Patent Litigation 2026

Last Updated February 12, 2026

Australia

Law and Practice

Authors



Spruson & Ferguson Lawyers was Australia’s first law firm to specialise exclusively in intellectual property law. With decades of experience, the team is consistently recognised for its deep expertise in patents, trade marks, designs and copyright law – and for its role in shaping landmark IP cases across the country. The team advises on all aspects of IP disputes and litigation, commercialisation strategy, technology transactions, privacy laws and data protection. Whether defending rights or unlocking new opportunities, it is client-focused and delivers practical, strategic legal solutions tailored to client needs. Spruson & Ferguson Lawyers has over 500 employees, including over 200 professionals, servicing clients from across the globe – offering true regional capability, knowledge and experience.

Australia provides two principal types of patent protection for inventions: the standard patent and the innovation patent. Standard patents are the primary form of patent protection and are subject to the full range of validity requirements, including novelty, inventive step, utility, sufficiency of disclosure, best method, support and clarity. Innovation patents constitute a second-tier system conferring the same enforcement rights as standard patents but with a lower threshold for patentability – in particular, there is no inventive step requirement, only an “innovative step” requirement, which is a less demanding standard. The innovation patent system is currently being phased out; it has not been possible to file new applications for innovation patents since 26 August 2021. Innovation patents can still, however, be pursued via divisional applications based on standard patent applications filed before that date, or by converting a pending standard patent application to an innovation patent application where the standard application has a filing date on or before 25 August 2021. Existing innovation patents remain in force subject to payment of renewal fees.

Both types of patent are creatures of statute, being governed by the Patents Act 1990 (Cth). However, Australia is a common law jurisdiction, and the interpretation and application of the statutory provisions is significantly influenced by case law, including persuasive decisions from other common law jurisdictions. Since 2013, decisions of the European Patent Office and UK courts on sufficiency and support have become particularly influential following legislative reforms that aligned Australian patent law more closely with European standards in these areas.

In addition to the statutory patent system, the equitable doctrine of breach of confidence provides an alternative means of protecting inventions under Australian law. Unlike patent protection, an action for breach of confidence does not require any formal application for the grant or registration of rights.

Pursuing patent protection and relying on trade secrets (protected through the equitable doctrine of breach of confidence) are, in practice, alternative choices. A standard patent application will be published in due course and will disclose the invention to the public regardless of whether the application proceeds to grant. A decision regarding which avenue to pursue can, however, be deferred to some extent as a patent application is not required to be published until 18 months after its earliest claimed priority date. It can be withdrawn before that time, keeping its contents unpublished.

Australian Standard Patents

Australian standard patents are governed by the Patents Act 1990 (Cth) and administered by IP Australia. An applicant may first file an optional provisional application, which secures a right of priority and provides 12 months to file a complete application containing a full description of the invention, disclosure of the best method  to use it, and at least one claim. A complete application is published approximately 18 months after the priority date. The applicant must then request substantive examination within five years of filing. However, the Commissioner of Patents may direct an earlier request, in which case the applicant must comply within two months. During examination, an examiner assesses the invention for novelty, inventive steps, usefulness, and the patent eligibility of the claimed subject matter (ie, “manner of manufacture”), as well as sufficiency of the disclosure and support for, and clarity of, the claims. Assuming that any objections are overcome, the application is then accepted and advertised. Third parties then have three months to oppose the grant. If unopposed, or if any opposition is unsuccessful, the patent is sealed and granted. An innovation patent requires a complete specification with a maximum of five claims but is granted without substantive examination, typically within one to two months of filing. However, an innovation patent cannot be enforced until it undergoes substantive examination and is certified. Examination can be requested by the patentee or a third party at any time during the innovation patent’s lifespan. A granted innovation patent has a maximum term of eight years.

Trade Secrets

Australia has no dedicated statutory regime for trade secrets. Protection arises automatically under the equitable doctrine of breach of confidence, without any registration or formality, and lasts for as long as the information remains confidential. To succeed in an action for breach of confidence, a plaintiff must:

  • identify the confidential information with sufficient specificity;
  • establish that the information has the necessary quality of confidence (ie, it is not public knowledge, relative secrecy suffices);
  • demonstrate that the respondent received the information in circumstances importing an obligation of confidence, assessed by whether a reasonable person in the recipient’s position would have recognised the information was confidential; and
  • establish actual or threatened misuse of the confidential information without consent.

Confidential information may also be protected through contractual provisions (eg, non-disclosure agreements) and statutory duties of senior employees of Australian companies under Sections 182–183 of the Corporations Act 2001 (Cth).

Duration of the Grant Procedure

For a standard patent, the procedure from filing to grant typically takes four to five years, though this can be shortened to two to three years with the right strategy, or to approximately four to six months from the request for examination if expedited examination is obtained.

Representation

For both standard and innovation patents, in practice the only two options are self-filing or filing through an Australian registered patent attorney. Legal practitioners (solicitors and barristers) can advise on the validity and/or infringement of a patent. However, as set out in Sections 201-204 Patents Act 1990 (Cth), only a registered patent attorney is permitted to prepare patent specifications and documents relating to amendments to patent specifications.

Average Costs to Grant

Professional fees associated with drafting, examination and prosecution of patent applications vary depending on the complexity of the technology involved, the number and complexity of objections raised by the Australian Patent Office during prosecution, and the steps required to address those objections. Where grant is opposed by a third party, additional fees will be incurred.

A standard Australian patent has a term of 20 years from the filing date of the complete specification. In the case of divisional applications, the term runs from the filing date of the complete specification of the parent case in which the invention was first disclosed.

An innovation patent has a term of eight years from the date of the patent. This is the date on which the complete specification was filed, or, for divisional applications, the date of filing of the complete specification of the parent case in which the invention was first disclosed.

Australian standard patents claiming a pharmaceutical substance per se (or claiming a pharmaceutical substance when produced by a process  involving the use of recombinant DNA technology) are eligible for a term extension of up to five years, provided that certain statutory conditions are fulfilled. These conditions include that the pharmaceutical substance (or a product containing or consisting of that substance) is included in the Australian Register of Therapeutic Goods and that there has been a delay of at least five years between the filing date of the patent application and the first regulatory approval of any product containing or consisting of the pharmaceutical substance.

Under Section 13 of Australia’s Patents Act 1990 (Cth), a patent gives the patentee exclusive rights to “exploit” the invention, and a patent “has effect throughout the patent area” (i.e., Australia). “Exploit” is defined in Schedule 1 of the Act and differs depending on whether the claimed invention is a product or a method/process:

  • Product claims – “exploit” includes making, hiring, selling, offering to sell, using, importing, or keeping the product for any of those purposes.
  • Method/process claims – “exploit” includes using the method or process, or doing any of the acts identified above (making, selling, offering to sell, importing, etc) in respect of “a product resulting from such use”.

Australia has only a very limited form of patent linkage, not directly comparable to the US Orange-Book system. Under Section 26B of the Therapeutic Goods Act 1989 (Cth), a person seeking regulatory marketing approval for a generic or biosimilar product must certify to Australia’s Therapeutic Goods Administration (TGA) either that:

  • their product will not be marketed in a manner that infringes a valid patent claim; or
  • that notice has been given to the patent holder of the generic or biosimilar supplier’s intention to market their product before patent expiry.

In practice, generic and biosimilar suppliers generally certify under the first option.

The TGA does not adjudicate patent disputes – it merely requires that certification has been provided. Critically, no stay of marketing approval is triggered by the filing of patent infringement proceedings, and the TGA may grant regulatory marketing approval for a generic or biosimilar product irrespective of any pending patent dispute. Applications made to the TGA for regulatory marketing approval of generic or biosimilar products remain confidential until approval. As a result, patentees typically learn of an impending generic or biosimilar launch only after the product has been granted marketing approval and entered on the Australian Register of Therapeutic Goods (ARTG), a publicly-accessible database. Another limited aspect of patent linkage is the ability to search the online Australian Register of Patents for patents that have had their term extended to account for delays in regulatory approval of a therapeutic product (see 1.6 Further Protection After Lapse of the Maximum Term) – although such searches do not identify other, non-extended patents related to that therapeutic product.

