Biosimilars Deals 2021

uniQure IP B.V. [2025] APO 14 (19 May 2025)

Introduction

The Australian Patent Office (APO) has refused to grant a patent on Australian Patent Application 2018299865 (the Application) in the name of uniQure IP B.V.  The Application sought to protect using known AAV5-based gene therapy for patients with pre-existing anti-AAV5 neutralizing antibodies, who were said by uniQure to have previously been thought to be unsuitable for this treatment.  While the claims were found to be clear, supported, and novel, they all failed for lack of inventive step.  Treating antibody-positive patients was considered an obvious extension of the prior art and common general knowledge.

Background

The Application was filed on 10 July 2018.  The invention related to a method of treating human genetic diseases, particularly haemophilia, using AAV5 viral gene therapy vectors.  Specifically, the invention was said to lie in the realisation that treatment could be efficacious even for patients with pre-existing neutralizing antibodies against the AAV5 vector.   The specification stated that the “general consensus in the field” was to avoid treating patients who had the neutralizing antibodies, and that current clinical practice was to screen patients and exclude from treatment those with these antibodies.

The case proceeded through multiple examination reports and amendments between December 2023 and July 2024, with objections being raised on a number of grounds.  On 11 December 2024, uniQure requested to be heard.  A hearing was conducted by written submissions, filed on 17 January 2025 accompanied by a declaration from Dr Sander van Deventer, and a set of further amendments.  The Delegate conducting the hearing expressed concerns with those amendments.  A final set of amendments was filed on 7 March 2025, including the deletion of the previous claims 1 and 2.

There were three independent claims to be considered.

Claim 1, former claim 3, as proposed to be amended, read:

A method of treating a genetic disease or disorder comprising administering an effective amount of an AAV5 gene therapy vector to a human in need thereof, wherein said human is subjected to a pre-screening with an assay to determine anti-AAV5 antibodies and wherein said human has not been subjected to a medical treatment with an AAV5 gene therapy vector prior to administering the effective amount of the AAV5 gene therapy vector, wherein said human tests positive for anti-AAV5 antibodies in the pre-screening assay; wherein the method does not further comprise administering to said human a therapy to reduce or inhibit anti-AAV5 antibodies, and said human has not been subjected to a prior therapy to reduce or inhibit anti-AAV5 antibodies.

Claim 2, former claim 4, was in Swiss form, directed to the use of an “AAV5 gene therapy vector in the preparation of a medicament for treating a genetic disease or disorder” in a similar manner to that described in claim 1.

Proposed claim 12 read:

A method for determining human patients eligible for a medical treatment with an AAV5 gene therapy vector, the method comprising selecting a human patient that has: (i) not been subjected to a prior AAV5 gene therapy treatment and (ii) not been subjected to a prescreening with an assay to determine anti-AAV5 antibodies, and identifying the human patient as eligible for the medical treatment.

Consideration

Clarity: The Delegate considered that the proposed amendments removed the examiner’s previous objection of lack of clarity.

Support: The examiner considered that the support in the specification did not extend to the general treatment method claimed, but was limited to the specific examples of treating haemophilia caused by blood-clotting factor IX deficiency by administration of a baculovirus-expressed AAV5 vector.  However, the evidence of Dr van Deventer was that “This discovery is not limited to a specific disease or condition, the expression system used to manufacture the AAV vector, nor is it specific to the therapeutic transgene expressed by the AAVS gene therapy vector.”  The Delegate was therefore satisfied that the claimed invention, across its whole scope, was supported by the complete specification as effective treatment of patients could be plausibly extrapolated from the observations made in the experimental example and the description as a whole.

Novelty:  The deletion of former claims 1 and 2 disposed of some of the examiner’s novelty objections which were based on a number of prior art documents.  Although some of the prior art documents disclosed the use of AAV5 vectors for delivering gene therapy without discussing a selection process for candidate patients, the Delegate did not consider that this amounted to a disclosure of every single possible approach, nor did it amount to clear and unmistakable directions for a method of administering AAV5-based gene therapy to a treatment-naïve person who is also positive in a pre-screening assay for anti-AAV5 antibodies.

