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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 Grants Priority Review for New KEYTRUDA® (pembrolizumab) Combo Treatment for Third Cervical Cancer Indication

Merck announced the US FDA accepted for priority review its supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA ®, Merck’s anti-PD-1 therapy, in a third cervical cancer indication.  The proposed indication is for KEYTRUDA ® in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment for newly diagnosed patients with high-risk locally advanced cervical cancer.  The FDA has set a PDUFA date of 20 January 2024.

BeiGene Regains Full Rights for Tevimbra® (tislelizumab) from Novartis

BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a mutual agreement between the parties to terminate their previous collaboration and licence agreement entered into in January 2021.  BeiGene now has complete global rights to Tevimbra® without having to pay royalties to Novartis and will supply Novartis with Tevimbra® for its clinical trials.  Beigene stated that Novartis will assist BeiGene to ensure the smooth development and commercialisation of Tevimbra®, including manufacture, regulatory, safety, and clinical facets.

On 21 July 2023, BeiGene received a positive CHMP opinion for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Approval Alert: EC Approves Fresenius Kabi’s Tyenne®, First Biosimilar to Roche’s Actemra® / RoActemra® (tocilizumab)

Fresenius Kabi announced that its Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra® has been approved by the European Commission (EC) for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and COVID-19.  Tyenne® is the first biosimilar to Actemra® / RoActemra® approved by the EC.

The CHMP issued a positive opinion recommending approval of Tyenne® on 21 July 2023.

Rani Therapeutics Begins Ph I Clinical Trial of Oral Ustekinumab with Celltrion’s CT-P43

Korea Biomed reported that Rani Therapeutics has begun its phase I clinical trial for oral ustekinumab (RT-111) using Celltrion’s CT-P43 (ustekinumab), biosimilar to Janssen’s Stelara®.  Rani will evaluate pharmacokinetics and safety of RT-111 in up to 55 participants.

On 5 June 2023, Rani Therapeutics announced that it has expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar RT-105, following their previous collaboration on an ustekinumab biosimilar.

BioBlast w/e 15 Sep 23

On 15 September 2023, Novartis shareholders approved the proposed Sandoz spin-off, Novartis’ generics and biosimilars business at its Extraordinary General Meeting.   The proposed spin-off was first announced by Novartis on 25 August 2022, a proposal which was unanimously endorsed by the Novartis board on 18 July 2023 with a target date of Q4/23.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s Herwenda® (trastuzumab, biosimilar to Genentech’s Herceptin®), to treat metastatic and early breast cancer and metastatic gastric cancer.

On the same day, Novartis’s shareholders approved the Sandoz spin-off which is scheduled for 4 October 2023.

On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Sandoz’s Herwenda® (trastuzumab, biosimilar to Genentech’s Herceptin®) for approval for the treatment of metastatic and early breast cancer and metastatic gastric cancer.

CHMP also recommended an extension of indication for AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) as monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

CHMP also adopted a positive opinion for three new biologics:

  • Eli Lily’s Ebglyss® (lebrikizumab) to treat moderate and severe forms of atopic dermatitis in adults and adolescents;
  • Novartis’ Finlee® (dabrafenib) to treat glioma; and
  • Daiichi Sankyo’s Vanflyta® (quizartinib) to treat patients with diagnosed acute myeloid leukaemia (ACL).

The CHMP recommended indication extensions for the following biologics:

  • Seagen’s Adcetris® (brentuximab vedotin) to treat patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma;
  • Vertex’s Kaftrio® (ivacaftor/tezacaftor/elexacaftor) two new presentations of (60mg/40mg/80mg and 75mg/50mg/100mg granules in sachet) for use in children aged 2 to 5 years of age;
  • Vertex’s Kalydeco® (ivacaftor) to include treatment of cystic fibrosis in children aged between 2 and 6 years in a combination regimen with ivacaftor/tezacaftor/elexacaftor;
  • Merck’s Keytruda® (pembrolizumab) as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy;
  • Eli Lilly’s Olumiant® (baricitinib) to treat moderate to severe atopic dermatitis in paediatric patients 2 years and older who are candidates for systemic therapy; and
  • Takeda’s Takhzyro® (lanadelumab) to prevent recurrent attacks of hereditary angioedema in patients aged 2 years and older.