Australian standard patents that disclose and claim a pharmaceutical substance per se, or a pharmaceutical substance when produced by processes involving recombinant DNA technology, are eligible for a term extension of up to five years. The conditions for obtaining such an extension include that the pharmaceutical substance (or a product containing or consisting of that substance) must be included in the ARTG (ie, have been granted regulatory marketing approval in Australia) and that there must have been a delay of at least five years between the filing date of the patent application and the first regulatory approval of any product containing or consisting of that pharmaceutical substance.

An application for term extension must be made during the original 20-year term of the patent and within six months after the date of patent grant or the date the relevant goods were first entered on the ARTG, whichever is later. The application must be advertised in The Australian Official Journal of Patents, and any person may oppose the extension.

During 2026, Australia’s High Court will consider the eligibility of pharmaceutical formulation patents for term extension in proceedings involving Otsuka Pharmaceutical Co and Sun Pharma ANZ.

Any person may submit prior art and observations to the Australian Patent Office during examination of a patent application. Typically, this involves submitting prior art with supporting submissions, but may also involve submitting sworn declarations from expert or factual witnesses. This is an ex parte procedure, in which the third party submitting information has no right to make further submissions. However, there are no formal limits on how many such requests can be made.

Australia has a pre-grant opposition system for standard patents, administered by the Australian Patent Office. This allows third parties to oppose the grant of a standard patent application after acceptance and prior to grant. Any natural or corporate person may oppose the grant of an Australian patent application. There is no post-grant opposition procedure for standard patents. For innovation patents, which are granted without substantive examination, opposition is only available post-grant following substantive examination and certification.

In addition, any person may request re-examination of a granted Australian patent at the Patent Office, and there is no standing requirement for such a request.

A patent applicant unable to overcome objections through correspondence and discussions with the Australian Patent Office Examiner can request to be heard by a more senior examiner. This process involves written and oral submissions as well as a published decision. There is a right of appeal to the Federal Court of Australia against an adverse decision of the senior examiner, at which point expert evidence is commonly adduced with respect to the validity of the invention, at least by the patent applicant. Following a decision of a single judge in such proceedings, any further appeal to the Full Federal Court is only available with leave.

If a renewal fee for a standard patent is not paid by the due date, a six-month grace period applies, during which the fee may be paid together with a surcharge for each month (or part thereof) of lateness. If the fee and surcharge are not paid within the grace period, the patent lapses (ceases).

After the grace period has expired, the patentee may apply for an extension of time under Section 223 of the Patents Act 1990 (Cth). The extension is discretionary and requires the patentee to demonstrate that the failure to pay was caused by an “error or omission” of a person concerned or their agent, or by a circumstance beyond that person’s control. The applicant must provide full and frank disclosure of all relevant circumstances, identifying the specific person(s) who made the error.

The extension fee is calculated at AUD100 per month of extension and the missed renewal fee must also be paid.

If the extension sought is for more than three months, the application for extension of time is advertised for two months to allow third-party opposition. Third parties who exploited (or took definite steps to exploit) a patented invention during a period of lapse may acquire limited rights, including the right to apply for a licence, which may be granted by the Patent Office. Overall, the Australian regime for restoration of lapsed patents has been described as relatively generous compared with similar regimes in other jurisdictions.

A patentee may seek to amend a granted Australian patent.

If the patent is not the subject of current litigation, any amendment request must be made to the Australian Patent Office. The amendment request is examined and, if deemed allowable, is published in the Official Journal with third parties having two months to file any notice of opposition.

If the patent is the subject of current litigation, any application to amend must be made to the court that has carriage of the litigation. The court applies the same substantive test as the patent office, with additional discretion as to whether to allow the amendment request in all of the prevailing circumstances.

For patents granted on applications filed before 15 April 2013 (and for which examination had been requested by that date), amendments will not be permitted if they would result in the patent claiming matter not disclosed in the specification as filed, if the amended claims would fall outside the scope of the pre-amendment claims, or if the amended specification would not comply with the internal validity requirements of the Patents Act 1990 (Cth). For later patents, an additional requirement applies: amendments must not result in the specification disclosing matter beyond that disclosed in the specification as filed (ie, no “added matter”).

Where the substantive requirements for amendment are met with respect to a patent that is the subject of existing court proceedings, the court retains a broad discretion to allow or refuse amendment, taking into account all the circumstances of the case. The exercise of this discretion is informed by several well-established principles developed by the case law.

First, the patentee must make full and frank disclosure of all matters relevant to the exercise of the court’s discretion, including the circumstances in which the need for amendment arose, the history of the patent’s prosecution (both in Australia and in respect of any foreign counterpart patents and applications), and the reasons why the amendment was not sought earlier. Mere delay is not, of itself, sufficient to refuse to exercise discretion. However, delay is relevant to whether the respondent or the public have suffered detriment as a result.

Second, the court may refuse amendment if it is satisfied that the patentee sought to take unfair advantage of the unamended patent, for example, by asserting claims that it knew or ought to have known required amendment.

Third, the public interest is a relevant consideration. The patent system confers a statutory monopoly in exchange for public disclosure. The court will have regard to the broader public interest in ensuring that the claims of a patent accurately reflect the patentee’s entitlement, and that the amendment process is not used to maintain claims that the patentee knows to be unjustifiably broad.

Fourth, the requirement for transparency means that the question of legal professional privilege arises frequently in the context of amendment applications. While a patentee is not compelled to waive privilege over communications with its patent attorneys and lawyers, failure to do so may leave the patentee unable to satisfy the court that the discretion should be exercised in its favour.

These discretionary factors are generally applied in a somewhat more rigorous manner to granted patents than to pending patent applications.

The owner of an Australian patent (or its exclusive licensee) may commence infringement proceedings in the Federal Court of Australia. Available remedies include declarations of infringement, interim (interlocutory) injunctions, final injunctions and an election between damages and an account of profits. Proceedings for unjustified threats of patent infringement may also be brought by an alleged infringer.

Australian patent owners may also apply to the Federal Court for orders that a potential infringer should give preliminary (pre-action) discovery of documents required for the patent owner to decide whether to commence patent infringement proceedings. Such applications can only be pursued where the patent owner requires further information to determine whether there is likely infringement of its Australian patent rights, or to assess the extent of potential infringement and the potential value (and commercial viability) of embarking upon infringement proceedings. Documents and information obtained through preliminary discovery in Australia may only be used for the purposes of commencing related infringement proceedings in Australia, unless the court’s permission is sought and obtained, eg, to use the documents in related proceedings overseas.

There are no special standing requirements for challenges to the validity of an Australian patent. Any natural or corporate person may seek revocation of a granted Australian patent in the Federal Court. Similarly, any natural or corporate person may oppose the grant of a standard patent application (pre-grant) or request re-examination of a granted patent in the Patent Office. The Patent Office may also undertake re-examination of its own initiative, such as following settlement of opposition proceedings. If litigation is under way in the Federal Court, the Patent Office cannot revoke a patent following re-examination or allow any amendment while the litigation remains pending.

Patent litigation is generally commenced in the Federal Court of Australia. First instance proceedings are conducted before a single judge of the Federal Court. The Supreme Courts in each Australian state and territory also have original jurisdiction to hear patent matters – though cases are very rarely commenced there, particularly as there is a legislative requirement that any appeal from a first-instance patent decision be heard by the Full Federal Court.

At second instance, a final first-instance decision may be appealed as of right to a full court of the Federal Court, comprising three to five judges. There are no permanent appeal judges; all Federal Court judges hear appeal cases from time to time. A full court hearing a patent appeal will typically include at least one judge, and usually multiple judges, with experience in patent cases.