Inventive Step:  The objection based on a lack of inventive step was based on a subset of the prior art documents also considered in respect of novelty.  The Delegate noted that two of these documents were not commented on by uniQure but were referenced in a document provided to Dr van Deventer in preparing his evidence.  These documents related to early clinical trials for AAV2 gene therapy and did not mention exclusion of patients having pre-existing anti-AAV2 antibodies.  They included discussions of successful treatment of patients with pre-existing anti-AAV2 antibodies.  This was taken by the Delegate as directly contradicting uniQUre’s submission, supported by Dr van Deventer’s evidence, that there was a prevailing belief that any AAV gene therapy would necessarily fail in patients with pre-existing antibodies for the AAV serotype intended for use in the gene therapy.  The Delegate held that although there may have been a preference for patients who were free of pre-existing antibodies against the AAV serotype used in the intended therapy, this preference did not translate to a universal acceptance of treatment failure in the presence of anti-AAV antibodies.

Outcome

The Application was refused on the grounds of lack of inventive step.  The Delegate observed that there was no subject matter that could be made the subject of a valid claim to overcome that conclusion so there would be no purpose in allowing any further opportunity to amend.  uniQure had previously filed and requested examination of a divisional application, which is currently yet to be examined by IP Australia.

Implications

A claim that there is an inventive step in identifying a new patient group for a method of treatment is likely to fail where the previous exclusion of that group was a matter of preference rather than a firm belief amongst skilled people that the treatment would fail in patients from that group.  This is especially the case where prior art includes examples of successful treatment of such patients.

About Pearce IP

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

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 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.

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.

Watson Webb Pty Ltd v Comino [2025] FCA 871

Introduction

In this article, we report on a Federal Court judgment in which Justice Halley determined two proceedings with a number of claims and cross-claims invoking statute, common law and equity.  The two proceedings arose from a breakdown in the commercial relationship between organisations involved in the design, fabrication, manufacture, importation and distribution of valves, meter boxes and brackets for water distribution systems.  Our report summarises only those parts of the decision concerning patent infringement and invalidity.  (Other parts of the judgment concern the laws of registered designs, copyright, confidential information, contract, consumer law, and trust.)

Background

The various parties had previously been in a web of commercial relationships regarding the design, supply and sale of plumbing products.  The First Applicant, All Valve Industries (“AVI”), previously was supplied and on-sold water meter assemblies including pipe-holding brackets that were made by the Second Respondent, Strongcast Pty Ltd.  Strongcast and its principal, the first respondent Mr John Comino, considered those products to be covered by Mr Comino’s Australian Innovation Patent AU 2017100757 (the Patent).  AVI subsequently began dealing in third party water meter assemblies, including pipe-holding brackets, not authorised by Mr Comino or Strongcast.  Mr Comino claimed the unauthorised assemblies and brackets infringed claims 1 to 4 of the Patent.  AVI cross-claimed alleging those claims of the patent to be invalid on the grounds that each lacked clarity, support and/or sufficiency under s 40(2)(a) or s 40(3) of the Patents Act 1990 (Cth).

AVI succeeded on its invalidity claim and an order was made revoking the patent.  Had it not, Justice Halley would have found no infringement in any case.  Both parties have filed appeals which are to be heard in March 2026.  Although it is not clear that these appeals include the patent claims and crossclaims, it seems likely.

Key Issues

The key issues were:

1)  Veracity of witnesses and experts.

2)  Interpretation of the asserted patent claims.

3)  Whether the asserted claims:

a)  lacked clarity;

b)  lacked support; and

c)  sufficiently described the invention.

4)  Whether AVI’s products infringed the asserted claims.

Consideration

Veracity of witnesses and experts

While his Honour was satisfied that AVI’s witnesses were honest, Justice Halley found that Mr Comino was combative, argumentative and inconsistent.  Justice Halley accordingly gave his evidence comparatively less weight in light of other contemporaneous evidence and the inherent logic of events.

Expert evidence was given by the experts in concurrent sessions, in the context of their joint expert reports.  Justice Halley found that the concurrent sessions provided an invaluable platform to expose the reasoning of each of the experts and permit it to be tested and evaluated.  His Honour considered that, at times, the experts strayed into positions that appeared to be driven more by advocacy than expertise but was generally satisfied that each of the experts was genuinely seeking to assist the court in a non-partisan and constructive manner.