According to the Pharmaceutical Benefits Assessment Committee (PBAC) November 2023 agenda published last week, the meeting will be jammed with biopharma applications for reimbursement.  PBAC will consider the following applications for PBS listing additions or amendments at its November 2023 meeting:

New listing applications: Amendment Applications
1. Organon’s Hadlima® (adalimumab) biosimilar to AbbVie’s Humira® 1. Sanofi-Aventis’ Libtayo® (cemiplimab)
2. GSK’s Jemperli® (dostarlimab) 2. BMS’s Opdivo® (nivolumab)
3. Vertex’s Kalydeco® (ivacaftor) 3. Merck’s Keytruda® (pembrolizumab)
4. GSK’s Menveo® (meningococcal vaccine) 4. AbbVie’s Skyrizi® (risankizumab)
5. Pfizer’s Prevenar 20® (pneumococcal conjugate vaccine) 5. Novartis’ Cosentyx® (secukinumab)
6. Generic Health’s Teriparatide Lupin® (teriparatide) biosimilar to Eli Lily’s Forteo®  
7. Gedeon Richter’s Terrosa® (teriparatide) biosimilar to Eli Lily’s Forteo®  
8. Beigene’s Tevimbra® (tiselizumab)  
9. AstraZeneca’s Enhertu® (trastuzumab deruxtecan) biosimilar to Genentech’s Herceptin®  

In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to Alphapharm’s Hulio® (adalimumab, biosimilar to AbbVie’s Humira®), Pfizer’s Zirabev® (bevacizumab, biosimilar to Genentech’s Avastin®) and Alphapharm’s Rymti® (etanercept) biosimilar to Amgen’s Enbrel®.

On 1 March 2023, the November 2022 PBAC outcomes were announced, with three biologics listed, including Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms, Merck’s pembrolizumab (Keytruda®) and AbbVie’s risankizumab (Skyrizi®).

Takeda announced that the FDA accepted its Biologics License Application (BLA) for its subcutaneous formulation of vedolizumab (Entyvio®) for maintenance therapy in patients with moderate to severe active Crohn’s disease after induction therapy with IV Entyvio®.  Currently Takeda’s Entyvio® is formulated and approved in the US for IV use only.

On 30 March 2023, Takeda published a study demonstrating that Entyvio® was more effective than a placebo inducing remission of chronic pouchitis after undergoing ileal pouch–anal anastomosis (IPAA) for ulcerative colitis.  Shortly prior on 27 March 2023 Takeda secured approval in Japan for Entyvio® SC as maintenance therapy for moderate to severe ulcerative colitis in patients with inadequate response to conventional treatment.

Sandoz and Samsung Bioepis announced they have entered an exclusive agreement to develop and commercialise SB17 (ustekinumab, biosimilar to Janssen’s Stelara®) in the US, Canada, EEA, Switzerland and the UK.  Others details of the deal are confidential.

This follows a confidential settlement in August 2023 between Samsung Bioepis and Janssen which resolved all pending disputes between the parties.  In that same month, Samsung Bioepis and Janssen filed a joint motion to terminate Samsung Bioepis’ IPR against Janssen’s US patent 10,961,307 filed 2 months earlier.

Pfizer and BioNTech announced that the FDA approved their sBLA for their 2023-2024 COVID-19 vaccine for patients over 12 years of age, and granted emergency use authorisation for patients from 6 months to 11 years old.  The vaccine is an omicron XBB.1.5-adapted monovalent vaccine indicated as a single dose for most patients over 5.

On 26 May 2023, Alnylam sued both Moderna and Pfizer for a third time claiming patent infringement regarding COVID-19 vaccines.

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.

Sian Hope

Sian Hope

Lawyer

Sian is a life sciences focussed intellectual property lawyer with a particular focus on the pharmaceutical, biotechnology and healthcare industries. Her practice is primarily in patent litigation, but includes non-contentious patent matters, trade mark matters, health regulatory legal matters and consumer law.

