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Still stuck in the mud

Date:

Body:

Adjudicator:

5 March 2024

Australian Patent Office

M. Umehara 

On 5 March 2024, the Australian Patent Office (APO) issued its decision in the opposition filed by Clearview Towing Mirrors Pty Ltd in respect of Australian patent application AU2020281026 (Opposed Application). Clearview had opposed the grant of the Opposed Application on the grounds of inventive step, novelty, sufficiency, support and clarity. The APO upheld the opposition only on the grounds of novelty (Claims 1 to 9) and inventive step (Claims 1 to 4 and 6 to 9), with claims 10 to 12 remaining.  Even though the applicant (Mr Miles) requested withdrawal of the patent application early in the opposition process, the opposition proceeded to hearing, ultimately resulting in a costs award against Mr Miles.   

The bigger picture 

This opposition isn’t the only patent dispute between the parties.  We recently reported on the Federal Court’s decision in MSA 4×4 Accessories Pty Ltd v Clearview Towing Mirrors Pty Ltd [2024] FCA 24.  Mr Miles is a director of MSA and is also the owner of the patent the subject of that dispute (which was exclusively licensed to MSA).  

Furthermore, the Opposed Application is one of seven related applications, some of which had been accepted and some of which have lapsed for failure to gain acceptance.  In February 2024, Clearview filed another opposition, this time to the grant of a divisional of the Opposed Application.  The Opposed Application itself lapsed for failure to pay the acceptance fees but was reinstated pursuant to an extension of time granted under s223 of the Patents Act 1990 (Cth). The Opposed Application then entered a state of lapse for a second time due to non-payment of the renewal fee, which was ultimately paid during the relevant grace period. 

So, at present there is a complex web of patents, applications and disputes between Clearview and MSA, all relating to the same field – storage systems typically installed in off-road vehicles.  Perhaps mindful of this broader context, the Commissioner in this opposition proceeding indicated that he would not consent to Mr Miles’ request to withdraw the Opposed Application without Mr Miles undertaking not to pursue in any further applications (whether already filed or not), the same, or substantially the same, invention as had already been opposed here.  Mr Miles did not provide the undertaking and so the hearing proceeded.   

Mr Miles filed submissions but no evidence in the opposition proceedings. It is therefore perhaps unsurprising that the opposition was successful, at least on novelty and inventive step grounds with respect to some of the claims.  Compounding this, the Commissioner awarded costs against Mr Miles.  However, the Commissioner indicated that the novelty and inventive step grounds could potentially be overcome through appropriate amendments and Mr Miles was granted a two-month window of time in which to propose suitable amendments. 

While the strategy of Mr Miles and MSA is unclear, this decision serves as a reminder that filing a patent application is not without potential downstream cost exposure, particularly in the presence of a motivated competitor, and there may be no quick way to withdraw a patent application without impacting your ability to file further patent applications to protect your invention. 

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.   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.

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.   

Leading Light Series: International Women’s Day 2024 | Spotlight on Pearce IP’s Executive Lawyer, Helen Macpherson

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!

Helen Macpherson – Executive, Lawyer (Head of Legal)

What does International Women’s Day mean to you?

It is a time to come together and take stock of what we have achieved for women – their well-being, their human rights and position in society – and to look forward to what we still need to and want to achieve for women.

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

I would say that any success I have had has been a consequence of my innate curiosity about the world, my drive to do the best that I can and my desire to work with others to help them succeed. I thank my family, particularly my parents, for encouraging and instilling these values in me.

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

You want to have a fulfilling life.  So, work out what matters to you and what drives and energises you and be led by that.

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

I simply seek to be true to my values, to act in accordance with my values and to be empathetic.  I also try to be candid and honest with people about my career journey. 

Why is diversity, equity and inclusion important to you?

Diversity, equity and inclusion are important to me because they are for the benefit of us all.  We are individually and collectively better off in a society that is diverse, equitable and inclusive.