However, his Honour criticised the way in which affidavits were prepared for AVI’s expert, Mr Smerdon.  This was done by video conferences between Mr Smerdon and AVI’s solicitors.  A solicitor would type up a first draft of the affidavit.  The draft affidavit would then be sent to Mr Smerdon for his review, and then amended in a second conference call before Mr Smerdon gave his final approval.  Justice Halley placed little weight on Mr Smerdon’s affidavit evidence, given the potential for the independence of the evidence to be subverted,  and the possibility of a  solicitor “ with the best will in the world” framing the evidence in the initial draft in a manner that fails to reflect the expert’s evidence accurately or free of potential ambiguity.  His Honour considered that the process of preparing Mr Smerdon’s evidence was not consistent with the principles of the expert witness code of conduct or with the principles underpinning the reception of expert evidence in proceedings.  As a result, Justice Halley principally relied on Mr Smerdon’s oral evidence, and the evidence attributed to him in each of four joint expert reports.

Construction of the asserted patent claims

The relevant claims of the specification were as follows:

1)  A bracket for holding pipes, the bracket comprising:

an elongate base comprising:

an upper side;

an underside which is adapted for mounting on a surface;

fasteners located at opposing longitudinal edges of the base and configured for a housing to be releasably fastenable thereto; and

apertures configured to receive surface engaging fasteners therethrough,

pipe receiving members located at opposing sides of the upper side of the base, each pipe receiving member being configured to receive a respective pipe, whereby pipes are alignable above a longitudinal axis of the base and joinable via an intermediate component locatable substantially centrally over the base, wherein a footprint of the bracket has a width similar to that of the pipes and intermediate component but whereby the pipes and intermediate component do not overlap the opposing longitudinal edges of the base.

2)  The bracket of claim 1, wherein the fasteners comprise snap fit tabs configured for releasably fastening the housing to the bracket.

3)  The bracket of claim 1 or claim 2, wherein the housing comprises side walls that are configured to define an enclosure around the bracket when the housing is fastened to the bracket and a lower edge of the side walls is complementary to the longitudinal edges of the bracket, wherein a substantially continuous barrier around the bracket is provided when the housing is fastened to the bracket.

4)  The bracket of claim 3, wherein the side walls of the housing taper outwardly.

5)  The bracket of any one of claims 1 to 4, wherein the pipe receiving members comprise clamping members, each clamping member comprising clamping jaws configured to receive and clamp the pipe therebetween.

Justice Halley considered competing constructions of the following integers of the claims:

“holding pipes” in claim 1:

AVI submitted that “holding pipes” meant merely pipes “resting” on the bracket.  Mr Comino submitted that it meant “holding securely so as to not fall”.  AVI countered stating that secure holding represented the more limited embodiment of claim 5.  Each side also referred to other related terms in the body of the specification said to favour their respective interpretations.

Justice Halley took a middle course, holding that, as a matter of English language “holding” means more than simply “resting” an item in a cradle, requiring the pipes to be securely fastened.  Read as a whole, Justice Halley found that the specification disclosed three discrete concepts: a broad concept of “holding”, a narrower concept of “gripping”, and a further narrower concept of “clamping”.  “Holding” was construed as providing a “mechanism whereby the pipes will remain in position and not move if the bracket is placed on a level horizontal surface without the use of gripping members.”

“an underside to be adapted for mounting on a surface” in claim 1:

AVI submitted that this meant the base of the bracket must have something added to it which enables the base to be firmly fixed to a mounting surface.  Mr Comino submitted that it simply required the underside of the bracket to be suitable for mounting on a surface, e.g.  by both being planar.

Justice Halley agreed with Mr Comino.

“longitudinal edges of the base” in claim 1

AVI submitted that this meant the area “on or at close proximity to the longitudinal edge”.  Mr Comino argued for less precise “longitudinal edge regions”.  Justice Halley preferred AVI’s position as it was a common sense construction of the integer which did not render the integer meaningless and which did not involve rewriting the integer.

“pipe receiving members located at opposing sides of the base, each pipe receiving member being configured to receive a respective pipe” in claim 1:

The issue to be resolved with this integer was the meaning of “receiving” a pipe in the context of the meaning of “holding pipes” discussed above.  AVI submitted it meant merely that the pipe had to “rest on” the pipe receiving members (as opposed to claim 5’s requirement to “receive and clamp the pipe”).  Mr Comino submitted that it meant to “hold the pipes securely”.  Justice Halley, again took a middle course, holding that “receiving” meant more than to hold or rest, but required the “pipe to remain in position, at least on a horizontal plane” but the integer did not include “any requirement that the pipe be held securely in the sense that it will remain in place if the base is attached to a vertical surface.”

