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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.

FDA Accepts Organon/Shanghai Henlius’ BLA for Biosimilar Denosumab

Organon and Shanghai Henlius Biotech announced on 30 October 2024 that the FDA accepted their BLA for HLX14, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).  This comes 5 months after the European Medicines Agency (EMA) validated Henlius’ and Organon’s applications for denosumab in May 2024.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024.  US BPCI litigation commenced by Amgen against Sandoz in May 2023 in relation to denosumab was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025, or earlier in certain (undisclosed) circumstances.  No other denosumab biosimilars are currently approved in the US, although Fresenius Kabi’s BLA for its denosumab biosimilar was accepted by the FDA in May 2024 and Teva’s BLA for TVB-009P (denosumab) was accepted by the FDA in October 2024.

In June 2022, Shanghai Henlius entered into a licence agreement with Organon regarding HLX14 (and pertuzumab) under which Organon has exclusive global commercialisation rights for all countries except China, Hong Kong, Macau and Taiwan.

Celltrion’s Positive Results in Study Comparing Infliximab SC Monotherapy and Immunosuppressant Combination Therapy

On 30 October 2024, Celltrion announced results of a global phase 3, 2-year follow-up study comparing infliximab SC (CT-P13, Zymfentra™) as monotherapy and in combination with immunosuppressants.  Celltrion reports that the study found Zymfentra™ as monotherapy was just as effective and safe as when combined with immunosuppressants for patients with Crohn’s disease or ulcerative colitis, suggesting “monotherapy can be a sufficiently safe and effective treatment option”.  The results were presented at the 2024 American College of Gastroenterology conference (25-30 October 2024).

This news follows Celltrion’s 19 August 2024 announcement that the FDA has approved a phase 3 clinical trial of Zymfentra™ for rheumatoid arthritis.

Zymfentra™ was the first subcutaneous formulation of infliximab approved by the FDA for ulcerative colitis and Crohn’s disease in October 2023.  It was launched in the US in March 2024.

In Europe, Zymfentra™ is known as Remsima SC® and has been approved since 2013.

Novo Nordisk’s Wegovy® and Ozempic® US Supply Crisis Over

On 30 October 2024, the US Food and Drug Administration (FDA) provided an update on its drug shortage database, reporting that all doses of Novo Nordisk’s popular weight loss injection Wegovy® and diabetes drug Ozempic® (both of which comprise semaglutide) are now available in the US.  This demonstrates Novo Nordisk’s ability to increase supply amid growing demand.

Novo Nordisk stated to US media that all doses are now shipped regularly to wholesalers, thanks to expanded manufacturing capacity and close communication with the FDA.  Novo Nordisk emphasised a gradual supply increase to ensure patient care and track prescribing trends.

Sandoz’s Q3/9M Results: Strong Biosimilars Growth of 37%/32%

On 30 October 2024, Sandoz announced its Q3 and 9-month 2024 financial results, reporting third quarter net sales of USD 2.6 billion, up 12% in constant currencies, year-on-year.  Net sales for the first 9 months of the year were USD 7.6 billion, an increase of 9% in constant currencies compared to the same period in 2023.

Sandoz experienced strong biosimilars growth of 37% (to USD 741 million) and 32% (to USD 2.1 billion) in constant currencies (YoY) for the quarter and the year to date respectively.  This is attributed to the European launches of Pyzchiva® (ustekinumab) in July 2024 and Tyruko® (natalizumab) in January 2024, the Canadian launch of Wyost®/Jubbonti® (denosumab) in August 2024, the acquisition of Cimerli® (ranibizumab) from Coherus announced in January 2024, the uptake of Hyrimoz® (adalimumab) in the US and the continued strong demand for Sandoz’s very first biosimilar Omnitrope® (somatropin).

Key biosimilar milestones for Q3/2024 are reported to include the FDA approvals of EnzeevuTM (aflibercept) in August 2024 and Pyzchiva® (ustekinumab) in July 2024, and the launch of the first European biosimilar to Janssen’s Stelara®, Pyzchiva® (ustekinumab), in July 2024.  Sandoz intends to launch Pyzchiva® in the US in February 2025 in the first wave of biosimilars, while the US-launch of Enzeevu™ is dependent upon factors including the outcome of ongoing BPCIA litigation.

Amgen Launches Aflibercept in the US, Prepares to Launch Ustekinumab & Eculizumab

Following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for injunction against Amgen earlier in October 2024, Amgen confirmed during its earnings call on 30 October 2024 that it has launched Pavblu®/aflibercept (biosimilar to Regeneron/Bayer’s Eylea®) in the US and is preparing to launch Wezlana®/ustekinumab (biosimilar to Amgen’s Stelara®) and Bekemv®/eculizumab (biosimilar to Alexion’s Soliris®) in the first and second quarters of 2025 respectively.

Amgen’s Executive Vice President of Global Commercial Operations Murdo Gordon said:

“Our biosimilar products increased 9% year-over-year in the third quarter.  We have fully deployed our team in support of the recent U.S. launch of PAVBLU, a biosimilar to EYLEA. Our teams moved quickly to engage retina specialists, and we’re encouraged by the enthusiastic feedback from customers. Our teams are also ready for the upcoming U.S. launches of WEZLANA, a biosimilar to STELARA and BEKEMV, a biosimilar to Solaris, expected in the first and second quarters of 2025, respectively.  Overall, our biosimilars portfolio continues to deliver attractive returns driven by our efficient business model.”

Biocon Biosimilar Business Grows 19% in Q3/2024 Driven by US Oncology and Insulin Franchises

On 30 October 2024, Biocon Limited announced its financial results for Q3 2024, reporting that while its total consolidated revenue was flat (year on year), it experienced “robust performance” in its biosimilars business with growth of 19% (year on year).  Biocon attributes the biosimilar growth to an increase in market share in the US, expansion in Europe and 15 new launches in emerging markets.

Biocon reports that its oncology franchise, including Ogivri® (biosimilar trastuzumab, US launch in December 2019) and Fulphila® (biosimilar pegfilgrastim, US approval in June 2018), has experienced an increase in market share over the quarter (YoY), with the market share for Ogivri® increasing from 11% to 18% and that for Fulphila® increasing from 15% to 21%.  Biocon’s insulin products have also grown in market share with unbranded bGlargine and Semglee® (insulin glargine-yfgn) surpassing 15%.

