Australia: High Court unanimously invalidates Crestor patent, but starting point is still a numbers game

Last Updated: 16 September 2015
Article by Louise Dumbrell and Rohan Sridhar

What it means:

  • The final patent protecting Crestor, AstraZeneca's blockbuster anti-cholesterol drug, has been invalidated by the High Court.
  • The High Court's decision to avoid clarifying the "starting point" means that, at least under the Patents Act 1990, the starting point for assessing an inventive step must be the common general knowledge rather than the disclosure of the patent, for example through the adoption of a "problem-solution" approach as Apotex v Sanofi had indicated.
  • The High Court decision opens the door to damages claims by generic manufacturers who were restrained from launching rosuvastatin products during the proceedings. The manufacturers may however face difficulties in accurately quantifying their damages.
  • AstraZeneca may also face a claim for damages by the Commonwealth, akin to other claims the Commonwealth is currently pursuing.

The High Court recently handed down its decision in the ongoing battle between AstraZeneca and three generic companies (Apotex, Watson and Ascent) over AstraZeneca's Crestor® (rosuvastatin). The High Court has affirmed previous rulings that the only patent the subject of the appeal is invalid.

The primary issue on appeal was whether or not the claimed invention possessed an inventive step. The High Court, having found no inventive step was disclosed, declined the opportunity to consider other significant issues raised in the appeal.

The Court was required to consider the construction and interpretation of sections 7(2) and 7(3) of the Patents Act 1990, which relate to the use of prior art publications. When conducting searches to identify documents relevant to inventive step, experts for the generic companies identified multiple documents which disclosed novel compounds for the treatment of hypercholesterolemia. One document disclosed rosuvastatin, the active ingredient in Crestor, while another article disclosed an alternative compound. A third document disclosed that rosuvastatin was then in clinical trials. The experts had utilised a combination of these documents as multiple sources of information, none of which formed part of the common general knowledge, with a view to identifying single documents that were 'regarded as relevant' as is required by section 7(3) of the Patents Act. AstraZeneca argued that utilising multiple documents to identify the most relevant course to pursue was in breach of section 7(2).

The High Court agreed with the decision of the Full Federal Court, finding that section 7(2) precluded the use of a combination of documents in determining whether the patent disclosed an inventive step, but not for the purposes of satisfying the 'regarded as relevant' requirement in section 7(3). The comparison of documents for the purposes of deciding that a document was relevant was within the scope of section 7(2).

Having dismissed the appeal on this basis, the High Court declined to take a position on the validity of the "starting point" analysis for an assessment of whether an inventive step is disclosed. This area of patent law has been in flux since the Full Federal Court decision, which was inconsistent with the earlier Full Federal Court decision in Apotex v Sanofi-Aventis. In the Sanofi-Aventis decision, the Full Federal Court had decided that, with respect to a patent specification which disclosed a 'problem' and its 'solution', the appropriate starting point was the disclosed problem. The Full Federal Court in AstraZeneca had decided that the reasoning in Sanofi-Aventis was, at most, relevant for the purposes of the Patents Act 1952. Most commentators awaiting the decision had expected the High Court to rule on whether the "starting point" approach could be followed. Given the Court has elected not to do so, it leaves considerable doubt as to the appropriate starting point for patents granted under the 1952 Act. These patents are, however, diminishing in number, meaning this point may not be litigated again.

AstraZeneca will now face claims for damages from each of the three generic companies pursuant to the undertaking AstraZeneca proffered when it was granted interlocutory injunctions preventing the generics from launching. Quantifying this sum is likely to be complicated by the fact that multiple generic parties will have claims to damages, and determining the respective damage of each will require evidence on the market share each would have had if not restrained.

The Commonwealth may also make a claim for damages under the same undertaking consistent with the Commonwealth's recent position in other cases. Unusually, the Commonwealth's position might well be complicated by the listing, on the same date the Apotex generic was scheduled to list, on the Pharmaceuticals Benefit Scheme of two generic versions of atorvastatin. This listing triggered a mandatory price reduction in the cost of Crestor on that date. Therefore, the Commonwealth's loss is likely be confined to the quantum of damage caused by the delayed application of the price disclosure regime. The result is likely to be that the Commonwealth's damages are significantly reduced, and also far more difficult to quantify. It is also worth noting that the Commonwealth's entitlement to damages under the undertakings are still awaiting judicial opinion.

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 Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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