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Biosimilars Deals 2021

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast updates below.

Celltrion Launches Biosimilar Tocilizumab in Europe

On 30 January 2026, Celltrion announced that it has launched Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in major European countries, including Germany, France and Spain.

Celltrion’s launch strategy in France has involved winning bids from private hospital groups by prioritising supply stability.  According to Celltrion, this has resulted in securing 80% of the French private tocilizumab market (by volume).  In Spain, Celltrion secured Avtozma® contracts in regional public tenders held in the Basque Country, Madrid, and Andalucia and it was selected as the supplier by a Ministry of Health bidding agency, INGESA, for 8 regions.  Celltrion is also leveraging its sales of existing products, such as Remsima SC® (infliximab) and Yuflyma® (adalimumab), to expand prescriptions to tocilizumab in European retail markets.

Avtozma® was the third tocilizumab biosimilar approved in the EU, in February 2025, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence® in June 2024.

Avtozma® was launched in the US in an IV formulation in October 2025, following its US approval in January 2025.  It had previously been launched in Korea in June 2025.  The biosimilar has also been granted marketing authorisation in a number of other regions, including as the first tocilizumab biosimilar approved in Australia (May 2025)Japan (September 2022) and New Zealand (December 2025).

PBAC Recommends Broad, Multi-Indication Funding for MSD’s Keytruda® (Pembrolizumab)

At its December 2025 Intracycle Meeting (the outcomes of which were published on 30 January 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended a broad, multi-indication PBS listing of MSD’s Keytruda® (pembrolizumab) for the treatment of advanced or metastatic cancers.

The recommendation comes after MSD received a knock-back from PBAC for the multi-indication (broad) listing for Keytruda® in July 2025.  At that time, in a decision MSD described as “bewildering”, PBAC had considered that because the proposed funding model “was restricted to the indications for which pembrolizumab was registered with the Therapeutic Goods Administration” it “would not provide access to some patient groups in which there is a significant unmet clinical need, such as rare cancers.”  In reporting the outcomes of the December 2025 meeting, the PBAC noted that MSD has now “largely addressed its concerns from the July 2025 submission”.

The PBAC recommendation for Keytruda® follows a similar recommendation, made at PBAC’s September 2025 meeting, for a broad, multi-indication listing for BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) in advanced or metastatic cancers.

The PBAC has recommended that pembrolizumab join the Risk Sharing Arrangement (RSA) that it had previously recommended for the nivolumab/ipilimumab broad listing (if that proceeds to listing), given that there are several indications where both pembrolizumab and nivolumab (± ipilimumab) would be treatment options in the same or similar population.  The PBAC has asked the Department of Health to review each of the recommended broad listings after three years to ensure the use remained consistent with its intention.

In August 2025, Bioéticos launched the first pembrolizumab biosimilar in Paraguay under the name Pembrolizumab Bioéticos.  In November 2025, Biocad’s Pembroria™ (pembrolizumab) was approved in Vietnam.  A number of other pembrolizumab biosimilars are currently in clinical trials, including by Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera and BioNTech.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to Keytruda®.  In December 2025, Formycon announced agreements with MS Pharma for the commercialisation of pembrolizumab biosimilar FYB206 in the MENA region and with Zydus Lifesciences for the US and Canada.

Samsung Bioepis & Regeneron/Bayer Strike Ex-US/Canada Settlement for Aflibercept Biosimilar; 2026 Launches Planned

On 30 January 2026, Samsung Bioepis announced that it has secured a settlement and licence agreement with Regeneron and Bayer for the commercialisation of SB15, biosimilar to Eylea® (aflibercept, 2 mg), in countries excluding the US and Canada.  The announcement comes a day after Alvotech announced a similar settlement with Regeneron/Bayer on the same molecule.

Samsung Bioepis is permitted to launch SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement (excluding Korea where it is already on the market) from May 2026.

SB15 was the third aflibercept biosimilar to be approved in the EU in November 2024 as Opuviz®, and was approved in the UK under the same brand name in April 2025.  The biosimilar received Korean approval (as Afilivu®) in February 2024 and Australian approval (as Opuviz®) in September 2025.

Samsung Bioepis and Regeneron/Bayer have been in litigation regarding aflibercept in multiple countries.  In October 2025, the Hague District Court granted an injunction preventing Samsung Bioepis from launching SB15 in the Netherlands.  In the UK, Samsung Bioepis defeated an injunction application brought by Regeneron/Bayer in October 2025 and in December 2025, Samsung Bioepis successfully overturned a Korean preliminary injunction.

BPCIA litigation in the US remains on foot.  On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Samsung Bioepis from launching its aflibercept biosimilar in the US without a licence from Regeneron.  This affirmed an earlier decision in June 2024 (US District Court -Northern District of West Virginia), finding that Samsung Bioepis infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.

Dispute Over First US-Approved Pertuzumab Biosimilar Resolved as Genentech/Roche Settle with Henlius/Organon

On 30 January 2026, a Joint Stipulation of Dismissal was filed in the US District Court for the District of New Jersey dismissing all claims in the BPCIA litigation commenced by Genentech/Roche in August 2025 in relation to Shanghai Henlius/Organon’s Poherdy® (HLX11, pertuzumab), biosimilar to Genentech/Roche’s Perjeta®.  While the Joint Stipulation confirms that the parties have entered into a settlement agreement, the terms of that settlement remain confidential and no details of any planned US launch of Poherdy® have been disclosed to date.

In the legal proceedings, Genentech and Roche had alleged infringement by Henlius and Organon of 24 US patents relating to pertuzumab, pharmaceutical compositions comprising pertuzumab, methods of treatment using pertuzumab and methods of manufacturing therapeutic antibodies like pertuzumab.  In response, Shanghai Henlius and Organon sought declarations of non-infringement and invalidity of the patents.

The litigation followed FDA acceptance of Henlius/Organon’s Biologics Licence Application for HLX11 in January 2025.  HLX11 received FDA approval, as Poherdy® in November 2025 and was designated as interchangeable to Perjeta®.  No other pertuzumab biosimilars have received US approval.

Henlius and Organon struck a licensing deal in June 2022 giving Organon exclusive global commercialisation rights to Henlius’ pertuzumab and denosumab biosimilars, “except for China; including Hong Kong, Macau and Taiwan”.

Biocad’s pertuzumab biosimilar, Pertuvia™, was approved in Russia in May 2025 and pertuzumab biosimilars have been approved in India (Enzene, Zydus and Intas).  R-Pharm and Sandoz/EirGenix have pertuzumab biosimilars in their pipelines.

Lights Out – Patentee’s Own Publications Prove Fatal for Lighting Tower Patent

 

Date of decision: 11 November 2025
Body: Federal Court of Australia
Adjudicator:
Justice Downes

Introduction

In Southern Cross Industrial Group Pty Ltd v Mickala Mining Maintenance Pty Ltd (Liability Trial) [2025] FCA 1363, Justice Downes of the Federal Court found an innovation patent for LED lighting towers invalid for lack of novelty and innovative step.  Mickala admitted infringement of claims 1 and 4 of Southern Cross’ innovation patent, but successfully cross-claimed for revocation on the basis of five pieces of prior art, including the patentee’s own prior publications.  The decision addressed claim construction, the limits of implicit disclosure in prior art, and the standard of evidence required to establish prior public use.

Background

Southern Cross Industrial Group Pty Ltd (Southern Cross) is the owner of Innovation Patent No. 2013100095 entitled ‘Lighting Tower’ (the Patent), which claims a priority date of 30 January 2013.  The Patent relates to portable LED lighting towers used for night construction and mining operations.

The claimed invention addresses inefficiencies in conventional lighting towers by combining a low-voltage alternator directly connected to the engine shaft with an LED lighting unit mounted on a manoeuvrable mast.  Claim 1 requires that the LED lighting unit comprise a plurality of arrays of LED elements arranged at an angle relative to each other.  Claim 4 adds that the LED lighting unit comprises at least one capacitor electrically connected in parallel to the alternator.

Claims 1 and 4 are as follows (with integers identified):

Claim 1

A lighting tower comprising [integer 1.1]:

an engine [integer 1.2];

an alternator mechanically connected to the engine [integer 1.3]; and

an LED lighting unit electrically connected to the alternator [integer 1.4];

the LED lighting unit being mounted on a manoeuvrable mast [integer 1.5];

wherein the alternator is a low voltage alternator [integer 1.6];

[the alternator] having a voltage output of less than 50V [integer 1.7];

[the alternator] connected directly to a shaft of the engine [integer 1.8];

wherein the LED lighting unit comprises a plurality of arrays of LED elements [integer 1.9]; and

at least some of the plurality of arrays being arranged at an angle relative to at least some of the other arrays [integer 1.10].

          Claim 4

The lighting tower of any one of the preceding claims, wherein the LED lighting unit comprises at least one capacitor electrically connected in parallel to the alternator [integer 4.1].