Biosimilar highlights for the third quarter include the EMA’s validation of Biocon’s application for biosimilar denosumab and Biocon’s settlement and licence agreement in August 2024 for Yesintek (Bmab 1200), biosimilar to Janssen’s Stelara® (ustekinumab), permitting Biocon to launch in Europe, the UK, Canada and Japan following regulatory approval.  Biocon had previously entered a settlement agreement with Janssen in relation to ustekinumab in May 2024, allowing US launch in February 2025.  The FDA accepted Biocon’s BLA for Bmab 1200 for review under the 351(k) pathway in May 2024.

In emerging markets, Biocon specifically refers to launches of biosimilar bevacizumab and pegfilgrastim in Saudi Arabia and regulatory approvals for biosimilars of bevacizumab, etanercept, adalimumab, insulin aspart and rh-insulin in several countries in the Latin American, African and Middle East regions.

Biocon’s licensing and supply agreement with Tabuk Pharmaceutical for commercialisation of its GLP-1 products for diabetes and chronic weight management in certain Middle East countries and its exclusive distribution and supply agreement with a leading pharmaceutical company in Brazil (October 2024) for commercialisation of liraglutide (generic of Novo Nordisk’s Victoza®/Saxenda®) are also said to be Q3 2024 highlights.

Litigation Update: Court Dismisses Janssen’s Ustekinumab Patent Infringement Counterclaim against Samsung Bioepis

On 29 October 2024, the Canadian Federal Court dismissed Janssen’s motion to add an infringement counterclaim against Samsung Bioepis in existing patent proceedings.  Samsung Bioepis commenced proceedings against Janssen seeking to impeach (invalidate) Janssen’s CA Patent 3,113,837 for Stelara® (ustekinumab) in November 2023.  

Samsung commenced the impeachment proceedings as an interested person, on the basis that it had filed a submission for a notice of compliance (NOC) for Pyzchiva®, biosimilar to Stelara® (ustekinumab).  Samsung received an NOC for Pyzchiva® in August 2024.  At that time, Health Canada published a product monograph for Pyzchiva®, which listed Sandoz as a distributor of Pyzchiva®. 

The Federal Court dismissed Janssen’s motion to add an infringement counterclaim because it was not satisfied that the proposed pleading was adequately particularised, and considered that it did not disclose a reasonable cause of action.  The Court stated that, “considering the allegations of direct and induced infringement, both individually and collectively, it is apparent that Janssen does not know what Samsung and Sandoz are presently doing with Pyzchiva beyond obtaining regulatory approval, but is hoping to use the discovery process to find out.  This is not a proper pleading”. 

Ahead of Samsung Bioepis and Sandoz in Canada with ustekinumab biosimilars are: JAMP who launched the Alvotech developed first biosimilar Jameteki™ on 1 March 2024, Amgen who launched Wezlana™ on 4 March 2024 and Celltrion who reported on 31 July 2024 its Canadian approval for Steqeyma (CT-P43)Biocon has also submitted a Canadian regulatory application, following a signed patent settlement and licence agreement with Janssen which enables Biocon to commercialise its ustekinumab biosimilar “Bmab 1200” in Europe, the United Kingdom, Canada and Japan. 

NICE recommends Pfizer’s Elrexfio® (Elranatamab) for NHS Cancer Drugs Fund

On 29 October 2024, UK’s National Institute for Health and Care Excellence (NICE) recommended Pfizer’s Elrexfio® (elranatamab) for use in the NHS’ Cancer Drugs Fund.  The Cancer Drugs Fund provides funding for certain cancer medicines before they have been approved by NICE for use in the NHS.  Elranatamab is a sub-cutaneous injection therapy for the treatment of multiple myeloma.

In the media release, the director of medicines evaluation at NICE states that use of Elrexfio® through the Cancer Drugs Fund “will give people access to this promising new fourth-line treatment while longer-term data on its use is collected to establish whether it is clinically and cost effective”.

Elrexfio® is approved for relapsed or refractory multiple myeloma in the US (August 2023) and EU (December 2023).

Eli Lilly’s Kisunla™ (Donanemab) Demonstrates Brain Swelling Reduction in Alzheimer’s Patients

On 29 October 2024, Eli Lilly announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study, which demonstrated that patients with early symptomatic Alzheimer’s disease (AD) who received a slightly modified titration of Kisunla™ (donanemab) showed a reduction in amyloid-related imaging abnormalities with oedema/effusion (ARIA-E) at the 24-week primary endpoint.  Eli Lilly reports that the modified titration of Kisunla™ lowered ARIA-E to 14% compared to 24% in patients receiving the standard dosing regimen.  Eli Lilly is intending to submit this data to global regulators for a potential label update for Kisunla™.

One week earlier, Eli Lilly announced that Kisunla™ was approved in the UK as a treatment for mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients who are apolipoprotein E ε4 heterozygotes or non-carriers.  Kisunla™ was first approved in the US (July 2024) and subsequently in Japan (September 2024) for the same indication.

New Indication Alert: AstraZeneca’s Fasenra® (Benralizumab) EU-Approved for EGPA

On 28 October 2024, AstraZeneca announced that the European Commission has approved its Fasenra® (benralizumab) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).  The indication received a positive recommendation from the EMA’s CHMP in September 2024, based on positive results from the MANDARA Phase III trial.

This follows FDA approval of Fasenra® for the same indication in September 2024.

Positive Ph 3 Results for J&J’s Tremfya® (Guselkumab) in Crohn’s Disease and Plaque Psoriasis

On 28 October 2024, Johnson & Johnson (J&J) announced that its Phase 3 GRAVITI study of Tremfya® (guselkumab) in moderately to severely active Crohn’s disease showed “robust” results in subcutaneous induction and maintenance therapy, demonstrating “significant” clinical remission and endoscopic response at 48 weeks.  Based on these results, J&J considers that guselkumab could become the first IL-23 treatment to offer both SC and IV induction options for Crohn’s disease.

In a separate Phase 3b study (SPECTREM), sponsored by J&J, Tremfya® was shown to result in clear or almost clear skin in the majority of patients with low body surface area moderate plaque psoriasis with special site involvement who had failed topical treatment.  These results were presented on 25 October at the 2024 Fall Clinical Dermatology Conference.

Tremfya® is approved in Europe, the USA and other countries for moderate to severe plaque psoriasis and active psoriatic arthritis.  Tremfya® received FDA approval in September 2024 for moderately to severely active ulcerative colitis.  J&J submitted applications for approval of Tremfya® for Crohn’s disease to the FDA in June 2024 and in Europe in May 2024.

