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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 w/e 4 March 2024

The Australian Financial Review reported that on 1 March 2024 TGA investigators raided Como Compounding Pharmacy in Melbourne and seized ‘off-brand’ Ozempic® (semaglutide) and other allegedly unlawfully made medications.  As reportedly revealed in a confidential TGA letter obtained by Australia’s national broadcaster, ABC, the TGA plans to ban the sale of pharmacy-made versions of Ozempic® due to serious safety concerns.  

The raid resulted in the seizure of compounded semaglutide, peptides, and human growth hormones.  

Ozempic® is manufactured by the Danish drug giant Novo Nordisk.  While it is primarily a diabetes medication, Ozempic® has gained popularity as a weight loss drug.  

The Financial Review reports that originator Novo Nordisk supports the ban, citing safety concerns and the need to halt pharmacy-made versions of its global blockbuster semaglutide product Ozempic®.   

This news follows the release on 31 January 2024 by Novo Nordisk of its 2023 Annual Report, where it presented a global increase in sales by 31% to DKK 232.3B in 2023, representing an increase in its operating profit by 37%. 

On 1 March 2024, JAMP Pharma announced that it launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada.  Jamteki was approved by Health Canada in November 2023 and JAMP’s launch follows a settlement between Alvotech and J&J last month regarding ustekinumab. 

Jamteki was developed by Alvotech and is JAMP Pharma’s second biosimilar launch in Canada in two years, following the Canadian launch of Simlandi® (adalimumab) biosimilar of AbbVie’s Humira® (adalimumab) in 2022.  The approved presentations for Jamteki™ are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

The Medicines and Healthcare Regulatory Agency issued a safety update regarding (dupilumab) and ocular side effects.  The regulator warned that side effects can include conjunctivitis and ulcerative keratitis

On 29 February 2024, Biocon Biologics Ltd, announced a settlement with J&J and Janssen, under which it can launch its Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in the USA from February 2025.  The FDA previously accepted for review Biocon’s Biologics License Application for Bmab 1200. 

The settlement will result in the termination of the pending Inter Partes Review petition filed by Biocon in November 2023 against Janssen’s US method of treatment (severely active ulcerative colitis (UC)) patent 10,961,307 relating to Stelara® (ustekinumab). 

J&J and Janssen recently entered into ustekinumab settlements with Alvotech (launch dates of no later than 21 February 2025 (US), May 2024 (Japan), late July 2024 (EU) and Q1 2024 (Canada)), BioPharma (US launch date of 15 May 2025), Samsung Bioepis (US launch date from 22 February 2025), Celltrion (US launch date of 7 March 2025), Fresenius Kabi and Formycon (US launch date no later than 15 April 2025), and Amgen (US launch date no later than 1 January 2025).  To date, only Amgen has obtained FDA approval for its ustekinumab biosimilar, with its Wezlana® approved in October 2023. 

On 29 February 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for Xgeva® (denosumab) as a 120mg solution for injection in a prefilled syringe.  This Xgeva PFS product is a high concentration product which is a line extension of the original Xgeva® sold as a vial product containing 120mg solution for injection. 

This is the first product to be authorised by the MHRA via the new International Recognition Procedure (IRP) introduced in January this year.    

The IRP allows the MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and/or the United States.  In fast-tracking the authorisation of the new Xgeva® high concentration formulation, the MHRA considered a positive opinion issued by the European Medicines Agency on 25 January 2024. 

On 28 February 2024, Celltrion announced that it filed an application with MFDS for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab).  The application seeks registration across the full Actemra® label and is based on Phase 3 results confirming equivalence of CT-P47 to Actemra®.  Celltrion announced that it will use these results to accelerate applications for product approvals in other countries. 

This follows Celltrion’s announcement on 13 February 2024 that it submitted a Marketing Authorisation Application to the EMA for CT-P47.  On 28 January 2024, Celltrion also announced it had submitted a BLA in the US for CT-P47.  

On 28 February 2024, Celltrion announced that its first batch of Zymfentra® (SC infliximab) arrived in Atlanta, with three more shipments expected to arrive by early March this year.  Zymfentra® was approved by the FDA in October 2023. 

Zymfentra® (SC infliximab), also known as Remsima SC in Europe, is the world’s first subcutaneous injection of infliximab.  Zymfentra® can be self-administered increasing patient convivence and reducing hospital burden.  Celltrion aims to distribute Zymfentra® to US wholesalers by mid-March.  

Zymfentra® was approved by the FDA in October 2023. 

On 27 February 2024, Akeso announced results of a Phase II clinical trial focadonilimab combined with standard treatment (chemotherapy +/- bevacizumab) for treating recurrent/metastatic cervical cancer The results were published in the American Association for Cancer Research’s Clinical Cancer Research journal and, amongst other things, the results showed that 63.6% of patients experienced tumour reduction of more than 50%. 

On 27 February 2024, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted priority review of its supplemental Biologics License Application for EPKINLY® (epcoritamab) for the treatment of Adult Relapsed or Refractory Follicular Lymphoma (R/R FL).  Priority review will decrease the review time to six months, compared to a standard 10 months.  If approved by the FDA, EPKINLY® will be the first and only subcutaneous bispecific antibody to treat adults with R/R FL after two lines of prior therapy. 

