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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.

Pearce IP BioBlast fortnight ending 14 June 2024

14 June 2024 | AU | Approval Alert: Bayer’s High Dose Eylea® (aflibercept) Approved in Australia

On 14 June 2024, Australia’s Therapeutic Goods Administration (TGA) approved Regeneron’s and Bayer’s Eylea® (aflibercept) 8mg intravitreal injection for nAMD and DME.

High dose Eylea® has previously been approved in multiple countries including the US (August 2023 – nAMD, DME and diabetic retinopathy), the EU (January 2024 – nAMD and DME), Japan (January 2024 – nAMD and DME) and Korea (April 2024 – nAMD and DME).

13 June 2024 | EU | Adalvo’s Liraglutide Pre-Filled Pen Obtains First Generic Approval in Europe

On 13 June 2024, Adalvo announced its liraglutide pre-filled pen has been approved in the EU, making it the first EU approved generic liraglutide.  Originator Novo Nordisk supplies liraglutide as Victoza® in EU, which is indicated for the treatment of type 2 diabetes. Adalvo received approval via the decentralised procedure.

According to Adalvo’s announcement, Victoza achieved over $4.8 billion in global sales in 2023.

This news follows Biocon’s 27 March 2024 announcement of its approval of synthetic liraglutide in the UK.

13 June 2024 | Formycon Commences Ph 1 Clinical Trials for Pembrolizumab Biosimilar

On 13 June 2024, Formycon announced that it has commenced Phase 1 trials for its FYB206, biosimilar to Merck’s (MSD) blockbuster Keytruda® (pembrolizumab), in malignant melanoma.  A parallel Phase 3 trial, yet to commence, will compare the safety and efficacy of FYB206 with Keytruda® in non-small cell lung cancer (NSCLC).  Formycon says it expects the earliest market entry for FYB206 to be in 2029 in the US (after Keytruda’s market exclusivity expiry) and in 2030 in Europe.

Other pembrolizumab biosimilars in clinical trials are Amgen’s ABP 234 (Ph 3 study in non-squamous NSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 study for metastatic non-squamous NSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 and 3 clinical trials commenced in April/May 2024).  In March 2024, Korea Biomedical Review reported that Rophibio entered into an agreement with US biotech Avantor in relation to the development of a pembrolizumab biosimilar.

13 June 2024 | KR | Approval Alert: Celltrion’s Ustekinumab Biosimilar Receives South Korean Approval 

On 13 June 2024, the Korea Herald reported that Celltrion’s Steqeyma (CT-P43), biosimilar to J&J’s Stelara® (ustekinumab), has been approved by the South Korean Ministry of Food and Drug Safety for all indications of Stelara®.  No launch date has been announced.

Celltrion is also seeking approval for Steqeyma in Europe, the United States, and Australia.  The company submitted applications with the EMA in May 2023, the FDA in June 2023, and the TGA in April 2023.

Over the last 9 months, a number of ustekinumab biosimilars have been launched, approved or recommended for approval:

  • Amgen’s Wezlana® – approved in US (October 2023) and Australia (January 2024, and  PBS listed in April 2024), launched in Canada (March 2024), and received a positive recommendation from EMA’s CHMP (April 2024);
  • Alvotech’s AVTO4 – approved in US (as Selarsdi®, with Teva, April 2024), Europe (as Uzpruvo®, with STADA, January 2024) and Japan (with Fuji Pharma, September 2023), and launched in Canada (as Jamteki®, with JAMP Pharma, March 2024); and
  • Samsung Bioepis’ SB17 – approved in Europe and Korea (as Pyzchiva® and EpyztekTM, respectively, April 2024).  Samsung Bioepis is challenging two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court. The trial is provisionally scheduled for November 2024.

12 June 2024 | Zumutor Biologics Commences First-In-Human Ph 1 Trial of ZM008

On 12 June 2024, Boston-based Zumutor Biologics announced that it has commenced its open-label, first-in-human, multicentre, Ph 1 trial of ZM008 in patients with advanced solid tumours.  The trial (NCT06451497) is evaluating ZM008 alone and in combination with pembrolizumab.  ZM008 is a fully human IgG1 monoclonal antibody against LLT1 and disrupts LLT1’s interaction with CD16 receptor on natural killer cells.

The FDA granted Zumutor’s Investigational New Drug (IND) application for ZM008 on 11 August 2023.

11 June 2024 | US | Ono Completes Acquisition of Deciphera for $2.4 Billion
On 11 June 2024, Japan’s Ono Pharma announced completion of its acquisition of US biopharmaceuticals company Deciphera for approximately $2.4 billion.

Ono plans to leverage Deciphera’s oncology research and development capabilities, as well as its sales presence in Europe and the United States, to accelerate Ono’s global expansion.

11 June 2024 | US | Court Orders Permanent Injunction Against Biocon in US Aflibercept Dispute

On 11 June 2024, Judge Kleeh of the US District Court for the Northern District of West Virginia made a permanent injunction order against Biocon in the dispute brought by Regeneron in relation to patents relating to aflibercept.  The order is currently sealed.

As previously reported, following a December 2023 judgment that Biocon infringed eight claims of Regeneron’s US patent 11,084,864, a temporary restraining order was granted on 17 May 2024, and extended on 30 May 2024, preventing Biocon from launching its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron.  The temporary order was made to preserve the status quo until the Court could determine the motion for a permanent injunction.

Preliminary injunction motions remain pending against Celltrion (aBLA for CT-P42 submitted to FDA in June 2023), Formycon (aBLA for FYB203 accepted by FDA in August 2023) and Samsung Bioepis (Opuviz FDA-approved in May 2024) in respect of alleged infringement of US Patent No. 11,084,855 (ophthalmic formulations of a VEGF antagonist). On 7 June 2023, Regeneron filed a preliminary injunction motion (under seal) against Amgen (aBLA for ABP 938 accepted by FDA in October 2023) in relation to the same patent.

11 June 2024 | EU | UK | CH | Alvotech and STADA Expand Partnership to Include Denosumab Biosimilar in EU, UK & Switzerland 

On 11 June 2024, Alvotech announced that it has expanded its current partnership with STADA to include AVT03  (denosumab), biosimilar to Amgen’s Prolia®/Xgeva®.