Pearce IP BioBlast® for the week ending 25 October 2024

Aflibercept

23 October 2024 | Biocon Switching Study for Aflibercept Confirms Safety & Efficacy

On 23 October 2024, Biocon announced follow-up results from a Phase 3 study of MYL-1701P, biosimilar to Regeneron’s Eylea® (aflibercept).  According to Biocon, the study… Read more here.

22 October 2024 | US | Regeneron Fails to Injunct Amgen’s US Aflibercept Biosimilar for Second Time; Amgen to Launch At Risk

On 22 October 2024, the United States Court of Appeals for the Federal Circuit ruled that Regeneron was not entitled to an injunction preventing Amgen from launching its aflibercept… Read more here.


Daratumumab

23 October 2024 | EU | New Indication Alert: J&J’s Darzalex® (Daratumumab) Quadruplet Regimen for Multiple Myeloma Approved in the EU

On 23 October 2024, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous… Read more here.


Donanemab

23 October 2024 | UK | Approval Alert: Eli Lilly’s Kisunla™ (Donanemab-azbt) UK Approved but Not Reimbursed

On 23 October 2024, Eli Lilly announced that its Kisunla™ (donanemab-azbt) received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as… Read more here.


Dupilumab

25 October 2024 | Sanofi’s Q3/24 Global Dupixent® Sales Reach €3.5 billion

On 25 October 2024, Sanofi announced its Q3 2024 results, including strong growth for Dupixent® (dupilumab) across indications and geographies.  Sanofi reports that sales… Read more here.


Nivolumab, Certolizumab

21 October 2024 | Update on Xbrane Out-Licensing Nivolumab & Certolizumab Biosimilars

In August 2024, Xbrane commenced its out-licensing process for Xdivane™, biosimilar to BMS’ Opdivo® (nivolumab), and XB003 (previously known as Xcimzane™, BIIB801)… Read more here.


Pembrolizumab

24 October 2024 | EU | Two New Gynaecological Cancer Indications for MSD’s Keytruda® in Europe

On 24 October 2024, MSD announced that Keytruda® (pembrolizumab) has received marketing approvals from the European Commission for two new gynaecological cancer… Read more here.


Semaglutide

22 October 2024 | US | Novo Nordisk Nominates Semaglutide for Inclusion in FDA’s DDC List

On 22 October 2024, the US Food and Drug Administration (FDA) posted notices detailing Novo Nordisk’s request to include semaglutide in the FDA’s Demonstrable… Read more here.

21 October 2024 | Novo Nordisk Positive Results from Semaglutide Cardiovascular Outcomes Trial

On 21 October 2024, Novo Nordisk announced positive results from the SOUL cardiovascular outcomes trial, which evaluated the impact of Rybelsus® (oral semaglutide)… Read more here.


Ustekinumab

22 October 2024 | US | Alvotech/Teva’s Biosimilar Ustekinumab – Second Presentation FDA Approved

On 22 October 2024, Alvotech and Teva announced US FDA approval of an additional presentation of Selarsdi™ (ustekinumab), biosimilar to Janssen’s Stelara®.  The additional… Read more here.

21 October 2024 | AU | Approval Alert: Samsung Bioepis Ustekinumab Biosimilar Approved in Australia

On 21 October 2024, the Australian TGA approved three presentations of Samsung Bioepis’ Epyztek®, biosimilar to Janssen’s Stelara® (ustekinumab): 90 mg/1 mL solution for injection… Read more here.


Company Announcements

23 October 2024 | Samsung Biologics’ Q3/24 Results: Accumulated Revenue at Record High

Samsung Biologics has announced its Q3/2024 financial results, reporting that its accumulated revenue has surpassed KRW 3T for the first time and raising its annual revenue… Read more here.


Biopharma Deals 2024

22 October 2024 | Samsung Biologics’ Record-Breaking Contract Manufacturing Deal Worth USD 1.24B

On 22 October 2024, Samsung Biologics announced that it has entered a contract manufacturing deal worth USD 1.24 billion, with an un-named Asia-based pharmaceutical… Read more here.

 

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

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

 

Naomi Pearce

Naomi Pearce

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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

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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.

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Imogen is a paralegal supporting Pearce IP’s legal and trade mark teams. Imogen prepares patent litigation updates, conducts legal research, and provides paralegal and administrative assistance.

Imogen comes from a background working in hospitality, where she has learnt how to be an effective communicator and work efficiently. Imogen has an interest in the design space, having completed her Certificate III in Design Fundamentals. Her knowledge of the design industry has improved her understanding of the IP realm and has strengthened her passion for IP law. Imogen is a highly disciplined and organised individual who works to assist her colleagues with dedication and optimism.

 

Positive Results for Eli Lilly’s Ebglyss™ (Lebrikizumab-lbkz)

On 25 October 2024, Eli Lilly announced results from the Phase 3b ADapt study demonstrating that Ebglyss™ (lebrikizumab-lbkz) improved skin (including hand and face) and itch among patients with moderate-to-severe atopic dermatitis (eczema) who were previously treated with dupilumab.

In September 2024, Eli Lilly published three-year data for Ebglyss™ reportedly showing that more than 80% of adults and adolescents with moderate-to-severe atopic dermatitis who responded to Ebglyss™ at week 16 and continued treatment for up to three years experienced sustained skin clearance with monthly maintenance dosing.

This news follows Eli Lilly’s announcement on 13 September 2024 that Ebglyss® received FDA approval for adults and children 12 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies.

Sanofi’s Q3/24 Global Dupixent® Sales Reach €3.5 billion

On 25 October 2024, Sanofi announced its Q3 2024 results, including strong growth for Dupixent® (dupilumab) across indications and geographies.  Sanofi reports that sales of Dupixent® for the quarter have increased globally by 24% to €3.5 billion and are expected to total about €13bn for the full year.

Sanofi’s biopharma highlights for Q3 are reported to include its September 2024 new indication approvals for Dupixent® (COPD in the US and China and CRSwNP adolescents in the US) and for Sarclisa® (isatuximab) (newly diagnosed multiple myeloma (NDMM) in the US).

Full Court Clarifies and Recalibrates the Obviousness Test for “Pre-Raising the Bar” Patents

 

Date of decision: 23 October 2024
Body:  Full Court of the Federal Court of Australia
Adjudicator: Justices Yates, Burley and Downes

 

Sandoz has triumphed in its appeal regarding the validity of two of Bayer’s Australian Xarelto® (rivaroxaban) patents.  On 23 October 2024, the Full Court unanimously overturned Justice Rofe’s decision of 2 November 2023, holding that the two Bayer patents lack an inventive step in light of the common general knowledge taken together with a prior art patent specification.  The parties have been given until 4 November to propose orders giving effect to the Full Court’s decision.