Read more about Diversity at Pearce IP

Regeneron Appeals PTAB Invalidity Findings for Two Aflibercept Patents

On 12 March 2024, Regeneron filed notices of appeal in the United States Court of Appeals for the Federal Circuit challenging findings of the Patent Trial and Appeal Board (PTAB) that claims of two of its patents are invalid. The Regeneron patents at issue are 10,130,681 and 10,888,601  relating to methods of treatment using Eylea® (aflibercept).

As previously reported, the PTAB findings were made in inter partes review proceedings IPR2022-01225 and IPR2022-01226, commenced by Mylan in July 2022.  PTAB held that all challenged claims of the two patents were anticipated by a prior art journal publication.

Leading Light Series: International Women’s Day 2024 | Spotlight on Pearce IP’s Deputy CEO & Head of Talent Adele Chadwick

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!

Adele Chadwick – Deputy CEO & Head of Talent

What does International Women’s Day mean to you?

International Women’s Day is a day to reflect and celebrate the advances made by women across the globe whether social, political, cultural or economic. I also take time on this day to celebrate women in my life who inspire me. My beautiful mum and sister, our inspiring leader at Pearce IP, Naomi Pearce, and my colleagues who are constantly achieving new heights in their profession.

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

Two people influenced me to be successful in my chosen profession.  Firstly, my Dad, who instilled in me a work ethic and intestinal fortitude to be the best I could be.  I can still hear him saying “you only get one shot at life, make it count”.  Secondly, my high school careers teacher – a woman – who told me I wouldn’t amount to much “so go and find yourself a rich husband”.  Those words, although cruel and inappropriate, still drive me to this day.

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

Take every opportunity you are offered that will help you achieve your goals, learn something from it and then teach others. Continue to be true to yourself, that’s why they chose you!

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

I listen, share experiences, offer guidance, and allow them to take flight.  I have a strong values base that keeps me centred, professional and approachable to all staff and love the opportunity to mentor those wishing to thrive.

Why is diversity, equity and inclusion important to you?

This year, International Women’s Day has the theme of “Inspire Inclusion”.  We need to ensure we create a sense of belonging and embrace those things that make us different from each other.  Those differences ensure we are well rounded, make us better at what we do and open our eyes to new ways of doing things.

Read more about Diversity at Pearce IP

Pearce IP BioBlast w/e 8 March 2024

On 9 March 2024, Samsung Bioepis presented two papers of study results for its immunology portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting being held from March 8 to 12 in San Diego, California, United States.   

For its Humira® biosimilar (adalimumab/SB5), Samsung Bioepis presented further information relating to its Phase 4 (switching) study results, which formed the basis of its sBLA seeking interchangeability filed in November 2023.  Results from the same trials were published in Ocular Immunology and Inflammation in January 2024, and in the BMJ Open Opthalmology in December 2023.  Hadlima™ is FDA approved and has been supplied in the US since 1 July 2023 under a licence from AbbVie entered into in 2018. 

For SB17, biosimilar to Janssen’s Stelara® (ustekinumab), Samsung Bioepis presented the Phase 3 results for SB17 with switching studies, which demonstrated efficacy, safety, and immunogenicity for 52 weeks.  These results were presented at ECCO last month. 

SB5/Hadlima™ is commercialised in the US by Organon.  SB17 will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreement  inked in September 2023.   

Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events (MACE) including death, myocardial infarction, or stroke in adults with obesity and/or established cardiovascular disease (CVD). The approval is based on results of the SELECT trial, which demonstrated that Wegovy® reduced MACE by 20%. It is the first US approved therapy to assist with weight management and reduce cardiovascular risk.

Novo Nordisk has also requested equivalent label expansion in EU with the decision expected in 2024.

The approval comes soon after Novo Nordisk announced results of its FLOW study for Ozempic® (semaglutide) for kidney outcomes..

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

Regeneron announced one-year results from studies show that extended dosing regimens (12 or 16 weeks) for Regeneron’s and Bayer’s Eylea® HD (aflibercept) 8mg injection demonstrated non-inferiority to Eylea® 2mg injection (with 8-week dosing) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).  The findings are based on the Regeneron and Bayer sponsored Phase III PULSAR (nAMD) and Phase II/III PHOTON (DME) trials. 