Under the agreement, STADA will be the sponsor of the Alvotech developed product, with semi-exclusive rights to commercialise AVT03 in Europe, Switzerland and the UK and exclusive rights in certain Central Asian and Middle Eastern countries.

The companies’ November 2019 strategic partnership already covers:

Under the June 2024 agreement, STADA’s commercialisation rights to the adalimumab and ustekinumab biosimilars will be extended to Commonwealth of Independent States (CIS).  Alvotech will regain commercial rights from STADA to AVT06, biosimilar to Regeneron’s Eylea (aflibercept), for which positive top-line results were reported in January 2024.

11 June 2024 | US | New Indication Alert: Regeneron’s and Sanofi’s Kevzara® (Sarilumab) FDA-Approved for Polyarticular Juvenile Idiopathic Arthritis

On 11 June 2024, Regeneron announced that the FDA approved its Kevzara® (sarilumab) for active polyarticular juvenile idiopathic arthritis (PJIA).  Kevzara® is jointly developed by Regeneron and Sanofi under a global collaboration agreement.

Kevzara® is approved in 25 countries for moderately to severely active rheumatoid arthritis after a DMARD has been used and in the US for polymyalgia rheumatica in patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.

10 June 2024 | US | FDA Accepts Eisai’s sBLA for Leqembi® (lecanemab-irmb) for IV Maintenance Dosing in Treating Early Alzheimer’s Disease

On 10 June 2024, Eisai and Biogen announced that the FDA has accepted Eisai’s Supplemental Biologics License Application (sBLA) for Leqembi® (lecanemab-irmb) for monthly intravenous maintenance dosing in treating early Alzheimer’s disease.  The target PDUFA action date is 25 January 2025.

Biogen reports that Leqembi® is approved for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia in the US, Japan, China, and South Korea, and applications are under review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.

6 June 2024 | EU| CHMP Issues Positive Opinion for New Remsima SC® (Infliximab) Dosing

On 6 June 2024, the Korea Biomedical Review reported that Celltrion has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for an additional dosing regimen and dose increase for RemsimaSC® (infliximab).

The new dosing regimen involves three additional IV doses for CD and UC patients commencing at week 10 of IV dosing.  The dose increase provides for as-needed escalation to 240 mg of RemsimaSC® maintenance therapy in CD patients and escalation in patients who have experienced decreased efficacy following 120mg of RemsimaSC®.

RemsimaSC® has been approved in Europe since 2013.  In February 2024, Celltrion launched RemsimaSC® as Zymfentra® in the US.

31 May – 4 June 2024 | Study Demonstrates Biosimilarity of Fresenius Kabi’s FKS518 (Denosumab) with Amgen’s Prolia

At the American Society of Clinical Oncology (ASCO) conference, held from 31 May to 4 June 2024, Fresenius Kabi presented results of a Phase 3 study comparing its FKS518 with Amgen’s Prolia® (denosumab) in postmenopausal women with osteoporosis.  FKS518 was shown to have therapeutic equivalence to Prolia®, with similar safety profiles.

On 27 May 2024, Fresenius Kabi announced that its BLA for denosumab was accepted for review by the US FDA as biosimilar to Prolia®.

 

 

Naomi Pearce

Naomi Pearce

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

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 renown 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 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner 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.

Faran Shahzad

Faran Shahzad

Foreign Qualified Lawyer (NZ)

Faran is a Foreign Qualified intellectual property lawyer (NZ) with a particular focus on patents and trade marks, managing contentious and non-contentious patent and trade mark matters, and assisting with office actions. 

With a background in physiology, Faran is passionate about life sciences industries.  His focus is on patent and trade mark legal issues relevant to pharmaceuticals, biopharmaceuticals, biotechnology, food technology, and animal health.   

Approval Alert: Bayer’s High Dose Eylea® (aflibercept) Approved in Australia

On 14 June 2024, Australia’s Therapeutic Goods Administration (TGA) approved Regeneron’s and Bayer’s Eylea® (aflibercept) 8mg intravitreal injection for nAMD and DME. 

High dose Eylea® has previously been approved in multiple countries including the US (August 2023 – nAMD, DME and diabetic retinopathy), the EU (January 2024 – nAMD and DME), Japan (January 2024 – nAMD and DME) and Korea (April 2024 – nAMD and DME). 

Don’t Dig Your Own Hole – Broad Claims and a Deficient Disclosure Can Lead to Support, Sufficiency and Utility Issues

 

Date:

Patent Office:

Adjudicator:

 

8 May 2024

Australian Patent Office

Greg Powell

CQMS Triumphs in Patent Opposition Against ESCO Group

CQMS has successfully opposed ESCO Group’s (ESCO) patent application on the grounds of lack of support and sufficiency.  In an interesting twist, the Delegate exercised their authority under section 60(3) of the Patents Act 1990 and raised the additional opposition ground of inutility, which was not asserted by CQMS.

Background

Wear parts (eg teeth, shrouds and lips) commonly provided along the edges of excavating equipment can disengage through carrying heavy loads or under abrasive conditions.  This may subsequently cause breakage or wear of downstream equipment, leading potentially to production inefficiencies.  Traditional monitoring systems have limitations, often failing to detect wear levels and breakage in real-time.  ESCO’s patent application proposed a system to monitor wear (ie via sensors and computerisation).  However, as the opposition revealed, the patent specification lacked specific details, leading to many ‘holes’ to fill by the skilled reader.

Key Issues and Findings

CQMS opposed the patent on several grounds, including novelty, inventive step, support and sufficiency.  The Delegate found that the claimed invention was novel and contained an inventive step, in contrast to CQMS’ assertions.  Interestingly, CQMS did not present submissions on all claims in relation to the ground of support, rather focussing on a subset of dependent claims.  The Delegate nevertheless agreed with CQMS that the subset of claims lacked support.

