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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.

International Day for the Elimination of Violence Against Women – 25 November 2024 – Rosie’s Story

Today is the International Day for the Elimination of Violence Against Women.  In 1993, the UN General Assembly defined violence against women as:

any act of gender-based violence that results in, or is likely to result in, physical, sexual or psychological harm or suffering to women, including threats of such acts, coercion or arbitrary deprivation of liberty, whether occurring in public or in private life.

In a way that is both strong and courageous, Pearce IP’s Rosie Stramandinoli has agreed to share the confronting story that affected her life when, as a child, violence in her home escalated to murder.

Rosie goes on to share how that single event shaped and impacted her life.  Be inspired by Rosie’s story of resilience, strength, and great success, despite trauma.

Warning: The following video contains material that may be disturbing to some.

You can watch Rosie’s story here:

 

 

About Pearce IP

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

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

 

New Indication Alert: Chugai/Zenyaku’s Rituximab Approved in Japan for Chronic ITP in Children

On 22 November 2024, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare for chronic idiopathic thrombocytopenic purpura (ITP) in children (IV injection, 100mg and 500mg).  Rituxan® was previously approved in Japan for chronic ITP in adults only.

Rituximab is not currently approved in the US or EU for chronic ITP.

Genentech and Biogen collaborate on Rituxan® in the United States, and Roche markets the drug as MabThera® in the rest of the world, except Japan, where Rituxan® is co-marketed by Chugai and Zenyaku.

Rituximab was one of the first mAbs to become “biosimilar”.  Both Pfizer and Sandoz/Kyowa Kirin market rituximab biosimilars in Japan.  There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020), Pfizer’s Rituxience® (launched in January 2020) and Amgen and Allergan’s RiabniTM (approved by the FDA in December 2020).

J&J Seeks FDA Approval for SC Induction Regimen of Tremfya® (Guselkumab) in Ulcerative Colitis

On 22 November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA seeking approval of a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).  The filing is supported by data from the Phase 3 ASTRO study (NCT05528510).

This follows the recent approval of Tremfya® in the US for UC, with an intravenous induction dose followed by subcutaneous maintenance (September 2024).  Tremfya® is also under consideration for approval for UC in Australia and Europe.

Celltrion Denosumab Biosimilars First to be Approved in Korea

On 22 November 2024, Celltrion announced that the Korean Ministry of Food and Drug Safety has approved its Stoboclo™ (CT-P41, denosumab) and Osenvelt™ (CT-P41, denosumab), biosimilars to Amgen’s Prolia® and Xgeva®, respectively.

Stoboclo™ and Osenvelt™ are the first denosumab biosimilars to be approved in Korea and are approved for all indications of the reference medicines.

Celltrion entered into a joint sales agreement with Daewoong Pharmaceutical in October 2024 under which the two companies will jointly promote Celltrion’s denosumab biosimilars in Korea.  According to Daewoong Pharmaceutical, CT-P41 is scheduled to be launched in the first half of 2025 in Korean hospitals and clinics.

In December 2023, Celltrion filed an abbreviated Biologics Licence Application for CT-P41 (denosumab biosimilar to Prolia®) in the US.  In May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab.  US litigation regarding denosumab biosimilars is also pending against Fresenius Kabi (FKS518/commenced October 2024), Samsung Bioepis (SB16/commenced August 2024), and Accord/Intas (INTP23, November 2024).  An earlier dispute between Amgen and Sandoz was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars Jubbonti® and Wyost® in the US from 31 May 2025 (or earlier in certain undisclosed circumstances).

Replimune Submits BLA for RP1 with Nivolumab for Melanoma

On 21 November 2024, Replimune announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec, a genetically modified oncolytic strain of HSV-1 virus) in combination with Opdivo® (nivolumab) for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen.  The submission was made under the Accelerated Approval pathway.  The Company also announced that the FDA has granted Breakthrough Therapy designation to RP1 in combination with nivolumab in the same setting. 

Opdivo® is was approved in Europe in August 2023 for treatment of melanoma as monotherapy. 

Approval Alert: FDA Approves Jazz Pharmaceutical’s Ziihera® (Zanidatamab-hrii) for Biliary Tract Cancer

On 20 November 2024, Jazz Pharmaceuticals announced that the US FDA has granted accelerated approval of Ziihera® (zanidatamab-hrii) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test.  The approval is supported by data from the Phase 3 HERIZON-BTC-01 trial (NCT04466891) which demonstrated a 52% objective response rate and a median duration of response (DOR) of 14.9 months as determined by independent central review.

Jazz Pharmaceuticals says that continued approval of this indication “may be contingent upon verification and description of clinical benefit in a confirmatory trial”.

Zanidatamab is being developed by Jazz and BeiGene under licence agreements from Zymeworks, which first developed the molecule.

Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Receives EU Approval

On 20 November 2024, Pfizer announced that the European Commission (EC) has approved its Hympavzi™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe haemophilia A without FVIII inhibitors or severe haemophilia B without FIX inhibitors.  Hympavzi™ is the first and only anti-tissue factor pathway inhibitor (anti-TFPI) approved in the EU for treating haemophilia A and B, and the first that can be delivered using a pre-filled auto-injector pen.

The approval is based on results from the Phase 3 BASIS trial (NCT03938792) which showed that Hympavzi™ significantly reduced the annualised bleeding rate for treated bleeds by 35% during the 12-month active treatment period, demonstrating non-inferiority and superiority compared to routine prophylaxis with FVIII or FIX administered as part of usual care.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Hympavzi™ in September 2024.  Hympavzi™ was approved by the US FDA in October 2024.

New Indication Alert: FDA Approves UCB’s Bimzelx® (Bimekizumab-bkzx) as First IL-17A/IL-17F Inhibitor for Hidradenitis Suppurativa

On 20 November 2024, UCB announced that Bimzelx® (bimekizumab-bkzx) was approved by the FDA as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa.

This follows the recommendation of the EMA’s Committee for Medicinal Products for Human Use (CHMP) of an indication extension for Bimzelx® for the treatment of hidradenitis suppurativa in March 2024, and its approval in April 2024.

