Australia: Constant vigilance: innovator life sciences companies must remain alert to the threat posed by patent infringement exemptions lurking in the "safe harbour"

Life Sciences Spotlight (Asia Pacific)
Last Updated: 5 June 2013
Article by Lisa Haile, Nicholas Tyacke and Jaimie Wolbers

US and Australian patent laws include exceptions to patent infringement for regulatory and experimental activities, the boundaries of which are either in a state of flux or are currently untested. Innovator Life Sciences companies must ensure that the boundaries of these "safe harbour" exceptions are not expanded to encroach on their legitimate patent rights.

Since the 1980's, the patent laws in many jurisdictions have included infringement exceptions that have made it possible for generic pharmaceutical companies to engage in otherwise infringing activities to obtain regulatory approval of their products so that they are able to launch those products immediately on the expiration of patent protection for the associated innovator product. These exceptions were generally introduced as part of a bargain that also included patent term extensions for particular types of pharmaceutical patents.

In Australia, the amendments to the Patents Act 1990 introduced by the Intellectual Property Laws (Raising the Bar) Act 2012 have expanded the scope of patent infringement exemptions, while in the US recent case law has indicated that in the view of some Federal Circuit justices, the scope of the existing US exception is broader than many previously thought. The broadening of these exceptions has not been matched by a corresponding broadening of what was part of the original bargain for the introduction of these exceptions, the extension of term for particular types of patents. Innovator Life Sciences companies must maintain a vigilant watch to ensure that their legitimate patent rights are not unreasonably encroached upon as a result of these exceptions.

The United States

In August 2011, the United States Court of Appeals for the Federal Circuit (Federal Circuit) reviewed a case on patent eligibility that was on remand from the United States Supreme Court, directed to methods for optimising immunisation. The decision in this case, Classen Immunotherapies v. Biogen, held that the patent infringement exception under 35 U.S.C. § 271(e)(1) does not apply to information that may be routinely reported to the United States Food and Drug Administration (FDA), long after marketing approval has been obtained.

The Court was asked to consider the question of whether the Defendant's activities fell within the "safe harbour" provisions of 35U.S.C. § 271(e)(1). In particular, the activities included post-approval studies to determine whether immunisations with certain vaccines increase the incidence of type 1 diabetes.

The United States Congress passed the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) in 1984. The Hatch-Waxman Act included two important provisions for pharmaceutical manufacturers:

  1. A patent term extension to allow for the FDA approval timeline; and
  2. A generic drug development infringement exception or safe harbour.

35 U.S.C. § 271(e)(1) states that "[i]t shall not be an act of infringement to make, use, offer to sell, or sell within the United States ... a patented invention ... solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products." In this case, Classen claimed thatBiogen and GlaxoSmithKline (GSK) infringed its methods of immunisation patents by participating in post-approval studies "to evaluate suggested associations between childhood vaccinations ... and risk of developing type 1 diabetes; and to determine whether timing of vaccinations influencesrisk." Astheir defence,Biogen and GSK stated that they were protected from allegations of infringement under section 271. It was Classen's position that section 271 only applied to activities conducted to obtain approval of generic equivalents of patented inventions but not to activities that were performed post-FDA approval.

The Federal Circuit agreed with Classen, stating that section 271(e)(1) provides "an exception to the law of infringement in order to expedite development of information for regulatory approval of generic counterparts of patented products." The dissent in part set up the Court for the case to follow in the next year, when it noted that "the question is not whether Congress intended to protect preapproval activity – but whether the enacted legislation covers more than just pre-approval activity. The language Congress chose to enact and that was signed by the President is plain on its face. There is no 'pre-approval' limitation."

Turning the clock ahead one year, on August 3, 2012, the Federal Circuit issued a decision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. extending the scope of the "safe harbour" under § 271(e)(1) to certain post-FDA approval activities. As noted above, the safe harbour is typically the time period during which drug development activities for the purpose of obtaining FDA approval are exempt from charges of patent infringement. Typically, the safe harbour period would conclude upon obtaining FDA approval.

In the more recent case, both Momenta and Amphastar commercially marketed generic versions of Lovenox (enoxaparin), which the FDA approved. The key issue in Momenta was Amphastar's alleged infringement of Momenta's patented manufacturing method relating to testing the purity and strength of enoxaparin, using quality control processesrequired to be carried out for each commercial batch of enoxaparin sold, after FDA approval.