Mickala Mining Maintenance Pty Ltd (Mickala) admitted infringement of claims 1 and 4 but cross-claimed for revocation based on five pieces of prior art:

(i)   an advertisement published by Southern Cross in the Australasian Mine Safety Journal (AMSJ Article);

(ii)   a Southern Cross brochure;

(iii)  Innovation Patent No. 201110074 (the 774 Patent);

(iv)  Two “EcoTower” lighting towers sold in Papua New Guinea; and

(v)   Lighting Towers manufactured by Exsto Group Pty Ltd (the Exsto Towers).

Key Issues

The key issues for determination were:

(i) The proper construction of “manoeuvrable mast” in claim 1 and “electrically connected in parallel to the alternator” in claim 4;

(ii) Whether claims 1 and 4 were anticipated by any of the five prior art references;

(iii) Whether claims 1 and 4 lacked an innovative step; and

(iv) If the claims were valid, whether Mr Englebrecht (the Director for Mickala) was personally liable for authorising infringement or as a joint tortfeasor.

Construction

Two construction issues arose.  The first concerned “manoeuvrable mast” in claim 1.  Southern Cross’ expert, Mr Sizer, considered that, in the context of the Patent, “manoeuvrable” meant the mast would be “able to rotate relative to the light tower chassis”, relying on preferred embodiments set out in the specification the Patent.

Justice Downes rejected this narrow construction.  Her Honour considered that the ordinary meaning of “mast” encompassed poles, latticework towers, and tripods, while “manoeuvrable” simply meant “able to be manoeuvred” without importing any requirement to be manoeuvrable in a specific way.  The Patent itself used “manoeuvring” to describe different movements – along the ground, height adjustment, and upward movement of the mast. Her Honour noted that selecting preferred embodiments to alter the plain meaning was impermissible as it would impose a gloss on the meaning of the word as claimed.

The second issue related to the meaning of the phrase “electrically connected in parallel to alternator” in claim 4, which was disputed by the parties.  Her Honour resolved this issue by reference to the experts, both of whom agreed that this phrase referred to a component connected across each side of the device, providing an alternate path for electricity.

Novelty

AMSJ Article

The AMSJ Article was a Southern Cross advertisement published in 2011 which included the following critical sentence: “The revolutionary Linz direct drive alternator also minimises maintenance costs”.

Mickala’s expert, Mr Fogarty, gave evidence that “direct drive” discloses an alternator connected directly to the engine via a shaft, as opposed to a belt.  Mr Sizer accepted it was likely directly connected but considered it was not “definitively and explicitly disclosed”.  Her Honour preferred Mr Fogarty’s evidence and found that integer 1.8 – ‘[the alternator] connected directly to a shaft of the engine’ – was present.  As a result, the AMSJ Article anticipated claim 1, as Southern Cross conceded that all other integers were present. However, the AMSJ Article did not anticipate claim 4 because there was no disclosure of capacitors “electrically connected in parallel”.  Mr Sizer gave uncontradicted evidence that there were multiple possible configurations for capacitors.

Southern Cross brochure

Southern Cross published the Southern Cross Brochure in 2011. Justice Downes found that this brochure did not anticipate claims 1 and 4 based on the shared views of the experts that the brochure did not disclose a lighting tower that possessed an alternator connected directly to a shaft of the engine (integer 1.8) or a lighting tower that possessed an LED lighting unit comprising at least one capacitor electrically connected in parallel to the alternator (integer 4.1).

774 Patent

Mickala also relied on Innovation Patent No. 2011100774 (the 774 Patent) entitled “A Portable Lightning Tower”, which was granted in August 2011.  The 774 Patent disclosed a “manoeuvrable mast”, but Justice Downes did not find that it anticipated claims 1 or 4.

While the 774 Patent referred to Coolon CP96 LED lights, a commercial LED lighting product, as suitable for use with the invention, and those lights were capable of angled mounting and contained parallel capacitors, the 774 Patent did not identify these features as criteria of suitability.  The person skilled in the art would understand they could use “any suitable LED lamp” without those features being required.  Her Honour observed that implicit disclosure is confined to what the document actually discloses – common general knowledge cannot be used complementarily to arrive at a disclosure the document alone does not make.

The EcoTowers

Mr Torok, another expert witness for Mickala (also the inventor of the 774 Patent), gave evidence regarding two EcoTower lighting towers sold by his company to a client in Papua New Guinea in September 2012.  Mr Torok gave unchallenged evidence that the LED lights were “capable of being arranged at different angles” and photographs showed the lights splayed on rotatable bolts, leading to Justice Downes’s finding that the EcoTowers anticipated claim 1.

However, the evidence was insufficient to establish that the EcoTowers anticipated claim 4.  Mr Torok’s affidavit stated capacitors were present, but under cross-examination, resiled from this position, stating only that “potentially there could also be capacitors installed in the lights” but that he did not know.  No direct evidence established that the Magna Vision light installed contained parallel capacitors.

The Exsto Towers

Mr Tate, a former director of Exsto Group, whom Mickala also relied on as an expert witness, gave evidence that five Exsto Towers were sold to Rio Tinto in December 2012.  The critical issue was whether the ‘LP33’ Exsto Lighting Tower was delivered on 29 January 2013, one day before the priority date of the Patent.

Mr Tate’s evidence was that he personally delivered LP33 to Clermont Coal Mine on 29 January 2013, exchanging it for a trial tower (LP14) loaned pending delivery.  His evidence was supported by a build spreadsheet recording “Send to Site” on 29 January 2013.

Southern Cross challenged this evidence on multiple grounds, including that Cyclone Oswald flooding would have prevented the journey.  Mr Tate explained that the flooding was in Bundaberg, not North Bundaberg where Exsto’s premises were located, and that he departed via Childers.  Her Honour found Mr Tate’s “spontaneous responses” reinforced his own genuine recollection, which he was able to recall by reference to the unusual flooding event, and was corroborated by contemporaneous documents.

Southern Cross admitted LP33 possessed all integers of claims 1 and 4, including the ‘Coolon CP56’ LED lights which contained capacitors connected in parallel.  Both claims were therefore anticipated by LP33.

LP14 (the trial tower loaned to Rio Tinto) was found also to have anticipated both claims, based on Mr Tate’s unchallenged evidence that all Exsto Towers from LP11 onwards had uniform features including the Coolon CP56 lights.

Innovative Step

Justice Downes found that claims 1 and 4 also lacked innovative step, on the basis that the claim integers relevant to this issue were not different to the prior art.

Infringement

Although unnecessary given the invalidity findings, Justice Downes addressed whether Mr Engelbrecht would have been personally liable for infringement.

As Mr Englebrecht was the sole director, in effective control, and the “guiding mind” of the Mickala, her Honour found that she would have inferred personal knowledge, approval and power to prevent infringing conduct, and thus, would have found Mr Englebrecht liable for authorising infringement but for the invalidity finding.

However, Mr Englebrecht would not have been liable as a joint tortfeasor, which would require showing that he “directed or procured” the tort with “close personal involvement” beyond the proper role of director.  Mickala’s admissions only established that Mr Englebrecht was involved in day-to-day management and effective control, which was insufficient to establish joint tortfeasorship.

Outcome and Implications

Sothern Cross’ infringement claims were dismissed, with Southern Cross subsequently ordered to pay Mickala’s costs on a standard basis until March 2023, and on an indemnity basis thereafter.  This aligned with Mickala’s third and final offer of compromise made on 28 February 2023 which provided that all related proceedings be dismissed and that Southern Cross pay Mickala’s costs in a fixed amount of $300,000. Her Honour considered that this offer constituted a significant compromise, given Mickala had incurred nearly $700,000 in costs to that date.

Justice Downes’s decision covered familiar territory in patent validity disputes: claim construction, the boundaries of implicit disclosure in prior art, the evidentiary requirements for establishing prior public use, and the personal liability of directors for authorised infringement and joint tortfeasorship.  Notably, the decision serves as a reminder that a patentee’s own prior publication can prove fatal to validity.


 

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.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renowned for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

New Indication Alert: CHMP Recommends BMS’ Opdivo® Combo for Classical Hodgkin Lymphoma

On 29 January 2026, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended authorisation of BMS’s Opdivo® (nivolumab) in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents and adults up to 30 years of age with relapsed or refractory classical Hodgkin lymphoma after one prior line of therapy.

Opdivo® has been approved in the EU for several other indications including a subcutaneous formulation for various solid tumours; non-small cell lung cancer; melanoma; gastric, gastroesophageal junction, or oesophageal adenocarcinoma; and in combination with Yervoy® for unresectable or advanced hepatocellular carcinoma;  microsatellite instability–high or mismatch repair deficient unresectable or metastatic colorectal cancer.

A number of nivolumab biosimilars are in development, with Zydus recently being first to market its biosimilar, Tishtha®, in India.  AmgenSandozXbrane/IntasBoan BiotechShanghai HenliusEnzeneReliance Life Sciences and Biocon have nivolumab biosimilars in their pipelines.

BMS Seeks Leave to Appeal Zydus’ Win in Biosimilar Nivolumab Dispute

BMS has applied to the Supreme Court of India for leave to appeal against the 12 January 2026 decision of the High Court of Delhi appellate division, which allowed Zydus to launch Tishtha®, biosimilar to BMS’ Opdivo®/Opdyta®, in India pending resolution of the patent infringement claim brought by BMS.  The petition for leave to appeal was listed by the Supreme Court of India on 29 January 2026.  A hearing is scheduled for 4 February 2026.