High Dose Eylea® is approved in multiple countries including the US (August 2023 – nAMD, DME and diabetic retinopathy, the EU (January 2024 – nAMD and DME and Japan (January 2024 – nAMD and DME. 

On 6 March 2024, Johnson & Johnson (J&J) announced that it has submitted an application to the European Medical Agency (EMA) for DARZALEX® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with multiple myeloma.  The application is supported by data from the Phase 3 PERSEUS study, which shows that when daratumumab is administered in a subcutaneous formulation it significantly reduces the risk of myeloma progression or death when compared to standard of care regimen. 

This follows J&J’s announcement on 30 January 2024 that it submitted a sBLA to FDA for the Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Combination 

On 6 March 2024, the FDA announced its approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for treatment of adults with unresectable or metastatic urothelial carcinoma.   

Previously in February 2024 and in December 2023, BMS announced that the FDA accepted its sBLA for neoadjuvant Opdivo® (nivolumab) with chemotherapy followed by surgery + adjuvant Opdivo® in the treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) and also accepted for priority review its sBLA for Opdivo® in combination with cisplatin-based chemotherapy for the treatment of unresectable or metastatic urothelial carcinoma. 

Johnson and Johnson (J&J) and Janssen have filed a Motion to Dismiss [Link to emailed document] a class action brought by several US health insurers alleging the companies unlawfully delayed biosimilar competition for Stelara® (ustekinumab) in the US.  J&J/Janssen argue that the alleged facts do not meet the standard of unlawful exclusionary conduct. 

The insurers filed the class action in the US District Court of East Virginia on 7 December 2023, alleging that the companies would lose exclusivity for Stelara® in the US on 25 September 2023 upon expiration of the relevant composition patent, and implemented a scheme to unlawfully prolong patent protection.   

On 5 March 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Genentech’s/Roche’s Actemra®, for the treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.  Tyenne® is the second FDA-approved tocilizumab biosimilar, following the approval of Biogen’s IV formulation Tofidence® in September 2023, but is the first approved subcutaneous formulation.  Tyenne® was approved by the FDA in both IV and subcutaneous forms. The US launch date for its tocilizumab products remains confidential following a patent settlement with Roche and Chugai in October 2022 

Tyenne® has launched in more than 10 countries to date, including in Europe in November 2023 in both IV and subcutaneous formulations.  Fresenius reports that its global roll out will continue through 2024 and 2025. 

On 5 March 2024, the FDA approved the first denosumab biosimilars in the US in Sandoz’s Wyost® and Jubbonti®.  The biosimilars are interchangeable with, and approved for all indications of, Amgen’s Xgeva® and Prolia® respectively. 

The US launch date for the newly approved biosimilars is uncertain given ongoing BPCI litigation regarding the products, commenced by Amgen in May 2023 relating to 21 patents. 

The US approval comes weeks after Sandoz announced the approval of Jubbonti® in Canada.  Prolia® biosimilars developed by Boan Biotech and Mabwell were approved in China respectively in November 2022 (BA6101, Byoubei®) and March 2023 (Mailishu®). 

Novo Nordisk announced the results of its Ozempic® (Semaglutide 1.0) FLOW study kidney outcomes.  In this study, semaglutide 1.0 mg was compared to placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in more than 3,500 people with type 2 diabetes and chronic kidney disease (CKD).  The trial demonstrated a 24% reduction in kidney disease progression, major adverse cardiovascular events (MACE) and death in people treated with semaglutide 1.0 mg compared to placebo.  Novo Nordisk intends to file for regulatory approval for label expansion around the world in 2024. 

This comes as the company is addressing counterfeit products around the world as reported on 1 March 2024 and 5 February 2024.  

On 5 March 2024, the Times of India reported that Roche launched Vabysmo® (faricimab) in India for the treatment of age-related macular degeneration (nAMD) and diabetic macular edema (DME).    