“taper outwardly” in claim 4:

Mr Smerdon’s evidence for AVI was that “taper outwardly” could mean that a housing could taper outwardly from base to top, or from top to base.  Mr Hunter, expert for Mr Comino, said that “taper outwardly” means from bottom to top; a taper from top to bottom would be an “inward taper” and in any event would not allow the invention to work.

Justice Halley preferred Mr Hunter’s view as being consistent with the plain meaning of the words, drawings in the specification, and the proper functioning of the invention.

Invalidity

Clarity, support and sufficiency

AVI alleged the claims were invalid on the grounds of lack of clarity, support and sufficiency.  All three of these grounds related to the integer of claim 1 requiring that the “footprint of the bracket has a width similar to that of the pipes and intermediate component”.

With respect to clarity, AVI argued that a skilled person would have no reasonable way to determine a non-infringing bracket width as there was an enormous variety of possible choices of type and size for the “intermediate component”.  A skilled person could not reasonably consider all possible alternatives and determine a “similar” width.

With respect to sufficiency and support, AVI submitted that there was no figure or embodiment in the specification where there was similarity between the bracket’s width and the width of the intermediate component.

Justice Halley agreed that there was not workable standard for determining infringement nor any teaching or disclosure by which the width of the bracket could be ascertained.  His Honour found that this integer of the claim was inherently circular; the width of the bracket was to be ascertained by reference to a broad range of different intermediate components with “similar” widths to that of the bracket.  His Honour noted that the position would have been very different if the claim was to dimensions of the bracket expressed as a range or with specific values, thus providing a specific teaching and a workable standard.

Accordingly, claim 1 was held to be invalid for want of clarity, sufficiency and support under s 40(2)(a) and 40(3) of the Patents Act.

Lack of novelty or innovative step

AVI alleged lack of novelty and innovative step compared with a limited range of previous products and related catalogues.  Although Justice Halley was satisfied that the limited evidence was sufficient to prove public availability of this prior art, his Honour held that it did not include fasteners that were “releasably fastenable” as required by claim 1, and therefore the invention did not lack novelty or an innovative step.

AVI also asserted that two US patents were invalidating prior art.  On the expert evidence, Justice Halley held that a number of integers of claim 1 simply were not present in this prior art, and again concluded that the patents lacked neither novelty nor an innovative step.

Infringement

Three versions of AVI’s bracket products were alleged to infringe the Patent.  The infringement claims came down to whether these products included each of four integers of claim 1.

The first two integers were largely resolved by the construction issues considered above:

• The first initially contested integer was the requirement for an “underside which is adapted for mounting”.  The experts agreed that this integer, as construed by Justice Halley, was present in the alleged infringing products.
• The second contested integer was the requirement for “fasteners located at opposing longitudinal edges of the base … housing to be releasably fastenable thereto”.  Justice Halley had rejected Comino’s interpretation of “longitudinal edge” and accordingly held that this integer was not present in the alleged infringing products.

The third issue was whether the alleged infringing products had “apertures configured to receive surface engaging fasteners therethrough”.  Each alleged infringing product required separate analysis in this respect as each had differing numbers and configurations of apertures in their bases.  Mr Hunter gave evidence for Mr Comino that each of the allegedly infringing brackets had at least four apertures that could be used to receive surface engaging fasteners.  Mr Smerdon, for AVI, accepted that it was “possible” that these apertures could be used for that purpose but considered it unlikely that they would be given their location on the brackets.  The experts generally agreed that at least some of these apertures could theoretically be used for screws to fasten the brackets to a wall, but that they were not in the most preferable place for doing so – the four corners of the rectangular base.  Some apertures would not be readily accessible for that purpose.  Rather, they appeared to be intended to provide alternatives for affixing the pipe receiving cradle.

Justice Halley stated, “The question of whether the AVI Brackets were configured to receive surface engaging fasteners therethrough is not answered by considering mere possibilities or speculation.  Applying a practical and common sense approach and a “purposive” construction and a generous measure of common sense it is readily apparent…that none of the apertures in any of the AVI Brackets were configured to receive surface engaging fasteners”.

The fourth integer contested in respect of invalidity was the one found to be unclear and was therefore not present in the alleged infringing products.