In November 2024, UCB presented new two-year data from phase 3 studies of Bimzelx® showing sustained improvements in clinical and patient-reported outcomes in adults with active psoriatic arthritis and ankylosing spondylitis.

Pearce IP Founder Naomi Pearce is the 2024 Lawyers Weekly Women in Law “Executive of the Year”

We are delighted to announce that Pearce IP’s Founder & CEO, Naomi Pearce, was named Executive of the Year at the 2024 Lawyers Weekly Women in Law Awards. 

The Women in Law Awards recognisethe influence of exceptional women across the Australian legal industry”.  The Executive of the Year Award honours the talent and dedication of female CEOs and Founders leading Australia’s law firmsThis award recognises Naomi’s exceptional leadership, dedication and unwavering commitment to advancing the legal profession. 

Naomi founded Pearce IP in 2017, and in 7 short years has grown it into a premier life sciences focused IP practice spanning Australia and New Zealand.  Pearce IP is certified as women ownedIt is a place where pay parity is a given, and where women in leadership is the normAt Pearce IP, generous policies enable women in law to thrive. 

Naomi was selected as the winner of “Executive of the Yearfrom a shortlist of 9 exceptional Executives Naomi was honoured at the award ceremony as a finalist for the Lawyers Weekly Excellence Award which recognises the highest scoring winners across all categories of the Women in Law Awards.

Pearce IP’s Executive, Deputy CEO and Head of Talent, Adele Chadwick, says: 

“The qualities of any leader include courage, commitment and excellence, and Naomi has all three in spades. 

 

Starting an IP law firm takes courage.  Ensuring staff are the best in their industry and backing them takes commitment.  Demonstrating expectations and values in the workplace shows excellence to all.  With those three things, Naomi has built a thriving firm with staff who are engaged and committed to ensuring Naomi’s vision for Pearce IP continues to exceed all expectations and comes to fruition. 

 

The team at Pearce IP are incredibly proud of Naomi’s achievements and while we are not surprised at the respect she has earned within the legal sector, we are constantly reminded of her humility and gratefulness. 

 

Congratulations Naomi!” 

We congratulate Naomi on this well-deserved recognition and thank her for her ongoing contributions to the legal profession and Pearce IP’s success.

 

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.

 

Settlement Sense and Costs Consequences: Federal Court’s Latest Guidance

Background

As patent proceedings involve substantial legal expenses, parties typically employ various mechanisms to optimise cost recovery, often by issuing Calderbank letters as well as formal Notices of Offer under the Federal Court Rules, which place the receiving party at risk of indemnity costs orders should the other party receive a more favourable judgment than the terms proposed in the offer.

The financial implications can be significant: while standard party/party costs orders typically result in recovery of approximately 60% of actual legal costs, an indemnity costs order can lead to recovery of up to 100%.

Here, we report on three recent decisions that demonstrate the Federal Court’s nuanced approach to costs orders and the consideration of settlement offers: Samsung Bioepis v Janssen, Stasiuk v Monster Energy Au, and Rakman International v Boss Fire & Safety.

Samsung Bioepis v Janssen

In January 2024, Samsung Bioepis AU Pty Ltd (Samsung) commenced proceedings against Janssen Biotech, Inc. (Janssen) seeking to revoke two certified innovation patents, AU2023100041 and AU2023100042 (the Old Patents), entitled ‘Safe and effective method of treating ulcerative colitis with anti-il12/il23 antibody’, citing certain prior art to allege a lack of novelty and innovative step.

In February, Janssen notified Samsung of new innovation patent application filings (AU2024100006, AU2024100007 and AU2024100016) (the New Patents) which excluded endpoints referred to in Samsung’s prior art citations.  Samsung opposed Janssen’s intention to incorporate the New Patents into the existing proceedings prior to certification.  Janssen subsequently agreed to proceed with a November 2024 trial date while reserving its rights in respect of the New Patents.  After the New Patents were certified in August 2024, Janssen filed separate proceedings rather than amending the pleadings (as it had foreshadowed earlier in March).  Justice Downes ordered the initial proceedings to be discontinued with Janssen to pay Samsung’s costs, prompting Samsung to seek indemnity costs, or alternatively on a special basis per James Hardie International Finance BV v CSR Limited [2007] FCA 366.

Consideration and Outcome

Justice Downes considered the following factors, ultimately rejecting Samsung’s application for indemnity costs or costs on a “James Hardie” special basis:

  1. Accrual of significant time and expense

Justice Downes noted that Samsung filed the proceedings without notice to Janssen and immediately sought to expedite them.  Samsung pushed for a November 2024 trial date despite knowing about the New Patents and the possibility that Janssen would seek to amend to include the New Patents.  Justice Downes concluded that this undermined Samsung’s complaint about accrued time and expenses.

  1. Surrender of Old Patents

Justice Downes rejected Samsung’s argument that Janssen’s lack of explanation as to the surrender of the Old Patents implied awareness of a weak case.  Her Honour found that Janssen likely filed the New Patents as a safeguard against potential losses and to strengthen its position generally.  Noting Janssen’s earlier intention to prosecute both the Old and New Patents, Justice Downes inferred that the decision to surrender was recent and thus declined to conclude that Janssen prolonged the pursuit of a hopeless or unmeritorious case.

  1. Disclosure of Intentions

Samsung complained that Janssen did not suggest that it would rely on the New Patents instead of the Old Patents.  Justice Downes, however, found no evidence that Janssen always intended to abandon the Old Patents, considering it just as likely that Janssen waited for the New Patents’ certification before deciding to surrender the Old Patents.

  1. Impact on the Dispute

Justice Downes considered that if Janssen had not surrendered the Old Patents and agreed to the discontinuance orders, a trial would have proceeded in November 2024 where Samsung, if successful, would only receive costs on a standard basis.  By surrendering the patents and consenting to discontinue the initial proceedings, her Honour observed that Janssen helped reduce costs and narrow the issues in dispute.