On 25 September 2023, AbbVie announced that its Tepkinly® (epcoritamab) received conditional marketing authorisation to Treat R/R DLBCL from the European Commission. 

On 27 February 2024, BeiGene, announced that the U.S. Food and Drug Administration (FDA) accepted BeiGene’s Biologics License Application (BLA) for TEVIMBRA® (tislelizumab), in combination with fluoropyrimidine-and platinum-containing chemotherapy, with a PDUFA date set for December 2024.  The product is intended to offer improved treatment options for patients diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.  

On 19 September 2023, BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a termination of the previous arrangement between the parties.  Furthermore, BeiGene announced on 26 February 2024, that CHMP issued a positive opinion for its TEVIMBRA® (tislelizumab) to treat NSLC. 

On 26 February 2024, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the use of Voydeya® (danicopan) as an add-on to ravulizumaboreculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia.   

CHMP based its positive opinion on results from the ALPHA Phase III trial which were published in The Lancet Haematology journal on 27 November 2023.  

On 26 February 2024, BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of TEVIMBRA® (tislelizumab) for the treatment of non-small cell lung cancer (NSCLC). The indications include treatment of squamous, non-squamous and locally advanced / metastatic NSCLC. BeiGene’s Phase 3 clinical trials, enrolling 1,500 patients, showed tislelizumab to be an effective therapy for patients with treatment-naive and treatment-resistant NSCLC. 

On 19 September 2023, BeiGene announced it regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following termination of the previous arrangement between the parties. 

On 26 February 2024, the results of an 18 month study sponsored by Takeda Pharmaceuticals were published in Crohn’s & Colitis 360.  The study involved 108 patients switched from IV to a subcutaneous vedolizumab.  The results of the study suggested that switching from an intravenous to a subcutaneous treatment of vedolizumab is convenient and safe. 

On 26 February 2024, Daily Pharm Korea reported that Samsung Bioepis received approval from the Korean Ministry of Food and Drug Safety for Afilivu®, biosimilar to Regeneron’s Eylea® (aflibercept).  This is the first aflibercept biosimilar approved in Korea and Samsung Bioepis’ second biosimilar for ophthalmic disease, after its Lucentis® (ranibizumab) biosimilar – Amelivu® – was approved in Korea in May 2022.  Afilivu® is indicated for treatment of wAMD, RVO, DME and mCNV.   

As previously reported, Samsung Bioepis will co-market Afilivu® in Korea with Samil Pharmaceutical, together with ranibizumab biosimilar Amelivu®. 

In the US, aflibercept biosimilars are the subject of patent infringement litigation commenced by Regeneron against Samsung BioepisAmgenFormyconCelltrion and Mylan and Biocon.  In Europe, Formycon announced in December 2023 that the EMA had accepted its marketing authorisation application for its aflibercept biosimilar FYB203. Biocon has received marketing approval for its aflibercept biosimilar Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023). Formycon announced in December 2023 that the EMA had accepted its application for its aflibercept biosimilar FYB203. 

On 26 February 2024, Alvotech announced the sale of 10,127,132 ordinary shares at a purchase price of USD 16.41 per share.  Alvotech’s U.S listed shares rose more than 12% to $18 in premarket trading following the announcement on 23 February 2024 that FDA approved Alvotech’s SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to AbbVie’s Humira®.  

Coherus Bioscience announced its US launch of Udenyca OnBody®, an on-body injector presentation of Undeyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®.  Udenyca® is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.  The on-body injector utilises LTS Lohmann Therapie-Systeme AG’s wearable drug delivery platform. 

Udenyca OnBody® received FDA approval in December 2023. 

On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals regarding the Patent Trial and Appeal Board’s (PTAB) decision in IPR2022-00578 and IPR2022-00579 The motion records that Celltrion (the petitioner) has not formally agreed to the dismissal and may file a response. 

Previously, Celltrion filed inter partes review (IPR) petitions IPR2022-00578 against Chugai/Genentech/Roche’s MOT (RA) patent no. US8580264 (‘264), and IPR 2022-00579 against Chugai/Roche’s device patent no. US10874677 (‘677).  The PTAB concluded that claims 1-12 of the ‘264 MOT patent and claims 1-8 of the ‘677 patent are invalid in view of the prior art.  Chugai, Genentech, and Hoffmann-La Roche appealed PTAB’s decision and are now seeking to have that appeal dismissed.

On 31 January 2024, the US District Court for the Northern District of West Virginia published a redacted version of Judge Thomas Kleeh’s Memorandum Opinion and Order, setting out the detailed reasons for his previous finding that Mylan and Biocon infringed eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®.  The Judge found asserted claims of two method of treatment patents (11,253,572 and 10,880,601) to be invalid.   

The infringement finding was made in relation to the aflibercept biosimilar Yesafili®.  Mylan filed a Biologics Licence Application (BLA) for Yesafili® in October 2021 seeking FDA approval to market it.  Mylan’s rights in the Yesafili® BLA were later transferred to Biocon, who intended to sell the product in the US. 

