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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.

ABC Law Report Podcast features Pearce IP Founder Naomi Pearce

The perils of prioritising commercial strategies over patenting strategies

Pearce IP’s Founder Naomi Pearce discusses this topic on prime time radio with ABC Law Report Host Damian Carrick, in light of the recent decision of the Federal Court in Allied Pumps Pty Ltd v LAA Industries Pty Ltd handed down in late November last year.

As Naomi said: “The lesson for inventors is make sure you have your IP strategy leading your commercial strategy. If you do it the other way around, beware – you may well result in your own conduct resulting that you can’t get valuable protection for your invention.”

Listen to Naomi here (discussion starts at [15:18]).

Pearce IP BioBlast w/e 22 March 2024

On 22 March 2024, the first case management hearing was held before Justice Nicholas in the Federal Court of Australia, Sydney, in proceedings commenced by Samsung Bioepis for revocation of at least two Janssen patents regarding the use of ustekinumab for the treatment of ulcerative colitis.  Samsung Bioepis informed the Court that it has applied for regulatory approval of its biosimilar referencing Stelara® and is expecting PBS (reimbursement) approval in July/August 2025.   The Court has provisionally scheduled a trial for 18 – 22 November 2024.

On 22 March 2024 Novo Nordisk announced that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Awiqli® (once-weekly basal insulin icodec) to treat diabetes in adults.

Once-weekly Awiqli® dosing demonstrated superior blood sugar reduction and time spent within the recommended blood sugar range compared to daily basal insulin in type 2 diabetes patients. For those not previously treated with insulin, rates of clinically significant or severe hypoglycemia were low. In type 1 diabetes patients, Awiqli® was non-inferior in reducing HbA1c but showed a higher rate of severe or clinically significant hypoglycemia compared to insulin degludec. The drug appeared safe and well-tolerated across the program.

Novo Nordisk anticipates final marketing authorisation from the European Commission in the coming months.

This news comes soon after Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events.

This news also follows on the 5 February 2024 announcement by Novo Holdings (Novo Nordisk’s parent company) that it will acquire global contract development and manufacturing company Catalent for USD $16.5B.

On 22 March 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency published the results of its March 2024 meeting.  CHMP adopted a positive opinion for the following Sandoz and Celltrion biosimilars:

Other positive opinions adopted by CHMP include:

An indication extension was recommended for UCB’s previously EU-approved Bimzelx® (bimekizumab) for the treatment of hidradenitis suppurativa.

On 22 March 2024, Korea Biomedical Review reported Geo-Young, South Korea’s largest pharmaceutical distributor,  signing a third-party logistics (3PL) contract with Samsung Bioepis for the distribution of biosimilar medicines within South Korea. This is the first business agreement between the two companies in which Geo-Young will carry out the entire distribution process from warehousing to storage and shipping.  Geo-Young will distribute Samsung Bioepis biosimilar products to general hospitals nationwide.

On 20 March, 2024, BMS announced that its CAR-T cell immunotherapy Abecma ®(idecabtagene vicleucel) was granted an extension of its therapeutic indication, now being approved for treatment of relapsed and refractory multiple myeloma (R/R MM) in patients undergoing their third line of treatment (the indication was previously limited to fourth line treatment). The approval of the amended indication by European Commission follows an earlier positive recommendation from the EMA – Committee for Medicinal Products for Human Use (CHMP). The approval positions Abecma® as the first CAR-T cell therapy approved in the European Union for adult patients with R/R MM undergoing their third line of treatment.

On 20 March 2024, Alvotech announced its full year financial results for 2023, highlighting increased product revenue and Alvotech’s acceptance of an offer from a group of investors for the sale of approximately 10 million ordinary shares in an Alvotech subsidiary for an approximate gross value of US$166 million, the net proceeds to be used for working capital.  (Alvotech subsequently announced on 22 March 2024 the issue of 13,000,000 new ordinary shares to that subsidiary).

The announcement also noted recent pipeline highlights including US approval of AVT02 (marketed as Simlandi®), biosimilar to Humira® (adalimumab), addressing an earlier CRL for the Reykjavik facility, approval of AVT04, biosimilar to Stelara® (ustekinumab) in Canada and Europe, and positive top-line results from studies on AVT05, biosimilar to Simponi® and Simponi Aria® (golimumab), AVT06, biosimilar to Eyelea® (aflibercept) and AVT03, biosimilar to Prolia® and Xgeva® (denosumab).  On the associated webcast Alvotech responded to a question by noting it is preparing for potential manufacturing/product changes to Keytruda®, reference product for AVT33 (pembrolizumab).