Stasiuk v Monster Energy Au

In April 2023, Joseph Stasiuk sued Monster Energy Au Pty Ltd (Monster) for infringement of his expired patent AU2006202191 (the ‘191 Patent) entitled ‘Laser-etched pull tab container opening devices and methods of making the same’.

Justice Nicholas ultimately dismissed Mr Stasiuk’s proceedings in March 2024 because he failed to fulfil a security for costs order, to file a Notice of Address for Service (Mr Stasiuk no longer had Australian legal representation and was based in the Cayman Islands) and to file evidence in chief on infringement.  Monster sought its costs of the proceeding on an indemnity basis to be assessed in a lump sum.

In seeking indemnity costs, Monster relied on two settlement offers:

  1. A July 2023 Calderbank offer on a “walk away” basis where each party would bear their own costs.  The offer explained that Mr Stasiuk’s likely unrecoverable costs would exceed the maximum possible damages (estimated at US$76,000 based on an existing third-party licence agreement for patents within the same family as the ‘191 Patent).  Monster applied the royalty rate used in that licence, which it considered to be highly favourable to Mr Stasiuk, to the total number of Monster Cans sold in Australia during the relevant period, despite Monster maintaining that many of those cans did not incorporate the allegedly infringing feature.  Stasiuk counteroffered for US$20 million, arguing that the existing licence was not comparable as it was negotiated during the patent’s “infancy”, and with a willing licensor as opposed to a “flagrant infringer”.
  1. A November 2023 Notice of Offer to Compromise (pursuant to r 25.01 of the Federal Court Rules) of US$220,000 plus costs (which included a 1.5x higher royalty rate and additional US$100,000 for supplementary damages), which Mr Stasiuk also rejected.

Consideration and Outcome

Justice Nicholas held that the July 2023 Calderbank ‘walk away’ offer was not a genuine compromise, observing that it was reasonable for Mr Stasiuk to reject an offer to discontinue proceedings with each party bearing its own costs, especially given the early stage of proceedings and unclear prospects at the time.

However, his Honour held that Mr Stasiuk unreasonably rejected the November 2023 offer considering its favourable terms (1.5x royalty rate plus additional damages and costs), appropriate consideration time (14 days) and clear expression.  Further, since Mr Stasiuk had access to Monster’s Product and Process Description for two months and had attended mediation at the time of offer, Justice Nicholas inferred that Mr Stasiuk no longer believed the costs and uncertainty of pursuing the case to be justified.  In accordance with r 25.14(2) of the Federal Court Rules, Justice Nicholas ordered Mr Stasiuk to pay Monster’s costs on a party/party basis before 1 December 2023, and indemnity costs thereafter.

Justice Nicholas also ordered that Mr Stasiuk pay Monster’s costs on a lump sum basis given his overseas residence in the Cayman Islands, failure to pay security for costs, and lack of legal representation after December 2023.  Adopting the ‘broad brush’ approach taken by Jackson J in Frigger v Trenfield (No 12) [2022] FCA 900, his Honor calculated Monster’s costs at AUD$522,947.98, but notably excluded Monster’s request for potential costs for enforcing the order in the Cayman Islands as this exceeded the Court’s jurisdiction.  Citing Coshott v Burke (No 2) [2018] FCAFC 81, Justice Nicholas applied a minor reduction to AUD$520,000 to account for possible overestimation.  Having rejected Monster’s second offer, Justice Nicholas’ orders represented an AUD$850,000 turnaround for Mr Stasiuk (not including his own legal costs), highlighting the consequences of non-compliance with court orders and the risks involved in rejecting reasonable settlement offers.

Rakman International v Boss Fire & Safety

Rakman International Pty Limited (Rakman) and Trafalgar Group Pty Ltd (Trafalgar Group) (together, Trafalgar) sued Boss Fire & Safety Pty Ltd (Boss) and its sole director, Mark Prior, for infringement of patent AU2017101778 (the Patent).  Boss counter-claimed seeking revocation as well as relief for unjustifiable threats and misleading conduct under the Australian Consumer Law.  Justice Yates found all patent claims invalid, meaning Trafalgar’s infringement case failed (though his Honour noted if the patent was valid, Trafalgar would have succeeded against Boss, but not Mr Prior).  While Boss’ unjustifiable threats claim failed, they succeeded in proving Trafalgar engaged in misleading conduct regarding a letter sent to building industry firms making statements concerning Boss’ conduct.

On costs, Trafalgar argued they should receive 90% of their infringement claim costs as it had succeeded on construction and infringement, subject to Justice Nicholas’ adverse findings on validity.  Trafalgar further submitted that it should only pay 30% of Boss’ cross-claim costs, estimating a significant portion of Boss’ written submissions and evidence addressed grounds of revocation which were abandoned or else failed.

Boss sought indemnity costs based on Trafalgar’s rejection of a July 2019 settlement offer (the Offer) to discontinue proceedings if Trafalgar paid 80% of Boss’s costs.  Justice Yates initially found Trafalgar’s rejection of the Offer to be unreasonable, thus engaging r 25.14(2) of the Federal Court Rules, and consequently ordered indemnity costs thereafter.

Trafalgar subsequently appealed, with the Full Court finding that an offer to merely discontinue proceedings would have left the Patent’s validity “at large” with no contractual barrier preventing Boss from bringing fresh revocation proceedings.  The Full Court ordered costs of the proceeding (including the cross-claim) on a party/party basis, and remitted the matter back to Justice Yates to determine what discount, if any, should apply to Boss’ costs to account for matters that were abandoned or unsuccessful.

Submissions

Trafalgar proposed that Boss receive costs on a global basis with a 60% discount for matters that were abandoned or unsuccessful.  Boss characterised this as a “deep discount” and argued that Trafalgar’s conduct in the proceedings was “wasteful”.  Citing Burchett J in Australian Conservation Foundation v Forestry Commission of Tasmania (1988) 81 ALR 166, Boss further submitted that although it raised grounds which it abandoned at trial or else were rejected, they were not raised unreasonably and so should not be penalised.  Finally, Boss submitted that its offer, and Trafalgar’s failure to accept it, remained relevant to the Court’s broad discretion in making an appropriate costs order.