On 27 December 2023, Judge Kleeh issued a short-form judgment setting out his conclusions.  At that time, the detailed reasons remained under seal.  Mylan and Biocon and Regeneron filed “protective” notices of appeal from the short form judgment on 26 January 2024, although the parties allege that the 27 December judgment was not a final, appealable one. 

Biocon has received marketing approval for Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023). 

Regeneron filed a complaint in the US District Court for the Northern District of West Virginia against Samsung Bioepis asserting 51 counts of patent infringement.  This is the second suit filed against Samsung Bioepis in the Regeneron aflibercept matters, the first of which was filed on 21 November 2023.  

Samsung has filed IPR petitions against a number of Regeneron aflibercept patents including  US10,464,992 on 18 August 2023, relating to formulations of aflibercept, and method of treatment patents US11,253,572 on April 2023US10,888,601 on April 2023 and US10,130,681 on January 2023. 

An AbbVie sponsored phase 3 study evaluating risankizumab for treatment of Crohn’s disease shows that risankizumab performs better than ustekinumab in primary and secondary endpoints. The study compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn’s disease. The safety results were consistent with the overall safety profile of risankizumab, with no new safety risks identified. 

In November 2023, the Korean MFDS approved AbbVie’s Skyrizi® (risankizumab) to treat Chron’s disease. 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer, Patent & Trade Mark Attorney

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is market leading in the field of pharma/biopharma, biotechnology and animal health.   

Underpinning Naomi’s legal work is a deep understanding of pharma/biopharma industries, resulting from 25+ years' experience, including as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm and as the Founding Principal of Pearce IP.

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 assists 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.   

Authorities raid Como Compounding Pharmacy in Melbourne and Seize Semaglutide

The Australian Financial Review reported that on 1 March 2024 TGA investigators raided Como Compounding Pharmacy in Melbourne and seized ‘off-brand’ Ozempic® (semaglutide) and other allegedly unlawfully made medications.  As reportedly revealed in a confidential TGA letter obtained by Australia’s national broadcaster, ABC, the TGA plans to ban the sale of pharmacy-made versions of Ozempic® due to serious safety concerns.  

The raid resulted in the seizure of compounded semaglutide, peptides, and human growth hormones.  

Ozempic® is manufactured by the Danish drug giant Novo Nordisk.  While it is primarily a diabetes medication, Ozempic® has gained popularity as a weight loss drug.  

The Financial Review reports that originator Novo Nordisk supports the ban, citing safety concerns and the need to halt pharmacy-made versions of its global blockbuster semaglutide product Ozempic®.   

This news follows the release on 31 January 2024 by Novo Nordisk of its 2023 Annual Report, where it presented a global increase in sales by 31% to DKK 232.3B in 2023, representing an increase in its operating profit by 37%. 

First Biosimilar Launch: JAMP Pharma Launches Alvotech-Developed Jamteki™ (ustekinumab) in Canada

On 1 March 2024, JAMP Pharma announced that it launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada.  Jamteki was approved by Health Canada in November 2023 and JAMP’s launch follows a settlement between Alvotech and J&J last month regarding ustekinumab. 

Jamteki was developed by Alvotech and is JAMP Pharma’s second biosimilar launch in Canada in two years, following the Canadian launch of Simlandi® (adalimumab) biosimilar of AbbVie’s Humira® (adalimumab) in 2022.  The approved presentations for Jamteki™ are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

The Next Chapter in the Carpark Patent Saga: The Full Court’s Decision on Infringement and Best Method

Date:

Court:

Judge:

9 February 2024

Full Federal Court of Australia

Burley, Jackson and Downes JJ

SARB partially successful in carpark overstay patent appeal

The Federal Court’s second patent decision of 2024 is a unanimous decision of the Full Federal Court relating to one of several long-running patent disputes in the field of carpark overstay detection.   In March 2023, Justice Besanko upheld the validity of two patents owned by Vehicle Monitoring Systems Pty Ltd (VMS), both entitled ‘Method, apparatus and system for parking overstay detection’.  His Honour also held that three versions of a vehicle detection and sensor system known as ‘PinForce’ sold by SARB Management Group Pty Ltd were infringing, with the first two versions infringing claims of both patents and the third version infringing only claims of one of the patents.  We reported Justice Besanko’s decision in an earlier blog.

Construction and infringement

SARB’s appeal to the Full Federal Court on infringement was confined to the finding regarding PinForce version 3 in respect of the one patent held to have been infringed by this version. Key to Justice Besanko’s infringement finding was the  construction of claim features directed to the step of determining whether a vehicle has overstayed, and particularly whether this determination is  carried out by the wireless ‘data collection apparatus’ (DCA) rather than solely by the ‘detection apparatus’ (DA) located beneath the carpark space.  Before Justice Besanko, all experts agreed that in the case of PinForce Version 3, all capability of determining overstay in the DA had been removed following a redesign.  The Full Court overturned  Justice Besanko’s decision finding that the claims should be construed to encompass a system where vehicle detection is determined only by the DA (not the DCA).  The effect of this change in construction was that the PinForce version 3 system fell outside the patent claims.