In overturning a preliminary injunction granted in July 2025 preventing launch of Tishtha®, the High Court appellate division put significant weight on the public interest in having access to lower cost, life-saving drugs and held that BMS’s interests could be preserved by Zydus providing accounts of its sales.  Presumably, if granted leave to appeal, BMS will ask the Supreme Court to revisit this balancing of interests.

Zydus launched Tishtha® in India on 22 January 2026, just over a week after the High Court decision.  The biosimilar had received regulatory approval in India in July 2024 and is the first nivolumab biosimilar in the world to reach the market.  In India, Tishtha® is priced at about one quarter the cost of BMS’ Opdivo®/Opdyta®.

BMS’ appeal will be closely watched by other companies with nivolumab biosimilars in the pipeline aimed at the Indian market, such as  Enzene and Reliance Life SciencesAmgenSandozXbrane/Intas, Boan Biotech, Shanghai Henlius and Biocon also have nivolumab biosimilars under development.

2026 Launches in EU & ROW For Alvotech’s Biosimilar Aflibercept Following Regeneron/Bayer Settlement

On 29 January 2026, Alvotech announced a settlement and licence agreement with Regeneron & Bayer in relation to all remaining patent disputes worldwide (excluding the US) concerning Alvotech’s AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg).  This follows an earlier settlement between the companies, announced in December 2025, in relation to the US launch of AVT06.

Under the settlements, Alvotech and its commercial partners are permitted to launch AVT06:

  • from 1 January 2026, in the UK and Canada, and in Japan (excluding the DME indication);
  • from 1 May 2026 in the European Economic Area and all other countries in the world (excluding the US);
  • from 1 November 2026 in Japan with all approved indications; and
  • in Q4/2026 (or earlier under certain undisclosed circumstances) in the US.

AVT06 was approved in the EU and UK (where it is being commercialised as Mynzepli® by Advanz Pharma), in the EU for commercialisation in Germany as Afiveg® by STADA in September 2025, and in Japan (where it is being commercialised as Aflibercept BS by Fuji Pharma) in September 2025.  A Biologics Licence Application for AVT06 was accepted by the FDA for review in February 2025.

In January 2026, the Munich Regional Court granted Regeneron/Bayer a preliminary injunction preventing Alvotech/Advanz Pharma from marketing AVT06 in 21 countries.  In November 2025, Alvotech succeeded in defending Regeneron/Bayer’s request for an injunction from the UK High Court to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to AVT06.  These proceedings, including any appeals, are now resolved by the settlement.

Pearce IP BioBlast® for the week ending 23 January 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 23 January 2026 are set out below:


Abatacept

21 January 2026 | US | EU | Dr Reddy’s Announces US & EU Launch Dates for Biosimilar Abatacept
In its Q3/FY26 earnings call on 21 January 2026, Dr Reddy’s announced that its abatacept biosimilar, referencing BMS’ Orencia®, is expected to be approved in the… Read more here.

Denosumab

On 19 January 2026, Hikma announced the US launch of Enoby™ and Xtrenbo™ (denosumab-gbde), biosimilars to Amgen’s Prolia® and Xgeva® respectively… Read more here.

Durvalumab

22 January 2026 | CN | New Indication Alert: AstraZeneca’s Imfinzi® Approved in China for Endometrial Cancer
On 22 January 2026, Zhitong Finance reported that AstraZeneca’s Imfinzi® (durvalumab) was approved by China’s National Medical Products Administration (NMPA)… Read more here.

Nivolumab

22 January 2026 | IN | Zydus Launches World First Nivolumab Biosimilar in India Following Court Victory Over BMS
Zydus has wasted no time in announcing the launch of its nivolumab biosimilar, Tishtha™, on 22 January 2026, following the High Court of Delhi’s 12 January 2026 reversal… Read more here.

Nivolumab, Ipilimumab

The Ontario government has reported that it is fast-tracking funding for a number of cancer drugs including the combination of BMS’ Opdivo® (nivolumab) and Yervoy®… Read more here.

Trastuzumab deruxtecan

22 January 2026 | CN | New Indication Alert: AZ/Daiichi Sankyo’s Enhertu® Approved in China for HER2 Positive Metastatic Gastric Cancer
On 22 January 2026, Daiichi Sankyo announced that Enhertu® (trastuzumab deruxtecan) has been approved by China’s National Medical Products Administration (NMPA)… Read more here.

Biosimilar Market

23 January 2026 | US | Samsung Bioepis Publishes Q1/2026 US Biosimilar Market Report
On 23 January 2026, Samsung Bioepis published its twelfth US Biosimilar Market Report, which has been released every quarter since April 2023.  The report provides an overview … Read more here.

 
 

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.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renowned for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Health Canada approves Dong-A ST’s Biosimilar Ustekinumab

On 28 January 2026, Korea Biomedical Review reported that Dong-A ST’s Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), has received marketing approval from Health Canada.

Imuldosa® has already been launched in 19 countries, including the UK and Ireland (April 2025) and the US (August 2025).  It has also obtained marketing approval in the Middle East and North Africa region, including Saudi Arabia, Qatar, and the United Arab Emirates.

Imuldosa® (previously known as DMB-3115) was developed jointly by Dong-A Socio Holdings and Meiji Seika Pharma and Dong A-ST acquired the development and commercialisation rights in 2020.  In July 2021, Dong-A ST signed a global out-licensing agreement with Intas Pharmaceuticals under which Intas received exclusive commercialisation rights to the ustekinumab biosimilar worldwide, excluding Japan, Korea and certain other Asian countries.  Intas is commercialising Imuldosa® through its global affiliates, including Accord BioPharma in the US and Accord Healthcare in Europe, the UK, and Canada.

A number of ustekinumab biosimilars have been approved and launched in Canada to date, including JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Samsung Bioepis’ Pyzchiva™ (approved August 2024), Fresenius’ Otulfi® (approved December 2024, launched May 2025) and Biocon’s Yesintek™ (approved October 2025).

Knowing Too Much – Expert Evidence Sinks Obviousness Challenge in Patent Dispute Over Veterinary Formulations

 

Date of decision: 24 September 2025
Body: Federal Court
Adjudicator:
Justice Jackman

Introduction

Justice Jackman of the Federal Court has handed down judgment in proceedings between Abbey Laboratories Pty Ltd. (Abbey) and Virbac Australia Pty Ltd (Virbac), in a dispute concerning Virbac’s patent for a veterinary topical pour-on formulation for cattle containing macrocyclic lactone and levamisole.  Justice Jackman found that the majority of the patent’s claims were valid and infringed by Abbey, while three claims concerning viscosity modifiers were found invalid for lack of inventive step.

Background

The patent, AU2012227241 entitled “Veterinary Topical Formulation” with a priority date of 23 September 2011 (the 241 Patent), relates to anthelmintic formulations for treating parasitic infections in cattle.  Anthelmintics are products used to treat parasites in livestock, an important aspect of modern livestock farming.

The specification identifies five major classes of broad spectrum anthelmintic.  Of these, macrocyclic lactones, introduced in the 1980s, are described as the most potent killers of worms with a unique quality of also killing external parasites such as lice, mites and ticks.  The 241 Patent addresses the challenge of formulating a stable combination of macrocyclic lactones and levamisole in a pour-on formulation, which is ordinarily difficult given their different physicochemical properties.  The invention claimed stable formulations using specific non-aqueous solvents, namely dimethyl acetamide (DMA), dimethyl isosorbide (DMI), diethyl phthalate (DEP) and dimethyl phthalate (DMP).

Abbey commenced revocation proceedings in May 2024 and subsequently launched its competing product, Levamox Duo, in January 2025,  after an interlocutory injunction was refused in December 2024 on balance of convenience grounds.  Virbac cross-claimed for infringement.  There was no dispute that if the Patent was valid, Abbey had infringed by offering to sell and supplying Levamox Duo in Australia.

Key Issues and Consideration

Inventive Step

Abbey challenged claims 1-10, 13, 15, 16, 18-21 on lack of inventive step.  Claim 1 is as follows (with integers identified):

1.1    A stable formulation including

1.1(a)   a levamisole active ingredient and

1.1(b)   at least one active selected from the group known as macrocyclic lactones

1.2    with both of said actives being dissolved in a non-aqueous system, including solvents selected from DMA, DMI, DEP and DMP

1.3    wherein the formulation is a topical formulation for administration

1.4    to cattle

Abbey had initially also challenged claims 11 and 12 (relating to additional anthelmintics such as triclabendazole), but abandoned that challenge.

Abbey’s inventive step challenge focused on two key propositions: that a person skilled in the art (PSA), would obviously adopt a non-aqueous solvent system, and that the PSA would select one of the four specified solvents.  Both these challenges failed.

