Australia: Interlocutory Injunctions for Pharmaceutical Patent Infringement

Key Point

  • Applications for interlocutory injunctions in pharmaceutical patent infringement litigation in Australia are complicated by the need to satisfy the requirements of the Therapeutic Goods Act and to consider the role of the PBS in pharmaceutical pricing.

Applications for interlocutory injunctions before Australian courts are generally governed by common standards. However, where the injunction is sought to prevent the infringement of an Australian pharmaceutical patent, additional factors outside the realm of patent law must be considered. These factors include the role of the Pharmaceutical Benefits Scheme ("PBS") in pharmaceutical pricing and the requirements of the Therapeutic Goods Act 1989 (Cth) ("the Act").

The principles governing interlocutory relief

It is well established that in order to be granted an interlocutory injunction, an applicant must demonstrate:

  1. that there is a serious question to be tried;
  2. that it will suffer irreparable harm for which damages will not be adequate compensation, unless an injunction is granted; and
  3. that the balance of convenience favours the granting of an injunction.

These principles generally govern the grant of interlocutory relief in patent cases. However, the application of these principles is complicated in the case of Australian pharmaceutical patents by the role that the PBS plays in pharmaceutical pricing. The Act imposes additional requirements that further regulate, and thus complicate, the application for an interlocutory injunction in the context of pharmaceutical patent infringement.

The PBS Listing Process

For a drug product to be marketed in Australia, its sponsor must apply for registration or listing on the Australian Register of Therapeutic Goods ("ARTG"). If the Australian Drug Evaluation Committee ("ADEC") recommends the drug for registration or listing on the ARTG, its sponsor can apply to the Pharmaceutical Benefits Advisory Committee ("PBAC") for listing on the PBS. The PBAC assesses the application and advises the Minister for Health and Ageing if the drug should be listed on the PBS. Finally, the Pharmaceutical Benefits Pricing Authority ("PBPA") negotiates with the manufacturer on the price at which the drug will be listed on the PBS and advises the Minister accordingly. If the drug is listed on the PBS, the Federal Government subsidises the medicine.

One important feature of the PBS listing process must be considered here. The first generic version of a drug within each reference class of drugs to be listed on the PBS on or after 1 August 2005 will trigger a 12.5% price reduction which will flow on to all other drugs within that class.

Two recent cases

Two recent decisions highlight the need to consider the role of the PBS in pharmaceutical pricing when seeking an interlocutory injunction for alleged infringement of an Australian pharmaceutical patent.

The combined case Hexal Australia Pty Ltd v Roche Therapeutics Inc. and Roche Therapeutics Inc. v Alphapharm Pty Ltd [2005] FCA 1218 (5 August 2005) (collectively "Hexal") concerned Australian Patent No. 702,106 entitled "Use of carbazole compounds for the treatment of congestive heart failure" ("the '106 patent"). The preferred compound was said to be carvedilol. The '106 patent was owned by Roche Therapeutics Inc and F.Hoffmann-La Roche AG and exclusively licensed by Roche Products Australia Pty Ltd (collectively "Roche").

In the first proceedings, Hexal sought revocation of the '106 patent asserting that the claims of that patent were invalid. Roche filed a cross-claim alleging that Hexal intended to apply for listing of a generic product known as Carvehexal on the PBS, and that as part of such an application, Hexal would be forced to make assurances to engage in conduct that Roche alleged would infringe the '106 patent. In the second proceedings, Roche alleged that Alphapharm intended to apply for listing of a generic product known as Dilol on the PBS, and that as part of such an application, Alphapharm would be forced to make assurances to engage in conduct that Roche alleged would infringe the '106 patent.

Roche sought interlocutory relief to restrain Hexal and Alphapharm respectively from applying to list generic versions on the PBS and from infringing its patent. The Court declined to grant the requested injunctions.

In Pharmacia Italia S.p.A. v Interpharma Pty Ltd [2005] FCA 1675 (23 November 2005) ("Pharmacia Italia"), Pharmacia Italia S.p.A. was the registered proprietor of Australian Patent No. 598197 entitled "Injectable ready-to-use solutions containing an anti-tumour anthracycline glycoside" ("the '197 patent") and Pfizer Pty Ltd had an exclusive licence in Australia under that patent. Under that licence, Pfizer manufactures and sells ready-to-use solutions of doxorubicin hydrochloride and epirubicin hydrochloride.

Interpharma Pty Ltd intended to import into Australia and thereafter sell and distribute ready-to-use solutions containing doxorubicin hydrochloride and epirubicin hydrochloride manufactured in Austria by Ebewe Pharma GmbH. Interpharma had procured the listing of its solutions on the PBS, effective from 1 August 2005. In order to do so, it had provided the PBAC written assurances that a stock of the imported solutions would be available for supply on the date of the PBS listing. However, as of 9 November 2005, it had not yet imported a supply of those solutions. Thus, as of that day, no supply of the solutions was available for sale in Australia, and the solutions had not yet been listed on the PBS.

In September 2005, Pharmacia and Pfizer sought an injunction (1) restraining Interpharma from importing or offering to import the solutions and (2) requiring Interpharma to procure the withdrawal of the PBS listing. Interpharma sought revocation of the patent. The Court granted Pharmacia an injunction restraining the importing or offering to import, but declined to grant an injunction requiring Interpharma to procure the withdrawal of the PBS listing.