Samsung Biologics and BMS Expand Manufacturing Agreement

Samsung Biologics announced a new agreement with Bristol Myers Squibb for large-scale manufacturing of a BMS antibody cancer drug.  The agreement expands the existing 10-year manufacturing deal signed in 2013, as Samsung Biologics will manufacture the commercial antibody at its latest and largest biomanufacturing facility, Plant 4, in Songdo, South Korea.

Recently, in July 2023, Samsung Biologics entered into agreement with Pfizer  worth US$897M to manufacture biosimilar products for oncology, inflammation and immunotherapy until 2029 in Plant 4.  Samsung also confirmed on 6 June 2023 that it will open its fifth manufacturing plant in April 2025.

FDA Releases Draft Industry Guidance for Labeling for Biosimilar and Interchangeable Biosimilar Products

The FDA has released draft industry guidance for biosimilar and interchangeable biosimilar product labeling.  The guidance includes proposed recommended approaches for:

  • product identification, including when to use the biosimilar or interchangeable biosimilar product name, reference product name;
  • content presentation; and
  • specific sections of labeling, including prescribing information, indications, usage (including specific populations and paediatrics) and clinical pharmacology.

The draft document is open for comments by 17 November 2023.

Celltrion to Supply Yuflyma®, Biosimilar to AbbVie’s Humira® (adalimumab), in Italy

KED Global reported that Celltrion won bids to supply Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in five regions of Italy – accounting for approximately 20% of the Italian adalimumab market.  Yuflyma® recorded ₩54B (USD$40.7M) of sales in the first half of 2023, which Celltrion says is due to its expansion into Europe.

On 11 May 2023, Celltrion won bids to supply Vegzelma® (bevacizumab) in Italy and Belgium.

CHMP Adopts Positive Opinion For Two Biosimilars, Three Innovator Biologics, Extends Indications for Six Other Biologics

On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Sandoz’s Herwenda® (trastuzumab, biosimilar to Genentech’s Herceptin®) for approval for the treatment of metastatic and early breast cancer and metastatic gastric cancer.

CHMP also recommended an extension of indication for AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) as monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

CHMP also adopted a positive opinion for three new biologics:

  • Eli Lily’s Ebglyss® (lebrikizumab) to treat moderate and severe forms of atopic dermatitis in adults and adolescents;
  • Novartis’ Finlee® (dabrafenib) to treat glioma; andlanadelumab
  • Daiichi Sankyo’s Vanflyta® (quizartinib) to treat patients with diagnosed acute myeloid leukaemia (ACL).

The CHMP recommended indication extensions for the following biologics:

  • Seagen’s Adcetris® (brentuximab vedotin) to treat patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma;
  • Vertex’s Kaftrio® (ivacaftor/tezacaftor/elexacaftor) two new presentations of (60mg/40mg/80mg and 75mg/50mg/100mg granules in sachet) for use in children aged 2 to 5 years of age;
  • Vertex’s Kalydeco® (ivacaftor) to include treatment of cystic fibrosis in children aged between 2 and 6 years in a combination regimen with ivacaftor/tezacaftor/elexacaftor;
  • Merck’s Keytruda® (pembrolizumab) as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy;
  • Eli Lilly’s Olumiant® (baricitinib) to treat moderate to severe atopic dermatitis in paediatric patients 2 years and older who are candidates for systemic therapy; and
  • Takeda’s Takhzyro® (lanadelumab) to prevent recurrent attacks of hereditary angioedema in patients aged 2 years and older.