The FederalCircuit first analysed the provision in the safe harbour section stating "solely for uses reasonably related to the development and submission of information under a federal law." The provision includes the language that the Federal law relates to "regulating the manufacture, use, or sale of drugs". The Federal Circuit held that the post-approval activities, which were necessary for Amphastar "to continue manufacturing and marketing enoxaparin," were exempt under the safe harbour because they generated information for submission to the FDA.

The Federal Circuit also examined the fact that Amphastar collected information but did not actually submit it to the FDA; concluding that since the information was gathered as part of a requirement by the FDA to maintain records for FDA inspection, the activity was "reasonably related to the development and submission of information to the FDA". The Federal Circuit also determined that the information gathered wasrequired to "maintain" FDA approval. Thus, Amphastar's allegedly infringing post-approval activities were found by the Federal Circuit to fall within the safe harbour of section 271.

At this point, the only thing that is clear is that the two decisions, Classen and Momenta, leave the question of the boundaries of the safe harbour provision difficult to reconcile. In January 2013, the US Supreme Court denied GSK's certiorari petition in Classen, while in March 2013, Momenta and Sandoz filed a certiorari petition for SupremeCourt review of the Federal Circuit's Momenta decision. Should the Supreme Court choose to hear this case, the questionsraised in the two decisions may be ultimately resolved. The final delineation of the safe harbour boundaries will impact on the patent rights of innovator Life Sciences companies operating in the US.


Australia's Patents Act was amended in late 2006 to include section 119A. This section provides an exception to conduct that would otherwise infringe a pharmaceutical patent if the patented invention is being exploited solely for purposes connected with obtaining registration with the Therapeutic Goods Administration on the Australian Register of Therapeutic Goods (ARTG). It also permits the conduct in relation to obtaining similar regulatory approval for goods intended for therapeutic use under the law of a foreign country.

Effective 15 February 2012, the Raising the Bar Act 2012 added sections 119B and 119C to the Patents Act. The former introduced an infringement exception for acts done solely for purposes connected with obtaining approval required by law to exploit a product, method or process other than for pharmaceutical products, while the latter introduced an exception for acts done for experimental purposes relating to the subject matter of the invention. The introduction of these exceptions was not accompanied by a broadening of the extension of term provisions.

None of these provisions, including section 119A which has now been in force for over six years, has been the subject of judicial interpretation as to their scope. It thus remains to be determined how Australian courts would treat the post-approval activities addressed in the Classen and Momenta cases.

However, it is notable that section 119A (and 119B) appears narrower in scope than U.S. section 271. The Australian provision refers to activities done solely for purposes connected with "obtaining" regulatory approval as opposed to the US provision which relates to the submission of information under a Federal law regulating manufacture, use or sale of drugs. It would appear unlikely that the post-approval activities discussed in the Classen case, such as studies into the incidence of type 1 Diabetes, and the post-approval activities in the Momenta case, which were to maintain regulatory approval, would fall within the scope of Australia's s 119A.


As discussed above, the scope of the primary patent infringement exception in the United States is currently in a state of flux, with a number of Federal Circuit justices indicating that the scope of that exception is broader than many previously thought; extending to post-regulatory approval activities. In Australia, patent infringement exceptions have also seen recent expansion by way of the legislature introducing new exceptions rather than the judiciary reinterpreting existing exceptions. Although the scope of Australia's patent infringement exceptions has yet to receive judicial consideration, it appears unlikely that they would extend to the post-approval activity in the majority of cases. Nevertheless, the expansion of the scope of patent infringement exceptions in each jurisdiction has not been matched by an expansion in the scope of patent term provisions. It thus remains important for innovator Life Sciences companies to maintain a vigilant watch to ensure that their legitimate patent rights are not unreasonably encroached upon as a result of these exceptions.

© DLA Piper

This publication is intended as a general overview and discussion of the subjects dealt with. It is not intended to be, and should not used as, a substitute for taking legal advice in any specific situation. DLA Piper Australia will accept no responsibility for any actions taken or not taken on the basis of this publication.

DLA Piper Australia is part of DLA Piper, a global law firm, operating through various separate and distinct legal entities. For further information, please refer to

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.