Vabysmo® was first approved in the US by the FDA in January 2022 and is now available in multiple countries, including Europe, Canada and Australia.  In October 2023, Roche received a new indication approval by FDA for the use of Vabysmo® to treat macular oedema following retinal vein occlusion.  Since its first launch date, Vabysmo ® has achieved global sales of US$2.7 billion.   

A paper published in Nature Communications on 5 March 2024 regarding a Phase II clinical trial sponsored by Arcagy-GINECO showed that FKB238 (bevacizumab biosimilar) + olaparib + durvalumab combination showed better survival for treatment of patients with relapsed ovarian cancer than patients with no treatment.  Between 1 March 2019 and 23 January 20202, a total of 74 patients were enrolled in nine French centres and were treated with the bevacizumab biosimilar FKB238 (15 mg/kg intravenously, once-every-3-weeks), olaparib (300 mg orally, twice daily), and durvalumab (1.12 g intravenously, once-every-3-weeks).  

On 4 March 2024, Sandoz announced the completion of its acquisition of biosimilar CIMERLI® (ranibizumab) from Coherus BioSciences. This VEGF inhibitor ranibizumab was approved by the FDA on 2 August 2022 and is indicated for the treatment of retinal diseases. The acquisition includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software. Sandoz announced its USD $170M deal to acquire CIMERLI® on 22 January 2024, and now reports that the deal was completed ahead of schedule.  

Amgen announced that Wezlana™ (ustekinumab injection) and Wezlana™ (ustekinumab for injection, solution for intravenous infusion), biosimilar to Janssen’s Stelara®, is now available in Canada.  Wezlana is the first biosimilar to be approved by Health Canada for all Stelara® indications, but the second ustekinumab Canadian launch following the launch of  the first ustekinumab biosimilar (Jamteki™)in Canada by JAMP Pharma on 1 March 2024.   

Jamteki™ was developed by Alvotech and was approved by Health Canada in November 2023. 

Biocon announced a settlement with Regeneron and Bayer under which it can launch its Yesafili® (aflibercept), biosimilar to Regeneron’s Eylea®, in Canada from 1 July 2025.  The settlement resolves multiple patent infringement proceedings in the Federal Court of Canda involving six patents relating to aflibercept.  The settlement does not appear to have resolved disputes beyond Canada, there being no impact to the ongoing US aflibercept dispute between Biocon and Regeneron.   

Yesafili® was granted tentative approval by Health Canada in March 2023, subject to resolution of patent issues.  Yesafili® was approved in the UK in November 2023 and in EU in September 2023. 

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.   

Celltrion Submits BLA for Interchangeable Omalizumab (Xolair®) Biosimilar

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.

Approval Alert: Formycon AG / MS Pharma’s Ranibizumab Biosimilar (Ravegza®) Approved in Saudi

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.

Approval Alert: MSD’s Keytruda® (pembrolizumab) Approved in Korea for HER2-negative Gastric Cancer

On 11 March 2024, Korea Biomedical Review reported that Merck Sharp & Dohme (MSD)’s anti-PD-1 therapy Keytruda (pembrolizumab) was approved in Korea as a 1st-line treatment for HER2-negative gastric cancer in combination with fluoropyrimidine and platinum-based chemotherapy.  Keytruda® is the first immuno-oncology drug approved in Korea for the treatment of all types of HER2-positive and negative metastatic gastric cancer.

Approval Alert: FDA Approves Regeneron’s Praluent® (alirocumab) Injection for Treating Children with Genetic Form of High Cholesterol

On 11 March 2024, Regeneron announced that the FDA approved Praluent® (alirocumab) injection for treating children with genetic form of high cholesterol on 8 March 2024.  The approval was based on Phase 3 randomized trials in patients aged 8-17.  The results, published in the Journal of the American Medical Association Pediatrics, show that those who received alirocumab every four weeks had 31% lower LDL-C than the placebo group at 24 weeks.

In 2014, Amgen commenced litigation against Sanofi, alleging that Sanofi’s and Regeneron’s Praluent® infringed genus claims of Amgen’s patents relating to Repatha® (evolocumab).  In May 2023, the US Supreme Court published its decision affirming a ruling of the Federal Circuit Court that Amgen’s genus claims were invalid for lack of enablement.