Biopharma Dominates November 2023 PBAC Agenda

According to the Pharmaceutical Benefits Assessment Committee (PBAC) November 2023 agenda published last week, the meeting will be jammed with biopharma applications for reimbursement.  PBAC will consider the following applications for PBS listing additions or amendments at its November 2023 meeting:

New listing applications: Amendment Applications
1. Organon’s Hadlima® (adalimumab) biosimilar to AbbVie’s Humira® 1. Sanofi-Aventis’ Libtayo® (cemiplimab)
2. GSK’s Jemperli® (dostarlimab) 2. BMS’s Opdivo® (nivolumab)
3. Vertex’s Kalydeco® (ivacaftor) 3. Merck’s Keytruda® (pembrolizumab)
4. GSK’s Menveo® (meningococcal vaccine) 4. AbbVie’s Skyrizi® (risankizumab)
5. Pfizer’s Prevenar 20® (pneumococcal conjugate vaccine) 5. Novartis’ Cosentyx® (secukinumab)
6. Generic Health’s Teriparatide Lupin® (teriparatide) biosimilar to Eli Lily’s Forteo®
7. Gedeon Richter’s Terrosa® (teriparatide) biosimilar to Eli Lily’s Forteo®
8. Beigene’s Tevimbra® (tiselizumab)
9. AstraZeneca’s Enhertu® (trastuzumab deruxtecan) biosimilar to Genentech’s Herceptin®

 
In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to Alphapharm’s Hulio® (adalimumab, biosimilar to AbbVie’s Humira®), Pfizer’s Zirabev® (bevacizumab, biosimilar to Genentech’s Avastin®) and Alphapharm’s Rymti® (etanercept) biosimilar to Amgen’s Enbrel®.

On 1 March 2023, the November 2022 PBAC outcomes were announced, with three biologics listed, including Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms, Merck’s pembrolizumab (Keytruda®) and AbbVie’s risankizumab (Skyrizi®).

Takeda’s BLA For New Formulation Of Entyvio® SC (Vedolizumab) Accepted By FDA

Takeda announced that the FDA accepted its Biologics License Application (BLA) for its subcutaneous formulation of vedolizumab (Entyvio®) for maintenance therapy in patients with moderate to severe active Crohn’s disease after induction therapy with IV Entyvio®.  Currently Takeda’s Entyvio® is formulated and approved in the US for IV use only.

On 30 March 2023, Takeda published a study demonstrating that Entyvio® was more effective than a placebo inducing remission of chronic pouchitis after undergoing ileal pouch–anal anastomosis (IPAA) for ulcerative colitis.  Shortly prior on 27 March 2023 Takeda secured approval in Japan for Entyvio® SC as maintenance therapy for moderate to severe ulcerative colitis in patients with inadequate response to conventional treatment.

Federal Court Shines Light on Patent Litigation Case Management

Hanwha Solutions Corporation v REC Pte Ltd [2023] FCA 1017

Date:

Court:

Judge:

29 August 2023

Federal Court of Australia

Burley J

Highlight

In this patent infringement/validity dispute, Hanwha failed to establish that REC infringed its “old Act” Australian patent No 2008323025, and its dependant ACL claims were dismissed.  REC’s unjustified threats claim succeeded in part, as did its novelty challenges to certain patent claims.  REC’s validity challenges based on inventive step (on different claims to the novelty challenge), clarity, utility and fair basis failed.

Burley J emphasised the importance of effective case management strategies in patent litigation, and reminded us that a prior art search is not always required to successfully challenge inventive step.

Background

Hanwha Solutions Corporation (HSC) and Hanwha Q CELLS Australia Pty Ltd (Hanwha) brought separate patent infringement proceedings against LONGi Green Energy Technology Co Ltd (and related companies) (LONGi), Jinko Solar Australia Holdings Co Pty Ltd (Jinko), and REC Pte Ltd (and authorised sellers) (REC) on AU2008323025.  The proceedings were heard together, but Hanwha settled the proceedings against LONGi and Jinko before judgment.

The “old Act” patent related to a solar cell with a silicon substrate, and methods for making such a cell.  The asserted claims relate to a solar cell comprising a first dielectric layer and a different, second dielectric layer containing hydrogen on a surface of the first dielectric layer.  Hanwha did not assert the method claims of the patent against REC, but asserted them against LONGi and Jinko.

Hanwha alleged that REC infringed certain product claims of the patent, and that the sale of the REC products in Australia involved misleading and deceptive conduct in breach of the Australian Consumer Law (ACL).