A judgment of the Full Federal Court can only be appealed to the High Court of Australia with special leave, which is granted only in significant cases dealing with new or disputed points of law. Only a minority of applications for special leave are successful.

First-instance patent cases in the Federal Court are ordinarily allocated to a member of a panel of judges within the Patents and Associated Statutes practice area, each of whom has experience in patent matters, some with a technical background. In this sense, while the Federal Court is a court of general jurisdiction, it has a specialist patents list for the management and determination of patent cases.

The Australian Patent Office also plays a role in patent disputes through the pre-grant opposition system and re-examination processes, as well as its jurisdiction over patent ownership disputes. Court-ordered mediations are routinely conducted by registrars trained and accredited by the court, and parties may also engage private accredited mediators.

Before commencing proceedings in the Federal Court of Australia, there is a statutory obligation to attempt to resolve the dispute without recourse to litigation. At the commencement of proceedings, a “genuine steps statement” must be filed, outlining the steps that were taken to attempt to resolve the dispute without litigation, such as communicating the basis for the dispute to the opposing party, responding constructively to such communications, considering alternatives to litigation and cooperating with any such alternatives.

Although parties are entitled to self-representation before the Australian Patent Office and Australia’s Federal Court, in practice this does not occur in intellectual property disputes (other than in relation to small claims involving indigent litigants).

In proceedings before the Australian Patent Office, the parties are ordinarily represented by registered patent attorneys, solicitors specialising in intellectual property disputes and/or barristers with IP expertise.

In proceedings before the Federal Court of Australia, the parties are ordinarily represented by solicitors specialising in intellectual property disputes and barristers with IP expertise. Registered patent attorneys commonly provide litigation support during such court proceedings.

Interim injunctions are available in Australian patent litigation. Interim injunctions are most commonly sought in pharmaceutical cases where “irreparable” harm may be easier to demonstrate, although even in that area the outcomes are becoming less predictable. Outside the pharmaceutical field, interim injunctions are not commonly sought or granted in Australian patent disputes.

Applications for interim injunctions are usually dealt with inter partes, but in cases of special urgency, a claimant may apply ex parte for a temporary injunction covering the period until an inter partes hearing can be held. The time taken to apply for and obtain an interim injunction is typically in the range of four to eight weeks, and up to 12 weeks in less urgent matters.

To obtain an interim injunction, the patentee or exclusive licensee must establish that:

  • there is a serious question to be tried on infringement;
  • damages will not be an adequate remedy; and
  • the balance of convenience and justice favour grant of the injunction.

Even if each of these conditions is met, the court retains discretion to grant or refuse relief. Delay is an important factor and it is critical that the claimant act as quickly as possible after learning of the threat to engage in allegedly infringing activity.

A party applying for an interim injunction must undertake to compensate the respondent and any third party adversely affected if the defendant is ultimately found not to have infringed or the patent is ultimately held invalid (known as the “usual undertaking as to damages”). In recent years, the Australian government has relied on such undertakings to seek compensation for additional expenses under the Pharmaceutical Benefits Scheme.

A potential opponent may take several protective steps. First, the respondent may seek security for costs, particularly where the applicant does not appear to have sufficient assets to meet any costs award, or has few assets located within Australia. Security typically takes the form of a bank guarantee.

Second, if there is doubt regarding the capacity of the patent owner and/or exclusive licensee to meet any award of damages, the opponent may seek orders requiring them to provide security for damages (again, typically in the form of a bank guarantee).

Third, a potential infringer may consider providing voluntary undertakings or entering settlement discussions to avoid injunction applications.

Fourth, an alleged infringer may commence proceedings for unjustified threats of patent infringement, seeking compensation for any harm it suffers by reason of such threats if infringement is ultimately not established, including where the asserted patent claims are ultimately held to be invalid.       

Proceedings for alleged infringement of an Australian patent must be commenced by the later of three years from patent grant or six years from the date of infringement. Subject to equitable defences including acquiescence, waiver and delay (laches), infringement proceedings may be commenced at any time during this limitation period. Delay and acquiescence can also potentially limit the damages or profits a patentee can recover, depending on the circumstances.

Australia’s Federal Court provides several mechanisms for obtaining evidence and information, both before and during patent litigation.

Before proceedings are commenced, preliminary (pre-action) discovery may be sought to determine whether a cause of action exists and to assess the potential value of a claim. A party seeking preliminary discovery must satisfy a number of statutory criteria, including demonstrating a reasonable belief that it may be entitled to final relief. The procedures for obtaining access to relevant information and evidence which apply at trial must now be understood in the context of the Federal Court of Australia’s Intellectual Property Practice Notes IP-1 and IP-2. These Practice Notes include a standard form of directions for patent litigation, from which the court will not lightly depart. They also require the parties to exchange positions statements on infringement and require the respondent to provide a sworn product/process description in relation to any disputed integers, before applying for discovery.

If, following exchange of the parties’ position statements on infringement and the respondent’s product/process description, the patentee believes that discovery is necessary, then the parties are required to exchange proposed categories of documents for discovery. The scope of discovery may be determined on the papers or referred to a registrar of the court for determination.

Interrogatories (ie, requests for sworn written answers to questions) are available but used relatively infrequently in Australian patent litigation. Anton Piller orders (ex parte orders for search and seizure of documents or property to preserve evidence) and Mareva orders (ex parte orders to prevent disposal of assets) are also available in appropriate circumstances but are obtained relatively infrequently.

Confidentiality regimes, including inter partes confidentiality agreements and court-ordered suppression regimes, are routine to protect sensitive information exchanged prior to and during patent litigation.

A party commencing patent litigation in the Federal Court must file an application identifying the relief sought and a statement of claim identifying each of the facts relied upon, together with particulars of infringement or invalidity as appropriate. A genuine steps statement must also be filed, detailing the steps taken in seeking to resolve the dispute prior to commencing litigation.

Each pleading filed in a proceeding must be accompanied by a certificate (provided by the filing party’s solicitor) confirming that the available factual and legal material provides a proper basis for each allegation, denial and non-admission contained in the pleading.

A party that is dissatisfied with the opposing party’s pleadings may apply for further and better particulars and/or apply to have some or all of the opposing party’s pleadings struck out. Where a party wishes to supplement or amend its pleadings in the course of patent litigation, it will require the consent of the opposing party and/or the court’s leave.

Evidence in chief is filed by affidavit approximately five months before the pre-trial case management hearing, with evidence in answer due approximately two months before that hearing. Parties should expect that the court’s leave would be required to file affidavit evidence in reply. Leave would also be required to file supplementary affidavit evidence after the completion of the standard evidentiary stages.

A regime for the conduct of class actions is provided in Part IVA of the Federal Court of Australia Act 1976 (Cth). In principle, that regime is available in intellectual property proceedings. To commence a representative proceeding, at least seven persons must have claims against the same person, the claims must arise out of the same, similar or related circumstances, and the claims must give rise to a substantial common issue of law or fact. In practice, class actions in patent matters are extremely rare in Australia.

Under Australian law, there are a limited number of patent-specific limitations or qualifications on the assertion of intellectual property rights. For example, a defence to patent infringement exists where the claimed invention is (or was at the time proceedings were commenced) the subject of a contract containing a provision inserted by the patentee. That provision must be void for impermissibly prohibiting the respondent from using or acquiring a product or process that is not the subject of the patent.

In addition, the assertion of intellectual property rights (including patent rights) is subject to the provisions of Australian competition law including  prohibitions on misuse of market power, cartel conduct and exclusive dealing.

Only a patentee and any exclusive licensee have standing to sue for infringement of an Australian patent. If infringement proceedings are commenced by an exclusive licensee, the patentee must be joined as an additional applicant (plaintiff) or, if the patentee does not consent to be joined as an applicant, as an additional respondent (defendant).