On 20 March 2024, China Daily reported that Novo Nordisk has announced investing USD 560 million in its Chinese facility (in Tianjin which was first opened in 1994) as part of its expansion project to further increase manufacturing capability to support the localization of more innovative medicines. The project also encompasses the development of a state-of-the-art filling facility equipped with isolator technology. Novo Nordisk has already started development and the expansion is estimated to be completed in 2027.

On 20 March 2024, Lonza announced it has entered an agreement to acquire Genentech’s large-scale biologics manufacturing site in Vacaville, California (US) from Roche for US$1.2 Billion.

The facility has a total capacity of around 330,000 liters which is reported to be one of the largest biologics manufacturing sites in the world by volume.

Under the agreement, approximately 750 of Genentech’s employees at the facility will be offered employment by Lonza. Lonza plans to invest approximately US$556 million to upgrade the facility and enhance its capabilities for commercial contract manufacturing.

On 19 March 2024, Dr. Reddy’s announced the launch of its Versavo® (bevacizumab) in the UK. Versavo® is a biosimilar to Genentech’s Avastin®(bevacizumab) and is indicated for the treatment of several types of cancers, including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer.   Versavo® is Dr. Reddy’s first biosimilar product to be approved and launched in the UK and is supplied in 100mg and 400mg single use vials.

Versavo® was launched in India just under 5 years earlier, in August 2019.   The first bevacizumab biosimilar was approved in the UK in January 2018  resulting in Dr Reddy’s launching its biosimilar more than 6 years after the first approved biosimilar.

On 18 March 2024 Fresenius Kabi and Formycon announced they reached a settlement with Johnson & Johnson regarding the commercialisation of FYB202, biosimilar to J&J’s Stelara® (ustekinumab) in Europe and Canada.  The announcements did not disclose the permitted launch dates for FYB202 in those regions.

In August 2023 the companies announced they had reached a settlement in the US with Johnson & Johnson for FYB202, enabling US launch “no later than 15 April 2025”.

On 18 March 2024, Bio-Thera Solutions announced that it is partnering with SteinCares to commercialise two unnamed biosimilars in LATAM.  SteinCares will have exclusive right to distribute and market Bio-Thera’s two biosimilar pharmaceuticals in LATAM and Bio-Thera is responsible for and regulatory filing with FDA and EMA that will support regulatory filings in the LATAM region.  Bio-Thera is responsible for commercial supply out of its manufacturing facilities in Guangzhou, China.

On 17 March 2024, Celltrion USA launched ZYMFENTRA™ (infliximab-dyyb), the first subcutaneous formulation of infliximab approved by the U.S. FDA in 2023.  Zymfentra is approved for maintenance therapy in adults with active ulcerative colitis or Crohn’s disease following an induction treatment regimen with an intravenous infliximab product.


Celltrion emphasised that the sub-cutaneous administration method offers patients greater flexibility in managing their disease. According to Celltrion, ZYMFENTRA™ is patent protected until 2037 for the formulation and 2040 for the method of treatment.

On 13 March 2024, Sandoz reported double-digit growth of 15% in its 2023 biosimilar sales.  Sandoz attributed this growth to the launch of Hyrimoz®(biosimilar to AbbVie’s Humira®,adalimumab)  in the US and entering an agreement to commercialise Samsung Bioepis’ SB17 (biosimilar to Janssen Biotech’s Stelara®) in the US, Canada, EEA, Switzerland, and UK.

In March 2024, Sandoz announced completion of its acquisition of Coherus Biosciences’ Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), for US$170M.

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Faran Shahzad

Faran Shahzad

Foreign Qualified Lawyer (NZ)

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

Samsung Bioepis Seeks to Revoke Janssen’s Stelara® (ustekinumab) Patents in Australian Court

On 22 March 2024, the first case management hearing was held before Justice Nicholas in the Federal Court of Australia, Sydney, in proceedings commenced by Samsung Bioepis for revocation of at least two Janssen patents regarding the use of ustekinumab for the treatment of ulcerative colitis.  Samsung Bioepis informed the Court that it has applied for regulatory approval of its biosimilar referencing Stelara® and is expecting PBS (reimbursement) approval in July/August 2025.   The Court has provisionally scheduled a trial for 18 – 22 November 2024.