Consideration and Outcome

Justice Yates emphasised Boss’ comprehensive victory, noting it had established invalidity, defeated the alleged infringement claim against Mr Prior personally, and succeeded in its misleading conduct claim against Trafalgar.  Nevertheless, his Honour was satisfied that some discount should be applied.  In reaching this conclusion, Justice Yates noted that:

1. Boss’ failed patent construction arguments were reasonable, supported by expert evidence, and formed a limited part of the case.  Justice Yates further observed that given Boss’ failed unjustified threats claim shared a factual basis with their successful misleading conduct claim, a discount in respect of this failed claim was not warranted.

2. Boss succeeded in establishing invalidity based on disclosures made at the ‘Seltor meeting’ (which his Honour found to be novelty-destroying).  While some invalidity grounds failed (utility and claim support), Justice Yates noted these were not Boss’ primary validity challenges and were partly determined by the construction issues.  Nevertheless, his Honour held that this warranted some discount as the utility ground proceeded on a misunderstanding of the invention.

3. Some discount should be applied for grounds which Boss abandoned, including the abandoned ground of lack of sufficient description.

4. In relation to the claims that were abandoned by Boss as part of its lack of novelty case or else were decided against it, Trafalgar had mounted a “fantastical” and “fruitless” attack on Boss’ evidence which it was forced to defend and which unnecessarily complicated the case.  His Honour also noted that, where Boss’ evidence did not independently prove lack of novelty, it was relevant to, and corroborative of, the evidence of what transpired at the ‘Seltor meeting’.  Consequently, his Honour held that a discount was not warranted with regard to these aspects of its cross-claim.

Noting the impossibility of precisely calculating the appropriate discount, based on his Honours experience of the trial and analysis of the evidence, Justice Yates determined a 20% discount was fair – rejecting Trafalgar’s “extravagant” 60% reduction proposal as unjust.  As a final observation, Justice Yates stated that Trafalgar’s rejection of the Offer was not relevant to his Honour’s determination.

Conclusion

These decisions illustrate that the strategic deployment and formulation of Notices of Offer and Calderbank letters can materially affect the ultimate costs position of parties in patent disputes.  However, their effectiveness depends on factors such as the stage of proceedings, available evidence, and the overall conduct of the parties.

As seen in Samsung Bioepis v Janssen, the Court will not grant indemnity costs without exceptional circumstances justifying such an order.  Similarly, in Rakman International v Boss Fire & Safety, the Full Court emphasised that an offer to merely discontinue proceedings, leaving fundamental issues unresolved, may not trigger the costs consequences under the Federal Court Rules.  Finally, Stasiuk v Monster Energy Au highlights the importance of compliance with court orders and the risks involved in rejecting reasonable settlement offers.

 

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.

 

Supreme Court of India Directs Delhi HC to Reconsider Injunction Against Zydus’ Pertuzumab Biosimilar

On 19 November 2024, the Economic Times reported that the Supreme Court of India has directed the Delhi High Court to move quickly on reconsidering an injunction, which was reinstated in October 2024, preventing Zydus from manufacturing, selling and marketing Sigrima™, biosimilar to Roche’s Perjeta® (pertuzumab).  The matter is scheduled for hearing on 2 December 2024.

The decision to reinstate the injunction followed an appeal by Roche of an earlier order of the Court on 9 October 2024, which reversed an injunction order originally granted in July 2024.

Roche commenced proceedings earlier this year, alleging that Zydus’ Sigrima™ infringes Indian patent numbers IN 268632 and IN 464646.  Zydus received conditional approval for its pertuzumab biosimilar from the Central Drug Standard Control Organisation (CDSCO) on 4 April 2024, obtaining permission to market the drug on 27 June 2024 and subsequently launching Sigrima™ on the Indian market.

MSD’s Positive Phase 3 Results for Subcutaneous Pembrolizumab

On 19 November 2024, MSD (Merck in the US and Canada) announced positive topline results from its Phase 3 trial evaluating subcutaneous (SC) administration of pembrolizumab, together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy.  The SC pembrolizumab (MK-3475A) demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab,) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC).

The Phase 3 trial (MK-3475A-D77) is part of MSD’s SC pembrolizumab clinical development program, which also includes a Phase 3 trial (MK-3475A-F84), evaluating SC pembrolizumab versus IV Keytruda®, each administered alone, for first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression, and a Phase 2 trial (MK-3475A-F65) evaluating SC pembrolizumab in relapsed or refractory classical Hodgkin lymphoma or primary mediastinal large B-cell lymphoma.  MSD is also conducting a Phase 2 patient preference study (MK-3475A-F11) to assess reported preference for SC pembrolizumab versus IV Keytruda®.

In October 2024, MSD reported 17% growth in Keytruda® sales for Q3 2024, to US$7.4 billion, attributed to increased global uptake in earlier stage indications, including triple negative breast cancer, renal cell carcinoma and NSCLC, together with continued global demand for metastatic indications.

Xbrane and Intas to Jointly Develop Nivolumab Biosimilar

On 19 November 2024, Xbrane and Intas announced they have entered an exclusive, global licensing and co-development agreement in relation to Xbrane´s nivolumab biosimilar candidate (referencing BMS’ Opdivo®).  The biosimilar will be commercialised through Intas’ subsidiary Accord Healthcare.

Under the agreement, Xbrane will receive an upfront payment of 10 million euros plus milestone payments of 3 million euros and royalties on profits.  Intas will finance and oversee the clinical and regulatory development activities and the global commercialisation of the biosimilar.

This announcement is in line with Xbrane’s previously published, updated expectation of finalising this agreement by the end of November 2024.  Xbrane says the product will be launched after expiry of relevant patents in the US in December 2028 and Europe in June 2030.

This deal adds to Intas’ portfolio of licensed biologics and biosimilars which includes:

Four Peptides, No Problem: Neoantigen Patent Stands Strong in Opposition Proceedings

 

Date of decision: 07 August 2024
Body:  Australian Patent Office
Adjudicator: Delegate K. Wagg

Background

Delegate Wagg of the Australian Patent Office has ruled in favour of Dana-Farber Cancer Institute, Inc. and The General Hospital Corporation (the Applicants) in “straw person” opposition proceedings brought by QIP Nominees Pty Ltd (QIP), a company within the QANTM intellectual property group.