In relation to the disclosure requirement, the Delegate again sided with CQMS noting that the detail provided in the specification was ‘schematic and very general’, requiring the person skilled in the art to perform undue experimentation, and apply ingenuity, to perform the invention.  In this regard, ESCO’s own evidence appeared to contribute to the Delegate’s finding given that there were challenges in mounting sensors on excavation buckets, which were not discussed in the specification and where claims defining sensor attachment had no constraints.

It was the Delegate’s authority under section 60(3) of the Act which also carried a heavy weight.  Specifically, the Delegate found that the claimed invention could not achieve the desired purpose of monitoring equipment under extreme conditions without sensor damage.  Accordingly, claims which do not include any form of sensor protection or obscuration prevention lacked utility.

Takeaways

The decision provides guidance to those seeking to challenge patent rights in Australia in that exploring all grounds of invalidity can increase chances of success.  From the patentee’s perspective, being mindful of overly broad claims, ensuring adequate disclosure, and having narrower dependent claims protecting the commercial embodiment as a fallback, could be useful strategies for surviving challenge.

ESCO has until 8 August 2024 to amend the claims of its application, though the grounds of invalidity raised by the Delegate will not be easily resolved through amendment.  Alternatively, ESCO may lodge an appeal before then – either to the Administrative Appeals Tribunal or Australian Federal Court.

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation – Australia)

Helen has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information.

Helen is a member of the Intellectual Property Committee of the Law Council of Australia, as well as a member of the Intellectual Property Society of Australia and New Zealand.

Chris Vindurampulle PhD

Chris Vindurampulle PhD

Executive, Patent & Trade Mark Attorney

Chris is a senior Patent and Trade Mark Attorney who is registered to practice before the intellectual property offices of Australia and New Zealand.  He is experienced in patent drafting, patent and trade mark prosecution and opposition, and freedom to operate, opinion and due diligence work.  Through his experience and delivery of highly-regarded client service, Chris has been recognised as a leading patent practitioner having been listed in the IAM Patent 1000 as a recommended individual for patent prosecution, and a Rising Star in 2021, 2022 and 2023 by Managing IP.

Approval Alert: Celltrion’s Ustekinumab Biosimilar Receives South Korean Approval

On 13 June 2024, the Korea Herald reported that Celltrion’s Steqeyma (CT-P43), biosimilar to J&J’s Stelara® (ustekinumab), has been approved by the South Korean Ministry of Food and Drug Safety for all indications of Stelara®.  No launch date has been announced.   

Celltrion is also seeking approval for Steqeyma in Europe, the United States, and Australia.  The company submitted applications with the EMA in May 2023, the FDA in June 2023, and the TGA in April 2023.   

Over the last 9 months, a number of ustekinumab biosimilars have been launched, approved or recommended for approval: 

  • Amgen’s Wezlana® – approved in US (October 2023) and Australia (January 2024, and  PBS listed in April 2024), launched in Canada (March 2024), and received a positive recommendation from EMA’s CHMP (April 2024); 
  • Alvotech’s AVTO4 – approved in US (as Selarsdi®, with Teva, April 2024), Europe (as Uzpruvo®, with STADA, January 2024) and Japan (with Fuji Pharma, September 2023), and launched in Canada (as Jamteki®, with JAMP Pharma, March 2024); and 
  • Samsung Bioepis’ SB17 – approved in Europe and Korea (as Pyzchiva® and EpyztekTM, respectively, April 2024).  Samsung Bioepis is challenging two of Janssen’s Stelara® (ustekinumab) Australian patents in the Australian Federal Court. The trial is provisionally scheduled for November 2024. 

Adalvo’s Liraglutide Pre-Filled Pen Obtains First Generic Approval in EuropeAdalvo’s Liraglutide Pre-Filled Pen Obtains First Generic Approval in Europe

On 13 June 2024, Adalvo announced its liraglutide pre-filled pen has been approved in the EU, making it the first EU approved generic liraglutide.  Originator Novo Nordisk supplies liraglutide as Victoza® in EU which is indicated for the treatment of type 2 diabetes. Adalvo received approval via the decentralised procedure. 

According to Adalvo’s announcement, Victoza achieved over $4.8 billion in global sales in 2023. 

This news follows Biocon’s 27 March 2024 announcement of its approval of synthetic liraglutide in the UK. 

Formycon Commences Ph 1 Clinical Trials for Pembrolizumab Biosimilar

On 13 June 2024, Formycon announced that it has commenced Phase 1 trials for its FYB206, biosimilar to Merck’s (MSD) blockbuster Keytruda® (pembrolizumab), in malignant melanoma.  A parallel Phase 3 trial, yet to commence, will compare the safety and efficacy of FYB206 with Keytruda® in non-small cell lung cancer (NSCLC).  Formycon says it expects the earliest market entry for FYB206 to be in 2029 in the US (after Keytruda’s market exclusivity expiry) and in 2030 in Europe.   

Other pembrolizumab biosimilars in clinical trials are Amgen’s ABP 234 (Ph 3 study in non-squamous NSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 study for metastatic non-squamous NSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 and 3 clinical trials commenced in April/May 2024).  In March 2024, Korea Biomedical Review reported that Rophibio entered into an agreement with US biotech Avantor in relation to the development of a pembrolizumab biosimilar.  Xbrane and Celltrion have also each previously announced a joint pembrolizumab biosimilar development. 

Zumutor Biologics Commences First-In-Human Ph 1 Trial of ZM008

On 12 June 2024, Boston-based Zumutor Biologics announced that it has commenced its open-label, first-in-human, multicentre, Ph 1 trial of ZM008 in patients with advanced solid tumours.  The trial (NCT06451497) is evaluating ZM008 alone and in combination with pembrolizumab.  ZM008 is a fully human IgG1 monoclonal antibody against LLT1 and disrupts LLT1’s interaction with CD16 receptor on natural killer cells. 

The FDA granted Zumutor’s Investigational New Drug (IND) application for ZM008 on 11 August 2023. 

Court Orders Permanent Injunction Against Biocon in US Aflibercept Dispute

On 11 June 2024, Judge Kleeh of the US District Court for the Northern District of West Virginia made a permanent injunction order against Biocon in the dispute brought by Regeneron in relation to patents relating to aflibercept.  The order is currently sealed. 