Novo Nordisk’s Awiqli® (insulin) Recommended for EU Approval

On 22 March 2024 Novo Nordisk announced that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Awiqli® (once-weekly basal insulin icodec) to treat diabetes in adults.

Once-weekly Awiqli® dosing demonstrated superior blood sugar reduction and time spent within the recommended blood sugar range compared to daily basal insulin in type 2 diabetes patients. For those not previously treated with insulin, rates of clinically significant or severe hypoglycemia were low. In type 1 diabetes patients, Awiqli® was non-inferior in reducing HbA1c but showed a higher rate of severe or clinically significant hypoglycemia compared to insulin degludec. The drug appeared safe and well-tolerated across the program.

Novo Nordisk anticipates final marketing authorisation from the European Commission in the coming months.

This news comes soon after Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events.

This news also follows on the 5 February 2024 announcement by Novo Holdings (Novo Nordisk’s parent company) that it will acquire global contract development and manufacturing company Catalent for USD $16.5B.

CHMP Positive Opinion for Sandoz’s Denosumab and Celltrion’s Omalizumab Biosimilars

On 22 March 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency published the results of its March 2024 meeting.  CHMP adopted a positive opinion for the following Sandoz and Celltrion biosimilars:

Other positive opinions adopted by CHMP include:

An indication extension was recommended for UCB’s previously EU-approved Bimzelx® (bimekizumab) for the treatment of hidradenitis suppurativa.

Samsung Bioepis Enters Collaboration Agreement with Geo-Young For Biosimilar Distribution

On 22 March 2024, Korea Biomedical Review reported Geo-Young, South Korea’s largest pharmaceutical distributor,  signing a third-party logistics (3PL) contract with Samsung Bioepis for the distribution of biosimilar medicines within South Korea. This is the first business agreement between the two companies in which Geo-Young will carry out the entire distribution process from warehousing to storage and shipping.  Geo-Young will distribute Samsung Bioepis biosimilar products to general hospitals nationwide.

MMD unsuccessful again on appeal in infringement case against Camco

 

Date:

Court:

Judge:

 

19 March 2024

Federal Court

Yates, Burley and Jackman JJ

MMD has been unsuccessful in its appeal of a decision of a primary judge of the Federal Court which held MMD’s patent valid but not infringed.

MMD’s patent AU2004289510 (MMD’s Patent) is directed to a tooth construction used in a mineral breaker for crushing mineral ore into smaller parts.  Camco initially provided repair services for these tooth constructions under contract with MMD, and then continued offering these repairs directly to MMD’s customers after the contract ended.

MMD brought proceedings alleging that Camco’s unauthorised repair services infringed MMD’s Patent, and that Camco contravened s 18 of the Australian Consumer Law by not informing customers about the existence of the patent.

Camco cross-claimed for revocation and also argued that the repair services were permissible under the exhaustion doctrine.  The exhaustion doctrine, as recognised under Australian law, provides that a patentee’s rights (other than the right of manufacture) are exhausted after the first authorised sale of the patented product anywhere in the world.  As a result, under Australian law, it is permissible for repairs to be made to a patented product after it is sold.

The primary judge found MMD’s Patent to be valid but not infringed, the non-infringement finding resulting from her claim construction.  However, the primary judge stated that, had infringement occurred, Camco would not have been able to rely on the repair defence as Camco’s activities amounted to a remaking (i.e. manufacture) of the invention.  We reported on that 2023 decision here.

The focus of the appeal was on whether the primary judge fell into error in her claim construction. The Full Federal Court upheld the primary judge’s construction, and therefore the finding of non-infringement.  In so doing, the Full Court emphasised the well-known principles of patent construction including the need to adopt a common-sense construction of the patent claims and that, if a claim is clear, it is not to be made obscure simply because obscurities can be found in particular sentences in other parts of the patent.  Consequently, MMD’s appeal was dismissed and Camco’s cross-appeal was also dismissed, with no consideration needed in respect of the repair defence.

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.

Kate Legge

Kate Legge

Special Counsel, Lawyer

Kate is an experienced life sciences patent lawyer, providing IP leadership for product development and commercialisation across global markets in pharmaceuticals, biopharmaceuticals, medical technology and devices, digital health and diagnostics – from initial scoping through to post-launch. She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.