Abbey’s expert, Dr Alawi (a pharmaceutical formulator with extensive experience in the animal health industry, including as co-inventor on competing patents), gave evidence that using a non-aqueous system was “the usual approach” for dissolving lipophilic molecules and that including water would be “unusual and a waste of time”.  However, Justice Jackman found that Dr Alawi’s evidence was based on his own specialised research experience rather than the common general knowledge.  Critically, Dr Alawi’s position was contradicted by his own prior conduct.  In developing the invention the subject of New Zealand patent NZ 20060552040 (the 040 Patent), Dr Alawi had tested twelve aqueous formulations combining abamectin and levamisole.  More significantly, for another patent in the same field filed just three months before the 241 Patent’s priority date, Dr Alawi had trialled over forty formulations with eleven out of thirteen test formulations using water and various salt forms of levamisole.

Justice Jackman accepted evidence from Virbac’s expert, Professor Bunt, that a PSA would not exclude water from consideration without first testing.  Professor Bunt explained that water and water-based solvents are generally safer on animals, easier to formulate and less expensive than organic solvents.  Professor Bunt considered that he would have begun testing levamisole’s solubility in water across different pH values, prioritising the salt form of levamisole as salts are the most water-soluble form of a compound.  Dr Alawi admitted in cross-examination that someone who had not conducted his research program would say: “Okay. Let’s try the water” and “let’s try the levamisole … hydrochloride format”.

The Court also considered whether the PSA would have selected any of the four solvents specified in claim 1 (namely, DMA, DMI, DEP and DMP).  Database search evidence relied upon by Virbac showed that DMI, DEP and DMP were not used in any veterinary product at the priority date, and DMA appeared in only one product.

Professor Bunt gave evidence that DMA would have been an unlikely choice due to its known skin irritancy, distinct unpleasant odour, being water-miscible and quite fluid, causing run-off concerns, links to reproductive and developmental toxicity, flammability concerns, and potential regulatory difficulties given its limited prior use in veterinary products.

As to DMI, Professor Bunt had never used it, did not keep it in his ‘library’ of solvents, was not aware of others using it for veterinary formulations, and noted concerns about regulatory approval and cost.  Dr Alawi had not used DMI in any of his prior research work for various patents, explaining he included it in his solvent list as a “back up”.  The Court rejected this explanation, finding the most plausible explanation was that Dr Alawi’s awareness of Virbac’s Cydectin Platinum product led him to include DMI in his list.

As to the phthalates (DEP and DMP), Dr Alawi had not used them in his work for the 040 Patent but listed them as a “back up”.  Neither Dr Alawi, Dr Agnew nor the database search evidence identified any veterinary products using phthalates.  Professor Bunt said it had never been his preference to consider a phthalate when other materials could function just as well.

Justice Jackman accepted Professor Bunt’s list of preferred solvents for the hypothetical task, which in order of preference were: water, PEGs; propylene glycol; glycerol formal; ethanol; benzyl alcohol; methyl ethyl ketone; and NMP – none of which were the solvents listed in claim 1.

Accordingly, his Honour held that it was not obvious that the PSA would adopt a non-aqueous solvent system, nor would the PSA select any of the four solvents listed in claim 1.  Abbey’s inventive step challenge to claim 1 and its dependent claims (claims 2-10, 13, 15) therefore failed.

As to the independent claim 16 (a method of preparation claim requiring dissolving actives in at least one of DMI, DMA, DEP or DMP), as the selection of those solvents was not obvious, his Honour also found this claim to be inventive.

However, claim 19 (a solvent-based topical formulation containing a macrocyclic lactone and levamisole in organic solvents with a viscosity modifier) did not require the use of DMI, DMA, DEP or DMP, but merely the use of one or more organic solvents together with a viscosity modifier.  Professor Bunt’s choice of potential solvents included a number of organic solvents, and his Honour considered that there was nothing inventive about the use of organic solvents in this kind of formulation.  The addition of viscosity modifiers was also common practice within the industry as at the priority date of the 241 Patent – 23 September 2011.  Justice Jackman consequently found claim 19 lacked an inventive step and was invalid.  Claims 20 and 21, being dependant on claim 19, and merely stipulating the concentration and type of viscosity modifier, were also invalid.

Abbey also relied on three pieces of prior art information in its inventive step challenge.  However, his Honour found these documents did not indicate that the development of an anthelmintic combination formulation for cattle should only use a non-aqueous system, nor did they identify any of the solvents specifically nominated in the 241 Patent for pour-on formulations.

Novelty

Abbey relied on a “whole of contents” novelty objection based on Australian patent AU2011234984 (the 984 Patent), directed to compositions comprising four different active agents (1–arylpyrazole, a macrocyclic lactone, an insect growth regulator, and an anthelmintic) for treating parasites.

A preliminary issue arose as to whether Abbey needed to formulate a set of “notional claims” to establish anticipation.  Since EI Du Pont de Nemours and Co v ICI Chemicals & Polymers Ltd [2005] FCA 892; (2005) 66 IPR 462 (Du Pont), it had been understood that a “whole of contents” objection required formulating notional claims that would be fairly based on the prior disclosure.

Justice Jackman declined to follow Du Pont, stating that its reasoning was “wrong”.  The statutory language – “if the information … were to be, the subject of a claim” – does not require information to actually be drafted as a claim.  The legislative history showed the “whole of contents” approach was introduced in response to the Industrial Property Advisory Committee’s recommendation to replace the “unsatisfactory” and “too narrow” prior claiming approach with a “simpler mechanism”.  Requiring notional claims would “re-re-route Australian patent law back towards something resembling prior claiming … but in an even more obscure form”.

His Honour also observed that, when considering whether to depart from earlier single judge decisions, a Judge should not approach such a task through the lens of “judicial comity”, a term which “creates the unfortunate impression that judges should give priority to questions of courtesy and politeness to each other over their duty to apply the law as properly understood”.  Instead, the question is whether there is a “compelling reason” to depart, rather than whether the earlier decision was “plainly” or “clearly” wrong.

Comparison with the 984 Patent

Turning to the comparison between the 241 Patent and the 984 Patent, Justice Jackman found there was no “clear and unmistakable direction” in the 984 Patent to make any formulation within the claims of the 241 Patent.  The 984 Patent required four active ingredients (whereas the Patent required two); listed levamisole as merely one of sixteen possible anthelmintic options; expressly encompassed aqueous formulations (the 241 Patent required non-aqueous); and listed DMA and DMI among over 25 solvents without preference or specific combination with levamisole.  Abbey’s approach of finding isolated references to individual claim features in different parts of the 984 Patent was rejected as failing to anticipate the specific combinations claimed.

Ferrocom Inferences

Abbey submitted that adverse inferences should be drawn under Commercial Union Assurance Company of Australia Ltd v Ferrcom Pty Ltd (1991) 22 NSWLR 389 (Ferrcom) from matters Virbac’s expert, Professor Bunt, had not addressed in evidence in chief – specifically, the obviousness of the solvent concentration ranges in claim 2.  Justice Jackman rejected this as “misplaced” as Professor Bunt had already explained that he would not have selected the relevant solvents in the first place, so there was no need for him to address the concentration ranges of solvents he would not have chosen.

More fundamentally, his Honour held that there would “rarely (if ever)” be scope for such an inference in contemporary expert evidence practice, given the requirement for expert conferences, joint reports, and declarations that all appropriate inquiries have been made.  These safeguards mean “contemporary practice thus does not leave any effective room for a party tactically to seek to ensure that certain subject matter is avoided by an expert witness”.

Outcome and Implications

Justice Jackman found that Abbey had infringed claims 1-10, 13, 15, 16 and 18, and granted an injunction preventing the sale of Levamox Duo, with an inquiry on costs to follow.  His Honour found claims 19-21 invalid.  Abbey has subsequently appealed the decision.

Justice Jackson’s decision demonstrates the importance of ensuring that an expert’s opinion on the issue of inventive step is based on the CGK and not knowledge specific to that particular expert which is not representative of the CGK. His Honour’s judgment also illustrates the power of prior patents and publications to corroborate or dispute the approach which PSAs would have taken to research around the time of the priority date.

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.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renowned for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

MS Pharma & Hetero Partner on 5 Biosimilars in Algeria

On 26 January 2026, MS Pharma announced that it has entered an exclusive agreement with Hetero Group in relation to the commercialisation in Algeria of 5 undisclosed “established biosimilars” in therapeutic areas including oncology, immunology and haematology.

The biosimilar portfolio is reported to have an estimated total market value of USD 45 million in Algeria (as of 2024).  The agreement will be implemented by MS Pharma’s Algerian affiliate, El Kendi, and Hetero Group’s subsidiary, Hetero Biopharma, and will involve “localisation and technology transfer”.

MS Pharma has entered into a number of agreements for commercialisation of biosimilars in the MENA region over the last year, including with Formycon for biosimilar pembrolizumab (December 2025); Polpharma for biosimilar guselkumab, ocrelizumab and vedolizumab (September 2025); and Kashiv Biosciences for biosimilar omalizumab (August 2025).

Celltrion’s High Dose (300mg) Biosimilar Omalizumab Approved in Canada in PFS and Autoinjector

On 29 January 2026, Celltrion announced the Canadian approval of its high-dose Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in 300mg pre-filled syringe (PFS) and autoinjector (AI) formulations.  Celltrion now has Canadian approved PFS and AI formulations of Omlyclo® in all strengths of Canadian approved Xolair® (75mg, 150mg and 300mg).