Best method

SARB also appealed the primary judge’s decision on validity, specifically his finding that SARB failed to establish that the two patents were invalid on the ground of best method.  Before Justice Besanko, SARB had  argued that the patent did not include the best method known to the patentee  of communicating data from the subterraneous DA using a functioning wake-up scheme because the patent did not describe the use in this scheme of a specific transceiver (the ASTRX2 transceiver), even though it was known to the inventor to have advantages which made it the best transceiver for communicating data from the subterraneous detection apparatus.   The Full Court, however, agreed with Justice Besanko that the invention disclosed in the two patents related to the wake-up scheme and not the wake-up scheme as carried out by a transceiver with particular features.   In reaching this conclusion, the Full Court emphasised the significance of the embodiments in the specification in identifying the invention, whereas SARB had focussed on the consistory clauses to the challenged claims.  The Court held the disclosure was adequate because the parameters of the wake-up scheme were clearly disclosed in the specification, and there was no evidence that transceivers other than the ASTRX2 could not meet these parameters.

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

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 across a wide range of industries, including the pharmaceutical/biopharmaceutical, biotechnology, medical device, life sciences, agricultural, manufacturing and tech sectors.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer, Patent & Trade Mark Attorney

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is market leading in the field of pharma/biopharma, biotechnology and animal health.   

Underpinning Naomi’s legal work is a deep understanding of pharma/biopharma industries, resulting from 25+ years' experience, including as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm and as the Founding Principal of Pearce IP.

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.

Biocon and J&J Ustekinumab Settlement, and Biocon’s US Launch Planned for Feb 2025

On 29 February 2024, Biocon Biologics Ltd, announced a settlement with J&J and Janssen, under which it can launch its Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in the USA from February 2025.  The FDA previously accepted for review Biocon’s Biologics License Application for Bmab 1200. 

The settlement will result in the termination of the pending Inter Partes Review petition filed by Biocon in November 2023 against Janssen’s US method of treatment (severely active ulcerative colitis (UC)) patent 10,961,307 relating to Stelara® (ustekinumab). 

J&J and Janssen recently entered into ustekinumab settlements with Alvotech (launch dates of no later than 21 February 2025 (US), May 2024 (Japan), late July 2024 (EU) and Q1 2024 (Canada)), BioPharma (US launch date of 15 May 2025), Samsung Bioepis (US launch date from 22 February 2025), Celltrion (US launch date of 7 March 2025), Fresenius Kabi and Formycon (US launch date no later than 15 April 2025), and Amgen (US launch date no later than 1 January 2025).  To date, only Amgen has obtained FDA approval for its ustekinumab biosimilar, with its Wezlana® approved in October 2023. 

Amgen High Concentration PFS Xgeva® (denosumab) Approved by UK MHRA in 30 Days under New International Recognition Procedure

On 29 February 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for Xgeva® (denosumab) as a 120mg solution for injection in a prefilled syringe.  This Xgeva PFS product is a high concentration product which is a line extension of the original Xgeva® sold as a vial product containing 120mg solution for injection. 

This is the first product to be authorised by the MHRA via the new International Recognition Procedure (IRP) introduced in January this year.    

The IRP allows the MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and/or the United States.  In fast-tracking the authorisation of the new Xgeva® high concentration formulation, the MHRA considered a positive opinion issued by the European Medicines Agency on 25 January 2024. 

Celltrion files Korean Application for CT-P47, Tocilizumab Biosimilar

On 28 February 2024, Celltrion announced that it filed an application with MFDS for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab).  The application seeks registration across the full Actemra® label and is based on Phase 3 results confirming equivalence of CT-P47 to Actemra®.  Celltrion announced that it will use these results to accelerate applications for product approvals in other countries. 

This follows Celltrion’s announcement on 13 February 2024 that it submitted a Marketing Authorisation Application to the EMA for CT-P47.  On 28 January 2024, Celltrion also announced it had submitted a BLA in the US for CT-P47.  

Celltrion’s Zymfentra® (SC infliximab) launched in US

On 28 February 2024, Celltrion announced that its first batch of Zymfentra® (SC infliximab) arrived in Atlanta, with three more shipments expected to arrive by early March this year.  Zymfentra® was approved by the FDA in October 2023. 

Zymfentra® (SC infliximab), also known as Remsima SC in Europe, is the world’s first subcutaneous injection of infliximab.  Zymfentra® can be self-administered increasing patient convivence and reducing hospital burden.  Celltrion aims to distribute Zymfentra® to US wholesalers by mid-March.  

Zymfentra® was approved by the FDA in October 2023. 

Stuck in the Mud: 4WD storage system patent valid but not infringed

Date:

Court:

Judge:

24 January 2024

Federal Court

Downes J

In the first Federal Court patent decision handed down in 2024, MSA 4×4 Accessories Pty Ltd failed to establish infringement by Clearview Towing Mirrors Pty Ltd of MSA’s patent to a mountable storage device, commonly used in off-road and trade vehicles.  The blow was compounded by the Court upholding Clearview’s claim of unjustified threats of infringement under s 128 of the Patents Act 1990 (Cth) and contravention of s 18 of the Australian Consumer Law (ACL) regarding external communications by or on behalf of MSA.  Although moot given the finding of non-infringement, the Court rejected Clearview’s validity challenge.  Significantly, the Court rejected or gave no weight to key parts of Clearview’s expert evidence on obviousness, pointing to significant deficiencies in its preparation.

