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.

Nalco Company v Cytec Industries Inc [2026] FCAFC 72

Introduction

The Full Court of the Federal Court of Australia (Justices Beach, Jackson and Jackman) has issued a further, and what appears to be the final, decision in the long-running litigation between Nalco Company (Nalco) and Cytec Industries Inc (Cytec).  The litigation relates to Nalco’s patent application AU2012220990 entitled “Reducing aluminosilicate scale in the Bayer process” (the 990 Application).

The Full Court decision upholds the primary judge’s decision on the opposition to grant of the 990 Application, but overrules the primary judge’s decision on Nalco’s amendment application.  So, Nalco’s persistence has finally paid off, with the 990 Application now ready to proceed to grant.

The decision provides important guidance on claim construction in chemical patent cases, the interaction between support and sufficiency under s 40 of the Patents Act 1990 (Cth) (the Act), and the Court’s approach to amendments to patent applications under s 105(1A) of the Act following adverse validity findings.

Background

990 Application

The 990 Application claims a method for reducing “desilication product” (DSP) scale by adding a composition which consists of specific silane-based small molecules (non-polymeric, low molecular weight compounds) to the process stream developed by Karl Bayer (the Bayer Process).  These silane-based small molecules are said to offer advantages of better diffusion, more active inhibiting moieties per unit, and lower viscosity.

The Bayer Process represented the industry-standard for extracting alumina from bauxite ore.  A significant operational problem was the formation of aluminosilicate DSP scale inside process equipment, which adversely affected the efficiency of the plant’s equipment, and required acid-based descaling.  One prior art solution developed and marketed by Cytec under the name “Max HT” comprised an oxysilane-based anti-scalant additive that would keep the silica in solution and prevent scale formation.

The claims of the 990 Application identify specific silane-based small molecules by structural diagrams (denoted by Roman numerals), all formed within a complex product mixture resulting from the reaction of particular chemical reagents (amines, 3-glycidoxypropyltrimethoxysilane, 2-ethylhexyl glycidyl ether).

Claim 1 specifically provided:

(1) A method for the reduction of aluminosilicate containing scale in a Bayer process comprising the step of:

(2) adding to the Bayer process stream an aluminosilicate scale inhibiting amount of a composition comprising at least one small molecule

(3) selected from the group consisting of compounds (I) through (XIII), (XV) through (XXX), (XXXII) through (XLVII), (LIII) through (LVIII) and (LX)

(4) within a product mixture formed from the reaction of a) hexane diamine, ethylene diamine or 1-amino-2-propanol; b) 3-glycidoxypropyltrimethoxysilane; and c) 2-ethylhexyl glycidyl ether:

[drawn thereafter are the 46 further compounds referred to in integer (3)]

Critically, integer (4) of claim 1 listed three constituent reactants from which the product mixture had to be formed:

(1) hexane diamine (HD), ethylene diamine (ED) or 1-amino-2-propanol (AP), being amines (A);

(2) 3-glycidoxypropyltrimethoxysilane (GPS) being an amine-reactive compound that has a silane (Si(OR)3) group; and

(3) 2-ethylhexyl glycidyl ether (E) being an amine-reactive hydrophobic hydrocarbon.

Procedural History

The case had a complex procedural history.  After Nalco filed its patent application in February 2012, it faced opposition from Cytec in August 2015.  What followed was a series of amendment attempts and opposition proceedings before the Patent Office, eventually leading to Federal Court proceedings.  As previously reported, in August 2021, Justice Burley found that the claims lacked support and sufficient disclosure, but rejected Cytec’s submissions in respect of lack of novelty or best method (the Substantive Decision).  In response, Nalco filed further amendment applications aimed at overcoming the lack of support and sufficient disclosure findings, culminating in its sixth proposed amendment application including, amongst other proposed amendments, the following proposed amendments to claim 1 shown in mark-up:

(1) A method for the reduction of aluminosilicate containing scale in a Bayer process comprising the steps of:

(2) adding to the Bayer process stream an aluminosilicate scale inhibiting amount of a composition comprising at least one small molecules is selected from the group consisting of compounds:

(3) (I) through (IX), (XXVIII) (XIII), (XV) through (XXX) and (XXXII) through (XLVII), (LIII)through (LVIII) and (LX)

(4) within a product mixture formed from the reaction of a) hexane diamine, ethylene diamine or1-amino-2-propanol; b) 3-glycdixoypropyltrimethoxysilane; and c) 2-ethylhexyl glycidyl ether:

[drawn thereafter are the 12 further compounds referred to in integer (3)].

As we previously reported, Justice Burley refused Nalco’s sixth proposed amendment application in his November 2024 decision (the Amendment Decision).