The definition of “exclusive licensee” under Australian patent law is restrictive. A licence will not be regarded as exclusive if it reserves to the patentee any right to exploit the claimed invention within Australia's patent area (eg, a right to manufacture the patented goods) or gives the patentee a right to grant additional licences. A non-exclusive licensee does not have standing to sue for infringement and is not a proper party to infringement proceedings.

Australian patent law distinguishes between direct and indirect (contributory) infringement.

A product claim is directly infringed by making, hiring, selling or otherwise disposing of the claimed product or offering to do so, using or importing the claimed product, or keeping the claimed product for the purpose of doing any of those things, within Australia’s “patent area”. A method or process claim is directly infringed by using the claimed method or process within Australia’s “patent area”, or by doing any of the above acts, in Australia’s “patent area”, in respect of a product resulting from use of the claimed method or process.

Indirect or contributory infringement may arise in three ways. First, a person who authorises another to engage in directly infringing conduct will be liable, pursuant to Section 13 of the Patents Act 1990 (Cth), which gives the patent owner the exclusive right to authorise exploitation of the claimed invention. Second, under Section 117 of the Patents Act 1990 (Cth), a person who supplies a product will be liable if:

  • the product is only reasonably capable of infringing use;
  • the product is not a staple commercial product and the supplier had reason to believe that the recipient would put it to an infringing use; or
  • the supplier gave instructions or inducement for the product to be put to an infringing use.

Third, at common law, a person who procures or induces another to infringe, or joins in a common design with another to undertake infringing conduct, will be jointly liable as joint tortfeasor.

Generally speaking, the remedies available for indirect (contributory) patent infringement are the same as those available for direct infringement and include declarations, injunctions, and an election between damages or an account of profits.

Several mechanisms are available for investigating infringement of process patents. Preliminary discovery, standard discovery or interrogatories may be sought with regard to an allegedly infringing process. The court may also require the respondent to file a process description under oath from a senior employee or director, detailing the steps of the allegedly infringing process.

A person who imports goods produced outside Australia by a method which is the subject of an Australian patent may be liable for direct infringement. Additionally, a person located outside Australia may be held jointly liable for infringement if they authorise, procure, induce or join in a common design with another person to engage in directly infringing conduct within Australia – for example, an overseas parent company may be held jointly liable with its Australian subsidiary.

Section 121A of the Patents Act 1990 (Cth) provides for a shifting of the onus of proof in proceedings for infringement of a patent claim directed at a process for obtaining a product where the court is satisfied that the respondent’s product is likely to have been made by the claimed process.

Patent claims are given a purposive, rather than purely literal, construction according to the principles explained by Lord Diplock in the UK’s Catnic Components case. The claims are construed through the eyes of the hypothetical person skilled in the relevant art, having regard to the common general knowledge in their field. Experts may give evidence on the meaning of technical terms used in the claims. While claims should be construed in the context of the specification as a whole, it is not legitimate to read down unambiguous claim language by importing “glosses” found elsewhere in the specification.

Currently, the prevailing view is that there is no recognised doctrine of equivalent under Australian patent law, although this issue has not been tested in any recent case. The doctrine of prosecution history (or file wrapper) estoppel is not currently applied in Australia, although in at least one case it was suggested that this is an open question.

Markman-style claim construction hearings are very rare in Australia, and issues of claim construction are ordinarily heard and determined together with all other issues of infringement and validity.

Beyond arguing non-infringement and invalidity of the asserted claims, an alleged infringer may rely on a number of statutory defences, including:

  • prior continuing use of the claimed invention before the priority date of the relevant claims;
  • exploitation of the claimed invention solely for regulatory purposes in Australia or overseas;
  • experimental use;
  • use of the invention on board a foreign vessel or aircraft; and
  • the defence that the claimed invention is (or was) the subject of a contract containing a void provision inserted by the patentee that impermissibly prohibits the respondent from using or acquiring a product or process that is not the subject of the patent.

In appropriate factual scenarios, equitable defences are also available, including acquiescence, waiver, delay (laches) and promissory estoppel, although these defences have received relatively little judicial consideration in Australian patent cases. Delay is specifically relevant to the court’s discretion on interim injunctions and can also potentially limit the damages or profits recoverable in patent infringement proceedings.

The doctrine of patent exhaustion provides a defence to patent infringement under Australia law as explained in the decision of the High Court of Australia in Calidad Pty Ltd v Seiko Epson Corporation (2020) 272 CLR 351. Australia’s Patents Act 1990 (Cth) provides for the grant of compulsory licences in two circumstances. First, where demand in Australia for the patented invention is not being met on reasonable terms or where the patentee has engaged in practices which breach Australian competition law. Secondly, to enable manufacture and export of the pharmaceutical to an eligible overseas country to address a public health issue.

In a number of Australian patent cases relating to standards-essential patents (or patents alleged to be standards-essential), the respondent has relied upon Fair, Reasonable and Non-Discriminatory (FRAND) principles in support of an argument that injunctive relief should be refused and/or that damages should be limited to a court-determined FRAND rate. However, Australian courts are yet to deliver a judgment on the merits of such arguments.

Expert evidence on technical matters is of primary importance in Australian patent litigation and accounts for a significant proportion of total litigation costs. Expert evidence is ordinarily given in affidavit form (a sworn written statement), and the parties’ legal representatives work together with the expert witnesses to prepare the affidavit to ensure evidence is presented in admissible form. Experts may be, and usually are, cross-examined at trial.

Expert witnesses are usually retained and compensated by the parties. At the time of their engagement, experts must be provided with a copy of the Federal Court of Australia’s code of conduct for expert witnesses, which details their obligations regarding independence and impartiality. Court-appointed experts are relatively uncommon in Australian patent cases.

The court can be expected to issue directions regarding the number and field of experts permitted to give evidence in patent proceedings. Joint expert evidence processes are encouraged, including pre-trial expert conclaves in the absence of lawyers, during which experts prepare a joint report setting out matters of agreement and disagreement. At trial, concurrent expert evidence (“hot tubs”) is now routine.

There is no separate procedure for construing the terms of a patent's claims in Australia. Markman-type claim construction hearings are extremely rare, and issues of claim construction are ordinarily heard and determined together with all other issues of infringement and validity. While the Federal Court of Australia has the power to order separate determination of specific issues, this is relatively uncommon except for quantum of damages, which is frequently determined separately after liability has been resolved.

In practice, amicus curiae interventions in patent cases are uncommon but not unknown. An amicus curiae does not become a party to the proceedings but may, with the leave of the court, make submissions on questions of law or matters of public interest arising in the case. The primary objective of the amicus curiae procedure is to assist the court rather than to advance the interests of the amicus. Generally speaking, amicus curiae briefs are only likely to be permitted on a final appeal to the High Court of Australia.

Any natural or corporate person may seek revocation of a granted Australian patent in the Federal Court of Australia; there are no special standing requirements. Similarly, any person may request re-examination of an Australian patent in the Patent Office.

The key grounds of invalidity for Australian standard patents include:

  • that a claim is not directed to patent-eligible subject matter (ie, not a “manner of manufacture”);
  • lack of novelty;
  • lack of inventive step (obviousness);
  • lack of utility;
  • prior secret use;
  • insufficient disclosure;
  • failure to disclose best method;
  • lack of support for the claims (or lack of fair basis, for patents granted on applications filed before 15 April 2013 for which examination had been requested before that date);
  • lack of clarity;
  • lack of entitlement (which has not been rectified); and
  • false suggestion.

For innovation patents, the validity requirements are the same except that there is no inventive step requirement. Instead, the claimed subject matter must possess an “innovative step”.

Where infringement proceedings are brought by the patentee, the respondent may cross-claim for revocation in the same proceeding.

Revocation proceedings may relate to one or more claims of a patent. Where one or more claims of a patent have been found invalid, revocation of those claims will be ordered, although revocation is routinely stayed pending the determination of any appeal.