REC denied infringement, cross-claimed for invalidity of the asserted claims (and further claims) on the grounds of novelty, inventive step, clarity, fair basis, and utility, and asserted that Hanwha had made unjustified threats in contravention of s 128 of the Patents Act 1990 (Cth) (the Act).

Hanwha failed to establish infringement by REC, and its dependant ACL claims were dismissed.  REC’s unjustified threats claim succeeded in-part, as did its novelty challenges to certain patent claims.  REC’s validity challenges based on lack of fair basis, inventive step, clarity and utility also failed.

Key issues

Claim construction

Construction has always been a matter for the Court, and Burley J reminded us that expert evidence does not bind the Court on construction by construing one phrase in a manner that was inconsistent with the expert evidence led by the parties.  Regarding product claim 9, Burley J interpreted the phrase “hydrogen being embedded into the second dielectric layer” inconsistently with expert evidence led by both parties, finding that “embedded” is a requirement that hydrogen merely be present in the second dielectric layer in the completed product.  Burley J commented that the evidence “tends to fuse the teaching of the specification and the requirements of the claims” and to that extent, it must be set aside [para 207].

Burley J found that Hanwha’s construction distorted the language of the claim by adding a qualification that hydrogen must be present before any firing step in a form enabling its release during a subsequent firing.  His Honour noted that this might make sense in the context of a sequential method claim (like claim 1) but not a product claim like claim 9.   He concluded that whilst the skilled reader might understand that hydrogen may be embedded to act as a source during a subsequent firing step, that is not the teaching of the specification nor a requirement of the asserted claim.

Validity

REC submitted that the patent lacked novelty, inventive step, fair basis, utility and clarity.

Burley J found that two of the recited novelty references either did not provide clear direction to produce something within the claim as it did not require the use of a second dielectric layer, or did not direct, recommend or suggest that following the instructions in the reference (namely, to optionally add aluminium oxide as the second passivating layer) will result in the claimed invention.  A skilled addressee following the second reference would only achieve the result of the claimed invention if the conditions happened to be right.  Therefore, the carrying out of the instructions in the reference did not inevitably result in something being made which would constitute an infringement.

REC argued that the final reference (Nakano) anticipated claims 9, 12, 16 and 21.  There was dispute whether Nakano contained two relevant integers.  There were minor differences in the expert’s views.  Hanwha argued that REC’s construction involved impermissible mosaicking of discrete parts of Nakano.  His Honour disagreed, concluding that REC’s construction involved permissible mosaicking and therefore Nakano anticipated claims 9 and its relevant dependant claims 12, 16 and 21.

REC submitted that two prior art documents rendered claims 9, 11-14 and 16-21 obvious.  Under the old Act (i.e. prior to the 2012 changes introduced by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Cth) (RTB)) it is necessary to establish that the person skilled in the art (PSA) would have ‘ascertained’ the cited obviousness references.  Justice Burley found that the PSA would have so ascertained them.

  • A first reference was published in a widely read and respected journal that all the experts had published in, two of the experts had read the prior art before the priority date, and a pre-priority date survey named the article itself as one of the most relevant publications in the field.
  • The second reference was a later reference by the same author. It is in this context that Burley J found that an artificial ex post facto literature search does not need to be carried in patent litigation to establish that the prior art information would have been “ascertained” pursuant to s 7(3) of the Act pre-RTB, noting that such searches initiate an enquiry that adds unnecessary expense.  Given the likelihood the earlier obviousness reference would have been ascertained for the reasons explained above, his Honour J did not require an artificial search in this case, despite submissions from Hanwha to the contrary [at 367]:

“Finally, I note that… it is not the case that an artificial ex post facto literature search must be carried out at the time of the conduct of patent litigation in order to establish the “ascertained” aspect of s 7(3) of the Patents Act.  Whilst such a search, if properly conducted, may quell controversy about the question, frequently it spawns an enquiry that adds unnecessary expense and argument to an already time consuming aspect of a validity challenge.  In the present case, in my view a search of this type was not required because the paper was likely to have been heard of, even if not read, by those skilled in the field.”