Nalco sought leave and was granted leave to appeal both the Substantive and Amendment Decisions.

Appeal from the Substantive Decision

The key issues in this appeal revolved around the correct construction of unamended claim 1, and the implications of this construction for the issues of support and sufficient disclosure.

In upholding Justice Burley’s Substantive Decision, the Full Bench agreed with Justice Burley that:

Construction

• Properly construed, unamended claim 1 included within its scope both:
  • a complex reaction mixture, formed from the reaction of A + GPS + E, that included within it many of the identified small molecules as well as many more compounds; and
  • a reaction mixture, formed from the reaction of A + GPS + E, that was made up of a single type of small molecule identified in the claim.

Justice Burley considered this to be the proper construction because of the use of the language “comprising at least one small molecule” which indicated that the claim covered the spectrum between these two possibilities.

• The evidence was not that it was scientifically impossible to have a composition comprising only one single type of small molecule or only specified small molecules.  Rather, there was no known way of making such a composition.  It was in principle possible but statistically very unlikely that such a composition would result from simply reacting the precursor molecules with each other as described.
• There was no evidence that a composition comprising a single type of small molecule would not work in the claimed method.

Support

• The 990 Application did not identify or describe the beneficial effects of particular small molecules.  The 990 Application also did not identify or describe how to produce a reaction mixture that consisted of only one or other of those small molecules.
• Accordingly, to the extent that unamended claim 1 included a reaction product mixture containing only particular small molecules identified in the claim, that aspect of the claim was not supported.  However, the broader embodiment encompassed within the claim, where the reaction product is a complex mixture containing many of the listed small molecules and many more compounds, did not suffer from lack of support.

Sufficiency

• For the same reasons as unamended claim 1 lacked support, the disclosure of the 990 Application was not sufficient to enable the invention claimed to be performed without undue experimentation to the extent that those claims included a product mixture made up of a single type of small molecule.

Appeal from the Amendment Decision

The key issues in this appeal again revolved around the correct construction of claim 1 (but now in its proposed amended form), and the implications of this construction for the allowability of the amendments.  Cytec argued that amended claim 1 still encompassed product mixtures containing only the listed small molecules, and that as a result, the amendments were not allowable because, amongst other things, the amended claim 1 would lack support and clarity and that the 990 Application (as proposed to be amended) did not provide a clear enough and complete enough disclosure for the invention to be performed by a person skilled in the art.

At first instance, Justice Burley agreed with Cytec’s construction, finding that, while the claims required all specified small molecules to be present, they did not require the presence of additional molecules – more may be included, but were not essential.  Justice Burley also rejected Nalco’s argument based on “practical impossibility”, noting that the claims should be understood according to their terms, and not by reference to technical limitations or practical impossibilities.  As a result, his Honour considered that amended claim 1 still encompassed product mixtures containing only the specified molecules without providing sufficient technical disclosure to support such claims and without providing a clear enough and complete enough disclosure for the invention to be performed by a person skilled in the art.

Justices Beach and Jackman (with Justice Jackson dissenting), however, disagreed with Justice Burley.  In overturning Justice Burley’s Amendment Decision, Justices Beach and Jackman stated that:

• The words “at least one” and “selected from” had been removed from claim 1, such that the composition now comprised the identified small molecules within a product mixture formed from the reaction of A, GPS and E.
• As a matter of ordinary English, the fact that the identified small molecules are “within” a product mixture meant that the product mixture is a complex mixture that includes but is not limited to the identified small molecules.
• The claims do not include within their scope a product mixture made up of only the identified small molecules and nothing else.
• The claims must be construed in the context of the common general knowledge which included knowledge that:
  • when one of the three different forms of A was reacted with GPS and E, the resulting product mixture would always contain an extremely large variety of small molecules which included all of the small molecules listed in the amended and unamended claims, as well as many others, as well as polymers; and
  • it was not practically possible to react A, GPS and E in a way that results in only those small molecules being present to the exclusion of other small molecules or polymers.
• Accordingly, the skilled addressee would not think that the claims are directed to anything other than a product mixture that includes small molecules.
• Given this construction, amended claim 1 does not lack support and clarity and the 990 Application (as proposed to be amended) does provide a clear enough and complete enough disclosure for the invention to be performed by a person skilled in the art.

Discretion under s 105(1A)

Cytec also contended that the proposed amendments should be refused on discretionary grounds under s 105(1A) of the Act for reasons related to alleged delay and misconduct in seeking the amendments.

Relevantly, Justices Beach and Jackman considered that the rationale underlying the Court’s discretion to refuse amendments to a granted patent under s 105(1) was not a rationale that could simply be applied to the power of amendment to a patent application under s 105(1A).  In particular, unlike with a granted patent, a patent application did not give rise to a monopoly and so no abuse of monopoly could arise.