A patentee may seek to amend a patent that is the subject of litigation, including revocation proceedings. Any amendment application must be made to the court that has carriage of the proceedings under Section 105 of the Patents Act 1990 (Cth). The Patent Office may not consider an amendment application in respect of a patent that is the subject of current litigation (Patents Act 1990 (Cth), Section 112). The substantive requirements regarding amendments are addressed in 1.10 Post-Grant Proceedings Available to Owners of Intellectual Property Rights.

In Australia, issues of infringement and validity are ordinarily heard and determined concurrently, by the same Federal Court judge, in the same proceeding – that is, without bifurcation. Where a patentee commences infringement proceedings, the respondent commonly cross-claims for revocation, and vice versa. While the court has the power to order separate determination of specific issues, this is relatively uncommon, except that quantum of damages is frequently ordered to be determined separately after liability (including both infringement and validity) has been resolved.

Australian patent cases are subject to specific case management practices within the Federal Court’s Patents and Associated Statutes practice area. In August 2025, the Federal Court introduced the Intellectual Property Practice Note – Standard Directions for Australian Patent Proceedings (IP-2), which now applies to all patent proceedings (including those already under way) and sets out standardised directions designed to reduce the length and complexity of patent cases, increase procedural consistency and encourage early identification of issues.

Under the IP-2 Standard Directions, a structured timetable is set at the first case management hearing, which takes place approximately four to six weeks after commencement of proceedings. First-instance hearings usually conclude within 12 to 24 months of commencement, with judgment delivered within approximately nine to 12 months thereafter, although longer periods may arise in complex cases.

Typical steps include pleadings, any interlocutory injunction application, filing of evidence, discovery, pre-trial steps (including expert conclaves) and trial, with possible interlocutory hearings on issues such as amendment, adequacy of pleadings and scope of discovery.

Expert evidence is given by affidavit in chief and answer, and experts are usually cross-examined at trial. Concurrent expert evidence (“hot tubs”) is now routine at trial.

The quantum of damages is routinely determined separately, after all issues of liability have been resolved.

First-instance patent proceedings are conducted before a single judge of the Federal Court. There is no jury trial in Australian patent cases. First-instance patent cases are ordinarily allocated to a member of a panel of judges within the Patents and Associated Statutes practice area, each of whom has experience in patent matters, some with a technical background.

On appeal, a Full Court comprising three to five judges hears the matter, and will typically include at least one judge, and usually multiple judges, with experience in patent cases.

The Federal Court has the power to direct mediation of patent disputes. Court-ordered mediations are commonly conducted by registrars trained and accredited by the court, although parties can and often do choose to engage private accredited mediators. The use of mediation is increasing in frequency in Australian intellectual property disputes, particularly where the quantum of damages is likely to be small relative to the cost of litigation.

Formal offers of compromise compliant with the Federal Court Rules carry specific costs consequences, and less formal Calderbank letters of settlement may be taken into account by the court as a discretionary matter relevant to any award of costs. A potential infringer may also consider voluntary undertakings or settlement to avoid interlocutory applications.

It is possible for one or more granted patents to be the subject of revocation proceedings before the Federal Court at the same time as one or more related divisional patent applications are the subject of opposition proceedings before the Australian Patent Office. In these circumstances, complex strategic considerations may arise concerning the timing of steps in the Federal Court and Patent Office, including the timing of evidence and any application for amendment. It cannot be assumed that the opposition proceedings will be stayed by the Patent Office pending the outcome of the court proceedings. If court proceedings are commenced, the Patent Office cannot revoke a patent following re-examination, or allow any amendment while the litigation remains under way. If court proceedings are commenced by the patentee for alleged infringement of a certified innovation patent, any opposition proceedings will be stayed by the Patent Office pending the outcome of the litigation.

Australian courts may grant anti-suit injunctions where foreign proceedings interfere with, or threaten to interfere with, ongoing domestic litigation, or where parallel proceedings are vexatious or oppressive. Such injunctions are an exercise of the court’s inherent and equitable jurisdiction, designed to protect the integrity of its own processes and to prevent injustice.

The remedies available for infringement of an Australian patent include:

  • a declaration that the relevant conduct has infringed the patentee’s rights;
  • a final injunction restraining the respondent from repeating the infringing conduct or engaging in any other infringing conduct; and
  • either damages or an account of profits, at the election of the successful patentee.

A patentee may generally defer the election between damages and an account of profits until the quantum stage of proceedings, after discovery of the respondent’s relevant books and accounts. Additional damages may be awarded where the infringer’s conduct is flagrant or where compensatory damages are inadequate. The amount of additional damages is not limited by statute. Current case law suggests that additional damages will not be available if the patentee elects an account of profits.

A final injunction is a discretionary remedy but is granted in a significant majority of cases in which valid patent claims are found to have been infringed. However, in some pharmaceutical second-medical-use cases, the court has indicated it might refuse an injunction where the respondent’s product is capable of substantial non-infringing use and difficulties arise in seeking to craft appropriate injunctive relief.

The ordinary rule in Australian patent litigation is that costs follow the event, meaning that an unsuccessful party is ordered to pay a portion of the costs incurred by the successful party. A prevailing defendant would therefore generally be entitled to an award of costs representing approximately 50–70% of the actual costs it incurred in defending the proceedings.

Innovation patents confer the same enforcement rights as standard patents.

A judgment which has been appealed is not automatically stayed pending the outcome of the appeal. In particular, an injunction is likely to be ordered where a first instance decision upholds patent claims as valid and infringed and may not be stayed even while an appeal on infringement or validity is being pursued. However, where one or more claims of a patent have been found invalid, it is routine for revocation of those claims to be stayed pending the determination of any appeal. In appropriate cases, a party seeking a stay of a judgment pending appeal may be required to undertake to compensate the opposing party for any losses suffered during the stay if the appeal is unsuccessful.

A final first-instance decision of the Federal Court of Australia on patent infringement or validity may be appealed as of right to a Full Court of the Federal Court, comprising three to five judges. An interim decision of the Federal Court may only be appealed to the Full Federal Court with leave. Leave is also required to appeal to the Full Federal Court from a decision of a single Federal Court judge in an appeal from a Patent Office decision.

A judgment of the Full Court can only be appealed to the High Court of Australia with special leave, which is granted only in significant cases dealing with new or disputed points of law of broad significance.

It is unusual for new evidence to be permitted at the appeal stage. However, the opposing party may raise additional issues on appeal via a notice of contention or cross-appeal.

An appeal from a first-instance decision of the Federal Court to the Full Federal Court proceeds by way of rehearing, not by way of a hearing de novo. The Full Court has the power to review both questions of law and findings of fact. For an appeal to succeed, the appellant must demonstrate that the primary judge made an error of law or that a finding of fact was not reasonably open on the evidence. It is unusual for new evidence to be permitted at the appeal stage. In the context of appeals against Patent Office opposition decisions, by contrast, the appeal is conducted as a hearing de novo, with the court able to permit new grounds and new evidence.

For patent owners and their exclusive licensees, costs will be incurred before the commencement of proceedings in relation to (for example) the conduct of inter partes correspondence, the identification and engagement of expert witnesses, preparation of pleadings and preparation of evidence. Additional costs will be incurred where preliminary (pre-action) discovery is required to determine whether to commence infringement proceedings.

Court filing fees for commencing patent proceedings in the Federal Court of Australia are set by regulation and published on the Federal Court’s website. The fees are fixed amounts (not value-dependent, per-patent or per-defendant) and are subject to periodic revision. Exemptions or deferrals may be available in certain circumstances (although these are rarely obtained). Current fee schedules are available at the website of the Federal Court of Australia (www.fedcourt.gov.au).

The ordinary rule in Australian patent litigation is that costs follow the event – that is, the unsuccessful party is ordered to pay a portion of the costs incurred by the successful party. The amount awarded in costs typically represents around 50–70% of the actual costs incurred by the successful party. Increasingly, interlocutory costs are determined separately on a lump-sum basis and ordered to be paid forthwith.

