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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® for the week ending 24 January 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the week ending the 24 January 2025 are set out below:


Aflibercept

20 January 2025 | EU | New Approval Alert: Formycon’s Aflibercept Biosimilar Approved in Europe

On 20 January 2025, Formycon and Klinge Biopharma announced that FYB203/Ahzantive®/Baiama® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, has been granted marketing approval … Read more here.
 
 

15 January 2025 | US | Celltrion Challenges Regeneron’s US Aflibercept Formulation Patent in IPR Filing

On 15 January 2025, Celltrion filed a petition for inter partes review (IPR2025-00456) of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept, such as Eylea® … Read more here.

 

Amivantamab 

16 January 2025 | CA | New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

On 16 January 2025, Johnson & Johnson (J&J) announced that Health Canada has approved its Rybrevant® (amivantamab for injection) in combination with standard of care chemotherapy … Read more here.
 

Bimekizumab

16 January 2025 | US | UCB Launches High Dose Bimekizumab in the US

On 16 January 2025, UCB announced that it has launched in the US a high dose presentation of Bimzelx® (bimekizumab-bkzx) in a single-injection 2 mL prefilled syringe and autoinjector… Read more here.


Daratumumab

22 January 2025 | J&J Reports Q4 2024 Results; Annual Darzalex® Sales Total USD11.7B

On 22 January 2025, Johnson & Johnson (J&J) reported its results for Q4 2024, which saw sales growth of 5.3% to $22.5B. On the same day, Genmab announced that worldwide … Read more here.

 

Denosumab

24 January 2025 | US | Amgen and Celltrion Settle US Denosumab Litigation

On 24 January 2025, Amgen announced that it has settled its patent infringement litigation against Celltrion in the US District Court for the State of New Jersey … Read more here.

20 January 2025| US | EU | JP | Celltrion Plans 2025 US/EU/JP Launch of Biosimilar Denosumab at Significant Discount for Osteoporosis Prevention

On 20 January 2025, Korea Biomedical Review reported that, at the JP Morgan Healthcare Conference on 14 January 2025, Celltrion revealed its plans to launch CT-P41 … Read more here.
 

Faricimab

20 January 2025 | CA | Health Canada Approves Roche’s Vabysmo® PFS

On 20 January 2025, Roche announced that Health Canada has approved its Vabysmo® (faricimab) 6.0 mg single-use pre-filled syringe (PFS) for use in the treatment of nAMD … Read more here. 

 

On 24 January 2025, CSL announced that the Australian Therapeutic Goods Administration (TGA) has approved Andembry® (garadacimab)for routine prevention of recurrent hereditary … Read more here.

On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their Biologics Licence Applications for AVT05, biosimilar to Johnson & Johnson’s Simponi® … Read more here.


Isatuximab

22 January 2025 | EU | New Indication Alert: Sanofi’s Isatuximab Combination Therapy EU Approved for Multiple Myeloma

On 22 January 2025, Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved Sarclisa® (isatuximab) … Read more here.
 

Lecanemab

27 January 2025 | US | FDA Approves Eisai/Biogen’s Leqembi® IV Maintenance Dosing for Early Alzheimer’s Disease

On 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® (lecanemab-irmb) IV maintenance dosing for the treatment of Alzheimer’s … Read more here.
 

Tocilizumab

15 January 2025 | Positive Topline Results for Ph 1 & 3 Studies of Mochida/Richter’s Tocilizumab Biosimilar

On 15 January 2025, Gedeon Richter and Mochida Pharmaceutical Co. announced positive topline results from Phase 1 and Phase 3 clinical studies for RGB-19, biosimilar to Roche’s  Read more here.
 

Toripalimab

17 January 2024 | AU | Approval Alert: Junshi Biosciences/Dr Reddy’s Tuoyi® (Toripalimab) Approved in Australia

On 17 January 2024, Junshi Biosciences announced that Australia’s Therapeutic Goods Administration (TGA) has approved Tuoyi® (toripalimab) for the treatment of adults … Read more here.
 

Ustekinumab

23 January 2025 | EU | Celltrion Confirms Launch of Biosimilar Ustekinumab in 5 Major EU Countries

On 23 January 2025, Celltrion confirmed that it has completed the launch of Steqeyma®/CT-P43, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in France, Italy, Spain, the UK, and Germany … Read more here.

16 January 2025 | US | Amgen’s Ustekinumab Biosimilar First to Launch in US; Available Through Nuvaila

On 16 January 2025, AIS Health reported that Amgen has launched Wezlana® (ustekinumab), biosimilar to J&J/Janssen’s Stelara® in the US through Optum Health Solution’s … Read more here.


Company News 

22 January 2025 | Samsung Biologics Achieves Record 2024 Sales of KRW 4.54T

On 22 January 2025, Samsung Biologics revealed its Q4 and 2024 annual financial results, reporting full year 2024 consolidated revenue of over 4 trillion won(approx. USD2.78bn), … Read more here.

 

 

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.

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.

Nathan Kan

Nathan Kan

Graduate (Law)

Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science.  Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

 

FDA Approves Eisai/Biogen’s Leqembi® IV Maintenance Dosing for Early Alzheimer’s Disease

On 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® (lecanemab-irmb) IV maintenance dosing for the treatment of Alzheimer’s disease in patients with mild cognitive impairment (MCI) or mild dementia stage of disease.  The sBLA for monthly Leqembi® IV maintenance dosing had been accepted by the FDA in June 2024.