Relief and Outcome

There was no order for relief as the Patent was held to be both invalid and not infringed.  Justice Halley also observed that the request for an injunction had become otiose as the Patent had expired before judgment was issued (albeit after the hearing).

Implications

Justice Halley’s decision illustrates the importance of patent specifications and claims being precisely drafted.  The Patent’s validity was compromised by the lack of clear demarcation of the invention claimed.  If a competitor cannot reasonably determine where the bounds of the claims are, they are likely to be invalid.  The validity of the claims was also affected by the use of related concepts (e.g.  “holding”, “receiving”, “gripping” and “clamping”) without clearly defining and distinguishing them.

From a litigation strategy perspective, the principal lesson to be drawn from this case is that, in order for expert affidavit evidence to be given full weight, it must be prepared carefully and in accordance with the relevant code of conduct and accepted practice.  However, in cases where this is not done, the shortcomings can be overcome, at least to some extent, by reliance on the expert’s oral evidence and contribution to joint expert reports.

About Pearce IP

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

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 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.

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.

PI decision to be handed down 6 days after PI hearing. 

Justice Downes of the Federal Court of Australia is setting new records for expedition in a patent dispute between AstraZeneca and Pharmacor, relating to the latter’s generic dapagliflozin.  Following the hearing last Friday (6 February 2026) on the first week of the Court sitting in 2026, judgment on AstraZeneca’s PI application will be handed down next Monday (16 February), the 6^th working day after the hearing.  The hearing was 7 weeks from AstraZeneca’s application and the decision will be delivered 2 months from commencement despite the Court’s 6-week summer recess.  The substantive trial is likely to be scheduled to begin on 31 August 2026, 8 and a half months from commencement.

These timelines are unprecedented.  Justice Downes is demonstrating the Court’s sensitivity to commercial drivers where circumstances require it.

Assuming the matter proceeds to hearing in August, Justice Downes will be setting a new record for a substantive hearing in the Federal Court.  This will be faster even than Juno and Natco’s expedited hearing against Celgene before Justice Beach in 2021 regarding validity (and infringement) of a patent relating to blockbuster lenalidomide (in which Pearce IP acted for Juno and Natco).  That case went to hearing in 10 months (but without an interlocutory dispute) with his Honour promising judgement within 6 weeks (although the matter settled following the hearing).

The dispute between AstraZeneca and Pharmacor relates to infringement and validity of AU2003237886, AstraZeneca’s Australian patent to dapagliflozin, the active ingredient of its FORXIGA® type II diabetes treatment.  Pharmacor obtained ARTG registration of generic dapagliflozin products on 14 November 2025.

AstraZeneca filed infringement proceedings on 16 December 2025, with an application for a preliminary injunction restraining the launch of Pharmacor’s products.  Timetable orders were made by consent on the last sitting day of the year (19 December 2025), and the application for interlocutory injunction was heard on the first sitting week of the year.

At the beginning of the 6 February PI hearing, counsel for AstraZeneca informed the Court that the Department of Health’s position was if Pharmacor’s PBS listing application was to be withdrawn, it would need to do so by 18 February 2026.  AstraZeneca therefore sought a decision by this date.  The Court has met AstraZeneca’s request and will deliver a decision on 16 February, a record breaking 6 business days from the hearing, and 62 days from commencement, 44 of which were during the Court recess!

During the hearing, the parties discussed the possibility of a substantive trial, of five to seven days’ duration, commencing on 31 August 2026, i.e. only 258 days from commencement (including holidays).  The trial date is yet to be confirmed by Court orders.

Pearce IP maintains a close watch on all Australian patent proceedings and there has not been any first instance trial in a pharmaceutical patent dispute in less time than is proposed here in the last 30 years.

AstraZeneca has asserted four claims of one patent, which expires in 20 months.  Pharmacor is contesting validity of the asserted claims and is relying on one prior art publication, PCT/US0027187.  Pharmacor has also raised defences to infringement of a composition claim and a method of treatment claim under the term extension provisions of the Patents Act.

Generic pharmaceutical manufacturers setting strategies to enter the Australian market will already be aware of the current trend of the Courts to refuse PI.  It remains to be seen whether this proceeding will continue or buck this trend.  They should also take account of the potential for rapid resolution of both PI applications and substantive patent infringement/invalidity matters.

We will report further on Monday, once the interlocutory decision is issued.

About Pearce IP

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

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 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.

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.