Having found the amendments allowable, Justices Beach and Jackman addressed the issue of discretion.  The key factors included:

• Delay: Cytec argued that Nalco had been on notice of support/sufficiency vulnerabilities since at least 2016 and deliberately delayed filing amendments (including the “third amendments” in 2018) to tactically disadvantage Cytec.  Justices Beach and Jackman found that the 2018 conduct (which concerned different amendments addressing a different issue — the isolation of individual small molecules) was not causally connected to the amendments now sought.  Since the successful support/sufficiency grounds were first raised by Cytec only on the eve of trial in October 2020, in substantially amended form, their Honours found that Nalco had reasonable grounds to believe amendments were unnecessary while it maintained a tenable construction.  As such, Justices Beach and Jackman did not consider that Nalco had unreasonably delayed in seeking to make the amendments.  Further, if there had been any delay, such delay had not caused any significant and relevant prejudice to Cytec.
• Full and frank disclosure: Justices Beach and Jackman found Nalco had provided detailed and fulsome disclosure, annexing all relevant internal correspondence.  Their Honours did not agree that Cytec’s criticisms (failure to call one inventor, filing late lay evidence after Cytec objected to hearsay, adducing voluminous documents) established a material failure of disclosure.
• Re-litigation: Justices Beach and Jackman also rejected Cytec’s argument that the amendment application was impermissible re-litigation.  Nalco was seeking to address by means of the amendments sought Justice Burley’s findings in the Substantive Decision that were based on his Honour’s conclusion as to construction.  Their Honour’s considered that section 105(1A) of the Act was enacted to overcome the difficulty of amending a patent application in the context of an appeal from the Commissioner’s decision.
• Other discretionary factors: Finally, Justices Beach and Jackman did not consider the amendments to be futile or an abuse of monopoly (given the patent had not been granted).

Justices Beach and Jackman accordingly exercised the discretion in Nalco’s favour and allowed the amendments.

Outcome

The key outcomes were:

• Leave to appeal was granted in respect of both the Substantive and Amendment Decisions, with the appeal on the Substantive Decision then being dismissed and the appeal on the Amended Decision then being allowed.
• Justice Burley’s order refusing the amendment application was set aside, and Nalco’s amendment application was granted.
• Australian patent application no 2012220990 is to proceed to grant in the amended form.

Implications

1. Claim construction in chemistry patents: The decision reinforces that claims will be given their ordinary meaning even where a particular embodiment within their scope is chemically near-impossible. Patentees must take care to draft claims that are limited to what the specification actually teaches, rather than claims whose breadth (even if theoretically very narrow in practice) outruns the disclosure.
2. The interplay between ss 40(2)(a) and 40(3): The decision confirms that where a claim’s scope includes an embodiment for which no method of performance is disclosed, the claim will fail both the support and enablement requirements, regardless of whether that embodiment is practically achievable.
3. Scope of s 105(1A): The decision provides important guidance on the breadth of the Court’s power and discretion to allow amendments to a patent application during an appeal from a Commissioner’s opposition decision. It confirms that: (a) s 105(1A) is designed to allow a patent applicant to address invalidity findings made during appeal proceedings, not merely pre-existing invalidity risks; (b) the discretionary factors applicable to amendments of granted patents under s 105(1) do not translate directly to s 105(1A) given the different context (no monopoly yet conferred, no abuse of monopoly possible); and (c) the Court will not treat an amendment application as impermissible re-litigation merely because it arises from adverse findings in the same appeal.
4. Delay: The decision clarifies that the relevant clock for unreasonable delay in an amendment application under s 105(1A) runs from the time the applicant has (or ought to have had) knowledge of the specific invalidity ground requiring amendment — not from awareness of general vulnerability in the specification. Where an opposing party significantly reformulates its case on the eve of trial, the patent applicant will not ordinarily be penalised for failing to pre-emptively address the reformulated ground.

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.

Gilead Sciences Pty Ltd v Minister for Health and Ageing [2026] FCA 232

Introduction

In March this year, Justice Downes of the Federal Court of Australia delivered her decision in Gilead Sciences’ (Gilead) case against the Minister for Health and Ageing (the Health Minister).  Finding against Gilead, her Honour held that once Alphapharm’s generic of Gilead’s Descovy® (which contains 2 antiviral compounds) is PBS listed, price reductions would also apply to Gilead’s Odefsey® and Biktarvy® (each containing the same 2 compounds plus another), and Genvoya® (containing the same 2 compounds, plus 2 others) under s 99ACC of the National Health Act 1953 (Cth) (the Act).  Her Honour’s decision has wide-reaching implications for the pricing of combination drugs.