This news comes two weeks after the US FDA accepted Eisai/Biogen’s Biologics Licence Application for Leqembi® subcutaneous autoinjector for weekly maintenance dosing for the same indication.

Leqembi® is approved for MCI and Early Alzheimer’s disease in the UKUSJapanChinaSouth KoreaMexicoHong Kong and Israel, and the UAE.  In November 2024, the product received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.  Earlier announcements made by Eisai note that applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland.  In October 2024, Australia’s Therapeutic Goods Administration (TGA) declined to approve Leqembi® due to safety and efficacy concerns.

Alvotech/Teva’s BLAs for Biosimilar Golimumab First to be Accepted by FDA

On 27 January 2025, Alvotech and Teva Pharmaceuticals announced that the US FDA has accepted for review their Biologics Licence Applications for AVT05, biosimilar to Johnson & Johnson’s Simponi® and Simponi Aria® (golimumab), which are indicated for a variety of chronic inflammatory diseases.  This is the first BLA filing acceptance for biosimilar golimumab in the US.

Alvotech/Advanz Pharma’s marketing authorisation application (MAA) for AVT05 was accepted by the European Medicines Agency in November 2024.  This was the first golimumab biosimilar MAA to be filed and accepted anywhere in the world.

Alvotech expects the approvals process in both the EU and the US to be completed in Q4 2025.

AVT05 is being commercialised in the US by Teva pursuant to a strategic partnership entered into with Alvotech in August 2020.  In May 2023, Alvotech and Advanz Pharma entered into a master licence and supply agreement to commercialise and supply AVT05 in Europe.

 

Australia’s TGA Approves CSL’s Garadacimab in World First

On 24 January 2025, CSL announced that the Australian Therapeutic Goods Administration (TGA) has approved Andembry® (garadacimab) for routine prevention of recurrent hereditary angioedema (HAE) attacks in patients 12 years and older with C1 esterase inhibitor deficiency or dysfunction.  The regulatory approval for registration in Australia is the first in the world for Andembry®.

Andembry® was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) for funding on Australia’s Pharmaceutical Benefits Scheme (PBS) at its November 2024 meeting.

It received a positive opinion in December 2024 from the European Medicine Agency’s CHMP and is currently under review by the US FDA, with CSL’s Biologics Licence Application (BLA) for Andembry® (previously referred to as CSL312) accepted in December 2023.

Amgen and Celltrion Settle US Denosumab Litigation

On 24 January 2025, Amgen announced that it has settled its patent infringement litigation against Celltrion in the US District Court for the State of New Jersey, relating to Celltrion’s biosimilar denosumab.

Amgen had commenced proceedings against Celltrion in May 2024, alleging infringement of 29 patents relating to denosumab.  The allegations followed Celltrion’s abbreviated Biologics Licence Application (aBLA) submitted in December 2023 for CT-P41, its biosimilar to Amgen’s Xgeva® and Prolia® (denosumab).

Pursuant to the settlement agreement, the parties consented to the Court making an order that the asserted claims of the 29 patents in suit are valid, enforceable and infringed by the exploitation of Celltrion’s biosimilar products in the US.  The Court further granted an injunction, by consent, preventing it from making or selling its biosimilar denosumab in the US, except as permitted by the confidential settlement agreement.

The injunction expires on 1 June 2025, permitting Celltrion to launch its denosumab products in the US from that date.

The proceeding against Celltrion was one of five that Amgen had commenced in the US in relation to denosumab biosimilars.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, from 31 May 2025 (or earlier in certain undisclosed circumstances).  The remaining court proceedings, against Fresenius Kabi (FKS518/commenced October 2024), Samsung Bioepis (SB16/commenced August 2024) and Accord/Intas (INTP23/commenced November 2024), remain pending.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024.  No other denosumab biosimilars have been approved in the US to date, although Gedeon Richter/Hikma (December 2024), Organon/Shanghai Henlius (October 2024), Teva (October 2024), and Fresenius Kabi (May 2024) have each had Biologics Licence Applications accepted for review by the FDA.

Celltrion’s Osenvelt®/CT-P41, biosimilar to Amgen’s Xgeva®, and Stoboclo®/CT-P41, biosimilar to Amgen’s Prolia®, received positive opinions from the EMA’s CHMP in December 2024.

Celltrion Confirms Launch of Biosimilar Ustekinumab in 5 Major EU Countries

On 23 January 2025, Celltrion confirmed that it has completed the launch of Steqeyma®/CT-P43, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in France, Italy, Spain, the UK, and Germany.

Steqeyma® was launched in France on 20 January 2025, Italy and Spain in mid-January 2025, the UK on 2 December 2024, and Germany in November 2024.

Celltrion was the third company to launch an ustekinumab biosimilar in Europe.  On 22 July 2024, STADA and Alvotech announced the launch of biosimilar ustekinumab Uzpruvo® across the majority of European countries.  This was quickly followed by Sandoz announcing the European launch of Pyzchiva® on 25 July 2024.

Steqeyma® was approved in Europe in August 2024, following a positive CHMP opinion in June 2024.  It received approval in the UK in September 2024.

On 17 December 2024, Celltrion announced that the US FDA had approved Steqeyma®.  According to Celltrion it is in the planning stages for the US launch of the product.

Samsung Biologics Achieves Record 2024 Sales of KRW 4.54T

On 22 January 2025, Samsung Biologics revealed its Q4 and 2024 annual financial results, reporting full year 2024 consolidated revenue of over 4 trillion won (approx. USD2.78bn), a 23% increase compared to 2023.  According to the Korea Herald, this makes Samsung Biologics the first biotech company in South Korea to reach this sales milestone.

