Biosimilars Deals 2021

Kutti Bay Investments Pty Ltd v Rattlejack Innovations Pty Ltd [2026] FCA 422

Introduction

Justice Rofe of the Federal Court of Australia has delivered yet another decision in the long running dispute between Kutti Bay Investments Pty Ltd (Kutti Bay, formerly Jusand Nominees Pty Ltd) over patents for a “Safety System and Method for Protecting Against a Hazard of Drill Rod Failure in a Drilled Rock Bore”.  In this decision, Justice Rofe held that Kutti Bay’s application to amend three standard patents (the Standard Patents) constituted an abuse of process, insofar as it sought to “overcome” the Court’s decisions in Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2022] FCA 540 and Jusand Nominees Pty Ltd v Rattlejack Innovations Pty Ltd [2023] FCAFC 178 (the Jusand Proceedings).  See our reports on these decisions here and here.

Background

Kutti Bay commenced proceedings alleging infringement of the Standard Patents against Rattlejack Innovations Pty Ltd, Pan Australis Pty Ltd, Murray Engineering Pty Ltd and Leigh Maurice Sutton (together, Rattlejack).  Shortly after commencing proceedings, Kutti Bay applied to amend the Standard Patents under s 105(1) of the Patents Act 1990 to correct “obvious mistakes” in the Standard Patents.  Rattlejack opposed Kutti Bay’s patent amendment application, ultimately on the basis that the amendment application (and the expert evidence intended to be relied on for the purpose of that application) gave rise to an abuse of process.

So, what was the basis for Rattlejack’s abuse of process allegation? The answer to this question requires us to delve into the previous patent disputes between these parties, which led to the decisions in the Jusand Proceedings.

In the Jusand Proceedings, Rattlejack had successfully defended Jusand’s allegations of infringement in respect of three innovation patents (the Innovation Patents).  The Federal Court (at first instance and on appeal) had also found the Innovation Patents to be invalid for lack of disclosure and support.  Relevantly:

• the Standard Patents had the same priority date as the Innovation Patents;
• the Standard Patents (in their unamended form) were in materially the same terms as the Innovation Patents.  The Standard Patents were also in substantially the same terms as each other; and
• in the Jusand proceedings, the Court had made findings as to the construction of the Innovation Patents and as to the common general knowledge.

In November 2024, IP Australia re-examined all the patents in the same patent family as the Innovation Patents, including the Standard Patents.  The examiner considered that each of the claims of the Standard Patents lacked disclosure/support, for the same reasons as those identified in the Jusand Proceedings.  Given the examiner’s view, Kutti Bay considered it necessary to file the current patent amendment application to prevent revocation of the Standard Patents.

Kutti Bay relied on the evidence from three new expert witnesses, none of whom gave evidence in the Jusand Proceedings.  Justice Rofe noted that it was clear in the case of one of these experts that he did not read the Standard Patents to describe and claim the same invention that the Court found to be disclosed and claimed in the Innovation Patents.  Her Honour also noted that the conclusion of a second expert as to the routine nature of material selection was at odds with the findings in the Jusand Proceedings, and that this conclusion was only available based on an enlarged body of common general knowledge beyond what was found to exist on the evidence at first instance during the Jusand Proceedings.

Key Issues

Rattlejack filed an application alleging that Kutti Bay’s amendment application constituted an abuse of process to the extent that it sought to “overcome” the decisions in the Jusand Proceedings, for the following reasons:

• The amendment application sought to re-agitate and/or challenge issues of construction determined by the Full Court.
• The amendment application sought to invoke the Court’s statutory power in a manner that would undermine its earlier decisions.

In these circumstances, Rattlejack argue that allowing the amendment application to proceed would bring the administration of justice into disrepute, create a material risk of inconsistent findings and prejudice Rattlejack (including by exposing Rattlejack to being “twice vexed”).

Kutti Bay, however, argued that no such abuse of process arose as the proposed amendments merely corrected an “obvious mistake” in the Standard Patents, that is, a mistake which was apparent on the face of the Standard Patents and for which the correction was also obvious.