Omlyclo® was the first omalizumab biosimilar approved in Canada in December 2024 and remains the only Canadian approved biosimilar omalizumab to date.

The approval of the high dose formulations of Omlyclo® in Canada follows approvals of a PFS presentation of the 300mg dosage form in the US, in December 2025, and in the EU, in November 2025.

AurobindoTevaGlenmark and Kashiv  also have omalizumab biosimilars under development.   On 11 August 2025, Kashiv BioSciences announced that it entered into a licence and supply agreement with Brazilian pharmaceutical company, CRISTÁLIA, for Kashiv’s biosimilar omalizumab, ADL-018, for the Latin American Market.  Kashiv has previously entered into agreements for commercialisation of ADL-018 in other regions, including with MS Pharma for MENA markets (August 2025) and Alvotech for the EU, UK, Australia, Canada and New Zealand (AVT23, October 2023).  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025 and by the European Medicines Agency in October 2025.

Samsung Bioepis Publishes Q1/2026 US Biosimilar Market Report

On 23 January 2026, Samsung Bioepis published its twelfth US Biosimilar Market Report, which has been released every quarter since April 2023.  The report provides an overview of the US biosimilar market and details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q1/2026 edition reports that, as of December 2025, the FDA has approved up to 90 biosimilars across 20 unique biosimilar molecules, 63 of which have been launched in the US.  This is an increase over Q4/2025, when there had been 80 US biosimilar approvals and 58 US biosimilar launches.

The biosimilars FDA approved in Q4 2025 were Celltrion’s Eydenzelt® (aflibercept) (approved October 2025due to launch Q4/2026, referencing Regeneron’s Eylea®), Shanghai Henlius’ Poherdy® (pertuzumab) (approved November 2025, referencing Roche’s Perjeta®), Lupin’s Armlupeg™ (pegfilgrastim) (approved December 2025, referencing Amgen’s Neulasta®), Formycon’s Nufymco® (ranibizumab) (approved December 2025, referencing Genentech’s Lucentis®) and Accord’s Osvyrti®/Jubereq® (approved November 2025) and mAbxience’s Boncresa™/Oziltus™ (approved December 2025), referencing Amgen’s Prolia® and Xgeva® (denosumab) respectively.

The Q4/2025 US biosimilar launches were: Shanghai Henlius/Organon’s Bildyos® & Bilprevda® (denosumab) (October 2025), Celltrion’s Avtozma® (tocilizumab) (October 2025), Bio-Thera/Hikma’s Starjemza™ (ustekinumab) (November 2025) and Polpharma/Sandoz’s Tyruko® (natalizumab) (November 2025).

Samsung Bioepis reports that key highlights from the market analysis include:

  • ASPs decreased by 52% (on average) within 5 years of the first biosimilar launch. More mature markets achieve greater price reductions over time (up to 77%).  However, trends in ASPs within specific markets may be affected by “intentional ASP repositioning and the deliberate removal of products from the market”.
  • As was the case in Q4/2025, there remains only a single biosimilar competitor to Regeneron’s Eylea® (aflibercept) in the US market (Amgen’s Pavblu®, launched October 2024) offering a WAC discount of -12%. However, there are four approved aflibercept biosimilars, which have scheduled 2026 launch dates as a result of litigation settlements: Biocon’s Yesafili® (approved May 2024due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024due to launch Q4/2026) and Celltrion’s Eydenzelt® (approved October 2025due to launch Q4/2026).  A preliminary injunction was granted, and remains in place, preventing Samsung Bioepis’ US launch of Opuviz® (14 June 2024upheld on appeal on 29 January 2025).
  • In the immunology market, private label brands are common for adalimumab and ustekinumab, but, unlike the case for adalimumab, most ustekinumab biosimilars have not adopted a dual or high WAC strategy.

The report predicts that the evolution from rebate-driven PBM contracts to transparent and fiduciary models may present a “catalyst for widespread adoption” of biosimilars.

Seeds Of Dispute – APO Invalidates Limagrain’s Canola Patent Claims

 

Date of decision: 8 August 2025
Body: Australian Patent Office
Adjudicator:
Felix White

Introduction

The Australian Patent Office (APO) upheld an opposition by Nuseed Pty Ltd and Norddeutsche Pflanzenzucht Hans Georg Lembke KG against Limagrain Europe’s Australian patent application number 2016307234 (the Application) relating to Brassica (canola) plants with pod shattering tolerance.  The Delegate found multiple grounds of opposition successful, namely, certain claims lacked novelty in view of prior use, certain claims lacked inventive step, and all claims lacked sufficiency and support across their full scope.

Limagrain Europe was given two months to propose amendments to remedy the deficiencies and has since filed a request to amend the claims of the application, which is currently being processed by IP Australia.

Background

Australian patent application 2016307234, entitled ‘Brassica plant with pod shattering tolerance’, generally relates to the field of breeding oilseed rape (Brassica napus), which is more commonly known in Australia as canola.  Traditional breeding has focused on reducing harmful seed components (erucic acid and glucosinolates) and improving yield through hybrid vigour.  Canola breeding commonly uses male sterility systems to control pollination, including the Ogura cytoplasmic male sterility (CMS) system from radish (Raphanus sativus), along with its corresponding restorer (Rf) gene.  Introgression of this radish genetic material unexpectedly improved pod shatter resistance, but also caused undesirable traits such as higher glucosinolate levels and lower yield.  Because the genetic mechanisms behind these traits were unclear, the invention aims to provide canola plants with a shortened Raphanus introgression that maintains fertility restoration and pod shatter resistance, while minimising negative traits.  It also discloses SNP (single nucleotide polymorphism) markers to detect the presence or absence of the relevant introgressed regions.  The application is accompanied by a deposit, made under the provision of the Budapest Treaty, of seeds of the B. Napus line R42141F at the National Collections of Industrial, Food and Marine Bacteria in Aberdeen, Scotland.

The application included 27 claims at acceptance, summarised as follows:

  • Claims 1 – 11 directed to Brassica plants comprising a Raphanus genomic fragment conferring pod shatter tolerance (POSH+) characterised by the absence of at least one Raphanus SNP within SEQ ID Nos 4–18 and the presence of at least one Raphanus SNP within SEQ ID Nos 19–21.
  • Claims 12 – 16 directed to methods of identifying POSH+ Brassica plants by detecting the presence and absence of the specified Raphanus SNPs;
  • Claim 17 directed to a method of using one or more primers for detecting one or more of the Raphanus SNPs;
  • Claims 18 – 20 directed to conventional uses of the plants for oil, food, or breeding purposes; and
  • Claims 21 – 27 directed to marker-assisted selection (MAS) methods.

The application was challenged on the grounds of novelty, inventive step, support, sufficiency, and utility.

Evidence from six expert witnesses was submitted.  The Opponents’ five experts provided technical and historical evidence on canola breeding, marker use, and prior seed availability.  The Applicant’s expert responded on molecular biology and SNP assay issues.  The key issues in dispute in the evidence included the reliability of KASP assays in detecting SNPs; whether seeds used in tests were genetically stable and available before the priority date of the application; and the extent of the common general knowledge, especially in respect of material presented at International Rapeseed Congresses.

Key Issues

Novelty

The Opponents relied solely on prior use to establish a lack of novelty, namely the sale of seeds having the claimed SNPs before the priority date.  Evidence was submitted in respect of the sale of various seeds before the priority date, which were purported to have the claimed SNPs.  The Delegate noted that there is a high burden on the Opponents to establish that the same seeds in question, by necessity tested well after the priority date, had been available free in law and equity many years before.  The Delegate rejected some of the evidence on the basis that it did not establish on the balance of probabilities that the seeds tested were ones that were commercially available before the priority date.  However, the Delegate accepted evidence of a purchase order showing the purchase of Ogura restorer line CR51 seeds before the priority date.  The CR51 seeds were homozygous for Brassica at SEQ ID NO. 9 and were homozygous for Raphanus at all other loci tested.  As these seeds, when grown, would have inevitably made a plant with the properties of claim 1, claim 1 was found to lack novelty according to the reverse infringement test.  The Delegate also found claims 6 – 8, 11 and 18 – 20 to be anticipated by the prior use of the CR51 seeds.

The Delegate rejected the Applicant’s argument that there could have been no public disclosure of the genotype because the claimed SNPs had not yet been characterised.  The Delegate stated that a plant bearing the claimed SNPs would have infringed the claim before the priority date, whether its genotype was known at the time or not.

Inventive Step

The Opponents core submission was that each of the claims involved nothing more than the use of a standard marker-assisted selection approach to a known breeding problem.  The Opponents alleged that the invention as claimed lacked an inventive step in view of the common general knowledge alone, as well as in view of the common general knowledge in combination with the disclosure of three different prior art documents.

The Delegate applied the commonly used test for inventive step, namely the “Cripps Question”: would the skilled worker have been directly led to the claimed invention with a reasonable expectation of success?