New Indication Alert: BMS’s Abecma® (idecabtagene vicleucel) Receives EU Approval For Extended Indication

On 20 March, 2024, BMS announced that its CAR-T cell immunotherapy Abecma ® (idecabtagene vicleucel) was granted an extension of its therapeutic indication, now being approved for treatment of relapsed and refractory multiple myeloma (R/R MM) in patients undergoing their third line of treatment (the indication was previously limited to fourth line treatment). The approval of the amended indication by European Commission follows an earlier positive recommendation from the EMA – Committee for Medicinal Products for Human Use (CHMP). The approval positions Abecma® as the first CAR-T cell therapy approved in the European Union for adult patients with R/R MM undergoing their third line of treatment.

Alvotech Reports Full Year Financial Results and Provides a Business Update

On 20 March 2024, Alvotech announced its full year financial results for 2023, highlighting increased product revenue and Alvotech’s acceptance of an offer from a group of investors for the sale of approximately 10 million ordinary shares in an Alvotech subsidiary for an approximate gross value of US$166 million, the net proceeds to be used for working capital.  (Alvotech subsequently announced on 22 March 2024 the issue of 13,000,000 new ordinary shares to that subsidiary).

The announcement also noted recent pipeline highlights including US approval of AVT02 (marketed as Simlandi®), biosimilar to Humira® (adalimumab), addressing an earlier CRL for the Reykjavik facility, approval of AVT04, biosimilar to Stelara® (ustekinumab) in Canada and Europe, and positive top-line results from studies on AVT05, biosimilar to Simponi® and Simponi Aria® (golimumab), AVT06, biosimilar to Eyelea® (aflibercept) and AVT03, biosimilar to Prolia® and Xgeva® (denosumab).  On the associated webcast Alvotech responded to a question by noting it is preparing for potential manufacturing/product changes to Keytruda®, reference product for AVT33 (pembrolizumab).

Novo Nordisk Announces USD 560 Million Investment in its Chinese Facility

On 20 March 2024, China Daily reported that Novo Nordisk has announced investing USD 560 million in its Chinese facility (in Tianjin which was first opened in 1994) as part of its expansion project to further increase manufacturing capability to support the localization of more innovative medicines. The project also encompasses the development of a state-of-the-art filling facility equipped with isolator technology. Novo Nordisk has already started development and the expansion is estimated to be completed in 2027.

Lonza Buys Vacaville (US) Biologics Site from Roche for $1.2 Billion to Increase Lonza’s Commercial Manufacturing Capabilities

On 20 March 2024, Lonza announced it has entered an agreement to acquire Genentech’s large-scale biologics manufacturing site in Vacaville, California (US) from Roche for US$1.2 Billion.

The facility has a total capacity of around 330,000 liters which is reported to be one of the largest biologics manufacturing sites in the world by volume.

Under the agreement, approximately 750 of Genentech’s employees at the facility will be offered employment by Lonza. Lonza plans to invest approximately US$556 million to upgrade the facility and enhance its capabilities for commercial contract manufacturing.

Dr Reddy Launches its First UK Biosimilar (bevacizumab) 5 Years After Indian Launch and 6 Years After First Bevacizumab UK Biosimilar Approval

On 19 March 2024, Dr. Reddy’s announced the launch of its Versavo® (bevacizumab) in the UK. Versavo® is a biosimilar to Genentech’s Avastin®(bevacizumab) and is indicated for the treatment of several types of cancers, including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer.   Versavo® is Dr. Reddy’s first biosimilar product to be approved and launched in the UK and is supplied in 100mg and 400mg single use vials.

Versavo® was launched in India just under 5 years earlier, in August 2019.   The first bevacizumab biosimilar was approved in the UK in January 2018  resulting in Dr Reddy’s launching its biosimilar more than 6 years after the first approved biosimilar.

Fresenius & Formycon Settle with J&J in Europe and Canada over Ustekinumab Biosimilar

On 18 March 2024 Fresenius Kabi and Formycon announced they reached a settlement with Johnson & Johnson regarding the commercialisation of FYB202, biosimilar to J&J’s Stelara® (ustekinumab) in Europe and Canada.  The announcements did not disclose the permitted launch dates for FYB202 in those regions.

In August 2023 the companies announced they had reached a settlement in the US with Johnson & Johnson for FYB202, enabling US launch “no later than 15 April 2025”.