In relation to claims 9, 11-14 and 16-21, Burley J concluded that the prior art references were insufficient to demonstrate lack of inventive step.

REC’s remaining grounds of invalidity (fair basis, clarity, utility) also failed.

Unjustified threats

REC argued that both HSC’s letters of demand to REC, and an HSC media release relating to the proceedings constituted unjustified threats of patent infringement contra to s 128 of the Act.  Surprisingly, HSC agreed that the letters contravened s 128 (the content of the letters is not set out in the decision), but disputed that the media release amounted to an unjustified threat.  His Honour agreed, finding that the three-page press release published after commencement of proceedings merely reported that HSC had brought patent infringement proceedings, and therefore could not constitute a threat that HSC would bring proceedings.

Case management

Burley J noted that the conduct of the multiple independently represented parties was a testament to the pragmatism of the parties.  His Honour was grateful for the cooperation of the parties, and took time in his judgement to call out the key case management strategies employed by the parties, namely:

  • the respondents agreed to use one substantive witness (between them) on invalidity;
  • the respondents each provided product descriptions and non-infringement statements, and Hanwha replied with an infringement position, noting areas of difference;
  • the parties jointly prepared a final primer and CGK statement with areas of disagreement marked up for the Court’s convenience;
  • the respondents combined their particulars of invalidity, reducing repetition and complexity;
  • the parties set confidentiality rules, collaborating together with minimal court involvement; and
  • judicial registrars and experts together created six joint expert reports on various topics.

It is refreshing to see parties to litigation avoiding an unnecessarily combative approach to patent litigation.  Whilst not unheard of, it is not yet the norm.  With the encouragement of Burley J, this may become more common.

Outcome

Justice Burley found no infringement by the REC Products, with invalidity (novelty) established in relation to a subset of claims.  His Honour’s reasons for the infringement finding are redacted until at least 13 October 2023, as REC has asserted confidentiality over the findings.

Implications

This decision demonstrates the Federal Court’s focus on improving case management practices in patent litigation.  His Honour’s comments regarding the artificial searches undertaken to satisfy s 7(3) of the pre-RTB Act, alongside his summary and gratitude towards the parties for their cooperation in complex multi-party litigation, demonstrate that the Court encourages, and may implement, pragmatic case management.

The case reaffirmed that the judicial role in construing patent claims cannot be usurped by expert evidence.

 

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.

Kate Legge

Kate Legge

Special Counsel, Lawyer

Kate is an experienced IP and patent lawyer, providing IP leadership for pharmaceutical product development and commercialisation in global markets – from initial scoping through to post-launch.

She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.

Sian Hope

Sian Hope

Lawyer

Sian is a driven intellectual property associate with a background in molecular genetics and experience in both private practice and within State Government. Sian’s experience working in medical research and advanced therapeutics policy supports Pearce IP’s clients on policy issues relating to the regulation of pharmaceutical/biopharmaceutical products in Australia.

BioBlast w/e 08 Sep 23

Coherus Biosciences announced that it completed its acquisition of Surface Oncology, Inc., a clinical-stage immuno-oncology company.  Coherus’ pipeline now has a number of new clinical-stage assets, including:

  • Toripalimab: an anti-PD-1 monoclonal antibody under BLA review for treatment of advanced recurrent or metastatic nasopharyngeal carcinoma (NPC);
  • CHS-006: a TIGIT-targeted antibody currently in a phase I / II study in combination with toripalimab in patients with advanced solid tumours;
  • Casdozokitug (SRF388 or casdozo): a first-in-class IL-27-targeted antibody in phase II clinical trials in lung cancer and liver cancer; and
  • CHS-114 (SRF114): an ADCC-enhanced CCR8-targeted antibody in a phase I / II study as a monotherapy in patients with advanced solid tumors.

On 2 August 2023, Coherus announced its Q2 2023 financial results, reporting that sales of its Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis®, had quadrupled to US$26.7M since the last quarter.