All experts agreed that the International Rapeseed Congresses were key information-sharing events in the field, and that information presented there was most likely common general knowledge.  The Delegate noted that before the priority date, it was already known that the Raphanus introgression used for fertility restoration in canola also conferred pod shatter resistance, but introduced undesirable traits like higher glucosinolate content and smaller pods.  Experts agreed there was industry motivation to reduce the size of the introgression to retain benefits while removing drawbacks.  A 2011 Rapeseed Congress poster confirmed this goal and reported successful selection of restorer lines with improved pod size and quality while maintaining pod shatter resistance.  The Delegate accepted this as representative of common general knowledge and concluded that the skilled person would have had a reasonable expectation of success in achieving shorter introgressions through conventional breeding.

Consequently, the Delegate found that claims 1–11 directed to the Brassica plants, and claims 18 – 20 directed to their uses, lacked an inventive step in view of the common general knowledge alone, on the basis that the development of such plants would have been an inevitable outcome of routine breeding, even if the precise molecular basis was unknown.

However, the Delegate found that claims 12 – 17 and 21 – 27 directed to specific SNP markers and primer-based detection methods were inventive.  There was no evidence to suggest that the skilled worker would have been directly led to the particular marker sequences based on the common general knowledge or any of the cited documents. The Delegate noted that the evidence fell well short of the requirement in the Cripps Question of establishing a motivation to try any of the claimed markers with a reasonable expectation of success in distinguishing Raphanus from napus DNA.

Support and Sufficiency

The Opponents identified three areas where they alleged the scope of the claims exceeded the enabled subject matter: the species of Brassica, the identity of the Raphanus SNPs and the combination of Raphanus SNPs.  The Delegate was particularly critical of the breadth of the claims and found the claims to be broader than the Applicant’s technical contribution to the art.  The Delegate noted that the Applicant’s technical contribution to the art in the application is a set of SNP markers from the Raphanus introgression into B. napus Ogura restorer lines, some of which are associated with pod shatter tolerance and some which are not, and claimed plants that have some of the former and lack some of the latter.

In relation to the claim extending to all Brassica species, the Delegate found that there was no evidence that the phenotype of pod shatter resistance would be achieved in Brassica species other than B. napus or with any different introgression.  The technical contribution was limited to B. napus Ogura restorer lines.

In relation to the claims extending to any Raphanus DNA, the Delegate found that the reference to the Raphanus DNA in claim 1 only makes sense when it refers to the introgression found in Ogura restorer B. napus lines, so the technical contribution is limited to that genetic background.  The Applicant did not sufficiently establish a principle of general application in terms of the combination of Brassica species and the nature of Raphanus DNA.

In relation to the nature of the Raphanus SNPs, the Delegate considered the technical contribution with respect to marker assisted selection was only the SNPs at the underlined positions, and the evidence suggests that to identify new Raphanus specific SNPs in those sequences would require restarting the entire research project which would amount to undue experimentation.

On the question of sufficiency, the Delegate was not convinced that any of the above three variables were principles of general application.  In particular, the Delegate was not convinced that it was plausible that the prediction for pod shatter phenotype would be relevant for plants other than B. napus with the Ogura restorer Raphanus introgression on chromosome 9.  The Delegate noted that while it is plausible that other SNPs could exist within SEQ ID Nos 4-21, identifying those would involve undue experimentation.

Utility

The Opponents argued that the claimed plants did not deliver promised benefits of improved pod size and reduced glucosinolates.  The Delegate rejected this argument, finding that the utility of the invention was more limited, namely, to act as markers for selecting out unnecessary parts of the Raphanus introgression while maintaining pod shattering tolerance.  There was nothing in the evidence that was inconsistent with this.

Outcome

The Opposition was successful on the following grounds:

  • Claims 1, 6-8, 11 and 18-20 were found to lack novelty in view of the prior use of the Ogura restorer line CR51, which was available free of law and equity before the priority date, and which was demonstrated to lack the Raphanus SNP of SEQ ID 9.
  • Claims 1-11 and 18-20 to plants per se were found to lack inventive step in view of the common general knowledge, in that the skilled worker would have been directly led to reduce the size of the Raphanus introgression through conventional breeding techniques.
  • All claims were found to lack support and sufficiency over their full scope, to the extent that they encompass plants other than B. napus with the Raphanus introgression on chromosome 9, derived from the Ogura restorer line, and to the extent that they encompass SNPs other than those underlined in Figures 1 and 2.

As there was a clear prospect that these grounds could be overcome by amendment, the Delegate provided the applicant with an opportunity to amend the claims.  The Applicant has since filed a request to amend the claims, namely, to delete claims 1 – 11 and 18 – 20, and to amend claims 12 – 17 to limit the methods to Brassica napus plants comprising a Raphanus Ogura restorer fragment, and to define the Raphanus SNP as corresponding to the underlined nucleotides in Table 1 of the application.  The Opponents will have an opportunity to comment on the proposed amendments before a decision is made as to their allowability or otherwise.

Implications

This decision highlights the APO’s strict approach to claim breadth in biotechnology patents.  The APO in this case emphasised a strict post-raising the bar sufficiency standard – claims must match the demonstrated technical contribution to the art, and evidence must be sufficient to establish any claimed principle of general application.  Where the technical contribution is limited to a specific species, introgression, or identified markers, claims will not be allowed to extend to broader plant categories or uncharacterised SNPs.  To withstand opposition, the specification should provide sufficient description and examples to enable broader claims, and ability to argue a principle of general application.  Clear, narrower fallback options should also be included in the claims to ensure amendment is possible to survive opposition.  Alternatively, claims should be drafted carefully to align with the Applicant’s demonstrated technical contribution to the art.

This decision also highlights that seed sales can be novelty-destroying even if their genetic content is undisclosed or uncharacterised.

A further takeaway is the Delegate’s finding on inventive step, namely that the claims to the Brassica plants per se were not inventive, yet the claims to the MAS methods were.  This highlights that while conventional plant breeding outcomes may be found to be obvious, claims directed to the molecular tools (for example, specific SNPs/primers) used to breed them can still be inventive, and worthy of patent protection.


 

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.

 

Sally Paterson

Sally Paterson

Executive, Lawyer (NZ), Patent & Trade Mark Attorney (AU, NZ)

Sally is a senior Trans-Tasman Patent and Trade Mark Attorney, and a New Zealand registered lawyer with over 20 years’ experience in IP.  Sally’s particular expertise is in life sciences, drawing from her background in biological sciences. Sally is well respected in the New Zealand IP community for her broad ranging skills in all aspects of intellectual property advice, protection and enforcement. Sally has extensive experience securing registration for patents, designs and trade marks in New Zealand, Australia and internationally, providing strategic infringement, validity and enforceability opinions, acting in contentious disputes including matters before the courts of New Zealand and before IPONZ and IP Australia, and advising on copyright and consumer law matters.
Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

New Indication Alert: AZ/Daiichi Sankyo’s Enhertu® Approved in China for HER2 Positive Metastatic Gastric Cancer

On 22 January 2026, Daiichi Sankyo announced that Enhertu® (trastuzumab deruxtecan) has been approved by China’s National Medical Products Administration (NMPA) as the first and only HER2-directed antibody-drug conjugate for the second line treatment of adults with HER2 positive metastatic gastric or gastroesophageal junction cancer who have received one prior trastuzumab based regimen.  This is the sixth indication approved for Enhertu® in China.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights.  Daiichi Sankyo is solely responsible for manufacturing and supply.

Samsung Epis recently announced that Samsung Bioepis is adding a trastuzumab deruxtecan biosimilar to its pipeline, with the biosimilar in the early development stage in preparation for preclinical trials.

Ontario Fast-Tracks Funding of Cancer Treatments, Including BMS’ Opdivo®/Yervoy® Combo

The Ontario government has reported that it is fast-tracking funding for a number of cancer drugs including the combination of BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) for treatment of both colorectal and liver cancers.

A number of nivolumab biosimilars are in development, with Zydus recently being first to market its biosimilar, Tishtha®, in India.  AmgenSandozXbrane/IntasBoan BiotechShanghai HenliusEnzeneReliance Life Sciences and Biocon have nivolumab biosimilars in their pipelines.

Ipilimumab biosimilars are also on their way, with Sandoz and Shanghai Henlius Biotech announcing a global collaboration agreement for an ipilimumab biosimilar in April 2025.

Zydus Launches World First Nivolumab Biosimilar in India Following Court Victory Over BMS

Zydus has wasted no time in announcing the launch of its nivolumab biosimilar, Tishtha™, on 22 January 2026, following the High Court of Delhi’s 12 January 2026 reversal on appeal of a preliminary injunction granted to BMS in relation to the biosimilar.

Zydus’ nivolumab biosimilar, previously referred to as ZRC-3276, received regulatory approval in India in July 2024.  It is the first nivolumab biosimilar in the world to reach the market and is priced at about one quarter the cost of the reference product, BMS’ Opdivo® (sold in India as Opdyta®).

Competing nivolumab biosimilars are under development for the Indian market by Enzene and Reliance Life Sciences.  Globally, Amgen, Sandoz, Xbrane/Intas, Boan Biotech, Shanghai Henlius and Biocon also have nivolumab biosimilars under development.