Samsung Biologics’ Q2/24 consolidated revenue was KRW 1.26 trillion, with operating profit of KRW 325.7 billion.

Samsung Biologic’s biosimilar subsidiary, Samsung Bioepis, achieved 2024 consolidated revenue of 1.537 trillion won, a 51% increase year on year.  Its operating profit more than doubled compared to 2024, at 435 billion won.

Biosimilar highlights for 2024 are reported to include the European launch (July 2024) and US FDA approval (July 2024) of SB17/Pyzchiva® (ustekinumab, biosimilar to J&J/Janssen’s Stelara®), the US approval (July 2024) of SB12/Epysqli™ (eculizumab, biosimilar to Alexion’s Soliris®), the European (November 2024) and US FDA approval (May 2024) of SB15/Opuviz® (aflibercept, biosimilar to Regeneron’s Eylea®), and the positive CHMP opinion (November 2024) for SB16/Obodence®/Xbryk® (denosumab, biosimilar to Amgen’s Prolia® and Xgeva®).

New Indication Alert: Sanofi’s Isatuximab Combination Therapy EU Approved for Multiple Myeloma

On 22 January 2025, Sanofi announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has approved Sarclisa® (isatuximab) in combination with a standard-of-care regimen, bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplant (ASCT).

This news follows the CHMP’s positive recommendation (November 2024) and US FDA approval (September 2024) for the same combination therapy and indication.  In November 2024, Sanofi succeeded in an appeal in the UK against the NICE’s June 2024 Final Draft Guidance recommending against Sarclisa® as a regimen alongside pomalidomide and dexamethasone for relapsed relapsed/refractory multiple myeloma (RRMM).

J&J Reports Q4 2024 Results; Annual Darzalex® Sales Total USD11.7B

On 22 January 2025, Johnson & Johnson (J&J) reported its results for Q4 2024, which saw sales growth of 5.3% to $22.5B.

On the same day, Genmab announced that worldwide annual net sales of Darzalex® (daratumumab) for 2024, as reported by J&J, totalled USD11.7 billion.  US sales accounted for more than half of this total, reaching USD6.6 billion.  Genmab receives royalties on the worldwide net sales of Darzalex® (IV and SC), under its exclusive worldwide licence to Janssen to develop, manufacture and commercialise daratumumab.

J&J reports that it achieved several significant regulatory milestones in Q4 2024 across the EU and US.  This includes the European approval for several new indications of J&J biologics, such as Darzalex® SC based quadruplet regimen for multiple myeloma (October 2024), and Rybrevant® (amivantamab) in combination with Lazcluze® (lazertinib) for non-small cell lung cancer (December 2024).  J&J also submitted an application in the EU for approval of Darzalex® SC for high-risk smouldering multiple myeloma (November 2024).

In the US, J&J submitted an application for approval of a new indication of Darzalex Faspro® (daratumumab and hyaluronidase-hj) for high-risk smouldering multiple myeloma (November 2024), and received Breakthrough Therapy designation (BTD) for nipocalimab for the treatment of adults living with moderate-to-severe Sjögren’s disease (November 2024).  J&J also sought FDA approval for a subcutaneous induction regimen of Tremfya® (guselkumab) for ulcerative colitis (November 2024).

Pearce IP BioBlast® for the period 22 December 2024 to 17 January 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®.  Significant biosimilar activities for the period 22 December 2024 to 17 January 2025 are set out below:

Adalimumab

1 January 2025 | AU | Sandoz’s High Concentration Adalimumab Biosimilar PBS-Listed

On 1 January 2025, Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in a 40 mg/0.4 mL injection, 2 x 0.4 mL pen formulation for the same indications as Humira®… Read more here.


Aflibercept

13 January 2025 | EU | IS | Teva and Klinge/Formycon Partner to Commercialise Aflibercept Biosimilar in EU and Israel

On 13 January 2025, Teva Pharmaceuticals announced that it has entered into a strategic collaboration agreement with Klinge Biopharma and Formycon for the commercialisation of … Read more here.
 

Amivantamab 

30 December 2024 | EU | New Indication Alert: J&J Receives EU Approval for Amivantamab Combination Treatment for NSCLC

On 30 December 2024, Johnson & Johnson (J&J) announced that the European Commission has approved a Type II variation extension of indication for its Rybrevant® (amivantamab) as … Read more here.


Bevacizumab

16 January 2025 | US | Outlook Therapeutics Plans BLA Resubmission to FDA for Ophthalmic Bevacizumab Following Positive Clinical Trial Results

On 16 January 2025, Outlook Therapeutics announced 12-week results of its NORSE EIGHT clinical trial evaluating ONS-5010 (Lytenava™, ophthalmic bevacizumab) in wet AMD.  The results are said to… Read more here.

 

21 December 2024 | UK | Approval Alert: CuraTeQ’s Biosimilar Bevacizumab Receives UK Approval

On 21 December 2024, CuraTeQ Biologics announced that it has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Bevqolva™,… Read more here.


Daratumumab

27 December 2024 | US | FDA Approves Global Phase 3 Trial for Celltrion’s Daratumumab Biosimilar

On 27 December 2024, Celltrion announced that the US FDA has approved its Investigational New Drug (IND) application for a global Phase 3 clinical trial of CT-P44, biosimilar to Johnson & Johnson’s… Read more here.


Datopotamab deruxtecan

18 January 2025 | JP | US | EU | Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

On 18 January 2025, Daiichi Sankyo announced that Daiichi/AstraZeneca’s antibody drug conjugate Datroway® (datopotamab deruxtecan-dlnk) has been approved in the US for treatment of adults… Read more here.