Bio-Thera Solutions Partners with SteinCares to Market Two Biosimilars in LATAM

On 18 March 2024, Bio-Thera Solutions announced that it is partnering with SteinCares to commercialise two unnamed biosimilars in LATAM.  SteinCares will have exclusive right to distribute and market Bio-Thera’s two biosimilar pharmaceuticals in LATAM and Bio-Thera is responsible for and regulatory filing with FDA and EMA that will support regulatory filings in the LATAM region.  Bio-Thera is responsible for commercial supply out of its manufacturing facilities in Guangzhou, China.

Celltrion’s Sub-cutaneous Zymfentra™ (infliximab-dyyb) US Launched

On 17 March 2024, Celltrion USA launched ZYMFENTRA™ (infliximab-dyyb), the first subcutaneous formulation of infliximab approved by the U.S. FDA in 2023.  Zymfentra is approved for maintenance therapy in adults with active ulcerative colitis or Crohn’s disease following an induction treatment regimen with an intravenous infliximab product.


Celltrion emphasised that the sub-cutaneous administration method offers patients greater flexibility in managing their disease. According to Celltrion, ZYMFENTRA™ is patent protected until 2037 for the formulation and 2040 for the method of treatment.

Pearce IP BioBlast w/e 15 March 2024

On 15 March 2024, the Australian Department of Health and Aged Care published the public summary documents considered at the November 2023 PBAC meeting. Decisions included:

On 15 March 2024, CuraTeQ Biologics (a subsidiary of Aurobindo) announced that it successfully completed phase I trials for omalizumab biosimilar (BP11), demonstrating pharmacokinetic and pharmacodynamic equivalence to Genentech’s/Novartis’ US and EU-sourced Xolair®.  The trials were conducted on 165 healthy adults in Australia and New Zealand.

CuraTeQ commenced Phase III trials of BP11 in Europe for the treatment of chronic spontaneous or idiopathic urticariaand in India for the treatment of asthma patients.  CuraTeQ expects to seek regulatory approval of BP11 in India in 2024 and in regulated markets in 2025.

Each of Celltrion, Glenmark, Teva, Synermore, Sorrento and Kashiv Biosciences also has omalizumab biosimilars in development.  Celltrion submitted an A-BLA in the US  earlier this week, and applications for approval in Europe in April 2023, Canada in December 2023 and Korea in June 2023.

Celltrion announced that it has submitted an abbreviated Biologics License Application (A-BLA) in the US for approval of CT-P39, as interchangeable biosimilar to Genentech’s Xolair® (omalizumab).  Celltrion’s application seeks approval for all Xolair® indications, as well as interchangeability status.

Celltrion submitted applications for CT-P39 in Europe in April 2023, Canada in December 2023 and Korea in June 2023.   Celltrion’s is the first reported regulatory submission for omalizumab biosimilars in these jurisdictions.   CuraTeQ Biologics (a subsidiary of Aurobindo), Alvotech/Kashiv Biosciences, Teva, Synermore, Glenmark and Sorrento have also been reported to be developing omalizumab biosimilars.

On 11 March 2024, Formycon AG and MS Pharma announced that ranibizumab (FYB201 / Ravegza®), biosimilar to Genentech’s Lucentis®, was approved in Saudi Arabia for the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases including retinopathies secondary to diabetes.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics). Teva entered into a strategic partnership for the exclusive commercialisation of FYB201 in Canada, Europe and selected other countries in mid 2021. FYB201 has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli® by Coherus) and the EU (in August 2022, marketed as Ranivisio® by Formycon). In January 20204, Sandoz announced that it had signed an agreement to acquire Coherus’ Cimerli® for US$170M.

On 4 March 2024, Merck filed petitions for inter partes review against four Johns Hopkins University (JHU) patents relating to methods of treatment using pembrolizumab in patients whose cancers have a genetic instability called microsatellite instability-high (MSI-H).    These four IPRs are IPR2024-00622(against US10,934,356), IPR2024-00623 (against US11,325,974), IPR2024-00624 (against US11,325,975), and IPR2024-00625 (against US11,339,219).  Each IPR is based on anticipation and obviousness.  The petitions have not yet been instituted by the USPTO.

In November 2022 Merck filed a complaint in the United States District Court (District of Maryland) against JHU seeking declarations of breach of contract, non-infringement and promissory estoppel in relation to the same four patents.   The trial has not yet been scheduled.