A bet both ways wins PTE for Ono for OPDIVO® (nivolumab) patent based on Merck’s KEYTRUDA® (pembrolizumab)

On 16 February 2024, IP Australia published that Ono Pharmaceutical Co. Ltd (Ono) was granted a patent term extension (PTE) in respect of its Australian Patent No. 2011203119 (Patent).  This is the quiet conclusion to Ono’s dispute with the Patent Office relating to OPTIVO® (nivolumab) which culminated in an appeal court decision rejecting its previous application for PTE.

We have previously written about Ono’s application for a PTE for this Patent which, in the absence of PTE, would expire on 2 May 2026.  The Patent covers the blockbuster cancer drugs OPDIVO® (Ono’s product) and, indirectly KEYTRUDA® (pembrolizumab, competitor Merck’s product). Regulatory approval for Ono’s OPDIVO® and Merck’s KEYTRUDA® in Australia was obtained on 11 January 2016 and 16 April 2015, respectively.

The Courts have confirmed that an Australian patent can be extended based on a competitor’s product.  To recap:

  • Ono filed two requests for PTE for AU 2011203119, the first based on its approval for OPDIVO® and the second (which was stayed by the patent office pending resolution of the first) based on KEYTRUDA®.

  • The Patent Office denied Ono’s request for PTE based on OPDIVO®, which was ultimately upheld by the Court.

  • On appeal to the Federal Court, Beach J overturned the decision, finding that the PTE provisions of the Patents Act which require PTE to be based on the earliest regulatory approval, were not intended to encompass competitor products.

  • The Commissioner appealed to the Full Federal Court, which confirmed that PTEs must be based on the first approved product, even if that is a competitor’s product.

While Ono’s request for PTE based on its OPDIVO® failed, the separate extension application based on Merck’s KEYTRUDA® has now succeeded.  The new extended expiry date for the Patent (16 April 2030) is about 9 months shorter than the expiry date of 11 January 2031 which the Full Court rejected.  A 4 year extension is better than none.

Under Australian law, there is no limit to the number of patents that can be extended for a given product, provided that patentability and eligibility criteria are met.  If Ono had separate patents to each of OPTIVO and KEYTRUDA, it would not have had to choose between the two products when considering its PTE.  It would be prudent for patentees to now deploy divisional strategies to ensure they secure patents specific to each product covered by the claims of the parent patent to maximise both the number and length of PTE eligibility. Ono’s failure to do so, cost it 9 months in patent term.

The AU PTE issue is a minor part of a global patent dispute between Merck and Ono (and Ono’s collaborator Bristol-Myers Squibb (BMS)).  Ono/BMS co-developed the first PD-1 antibody (OPDIVO®) and sued Merck in 2014 alleging patent infringement in relation to the sale of KEYTRUDA® in markets including the US, Europe, Australia and Japan.  Ultimately Ono/BMS and Merck reached settlement which resulted in a licence.

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.

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.

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.

Leading Light Series: International Women’s Day 2024 | Spotlight on Pearce IP’s Founder Naomi Pearce

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!

Naomi Pearce – CEO, Founder

What does International Women’s Day mean to you?

It is a moment to celebrate the resilient, capable, glorious women in my life, and to inspire the little women in my life to dream big, ridiculous dreams!

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

Drive is part nature, part nurture.  A drive for excellence is hard-wired into me – let’s say genetic – which can be both a blessing and a curse.  I was also gifted – from my mother and grandmother – a strong conviction that I could achieve any goal if I set my mind on it.  (This is an incredible gift from brilliant women who were both raised in an era where a brilliant mind on a woman was a waste.)  As a child it was beyond the realms of my imagination that being a woman would, or could, limit my success.

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

Fear of failure is the greatest impediment to success for women.  I would say “Set your goal.  Get yourself ready (your head first, but also your tools, skills, CV, network).  Induce your moment with sacrifice.  Abandon FOMO.  And when your moment comes, JUMP.  You may be scared, but JUMP anyway.”

