Australia: Amendments to a patent during court proceedings – how much transparency is required?

In Apotex Pty Ltd v ICOS Corporation [2017] FCA 466, the Federal Court has provided guidance regarding the level of disclosure required by a patentee in order for a court to exercise its discretion in allowing amendments to the specification during court proceedings.

Eli Lilly and Company (Lilly) is the holding company of ICOS Corporation (ICOS) and holds a number of patents worldwide that relate to a compound known as tadalafil (a PDE5 inhibitor that is useful in the treatment of erectile dysfunction).

As part of a Federal Court proceeding brought by Apotex relating to the validity of AU 773666 (the "666 Patent", relating to compositions containing tadalafil, including in micronised particle sizes, and methods of treatment using such compositions) and the AU 769946 (the "946 Patent", relating to compositions containing particular daily dosages of tadalafil for oral administration and methods of treatment using such dosages), ICOS sought orders to amend the specifications of the patents under s105(1) of the Patents Act 1990 (which deals with court-directed amendments).

The proposed amendments to the 666 Patent involved the addition of 15 dependent claims directed to specific doses or dosage ranges of tadalafil. The purpose of these amendments was to strengthen ICOS's defence to Apotex's inventive step challenge.

The proposed amendments to the 946 Patent involved removing statements in the specification concerning the side effect profile of tadalafil when co-administered with organic nitrates. One of the grounds of invalidity raised by Apotex was inutility on the basis that tadalafil did not eliminate particular side effects, or reduce them to clinically insignificant levels, when co-administered with an organic nitrate. The purpose of the amendments was to strengthen ICOS's defence to Apotex's utility challenge by removing any promises that could be found to have not been met (in Ronneby Road Pty Ltd v ESCO Corporation [2016] FCA 588, Jessup J found that failure of one of the promised results, even though others were attained, could give rise to revocation for inutility).

Apotex opposed the amendments for both the 666 Patent and the 946 Patent, arguing that ICOS had failed to make full disclosure of all relevant matters relating to the proposed amendments, that it had unreasonably delayed the proposed amendments, and that it had not adequately explained the reasons for the proposed amendments (Apotex subsequently withdrew their opposition to the amendments for the 666 Patent).

The Commissioner of Patents found that the amendments to the 666 Patent and the 946 Patent met the requirements of s102 of the Act (which deals with amendments which are not allowable). As such, the only issue was whether the amendments should be allowed in the exercise of the Court's discretion.

The relevant principles in relation to an application to amend a patent under s105(1) have been previously summarised by the Full Federal Court in Laboratoires Servier v Apotex Pty Ltd [2016] FCAFC 27; (2016) 117 IPR 415. In that case, the Court refused to allow the patentee to amend its specification to overcome a failure to describe the best known method of working the invention. The relevant principles established in that case were:

  • the onus to establish that amendment should be allowed is on the patentee;
  • generally, a permissible amendment (i.e. one which is permitted under s102 of the Act) will be allowed unless there are circumstances which would lead the court to refuse amendment;
  • the patentee must make full disclosure of all relevant matters;
  • amendment should be sought promptly and where a patentee delays for an unreasonable period, the patentee has the onus of showing that it delayed on reasonable grounds;
  • unreasonable delay is a circumstance likely to lead to refusal of an amendment;
  • in assessing delay, the relevant time is from when the patentee knows of the likely invalidity, or has its attention drawn to a defect in the patent, or is advised to strengthen the patent by amendment;
  • mere delay is not, of itself, sufficient to refuse to exercise the discretion to amend. The fact of delay is, however, relevant to whether the respondent or the general public have suffered detriment; and
  • if a patentee seeks to take unfair advantage of the unamended patent, knowing that it requires amendment, then refusal of the amendment is likely.

ICOS relied on affidavits sworn by Mr Gary Cox (lawyer and patent attorney at Wrays, acting for ICOS), Dr Mark Stewart (patent attorney at Lilly), Mr Danny Wood (patent attorney at Lilly), and Dr Malcolm Mitchel (formerly Medical Director at Lilly) setting out, in detail, the reasons for the proposed amendments to the 666 Patent and the 946 Patent, and the timing of events leading up to the application to amend. ICOS also provided verified discovery which included emails between Wrays and Lilly, emails between internal Lilly patent counsel and Lilly's clinical study reports. ICOS did not maintain a claim for privilege in respect of these documents.

The Court found that ICOS's conduct was reasonable, that it had made full disclosure and that there had been no unreasonable delay in seeking to amend the specifications of the the 666 Patent and the 946 Patent. The Court also found that there was no evidence that Apotex would suffer any prejudice if the amendments were allowed, other than the possible effect on its utility challenge. Apotex had given an undertaking not to market, sell or exploit its generic tadalafil products during the term of AU 689205 (Lily's tadalafil composition patent), so the patents which ICOS sought to amend had not been instrumental in Apotex refraining from entering the market. In addition, the Court noted that the application to amend had been made before trial, and that no third party had sought to oppose the application to amend.

Apotex identified four matters which it submitted were relevant to the Court's exercise of its discretion.

Firstly, Apotex submitted that the amendments to the 946 Patent did not involve a narrowing of the claims so as to avoid an argument based on a piece of prior art. Rather, they involved the removal of statements about the co-administration of tadalafil and organic nitrates. Apotex submitted that the obligation to make promises that were met or could be met crystallised on the filing of the patent application or, in the alternative, on the grant of the patent. However, the Court found that unlike best method and sufficiency, the patentee was not required to make statements regarding the utility of the invention, so that no such obligation crystallised on filing.

Secondly, Apotex argued that ICOS's conduct in relying on statements about the co administration of tadalafil and organic nitrates in correspondence with the Commissioner of Patents during prosecution of the 946 Patent should be taken into account and was a reason not to allow the amendments. However, the Court was not satisfied that the statements made by ICOS during prosecution were material in overcoming the objections raised by the examiner.

Thirdly, Apotex argued that the amendments sought by ICOS involved the removal of the main promises in the 946 Patent. However, the Court found that while the statements about the co-administration of tadalafil and organic nitrates were an important aspect of the specification, they were not the only advantage identified.

Fourthly, Apotex argued that the 946 Patent is a selection patent and that the advantages of the selected members are critical to the validity of the patent. However, the Court found that even if the 946 Patent is a selection patent and the amendments are allowed, a number of advantages or benefits of the invention remain in the specification.

The Court was not satisfied that the matters identified by Apotex warranted a refusal of the application to amend. Consequently the Court directed that, pursuant to s105(1), the complete specification of the 666 Patent and the 946 Patent be amended. The invalidity trial is listed for June 2017 and Shelston IP will keep you informed of developments.

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.

Shelston IP ranked one of Australia's leading Intellectual Property firms in 2015.

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.

Katrina Crooks
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
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
Registration (you must 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