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

Faran Shahzad

Faran Shahzad

Foreign Qualified Lawyer (NZ)

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

November 2023 PBAC Public Summary Documents Feature Biopharma

On 15 March 2024, the Australian Department of Health and Aged Care published the public summary documents considered at the November 2023 PBAC meeting. Decisions included:

CuraTeQ’s Omalizumab Biosimilar (BP11) Phase I Completion

On 15 March 2024, CuraTeQ Biologics (a subsidiary of Aurobindo) announced that it successfully completed phase I trials for omalizumab biosimilar (BP11), demonstrating pharmacokinetic and pharmacodynamic equivalence to Genentech’s/Novartis’ US and EU-sourced Xolair®.  The trials were conducted on 165 healthy adults in Australia and New Zealand.

CuraTeQ commenced Phase III trials of BP11 in Europe for the treatment of chronic spontaneous or idiopathic urticariaand in India for the treatment of asthma patients.  CuraTeQ expects to seek regulatory approval of BP11 in India in 2024 and in regulated markets in 2025.

Each of Celltrion, Glenmark, Teva, Synermore, Sorrento and Kashiv Biosciences also has omalizumab biosimilars in development.  Celltrion submitted an A-BLA in the US  earlier this week, and applications for approval in Europe in April 2023, Canada in December 2023 and Korea in June 2023.

Aristocrat down to felt in the Federal Court on remitter

 

Date:

Court:

Judge:

 

8 March 2024

Federal Court

Burley J

On 8 March 2024 Justice Burley of the Federal Court issued the latest in a series of decisions relating to the patent-eligibility of Aristocrat’s electronic gaming machines (EGMs).  Unfortunately, the decision does not resolve the legal uncertainty created by the High Court’s 2022 split decision on the issue of the patentability of computer-implemented inventions such as EGMs.

The procedural history has been labelled ‘tortuous’ – from the initial Patent Office decision in 2018 finding Aristocrat’s claimed invention was not a manner of manufacture, Justice Burley reversing that decision on appeal and finding the claims valid, the Full Federal Court reversing that decision on further appeal (specific to one of the claims only), and then the High Court’s split decision.  Ultimately, the effect of the 3:3 High Court judgment was to affirm the decision of the Full Federal Court that the claim was not a manner of manufacture.  This triggered the operation of the Full Federal Court order remitting the remaining claims to the primary judge for determination on patentability.

Justice Burley considers the correct legal approach to apply on remitter

The invention claimed is a system and method for providing ‘feature’ games on EGMs, also known as slot machines.  A feature game is a bonus or free game triggered by aligning the correct symbols on the reel, which can issue prizes to the player.  This aims to improve player engagement and enjoyment.

When the High Court delivers a split decision, section 23(2)(a) of the Judiciary Act 1903 (Cth) (Judiciary Act) provides that the decision appealed from is affirmed.  The High Court (in its decision which we reported here) was, however, critical of the ‘two-step’ test applied by the Full Court majority to conclude the claim was not to a manner of manufacture.  The two-step test asked:

  1. Is the invention claimed a computer-implemented invention?
  2. If so, can the invention claimed broadly be described as an advance in computer technology?

According to the Full Court majority, if the answer to question 2. was no, the invention was not patentable subject matter.  If the answer to question 1. was no, the Court should consider the general principles of patentability.   The Full Court majority found the invention the subject of the claim on appeal did not relate to the development of computer technology and was in substance an abstract idea, being a scheme or set of rules for playing a game which is implemented using a conventional gaming machine for its known and understood functions.

The High Court’s criticism of this two-step test raised the question of what approach Justice Burley should take when considering the remaining claims on remitter from the Full Court – in particularly, whether His Honour was required to follow the two-step test applied by the Full Court majority or whether he could be informed by the reasoning of the High Court.

Justice Burley considered the language of s23(2)(a) to be plain and the remittal order unequivocal.  This meant that he must apply the reasoning of the Full Federal Court (and not the High Court) to determine whether there is a manner of manufacture, with his starting point being that the Full Court, using the two-step approach, held that claim 1 of innovation patent number AU2016101967 was not to a manner of manufacture.

Aristocrat argued unsuccessfully that Justice Burley could draw on legal principles enunciated by the High Court.  His Honour rejected this approach because, while all six High Court judges criticised the two-step test, there was otherwise no uniform approach across the divide.  Further Justice Burley stated that, even if the High Court decision had established a principle of law, he could not consider it because the wording of s23(2)(a) and the remittal order clearly required him to apply the reasoning of the Full Federal Court as it had been affirmed.