The Financial Express reported that Enzene Biosciences, subsidiary of Alkem Labs, plans to imminently launch its ranibizumab biosimilar in India. This will be Enzene’s seventh Indian biosimilar.  Enzene’s CEO confirmed that the company plans to launch two biosimilars every year.

Enzene is on market in India for bevacizumab (biosimilar to Genentech’s Avastin®) launched 29 June 2023, adalimumab (biosimilar to AbbVie’s Humira®) launched 28 February 2023, denosumab (biosimilar to Amgen’s Xgeva®), approved 27 August 2021, romiplostim (biosimilar to Amgen’s Nplate®), approved 10 August 2021, and teriparatide (biosimilar to Eli Lily’s Forteo®), approved 4 February 2021.

06 SEP 2023 | CA | US | Biocon Completes Viatris Integration

Biocon Biologics announced that it has completed the integration of Viatris in North America ahead of schedule, effective 1 September 2023.  The target date for the integration of Viatris was end Q3 2023.

On 5 July 2023, Biocon Biologics announced it had completed a third of the integration of Viatris’ biosimilars business in over 70 countries in ‘emerging markets’. The multi-billion dollar deal was finalised on 29 November 2022, whereby Biocon has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept.

The Therapeutic Goods Administration (TGA) approved Celltrion’s Vegzelma®, biosimilar to Genentech’s Avastin® (bevacizumab) for a range of indications, including metastatic colorectal cancer, locally recurrent or metastatic breast cancer, advanced, metastatic or recurrent non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell cancer, grade IV glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and cervical cancer.

Although Celltrion is yet to announce its latest approval, it has been reported by Korean news media including the JoongAng Daily and KoreaBioMed.

Celltrion now has six biopharma products approved in Australia: Vegzelma® (bevacizumab, biosimilar to Genentech’s Avastin®) approved 5 September 2023; Yuflyma® (adalimumab, biosimilar to AbbVie’s Humira®) approved on 25 March 2022; Remsima® SC (infliximab “biobetter” to Janssen’s Remicade®) approved on 12 November 2020; Herzuma® (trastuzumab, biosimilar to Genentech’s Herceptin®) approved on 17 July 2018; and Truxima® (rituximab, biosimilar to Genentech/Biogen’s Rituxan®) approved on 14 April 2018.  The TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) to treat COVID-19 on 6 December 2021.

The Korea Economic Daily reported that Celltrion, Inc. announced plans to enlarge its finished pharmaceuticals manufacturing facility at its Songdo campus in Incheon, and has allocated about ₩126B (US$95M) for the project.  The expansion is scheduled to be completed by early 2026 and production to begin in 2027, with an annual production capacity of around 8 million liquid vials.

AstraZeneca announced that the Chinese National Medical Products Administration (NMPA) has approved its Calquence® (acalabrutinib) to treat a new indication: chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy.

On 24 August 2023 AstraZeneca had Soliris® (eculizumab) approved in Japan for a new indication to treat paediatric patients with gMG.  

The US Department of Health and Human Services (DHHS), through the Centers for Medicare & Medicaid Services (CMS), announced the first 10 drugs selected for pricing negotiation as part of the Inflation Reduction Act 2022 (IRA).  The negotiations with the relevant pharmaceutical companies will occur in 2023 and 2024, and any price negotiations will come into force in 2026.

The ten drugs selected were:

  • Bristol Myers Squibb / Pfizer’s Eliquis® (apixaban)
  • Eli Lilly / Boehringer Ingelheim’s Jardiance® (empagliflozin)
  • Johnson & Johnson’s Xarelto® (rivaroxaban)
  • Merck’s Januvia® (sitagliptin)
  • AstraZeneca’s Farxiga® (dapagliflozin)
  • Novartis’ Entresto® (sacubitril/valsartan)
  • Amgen’s Enbrel® (etanercept)
  • AbbVie / Johnson & Johnson’s Imbruvica® (ibrutinib)
  • Johnson & Johnson’s Stelara® (ustekinumab)
  • Novo Nordisk’s Novolog®/Fiasp® (insulin aspart)

Only two days after this announcement, on 1 September 2023, Novartis brought proceedings against the US Government, arguing that these pricing negotiations are unconstitutional.  Other pharmaceutical companies have also sued the Government on this same legislation, including Merck, Bristol Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, AstraZeneca and the industry group Pharmaceutical Research and Manufacturers of America.