MSA, as exclusive licensee, and the patentee (a director of MSA), asserted infringement by Clearview of Australian patent AU2009245888 (Patent).  The Patent is directed to a slide-out apparatus for holding and storing items in vehicles, marketed under the name MSA4X4 DropSlide™.  Clearview’s “Easy Slide” product, designed for the same purpose, was at the centre of the infringement dispute.

Unjustified threats

The Court’s finding of non-infringement was not automatically determinative of the unjustified threats counterclaim.   These counterclaims related to two announcements sent by MSA to customers and potential customers, while a further unjustified threats claim related to a letter from the lawyers for MSA and the patentee.  Despite acknowledging that the Court has typically found infringement threats to be unjustified where a patent is held not infringed, Justice Downes held that this will not always be the case.

While differing in tone, all the communications referred to the potential for Clearview to bring infringement proceedings.  However, both the first announcement and the lawyer’s letter specifically referred to the Clearview Easy Slide product infringing the Patent, while the second announcement did not specifically refer to the Clearview product.  This appeared to be key to the Court’s finding that the former constituted a threat of infringement while the latter did not, although the ‘strident’ tone of the first announcement was also a factor.

Having made this finding, the Court then found that MSA and the patentee had failed to discharge their onus to demonstrate why these threats were not unjustified in light of the non-infringement finding.  The ACL claim followed the finding on unjustified threats.

The obviousness case and expert evidence

Clearview’s invalidity case ultimately failed.  While moot given the non-infringement finding, her Honour’s judgment on invalidity is a salient reminder of the expectations of Australian courts when it comes to the preparation of expert evidence.

Justice Downes excluded some expert evidence led by Clearview on obviousness because the expert had been provided with the Patent before giving his evidence on his knowledge and experience as at the Patent’s priority date.  Her Honour accepted that it is not a blanket rule that expert evidence should always be excluded when the expert had reviewed the patent in suit prior to giving evidence on the issue of obviousness. However, in this case there was no evidence that Clearview’s lawyers had instructed him on what it meant for an invention to be “obvious” as that term is understood in patent litigation. There was also insufficient evidence to demonstrate what the expert understood “obvious” to mean when he expressed his opinions. Her Honour therefore determined not to admit key paragraphs of the expert’s first affidavit into evidence.

Justice Downes also gave no weight to the expert’s evidence as to the approach he would have taken to a hypothetical ‘design task’ because the design task parameters provided to the expert included parameters which did not form part of the common general knowledge at the priority date.  Her Honour further held that the framing of the design task infected the expert’s evidence on obviousness as it impermissibly enlarged the “body of knowledge and information” against which inventive step was to be tested, which was contrary to principle, and infected the expert’s evidence.

Finally, Justice Downes identified significant shortcomings in Clearview’s evidence as to whether one of the prior art documents would have been “ascertained, understood, [and] regarded as relevant” at the priority date, as required by the Patents Act 1990 (Cth) in its pre-Raising the Bar form.  In particular, her Honour was not persuaded that the expert would have searched Google Patents which became available only a year before the priority date. Nor was her Honour persuaded that the expert would have used the search terms set out in his affidavit evidence, given the choice of search terms was likely impermissibly influenced by exposure to the Patent and the design task parameters (which included parameters that did not form part of the common general knowledge as at the priority date).

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

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 across a wide range of industries, including the pharmaceutical/biopharmaceutical, biotechnology, medical device, life sciences, agricultural, manufacturing and tech sectors.

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer, Patent & Trade Mark Attorney

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is market leading in the field of pharma/biopharma, biotechnology and animal health.   

Underpinning Naomi’s legal work is a deep understanding of pharma/biopharma industries, resulting from 25+ years' experience, including as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm and as the Founding Principal of Pearce IP.

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.

Akeso Announces Phase 2 Clinical Study Results for Cadonilimab

On 27 February 2024, Akeso announced results of a Phase II clinical trial for cadonilimab combined with standard treatment (chemotherapy +/- bevacizumab) for treating recurrent/metastatic cervical cancer The results were published in the American Association for Cancer Research’s Clinical Cancer Research journal and, amongst other things, the results showed that 63.6% of patients experienced tumour reduction of more than 50%. 

FDA Grants Priority Review of AbbVie’s sBLA for EPKINLY® (epcoritamab SC)

On 27 February 2024, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted priority review of its supplemental Biologics License Application for EPKINLY® (epcoritamab) for the treatment of Adult Relapsed or Refractory Follicular Lymphoma (R/R FL).  Priority review will decrease the review time to six months, compared to a standard 10 months.  If approved by the FDA, EPKINLY® will be the first and only subcutaneous bispecific antibody to treat adults with R/R FL after two lines of prior therapy. 