New Indication Alert: AstraZeneca’s Imfinzi® Approved in China for Endometrial Cancer

On 22 January 2026, Zhitong Finance reported that AstraZeneca’s Imfinzi® (durvalumab) was approved by China’s National Medical Products Administration (NMPA) for use, in combination with carboplatin and paclitaxel, as a first-line treatment for adult patients with mismatch repair-deficient (dMMR) primary advanced or recurrent endometrial cancer, followed by maintenance therapy with durvalumab alone.

Imfinzi® has been approved for this indication in other jurisdictions, including the US (June 2024), the EU (August 2024) and Australia (where it is listed on the PBS as of August 2025).

To date, there have been no announcements of any therapeutic durvalumab biosimilars in development.

Triple Null Trouble – APO Finds CSIRO’s High Amylose Wheat Claims Unsupported

 

Date of decision: 14 April 2025
Body: Australian Patent Office
Adjudicator:
Dr S.J. Smith

Introduction

The Australian Patent Office (APO) upheld an opposition by Urrbrae Foods Pty Ltd against CSIRO’s patent application number AU2017292900 (the Application) directed to high amylose wheat.  While grounds of manner of manufacture and entitlement failed, the Delegate found the claims lacked support and the opposition was successful on that ground.  CSIRO was given two months to amend, and costs were awarded against it.  No amendments have been filed.  Instead, CSIRO has filed an appeal of the decision in the Federal Court.

Background

The application, entitled “High amylose wheat – III” relates to high amylose wheat plants and methods of producing them.  The invention concerns wheat grains having null mutations in all three SSIIa genes (A, B and D genomes), leading to increased amylose content (≥45%) and higher dietary fibre fractions such as β-glucan, arabinoxylan, cellulose and fructan.  These traits are purported to improve nutritional value and human health outcomes.

The application contained 28 claims at acceptance.  Claim 1, as the only independent claim, reads as follows:

Wheat grain of the species Triticum aestivum, the grain comprising

i.       mutations in each of its SSIIa genes such that the grain is homozygous for a null mutation in its SSIIa-A gene, homozygous for a null mutation in its SSIIa-B gene and homozygous for a null mutation in its SSIIa-D gene,

ii.       a total starch content comprising an amylose content and an amylopectin content,

iii.    a fructan content which is increased relative to wild-type wheat grain on a weight basis, preferably between 3% and 12% of the grain weight,

iv.      a β-glucan content,

v.       an arabinoxylan content,

vi.      a cellulose content,

the grain having a grain weight of between 25mg and 60mg, wherein the amylose content is between 45% and 70% on a weight basis of the total starch content of the grain as determined by iodine binding assay, wherein the amylopectin content on a weight basis is reduced relative to the wild-type wheat grain, wherein each of the β-glucan content, arabinoxylan content and cellulose content are increased relative to the wild-type grain on a weight basis, such that the sum of the fructan content, β-glucan content, arabinoxylan content and cellulose content is between 15% and 30% of the grain weight.

Dependent claims are directed to flour, food products, methods of producing the wheat, and uses in human nutrition.

Urrbrae initially opposed the application on the grounds of entitlement, manner of manufacture, novelty, inventive step, utility and support.  At the hearing, however, Urrbrae pressed only the grounds of manner of manufacture, support and entitlement.

Key Issues

Lack of Support

The central issue in the case concerned whether the claimed invention—wheat grains exhibiting high amylose and fibre content—was enabled and supported across the full scope of the claims, or whether the disclosure only enabled and supported claims to wheat grains from specific genetic backgrounds.

Urrbrae argued that the CSIRO’s technical contribution was confined to grains developed from the Sunco genetic background.  The specification itself, via the worked examples, highlighted Sunco as uniquely successful in achieving the claimed characteristics of the wheat, while grains from other genetic backgrounds such as EGA-Hume and Westonia lines either failed to achieve the claimed characteristics or achieved inconsistent results.  Urrbrae submitted that this demonstrated that the invention could not be performed across its full breadth, and that the claims therefore extended beyond what was enabled or supported by the specification.

In contrast, the CSIRO argued that the invention lay not simply in the generation of the claimed grain lines from one genetic background, but in the method of generating, screening, and selecting suitable lines.  CSIRO maintained that the specification provided sufficient guidance to enable the skilled person to reproduce the invention across different wheat cultivars, without undue experimentation, and that it was unnecessary to exemplify every possible genetic background.  CSIRO characterised Urrbae’s objection as being that, a priori, it is not possible to generate only wheat grain with the required characteristics.

The Delegate agreed in part with Urrbrae, finding that while the specification clearly enabled production of grains meeting the claimed parameters in Sunco and Westonia backgrounds, it provided no guiding principle for extending those results to other genetic lines such as EGA-Hume.  The Delegate noted that, while the specification lists a number of possible genetic backgrounds into which the triple null mutation could be introduced, it does not provide any indication that success in achieving the claimed phenotype is likely in those strains.  The Delegate referred to the comments of Lord Hoffman in Biogen to the effect that where a patentee provides a new product with a beneficial effect but cannot demonstrate a common principle by which a beneficial effect will be shared by other products of the class, they will not be entitled to a claim to the entire class, as being apt in this case.  The Delegate found that the specification recognises that the genetic background of the wheat is important to achieving the claimed results, but there is no further elucidation of any associated principle that would support a technical contribution to the art of the scope claimed.  Determination of whether wheat grains from any particular genetic background will afford the claimed results effectively left the skilled person to conduct a trial-and-error research project where the outcome is uncertain.  As such, the Delegate found that the technical contribution was limited to the success demonstrated in the Sunco and Westonia genetic lines, and the broader claims were not supported to the extent that they encompassed other wheat grains from other genetic backgrounds.

Manner of Manufacture

Urrbrae argued that the invention did not constitute a manner of manufacture under s 18(1)(a) of the Patents Act 1990, contending that (i) the claims lacked inventive character on the face of the specification, and (ii) not everything within the claims was the result of human action.

Lack of Inventive Character

Urrbrae submitted that there is no inventiveness in developing triple null grain with the intention of producing high amylose wheat plants, particularly where there is a need for improving high amylose wheat plants.  Urrbrae argued that the invention was no more than the use of a known property (increased amylose content) of a known article (triple null wheat) for a new use for which that property makes it suitable, and the serendipitous discovery of other properties or characteristics of that wheat do not take it outside of this category.

CSIRO responded that the prior art incorporated into the specification does not state that grain with the defined characteristics could be produced and that admissions that it was known that triple null wheat had a higher amylose content than wild type do not amount to an admission that grain with the combined claimed characteristics was known. CSIRO also pointed to the specification’s reference to the SBEIIa gene as a more obvious target if seeking to produce wheat with at least 50% amylose.

The Delegate was not persuaded that the specification on its face reveals an absence of the requisite quality of inventiveness, stating that while it may have been obvious to generate triple null wheat with an objective of increased amylose content, the specification makes no clear admission that a grain having an amylose content of 45% and the other parameters defined in the present claims was known or a desired result.  To the contrary, that is presented as the invention.  The Delegate stated that it was not apparent on the face of the specification that the claimed invention would be arrived at without invention.

Result of Human Action

Urrbrae argued that the claimed wheat plants were not the result of human action, since the specification allowed for the possibility of naturally occurring mutations and natural crossing or self-fertilisation of grain lines.  On that basis, Urrbrae submitted that the claims could capture plants arising without human intervention.

CSIRO responded that there was no evidence that triple-null wheat plants—those with mutations in all three SSIIa genes and exhibiting the claimed composition—occur naturally.  The specification, particularly Example 4 and its breeding schematics, demonstrated extensive human involvement through controlled crossing, backcrossing, and selection to achieve the desired phenotype.

The Delegate noted that even if natural mutations are theoretically possible, that does not mean they exist in practice.  There was no evidence that any naturally occurring plants fell within the scope of the claims.

The Delegate held that the claimed invention was clearly the product of deliberate human breeding and selection, not a spontaneous natural occurrence.  A mere possibility of natural existence does not meet the balance of probabilities threshold.  Accordingly, the ground that the claims were not the result of human action was not made out.

Lack of Entitlement

Urrbrae alleged the invention was first made by Dr Colin Jenner, whose ‘Cross III’ wheat achieved amylose contents of up to 55%.  However, the Delegate found that there was no persuasive evidence that CSIRO derived its invention from Dr Jenner.  Whilst no evidence was filed by the named inventor, which the Delegate noted would have been the best evidence, internal CSIRO documentation showed the inventive concept was developed independently of Dr Jenner.  The entitlement ground therefore failed.

Outcome

The opposition succeeded on the ground of lack of support.  The grounds of manner of manufacture and entitlement were rejected.  CSIRO was given two months to file amendments to narrow the claims to align with its demonstrated contribution to the art. Costs were awarded against CSIRO.  CSIRO has not filed any amendments.  Instead, CSIRO has filed an appeal with the Federal Court.