Denosumab

10 January 2025 | NZ | New Zealand’s Pharmac Widens Access to Amgen’s Denosumab

On 10 January 2025, New Zealand’s Pharmac announced that it will be expanding access to Amgen’s Prolia® and Xgeva® (denosumab)… Read more here.

 

24 December 2024 | GlycoNex Announces Licensing Deal for Denosumab Biosimilar

On 24 December 2024, GlycoNex announced that it has entered into a licensing agreement with an undisclosed partner for SPD8 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®.  Under the… Read more here.


Eculizumab

10 January 2025 | US | Samsung Bioepis and Teva Strike Partnership for US Commercialisation of Eculizumab Biosimilar

On 10 January 2025, Samsung Bioepis and Teva announced they have entered into a licence, development and commercialisation agreement for Epysqli® (eculizumab-aagh), biosimilar to… Read more here.

 

20 December 2024 | EU | UPC Eculizumab Litigation Update: Preliminary Injunctions Against Samsung Bioepis and Amgen Denied by Court of Appeal

On 20 December 2024, the UPC Court of Appeal denied Alexion preliminary injunctions against Samsung Bioepis and Amgen in relation to the sale of biosimilars to Alexion’s Soliris® (eculizumab) in … Read more here.


Enfortumab vedotin

8 January 2025 | CN | New Indication Alert: Astellas’ Padcev™ Combination Therapy Approved in China for Urothelial Cancer

On 8 January 2025, Astellas Pharma announced that China’s National Medical Products Administration (NMPA) has approved its Padcev™ (enfortumab vedotin) in combination with Merck’s … Read more here.


Epcoritamab

6 January 2025 | AU | Approval Alert: AbbVie’s Epkinly® (Epcoritamab) Provisionally Approved in Australia

On 6 January 2025, the Therapeutic Goods Administration (TGA) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate solution and 48mg/0.8mL solution for injection vial… Read more here.


Lecanemab

14 January 2025 | US | US FDA Accepts Eisai/Biogen’s BLA for Leqembi® Subcutaneous Maintenance Dosing

On 13-14 January 2025, Eisai and Biogen announced that the US FDA has accepted Eisai’s Biologics Licence Application (BLA) for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly… Read more here.


Liraglutide

15 January 2025 | Lexaria Bioscience to Commence Human Study of Oral Liraglutide Formulation

On 15 January 2025, Lexaria Bioscience announced that it has received independent ethics board approval to begin its first-ever human study of oral liraglutide, formulated from the DehydraTECH… Read more here.

 

2 January 2025 | US | Novo Nordisk Submits Citizen Petition Seeking to Block Compounded Victoza®

On 2 January 2025, the FDA published a Citizen Petition filed by Novo Nordisk seeking to exclude its type 2 diabetes liraglutide injection Victoza® (liraglutide) from a proposed list of drugs eligible for… Read more here.

 

26 December 2024 | US | Hikma’s Generic Version of Novo Nordisk’s Diabetes Drug Victoza® Approved and Launched in US

On 26 December 2024, Hikma Pharmaceuticals announced that it has received FDA approval for, and launched, its generic version of Novo Nordisk’s Victoza® (liraglutide) in the US in a 6mg/mL dosage… Read more here.

 

24 December 2024 | EU | Biocon Receives EU Approval for Generic Liraglutide

On 24 December 2024, Biocon announced that the company and its European partner, Zentiva, have received Decentralised Procedure (DCP) approval for liraglutide in the European Union.  The approval … Read more here.


Mepolizumab

3 January 2025 | CN | New Indication Alert: GSK’s Nucala® Approved in China for CRSwNP

On 3 January 2025, GSK announced that China’s National Medical Products Administration (NMPA) has approved Nucala® (mepolizumab) as an add-on therapy with intranasal corticosteroids for the … Read more here.


Mirikuzumab

15 January 2025 | US | New Indication Alert: FDA Approves Eli Lilly’s Omvoh® for Crohn’s Disease

On 15 January 2025, Eli Lilly announced that the US FDA has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults.  This follows FDA approval of Omvoh® for ulcerative… Read more here.


Nipocalimab

9 January 2025 | US | J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

On 9 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted its nipocalimab Priority Review designation for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) … Read more here.


Nivolumab

27 December 2024 | US | BMS’ Subcutaneous Nivolumab FDA-Approved

On 27 December 2024, BMS announced that the US FDA has granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, a combination product of … Read more here.

 

23 December 2024 | EU | New Indication Alert: BMS’ Opdivo® and Yervoy® Combination Therapy Receives New EU Approval

On 23 December 2024, following the November 2024 recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission… Read more here.


Ocrelizumab 

13 January 2025 | Amgen’s Ocrelizumab Biosimilar in Phase 3 Trials

At the JP Morgan Annual Healthcare conference on 13 January 2025, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) in Phase 3 trials.  The Phase 3 study … Read more here.


Pembrolizumab

14 January 2025 | MSD Planning 2025 SC Pembrolizumab Launch

At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, Merck (known as MSD outside the US and Canada) announced that it is expecting to “file, have approval, and launch… Read more here.


Posdinemab

8 January 2025 | US | J&J’s Posdinemab Receives FDA Fast Track Designation for Alzheimer’s Disease

On 8 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted Fast Track designation to its posdinemab.  Posdinemab is a phosphorylated tau-directed monoclonal antibody … Read more here.