Subject to Bayer applying for, and being granted, special leave to appeal to the High Court of Australia, the Full Court decision marks the end of the road for Bayer’s domination of the Australian rivaroxaban market. As we reported at the time of Justice Rofe’s decision (see here and here for our article and blog), 158 rivaroxaban products have been approved by the TGA (149 of them generic products).  This number has not changed, although Teva and Alphapharm have now obtained PBS listing for generic rivaroxaban products.  We would expect to see many more generic competitors moving swiftly to obtain PBS listing for, and launch, their rivaroxaban products in Australia.

In overturning Justice Rofe’s decision, the Full Court has clarified the bar that needs to be met to prove obviousness and has recalibrated the “ascertainment” test under the “pre-Raising the Bar” (pre-RTB) version of the Patents Act.  This clarification and recalibration will not be welcome news for patentees but will be celebrated by companies seeking to challenge the validity of pre-RTB patents.

The Patents

The two Bayer patents in suit were:

  • Australian Patent No. 2004305226, entitled “Method for the production of a solid, orally applicable pharmaceutical composition” (the 226 Patent). The 226 Patent is directed to orally administrable pharmaceutical compositions comprising rivaroxaban in hydrophilized form and the use of those pharmaceutical compositions for the prophylaxis and/or treatment of a thromboembolic disease; and
  • Australian Patent No. 2006208613, entitled “Prevention and treatment of thromboembolic disorders” (the 613 Patent). The 613 Patent is directed to a method of treatment of thromboembolic disorders by once daily administration of a rapid-release tablet comprising rivaroxaban.

Appeal Grounds

Sandoz’s appeal was limited to appealing Justice Rofe’s obviousness finding, specifically raising the following three grounds of appeal:

  • Ground One – Ascertainment: that Justice Rofe incorrectly found that a person skilled in the relevant art could not be reasonably expected to have ascertained International Patent Publication No. WO 01/47919 (WO 919) within the meaning of s 7(3) of the pre-RTB version of the Patents Act;
  • Ground Two – CGK + WO 919 Obviousness: that Justice Rofe incorrectly found that the inventions claimed in each of the 226 Patent and the 613 Patent involved an inventive step in light of the common general knowledge (CGK) together with WO 919; and
  • Ground Three – CGK + Blood Extracts Obviousness: that Justice Rofe incorrectly found that the invention claimed in the 613 Patent involved an inventive step in the light of the CGK together with Abstracts 3003, 3004 and 3010 published in the November 2003 supplement of Blood (the Blood Abstracts).

Sandoz succeeded on Appeal Grounds One and Two, resulting in Justice Rofe’s decision being overturned.

The Full Court’s Decision

Ground One – Ascertainment

Under the pre-RTB law, in order to rely on WO 919 to show lack of inventive step under s 7(3) of the Patents Act 1990 (Cth), Sandoz had to establish that the person skilled in the relevant art could be reasonably expected to have ascertained, understood and regarded WO 919 as relevant.  This requirement no longer applies under post-RTB law.

At first instance, Justice Rofe had been critical of Sandoz’s evidence on “ascertainment”.  Justice Rofe considered that Sandoz had taken an impermissible “short cut” in its evidence, including because:

  • its evidence of a hypothetical literature search conducted by a patent searcher for the purpose of the litigation was limited to one search term (“factor Xa inhibitors”) and one database, when Sandoz’s expert witness (Professor Roberts) had said he would have conducted searches on more than one database and with a number of search terms; and
  • Professor Roberts was provided with a spreadsheet of search results and identified 190 of the 218 search results as being “top priority”, including WO 919. However, he had not been provided with copies of any of those documents to consider.

In these circumstances, Justice Rofe said: “The question of whether Professor Roberts would have selected WO 919 if he was provided with the full suite of results from searches undertaken across all his suggested databases, and with broader search terms than just “factor Xa inhibitors”” could not be answered on the evidence before her.

The Full Court held that Justice Rofe had fallen into error in determining lack of ascertainment for WO 919, in particular because:

  • The standard imposed by s 7(3) does not require proof that the hypothetical skilled person would ascertain the document. Rather, it requires proof sufficient to demonstrate a reasonable expectation that the skilled person would do so, on the balance of probabilities.
  • In this case, the evidence established that the person skilled in the art would have conducted searches of (inter alia) the patent database using search terms including “factor Xa inhibitors”. Contrary to the submission by Bayer, it therefore did not matter that the skilled person would have also conducted searches using additional search terms.
  • In relation to Bayer’s complaint that Professor Roberts was not provided with all of the documents which he identified from the spreadsheet as being “top priority” the Full Court said it was not necessary for evidence to be adduced that the skilled person would prefer, prioritise or select WO 919 over all other information which they could be reasonably expected to have discovered or found out, including other information which was not adduced into evidence
  • Despite accepting that it was not necessary in every case for a literature search to be carried out in order to establish the “ascertainment” requirement, Justice Rofe required, in effect, that such a search be performed, and that Professor Roberts select WO 919 from the broader array of search results.
  • In summary, it was not to the point that additional searches might have been performed (including by reference to additional search terms), or that the skilled person could also be expected to have found additional documents or information, or that the skilled person would have been required to review such additional documents or information. This was especially the case as Bayer had led no evidence to suggest that a reasonable search of a patent database would not have found WO 919, or that WO 919 would not have been identified out of a broader search involving other databases or search terms, or that WO 919 would not have been identified as being relevant upon being reviewed.

Ground Two –CGK +  WO919 Obviousness

In holding that the inventions claimed in each of the 226 Patent and the 613 Patent involved an inventive step (were not obvious) in light of the CGK together with WO 919, Justice Rofe accepted the evidence that:

  • WO 919 would be of interest and value to a drug development team seeking to develop a new antithrombotic drug and that, on reading WO 919, the skilled reader would focus in particular on rivaroxaban because it was listed as a particular chemical, discussed in examples and the only compound the subject of a claim; and
  • the skilled person reading WO 919 would be likely to select rivaroxaban as a or the lead candidate, to take into further drug development work which would involve the full suite of pre-clinical tests required in order to consider whether rivaroxaban was suitable to take into Phase I, first-in-human trials.