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

Pearce IP is a place where it is normal to see women in leadership and where pay parity is a given.  Our team has access to leave policies that are intentionally generous to women (menstrual and menopause leave; miscarriage and loss leave), and we operate in a “work from anywhere” model which cuts the commute time for our team members, giving them more time with those that matter most to them.

Why is diversity, equity and inclusion important to you?

It is still shocking to me that we need to keep having a conversation around women in law.  It remains abrasive that law firms limp toward parity in the number of women in leadership.  It is outrageous that pay disparity is real in our industry.  But it is real, and so I will keep shouting for Diversity, Equity and Inclusion until the conversation is no longer needed!

Read more about Diversity at Pearce IP

Eli Lilly’s ADmirable Lebrikizumab Study Shows Positive Results

On 10 March 2024, Eli Lilly announced results for its ADmirable lebrikizumab study.  This is the first-of-its-kind study of lebrikizumab specifically designed to treat people with moderate-to-severe atopic dermatitis. This is also commonly known as eczema.  The results show that two-thirds of the patients with atopic dermatitis experienced improvements by taking lebrikizumab.  The study lasted for 16 weeks and evaluated a total of 50 patients.

Samsung Bioepis Presents Interchangeability Updates for its Adalimumab and Ustekinumab Biosimilars at AAD

On 9 March 2024, Samsung Bioepis presented two papers of study results for its immunology portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting being held from March 8 to 12 in San Diego, California, United States.   

For its Humira® biosimilar (adalimumab/SB5), Samsung Bioepis presented further information relating to its Phase 4 (switching) study results, which formed the basis of its sBLA seeking interchangeability filed in November 2023.  Results from the same trials were published in Ocular Immunology and Inflammation in January 2024, and in the BMJ Open Opthalmology in December 2023.  Hadlima™ is FDA approved and has been supplied in the US since 1 July 2023 under a licence from AbbVie entered into in 2018. 

For SB17, biosimilar to Janssen’s Stelara® (ustekinumab), Samsung Bioepis presented the Phase 3 results for SB17 with switching studies, which demonstrated efficacy, safety, and immunogenicity for 52 weeks.  These results were presented at ECCO last month. 

SB5/Hadlima™ is commercialised in the US by Organon.  SB17 will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreement  inked in September 2023.   

NEW INDICATION ALERT: FDA Approves Novo Nordisk’s Wegovy® (semaglutide) for Cardiovascular Risk Reduction

Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events (MACE) including death, myocardial infarction, or stroke in adults with obesity and/or established cardiovascular disease (CVD).  The approval is based on results of the SELECT trial, which demonstrated that Wegovy® reduced MACE by 20%.  It is the first US approved therapy to assist with weight management and reduce cardiovascular risk. 

Novo Nordisk has also requested equivalent label expansion in EU with the decision expected in 2024. 

The approval comes soon after Novo Nordisk announced results of its FLOW study for Ozempic®  (semaglutide) for kidney outcomes.

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

Regeneron’s High Dose Eylea® (aflibercept) With Extended Dosing Intervals May Reduce Treatment Burden

Regeneron announced one-year results from studies show that extended dosing regimens (12 or 16 weeks) for Regeneron’s and Bayer’s Eylea® HD (aflibercept) 8mg injection demonstrated non-inferiority to Eylea® 2mg injection (with 8-week dosing) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).  The findings are based on the Regeneron and Bayer sponsored Phase III PULSAR (nAMD) and Phase II/III PHOTON (DME) trials. 

High Dose Eylea® is approved in multiple countries including the US (August 2023 – nAMD, DME) and diabetic retinopathy, the EU (January 2024 – nAMD and DME) and Japan (January 2024 – nAMD and DME). 

Leading Lights: Celebrating our Female Trailblazers on International Women’s Day 2024

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. 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!

Naomi Pearce – CEO, Founder

What does International Women’s Day mean to you?

It is a moment to celebrate the resilient, capable, glorious women in my life, and to inspire the little women in my life to dream big, ridiculous dreams!

