the priority date was January 2005 the Cation Patent lacked novelty.

The 2005 amendments excluded from the claims certain inorganic salts (where the counter anion is a phosphate). AstraZeneca argued that the effect of the amendments was to narrow the claims of the Cation Patent, with the result that the patent continued to enjoy the August 2000 priority date.

Justice Jagot found that the priority date was deferred to January 2005 because the amendments introduced a limitation on the claim (disclaiming compositions which used phosphate as the counter anion) which changed the nature of the invention.

The Full Court upheld this finding, holding that the patent before amendment did not disclose the invention (after amendment) because the patent before amendment positively recommended the use of the embodiment of the invention (i.e. counter anion is a phosphate) and this was excluded in 2005.

This finding reinforces the need to give careful consideration to the consequences of amending a patent as it demonstrates that even narrowing amendments can be problematic. Equally, it highlights the need for those challenging the validity of a patent to consider the file history, including the scope of any amendments, in detail.


AstraZeneca acquired the rights to the compound rosuvastatin from the company responsible for its discovery, Shionogi & Co Ltd (Shionogi).

The generics argued that that the Low Dose Patent was invalid for lack of entitlement on the basis that the employees of Shionogi had contributed to the invention. Justice Jagot accepted this argument and the Full Court affirmed this finding.

AstraZeneca argued that while Shionogi had invented the compound rosuvastatin it had not proved a method of administration (i.e. dosage regimen). However, the Court found that Shionogi had conceived a method of administration and was entitled to the invention.

Further, the Full Court held that AstraZeneca could not rely on s22A and s138(4) of the Act which provide that a patent is not invalid merely because it is was not granted to the person entitled and limit the Court's discretion to revoke a patent for lack of entitlement to circumstances in which it is "just and equitable to do so". These provisions were introduced following Justice Jagot's decision and the Full Court found that its function was limited to reviewing Her Honour's decision.

Notwithstanding the introduction of s22A and s138(4) which clearly favour patentees in relation to this ground of invalidity, the Full Court's finding highlights the need for patentees to carefully consider all contributions to the invention before filing a patent application. In the case of follow-on inventions it is important to consider whether inventors of earlier related inventions have made a material contribution to the invention in question.


Justice Jagot found that the Low Dose Patent was anticipated by an earlier patent (the 471 Patent) which disclosed a broad class of compounds with cholesterol lowering activity and a dosage regimen. The Full Court overturned this finding on the basis that while the 471 Patent disclosed a dosage range which was broad enough to include the regimen claimed in the Low Dose Patent, it did not specifically disclose the regimen (a starting dose of 5 to 10mg) claimed in the Low Dose Patent.

Justice Jagot also found that the Low Dose patent was anticipated by an article which reported on the synthesis and characteristics of a number of compounds including rosuvastatin (the Watanabe article). The Watanabe article discussed the activity of the compounds based on animal tests.

AstraZeneca argued that there was no disclosure of any dosage range in the Wantanabe article and Justice Jagot impermissibly took into account the common general knowledge regarding the potency of rosuvastatin and suitable dosage ranges. In this regard, Justice Jagot relied on evidence given by Professor O'Brien, an expert for the generics, in relation to inventive step.

The Full Court overturned Justice Jagot's finding on the basis that Her Honour used the common general knowledge to supplement the disclosure in the Watanabe article which did not itself (expressly or impliedly) disclose any dosage regimen for the use of the rosuvastatin in humans. The Court held that while the common general knowledge can be used to construe a prior art document for the purposes of assessing novelty it is impermissible to use the common general knowledge as a separate resource (as is permissible in the case of inventive step).

This aspect of the Court's decision highlights the need to ensure that novelty challenges are based on the understanding of prior art by a skilled addressee in light of their acquired knowledge but not using that knowledge to "fill gaps" in the prior art. As this case demonstrates, the distinction can be elusive.


AstraZeneca argued that the supply of 20mg and 40mg dosages of rosuvastatin by the generics would infringe the Low Dose Patent under the 'infringement by supply' provisions in s117 of the Act. Under s117 a supply of a non-staple commercial product (rosuvastatin was found be such a product) will be an infringement where:

  1. the supplier had reason to believe it would be put to an infringing use (s117(2)(b)); or
  2. the supplier has provided instructions for the use of the product which would lead users to infringe (s117(2)(c)).

AstraZeneca argued that the generics were aware that consumers would engage in "tablet-splitting" and consequently follow the dosage regimen claimed in the Low Dose Patent.

At first instance Justice Jagot found that the generics would not infringe under s117 because there was insufficient evidence that the generics had reason to believe that consumers would engage in tablet splitting, though Her Honour accepted that there was a risk this may take place. In relation to Watson's product information, which acknowledged that tablets could be split, Her Honour did not consider that this amounted to a sufficient instruction that would "induce" consumers for the purpose of s117(2)(c).

The Full Court overturned Justice Jagot's findings in relation to s117. The Court held that, even though the proportion of consumers that would engage in tablet-splitting was likely to be small (only 2.75% of prescriptions were for "half a 20mg tablet"), the generics "had reason to believe" that at least some consumers would engage in that practice.

However, the Full Court cautioned that, when considering whether to grant an injunction, "some consideration of proportionality as between the extent of the infringing use that is forecast and the scope of any injunctive relief is warranted". The Court noted that, where only a small proportion of use is likely to be infringing, it should be more difficult to obtain an injunction. Similarly, the Full Court was satisfied that Watson's product information provided a relevant instruction for the purposes of s117(2)(c).

While the Full Court's comments are clearly motivated by a desire to achieve a "fair" and "proportionate" outcome, the approach may be challenged on the basis that the Act deems the supply to be infringing irrespective of the end use.

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.

Most awarded firm and Australian deal of the year
Australasian Legal Business Awards
Employer of Choice for Women
Equal Opportunity for Women
in the Workplace (EOWA)

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.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

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
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.

    By clicking Register you state you have read and agree to our Terms and Conditions