On 25 September 2023, AbbVie announced that its Tepkinly® (epcoritamab) received conditional marketing authorisation to Treat R/R DLBCL from the European Commission. 

BeiGene’s BLA for TEVIMBRA® (tislelizumab) Accepted by FDA for Treatment of First-Line Gastric or Gastroesophageal Junction Cancers

On 27 February 2024, BeiGene, announced that the U.S. Food and Drug Administration (FDA) accepted BeiGene’s Biologics License Application (BLA) for TEVIMBRA® (tislelizumab), in combination with fluoropyrimidine-and platinum-containing chemotherapy, with a PDUFA date set for December 2024.  The product is intended to offer improved treatment options for patients diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.  

On 19 September 2023, BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a termination of the previous arrangement between the parties.  Furthermore, BeiGene announced on 26 February 2024, that CHMP issued a positive opinion for its TEVIMBRA® (tislelizumab) to treat NSLC. 

CHMP Recommends AZ’s Voydeya® (danicopan) with Ravulizumab or Eculizumab

On 26 February 2024, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the use of Voydeya® (danicopan) as an add-on to ravulizumaboreculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia.   

CHMP based its positive opinion on results from the ALPHA Phase III trial which were published in The Lancet Haematology journal on 27 November 2023.  

CHMP Issues Positive Opinion for BeiGene’s TEVIMBRA® (tislelizumab) for NSCLC

On 26 February 2024, BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of TEVIMBRA® (tislelizumab) for the treatment of non-small cell lung cancer (NSCLC). The indications include treatment of squamous, non-squamous and locally advanced / metastatic NSCLC. BeiGene’s Phase 3 clinical trials, enrolling 1,500 patients, showed tislelizumab to be an effective therapy for patients with treatment-naive and treatment-resistant NSCLC. 

On 19 September 2023, BeiGene announced it regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following termination of the previous arrangement between the parties. 

Pearce IP BioBlast w/e 23 Feb 2024

On 23 February 2024, Samsung Bioepis presented two new study results for ustekinumab SB17 (biosimilar to Janssen’s Stelara®) at the 19th Congress of European Crohn’s and Colitis Organisation (ECCO) in Stockholm, Sweden.  The results demonstrate SB17 is highly similar to Stelara® in structural, physicochemical, and biological attributes.  On 25 February 2024, CHMP provided a positive recommendation for SB17.   

The medicine will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreement  entered in September 2023 

Alvotech and Teva Pharmaceuticals announced that FDA approved SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to Humira®.  SIMLANDI® is the first high concentration adalimumab product to be US approved. It is approved for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, and adult ankylosing spondylitis.  AVT02 is already approved in CAAUEG, EC and Saudi 

On 23 February 2024, the Australian quoted Eli Lilly’s CEO David Ricks as stating that its Alzheimer’s drug donanemab is expected to receive US approval “any day” with approval elsewhere to follow later this year.  This news comes after Phase 3 clinical trial results for donanemab, presented at the Alzheimer’s Association International Conference in July 2023, showed that the drug significantly slowed cognitive and functional decline for amyloid-positive early symptomatic Alzheimer’s disease patients. 

On 23 February 2024, Regeneron and Sanofi announced that the FDA has accepted to priority review their Dupixent®’s supplemental biologics license application (sBLA) for a 6th indication of uncontrolled chronic obstructive pulmonary disease (COPD) in adults. The target action date for the FDA decision is 27 June 2024.  Priority review was granted following positive results from two phase 3 trials. Notably, if approved, Dupixent® would be the first new treatment for COPD in over a decade and the only biologic for this disease. 

AstraZeneca announced the successful acquisition of Gracell Biotechnologies, a global clinical-stage biopharmaceutical company specialising in cell therapies for cancer and autoimmune diseases. Gracell’s portfolio notably includes GC012F a clinical stage chimeric antigen receptor T-cell therapy, which is potential new treatment for multiple myeloma, autoimmune diseases and haematologic malignancies. The total transaction is valued at $1.2B USD Previously on 12 December 2020, AstraZeneca announced its acquisition of Alexion.  

On 22 February 2024, EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Samsung Bioepis’s Pyzchiva® (ustekinumab biosimilar).  Pyzchiva® is recommended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease in adults.  Pyzchiva® is intended to be supplied as 45 mg and 90 mg solutions for injection and a 130 mg solution for infusion.  

Pyzchiva® will be commercialised by Sandoz pursuant to a deal entered into in September 2023, between Sandoz and Samsung Bioepis for SB17 which covers the US, Canada, EEA, Switzerland and the UK. 

On 21 February 2023, Polpharma Biologics announced that PB016 (vedolizumab) demonstrated topline pharmacokinetic (PK) and pharmacodynamic (PD) results in comparison to Entyvio® (vedolizumab).  The results came from a double blinded, randomised, single dose study which assessed PB016’s PK/PD and immunogenicity in 120 subjects, and demonstrated that PB016 has comparable PK/PD and immunogenicity to Entyvio®. 

Samsung Bioepis announced that it has commenced a Ph 1 clinical trial for SB27, biosimilar to Merck’s Keytruda® (pembrolizumab).  The study will compare the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 with EU and US-sourced Keytruda®, in patients with stage II-IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy.  This announcement follows the report on 15 November 2023 that Samsung Bioepis had received approval from the Ministry of Food and Drug Safety for a Ph I clinical trial of SB27. 