Justice Rofe then went on to apply the well accepted “reformulated Cripps question”; that is: whether the person skilled in the art at the relevant date with the relevant knowledge would directly be led, as a matter of course, to try the claimed invention in the expectation that it might well produce a useful alternative to, or a better drug than, the existing compound.  Applying this test, Justice Rofe held that:

  • the well-known standard series of steps of a drug development pathway were not “routine steps”; and
  • Bayer’s drug development journey was more akin to a “voyage of discovery” than the “working towards the invention with an expectation of success”.

The Full Court disagreed with her Honour’s application of the reformulated Cripps question, finding, in summary that:

1. Routine Steps: In the field of drug development, the need to carry out clinical trials and other tests in order to obtain relevant data can be regarded as routine work consistent with a finding of obviousness. In the Full Court’s opinion, Justice Rofe had applied the incorrect test by:

  • placing too much emphasis on the “risks and unknowns” associated with the pre-clinical and clinical tests, which would have been undertaken as a matter of course following the selection of rivaroxaban as a lead candidate. In this regard, the Full Court noted that, notwithstanding those risks and uncertainties, Justice Rofe had found that the skilled person reading WO 919 was likely to select rivaroxaban as a or the lead candidate to take into further drug development work; and
  • determining that those steps, which followed such a selection, would not be “routine”. In this regard, the Full Court noted that there was no evidence before Justice Rofe, and that her Honour made no finding, that any particular problem, difficulty or issue would have been expected to have arisen or would have arisen during the pre-clinical and clinical trials which would conventionally be carried out following the selection of rivaroxaban as a lead candidate. There was also no evidence, or finding, that the formulation of rivaroxaban in the 226 Patent or its dosage regime adopted in the 613 Patent would not have been identified during the course of these trials.

2. Expectation of Success: The Full Court held that the relevant expectation is to be measured against the ordinary level of expectation and risk inherent in routine work in the particular field. The relevant test is not knowing that steps will or would or even may well work, but merely expecting that the steps may well work.  In the Full Court’s opinion, Justice Rofe had applied the incorrect test by:

  • using language which indicated that, to have the requisite expectation, the person skilled in the art would need to be able to make predictions as to efficacy, side effects and safety or adverse events and toxicities and that, in order to have the requisite expectation, the research project could not be unpredictable; and
  • requiring that it be demonstrated that the person skilled in the art would have the requisite expectation at each stage of the drug development process, such that they need to have an expectation that the chosen compound would pass through all the drug development stages.

Ground 3 – Disclosure of Blood Abstracts

Ground three related to the nature of the disclosure in other s7(3) documents, collectively referred to as the Blood Abstracts.  Justice Rofe had found that the Blood Abstracts could be reasonably expected to have been ascertained, understood, and regarded as relevant by the person skilled in the art.  However, it was held that there was no disclosure of rivaroxaban in the Blood Extracts as they referred to rivaroxaban as “BAY 59-7939”, and that reference was not CGK.

Although the Full Court did not need to consider this ground given the findings on the first two grounds, the Full Court, in obiter, agreed with Justice Rofe that there was no disclosure of rivaroxaban in the Blood Abstracts.

Conclusion

The Full Court’s decision is significant for both patentees and patent challengers.  The Full Court has clarified the bar that needs to be met to prove obviousness and has recalibrated the bar that needs to be met to meet the “ascertainment” test under the “pre-Raising the Bar” version of the Patents Act. This clarification and recalibration will not be welcome news for patentees but will be welcomed by companies seeking to challenge the validity of “pre-Raising the Bar” patents.

Given the decision’s importance both legally and commercially, Bayer may apply for special leave to appeal to the High Court of Australia.  In the meantime, generic competitors may now move swiftly to obtain PBS listing for, and launch, their rivaroxaban products in Australia.

 

About Pearce IP

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation – Australia)

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

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

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.

Two New Gynaecological Cancer Indications for MSD’s Keytruda® in Europe

On 24 October 2024, MSD announced that Keytruda® (pembrolizumab) has received marketing approvals from the European Commission for two new gynaecological cancer indications.  This means Keytruda® is now approved for 30 indications in Europe, including 5 for gynaecological cancer.

The first new indication is for Keytruda®, in combination with carboplatin and paclitaxel, for first line treatment of primary advanced or recurrent endometrial carcinoma in adults who are candidates for systemic therapy.  This indication was approved by the FDA in June 2024.

The second is Keytruda®, in combination with chemoradiotherapy, for treatment of FIGO (International Federation of Gynaecology and Obstetrics) 2014 Stage III-IVA locally advanced cervical cancer in adults who have not received prior definitive therapy.  This indication was approved by the FDA in January 2024 and in Korea in April 2024.

The new indications received positive CHMP approvals in September 2024.

Nose Dive – ResMed’s Opposition Gets a Rude Awakening

 

Date of decision: 05 July 2024
Body:  Australian Patent Office
Adjudicator: Delegate McCaffery

Background

In a recent decision of the Australian Patent Office, Delegate McCaffery has ruled on opposition proceedings between ResMed Pty Ltd (ResMed) and Fisher & Paykel Healthcare Limited (Fisher & Paykel).  The proceedings concerned six patent applications relating to patient interfaces for delivering breathing gases, with specific focus on nasal seals for continuous positive airway pressure (CPAP) therapy:

Each application claimed an inflatable nasal seal with a soft, flexible central portion and stiffer side portions conforming to the nose under pressure, including nasal locators with varying stiffness to ensure proper fit and seal. 

ResMed challenged the validity of these applications on multiple grounds, such as novelty, inventive step, clarity, support, succinctness, utility and manner of manufacture.  ResMed failed on all grounds of invalidity it raised.  However, in exercising his discretion under section 60(3) of the Patents Act 1990 to consider additional grounds of invalidity, the Delegate found the ‘841 patent’s claims invalid for lack of support.

Key Issues:

The key issues included:

Novelty

ResMed raised several prior art citations on novelty: four US patents, as well as public use information regarding the Sullivan Bubble Mask, the Respironics ComfortCurve™, and the Respironics Monarch Mini. In all cases, the Delegate found that the prior art did not anticipate the claims, noting:

  • the lack of “clear and unmistakable directions” in respect of the US patents; and
  • the lack of clear evidence that users, at the relevant time, fitted the prior use masks in a manner that took all the essential features of the claims in issue.

Inventive Step

ResMed presented two main arguments on inventive step based on common general knowledge (CGK) alone:

  1. The applications failed to disclose useful advances over prior art, solutions to particular problems, or overcoming any difficulty.

  2. Absent a specific problem, the invention merely related to an alternative nasal mask for CPAP therapy, with the claims’ features being “well known” or routine variations.