As previously reported, following a December 2023 judgment that Biocon infringed eight claims of Regeneron’s US patent 11,084,864, a temporary restraining order was granted on 17 May 2024, and extended on 30 May 2024, preventing Biocon from launching its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron.  The temporary order was made to preserve the status quo until the Court could determine the motion for a permanent injunction.  

Preliminary injunction motions remain pending against Celltrion (aBLA for CT-P42 submitted to FDA in June 2023), Formycon (aBLA for FYB203 accepted by FDA in August 2023) and Samsung Bioepis (Opuviz FDA-approved in May 2024) in respect of alleged infringement of US Patent No. 11,084,855 (ophthalmic formulations of a VEGF antagonist). On 7 June 2023, Regeneron filed a preliminary injunction motion (under seal) against Amgen (aBLA for ABP 938 accepted by FDA in October 2023) in relation to the same patent. 

Alvotech and STADA Expand Partnership to Include Denosumab Biosimilar in EU, UK & Switzerland

On 11 June 2024, Alvotech announced that it has expanded its current partnership with STADA to include AVT03  (denosumab), biosimilar to Amgen’s Prolia®/Xgeva®.   

Under the agreement, STADA will be the sponsor of the Alvotech developed product, with semi-exclusive rights to commercialise AVT03 in Europe, Switzerland and the UK and exclusive rights in certain Central Asian and Middle Eastern countries. 

The companies’ November 2019 strategic partnership already covers: 

Under the June 2024 agreement, STADA’s commercialisation rights to the adalimumab and ustekinumab biosimilars will be extended to Commonwealth of Independent States (CIS).  Alvotech will regain commercial rights from STADA to AVT06, biosimilar to Regeneron’s Eylea (aflibercept), for which positive top-line results were reported in January 2024. 

New Indication Alert: Regeneron’s and Sanofi’s Kevzara® (Sarilumab) FDA-Approved for Polyarticular Juvenile Idiopathic Arthritis

On 11 June 2024, Regeneron announced that the FDA approved its Kevzara® (sarilumab) for active polyarticular juvenile idiopathic arthritis (PJIA).  Kevzara® is jointly developed by Regeneron and Sanofi under a global collaboration agreement. 

Kevzara® is approved in 25 countries for moderately to severely active rheumatoid arthritis after a DMARD has been used and in the US for polymyalgia rheumatica in patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. 

8 Honours for Pearce IP and its Leaders in IAM Patent 1000 Guide

We are delighted to announce that Pearce IP has received 8 rankings in IAM Patent 1000: The World’s Leading Patent Professionals 2024 for Australia and New Zealand.  IAM Patent 1000 is the definitive resource for identifying top patent professionals and firm-wide private practice patent expertise in key jurisdictions around the globe, and has ranked Pearce IP and its leaders in the following categories:

In Australia:

In New Zealand:

  • Executive and Head of Litigation (NZ) Paul JohnsRecommended for litigation: one of only 6 lawyers recommended;
  • Special Counsel (Patent Attorney) Julie BallanceRecommended for prosecution: one of only 4 women of a total of 33 recommended.

Of the Australian team, IAM Patent 1000 said:

“Since its establishment in 2017 boutique Pearce IP has dominated in the area of pharmaceutical patents. Thanks to its deep bench of talented professionals, any life sciences brief is dispatched with alacrity and poise.

Pacing the group is eponymous founder Naomi Pearce. With a background in molecular biology and stints at global pharma heavyweights, she fully understands the IP needs of the industry leaders; her practice traverses the contentious/non-contentious divide with ease.

Also on deck are Chris Vindurampulle and Jacinta Flattery-O’Brien. The former is a frequent contributor to the research and start-up sector, providing education and mentoring on the topics of identifying, protecting and leveraging intangible assets; while the latter draws judiciously upon her doctoral pedigree to provide commercially minded counsel to big names in the biopharmaceutical sector. The duo’s superb technical expertise has seen them entrusted with Novo Nordisk’s Association of Southeast Asian Nations patent portfolio.

Joining the team in February 2024, former Baker McKenzie lawyer Helen Macpherson has a particular focus in her career working with tech clients on high-value patent mandates.”

Of the New Zealand team, IAM Patent 1000 reported:

“At Pearce IP, Julie Ballance has an illustrious list of patrons that includes global corporations in the pharmaceutical and chemical industries. Joining her, with over 20 years of commercial litigation experience under his belt, strategically minded Paul Johns manages and resolves IP disputes with dexterity. He recently joined the firm as Head of Litigation from another outfit ranked in this chapter.”

Founder and CEO, Naomi Pearce says:

“The success of Pearce IP and its leaders never ceases to amaze and inspire. I am very proud of all that we have built together in less than 7 years. I thank IAM for this great honour which affirms again that we are well on our way to achieving our 2027 Vision to be the premier life sciences IP practice in Australia and New Zealand. My wholehearted congratulations to Helen, Paul, Chris, Jacinta and Julie, and the broader Pearce IP team, each of whom bring their A game to every task every day, and continue to set the standard for excellence. This honour is very well deserved!”

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is recognised by MIP as the only leading regional IP firm with a female founder, and is certified by WEConnect International as women owned.  Pearce IP is the 2021 Intellectual Property Team of the Year (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in Chambers & Partners, IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a 5 Star firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: Chambers & Partners, IAM Patent 1000, MIP IP Stars, Doyle’s Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

FDA Accepts Eisai’s sBLA for Leqembi® (lecanemab-irmb) for IV Maintenance Dosing in Treating Early Alzheimer’s Disease

On 10 June 2024, Eisai and Biogen announced that the FDA has accepted Eisai’s Supplemental Biologics License Application (sBLA) for Leqembi® (lecanemab-irmb) for monthly intravenous maintenance dosing in treating early Alzheimer’s disease.  The target PDUFA action date is 25 January 2025.  

Biogen reports that Leqembi® is approved for treating Alzheimer’s disease in patients with mild cognitive impairment or mild dementia in the US, Japan, China, and South Korea, and applications are under review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.  