Applying the principles governing the grant of an interlocutory injunction

The PBS listing process does not play a significant role in determining whether there are serious questions to be tried on the issues of infringement and validity of the patent-in-suit or in assessing the balance of convenience.[1] However, the PBS listing process provides an important consideration in the determination of whether irreparable harm will be caused by the grant or failure to grant interlocutory relief. That factor will be discussed below.

Irreparable harm - the irreversible reduction of the PBS price

As stated above, the first generic version of a drug to be listed on the PBS on or after 1 August 2005 will trigger a 12.5 % price reduction which will flow on to all other products within that drug's reference class. Although such a price reduction is automatically triggered by the first generic listing on or after 1 August 2005, there is no provision for that reduction to be reversed if the generic is delisted. Any attempt to reverse that reduction would almost certainly face considerable consumer resistance.

In denying Roche's application for interlocutory relief, the Hexal Court does not appear to have considered the role of the PBS in pharmaceutical pricing and the irreversible nature of the 12.5% price reduction. The Court held that Roche would not suffer irreparable harm that could not be adequately compensated by way of damages if the injunction were not granted. The Court relied on arguments by Hexal and Alphapharm that Roche's losses if the injunctions were not granted could be relatively easy quantified (and compensated) as Roche currently had 100% of the relevant market, while quantifying Hexal and Alphapharm's losses if the injunctions were granted would be far more difficult, as it would be impossible to predict the sales they would have made.

In the case of an irreversible price reduction triggered by the first PBS listing of a generic in that reference group on or after 1 August 2005, a simple account of profits would not provide redress. It would be impossible to predict what sales and profits Roche would have made. Thus, the possible harm is not as easily quantifiable as the Court concluded. Moreover, it is not clear that if Hexal and Alphapharm's products were subsequently delisted, that Roche's lost future profits as a result of the 12.5% price reduction would be recoverable as damages from Hexal and Alphapharm. The irreversible nature of the PBS price reduction should be a consideration in an assessment of whether the failure to grant an injunction will cause irreparable harm that cannot be compensated by way of damages.

The PBS listing process and the scope of the interlocutory injunction

In determining the form of any interlocutory injunction to be granted to restrain infringement of a pharmaceutical patent, the PBS listing process must again be considered.

As set out above, in Pharmacia Italia, Pharmacia and Pfizer sought an injunction (1) restraining Interpharma from infringing the '197 patent by importing or offering to import the generic solutions at issue; and (2) requiring Interpharma to procure the withdrawal of the PBS listing. The Court only granted the former relief. The reason for so limiting the relief lies within the specific features of the PBS. To be listed on the PBS, a product must be available for sale. By enjoining Interpharma from importing the generic solutions, no supply of that product was available and, as a result, it was not listed on the PBS. It was unnecessary to grant an order requiring Interpharma to procure withdrawal of the PBS listing.

The Therapeutic Goods Act 1989 (Cth)

The US Free Trade Agreement Implementation Act 2004 (Cth) introduced section 26D into the Act: This is a new section imposing additional requirements on a patentee seeking an interlocutory injunction to prevent or restrain the infringement of an Australian pharmaceutical patent. Section 26D states that a patentee may not apply for such an injunction unless she has first notified the Federal Attorney-General (or the Attorney-General of a State or Territory) in writing of the application. The Federal Attorney-General shall be deemed to be a party to any such proceedings unless the Attorney-General gives written notice to the prescribed court that he or she does not desire to be a party.

Furthermore, if an interlocutory injunction is granted but the patent infringement proceedings are subsequently dismissed or abandoned and the court declares that the proceedings brought by the patentee were baseless, vexatious or not reasonably pursued, the court may award the enjoined party compensation (including by way of an account of profits, which are not usually available in these circumstances), as well as make an award of damages to the Commonwealth, and/or any State or Territory, for costs incurred and damages suffered by it as a consequence of the grant of interlocutory relief.

The Act thus imposes a precondition to seeking an interlocutory injunction and a penalty if the proceedings in which the injunction was granted were not properly brought and are dismissed or abandoned, both of which are unique to an application to enjoin infringement of a pharmaceutical patent.


An application for an interlocutory injunction to enjoin infringement of an Australian pharmaceutical patent is governed by the same factors that generally govern the grant of such an injunction under Australian law. However, application of these factors is complicated by the role of the PBS in determining pharmaceutical prices in Australia. The Act further complicates an application for an interlocutory injunction to enjoin infringement of an Australian pharmaceutical patent by imposing a precondition on an application for such relief and imposing a potential penalty if an interlocutory injunction is granted; the proceedings in which it was granted are dismissed or abandoned; and the Court determines that they were not properly commenced or pursued.


[1] The written assurance that a stock of the new product will be available for supply on the date of the PBS listing is a consideration in assessing whether there is a serious question to be tried on the issue of infringement.

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

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”

Mondaq Advice Centre (MACs)
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
Check to state you have read and
agree to our Terms and Conditions

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.

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 by clicking here .

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.


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.