Ultimately, the Delegate was satisfied that the combination of features in the claims was not obvious in light of the CGK alone.  The Delegate highlighted that the invention’s configuration, where side portions seal against the outer surfaces of the sides of the nose to support and stabilize the seal, was not CGK.  The evidence suggested such designs were typically avoided due to potential discomfort, and demonstrated a focus on low-profile masks that sit below the user’s nose.

ResMed also argued obviousness on the basis of CGK taken together with individual prior art masks. ResMed argued that each prior art mask was an example of a useful inflatable mask, and any differences between each prior art mask and the claimed mask were routine variations.  ResMed did not support its position with any evidence. The Delegate rejected ResMed’s arguments, describing ResMed’s submissions as “boilerplate submissions” which were “so vague as to preclude any identification of the case to be answered.”

Clarity

The Delegate dismissed ResMed’s submissions that several terms in the claims lacked clarity.  The Delegate was satisfied that:

  • a skilled person could give terms, such as “side portions” and “central portions”, practical meaning, including where users have varying facial geometry;
  • terms like “outer-wall”, “inward-facing wall” and “perimeter portion/peripheral portion” were clear when read in context as referring to the structure forming the inflatable seal; and
  • terms like “top edge”, “end edge” and “lower edge” were clear in the context of the mask’s structure.

ResMed argued that terms like “substantially parallel” and “substantially normal” lacked a practical benchmark. The Delegate disagreed, finding that the specification provided sufficient context for proper interpretation.  The term “much stiffer” was challenged as being unclear, but the Delegate agreed with expert evidence that a skilled person would understand this to mean the material is sufficiently stiff to achieve the desired structural purposes.

Support

ResMed argued that the specification did not disclose an invention at all or identify the relevant technical contribution; and that, to the extent that the embodiments disclosed some technical contribution, then the claims were broader than those embodiments.  The Delegate dismissed these arguments, noting that ResMed’s submissions did not engage with key considerations relevant to the ground of support and that there was no requirement for the specification to explicitly state the technical contribution.  A key deficiency of ResMed’s case was that its expert was unable to determine what the invention actually was; so the Delegate considered that it followed that this expert would not be in a position to provide a definitive opinion on where the technical contribution lay.

The Delegate identified the technical contribution as a nasal seal with specific features, including a face-contacting side made of soft flexible material, a central portion extending across the nose base, and side portions extending from each end to cover the sides of the nose.  The seal’s face-contacting side was described as supple, conforming to the nose’s surfaces under internal pressure. Exercising his discretion under s 60(3) of the Patents Act 1990 to consider additional grounds of invalidity, the Delegate noted that the ‘841 patent’s claims did not include all these features and thus exceeded the technical contribution.  Fisher & Paykel conceded this point, indicating its intention to amend the ‘841 patent after the opposition decision was delivered.

Remaining grounds of opposition and finding

The Delegate quickly addressed the remaining grounds of opposition: succinctness, utility, and manner of manufacture.  On succinctness, ResMed’s argument regarding the “extraordinary” number of claims across the patent family was rejected, as each application had only a single independent claim and was not “unduly prolix” according to the Delegate.  On utility, the Delegate agreed with Fisher & Paykel that the patents provided a useful choice by offering an alternative CPAP interface with an inflatable nasal seal design.  On manner of manufacture, the Delegate found the mask’s features had a working interrelationship and were not a mere collocation of parts.

Outcome

ResMed’s opposition was entirely unsuccessful, with ResMed failing on all the grounds of invalidity it raised. The only successful ground (support) was one raised by the Delegate exercising his s 60(3) discretion. Accordingly, the Delegate directed all applications (except ‘841) to proceed to grant.  The ‘841 claims were found to be unsupported as they lacked the feature of a supple material conforming to the surface of the user’s nose.  Fisher & Paykel was given two months to propose amendments to ‘841’s claims to address this issue.

Implications

This decision emphasises the critical importance of expert evidence in opposition proceedings, as well as the power of the discretion given to the Commissioner and his delegates under s 60(3) of the Patents Act 1990 to consider additional grounds of invalidity.  In this case, ResMed’s evidence and arguments fell short in key respects, leading to ResMed failing on all the grounds of invalidity it raised.  The only successful ground (support) was one raised by the Delegate exercising his s 60(3) discretion.

 

About Pearce IP

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

Helen Macpherson

Helen Macpherson

Executive, Lawyer (Head of Litigation – Australia)

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

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

Imogen Bain

Imogen Bain

Paralegal

Imogen is a paralegal supporting Pearce IP’s legal and trade mark teams. Imogen prepares patent litigation updates, conducts legal research, and provides paralegal and administrative assistance.

Imogen comes from a background working in hospitality, where she has learnt how to be an effective communicator and work efficiently. Imogen has an interest in the design space, having completed her Certificate III in Design Fundamentals. Her knowledge of the design industry has improved her understanding of the IP realm and has strengthened her passion for IP law. Imogen is a highly disciplined and organised individual who works to assist her colleagues with dedication and optimism.

 

Biocon Switching Study for Aflibercept Confirms Safety & Efficacy

On 23 October 2024, Biocon announced follow-up results from a Phase 3 study of MYL-1701P, biosimilar to Regeneron’s Eylea® (aflibercept).  According to Biocon, the study demonstrated switching patients with diabetic macular oedema (DME) from Eylea® to MYL-1701P produced comparable results in terms of efficacy, safety and immunogenicity.  The results were presented at the annual meeting of the American Academy of Ophthalmology.

Biocon’s aflibercept biosimilar Yesafili was approved in the US in May 2024.  There are currently four other FDA-approved aflibercept biosimilars: Amgen’s Pavblu (August 2024), Sandoz’s Enzeevu™ (August 2024), Formycon/Klinge’s Ahzantive®/FYB203 (June 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024)

Regeneron has sued Biocon, Amgen, Samsung Bioepis, Formycon, Celltrion and Sandoz in US BPCIA litigation regarding aflibercept biosimilars.  A permanent injunction was granted against Biocon on 11 June 2024.  Biocon filed a Notice of Appeal on 21 June 2024.

Biocon’s Yesafili® is currently the only aflibercept biosimilar approved in the EU (September 2023, with UK approval following in November 2023).  Formycon’s MAA application for FYB203 (aflibercept) was accepted by EMA in December 2023 and Alvotech/Advanz Pharma’s MAA for AVT06 (aflibercept) was accepted by EMA in August 2024.  In July 2024, Altos Biologics announced that it submitted an MAA to the EMA for its aflibercept biosimilar ALT-L9, with marketing approval expected in 2025.  At its September 2024 meeting, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Sandoz’s Afqlir™ and Samsung Bioepis/Biogen’s Opuviz™.