The Federal Court has the power to direct mediation of patent disputes. Court-ordered mediations are commonly conducted by registrars trained and accredited by the court, although parties can and often do choose to engage private accredited mediators (eg, retired judicial officers). While it is possible to oppose mediation, if ordered by the court, the parties must attend. The use of mediation is increasing in frequency in Australian intellectual property disputes, particularly where the quantum of any damages is likely to be small relative to the cost of litigation.

Under Section 14(1) of the Patents Act 1990 (Cth), an assignment of an Australian patent must be in writing and signed by or on behalf of the assignor and the assignee. A patent may be assigned for a particular place in, or part of, the patent area under Section 14(2). Where the patent is co-owned, a co-owner cannot assign an interest in the patent without the consent of the other co-owners under Section 16(1)(c). There is no statutory requirement for the assignment to be executed as a deed. While registration of the assignment on the Register of Patents is not a precondition to the validity of the assignment between the parties, registration is important for the protection of the assignee’s interest. The patentee may deal with the patent as absolute owner subject only to rights appearing on the Register (Section 189), and an unregistered assignee may be vulnerable to a later purchaser in good faith for value without notice.

The procedure for assigning an Australian patent involves:

  • the execution of a written assignment document signed by or on behalf of the assignor and assignee under Section 14(1) of the Patents Act 1990 (Cth);
  • filing the assignment with IP Australia for entry on the Register of Patents, together with evidence of the assignment (such as a copy of the executed assignment document); and
  • upon registration, the particulars of the new owner are recorded on the Register.

The Patents Act 1990 (Cth) does not prescribe specific formalities (such as writing or registration) as preconditions to the creation of a valid licence. In practice, however, patent licences in Australia are invariably documented in writing, and the terms of the licence (including exclusivity, field of use, territory and sublicensing rights) are matters of contractual agreement between the parties. While there is no statutory requirement to register a licence with IP Australia, registration of prescribed particulars may be desirable for the protection of the licensee's interest. Notably, the definition of “exclusive licensee” under Australian patent law is restrictive. A licence will not be regarded as exclusive if it reserves to the patentee any right to exploit the claimed invention within Australia’s patent area (eg, a right to manufacture the patented goods) or gives the patentee a right to grant additional licences. This has important implications for standing, as only exclusive licensees (alongside the patentee) have standing to sue for infringement.

As noted in  10.3 Requirements or Restrictions to License an Intellectual Property Right, there is no prescribed statutory procedure for licensing an Australian patent. The creation of a patent licence is a matter of private agreement between the parties, and no approval from the Patent Office is required. The licence agreement should be documented in writing and should address key terms including exclusivity, territory, field of use, duration, royalty obligations and sublicensing rights.

While not legally required, it is advisable to register the licence (or prescribed particulars of it) on the Register of Patents maintained by IP Australia, both for the licensee’s own protection and to put third parties on notice.

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Maddocks Lawyers has offices in Sydney, Melbourne and Canberra, and its national IP team is recognised for its market-leading expertise in strategic IP advice and disputes. It acts on some of the most complex matters, particularly in the life sciences, mining & engineering and technology sectors. The team has a strong track record in high-stakes patent litigation, recently acting in Samsung Bioepis v Janssen (ustekinumab), AUPharma v Mundipharma (controlled release oxycodone/naloxone), Cipla v BMS (apixaban), AstraZeneca v Pharmacor (ticagrelor), Samsung Bioepis v Formycon (aflibercept, ranibizumab), Cipla v Novo Nordisk (liraglutide), CSIRO v Urrbrae Foods (high amylose wheat), Orthalign v Navbit (medical devices), Metso Sweden v FLSmidth (HPGR mining equipment), and AstraZeneca v Pharmacor (dapagliflozin). The firm’s lawyers bring exceptional technical insight and offer in-depth advisory and dispute resolution services for patent matters. The firm combines its IP expertise with leading healthcare, regulatory and technology practices.

Current Australian Patent Litigation

2025 saw a number of seismic shifts in the Australian patent litigation landscape. Two key appellate decisions with important legal and commercial ramifications have been raised for consideration by the High Court of Australia in special leave applications in early 2026. The Federal Court has also released a new practice direction to harmonise and streamline patent litigation practice and procedure, and has changed the ground rules for the conduct of disputes.

Gaining the most attention in the life sciences field is the decision of the Full Court of the Federal Court of Australia in Otsuka v Sun Pharma that formulation patents are not eligible for patent term extension. The Full Court also handed down its decision in the long-running dispute between Aristocrat Technologies and the Commissioner of Patents, paving the way for an expansion of patentable subject matter for computer-implemented inventions. In early February 2026, the High Court of Australia refused special leave to appeal, effectively endorsing the Full Court’s decision.

The Federal Court was also called on to decide three interlocutory injunction applications in Regeneron v Sandoz, Abbey Laboratories v Virbac and Janssen v Juno, in which the Court weighed the various factors in the balance of convenience, with different results. The Court’s decision in Perfect Day v Commissioner of Patents was notable in underlining the relative strictness of the sufficiency and support requirements for post-Raising the Bar patents. The decisions of NOCO v Brown and Watson and Zoetis v Boehringer provided further guidance on the Australian requirement for disclosure of the best method known to the patentee, including the relevant date for disclosure.

The Federal Court’s new practice note now applies to all patent cases, and is designed to standardise how Australian patent litigation is managed to minimise delays and promote the early identification of issues. The key changes are discussed in this chapter.

No PTEs for formulations: Sun Pharma v Otsuka

In December 2025, the Full Court of the Federal Court delivered its decision in Otsuka Pharmaceutical Co v Sun Pharma ANZ [2025] FCAFC 161, regarding the scope of the patent term extension (PTE) provisions of the Patents Act.

Otsuka’s patent covered certain controlled release injectable and freeze-dried formulations of aripiprazole. Sun Pharma challenged the validity of the PTE, arguing that the claims of the patent did not meet the statutory requirements for an extension. The central issue was whether a patent claiming a new formulation of a known active pharmaceutical substance (API) falls within the definition of a “pharmaceutical substance” eligible for a PTE.

In a unanimous decision, the Full Court found that, in light of a proper consideration of the legislative context, the natural and ordinary meaning of the definition of pharmaceutical substance “immediately and naturally puts the focus on the substance which itself produces the therapeutic effect”, and does not extend to new formulations, delivery methods or dosage forms containing known APIs. As a result, the patent was not eligible for a PTE. The Court found that the reasoning in earlier first instance decisions that had found formulations to qualify was incorrect, and preferred the construction given to the definition in other Full Court decisions which had focused on the API.

Otsuka has applied for special leave to appeal the decision to the High Court of Australia, which is due for consideration in March 2026. If special leave is refused, or if the High Court confirms the decision, it is a major course correction with significant implications. Australia’s Patent Office, IP Australia, has followed a practice of allowing PTEs on formulation patents over more than a decade based on earlier first instance decisions, despite the clear difficulties in their reasoning. If the Full Court’s decision stands, it will lead to action by IP Australia to rectify the register to remove PTEs granted on secondary patents, such as those claiming new formulations of known drugs. Actions by generics and biosimilar companies to clear the way can also be expected. It will also present new opportunities for earlier generic and biosimilar market access for a host of products that may be covered by invalid PTEs.

Aristocrat v Commissioner of Patents: update on computer-implemented inventions

The long-running quest by Aristocrat Technologies to secure patent protection for its gaming technologies has reached a successful conclusion. In September 2025, the Full Court in Aristocrat Technologies Australia Pty Ltd v Commissioner of Patents [2025] FCAFC 131 (Aristocrat 2025) held in Aristocrats’ favour, finding that the claims in four patents concerning electronic gaming machines would satisfy the “manner of manufacture” requirement for patentable subject matter.