Adopting the reasoning of the Full Federal Court, Justice Burley considered that the only available conclusion on the residual claims was that they are not a manner of manufacture.   He ultimately held the residual claims to be invalid because they were not substantially different from the claim already found invalid by the Full Federal Court.

Where does this leave us on manner of manufacture for computer-implemented inventions?

After the High Court’s split decision, we are left without a clear finding on the correct approach to the patent-eligibility of computer-implemented inventions.  Justice Burley’s decision does not resolve this uncertainty, being necessarily confined by the provisions of the Judiciary Act and the remittal order.   Given the investment in these proceedings to date, this may not, however, be the end for Aristocrat, with scope to appeal the decision on the remitted claims.

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.

Kate Legge

Kate Legge

Special Counsel, Lawyer

Kate is an experienced life sciences patent lawyer, providing IP leadership for product development and commercialisation across global markets in pharmaceuticals, biopharmaceuticals, medical technology and devices, digital health and diagnostics – from initial scoping through to post-launch. She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.

James Downie

James Downie

Laywer

James is a life sciences focussed intellectual property lawyer with a background in biotechnology. His practice addresses all legal aspects of patents, trade marks, and consumer law in Australia. With a particular focus on the biotechnology, pharmaceutical, biopharmaceutical, ag-tech and food-tech industries, James assists with patent freedom to operate clearance work, and supports Pearce IP’s attorney team with office actions. He is a contributing author of the Pearce IP BioBlast® and Pearce IP’s regular blogs.

AstraZeneca to Acquire Amolyt Pharma for $1.05B

On 14 March 2024, AstraZeneca announced that it has entered into an agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases.  Amoylt’s portfolio notably includes eneboparatide (AZP-3601) currently a phase III investigational therapeutic peptide for the hypoparathyroidism.  The deal consists of $800m upfront and then $250m contingent on achieving specified regulatory milestones.

Leading Light Series: International Women’s Day 2024 | Spotlight on Pearce IP’s Julie Ballance – Special Counsel (NZ)

As a Women Owned and led boutique IP firm, where pay parity is a given, Pearce IP celebrates International Women’s Day and the diversity, equity and inclusion of which we are proud.  With more than 70% female leaders, menstrual and menopause leave, fertility leave, miscarriage and loss leave, more than 20% part-timers, and a “work from anywhere” business model, there is much to celebrate with diversity at Pearce IP.

We take a moment now to shine the spotlight on some of our incredible female leaders in our Leading Lights series. These trailblazing women are not just leading the way in their fields, they are redefining what it means to be a leader in today’s world.

Happy International Women’s Day 2024!

Julie Ballance – Special Counsel (NZ), Patent Attorney, Lawyer & Notary

What does International Women’s Day mean to you?

International Women’s Day is a time to reflect on the opportunities open to women today, but also to note how much there is still to achieve.  My mother desperately wanted to have a career, but she did not have the opportunity.  I compare my mother’s situation as a young woman with that of my daughter – they are worlds apart, thankfully!

As a successful woman in your chosen field, what or who drove you to be successful?

I was largely driven by my own desire to do a good job for clients, and to learn as much as I could about the profession of the patent attorney.  When I joined the profession back in 1985, there was only one female partner in the firm I joined.  At the time, I thought she was a real pioneer in what was then a very male-dominated world.

What’s the best piece of advice you can give to young women who are looking to you for leadership?

“Stay strong.”  Things don’t always go to plan, and life can present many hurdles.

How do you ensure that you are a role model for women in the workplace?

By working hard and taking on whatever task is in front of me with enthusiasm.  Also, by trying to ensure everyone I deal with is treated with dignity and respect, no matter what part they play.

Why is diversity, equity and inclusion important to you?

We are all human and we all deserve to achieve the best we can.  Those of us in positions of responsibility need to provide opportunities to others wherever we can. Being mindful of diversity, equity and inclusion can help us make the world a better place for everyone.

Read more about Diversity at Pearce IP

Leading Light Series: International Women’s Day 2024 | Spotlight on Pearce IP’s Jacinta Flattery-O’Brien PhD – Special Counsel

As a Women Owned and led boutique IP firm, where pay parity is a given, Pearce IP celebrates International Women’s Day and the diversity, equity and inclusion of which we are proud.  With more than 70% female leaders, menstrual and menopause leave, fertility leave, miscarriage and loss leave, more than 20% part-timers, and a “work from anywhere” business model, there is much to celebrate with diversity at Pearce IP.