QIP failed on all grounds it argued, including sufficiency, support, utility, novelty, inventive step and manner of manufacture.  Delegate Wagg’s decision highlights the central importance of expert evidence when mounting an invalidity challenge.  QIP’s failure to support key invalidity grounds, such as sufficiency, support and utility, with adequate expert evidence led to the Delegate rejecting these grounds of invalidity.

The proceedings related to divisional application AU2018206769 (the Opposed Application) entitled ‘Compositions and methods of identifying tumor specific neoantigens’.

The claim the subject of the Opposed Application is for a personalised cancer treatment approach that identifies and utilises tumor-specific neoepitopes for cancer vaccines.  The method involves three main steps:

1. Identification of DNA mutations by comparing whole genome, whole exome, or RNA sequencing of a patient’s tumor cells to their normal cells.

2. Application of validated peptide-MHC binding prediction algorithms to generate candidate T cell epitopes that may bind to the patient’s HLA alleles, based on non-silent mutations present in the tumor.

3. Optional demonstration of antigen-specific T cells against the peptides or demonstration that a candidate peptide binds to HLA proteins on the tumor surface.

This approach results in a patient-specific and tumor-specific composition comprising at least four peptides, each representing a different tumor neoepitope.  These peptides are predicted to bind to the patient’s HLA alleles with high affinity (IC50 < 150 nM) and represent expression products of subject-specific and tumor-specific mutations absent in the patient’s normal cells.

Key Issues

Construction and Clarity

The Delegate first considered how the claims would be construed and whether he agreed with QIP’s allegation of lack of clarity.

One of the key issues on construction was whether, in the context of the claims of the Opposed Application, a distinction should be drawn between “a method of treatment” claim (the formulation used in the Opposed Application) and a “method for treatment” claim.  The Delegate did not agree that there was “much of a distinction”, but noted that in every case the claims are to be construed in the context of the specification, the terms used and what it means to the skilled person.  The Delegate agreed with the Applicants’ construction of the Opposed Application’s method of treatment claims, stating that the method of treatment indicates that the claim must treat the particular condition.

The Delegate then went on to consider a range of terms which QIP had alleged were unclear.  The Delegate noted that a claim will be clear if a person skilled in the art could ascertain “whether or not what he proposes to do falls within the ambit of the claim”.  The lack of a precise definition in claims may not be fatal so long as the claims provide a workable standard suitable to the intended use.  However, if the monopoly defined by the claims cannot be determined, then the claims must fail for want of clarity.

Although QIP did not file submissions on clarity, QIP’s Statement of Grounds and Particulars alleged that:

1. The words “neoantigen”, “neoepitope” and “mutant peptide” used in the claims were unclear as they were used interchangeably, and that the phrase “at least 4” was vague and open-ended.  The Delegate disagreed, finding that a skilled person would be familiar with these terms and their meanings in context and that they denoted a minimum of 4 peptides, with no maximum specified.  No evidence was submitted that these terms would be unclear to a skilled person.

2. The phrases “bind to”, “is predicted to bind”, “the class I HLA allele”, and “IC50 of less than 150 nM” were unclear.  The Delegate disagreed, finding that these terms provided workable standards and limitations, and that there was no evidence that specific affinities were required in this technology or that the terms were unclear.

Sufficiency

QIP argued that the specification did not disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art.  QIP contended that:

1. Not all peptides with predicted binding would work, the IC50 threshold of less than 150nM was arbitrary, and that it was implausible that everything within the scope of the claims would work.  QIP relied on expert evidence that if large-scale testing was done, it is likely that more peptides with a predicted IC50 of less than 150 would show an experimentally determined IC50 of greater than 500.  In reply, the Applicants relied on expert evidence which showed that all but one of the peptides with a predicted IC50 below 150nM had an experimentally determined IC50 of less than 500nM.  In dismissing QIP’s arguments, the Delegate relied on the Applicants’ expert evidence, noting that large-scale testing would merely provide a low probability that one could end up with a composition where all four peptides in the composition failed.  The Delegate also note that QIP had not provided any calculations of this probability or evidence as to additional peptides wherein the predicted and experimental binding affinities are inconsistent.

2. The claims, being directed to “cancer”, could not satisfy the sufficiency requirements as it would be unlikely that all cancers could be treated this way.  The Delegate disagreed, finding that the method’s reliance on cancer-specific neoepitopes made it applicable to various cancer types.  QIP had not provided evidence of cancers without neoepitopes or mutated peptides.

3. Carrying out the invention would be an undue burden.  The Delegate disagreed, finding that the specification provided the methodology.  While the application of the methodology to the specific patient required work (using genomics, algorithms and assays), the amount of work required to perform the invention was not of a type that would give rise to a lack of clear enough or complete enough disclosure.

Consequently, QIP failed to establish this ground.

Support

On Support, QIP relied on their sufficiency submissions that the claims were directed to a method of treating any cancer, yet the specification did not show the treatment of any cancer.  The Delegate acknowledged that the specification did not include treatment that one would expect in a clinical study and instead included cell-based assays.  Nevertheless, the Delegate identified the technical contribution of the invention as a method involving: (i) identifying epitopes in an individual’s own cancer cells; (ii) screening them for epitopes with a predicted binding of less than 150nM; and (iii) using at least four of them for a vaccine.  The Delegate reasoned that it would logically follow that this methodology would work in all cancers that produce epitopes.  As QIP did not file evidence of cancers that do not produce epitopes, the Delegate concluded that the claims did not exceed the technical contribution to the art.

Utility

QIP argued that the claims failed for inutility on a number of grounds, including because they did not inevitably meet the promise of treating cancer, lacked specificity in peptide amount, and failed to provide data supporting treatment across all cancer types.  QIP also raised concerns about the effectiveness of peptides with predicted binding, the open-ended nature of the “at least four” peptides claim, and the lack of data on combinations with additional therapeutics.