Aristocrat 2025 was an appeal from the decision of Aristocrat Technologies Australia Pty Ltd v Commissioner of Patents (No 3) [2024] FCA 212, in which Justice Burley found that Aristocrat had not established that any of the residual claims were a manner of manufacture, following the earlier Full Court decision of Commissioner of Patents v Aristocrat Technologies Australia Pty Ltd [2021] FCAFC 202 (Aristocrat 2021). In Aristocrat 2025, the Full Court determined that all claims remitted for consideration after the earlier Full Court and High Court rulings did qualify as patentable subject matter.

The Full Court held that it was too restrictive to conclude that the implementation of an idea using well-known computer functionality cannot be a “manner of manufacture”. Instead, the Full Court agreed with the views expressed by Justices Gordon, Edelman and Steward in the High Court (Aristocrat Technologies Australia Pty Ltd v Commissioner of Patents [2022] HCA 29) that a clearer approach is to ask whether, when properly characterised, the subject matter is:

  • an abstract idea that is manipulated on a computer; or
  • an abstract idea that is implemented on a computer to produce an artificial state of affairs and a useful result.

The Full Court accepted Aristocrat’s submission that each of the residual claims is a combination claim that involves an altered electronic gaming machine to produce an artificial state of affairs and a useful result. The Full Court found that the integers concerning the game controller’s functions interact and depend on the integers concerning the user interface. In addition to the interdependent player interface, the invention included feature games, special symbols and a jackpot prize when a predefined number of special symbols was achieved. As such, the Full Court found that each of the residual claims was a manner of manufacture.

The Full Court also endorsed the primary judge’s observation that it would be hard to justify why an electronic implementation of an electronic gaming machine, which takes advantage of the efficiencies of electronic technology, should be excluded from patent eligibility when a patent claiming older mechanical technologies would not have been.

In a disposition from all seven judges of the High Court on 5 February 2026, the High Court refused the Commissioner of Patents’ application for special leave to appeal, stating that there is insufficient reason to doubt the correctness of the decision of the Full Court, which had applied established principles and reached a clear conclusion. As a result, the Full Court’s decision now stands with the endorsement of the High Court as the correct approach to the patent eligibility of computer-implemented inventions in Australia.

The decision rejects the requirement for an advancement in computer technology itself in favour of a broader question: whether the claimed invention, as a whole, produces an artificial state of affairs and a useful result, rather than being a mere abstract idea or scheme implemented on a computer. It is likely that many more patents will now be granted for computer-implemented inventions in Australia.

Interlocutory injunctions: does the balance of convenience favour biosimilars?

Until recently, patentees in Australian pharmaceutical cases routinely obtained interlocutory injunctions by arguing that generic or biosimilar entry and listing on the Pharmaceutical Benefits Scheme (PBS) would trigger statutory price reductions, with lasting price effects, which would be difficult to remedy with damages alone. The Court’s tendency to preserve the status quo kept generics and biosimilar entrants at the gate pending a final hearing, protected by the usual undertaking as to damages – an undertaking by the patentee to compensate any person adversely affected by the injunction if ultimately wrongly granted.

However, a series of cases in which patents have later been found invalid have since inundated the Court with a wave of protracted compensation claims, including claims by the Commonwealth Government, involving multiple hypothetical scenarios in which the Court has been called on to determine compensation. The experience has brought an evolution in how the Federal Court assesses the balance of convenience in patent disputes, particularly in the context of first generic or biosimilar launches and PBS price dynamics.

The Court declined to grant an interlocutory injunction in Regeneron Pharmaceuticals v Sandoz [2025] FCA 1067. The applicants (Regeneron and Bayer) sought urgent injunctive relief to restrain Sandoz from launching its aflibercept products, which are biosimilar versions of the applicants’ EYLEA® products. The applicants alleged that the Sandoz products would infringe Regeneron’s patent claiming use of aflibercept according to a particular dosing regimen to treat angiogenic eye disorders.

Rofe J considered a number of arguments typically raised in pharmaceutical injunction cases, including:

  • the mandatory statutory price reduction applied to an originator product when the first generic or biosimilar is listed on the PBS, alongside other price reductions;
  • the originator’s loss of market share;
  • the originator’s loss of revenue as a result of the PBS price drop;
  • the implications of international pricing regimes to reduce the price in other countries;
  • the impact of the biosimilar’s loss of first mover advantage and competitive edge over biosimilar contenders;
  • changing market dynamics and the preservation of the status quo; and
  • lost expenditure.

The 25% mandatory statutory price reduction that is applied to an originator product when the first generic or biosimilar is listed on the PBS is always a significant factor weighing in favour of the grant of an interlocutory injunction, as this price reduction changes the “status quo” with no guarantee that it would be reversed if the generic or biosimilar were later removed by a final injunction. However, Rofe J found that the applicants’ loss as a result of this price drop could be readily quantified and damages would be adequate to compensate the applicants.

Rofe J accepted Sandoz’s argument that loss of the first mover advantage would be significant to its business, particularly for a biosimilar medicine, and that the changing market dynamics (in circumstances where the applicants were moving to switch patients to a different patented product) would make Sandoz’s loss difficult to calculate.

Ultimately, Rofe J found that calculating the loss Sandoz would suffer if an interlocutory injunction was granted would involve more unknowns, and significant speculation as to market impact. Conversely, if Sandoz entered the market and were later found to have infringed the patent, the financial impact could be reasonably measured and the applicants could pursue damages or an account of profits. Ultimately, the Court held that the balance of convenience did not favour the grant of an interlocutory injunction, which was supported by the assessment of the applicants’ infringement case as relatively weak.

The Court also declined to grant an interlocutory injunction in Abbey Laboratories v Virbac (Australia) [2024] FCA 1488, for similar reasons. Virbac sought an interlocutory injunction to restrain Abbey from selling and marketing its Levamox Duo product, which it alleged infringed its patent for a veterinary topical formulation. The Court held that the balance of convenience did not favour the grant of an injunction for two main reasons.

  • There was a “very substantial delay on the part of Virbac”. Virbac had known for over 10 months that Abbey intended to launch Levamox Duo in Australia but had not sought undertakings not to launch, and raised the possibility of an interlocutory injunction application very late.
  • If the injunction was not granted, any financial harm to Virbac could be reasonably estimated and compensated with damages, given Virbac’s established sales history. In contrast, the potential harm to Abbey if the injunction was granted would be harder to quantify.

These decisions reflect a broader trend in Australia that courts are becoming increasingly reluctant to grant interlocutory injunctions in patent cases, especially where the restraint could cause disproportionate harm to generic or biosimilar companies or where the relevant market is likely to change even if an injunction is granted.

However, the recent decision in Janssen Pharmaceutica v Juno Pharmaceuticals [2025] FCA 1538 illustrates that the Federal Court will still grant interlocutory injunctions in the pharmaceutical context, particularly where there is a very strong prima facie infringement case that is not diminished by the strength of the prima facie invalidity case.

Post-Raising the Bar: a high bar for sufficiency and support requirements

The decision of Perfect Day v Commissioner of Patents [2025] FCA 270 illustrates the Federal Court’s approach to assessing the validity of patents in view of the amendments to the Patents Act 1990 (Cth) made by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth). In this case, the Court upheld the decision of the Commissioner, which found the claims of a patent application to a milk substitute product to lack support and held that the specification did not provide sufficient disclosure.

In 2019, Fonterra opposed the grant of Perfect Day’s patent application entitled “Compositions comprising a casein and methods of producing the same”. The main issue was that the specification, including the title, centred on compositions containing casein proteins. However, the claims were restricted to food compositions consisting solely of α-lactalbumin (ALA) and β-lactoglobulin (BLG), but explicitly excluding any other milk proteins, and having one or more characteristics of a dairy food product. In 2022, a Delegate of the Commissioner held that the specification failed to meet the sufficiency of disclosure requirement under Section 40(2)(a) of the Patents Act. Perfect Day appealed the Delegate’s decision to the Federal Court.