New Indication Alert: J&J’s Darzalex® (Daratumumab) Quadruplet Regimen for Multiple Myeloma Approved in the EU

On 23 October 2024, Johnson & Johnson (J&J) announced that the European Commission has approved an indication extension for Darzalex® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT).

This news follows J&J’s Type II variation application to the European Medicines Agency (EMA), and its submission of a supplemental Biologics License Application to the US FDA for the same indication.

In July 2024, the combination regimen was approved by the FDA for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.  In March 2024, J&J submitted an application to the European Medicines Agency for Darzalex® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with multiple myeloma.

Approval Alert: Eli Lilly’s Kisunla™ (Donanemab-azbt) UK Approved but Not Reimbursed

On 23 October 2024, Eli Lilly announced that its Kisunla™ (donanemab-azbt) received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a treatment for mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients who are apolipoprotein E ε4 heterozygotes or non-carriers.  According to Eli Lilly, donanemab is the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed.

Despite this approval, the UK’s National Institute for Health and Care Excellence (NICE) determined that it will not provide coverage of Kisunla™ on the NHS, stating that “the costs of providing donanemab…balanced against the relatively small benefit it provides to patients, means it cannot currently be considered good value for the taxpayer”.

Kisunla™ was first approved in the US (July 2024) and subsequently in Japan (September 2024) for the same indication.  With the UK approval, donanemab becomes the second drug approved by the MHRA as a disease modifying treatment for some people with early-stage Alzheimer’s disease, following the approval of Eisai/Biogen’s Leqembi® (lecanemab) in August 2024.

Samsung Biologics’ Q3/24 Results: Accumulated Revenue at Record High

Samsung Biologics has announced its Q3/2024 financial results, reporting that its accumulated revenue has surpassed KRW 3T for the first time and raising its annual revenue growth guidance to +15-20%.  Samsung’s consolidated revenue reached KRW 1.2T for the quarter, an increase of 15% from Q3/2023.

Samsung Biologics’ quarterly highlights include entering into its largest contract manufacturing organisation (CMO) deal to date with an unnamed US based pharmaceutical company valued at KRW 1.7T (USD $1.06b) and securing 17 out of the global top 20 big pharma companies as clients.

Its subsidiary, Samsung Bioepis, reports increased revenue and operating profit of 26% and 38%, respectively, YOY.  Its quarterly highlights include the launch of ustekinumab biosimilar SB17 in Europe (as Pyzchiva® in July 2024) and Korea (as Epyztek™, approved in April 2024), approval of eculizumab biosimilar SB12 in the US (as Epysqli in July 2024) and a positive CHMP opinion for aflibercept biosimilar SB15 in Europe (as Opuviz in September 2024).

The importance of accurate pleadings: Barilla’s opposition to the BARILLA DUMPLING trade mark in NZ

New Zealand Intellectual Property Office- Trade Marks [2024] NZIPOTM 31 (06 August 2024)

 

Date of decision: 06 August 2024
Body:  IPONZ
Adjudicator: Virginia Nichols, Assistant Commissioner of Trade Marks

Barilla G. e R. Fratelli- Societa per Azioni (”Barilla Group”), owner of the famous BARILLA brand, unsuccessfully opposed an application to register the words “Barilla Dumpling” as a trade mark in respect of “Asian-style restaurant services” in New Zealand.  This case demonstrates the necessity of accurate pleadings in trade mark opposition and revocation proceedings in New Zealand.

Background

The Applicants, the Shaos, applied in August 2016 to register the mark BARILLA DUMPLING for Asian-style restaurant services.  During examination, Barilla Group’s registration for CASA BARILLA was cited as an objection with the applicants overcoming the objection by relying on honest concurrent use and the application was accepted on that basis.  On 20 April 2018, Barilla Group opposed the BARILLA DUMPLING application based on several registrations for marks being or including the word BARILLA.

Key Issues:

1. Oppositions based on prior marks

The New Zealand trade mark opposition system requires the Assistant Commissioner to consider the status of the Opponent’s marks at the filing date of the opposed application and at the time the opposed application would proceed to registration (ie at the date of the hearing): International Consolidated Business Proprietary Limited v SC Johnson & Son Incorporated [2020] NZSC 110 (ZIPLOC).  Following ZIPLOC, the usual practice is to request that the effective date of revocation for non-use of a blocking mark be backdated to a date before the filing date of the opposed application.  This eliminates the blocking mark’s existence at the relevant time being the filing of the blocked application.

In this case, the Opponent’s partially-revoked marks had to be considered with their original, unrevoked specifications for the purposes of the opposition.  The Assistant Commissioner was bound by the Supreme Court’s interpretation in ZIPLOC of the Trade Marks Act 2002, requiring consideration to be given to the state of the registry at the time opposed application was filed.  The Applicants had been successful in partially revoking three of the opponent’s registrations for non-use, but only as of various dates after the filing date of the BARILLA DUMPLING application.  In addition, it was not possible to backdate revocation of the Opponent’s marks to before their application date because that date was less than the minimum three-year non-use period from the date of actual registration.  (The Applicants were also probably unaware of the need to backdate, given that ZIPLOC had not yet been determined at the time of the revocation applications.)

2. Similarity of the marks and the likelihood of confusion (s25(1)(b)

25(1)(b) of the Trade Marks Act 2002 prohibits the Commissioner from registering a trade mark if it is similar to a prior trade mark and covers similar goods/services as the prior mark, and use is likely to deceive or cause confusion.

Barilla Group pressed several marks under this ground including BARILLA CENTRE FOR FOOD & NUTRITION in Classes 35, 41 and 42, BARILLA and in Class 30 and CASA BARILLA in Classes 29, 30, 41 and 43.  Of these marks, only the CASA BARILLA mark was held to cover relevant goods and services but, at the time of the hearing, the mark had been partially revoked for non-use and only covered “entertainment namely wine and food tasting” services in Class 41.  The Applicants’ Asian-style restaurant services were held to be similar to Barilla Group’s wine and food tasting services, the marks were held to be similar for the purpose of section 25, and the Assistant Commissioner found that there was a likelihood of confusion at the filing date of the opposed application due to the broader range of goods and services (even if the likelihood of confusion had subsided by the time of the hearing).