More than 70% of Pearce IP Patent Professionals Honoured in MIP’s IP Stars Guide

Following the rankings released by Managing IP at the end of last week, more than 70% of Pearce IP’s patent professionals are now ranked in the IP Stars Guide.

Three of Pearce IP’s leaders have been recognised as Managing IP (MIP) Patent Stars for 2024 for their leadership and excellence:  Pearce IP’s CEO and Founder Naomi Pearce (Lawyer, Patent & Trade Mark Attorney); Executive and Head of Litigation (AU) Helen Macpherson (Lawyer); and Special Counsel Jacinta Flattery-O’Brien PhD (Patent Attorney).  Jacinta has been consistently ranked as an IP Star since 2020, Naomi since 2021 and Helen since 2023.

Executives Chris Vindurampulle PhD (Patent Attorney, Head of Prosecution) is honoured by MIP as a ‘rising star’, and Executive Paul Johns (Lawyer, Head of Litigation-NZ), Special Counsel Julie Ballance (Lawyer, Patent Attorney, Notary) and Associate Patent Attorney Donna Meredith are honoured by MIP as Notable Practitioners .  In addition, Pearce IP has been ranked as a firm since 2022.

The IP Stars Guide is highly coveted amongst patent practitioners as a leading specialist rankings publication. We extend our heartfelt congratulations to Jacinta, Helen, and Naomi for their well-deserved recognition, and acknowledge the broader Pearce IP team who enable their success.

Pearce IP’s Founder and CEO, Naomi Pearce says:

“It is staggering that in 7 short years from commencement, more than 70% of Pearce IP’s patent practitioners are now honoured in the MIP IP Stars Guide, one of the most highly coveted amongst patent professionals. This acknowledgement by MIP is testimony to the quality of our team, their investment in excellence, and their commitment to their craft and demonstrates again that we are well on our way to achieving our 2027 Vision to be the premier life sciences IP practice in Australia and New Zealand”

Pearce IP’s Deputy CEO & Head of Talent, Adele Chadwick says:

Naomi, Helen, and Jacinta epitomise the true meaning of excellence, in the work they do for our clients, the impact they make at Pearce IP, and in the way the they mentor and develop their teams. 

We are all proud to be working with three of the best, who are held up by their peers and the Pearce IP team.  We are excited about our future with Naomi, Helen and Jacinta leading the charge in further growing our local footprint, rapid expansion in New Zealand and ensuring we have the best workplace culture in the sector.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is recognised by MIP as the only leading regional IP firm with a female founder, and is certified by WEConnect International as women owned.  Pearce IP is the 2021 Intellectual Property Team of the Year (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in Chambers & Partners, IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a 5 Star firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: Chambers & Partners, IAM Patent 1000, MIP IP Stars, Doyle’s Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Naomi Pearce

Naomi Pearce

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

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 renown 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 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner 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.

Adele Chadwick

Adele Chadwick

Executive, Deputy CEO & Head of Talent

Adele brings to Pearce IP her extensive experience in senior human resources and executive roles, predominately in the private sector with companies including Qantas, Speedo, Calvary and Australian Ethical Investment.

CHMP Issues Positive Opinion for New Remsima SC® (Infliximab) Dosing

On 6 June 2024, the Korea Biomedical Review reported that Celltrion has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for an additional dosing regimen and dose increase for RemsimaSC® (infliximab).   

The new dosing regimen involves three additional IV doses for CD and UC patients commencing at week 10 of IV dosing.  The dose increase provides for as-needed escalation to 240 mg of RemsimaSC® maintenance therapy in CD patients and escalation in patients who have experienced decreased efficacy following 120mg of RemsimaSC®.   

RemsimaSC® has been approved in Europe since 2013.  In February 2024, Celltrion launched RemsimaSC® as Zymfentra® in the US 

Study Demonstrates Biosimilarity of Fresenius Kabi’s FKS518 (Denosumab) with Amgen’s Prolia

At the American Society of Clinical Oncology (ASCO) conference, held from 31 May to 4 June 2024, Fresenius Kabi presented results of a Phase 3 study comparing its FKS518 with Amgen’s Prolia® (denosumab) in postmenopausal women with osteoporosis.  FKS518 was shown to have therapeutic equivalence to Prolia®, with similar safety profiles.  

On 27 May 2024, Fresenius Kabi announced that its BLA for denosumab was accepted for review by the US FDA as biosimilar to Prolia®.   

Pearce IP BioBlast w/e 31 May 2024

31 May 2024 | EU | US | Europe’s CHMP Recommends Dupixent® (Dupilumab) as COPD Add-On Treatment

On 31 May 2024, Regeneron and Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Dupixent® (dupilumab) as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD).

This comes after the FDA accepted Dupixent® for priority review for the same indication in February 2024.  The target action date for the FDA decision was 27 June 2024 but, on 31 May 2024, was revised to 27 September 2024.

30 May 2024 | Samsung Bioepis Announces Post-Hoc Analysis of Phase 3 Results for Eculizumab Biosimilar

On 30 May 2024, Samsung Bioepis announced that it will present a post-hoc analysis of the Phase 3 study results for its EpysqliTM (SB12), biosimilar to Alexion’s Soliris® (eculizumab), at the 29th European Hematology Association Congress to be held in Spain from 13-16 June 2024.

The analysis compared the proportion of patients with paroxysmal nocturnal hemoglobinuria (PNH) who remained transfusion-free when treated with SB12 or Soliris®.  Samsung Bioepis reports that the data “adds to the growing body of evidence that supports comparable clinical efficacy of SB12 with reference eculizumab in treating PNH patients”.

Epysqli® (SB12) was launched in Germany, Italy and Spain in 2023 and in Korea in April 2024.

Epysqli® is one of two eculizumab biosimilars approved in Europe, including Amgen’s Bekemv®, which was EMA approved in April 2023.

Alexion filed proceedings in the UPC against Samsung Bioepis and Amgen in March 2024, seeking provisional measures in relation to EP 3 167 888 (method of treating PNH).  In January 2024, Alexion also commenced US BPCIA litigation against Samsung Bioepis alleging infringement of 6 US eculizumab patents.