On appeal, the parties disagreed on the interpretation of claim 1, specifically the meaning of the phrase “one or more” as it pertained to the list of dairy food product characteristics. Perfect Day argued that claim 1 should be construed as requiring only one of the listed characteristics, and essentially as 16 distinct claims (one for each characteristic). The Court rejected this construction, instead finding that “one or more” means “one”, “more than one”, or “all” of the listed characteristics.

The Court found that claim 1 was not supported by matter disclosed in the specification. When properly characterised, the invention claimed was a food composition that comprised ALA and BLG proteins as the only milk proteins (rather than the invention of a dairy substitute composition). This claimed invention was distinct from that described in the specification, which, when viewed as a whole, described a food composition comprising casein and possibly other milk proteins, as well as the methods for its production. The Court also rejected Perfect Day’s reliance on the consistory clause as being sufficient disclosure and support for claim 1.

Furthermore, the Court held that claim 1 lacked sufficiency, as the specification provided no guidance to the person skilled in the relevant art seeking to perform the invention by making a dairy substitute composition with two or more of the listed characteristics; rather, they would need to embark on a prolonged research programme, inquiry or experimentation.

The Australian requirements for disclosure of best method – what and when?

Recent cases have provided welcome clarity on the Australian requirement under Section 40(2)(aa) of the Patents Act to disclose the best method known to the applicant of performing the invention.

In Zoetis Services v Boehringer Ingelheim Animal Health USA [2024] FCAFC 145, the Full Court clarified that an applicant will have failed to disclose the best method if the specification omits information known to the applicant that is material to achieving the advantages of the invention.

The decision noted the authority of Les Laboratoires Servier v Apotex [2016] FCAFC 27 in relation to the obligation for the patentee to include “aspects of the method of manufacture that are material to the advantages it is claimed the invention brings”. In Zoetis, the Full Court unanimously held that the specific antigen concentration was material to the advantages claimed and that the “disclosure of a range of antigen concentrations did not constitute a fair disclosure of the best method known”.

The Federal Court’s decision in The NOCO Company v Brown and Watson International Pty Ltd [2025] FCA 887 has provided guidance for now regarding the relevant date by which the applicant must satisfy the best method requirement for divisional applications. The litigation concerned three of NOCO’s patents relating to “jump starter apparatus for boosting a depleted or discharged battery”. NOCO’s patents were filed between 2020 and 2022, each claiming an earliest priority date of 3 July 2014 based on the filing date of the relevant PCT application. NOCO alleged that a number of Brown and Watson’s products, branded as “Projecta” jump starters, infringed NOCO’s patents. Brown and Watson cross-claimed, alleging invalidity on a number of grounds, including lack of novelty and a failure to disclose the best method.

The main issue to be determined in relation to best method was the relevant date for ascertaining NOCO’s knowledge of the best method. Brown and Watson argued that NOCO was required to disclose the best method known to it at the time of filing the complete application for each patent – namely the relevant divisional filing dates in 2020, 2021 and 2022. NOCO, on the other hand, argued that the relevant date was the date of the first filed application in the claim of divisional applications which is the date from which the term of each patent runs – namely 3 July 2014.

Ultimately, Moshinsky J preferred NOCO’s position. Moshinsky J considered a variety of authorities, including Pfizer Overseas Pharmaceuticals v Eli Lilly & Co [2005] FCAFC 224, in which French J and Lindgren J held that the relevant date to assess the best method known to the applicant was the filing date of the complete specification. This was in contrast to a more recent and controversial decision in Dometic Australia v Houghton Leisure Products [2018] FCA 1573, in which White J held that the relevant date was the filing date of the divisional application itself.

In applying Pfizer, Moshinsky J considered that the relevant date for assessing the applicant’s knowledge is the filing date of the earliest complete application, which in this case was the international filing date of the PCT application. Moshinsky J found that this approach was consistent with Section 29A(2) of the Patents Act, whereby “[t]he description, drawings, graphics, photographs and claims contained in a PCT application are to be treated as a complete specification filed in respect of the application”. Based on this reasoning, Moshinsky J determined that the filing date of a PCT specification, which is the international filing date, could constitute the filing date for the complete specification, meaning that disclosure of the best method was required to be made in the complete specification for the PCT application when it was filed (ie, on 3 July 2014).

Although Moshinsky J agreed with NOCO on the date at which the best method requirement is to be assessed, the Court ultimately found all asserted claims invalid for lack of inventive step. NOCO has since appealed the decision to the Full Court, and Brown and Watson have filed a notice of contention, so it appears the Full Court will consider this issue on appeal in March 2026.

New standard directions for Australian patent proceedings

In August 2025, the Federal Court introduced the Intellectual Property Practice Note – Standard Directions for Australian Patent Proceedings (IP-2), which sets out a range of measures aimed at standardising the management of patent litigation in Australia to reduce delays and encourage early identification of issues. The practice note aims to manage disputes in a quicker, more cost-effective manner, and to increase consistency and certainty in procedure.

A key part of the Practice Note is a set of standard directions to be made at the first case management hearing. The following points are of particular note.

  • Applicants are expected to confine their allegations of infringement to as few claims as possible and, if feasible, one patent.
  • Respondents advancing cross-claims are expected to confine the number of prior art documents and grounds raised.
  • The parties must discuss the standard directions and inform the Court if they agree on any changes to the default orders or, if not, specify their points of disagreement. The standard directions will now be the default procedural orders, and the Court will not depart from them lightly.
  • At the first case management hearing, parties must disclose if the patent applicant intends to amend the patent or if a party seeks to rely on experimental evidence.
  • The trial is scheduled 12 to 18 months after the case management hearing, unless there are exceptional circumstances.
  • When it comes to expert evidence on infringement, the patentee’s expert is required to provide a “Primer” section outlining uncontroversial technical background relevant to infringement as of the priority date, including a glossary of key technical terms.
  • For expert evidence concerning invalidity, the revoker’s expert should include a “CGK Summary”, summarising widely accepted technical knowledge in the field before the relevant priority date(s).

The Court has also introduced a summary costs assessment procedure, borrowed from the UK, to encourage parties to resolve or narrow interlocutory disputes, and to discourage frivolous applications by the prospect of immediate cost consequences. Rather than deferring payment of costs of interlocutory disputes to after the final hearing, the Court now requires parties to submit statements of costs for the hearing of any interlocutory application, and may make a lump sum costs order payable within 14 days following an interlocutory decision.

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Spruson & Ferguson Lawyers was Australia’s first law firm to specialise exclusively in intellectual property law. With decades of experience, the team is consistently recognised for its deep expertise in patents, trade marks, designs and copyright law – and for its role in shaping landmark IP cases across the country. The team advises on all aspects of IP disputes and litigation, commercialisation strategy, technology transactions, privacy laws and data protection. Whether defending rights or unlocking new opportunities, it is client-focused and delivers practical, strategic legal solutions tailored to client needs. Spruson & Ferguson Lawyers has over 500 employees, including over 200 professionals, servicing clients from across the globe – offering true regional capability, knowledge and experience.

Trends and Developments

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Maddocks Lawyers has offices in Sydney, Melbourne and Canberra, and its national IP team is recognised for its market-leading expertise in strategic IP advice and disputes. It acts on some of the most complex matters, particularly in the life sciences, mining & engineering and technology sectors. The team has a strong track record in high-stakes patent litigation, recently acting in Samsung Bioepis v Janssen (ustekinumab), AUPharma v Mundipharma (controlled release oxycodone/naloxone), Cipla v BMS (apixaban), AstraZeneca v Pharmacor (ticagrelor), Samsung Bioepis v Formycon (aflibercept, ranibizumab), Cipla v Novo Nordisk (liraglutide), CSIRO v Urrbrae Foods (high amylose wheat), Orthalign v Navbit (medical devices), Metso Sweden v FLSmidth (HPGR mining equipment), and AstraZeneca v Pharmacor (dapagliflozin). The firm’s lawyers bring exceptional technical insight and offer in-depth advisory and dispute resolution services for patent matters. The firm combines its IP expertise with leading healthcare, regulatory and technology practices.

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