While Gilead has not appealed Justice Downes’ decision, the battle between Gilead and Alphapharm is far from over.  In May 2026, Gilead Sciences commenced patent infringement proceedings against Alphapharm, seeking and then obtaining (by consent) an interlocutory injunction in July 2026 to prevent the PBS listing and launch of Alphapharm’s Dencovir®.  These proceedings follow Gilead’s preliminary discovery application filed in March 2026 and resolved by consent orders later that month, with Alphapharm agreeing to provide Gilead with certain requested information regarding Dencovir®.

Background

The Legislation

Division 3A of the Act provides, amongst other things, that when the first generic brand of a pharmaceutical item is PBS listed, price reduction provisions will apply to brands of pharmaceutical items that are connected to the newly listed generic brand.  In particular, pursuant to s 99ACC:

• Price reductions apply to:
  • an existing brand of a combination item, that is, in summary, a drug that contains at least 2 other drugs or medicinal preparations, at least one of which is a listed component drug; and
  • a new generic brand of a pharmaceutical item that has that component drug which is listed for the first time.
• On the day the price reduction takes effect, the approved ex-manufacturer price (AEMP) of the single brand of the combination item is reduced in accordance with the method set out in the regulations (namely, reg. 65A).

Gilead’s PBS Listed Products

Gilead has the following products listed on the PBS:

• Descovy® (Emtricitabine + Tenofovir Alafenamide);
• Odefsey® (Emtricitabine + Rilpivirine + Tenofovir Alafenamide);
• Genvoya® (Tenofovir Alafenamide + Emtricitabine + Elvitegravir + Cobicistat); and
• Biktarvy® (Bictegravir + Emtricitabine + Tenofovir Alafenamide).

Following Alphapharm’s listing of Dencovir® (a generic version of Descovy®) on the ARTG in January 2026, Gilead became concerned that Alphapharm would soon PBS list Dencovir®.

Key Issues

Both parties agreed that, if Dencovir® was listed on the PBS, Division 3A of the Act would have the effect that a first new brand price reduction would apply to Dencovir®, and the same price reduction would apply to Descovy® itself.

The key question on which the parties disagreed was: would the listing of Dencovir® result in price reductions for any other products which included emtricitabine and tenofovir alafenamide (i.e. Odefsey®, Genvoya® and Biktarvy®)?

Gilead argued that there should not be any price reductions for Odefsey®, Genvoya® and Biktarvy®; the Health Minister disagreed.  Answering this question required Justice Downes to determine whether each of these products (i.e. Odefsey®, Genvoya® and Biktarvy®) is a combination item and whether the drug in each of them contains a listed component drug, namely “emtricitabine with tenofovir alafenamide”.

Gilead argued that if the Health Minister’s approach is correct, then reg. 65A (which provides the mechanism by which the price reduction is calculated) is invalid, stating that:

• Reg. 65A does not provide any direction as to how to choose between the different possible combinations of a combination product’s constituents when selecting the components to which the formula in reg. 65A(2) is applied; and
• as a result, the choice as to how to apply the formula was an entirely arbitrary one, generating different results depending on the choices made.

The Health Minister disputed Gilead’s position.

Consideration

Justice Downes analysed the statutory provisions and definitions.  Her Honour held that the price reductions would apply to Odefsey®, Genvoya® and Biktarvy® under s 99ACC of the Act if Dencovir® was PBS listed because each of Odefsey®, Genvoya® and Biktarvy® is a combination item.  Why?  Because Odefsey®, Genvoya® and Biktarvy® are each a pharmaceutical that contains at least 2 other drugs, at least one of which is a listed component drug (namely, “emtricitabine with tenofovir alafenamide”).  Her Honour also held that reg. 65A was not invalid.  Why?  Because her Honour considered that the manner in which reg. 65A works was not as stated by Gilead, and so rejected Gilead’s position.

Outcome and Implications

Gilead failed on all its arguments, with Justice Downes holding that the price reduction that would result if Dencovir® was to be listed on the PBS would also apply to Gilead’s Odefsey®, Genvoya® and Biktarvy®.  Gilead was also ordered to pay the Health Minister’s costs.

Her Honour’s decision has wide-reaching implications for the pricing of combination drugs.  The statutory price reductions which result from the listing of a generic product on the PBS will now impact the pricing of combination products that include the same listed component drug.

Her Honour’s decision also impacts innovator drug companies’ market enforcement strategies when faced with the imminent generic entry for a combination drug.  Gilead has moved swiftly to protect its Australian market position by commencing patent infringement proceedings against Alphapharm in May 2026 and obtaining (by consent) an interlocutory injunction to prevent the PBS listing and launch of Alphapharm’s Dencovir®.

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.