30 May 2024 | KR | Approval Alert: Celltrion’s Aflibercept Biosimilar Approved in Korea

On 30 May 2024, the Korea IT Times reported that Celltrion announced it received domestic approval from South Korea’s Ministry of Food and Drug Safety for EydenzeltTM (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept).  Eydenzelt was approved for the same indications as Eylea® including wet macular degeneration and diabetic macular oedema.

Celltrion sought EU marketing authorisation for CT-P42 in November 2023 and filed an NDA with the FDA in June 2023.

In November 2023 and May 2024, Regeneron commenced US BPCIA proceedings against Celltrion in the US District (Northern District of West Virginia), alleging infringement of 38 and 25 patents respectively relating to aflibercept.  These proceedings are ongoing.

30 May 2024 | US | Temporary Restraining Order Against Biocon Extended in US Aflibercept Patent Brawl

As previously reported, on 17 May 2024, a temporary 14 day restraining order was granted preventing Biocon from launching its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron.  The purpose of the temporary order was to maintain the status quo until preliminary injunction motions were heard.

On 30 May 2024, the temporary restraining order was extended for a further 14 days to allow additional time for the adjudication of the preliminary injunction motions.  Preliminary injunction motions are pending against each of Biocon, Celltrion, Formycon and Samsung Bioepis in respect of alleged infringement of US Patent No. 11,084,865 (ophthalmic formulations of a VEGF antagonist).

30 May 2024 | EU| CHMP Recommends Marketing Approval for Sandoz’s Bevacizumab Biosimilar

On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of marketing authorisation for FGK’s Avzivi®, biosimilar to Genentech’s Avastin® (bevacizumab).

The applicant for Avzivi in the EU is FGK Representative Service GmbH, which provides legal representative services to sponsor companies not based in the EU.  However, Bio-Thera is the developer of the product, which is to be marketed by Sandoz (including in the EU) pursuant to a licence and commercialisation agreement entered between Bio-Thera and Sandoz in September 2021.

Avzivi® was FDA approved in December 2023. 

29 May 2024 | US | FDA Priority Review of MSD’s sBLA for Keytruda® + Chemo for Malignant Pleural Mesothelioma

On 29 May 2024, MSD announced that the FDA accepted for priority review its sBLA for Keytruda® (pembrolizumab) plus chemotherapy as first line treatment for unresectable advanced or metastatic malignant pleural mesothelioma.  The target action date for the FDA decision is 25 September 2024.

This comes weeks after Amgen announced initiation of a Phase 3 study to evaluate its pembrolizumab biosimilar for advanced or metastatic non-squamous non-small cell lung cancer.

29 May 2024 | MSD Acquires EyeBio for US$3B

On 29 May 2024, Merck (MSD) announced the acquisition of privately owned opthalmology focussed biotech EyeBio for US$3 billion, including an upfront payment of US$1.3 billion and $US1.7 billion in milestone payments.  The acquisition has been unanimously approved by EyeBio’s board, and is expected to close in Q3/2024.

EyeBio’s lead candidate, Restoret™ (EYE103), is a tri-specific antibody for diabetic macular oedema (DME) and neovascular age-related macular degeneration and is expected to enter pivotal studies for DME in the second half of 2024.

In March 2024, MSD completed its acquisition of Harpoon Therapeutics for about US$650M with the aim of augmenting and diversifying its oncology pipeline.

28 May 2024 | US | Amgen Sues Celltrion Over Denosumab Biosimilar

On 28 May 2024, Amgen filed a complaint against Celltrion in the United States District Court for the District of New Jersey alleging infringement of 29 patents relating to denosumab.  The allegations relate to Celltrion’s abbreviated Biologics Licence Application (aBLA) submitted in December 2023 for CT-P41, its biosimilar to Amgen’s Xgeva® and Prolia® (denosumab).

In May 2023, Amgen sued Sandoz in the US over its denosumab biosimilars (Jubbonti® and Wyost®) asserting infringement of 21 denosumab patents.  That dispute was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances).

Jubbonti® and Wyost® were approved by the FDA on 5 March 2024 for all indications of, and as interchangeable with, Prolia® and Xgeva®, respectively.  No other denosumab biosimilars have received US approval to date.

28 May 2024 | EU | UK | CH | Bio-Thera & STADA Enter Exclusive Commercialisation Agreement for Golimumab Biosimilar in EU, UK and Switzerland

On 28 May 2024, Bio-Thera and STADA announced they have entered an exclusive commercialisation agreement in relation to BAT2506, biosimilar to Janssen’s Simponi® (golimumab).

Under the agreement, Bio-Thera has responsibility for developing and manufacturing BAT2506, while STADA has exclusive rights to commercialise the product in the EU, UK, Switzerland and certain other unnamed countries.  The agreement provides for an upfront payment to Bio-Thera of US$10M, plus milestone payments of up to US$147.5M, subject to fulfillment of certain conditions.

This comes after last month’s announcement by Alvotech of positive topline results from a confirmatory clinical study of its golimumab biosimilar, AVT05.

28 May 2024 | US | Approval Alert: FDA Approves Amgen’s Bkemv (eculizumab) as the First Interchangeable Biosimilar Ahead of March 2025 Launch

On 28 May 2024,  Amgen’s Bkemv® (eculizumab-aeeb) was approved by the FDA as the first interchangeable biosimilar to Alexion’s Soliris® (eculizumab).  Bkemv® is approved for the same indications as Soliris® (atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH)) in the same dosage form and strength.

Bkemv® is set to be launched in the US in March 2025, under a settlement reached by Amgen and Alexion in May 2020.

Amgen’s eculizumab biosimilar was approved in the EU as Bekemv® on 19 April 2023.  On 19 March 2024, Alexion filed proceedings against Amgen in the Unified Patents Court (UPC), seeking provisional measures in relation to alleged infringement of EP3167888, concerning a method of treating PNH using eculizumab.