Consideration

Justice Rofe held that Kutti Bay’s patent amendment application was an abuse of process for the following key reasons:

• On the basis of the evidence before it, the Court in the Jusand Proceedings had made findings as to the common general knowledge of the person skilled in the art as at the priority date.  The Court then construed the claims of the Innovation Patents, based on the findings as to the state of the common general knowledge at the priority date and assisted by the experts’ evidence as to their understanding of the claims.
• The Standard Patents were materially identical to the Innovation Patents construed by the Court in the Jusand Proceedings.The Standard Patents and the Innovation Patents also shared the same priority date.
• The amendment application, however, was premised on evidence which was not before the Court in the Jusand Proceedings and would require her Honour to reconsider the construction of the Standard Patents in light of this new evidence.  More particularly, Justice Rofe held at [93] and [94] that:

“Kutti Bay’s “obvious mistake” contention requires the Court to read relevantly the same specification that it construed in the Jusand Proceeding, and in order to allow the amendment, agree with the new person skilled in the art experts that a different invention is actually described and claimed, than the one previously identified and considered by the Court.

As the Respondents identify, the vice in Kutti Bay’s approach is that in order to accept the existence of an obvious mistake, the Court must accept the evidence of the new experts as to the safety system of the claimed invention.  Doing so would necessarily involve adopting a different construction of the claimed invention different from that reached in the Jusand Proceedings.”

Outcome and Implications

Justice Rofe held that Kutti Bay’s application to amend the Standard Patents constituted an abuse of process, insofar as it sought to “overcome” the Court’s decisions in the Jusand Proceedings.  Justice Rofe also ordered Kutti Bay to pay Rattlejack’s costs of and incidental to its abuse of process application.

Justice Rofe’s decision is a salutary lesson for patentees: where construction of one patent in a patent family has already been the subject of a judicial decision, this construction may impact later litigation (including future amendment applications) in relation to other materially identical patents in the same family.

The proceedings continue, albeit very slowly, with the matter set down for a case management hearing in February 2027.

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.

Generics are now using preliminary discovery in AU to determine whether to mount validity challenges.

Introduction

Preliminary discovery applications are becoming increasingly common in the context of patent disputes in Australia. Typically, they have been deployed by patentees seeking documents to assist in determining whether to commence patent infringement proceedings. We report here on a new frontier in preliminary discovery in patent disputes: the use of preliminary discovery to obtain documents to assist a party to determine whether there are grounds to commence patent revocation proceedings. This is what recently happened in the dispute between Janssen and Juno over a patent relating to dosing regimens for INVEGA® (paliperidone).

Preliminary Discovery: A Primer

Preliminary discovery is a separate cause of action which enables a party to obtain discovery to determine whether it may have a right to obtain relief from a third party.

Rule 7.23 of the Federal Court Rules provides that a party may apply to the Court for a preliminary discovery order if that party:

1. reasonably believes that it may have the right to obtain relief from another;
2. after making reasonable inquiries, does not have sufficient information to decide whether to start a proceeding to obtain that relief; and
3. reasonably believes that:
   1. the other person or entity has (or is likely to have/had) in their control documents directly relevant to whether the first party has a right to the relief; and
   2. inspection of the documents by the first party would assist in making the decision.

The key case about the interpretation of r7.23 (Pfizer Ireland Pharmaceuticals v Samsung Bioepis AU Pty Ltd (2017) 257 FCR 62) (Pfizer) held that:

• rule 7.23 is a beneficial provision, which enables a person who believes they may have a right to relief to obtain information to make a responsible decision as to whether to start proceedings;
• the party seeking PD must prove that it has a reasonable belief that it may (not does) have a right to relief; and
• to defeat a claim for PD, the respondent will need to show, either that the subjectively held belief does not exist, or, that there is no reasonable basis for thinking that there may be (not is) a right to relief such as by demonstrating that no reasonable person, faced with the evidence relied on by the applicant, would think that a right to relief might exist.