Semaglutide

17 January 2025 | Novo Nordisk’s High Dose Semaglutide Demonstrates 20.7% Weight Loss in Ph 3b Trial

On 17 January 2025, Novo Nordisk announced results of its Phase 3b trial (STEP UP) of subcutaneous semaglutide 7.2 mg compared with semaglutide 2.4mg and placebo, each administered once weekly… Read more here.


Tislelizumab

6 January 2025 | US | AU | New Indication Alert: BeiGene’s Tevimbra® Receives New Indication Approvals in Australia and the US

On 6 January 2025, the Australian Therapeutic Goods Administration (TGA) approved an indication expansion for BeiGene’s Tevimbra® (tislelizumab) in combination with platinum-based… Read more here.


Ustekinumab

16 January 2025 | TR | Bio-Thera and World Medicine Partner to Commercialise Ustekinumab Biosimilar in Turkey

On 16 January 2025, Bio-Thera announced that it has signed an exclusive licence and commercialisation agreement with Turkish company, World Medicine, in relation to Bio-Thera’s … Read more here.

 

15 January 2025 | UK | CA | Formycon/Fresenius’ Biosimilar Ustekinumab Approved in UK and Canada

On 15 January 2025, Formycon and Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi®, biosimilar to J&J/Janssen’s… Read more here.

 

7 January 2025 | JP | Biocon’s Biosimilar Ustekinumab Approved in Japan

On 7 January 2025, Biocon announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved its subcutaneous ustekinumab (Bmab 1200), biosimilar to J&J/Janssen’s…  Read more here.

 

24 December 2024 | SA | Bio-Thera & Tabuk Pharmaceuticals Seal Saudi Arabian Licensing Deal for Ustekinumab Biosimilar

On 24 December 2024, Bio-Thera Solutions announced that it has entered an exclusive licensing agreement with Tabuk Pharmaceutical Manufacturing Company in relation to the commercialisation of BAT2206 (ustekinumab)… Read more here.


Zolbetuximab

9 January 2025 | CA | CN | Astellas’ Vyloy® Combo Approved in Canada and China for Gastric and GEJ Cancer

On 9 January 2025, Astellas Pharma announced that Health Canada has approved Vyloy® (zolbetuximab for injection) in combination with fluoropyrimidine- and platinum-containing chemotherapy… Read more here.


Company News 

16 January 2025 | US | Samsung Bioepis Publishes Eighth Biosimilar Market Report

On 16 January 2025, Samsung Bioepis published its quarterly US Biosimilar Market Report.  The report has been released every quarter since April 2023 and details average sales price information … Read more here.

 

13 January 2025 | MENA | ASIA | LATAM | Henlius and Abbott Partner on Biosimilar Commercialisation in Emerging Markets

On 13 January 2025, Shanghai Henlius announced that it has entered a product licence and supply agreement with Abbott under which Abbott is granted exclusive or semi-exclusive rights to the… Read more here.

 

 

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.

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.

Nathan Kan

Nathan Kan

Graduate (Law)

Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science.  Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

 

Health Canada Approves Roche’s Vabysmo® PFS

On 20 January 2025, Roche announced that Health Canada has approved its Vabysmo® (faricimab) 6.0 mg single-use pre-filled syringe (PFS) for use in the treatment of nAMD, diabetic macular oedema (DME) and macular oedema secondary to retinal vein occlusion (RVO).  Vabysmo® PFS delivers the same dose as the currently available 6.0 mg vial formulation, and, according to Roche, will become available to Canadian ophthalmologists and their patients in the coming months.

Vabysmo® was first approved by Health Canada for nAMD and DME in June 2022, and for RVO in July 2024.  This news follows EU approval for Vabysmo® PFS for the same indications in December 2024, and in the US in July 2024.

Celltrion Plans 2025 US/EU/JP Launch of Biosimilar Denosumab at Significant Discount for Osteoporosis Prevention

On 20 January 2025, Korea Biomedical Review reported that, at the JP Morgan Healthcare Conference on 14 January 2025, Celltrion revealed its plans to launch CT-P41, biosimilar to Amgen’s Prolia® (denosumab) in the US, Europe and Japan in 2025, at a significant discount for the prevention of osteoporosis as well as its treatment.

Celltrion filed an abbreviated Biologics Licence Application for CT-P41 in the US in December 2023.  However, in May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab.  That litigation remains pending as at the date of Celltrion’s announcement at the JP Morgan Conference.

Celltrion’s Osenvelt®/CT-P41, biosimilar to Amgen’s Xgeva® (denosumab), and Stoboclo®/CT-P41, biosimilar to Amgen’s Prolia® (denosumab), received positive opinions from the EMA’s CHMP in December 2024.

According to KBM, at the JP Morgan Conference, Celltrion’s Chairman also revealed that the company plans to launch four other biosimilars in the US, EU and Japan in 2025: ustekinumab/Steqeyma®/CT-P43 (already launched in Europe in November 2024, approved in US in December 2024); aflibercept/Eydenzelt™/CT-P42 (NDA filed with the FDA in June 2023, positive CHMP opinion received from the European Medicines Agency in December 2024); tocilizumab/Avtozma®/CT-P47 (positive CHMP opinion received in December 2024; BLA submitted in the US in January 2024); omalizumab/Omlyclo®/CT-P39 (approved in Europe (May 2024) and aBLA submitted in the US in March 2024).