Implications

This decision demonstrates the APO’s strict application of post-Raising the Bar support requirements in the agricultural biotech space.  Broad claims encompassing wheat grains from all genetic lines were not allowed due to a lack of consistent experimental evidence that established a principle of general application.  This finding emphasises the importance, in biotechnology and plant breeding cases, of articulating a clear principle or rationale for why an invention should be expected to work across its claimed scope, particularly when results vary across genetic backgrounds.  Without this, patent applicants risk having their monopoly confined to specific examples rather than the broader class of products they intended to protect.

The decision also confirms that plant breeding inventions remain patentable in Australia where they involve deliberate human intervention, even if some mutations could theoretically occur in nature.  However, patentees should ensure their specifications clearly describe the inventive human contribution, particularly where the invention builds on naturally occurring traits or known breeding systems.


 

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.

 

Sally Paterson

Sally Paterson

Executive, Lawyer (NZ), Patent & Trade Mark Attorney (AU, NZ)

Sally is a senior Trans-Tasman Patent and Trade Mark Attorney, and a New Zealand registered lawyer with over 20 years’ experience in IP.  Sally’s particular expertise is in life sciences, drawing from her background in biological sciences. Sally is well respected in the New Zealand IP community for her broad ranging skills in all aspects of intellectual property advice, protection and enforcement. Sally has extensive experience securing registration for patents, designs and trade marks in New Zealand, Australia and internationally, providing strategic infringement, validity and enforceability opinions, acting in contentious disputes including matters before the courts of New Zealand and before IPONZ and IP Australia, and advising on copyright and consumer law matters.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation –Australia)

Helen is a highly regarded intellectual property specialist and industry leader with more than 25 years’ experience advising on patents, plant breeder’s rights, trade marks, copyright and confidential information. She is known for her expertise in complex, high-value patent matters and leverages her technical background in biochemistry and molecular biology to work across a wide range of technologies, including inorganic, organic, physical and process chemistry, biochemistry, biotechnology (including genetics, molecular biology and virology), and physics. Helen is an active member of the Intellectual Property Committee of the Law Council of Australia and the Intellectual Property Society of Australia and New Zealand.

Dr Reddy’s Announces US & EU Launch Dates for Biosimilar Abatacept

In its Q3/FY26 earnings call on 21 January 2026, Dr Reddy’s announced that its abatacept biosimilar, referencing BMS’ Orencia®, is expected to be approved in the US at the end of 2026 in IV form and in early 2028 in a subcutaneous formulation, with launches soon after those dates.  In Europe, Dr Reddy’s is aiming to simultaneously launch both IV and SC abatacept after expected approval in July 2027.

According to pipeline information on Dr Reddy’s website, its abatacept biosimilar has completed phase 1 clinical trials and phase 3 trials are underway.

In March 2023, Dr Reddy’s entered an exclusive worldwide agreement with Coya Therapeutics under which Coya is licensed to use Dr Reddy’s abatacept biosimilar to develop and commercialise a subcutaneous combination product, COYA 302 (abatacept with COYA-301, Coya’s low-dose interleukin-2 (IL-2)).

An abatacept biosimilar is also being developed by Kashiv Biosciences, which announced the successful completion of a phase 1 clinical trial of KSHB002 (abatacept) in January 2025.

PiPCast™ | Mediation of IP Disputes in New Zealand

Head of Litigation (New Zealand), Paul Johns, talks with expert IP mediator Sheana Wheeldon about mediation of intellectual property disputes in New Zealand.  The introduction of a new fast-track Commercial List for IP litigation and recent reforms to general court procedure will both lead to an increased focus on pre-litigation mediation.  Pearce IP is acting in the very first IP case on the Commercial List.  This edition of PiPCast™ explores the issues surrounding the use of mediation to resolve IP disputes in New Zealand.

Pearce IP BioBlast® for the week ending 16 January 2026

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending 16 January 2026 are set out below:


Aflibercept

16 January 2026 | EU | New Indication Alert: Bayer’s Aflibercept 8mg EU Approved for RVO
On 16 January 2026, Bayer announced that the European Commission has approved Eylea™ 8mg  (aflibercept 8mg, 114.3 mg/ml solution for injection) for macular oedema… Read more here.

Bevacizumab

On 13 January 2026, Shanghai Henlius Biotech announced that its Biologics Licence Application (BLA) for HLX04, biosimilar to Roche/Genentech’s Avastin® (bevacizumab)… Read more here.

Denosumab

9 January 2026 | BO | Boan Biotech’s Biosimilar Denosumab Approved in Bolivia
On 9 January 2026, Boan Biotech announced that it has received regulatory approval from Bolivia’s National Agency of Medicines and Health Technologies (AGEMED) for BA6101… Read more here.

Dupilumab

On 14 January 2026, Korea Biomedical Review reported that Korean-headquartered Chong Kun Dang has received approval from the European Medicines Agency (EMA) and the… Read more here.

Dupilumab, Guselkumab, Ixekizumab, Trastuzumab Deruxtecan, Vedolizumab, Ocrelizumab

14 January 2026 | Samsung Bioepis to Add 6 Biosimilars to Pipeline: Dupilumab, Guselkumab, Ixekizumab, Vedolizumab, Trastuzumab Deruxtecan & Ocrelizumab; 20 Biosimilars by 2030
At the J.P. Morgan Healthcare Conference on 14 January 2026, Samsung Epis Holdings announced the addition of six biosimilar candidates to Samsung Bioepis’ pipeline: dupilumab… Read more here.

Insulin Glargine

14 January 2026 | EU | Sandoz’s Biosimilar Insulin Glargine EU Approved
On 14 January 2026, Sandoz announced that the European Commission has approved Ondibta® (insulin glargine solution for injection in pre-filled pen), biosimilar to… Read more here.

Nivolumab

12 January 2026 | IN | Zydus Clear to Launch Nivolumab Biosimilar in India After BMS Injunction Overturned on Appeal
On 12 January 2026, an appellate Division of the High Court of Delhi issued its judgment overturning the grant of a preliminary injunction awarded to Bristol Myers Squibb (BMS) in July… Read more here.

Nivolumab, Ipilimumab

12 January 2026 | TW | New Indication Alert: BMS/Ono’s Opdivo®/Yervoy® Combo Approved in Taiwan for MSI-High/dMMR CRC
On 12 January 2026, Ono Pharmaceutical announced that the Taiwan Food and Drug Administration has approved a new indication for Opdivo® (nivolumab) intravenous infusion in… Read more here.

Pegfilgrastim

9 January 2026 | CA | CuraTeQ’s Pegfilgrastim Biosimilar Approved in Canada
On 9 January 2026, Aurobindo Pharma announced in a regulatory filing that its subsidiary, CuraTeQ Biologics, has received approval from Health Canada for Dyrupeg®, biosimilar… Read more here.

Ustekinumab

14 January 2026 | KR | Samsung Bioepis’ PFP Biosimilar Ustekinumab Approved in Korea
On 14 January 2026, Samsung Bioepis announced that Korea’s Ministry of Food and Drug Safety has approved a pre-filled pen formulation (PFP) of Epyztek®, biosimilar to J&J/Janssen’s… Read more here.

Biopharma Deals

15 January 2026 | Zydus Acquires Agenus’ Biologics Manufacturing Facilities in US $141M Deal
On 15 January 2026, Zydus Lifesciences Ltd and Agenus Inc. announced the closing of a deal in which Zydus acquired Agenus’ biologics manufacturing facilities in Emeryville and Berkeley… Read more here.
 
 
13 January 2026 | Celltrion Plans 41 Biosimilars By 2038; Opens First US Manufacturing Facility
On 13 January 2026, Celltrion revealed at the 44th Annual J.P. Morgan Healthcare Conference that it plans to commercialise up to 18 biosimilar products by 2030 and 41 products… Read more here.

 

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.

 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renowned for her successful and elegant IP/legal strategies.

Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the Lexology Client Choice Award recipient in 2022 and 2026, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2024 Lawyers Weekly Women in Law “Executive of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.

With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.

Richter/Hikma Launch Denosumab Biosimilars in US

On 19 January 2026, Hikma announced the US launch of Enoby™ and Xtrenbo™ (denosumab-gbde), biosimilars to Amgen’s Prolia® and Xgeva® respectively.

Enoby™ and Xtrenbo™ were approved by the FDA in September 2025.  The biosimilars were developed and are manufactured by Gedeon Richter.  Under a December 2021 licence and commercialisation agreement, Hikma is responsible for FDA registration and has exclusive rights to commercialise the biosimilars in the US.

In June 2025, Amgen commenced BPCIA litigation against Gedeon Richter and Hikma alleging infringement of 32 US patents relating to denosumab.  That litigation was settled in November 2025, with the terms of the settlement providing that Richter/Hikma’s denosumab biosimilars could not be launched in the US before at least 1 January 2026.

A number of denosumab biosimilars have been approved and launched in the US.  This includes Sandoz’s Jubbonti® and Wyost® (approved March 2024launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, launched October 2025), Biocon’s Bosaya™ and Aukelso™ (approved September 2025launched October 2025), Accord’s Osvyrti® and Jubereq® (approved November 2025, not yet launched), and Amneal/mAbxience’s Boncresa™ and Oziltus™ (MB09) (approved December 2025).

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

Naomi Pearce & Emily Bristow

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate

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