Australia: Combination Patents: Smith & Nephew v Wake Forest University Health Sciences

Last Updated: 28 October 2009

Article by Andrew McRobert and Kristen Migliorini

In a recent decision, the Full Federal Court has set aside an interlocutory injunction granted against Smith & Nephew in June of this year. That injunction restrained Smith & Nephew from entering the Australian market for negative pressure wound treatment therapies. The case, Smith & Nephew v Wake Forest University Health Sciences, is interesting for the way in which the Court dealt with the interaction that is required between the various parts of a combination patent in order for the patent to be valid.

The invention in the case was directed to negative pressure wound therapy which utilises a suction pump to create negative pressure in the area of a patient's wound and a foam dressing which is sealed in the wound by means of an adhesive dressing. The pump is then connected to the wound by tubing through which the negative pressure is applied.

Only one claim of the patent (claim 49) was in issue; it is directed to an "apparatus for applying negative pressure to a wound beneath a fluid-impermeable seal". The wording of the claim details the various components of the apparatus and ends with the words "and wherein said apparatus is in an aseptic package". This, in the Full Court's view, was of crucial importance.

Importantly, it was not in dispute that the components (the "integers") of the claim, apart from the aseptic package, do in fact interact to form "a new product and result"1. It was also not in dispute that the aseptic package plays no part in the application of negative pressure to a wound.

Principles Governing Interlocutory Injunctions In Patent Cases

The Full Court adopted the well-known formulations from Beecham Group v Bristol Laboratories and Australian Broadcasting Corporation v O'Neill as stating the principles to be applied in determining whether to grant an interlocutory injunction. Those principles can be stated as follows:

"The first is whether the plaintiff has made out a prima facie case, in the sense that if the evidence remains as it is there is a probability that at the trial of the action the plaintiff will be held entitled to relief ... The second inquiry is ... whether the inconvenience or injury which the plaintiff would be likely to suffer if an injunction were refused outweighs or is outweighed by the injury which the defendant would suffer if an injunction were granted."

The Court noted that in determining whether a patentee has made out a prima facie case, the Court must consider both the patentee's case for infringement and the respondent's case for invalidity.

The Full Court's Judgment

The Full Court considered that the primary judge (Ryan J) failed to consider, as a separate matter from novelty, whether claim 49 comprised a "mere collocation of separate parts" and was, therefore, invalid. This is relevant to the "manner of manufacture" requirement under the Patents Act 1990 (Cth).

Insofar as combination inventions are concerned, the claimed invention must reside in a combination of integers which in combination are not a mere collocation of separate parts but instead "interact to make up a new thing"2. In Firebelt v Brambles Australia, the High Court confirmed that:

"... a combination patent in the proper sense of that term ... combines a number of elements which interact with each other to produce a new result or product. Such a combination may be one constituted by integers each of which is old, or by integers some of which are new, the interaction being the essential requirement."

In the application before Ryan J, the patentee had argued that, as a matter of construction, the aseptic package is an "essential integer of the combination the subject of the claim". The Full Court said, "[p]ut another way, the invention claimed by the respondents ... included the package as an essential integer"3. The way in which the patentee put its case at first instance was of crucial importance to the Full Court's decision on appeal.

The Full Court found that the aseptic packaging in which the wound dressing kits were sold did not interact with the other integers in the combination to produce the new result: being the application of negative wound pressure. The Full Court said:

"It is the mere bag in which the device that 'does the work' is stored before use. It is discarded before any negative wound pressure is applied. No doubt it is beneficial to have sterile packaging for a therapeutic device, however, the aseptic bag itself does nothing to cause, limit or affect the functional result of negative wound pressure as desired."

In the Full Court's view, this was determinative of invalidity. Once the aseptic package was said by the respondents to be an essential integer of the invention claimed, "it must interact purposefully and functionally with the other integers to produce the negative wound pressure"4. Its failure to do so meant that claim 49 did not disclose a combination invention in the proper sense of that term. As such, no serious question to be tried arose and the Full Court set aside the interlocutory injunction.

Comments On The Full Court's Judgment

There are difficulties with the way in which the Full Court dealt with the claim to the aseptic package. It is arguable that the Court placed too much importance on the patentee's characterisation of the aseptic package as "essential". Of course, claim construction is ultimately a matter for the Court.

In the course of its judgment, the Full Court referred to two earlier decisions: Pugh5 and British United Shoe6 which, at the very least, are in tension with the Full Court's decision in this case. In essence, the Full Court distinguished those cases by saying that the language of the particular claim in issue is critical and, in this case, the aseptic package in the claim had been characterised as "essential".

Despite this, it is clear that the claim in the present case disclosed an invention: a new apparatus formed by the interaction of the integers other than the aseptic package. However, for a third party to infringe that claim, the patentee must show that the alleged infringer has taken all of the "essential" integers of the claim. That would include the aseptic package. A third party can avoid infringement by not doing so. However, it is difficult to see how adding the aseptic package to the claim in the patent means that the claim no longer obtains a "new result"7.

On a separate issue, the Full Court usefully confirmed that Smith & Nephew had no legal obligation to "clear the way" for its product by first revoking the patent before entering the market. The Court noted that the fact that a potential infringer goes into a market with "eyes wide open" is simply a factor that a court would consider in making an assessment of whether or not to grant an injunction. 


1. Smith & Nephew v Wake Forest University Health Sciences [2009] FCAFC 142 at [17].

2. Firebelt Pty Ltd v Brambles Australia Ltd [2002] HCA 21 at [21].

3. Smith & Nephew v Wake Forest University Health Sciences at [19].

4. Smith & Nephew v Wake Forest University Health Sciences at [33].

5. Pugh v Riley Cycle Co Ltd (1914) 31 RPC 266.

6. British United Shoe Machinery Company Ltd v Fussell & Sons Ltd (1908) 25 RPC 631.

7. In its judgment, the Full Court referred to the following comments in Bodkin C, Patent Law in Australia (2008) at [2440]: "Where a combination of features is claimed, one or more of which ... is new, the claim is not invalid merely because one or more of the features has no working interrelationship with the new feature".

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.