Each of FormyconXbrane and Celltrion announced (on 19 September 2022, 13 December 2021 and 14 February 2018 respectively) that they have pembrolizumab biosimilars in development. A pembrolizumab biosimilar (BCD-201) is currently the subject of clinical trials commenced by Biocad in July 2022. Sandoz is expecting to commence pembrolizumab biosimilar clinical trials in 2024  

On 21 February 2024, Regeneron announced that the FDA has accepted for priority review its BLA for Linvoseltamab for relapsed / refractory multiple myeloma.  The target action date is set for 22 August 2024.  Priority review was granted following data from a combined Ph 1 | 2 clinical trial (LINKER-MM1). 

Earlier in February 2024, the European Medicines Agency accepted for review the marketing authorisation application of linovoseltamab for the same indication.  

 

On 20 February 2024, BMS announced that FDA has accepted, for priority review, its supplemental new drug application (sNDA) for KRAZATI® (adagrasib) in combination with cetuximab for treating patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer FDA has assigned 21 June 2024 as the Prescription Drug User Fee Act (PDUFA) goal date. 

On 20 February 2024, FDA approved J&J ‘s supplemental biologics license application to use TECVAYLI® (teclistamab) with a reduced dosing frequency for cancer patients This approval increases dosing flexibility in patients on a weight-based dosing regimen TECVAYLI® was originally approved by the FDA in October 2022 for the treatment of adult patients with RRMM who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. 

On 20 February 2024, Sandoz announced that Health Canada approved Jubbonti® (denosumab) biosimilar to Amgen’s Prolia®, for all Prolia® indications.  Jubbonti® is the first and only Health Canada-approved denosumab biosimilar for osteoporosis and increasing bone mass.   

In February 2023 and May 2023 respectively applications for Sandoz’s denosumab biosimilar were accepted by the FDA and EMA.  

In March 2023, Mabwell (Shanghai) Bioscience announced that it received Chinese marketing approval for its Mailishu® (denosumab) and it was reported in December 2023 that Celltrion applied to the FDA for marketing authorisation for its Prolia® biosimilar (CT-P41).  Other companies have Prolia® biosimilars under development including Samsung BioepisAlvotechIntas,and Shanghai Henlius Biotech. 

Health Canada announced that Celltrion’s Remsima™ SC (SC infliximab) has been approved for maintenance therapy in adults with moderate to severe active ulcerative colitis and Crohn’s disease.  Remsima™ SC was previously approved by Health Canada for RA on 28 January 2021.  

This follows Celltrion’s success in January 2024 in securing the Norwegian government tender for the supply of Remsima SC until 2026.  

On 19 February 2024, AstraZeneca and Daiichi Sankyo announced that FDA has accepted its biologics license application (BLA) for the use of datopotamab deruxtecan in treating adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy FDA has decided the fourth quarter of 2024 as the Prescription Drug User Fee Act date The application was approved based on the Phase III results of study TROPION-Lung01 which showed that datopotamab deruxtecan significantly improved progression-free survival (PFS) in comparison to docetaxel (the current standard of care).

On 19 February 2024, the Korea Biomedical Review published that Celltrion secured a series of tenders to supply biosimilars in Peru including relating to Herzuma® (trastuzumab biosimilar) Truxima® (rituximab biosimilar) and Yulfyma® (adalimumab).  These contracts effectively secure more than 50% of the Peruvian rituximab and trastuzumab markets, and an estimated 20% of the Peruvian adalimumab market. 

Naomi Pearce

Naomi Pearce

CEO, Executive Lawyer, Patent & Trade Mark Attorney

Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners.  Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is market leading in the field of pharma/biopharma, biotechnology and animal health.   

Underpinning Naomi’s legal work is a deep understanding of pharma/biopharma industries, resulting from 25+ years' experience, including as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm and as the Founding Principal of Pearce IP.

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 assists 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: First Aflibercept Biosimilar Approved in Korea, as Samsung Bioepis’ Afilivu® Gets the Green Light

On 26 February 2024, Daily Pharm Korea reported that Samsung Bioepis received approval from the Korean Ministry of Food and Drug Safety for Afilivu®, biosimilar to Regeneron’s Eylea® (aflibercept).  This is the first aflibercept biosimilar approved in Korea and Samsung Bioepis’ second biosimilar for ophthalmic disease, after its Lucentis® (ranibizumab) biosimilar – Amelivu® – was approved in Korea in May 2022.  Afilivu® is indicated for treatment of wAMD, RVO, DME and mCNV.   

As previously reported, Samsung Bioepis will co-market Afilivu® in Korea with Samil Pharmaceutical, together with ranibizumab biosimilar Amelivu®. 

In the US, aflibercept biosimilars are the subject of patent infringement litigation commenced by Regeneron against Samsung Bioepis, Amgen, Formycon, Celltrion and Mylan and Biocon.  In Europe, Formycon announced in December 2023 that the EMA had accepted its marketing authorisation application for its aflibercept biosimilar FYB203. Biocon has received marketing approval for its aflibercept biosimilar Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023). Formycon announced in December 2023 that the EMA had accepted its application for its aflibercept biosimilar FYB203. 