New Approval Alert: Formycon’s Aflibercept Biosimilar Approved in Europe

On 20 January 2025, Formycon and Klinge Biopharma announced that FYB203/Ahzantive®/Baiama® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, has been granted marketing approval by the European Commission.  The approval covers all countries in the European Economic Area and indications for nAMD, diabetic macular oedema (DME), visual impairment due to myopic choroidal neovascularisation (CNV), and macular oedema following retinal vein occlusion (RVO).

FYB203 received a positive opinion from Europe’s Committee for Medicinal Products for Human Use (CHMP) in November 2024.  It was approved in the US in June 2024, where it is subject to a preliminary injunction granted in June 2024, resulting from a patent infringement proceeding brought by Regeneron in November 2023.  Formycon lodged an appeal from the preliminary injunction order on 25 June 2024.

In mid-January 2025, Formycon/Klinge and Teva Pharmaceuticals entered a collaboration agreement for the semi-exclusive commercialisation of FYB203 in Europe (excluding Italy) and Israel.

Approval Alert: Daiichi Sankyo/AstraZeneca’s Datopotamab Deruxtecan Approved in US and Japan for Breast Cancer

On 18 January 2025, Daiichi Sankyo announced that Daiichi/AstraZeneca’s antibody drug conjugate Datroway® (datopotamab deruxtecan-dlnk) has been approved in the US for treatment of adults with unresectable or metastatic hormone receptor positive HER2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy.  According to Daiichi, the drug will be available in the US by prescription in approximately two weeks.

This comes less than a month after Japan became the first country globally to approve Datroway® for the same indication, on 27 December 2024.

Daiichi and AstraZeneca are also pursing regulatory approval of Datroway® for the treatment of non-small cell lung cancer (NSCLC) in the US.  On 13 January 2025, the companies announced that the FDA has granted datopotamab deruxtecan Priority Review for patients with previously treated advanced EGFR-mutated NSCLC.

However, as of 24 December 2024, AstraZeneca/Daiichi have voluntarily withdrawn the marketing authorisation application (MAA) in the EU for datopotamab deruxtecan for the NSCLC indication, based on feedback from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.  According to the companies, they will “continue to work to bring datopotamab deruxtecan to patients with lunch cancer in the EU”.  The European application for datopotamab deruxtecan for breast cancer remains under review.

AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise datopotamab deruxtecan (DS-1062) in July 2020.

Novo Nordisk’s High Dose Semaglutide Demonstrates 20.7% Weight Loss in Ph 3b Trial

On 17 January 2025, Novo Nordisk announced results of its Phase 3b trial (STEP UP) of subcutaneous semaglutide 7.2 mg compared with semaglutide 2.4mg and placebo, each administered once weekly.  The results reportedly demonstrate a statistically significant and superior weight loss at week 72 with semaglutide 7.2 mg versus placebo, with patients treated with the high dose semaglutide achieving weight loss of 20.7% compared to a reduction of 17.5% with semaglutide 2.4 mg and a reduction of 2.4% with placebo.

Novo Nordisk expects results from a second high dose semaglutide Phase 3 trial (STEP UP T2D) in adults with type 2 diabetes and obesity within the next few months.

Approval Alert: Junshi Biosciences/Dr Reddy’s Tuoyi® (Toripalimab) Approved in Australia

On 17 January 2024, Junshi Biosciences announced that Australia’s Therapeutic Goods Administration (TGA) has approved Tuoyi® (toripalimab) for the treatment of adults with recurrent unresectable or metastatic nasopharyngeal carcinoma (NPC) with disease progression on or after a platinum-containing chemotherapy.  The TGA has also approved Tuoyi® in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced NPC.

In July 2023, Junshi and Dr Reddy’s entered into an exclusive licensing agreement for toripalimab, with Dr Reddy’s responsible for the development and commercialisation of toripalimab in Latin America, India, South Africa, and at the election of Dr. Reddy’s, also in Australia, New Zealand and nine other countries.  According to Junshi, toripalimab has been approved for marketing in over 35 countries including China, Hong Kong SAR, the United States, the European Union, the UK, Australia, and India.

In March 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider Dr Reddy’s application to PBS-list toripalimab for NPC.

Samsung Bioepis Publishes Eighth Biosimilar Market Report

On 16 January 2025, Samsung Bioepis published its quarterly US Biosimilar Market Report.  The report has been released every quarter since April 2023 and details average sales price information for US launched biosimilars and market share and price trends.

The Q1/2025 edition reports that, as of December 2024, the FDA has approved 64 biosimilars across 17 unique biological molecules, with 41 of those biosimilars having launched in the US market.  In Q4/2024, three new ustekinumab biosimilars were approved in the US (Accord Healthcare/Meiji Seika Pharma’s Imuldosa® (Oct 2024), Biocon’s Yesintek® (Dec 2024) and Celltrion’s SteQeyma® (Dec 2024).

Samsung Bioepis reports that in 2025 the industry is “set to witness the launch of biosimilars in new therapeutic areas and for new molecules such as eculizumab, aflibercept, ustekinumab and denosumab”.

According to the report, on average, biosimilar launches have resulted in 53% market share in biosimilar markets and a 53% reduction in average sales price after 5 years of biosimilar competition.  The fastest uptake of biosimilars has to date occurred in oncology, ophthalmology and pegfilgrastim markets, while biosimilars in immunology, insulin glargine, filgrastim and epoetin alfa markets demonstrate slower uptake.

It is reported that, as of November 2024, the US adalimumab biosimilar market share reached 23% (up 1% since August 2024), with most gains coming from Sandoz’s Hyrimoz® and Organon’s Hadlima®.  The market share for biosimilars which have had a longer time on the market include 86% for trastuzumab and 90% for bevacizumab.