Alexion has also sued Samsung Bioepis in the UPC and the US alleging infringement of eculizumab patents. Samsung Bioepis’ SB12 (Epysqli®) was granted EU marketing approval in May 2023 and its aBLA was accepted by the FDA in July 2023

28 May 2024 | EU | Outlook Therapeutics Obtains First EU Approval For Ophthalmic Bevacizumab

On 28 May 2024, Outlook Therapeutics announced it received EU marketing authorisation for LYTENAVATM (ONS-5010, bevacizumab-gamma) for the treatment of wet AMD.  Bevacizumab has been used off label for ophthalmic conditions for many years and this approval marks the first authorised ophthalmic formulation of bevacizumab in the EU.  The marketing authorisation grants LYTENAVATM 10 years of EU market exclusivity.

Outlook Therapeutics reports that it is aiming for the first commercial launch of the product in an EU Member State in Q1/2025.

Outlook Therapeutics is also seeking approval for ophthalmic bevacizumab in the UK, with its MAA submitted on 13 May 2024, and the US, having resubmitted a BLA to the FDA in August 2022.

27 May 2024 | KR | Approval Alert: Biogen’s Leqembi® (Lecanemab) Receives South Korean Approval for Treatment of Alzheimer’s Disease

On 27 May 2024,  Eisai and Biogen announced that South Korea’s Ministry of Food and Drug Safety approved Leqembi® (lecanemab) for treating adults with mild cognitive impairment or mild Alzheimer’s disease.

Leqembi® is reportedly the first approved treatment to reduce disease progression and slow cognitive and functional decline in patients with Alzheimer’s disease.  South Korea is the fourth country to approve Leqembi®, following the US in July 2023, Japan in September 2023, China in January 2024.

27 May 2024 | US | Fresenius’ Biosimilar Denosumab Application Accepted For FDA Review

On 27 May 2024, Fresenius Kabi announced that its BLA for denosumab has been accepted for review by the US FDA as biosimilar to Amgen’s Prolia®.  The biosimilar is to be indicated for osteoporosis, including glucocorticoid-induced osteoporosis, and bone loss due to prostate or breast cancer.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024.  Following the April 2024 resolution of US BPCIA litigation, commenced by Amgen against Sandoz in May 2023, Jubbonti® and Wyost® are expected to launch in the US from 31 May 2025.

On 28 May 2024, Amgen commenced BPCIA litigation against Celltrion in the United States District Court for the District of New Jersey, alleging infringement of 29 patents relating to denosumab.  Celltrion applied to the FDA for marketing authorisation of its denosumab biosimilar, CT-P41, in December 2023.

27 May 2024 | CN | Boan Biotech’s Denosumab Biosimilar Approved in China

On 27 May 2024, Boan Biotech announced that its Boluojia® (BA11021, denosumab injection, 120mg) received marketing approval from China’s National Medical Products Administration (NMPA) as biosimilar to Amgen’s Xgeva®.  Boluojia® is indicated for the treatment of giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.  Boan Biotech reports that it intends to expand the approved indications for Boluojia® to include bone metastases from solid tumours and multiple myeloma.

Boan Biotech’s Boyoubei® (BA6101), biosimilar to Amgen’s Prolia® (denosumab), was approved by China’s NMPA in November 2022 for postmenopausal women with osteoporosis at high risk of fractures.

In January 2024, Boan Biotech completed enrolment for its international, multi-centre, phase 3 studies of Boluojia® and Boyoubei®, which are being conducted simultaneously in Europe, the US and Japan.

27 May 2024 | Samsung Bioepis Switching Studies For Denosumab Confirm Safety & Efficacy

On 27 May 2024, Samsung Bioepis presented follow-up results from a Phase 3 study on SB16, biosimilar to Amgen’s Prolia® (denosumab).  According to Samsung Bioepis, the study demonstrated that switching postmenopausal osteoporosis patients from Prolia® to SB16 produced comparable results up to 18 months in terms of efficacy, safety and immunogenicity.  The results were presented at the 2024 European Calcified Tissue Society (ECTS) Congress in France.

12-month results from the Phase 3 study were previously presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in October 2023.

Denosumab biosimilars have been approved in the US and EU (Sandoz’s Jubbonti® and Wyost®) and in China (Boan Biotech’s Byoubei® and Boluojia and Mabwell’s Mailishu® and MaiweijianTM).

 

Naomi Pearce

Naomi Pearce

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

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 renown 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 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner 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.

Faran Shahzad

Faran Shahzad

Foreign Qualified Lawyer (NZ)

Faran is a Foreign Qualified intellectual property lawyer (NZ) with a particular focus on patents and trade marks, managing contentious and non-contentious patent and trade mark matters, and assisting with office actions. 

With a background in physiology, Faran is passionate about life sciences industries.  His focus is on patent and trade mark legal issues relevant to pharmaceuticals, biopharmaceuticals, biotechnology, food technology, and animal health.   

Carpark Saga Reaches Finale

 

Date:

Body:

Adjudicator:

 

1 May 2024

Federal Court of Australia – Full Court

BURLEY, JACKSON AND DOWNES JJ

This is the second Federal Court decision of 2024 stemming from a dispute between the parties dating back to 2019. The earlier decision was reported here. This case revolves around two patents AU2005243110 (AU110) and AU2011204924 (AU924) owned by Vehicle Monitoring Systems Pty Ltd (VMS), which claim a method designed to detect vehicle overstay.  In March 2023, Justice Besanko held that both of these patents were infringed by SARB’s vehicle detection system Pinforce Versions 1 and 2, while Pinforce Version 3 only infringed AU110.  SARB appealed this decision and in February 2024, the Full Federal Court partially overturned Justice Besanko’s decision on the basis that Version 3 was not covered by AU110’s claims.

The Full Court has now made final orders to give effect to its February 2024 decision.

Setting Aside Previous Orders

The Full Court in its decision of February 2024 held that Version 3 did not infringe AU110.  In view of this, SARB applied to the Court to lift the permanent injunctions which the primary judge had originally put in place in June 2023.

The permanent injunctions prevented SARB from selling Version 1 and Version 2, and also:

  1. stopped SARB from manufacturing and selling Version 3; and
  2. stopped Melbourne City (who was also a party to the proceedings) from using Version 3.

The Full Court amended these orders by removing all references to Version 3.