3. Well-known prior marks (section 25(1)(c))

Barilla Group also opposed the BARILLA DUMPLINGS application on the basis that the BARILLA and  trade marks were well known in New Zealand at the filing date of the opposed application.  Surprisingly (to the Pearce IP trade mark team who love a heaping bowl of BARILLA pasta), the Assistant Commission rejected this ground of opposition, finding that the evidence submitted was not sufficient to establish that the Opponent’s BARILLA marks were well-known in New Zealand.

4. Defences to section 25

Section 26 of the NZ Trade Marks Act allows trade mark applicants to overcome objections, including oppositions, raised under section 25 if the applicant(s) can show either honest concurrent use of the applied-for mark or that special circumstances exist that merit the applied-for mark being allowed to proceed to registration (such as prior use).

The Applicants did not plead section 26 as a defence in their counterstatement to the opposition even though the Applicants had argued special circumstances at examination and the opposed application had been accepted on the basis of honest concurrent use.  The Assistant Commissioner found that the failure to plead section 26 in the counterstatement meant that it would be unfair to Barilla Group to rely on prior use alone to establish special circumstances under section 26.

However, the Assistant Commissioner held that special circumstances did, in fact, exist given that:

  1. There was no confusion or actual confusion despite a long period of concurrent use (since June 2010) so the impact on the public was likely to be minimal;

  2. Barilla Group’s use of its BARILLA marks (and any resulting goodwill) is strongly associated with Italian cuisine whereas the Applicants’ mark was specifically limited to Asian-style restaurants so any damage to Barilla Group’s goodwill seemed unlikely;
  3. There was honest concurrent use for at least a three year period between 2013 and 2016;
  4. It was impossible for the Applicants to ask for revocation of Barilla Group’s marks to take effect from before the filing date of their application; and
  5. Even taking into account the partial revocations which were backdated to July 2022, the parties’ marks had coexisted without confusion for almost six years.

As a result, the Applicants succeeded in obtaining registration of the BARILLA DUMPLING mark for Asian-style restaurant services based on special circumstances.

Implications

It is still possible to obtain registration of a trade mark in New Zealand, based on special circumstances, when:

  1. the application is blocked by an earlier-registered mark; and
  2. the blocking mark is revoked for non-use; but
  3. the revocation is not (or could not be) backdated to before the application date of the blocked mark.

Best practice remains to ensure that revocations of potentially blocking marks are backdated, where possible, to before the filing date of the blocked application.

To establish that a trade mark is well-known in New Zealand requires carefully prepared, cogent evidence. Evidence of fame in another country, or general evidence of sales and promotion in New Zealand, is unlikely to be enough on its own.

 

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.

 

Paul Johns

Paul Johns

Executive, Lawyer (Head of Litigation – New Zealand)

Paul is an intellectual property dispute resolution specialist with more than 24 years of experience across New Zealand and the UK. Paul is a seasoned lawyer, IP strategist, and Head of Pearce IP’s litigation team in New Zealand. He is experienced in managing contentious disputes regarding all types of intellectual property and related issues, including patents, copyright, trade marks, designs, confidential information and consumer law. With a background in molecular genetics, Paul has acted for clients across a vast range of industries, including pharmaceuticals, biotechnology, animal health, med-tech, food & beverage technologies, heavy vehicle engineering, fashion, hospitality, and entertainment.

Kimberley Evans

Kimberley Evans

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

Kim is a lawyer and registered Trans-Tasman trade mark attorney with a wide-ranging and impressive practice background spanning private practice, in-house experience and academic activities. Kim’s clients appreciate her responsiveness, and her ability to provide clear and pragmatic branding advice that is tailored to their commercial objectives and informed by industry developments.

Imogen Bain

Imogen Bain

Paralegal

Imogen is a paralegal supporting Pearce IP’s legal and trade mark teams. Imogen prepares patent litigation updates, conducts legal research, and provides paralegal and administrative assistance. Imogen is currently studying for a Bachelor of Laws at the University of Technology, Sydney.

Samsung Biologics’ Record-Breaking Contract Manufacturing Deal Worth USD 1.24B

On 22 October 2024, Samsung Biologics announced that it has entered a contract manufacturing deal worth USD 1.24 billion, with an un-named Asia-based pharmaceutical company.  The contract extends until December 2037, with production to occur at Samsung Biologics’ biomanufacturing site in Songdo, South Korea.

Samsung reports that this deal brings the value of its contracts for 2024 to over USD 3.3 billion.  Prior to this contract, Samsung’s largest contract manufacturing deal was worth USD 1.06 billion and was signed in July 2024 with an un-named US-based pharmaceutical company.

Regeneron Fails to Injunct Amgen’s US Aflibercept Biosimilar for Second Time; Amgen to Launch At Risk

On 22 October 2024, the United States Court of Appeals for the Federal Circuit ruled that Regeneron was not entitled to an injunction preventing Amgen from launching its aflibercept biosimilar pending appeal.  That appeal concerns a September 2024 decision of the US District Court for the Northern District of West Virginia denying Regeneron’s motion for a preliminary injunction against Amgen.

However, the Appeals Court has agreed to expedite the appeal proceeding, with the hearing set for January 2025.

Following the decision of the Appeals Court, media reports reveal that Amgen intends to launch its US aflibercept biosimilar, Pavblu™, “as quickly as possible”.  Pavblu™, biosimilar to Regeneron’s Eylea® was approved by the FDA in August 2024 for nAMD, macular oedema following RVO, diabetic macular oedema and diabetic retinopathy.

The proceedings brought by Regeneron against Amgen are part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Biocon (Yesafili™ approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions; aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024).

The US District Court’s refusal to grant a preliminary injunction against Amgen differs from decisions of the same Court to grant preliminary injunctions against Samsung Bioepis (14 June 2024), Formycon (21 June 2024) and Celltrion (June-July 2024), and a permanent injunction against Biocon (11 June 2024), based on findings of infringement of Regeneron’s US patent 11,084,865 (ophthalmic formulations of a VEGF antagonist).

Samsung Bioepis, Formycon and Celltrion lodged appeals from the preliminary injunction orders (on 14 June 2024, 25 June 2024, and 10 July 2024, respectively).  Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024.  Those appeals are all pending.

BioBlast® Editor and Contributing Author

Naomi Pearce & Emily Bristow

Naomi Pearce & Emily Bristow

Editor: Naomi Pearce, Executive Lawyer, Patent Attorney & Trade Mark Attorney
Contributing Author: Emily Bristow, Law Graduate

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