Alvotech Shares Rise Premarket After SIMLANDI® (Biosimilar to AbbVie’s Humira® (adalimumab)) Approval by FDA

On 26 February 2024, Alvotech announced the sale of 10,127,132 ordinary shares at a purchase price of USD 16.41 per share.  Alvotech’s U.S listed shares rose more than 12% to $18 in premarket trading following the announcement on 23 February 2024 that FDA approved Alvotech’s SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to AbbVie’s Humira®.  

Samsung Bioepis Presented Study Results for ustekinumab SB17, Biosimilar to Janssen’s Stelara®, at ECCO

On 23 February 2024, Samsung Bioepis presented two new study results for ustekinumab SB17 (biosimilar to Janssen’s Stelara®) at the 19th Congress of European Crohn’s and Colitis Organisation (ECCO) in Stockholm, Sweden.  The results demonstrate SB17 is highly similar to Stelara® in structural, physicochemical, and biological attributes.  On 25 February 2024, CHMP provided a positive recommendation for SB17.   

The medicine will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreemententered in September 2023 

Approval Alert: Alvotech announces US approval of First High Concentration Buffer Free Interchangeable Adalimumab Biosim

Alvotech and Teva Pharmaceuticals announced that FDA approved SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to Humira®.  SIMLANDI® is the first high concentration adalimumab product to be US approved. It is approved for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, and adult ankylosing spondylitis.  AVT02 is already approved in CA, AU, EG, EC and Saudi 

Eli Lilly’s Donanemab Nears FDA Approval Decision

On 23 February 2024, the Australian quoted Eli Lilly’s CEO David Ricks as stating that its Alzheimer’s drug donanemab is expected to receive US approval “any day” with approval elsewhere to follow later this yearThis news comes after Phase 3 clinical trial results for donanemab, presented at the Alzheimer’s Association International Conference in July 2023, showed that the drug significantly slowed cognitive and functional decline for amyloid-positive early symptomatic Alzheimer’s disease patients. 

Regeneron Announces FDA priority review of Dupixent® (Dupilumab) for the treatment of COPD with type 2 inflammation

On 23 February 2024, Regeneron and Sanofi announced that the FDA has accepted to priority review their Dupixent®’s supplemental biologics license application (sBLA) for a 6th indication of uncontrolled chronic obstructive pulmonary disease (COPD) in adults. The target action date for the FDA decision is 27 June 2024.  Priority review was granted following positive results from two phase 3 trials. Notably, if approved, Dupixent® would be the first new treatment for COPD in over a decade and the only biologic for this disease. 

New Head of Legal and Special Counsel join Pearce IP from Big Law

Pearce IP is delighted to welcome Executive Lawyer and Head of Legal Helen Macpherson, and Special Counsel Chantal Savage to its legal team.  Helen and Chantal join Pearce IP from Baker McKenzie where they were partner and special counsel respectively.     

Helen Macpherson has more than 25 years’ experience in developing and implementing successful patent litigation strategies for life sciences companies.  With her background in biochemistry/molecular genetics she has spear-headed the Australian counterpart litigation of significant global patent disputes.  Helen is well respected by her peers as one of the best and brightest minds in the industry, and is ranked in multiple leading legal/IP directories. 

Chantal Savage is an IP disputes lawyer with more than 20 years’ experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information.  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.   

Pearce IP’s founder and CEO Naomi Pearce says: 

“I am thrilled to welcome Helen and Chantal to the Pearce IP legal team.  Both Helen and Chantal are brilliant, hard working and have a 6th sense for successful legal arguments.  They were a powerful combination at Baker McKenzie and I am excited to introduce them to Pearce IP’s team and clients.   

Helen is both a safe pair of hands and a seasoned leader, and I am excited to equip and support her as she embarks on her new role as head of the Pearce IP legal team. ” 

Deputy CEO and Head of Talent Adele Chadwick says: 

‘What an honour to welcome both Helen and Chantal to Pearce IP.   The depth and breadth of their joint experience is known throughout the life sciences sector and sets our course to achieve our Mission to set the standard for excellence in the provision of legal and IP services in Australia and New Zealand.   Helen brings to our team leadership skills that will allow our team to thrive in a year that is already groundbreaking, while Chantal brings a maturity to her craft that is coveted by many and will support and inspire junior staff.’ 

Helen and Chantal are the fifth and sixth new lawyers hired this year, following the commencement of Kim Evans (formerly of Allens) as Head of Trade Marks earlier this month.  New Zealand lawyer Faran Shazhad formerly of AJ Pietras, and Australian lawyer James Downie Lawyer, formerly at the ACCC, joined Pearce IP’s Sydney team in January 2024, the same month that Wellington based seasoned US patent lawyer and prosecutor Carol Johns PhD (formerly of AJ Park) joined the firm.  Special Counsel lawyer and patent attorney Julie Ballance (also NZ based) joined Pearce IP in October 2023.  

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.