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

Drive is part nature, part nurture.  A drive for excellence is hard-wired into me – let’s say genetic – which can be both a blessing and a curse.  I was also gifted – from my mother and grandmother – a strong conviction that I could achieve any goal if I set my mind on it.  (This is an incredible gift from brilliant women who were both raised in an era where a brilliant mind on a woman was a waste.)  As a child it was beyond the realms of my imagination that being a woman would, or could, limit my success.

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

Fear of failure is the greatest impediment to success for women.  I would say “Set your goal.  Get yourself ready (your head first, but also your tools, skills, CV, network).  Induce your moment with sacrifice.  Abandon FOMO.  And when your moment comes, JUMP.  You may be scared, but JUMP anyway.”

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

Pearce IP is a place where it is normal to see women in leadership and where pay parity is a given.  Our team has access to leave policies that are intentionally generous to women (menstrual and menopause leave; miscarriage and loss leave), and we operate in a “work from anywhere” model which cuts the commute time for our team members, giving them more time with those that matter most to them.

Why is diversity, equity and inclusion important to you?

It is still shocking to me that we need to keep having a conversation around women in law.  It remains abrasive that law firms limp toward parity in the number of women in leadership.  It is outrageous that pay disparity is real in our industry.  But it is real, and so I will keep shouting for Diversity, Equity and Inclusion until the conversation is no longer needed!

Adele Chadwick Deputy CEO & Head of Talent

What does International Women’s Day mean to you?

International Women’s Day is a day to reflect and celebrate the advances made by women across the globe whether social, political, cultural or economic.  I also take time on this day to celebrate women in my life who inspire me.  My beautiful mum and sister, our inspiring leader at Pearce IP, Naomi Pearce, and my colleagues who are constantly achieving new heights in their profession.

As a successful woman in executive management, what or who drove you to be successful?

Two people influenced me to be successful in my chosen profession.  Firstly, my Dad, who instilled in me a work ethic and intestinal fortitude to be the best I could be.  I can still hear him saying “you only get one shot at life, make it count”.  Secondly, my high school careers teacher – a woman – who told me I wouldn’t amount to much “so go and find yourself a rich husband”.  Those words, although cruel and inappropriate, still drive me to this day.

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

Take every opportunity you are offered that will help you achieve your goals, learn something from it and then teach others. Continue to be true to yourself, that’s why they chose you!

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

I listen, share experiences, offer guidance, and allow them to take flight.  I have a strong values base that keeps me centred, professional and approachable to all staff and love the opportunity to mentor those wishing to thrive.

Why is diversity, equity and inclusion important to you?

This year, International Women’s Day has the theme of “Inspire Inclusion”.  We need to ensure we create a sense of belonging and embrace those things that make us different from each other.  Those differences ensure we are well rounded, make us better at what we do and open our eyes to new ways of doing things.

Helen Macpherson - Executive Lawyer, Pearce IP

Helen Macpherson Executive, Lawyer (Head of Legal)

What does International Women’s Day mean to you?

It is a time to come together and take stock of what we have achieved for women – their well-being, their human rights and position in society – and to look forward to what we still need to and want to achieve for women.

As a successful woman in the legal industry, what or who drove you to be successful?

I would say that any success I have had has been a consequence of my innate curiosity about the world, my drive to do the best that I can and my desire to work with others to help them succeed. I thank my family, particularly my parents, for encouraging and instilling these values in me.

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

You want to have a fulfilling life.  So, work out what matters to you and what drives and energises you and be led by that.

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

I simply seek to be true to my values, to act in accordance with my values and to be empathetic.  I also try to be candid and honest with people about my career journey.

Why is diversity, equity and inclusion important to you?

Diversity, equity and inclusion are important to me because they are for the benefit of us all.  We are individually and collectively better off in a society that is diverse, equitable and inclusive.

Kim Evans – Executive, Lawyer & Trade Mark Attorney (Head of Trade Marks)

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.

Kimberley Evans, Executive, Trade Mark Attorney, Pearce IP

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 the Patents 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.

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!

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.