QIP ultimately failed to prove inutility due to a lack of evidence, with the Delegate noting that “utility essentially requires evidence of something within the scope of the claim failing to meet the promise”.

Novelty

QIP relied on three scientific papers for novelty.  The Delegate rejected QIP’s arguments, finding that none of the cited scientific publications provided clear and unmistakable directions to make the invention claimed in the Opposed Application.  In the case of two of the scientific publications, the Delegate considered that they looked to the future, for one publication the future of what an “ideal” vaccine would be (rather than providing specific instructions on how to achieve it), and for the other publication a future approach which did not outline specific features of the claims (such as using at least 4 peptides and screening to a threshold of IC50 of <150nM).  In the case of the third scientific publication, the Delegate considered that it did not disclose the use of whole genome sequencing (instead focusing on easily amplified areas of the genome), used a different IC50 threshold (500nM) than the claimed invention, and did not require at least 4 peptides to be used in any future immunological composition and method.

Inventive Step

The Opponent argued lack of inventive step based on common general knowledge (CGK) alone and in combination with prior art documents.

The Delegate first considered and rejected the lack of inventive step case based on CGK alone.  In reaching this conclusion, the Delegate addressed the parties’ submissions on CGK, finding that:

1. Neoantigens formed part of the CGK, given that the parties’ experts agreed that neoantigens were known in the field before the priority date and the Opposed Application discussed neoantigens and cited several documents discussing neoantigens.

2. Use of neoantigens in cancer vaccines appeared to be an area of interest to some research groups, but how widely known they were or their use in cancer vaccines had not been established as CGK.

3. Whole genome sequencing and cancer gene sequencing were known at the priority date.  The Delegate relied on the experts’ evidence to form this conclusion, noting that he did not consider that the prior art documents that used sequencing constituted sufficient evidence on their own to establish CGK in the field.

4. Algorithmic prediction of epitopes for HLA proteins was known before the priority date, however, the evidence did not establish how widely known or used these algorithms were in the field.

5. Rammensee et al., (2008) Genomics and Personalized Medicine “Cancer Vaccines: Some Basic Considerations” did not form part of the CGK.  In particular, there was no evidence to show that its contents were widely known or accepted.

The Delegate then considered whether the claimed invention lacked an inventive step when compared to the CGK in combination with three prior art documents which had previously been considered for the ground of novelty.  The Delegate rejected the lack of inventive step case based on the CGK and each of the prior art documents taken separately, finding that:

1. In the case of two of the prior art publications, while they suggested an ideal vaccine involving whole genome sequencing using algorithms to find potential epitopes or an “ultimate strategy” for cancer vaccines involving whole genome sequencing:

  • there were key differences between the prior art publications and the invention claimed in the Opposed Application such as the IC50 threshold of 150nM and the use at least four peptides; or
  • they did not provide guidance on the IC50 threshold or use of at least four peptides.

2. In the case of the third prior art publication, it did not teach the use of whole genomic sequencing, used a different IC50 threshold (500nM) than the claimed invention and did not suggest that at least four peptides are to be used.

Manner of Manufacture

QIP submitted that the requisite threshold of invention was not met as the methods of identifying subject and tumor-specific peptides were known in the art and would have been considered by a skilled person for use in cancer vaccines.  The Delegate rejected this argument, noting that there was nothing on the face of the Opposed Application to suggest a lack of inventiveness, and the mere assertion that a skilled person would have thought about using neoantigens for a cancer vaccine was insufficient.

Outcome

Ultimately, QIP failed on all grounds that it argued.  The Delegate directed that the Opposed Application proceed to grant and awarded costs against QIP.

Implications

The decision of Delegate Wagg offers a number of important lessons.  In particular, Delegate Wagg’s decision emphasises:

1. the central importance of expert evidence when mounting an invalidity challenge.  QIP’s failure to support key invalidity grounds, such as sufficiency, support and utility, with adequate expert evidence led to the Delegate rejecting these grounds of invalidity;

2. the high bar that must be met to invalidate a patent on the basis of novelty; and

3. the challenges in establishing CGK in evolving fields.  Although the prior art discussed and considered neoantigen use in cancer vaccines and whole genome sequencing, this was merely a ‘promising research area’ and not widely accepted at the time.

 

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.

 

Canada’s Drug Agency Recommends Against Reimbursement of Ebglyss™ (Lebrikizumab)

On 15 November 2024, Canada’s Drug Agency (CDA-AMC) published its final recommendation for Eli Lilly’s Ebglyss™ (lebrikizumab), recommending against reimbursement of Ebglyss™ by public drug plans, excluding Quebec, for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years of age and older.

On 19 November 2024, Eli Lilly published a statement expressing disappointment and “strong disagreement” with the CDA-AMC’s recommendation.  Kenneth Custer, General Manager for Lilly Canada, stated that the CDA-AMC’s recommendation is “inconsistent with all other HTA bodies that have reviewed Ebglyss”, and that “repeat misalignment with other domestic and international HTA agencies does not establish Canada as a predictable or competitive market for innovative medicines”.

Ebglyss™ was approved by Health Canada in June 2024 and received a positive reimbursement recommendation with conditions by the L’Institut National d’Excellence en Santé et Services Sociaux (INESSS) as a first line biological therapy in Quebec.  Ebglyss™ has also received positive recommendations in the EU (September 2023), UK, France and Australia (July 2024).

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

Regeneron Sues Sanofi For Breach of Dupixent® Collaboration Agreement

Regeneron has sued Sanofi, its partner in the commercialisation of the blockbuster eczema drug Dupixent® (dupilumab), in the US District Court for the Southern District of New York alleging that Sanofi is in breach of its commercialisation agreement.  The issues relate to contracts Sanofi negotiates with intermediaries between drug-makers, pharmacies, and insurance companies.  Regeneron alleges that Sanofi has not allowed it access to the relevant contracts to verify compliance with its profit-sharing arrangement. 

Regeneron and Sanofi have previously been on the same side in dupilumab patent proceedings against Amgen and Immunex.  In that matter, the PTAB denied the institution of a review, deciding that the petitioners had not established a reasonable likelihood that they would prevail in showing the unpatentability of the patent. 