We take a moment now to shine the spotlight on some of our incredible female leaders in our Leading Lights series. These trailblazing women are not just leading the way in their fields, they are redefining what it means to be a leader in today’s world.

Happy International Women’s Day 2024!

Jacinta Flattery-O’Brien PhD – Special Counsel, Patent Attorney

What does International Women’s Day mean to you?

A day to celebrate how far women have travelled on the road to equality and to think about areas where further improvements can be made.

As a successful woman in your chosen field, what or who drove you to be successful?

“Success” has many definitions.  In the business context, I believe success is largely a product of interest, motivation and tenacity. I was interested in science, was motivated to become a patent attorney to be involved in cutting edge advances in a broad range of bio/pharma technologies and had the tenacity to work long hours when needed to exceed clients’ expectations.

What’s the best piece of advice you can give to young women who are looking to you for leadership?

Make sure you are doing something that interests you.  That will ensure work is a joy and a motivation in your life – not a chore.  Your colleagues will sense your enthusiasm and that alone provides a strong foundation for leadership.

How do you ensure that you are a role model for women in the workplace?

“First, assume value.”  This means that when a colleague tells you something, whether it be about a work product, a client or another colleague, assume in the first instance that there is value in what they are saying.  Then ask questions before making your own assessment.  When practiced by all team members this creates a collaborative work environment where women (whose ideas in other workplaces may have been unheard or dismissed) can thrive.

Why is diversity, equity and inclusion important to you?

Workplaces that feature diversity, equity and inclusion have been proven to be more successful than those that do not.  This benefits employers, employees and clients.  There are no downsides!

Read more about Diversity at Pearce IP

Leading Light Series: International Women’s Day 2024 | Spotlight on Pearce IP’s Kim Evans – Executive, Lawyer & Trade Mark Attorney

As a Women Owned and led boutique IP firm, where pay parity is a given, Pearce IP celebrates International Women’s Day and the diversity, equity and inclusion of which we are proud.  With more than 70% female leaders, menstrual and menopause leave, fertility leave, miscarriage and loss leave, more than 20% part-timers, and a “work from anywhere” business model, there is much to celebrate with diversity at Pearce IP.

We take a moment now to shine the spotlight on some of our incredible female leaders in our Leading Lights series. These trailblazing women are not just leading the way in their fields, they are redefining what it means to be a leader in today’s world.

Happy International Women’s Day 2024!

Kim Evans – Executive, Lawyer & Trade Mark Attorney

What does International Women’s Day mean to you?

IWD is important to me because it celebrates what we can do and be and can achieve as women.  It also reminds the rest of the world of these things.

As a successful woman in your chosen field, what or who drove you to be successful?

While I was growing up, I saw my mother’s inability to choose her own path in life, limited by the social values of the time, by unfair expectations from others and by other factors that weren’t necessarily in her control.  It motivated me to be strong and determined and to be the driving force in my own life, including my career.

What’s the best piece of advice you can give to young women who are looking to you for leadership?

“Believe in yourself and back yourself!! We are stronger than we know, and we shouldn’t be afraid to try something that is outside our comfort zone”.

How do you ensure that you are a role model for women in the workplace?

I know my values and what is important to me – integrity, technical excellence, fairness, respect and trust.  I value these qualities in others and strive to always embody them myself.

Why is diversity, equity and inclusion important to you?

All human beings are valuable and have value, even if they look, sound or think differently to us. In the same way that our bodies aren’t comprised solely of legs or ears or livers, as teams we need to consist of more than one type of person to function well and holistically. An emphasis on diversity, equity and inclusion in the workplace allows us to fulfill our potential and to welcome those who may not have previously had a voice.

Read more about Diversity at Pearce IP

Earnings for Sandoz Biosimilars Grow by 15% in 2023

On 13 March 2024, Sandoz reported double-digit growth of 15% in its 2023 biosimilar sales.  Sandoz attributed this growth to the launch of Hyrimoz®(biosimilar to AbbVie’s Humira®,adalimumab)  in the US and entering an agreement to commercialise Samsung Bioepis’ SB17 (biosimilar to Janssen Biotech’s Stelara®) in the US, Canada, EEA, Switzerland, and UK.

In March 2024, Sandoz announced completion of its acquisition of Coherus Biosciences’ Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), for US$170M.