Despite SARB’s request, the Court did not lift the permanent injunctions in respect of Version 1 and Version 2.  SARB had argued that the permanent injunctions should be lifted in respect of all versions including Version 1 and Version 2 for the following reasons:

  1. Negligible Infringement Risk

SARB argued that Versions 1 and 2 posed negligible infringement risk so the permanent injunctions had no utility. The Court considered it not was in a position to determine this issue on the material before it, and considered that this issue should have been (but was not) raised during the appeal.

  1. Patents Lapsing

Both AU110 and AU 924 had lapsed as they were not renewed in time.  However, VMS had already filed an extension of time to pay the renewal fees and was anticipating that its request would be granted in 2-3 months’ time. The Court noted that once the extension of time request had been determined, it was open to the parties to approach the Court for a variation of the permanent injunction orders.

Costs

As SARB had won the substantive appeal, it argued that costs should follow the event, and that in this case, both VMS and its litigation funder, Balance Rev Ltd, should be held liable for SARB’s costs.  The Court agreed, and ordered that costs be paid on a lump sum basis.

 

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech).  Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022.  Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Naomi Pearce

Naomi Pearce

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

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 renown 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 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner 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 has over 25 years’ experience as an intellectual property specialist and is recognised as an industry leader. Helen advises on all forms of intellectual property including patents, plant breeder’s rights, trade marks, copyright and confidential information.

Helen is a member of the Intellectual Property Committee of the Law Council of Australia, as well as a member of the Intellectual Property Society of Australia and New Zealand.

Faran Shahzad

Faran Shahzad

Foreign Qualified Lawyer (NZ)

Faran is a Foreign Qualified intellectual property lawyer (NZ) with a particular focus on patents and trade marks, managing contentious and non-contentious patent and trade mark matters, and assisting with office actions. 

With a background in physiology, Faran is passionate about life sciences industries.  His focus is on patent and trade mark legal issues relevant to pharmaceuticals, biopharmaceuticals, biotechnology, food technology, and animal health.   

Europe’s CHMP Recommends Dupixent® (Dupilumab) as COPD Add-On Treatment

On 31 May 2024, Regeneron and Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Dupixent® (dupilumab) as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD). 

This comes after the FDA accepted Dupixent® for priority review for the same indication in February 2024.  The target action date for the FDA decision was 27 June 2024 but, on 31 May 2024, was revised to 27 September 2024. 

Samsung Bioepis Announces Post-Hoc Analysis of Phase 3 Results for Eculizumab Biosimilar

On 30 May 2024, Samsung Bioepis announced that it will present a post-hoc analysis of the Phase 3 study results for its EpysqliTM (SB12), biosimilar to Alexion’s Soliris® (eculizumab), at the 29th European Hematology Association Congress to be held in Spain from 13-16 June 2024. 

The analysis compared the proportion of patients with paroxysmal nocturnal hemoglobinuria (PNH) who remained transfusion-free when treated with SB12 or Soliris®.  Samsung Bioepis reports that the data “adds to the growing body of evidence that supports comparable clinical efficacy of SB12 with reference eculizumab in treating PNH patients”.   

Epysqli® (SB12) was launched in Germany, Italy and Spain in 2023 and in Korea in April 2024.   

Epysqli® is one of two eculizumab biosimilars approved in Europe, including Amgen’s Bekemv®, which was EMA approved in April 2023. 

Alexion filed proceedings in the UPC against Samsung Bioepis and Amgen in March 2024, seeking provisional measures in relation to EP 3 167 888 (method of treating PNH).  In January 2024, Alexion also commenced US BPCIA litigation against Samsung Bioepis alleging infringement of 6 US eculizumab patents.   

Approval Alert: Celltrion’s Aflibercept Biosimilar Approved in Korea

On 30 May 2024, the Korea IT Times reported that Celltrion announced it received domestic approval from South Korea’s Ministry of Food and Drug Safety for EydenzeltTM (CT-P42), biosimilar to Regeneron’s Eylea® (aflibercept).  Eydenzelt was approved for the same indications as Eylea® including wet macular degeneration and diabetic macular oedema. 

Celltrion sought EU marketing authorisation for CT-P42 in November 2023 and filed an NDA with the FDA in June 2023.  

In November 2023 and May 2024, Regeneron commenced US BPCIA proceedings against Celltrion in the US District Court (Northern District of West Virginia), alleging infringement of 38 and 25 patents respectively relating to aflibercept.  These proceedings are ongoing.   

Temporary Restraining Order Against Biocon Extended in US Aflibercept Patent Brawl

As previously reported, on 17 May 2024, a temporary 14 day restraining order was granted preventing Biocon from launching its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron.  The purpose of the temporary order was to maintain the status quo until preliminary injunction motions were heard. 

On 30 May 2024, the temporary restraining order was extended for a further 14 days to allow additional time for the adjudication of the preliminary injunction motions.  Preliminary injunction motions are pending against each of Biocon, Celltrion, Formycon and Samsung Bioepis in respect of alleged infringement of US Patent No. 11,084,865 (ophthalmic formulations of a VEGF antagonist). 

CHMP Recommends Marketing Approval for Sandoz’s Bevacizumab Biosimilar

On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of marketing authorisation for FGK’s Avzivi®, biosimilar to Genentech’s Avastin® (bevacizumab).   

The applicant for Avzivi in the EU is FGK Representative Service GmbH, which provides legal representative services to sponsor companies not based in the EU.  However, Bio-Thera is the developer of the product, which is to be marketed by Sandoz (including in the EU) pursuant to a licence and commercialisation agreement entered between Bio-Thera and Sandoz in September 2021. 

Avzivi® was FDA approved in December 2023. 

FDA Priority Review of MSD’s sBLA for Keytruda®+ Chemo for Malignant Pleural Mesothelioma

On 29 May 2024, MSD announced that the FDA accepted for priority review its sBLA for Keytruda® (pembrolizumab) plus chemotherapy as first line treatment for unresectable advanced or metastatic malignant pleural mesothelioma.  The target action date for the FDA decision is 25 September 2024. 

This comes weeks after Amgen announced initiation of a Phase 3 study to evaluate its pembrolizumab biosimilar for advanced or metastatic no-squamous non-small cell lung cancer.