NEW INDICATION ALERT: J&J Submits EMA Application for DARZALEX® (daratumumab) SC for Multiple Myeloma

On 6 March 2024, Johnson & Johnson (J&J) announced that it has submitted an application to the European Medical Agency (EMA) for DARZALEX® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with multiple myeloma.  The application is supported by data from the Phase 3 PERSEUS study, which shows that when daratumumab is administered in a subcutaneous formulation it significantly reduces the risk of myeloma progression or death when compared to standard of care regimen. 

This follows J&J’s announcement on 30 January 2024 that it submitted a sBLA to FDA for the Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Combination 

Approval Alert: FDA Approves BMS’s Opdivo (nivolumab) in Combination with Cisplatin and Gemcitabine for Metastatic Urothelial Carcinoma

On 6 March 2024, the FDA announced its approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for treatment of adults with unresectable or metastatic urothelial carcinoma.   

Previously in February 2024 and in December 2023, BMS announced that the FDA accepted its sBLA for neoadjuvant Opdivo® (nivolumab) with chemotherapy followed by surgery + adjuvant Opdivo® in the treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) and also accepted for priority review its sBLA for Opdivo® in combination with cisplatin-based chemotherapy for the treatment of unresectable or metastatic urothelial carcinoma. 

Janssen Moves to Dismiss Insurers’ Stelara® Class Action

Johnson and Johnson (J&J) and Janssen have filed a Motion to Dismiss a class action brought by several US health insurers alleging the companies unlawfully delayed biosimilar competition for Stelara® (ustekinumab) in the US.  J&J/Janssen argue that the alleged facts do not meet the standard of unlawful exclusionary conduct. 

The insurers filed the class action in the US District Court of East Virginia on 7 December 2023, alleging that the companies would lose exclusivity for Stelara® in the US on 25 September 2023 upon expiration of the relevant composition patent, and implemented a scheme to unlawfully prolong patent protection.   

Fresenius Announces First Subcutaneous Tocilizumab Biosimilar Approved in the US

On 5 March 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Genentech’s/Roche’s Actemra®, for the treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.  Tyenne® is the second FDA-approved tocilizumab biosimilar, following the approval of Biogen’s IV formulation Tofidence® in September 2023, but is the first approved subcutaneous formulation.  Tyenne® was approved by the FDA in both IV and subcutaneous forms. The US launch date for its tocilizumab products remains confidential following a patent settlement with Roche and Chugai in October 2022.   

Tyenne® has launched in more than 10 countries to date, including in Europe in November 2023 in both IV and subcutaneous formulations.  Fresenius reports that its global roll out will continue through 2024 and 2025. 

Sandoz Announces First US Denosumab Biosimilars Approved with Interchangeability

On 5 March 2024, the FDA approved the first denosumab biosimilars in the US in Sandoz’s Wyost® and Jubbonti®.  The biosimilars are interchangeable with, and approved for all indications of, Amgen’s Xgeva® and Prolia® respectively. 

The US launch date for the newly approved biosimilars is uncertain given ongoing BPCI litigation regarding the products, commenced by Amgen in May 2023 relating to 21 patents. 

The US approval comes weeks after Sandoz announced the approval of Jubbonti® in Canada.  Prolia® biosimilars developed by Boan Biotech and Mabwell were approved in China respectively in November 2022 (BA6101, Byoubei®) and March 2023 (Mailishu®). 

Novo Nordisk Ozempic® (Semaglutide 1.0) Study Demonstrates Reduction in Kidney Disease Events

Novo Nordisk announced the results of its Ozempic® (semaglutide 1.0mg) FLOW study kidney outcomes.  In this study, semaglutide 1.0 mg was compared to placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in more than 3,500 people with type 2 diabetes and chronic kidney disease (CKD).  The trial demonstrated a 24% reduction in kidney disease progression, major adverse cardiovascular events (MACE) and death in people treated with semaglutide 1.0 mg compared to placebo.  Novo Nordisk intends to file for regulatory approval for label expansion around the world in 2024. 

This comes as the company is addressing counterfeit products around the world as reported on 1 March 2024 and 5 February 2024.