Preliminary discovery in patent disputes

Over the past decade, patentees have increasingly used preliminary discovery as a mechanism to obtain documents in the context of brewing patent disputes. The seminal case which started the run of preliminary discovery applications was that of Pfizer in 2017. In that case, Pfizer sought preliminary discovery from Samsung Bioepis and its distributor to enable Pfizer to decide whether to bring an action for infringement of three process patents in respect of pharmaceutical blockbuster Brenzys® (etanercept). On appeal, the Full Federal Court ordered Samsung Bioepis and its distributor to provide preliminary discovery to Pfizer. In making this order, the Full Court made clear the low bar that needed to be met to obtain PD: the applicant must only establish that it reasonably believes that it may have, not has, a right to obtain relief.

Since then, patentees have continued to use preliminary discovery as a means to obtain the vital evidence they need prior to commencing patent infringement proceedings. In some cases, the PD application has been contested.  Some challenges succeeded, but most failed. In many cases, the parties have agreed to provide PD without contest, given the low bar set in Pfizer. Recent examples of preliminary discovery orders made by consent include the litigation between Amgen and Sandoz (now settled) in relation to Prolia®/Xgeva® (denosumab) and the ongoing litigation between Gilead and Alphapharm in relation to Descovy® (Emtricitabine + Tenofovir Alafenamide).

All of the previous PD cases involve the patentee seeking PD to determine whether to commence infringement proceedings. However Juno (an Arrotex subsidiary) has recently turned the tables demonstrating that preliminary discovery can also be used by alleged infringers – here a generic applicant – to obtain documents to assist in determining whether there may be grounds to commence patent revocation/invalidity proceedings.

Janssen filed proceedings against Juno in October 2025 seeking a preliminary injunction (PI) and final relief for alleged threatened infringement of a patent relating to dosing regimens for INVEGA® (long-acting injectable paliperidone esters).  The PI hearing was heard 6 weeks later on 21 Nov 2025, and by judgment delivered 5 December 2025, the court ordered a PI restraining Juno from supplying its generic paliperidone products.   Juno then filed a separate preliminary discovery action 13 May 2026 seeking documents to assist it in determining whether it has grounds to challenge the validity of Janssen’s patent.  Following a hearing on the preliminary discovery action 7 August 2026, the Court on 14 August 2026 ordered patentee Janssen to provide preliminary discovery, including discovery of clinical trial documents. The next step is for Juno to file and serve its Defence and any Cross-Claim within 4 weeks after it receives the documents which Janssen produces pursuant to the preliminary discovery order, which are due to be handed over by 28 September 2026.

Key Takeaways 

This is an interesting strategic “turning of the tables” by a generic company in Australia, and one that we expect to be followed by others.  The take home messages for patent litigants in Australia are:

1. It is extremely easy and straightforward to obtain preliminary discovery in the Federal Court of Australia.
2. Both patentees and alleged infringers can deploy preliminary discovery before commencing substantive proceedings to obtain documents relevant to infringement and invalidity.

About Pearce IP

Pearce IP is a privately owned/independent, specialist, life-sciences focussed, intellectual property/law firm offering lawyers and attorneys in Australia and New Zealand.

Our lawyers and attorneys specialise in pharma, biopharma, biotech, ag-tech, food-tech, med-tech, although our work is broader than these industries.

Pearce IP and its leaders are ranked in every notable legal directory including: Chambers & Partners, Legal 500, IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WTR 1000, Best Lawyers, WIPR Leaders, Best Law Firms, among others. In 2025, Pearce IP was honoured by Australasian Lawyer and New Zealand Lawyer as a Top Specialist Firm, 5 Star Employer of Choice, and the “Standout Winner” for Inclusion and Culture (<100 employees).  

Pearce IP is the only leading IP firm in Australia and New Zealand with a female founder, and is certified by WEConnect International as women owned.