Bio-Thera and World Medicine Partner to Commercialise Ustekinumab Biosimilar in Turkey

On 16 January 2025, Bio-Thera announced that it has signed an exclusive licence and commercialisation agreement with Turkish company, World Medicine, in relation to Bio-Thera’s BAT2206 (ustekinumab), biosimilar to Janssen’s Stelara®.

Under the terms of the agreement, Bio-Thera will manufacture BAT2206 in China and World Medicine will be responsible for regulatory approval, importation and commercialisation of the product in Turkey.

Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA, and its BLA was accepted by the FDA, in July 2024.  A marketing authorisation application is also currently under review by China’s National Medicinal Product Administration.

In December 2024, Bio-Thera announced a partnership with Tabuk Pharmaceuticals to commercialise BAT2206 in Saudi Arabia.  In October 2024, Bio-Thera and Gedeon Richter announced they had entered into an exclusive commercialisation and licence agreement for BAT2206, under which Richter has exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries.

Outlook Therapeutics Plans BLA Resubmission to FDA for Ophthalmic Bevacizumab Following Positive Clinical Trial Results

On 16 January 2025, Outlook Therapeutics announced 12-week results of its NORSE EIGHT clinical trial evaluating ONS-5010 (Lytenava™, ophthalmic bevacizumab) in wet AMD.  The results are said to show that ONS-5010 demonstrated non-inferiority to Genentech’s Lucentis® (ranibizumab) in terms of efficacy and safety.

The study was conducted following Outlook’s receipt of a Complete Response Letter from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding additional clinical trials.  Based on the results of the NORSE EIGHT trial, Outlook plans to resubmit its Biologics Licence Application (BLA) for ONS-5010 to the US FDA in the first quarter of 2025.

Lytenava™ was approved in the UK for wet AMD in July 2024 following its submission to the MHRA under the International Recognition Procedure (IRP).  The UK approval followed marketing authorisation granted to Lytenava™ in the EU in May 2024.  Lytenava™ is the first authorised ophthalmic formulation of bevacizumab in the EU.

Amgen’s Ustekinumab Biosimilar First to Launch in US; Available Through Nuvaila

On 16 January 2025, AIS Health reported that Amgen has launched Wezlana® (ustekinumab), biosimilar to J&J/Janssen’s Stelara® in the US through Optum Health Solution’s private label subsidiary Nuvaila.  The biosimilar is said to have been launched on 1 January 2025 and is available in both intravenous and subcutaneous forms for all indications of Stelara®.

Wezlana® was the first interchangeable ustekinumab biosimilar approved by the FDA in October 2023.  It was launched in Canada in March 2024 and has been approved in Europe (June 2024, as WezenlaTM) and approved (January 2024) and PBS-listed (April 2024) in Australia.

UCB Launches High Dose Bimekizumab in the US

On 16 January 2025, UCB announced that it has launched in the US a high dose presentation of Bimzelx® (bimekizumab-bkzx) in a single-injection 2 mL prefilled syringe and autoinjector, each containing 320 mg of Bimzelx®.  This is in addition to the currently available 1 mL (160 mg) device administration options and follows FDA approval of the presentation in October 2024.

UCB’s Bimzelx® has received several FDA approvals for new indications in recent months, including for moderate to severe hidradenitis suppurativa (November 2024), and for active psoriatic arthritis, active non-radiographic axial spondyloarthritis and active ankylosing spondylitis (September 2024).

In May 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider UCB’s application to PBS-list Bimzelx® for moderate to severe hidradenitis suppurativa.

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

On 16 January 2025, Johnson & Johnson (J&J) announced that Health Canada has approved its Rybrevant® (amivantamab for injection) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with osimertinib.

This follows US FDA approval for the same combination therapy and indication in September 2024, and a positive recommendation by the EMA in July 2024.  In December 2024, the EMA approved Rybrevant® in combination with Lazcluze® (lazertinib) for the same indication.

Formycon/Fresenius’ Biosimilar Ustekinumab Approved in UK and Canada

On 15 January 2025, Formycon and Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

This closely follows the Canadian approval of both subcutaneous and intravenous formulations of FYB202/Otulfi® on 8 January 2025, for the same indications.

FYB202/Otulfi® was approved in Europe and the US in September 2024.  It is being commercialised in the US, Canada and most of Europe by Fresenius Kabi, under a global licence agreement entered into between Formycon and Fresenius in February 2023.  Fresenius has exclusive commercialisation rights to the ustekinumab biosimilar in key global markets, while Formycon retains semi-exclusive commercialisation rights in Germany, parts of the MENA region and Latin America.

In March 2024, Formycon and Fresenius announced they reached a settlement with J&J/Janssen regarding the commercialisation of FYB202/Otulfi® in Europe and Canada.  This followed a US settlement in August 2023, enabling US launch of FYB202 “no later than 15 April 2025”.  The agreed launch dates for FYB202 in the UK and Canada remain confidential.

A Matter of Taste: IPONZ Decision Serves Up Important Reminders on Patent Practice

 

Date of decision: 8 October 2024
Body:  Intellectual Property Office of New Zealand
Adjudicator: Warren Coles (Assistant Commissioner of Patents)

Introduction

In October 2024, the Intellectual Property Office of New Zealand (IPONZ) issued a decision concerning a patent application NZ760443 by Suntory Holdings Limited (Suntory) relating to the enhancement of sweetness in beverages using specific combinations of high-intensity sweeteners and sodium, while maintaining palatability by avoiding saltiness.  The application faced objections through several examination reports, specifically regarding inventive step, clarity and support.  Following a third and final report issued after the expiry of the deadline for placing the application in order for acceptance under section 71 of the Patents Act 2013 (NZ) (the Act), Suntory requested a hearing and submitted a range of amended claims dealing with the examiner’s objections.  Using his discretion, the Assistant Commissioner allowed a limited number of amendments to be considered, and ultimately overturned the examiner’s objections subject to further refinement of the amended claims.