 

Pearce IP BioBlast® for the week ending 15 November 2024

Aflibercept

15 November 2024 | EU | Sandoz Aflibercept Biosimilars EU Approved & Formycon/Klinge Biosims Recommended

On 15 November 2024, Sandoz announced that its Afqlir®, biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), has been approved in Europe for the treatment of nAMD, macular… Read more here.


Daratumumab

8 November 2024 | US | EU | J&J Seeks US and EU Approvals for New Daratumumab Indications

On 8 November 2024, Johnson & Johnson (J&J) announced that it has submitted applications to the US FDA and European Medicines Agency (EMA) for approval of a new indication… Read more here.


Denosumab

14 November 2024 | EU | Positive CHMP Opinions for Samsung Bioepis’ Denosumab Biosimilars

On 14 November 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Samsung Bioepis’ Obodence™… Read more here.


Dupilumab

15 November 2024 | US | FDA Accepts Regeneron/Sanofi’s Dupixent® (Dupilumab) sBLA Resubmission for Chronic Spontaneous Urticaria

On 15 November 2024, Regeneron and Sanofi announced that the US FDA has accepted for review their resubmitted supplemental Biologics Licence Application (sBLA) for Dupixent®… Read more here.


Isatuximab

14 November 2024 | EU | UK | Sanofi’s Sarclisa® (Isatuximab) Recommended for EU Approval; Wins Appeal Against Rejection by UK’s NICE

On 14 November 2024, Sanofi announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion … Read more here.


Lecanemab

14 November 2024 | EU | EU’s CHMP Reverses Position on Eisai’s Lecanemab; Good News for Patients with Early Alzheimer’s Disease

On 14 November 2024, Eisai reported that it has received a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use… Read more here.


Nipocalimab

11 November 2024 | US | FDA Grants Breakthrough Therapy Designation for J&J’s Nipocalimab

On 11 November 2024, Johnson & Johnson (J&J) announced that the US FDA has granted nipocalimab Breakthrough Therapy designation (BTD) for the treatment of adults… Read more here.


Pembrolizumab, Nivolumab, Ipilimumab & More

15 November 2024 | EU | CHMP Green Light for InflaRx’s Gohibic® (Vilobelimab) & Expanded Indications for MSD, BMS, Janssen, Sanofi & Regeneron

At the November 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation… Read more here.


Semaglutide, Liraglutide

13 November 2024 | New Studies Show the Potential of Semaglutide for Treating Alcohol Use Disorder and Knee Pain

GLP-1 agonists (also known as GLP-1 receptor agonists) represent a class of medications used to treat type 2 diabetes mellitus.  Well-known examples of drugs in this class include those… Read more here.


Trastuzumab deruxtecan

7 November 2024 | US | Daiichi Sankyo and AstraZeneca Awarded Prix Galien Best Biotechnology Product Award for Enhertu®

On 7 November 2024, the Galien Foundation awarded Daiichi Sankyo and AstraZeneca the Prix Galien USA Award for Best Biotechnology Product in relation to Enhertu®… Read more here.


Company Announcements

13 November 2024 | Alvotech’s Biosimilars Sales Drive 4-Fold Revenue Increase

On 13 November 2024, Alvotech announced its financial results for the first 9 months of 2024, reporting an increase in total revenues of US $300 million and an over four… Read more here.


BioPharma Deals 2024

14 November 2024 | MSD Enters US$3.3B Deal to Develop and Commercialise LaNova’s PD-1/VEGF Bispecific Antibody

On 14 November 2024, Merck (known as MSD outside the US and Canada) announced that it has entered an exclusive global licence agreement with Shanghai-based LaNova… Read more here.

13 November 2024 | BioNTech to Acquire Biotheus and Investigational Bispecific Antibody Targeting PD-L1 and VEGF-A

On 13 November 2024, BioNTech announced that it has entered a definitive agreement to acquire Biotheus together with global rights to Biotheus’ late-stage clinical asset, BNT327… Read more here.

 

About Pearce IP

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

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

 

Naomi Pearce

Naomi Pearce

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

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

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

Chantal Savage

Chantal Savage

Special Counsel, Lawyer

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

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

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.

 

Approval Alert: AbbVie’s Elahere® (Mirvetuximab Soravtansine) EU-Approved for Platinum-Resistant Ovarian Cancer

On 18 November 2024, AbbVie announced that European Commission (EC) has approved Elahere® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens.  According to AbbVie, this makes Elahere® the first and only FRα-directed antibody drug conjugate medicine approved in the EU, as well as Iceland, Liechtenstein, Norway, and Northern Ireland.

The approval is supported by data from the Phase 3 MIRASOL trial which demonstrated a 35% reduction in the risk of tumour progression or death in patients treated with Elahere® compared with chemotherapy, which represented an improvement in progression-free survival.

This news follows the adoption of a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in September 2024.  Elahere® was approved by the US FDA in March 2024.

Celltrion Publishes Additional Phase 3 Study Results Supporting Denosumab and Tocilizumab Biosimilars

In April 2024, we reported that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), and published those results in late July.  On 18 November 2024, Celltrion presented additional data from that trial.  Celltrion has also presented additional data from a Phase 3 trial of CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), which follows encouraging findings in June 2024.

Results from week 52 to week 78 data showed comparable and sustained efficacy results to reference denosumab in treating postmenopausal women with osteoporosis after switching to CT-P41.  One-year results of CT-P47 supported biosimilarity to reference tocilizumab, demonstrating comparable and sustained efficacy, safety and immunogenicity profiles in patients with active moderate-to-severe rheumatoid arthritis.

This news follows the October 2024 announcement of a joint sales agreement between Celltrion and Daewoong Pharmaceutical under which the two companies will jointly promote CT-P41 in Korea.  Celltrion filed an aBLA for CT-P41 in the US in December 2023 and, in May 2024, was sued by Amgen in the US District Court of New Jersey for alleged infringement of 29 patents regarding denosumab.  That litigation is ongoing.

Amgen Sues Accord and Intas in Fifth US BPCIA Denosumab Patent Suit; Seeks to Consolidate Proceedings

On 13 November 2024, Amgen filed a BPCIA Complaint for Patent Infringement in the US District Court for the Eastern District of North Carolina against Accord Biopharma, Accord Healthcare and Intas Pharmaceuticals.  The Complaint asserts infringement of 34 of Amgen’s US patents relating to denosumab and methods of its manufacture.

The litigation follows Accord/Intas’ submission of an abbreviated Biologic Licence Application (aBLA) to the FDA for INTP23, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).

This is the fifth BPCIA litigation filed by Amgen in relation to denosumab, following actions against Fresenius Kabi (FKS518/commenced October 2024), Samsung Bioepis (SB16/commenced August 2024), Celltrion (CT-P41/commenced in May 2024) and Sandoz (Jubbonti®/Wyost®/commenced in May 2023).  Amgen’s dispute with Sandoz was resolved in April 2024, enabling Sandoz to launch its denosumab biosimilars, Jubbonti® and Wyost®, from 31 May 2025 (or earlier in certain undisclosed circumstances).  The other disputes remain pending.

On 18 November 2024, Amgen filed a motion seeking to transfer all four pending actions to the District of New Jersey so that they may be heard together.

Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in the US in March 2024.  No other denosumab biosimilars have been approved in the US, although Fresenius Kabi’s BLA for its denosumab biosimilar (FKS518) was accepted in May 2024, Teva’s BLA for TVB-009P (denosumab) was accepted in October 2024 and Organon/Shanghai Henlius’ BLA for HLX14 (denosumab) was accepted in late October 2024.

Approval Alert: Samsung Bioepis/Biogen’s Aflibercept Biosimilar Approved in EU

On 18 November 2024, Samsung Bioepis and Biogen announced that the European Commission has approved Opuviz™/SB15, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).  A positive CHMP opinion was adopted for Opuviz™ in September 2024.

Opuviz™ is approved for the treatment of nAMD and visual impairment due to: macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO); diabetic macular oedema (DME), and myopic choroidal neovascularisation (CNV).

Samsung Bioepis and Biogen entered into a commercialisation agreement for Opuviz™ (SB15) in November 2019 for US, Canada, Europe, Japan and Australia.  The agreement also covers a second ophthalmology biosimilar, Byooviz™ (SB11, ranibizumab).

Opuviz™ is the third aflibercept biosimilar to be approved in the EU, closely following last week’s approval of Sandoz’s Afqlir®Biocon’s Yesafili® was approved in September 2023 (with UK approval following in November 2023).  Alvotech/Advanz Pharma’s MAA for AVT06 (aflibercept) was accepted by the 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.  Formycon/Klinge announced on 15 November 2024 that their aflibercept biosimilar FYB203/Baiama®/Ahzantive® received a positive opinion from the CHMP.

CHMP Green Light for InflaRx’s Gohibic® (Vilobelimab) & Expanded Indications for MSD, BMS, Janssen, Sanofi & Regeneron

At the November 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation under exceptional circumstances for InflaRx’s Gohibic® (vilobelimab) for treatment of adults with SARS-CoV2-induced acute respiratory distress syndrome (ARDS) who are receiving systemic corticosteroids.  A marketing authorisation under exceptional circumstances is recommended when the benefit/risk assessment is positive but where the rarity of the disease means it is unlikely that comprehensive data can be obtained under normal conditions of use.

The CHMP also recommended the following indication extensions:

  • MSD’s Keytruda® (pembrolizumab), in combination with pemetrexed and platinum chemotherapy for first-line treatment of adults with unresectable non-epithelioid malignant pleural mesothelioma;
  • BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab), in combination, for mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer in first-line treatment of unresectable or metastatic colorectal cancer or for treatment of metastatic colorectal cancer after prior fluoropyrimidine-based combination chemotherapy;
  • Janssen’s Rybrevant® (amivantamab), in combination with lazertinib, for first-line treatment of adult patients with advanced NSCLC with EGFR Exon 19 deletions or Exon 21 l858R substitution mutations;
  • Sanofi’s Kevzara® (sarilumab), in a new strength (175mg/ml solution for injection in vial), for active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with conventional synthetic DMARDs, as monotherapy or in combination with MTX; and Sarclisa® (isatuximab), in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant;
  • Regeneron/Ultragenyx’s Evkeeza® (evinacumab) as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and paediatric patients aged 6 months and older with homozygous familial hypercholesterolaemia.

Four biosimilars also received positive opinions at CHMP’s November meeting; two Samsung Bioepis denosumab biosimilars (reported here) and two aflibercept biosimilars for Formycon/Klinge (reported here).

In addition, the CHMP adopted a positive opinion for Eisai’s Leqembi® (lecanemab), as reported here.

Sandoz Aflibercept Biosimilars EU Approved & Formycon/Klinge Biosims Recommended

On 15 November 2024, Sandoz announced that its Afqlir®, biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), has been approved in Europe for the treatment of nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (mCNV).  Afqlir® obtained a positive recommendation from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) in September 2024.  Sandoz expects to launch in Europe in Q4 2025.

Sandoz’s news comes the same day of Formycon’s announcement that the CHMP has issued a positive opinion for its aflibercept biosimilar, FYB203/Baiama®/Ahzantive®, for the same indications as those of Afqlir®.  Klinge Biopharma holds the global commercialisation rights for FYB203 and is the marketing authorisation applicant for Ahzantive® in Europe (Formycon is the applicant for Baiama®).  The positive CHMP opinion follows the EMA’s acceptance of Formycon’s marketing authorisation application (MAA) for FYB203 in December 2023.  Formycon expects to receive marketing authorisation in the second half of January 2025.

Sandoz’s Afqlir® is the second aflibercept biosimilar to be approved in Europe, following the approval of Biocon’s Yesafili® in September 2023 (with UK approval following in November 2023).  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.  A positive CHMP opinion was adopted for Samsung Bioepis/Biogen’s Opuviz™ in September 2024.

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

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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