Key Issues 

Timing

The Assistant Commissioner addressed a number of timing issues related to the final examination report having been issued shortly after the section 71 deadline.  The Assistant Commissioner emphasised that hearing proceedings should not be used as a mechanism to extend examination by proposing amendments that could have been made during the examination phase.  While the Assistant Commissioner used his discretion to allow amendments to existing claims, he declined to allow Suntory to add any new claims, noting that when new independent and/or dependent claims are added after the expiry of the section 71 deadline, and during the course of a hearing, “it may not be possible under the Act and Regulations for the Assistant Commissioner to defer the Application back to the examination team to consider whether the new claims comply with the requirements of the Act and Regulations”.

Further, the Assistant Commissioner criticised Suntory’s practice of responding to examination reports very close to the expiry of response deadlines.  While IPONZ aims to process examination reports within 20 working days, the Assistant Commissioner emphasised that responses received close to deadlines may not allow sufficient time for meaningful examination and response, particularly when approaching the final section 71 deadline – and thus may compromise an applicant’s ability to achieve acceptance of its application.

Inventive Step

On inventive step, the Assistant Commissioner noted that the examiner had considered a journal article (Starkey et al) in the third examination report which was not raised or discussed in the earlier reports.  Importantly, Starkey et al was published in January 2022, well after the priority date of the application, and therefore did not comply with the prior art requirements of sections 7 and 8(1) of the Act.  As such, the Assistant Commissioner did not uphold the examiner’s objection regarding the scientific foundation of the invention, as this was based on Starkey et al and the examiner had not provided any alternative basis for the objection.

Moreover, in conducting an inventive step analysis, the examiner failed to refer to or recite the appropriate test (the Windsurfing/Pozzoli test).  Consequently, the Assistant Commissioner was unable to conclude that the test had been properly considered and applied, and thus could not identify a foundation for the examiner’s assumption that the claimed invention would have been obvious to a skilled person based on the cited prior art documents.  Having considered Suntory’s submissions, the Assistant Commissioner agreed that the prior art cited did not teach that a sodium compound has a sweetness enhancing effect, and consequently declined to uphold the examiner’s objections on inventive step.

Clarity and Support

On clarity and support, the Assistant Commissioner identified that while the examiner had raised objections against independent claims 1, 9, 17 and 25, there was significant ambiguity in how these objections were presented.  Notably, the examination report only specifically discussed claim 25, leaving uncertain whether the objections in fact extended to the other claims.  Taking a pragmatic approach, the Assistant Commissioner considered all claims together, and considered whether the claimed sodium concentration ranges were adequately supported by the experimental data in the specification.  Although the applicant sought broader ranges, the Assistant Commissioner restricted the amended claims to experimentally verified concentrations where saltiness was not detected.

Outcome

The Assistant Commissioner overturned the examiner’s objection regarding inventive step, clarity and support.  However, this acceptance was subject to specific amendments, including the deletion of several claims and the adjustment of sodium concentration ranges to align precisely with the experimental data.

Implications

This decision highlights several important aspects of patent practice in New Zealand.  First, it reinforces that applicants may be well served to take a patent application to a hearing when they believe there are strong grounds to contest objections at the examination level.  In this case, the Assistant Commissioner identified fundamental issues with the examiner’s inventive step analysis, particularly the failure to apply the Windsurfing/Pozzoli test, as well as the erroneous reliance on prior art documents that were published after the relevant priority date.

However, the decision also serves as a cautionary tale regarding post-deadline amendments.  Unlike some jurisdictions such as Europe where alternative claim sets can be presented during appeal proceedings, the Assistant Commissioner emphasised that hearing proceedings should not be used to extend the examination process by proposing amendments that could have been made earlier.  While the Assistant Commissioner used his discretion to allow consideration of the amended claims, he did not allow the newly added independent and dependent claims.

The decision also contains pointed commentary about the timing of applicants’ responses during the examination process.  The practice of filing responses very close to deadlines was criticised as potentially prejudicing applications – such conduct may not leave sufficient time for a further examination report to be issued, nor for a further response to be filed and considered before the expiry of the section 71 deadline for placing the application in order for acceptance.

Finally, as is not too uncommon, the examiner’s reports in this case failed to provide explicit reference to, and consideration of, the Windsurfing/Pozzoli test, which the Assistant Commissioner noted as potentially hindering effective dialogue between the examiner and applicant regarding the inventive step analysis.  This observation suggests that applicants might benefit from proactively requesting more detailed reasoning when facing inventive step objections that lack clear explanation of how the test has been applied.

 

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.

Julie Ballance

Julie Ballance

Special Counsel (NZ), Patent Attorney, Lawyer & Notary

Julie is a senior Trans-Tasman patent attorney, and a New Zealand registered lawyer and notary public with more than 30 years’ experience across a range of technology areas and a first class honours degree in chemistry. Julie is internationally renowned for her considerable patent/trade mark/designs/legal prowess, including being ranked in IAM Patent 1000.

Nathan Kan

Nathan Kan

Graduate (Law)

Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science.  Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

 

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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