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.

Sian Hope

Sian Hope

Lawyer

Sian is a life sciences focussed intellectual property lawyer with a particular focus on the pharmaceutical, biotechnology and healthcare industries. Her practice is primarily in patent litigation, but includes non-contentious patent matters, trade mark matters, health regulatory legal matters and consumer law.

Sandoz & Samsung Bioepis Enter Exclusive Commercialisation Agreement For SB17 (Ustekinumab) In Europe and North America

Sandoz and Samsung Bioepis announced they have entered an exclusive agreement to develop and commercialise SB17 (ustekinumab, biosimilar to Janssen’s Stelara®) in the US, Canada, EEA, Switzerland and the UK.  Others details of the deal are confidential.

This follows a confidential settlement in August 2023 between Samsung Bioepis and Janssen which resolved all pending disputes between the parties.  In that same month, Samsung Bioepis and Janssen filed a joint motion to terminate Samsung Bioepis’ IPR against Janssen’s US patent 10,961,307 filed 2 months earlier.

FDA Approves Pfizer & BioNTech’s 2023-2024 COVID-19 Vaccine

Pfizer and BioNTech announced that the FDA approved their sBLA for their 2023-2024 COVID-19 vaccine for patients over 12 years of age, and granted emergency use authorisation for patients from 6 months to 11 years old.  The vaccine is an omicron XBB.1.5-adapted monovalent vaccine indicated as a single dose for most patients over 5.

On 26 May 2023, Alnylam sued both Moderna and Pfizer for a third time claiming patent infringement regarding COVID-19 vaccines.

Coherus Completes Acquisition Of Surface Oncology

Coherus Biosciences announced that it completed its acquisition of Surface Oncology, Inc., a clinical-stage immuno-oncology company.  Coherus’ pipeline now has a number of new clinical-stage assets, including:

  • Toripalimab: an anti-PD-1 monoclonal antibody under BLA review for treatment of advanced recurrent or metastatic nasopharyngeal carcinoma (NPC);
  • CHS-006: a TIGIT-targeted antibody currently in a phase I / II study in combination with toripalimab in patients with advanced solid tumours;
  • Casdozokitug (SRF388 or casdozo): a first-in-class IL-27-targeted antibody in phase II clinical trials in lung cancer and liver cancer; and
  • CHS-114 (SRF114): an ADCC-enhanced CCR8-targeted antibody in a phase I / II study as a monotherapy in patients with advanced solid tumors.

On 2 August 2023, Coherus announced its Q2 2023 financial results, reporting that sales of its Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis®, had quadrupled to US$26.7M since the last quarter.

Enzene Launches Biosimilar Ranibizumab In India

The Financial Express reported that Enzene Biosciences, subsidiary of Alkem Labs, plans to imminently launch its ranibizumab biosimilar in India. This will be Enzene’s seventh Indian biosimilar.  Enzene’s CEO confirmed that the company plans to launch two biosimilars every year.

Enzene is on market in India for bevacizumab (biosimilar to Genentech’s Avastin®) launched 29 June 2023, adalimumab (biosimilar to AbbVie’s Humira®) launched 28 February 2023, denosumab (biosimilar to Amgen’s Xgeva®), approved 27 August 2021, romiplostim (biosimilar to Amgen’s Nplate®), approved 10 August 2021, and teriparatide (biosimilar to Eli Lily’s Forteo®), approved 4 February 2021.

Biocon Biologics Completes Viatris Integration

Biocon Biologics announced that it has completed the integration of Viatris in North America ahead of schedule, effective 1 September 2023.  The target date for the integration of Viatris was end Q3 2023.

On 5 July 2023, Biocon Biologics announced it had completed a third of the integration of Viatris’ biosimilars business in over 70 countries in ‘emerging markets’. The multi-billion dollar deal was finalised on 29 November 2022, whereby Biocon Biologics has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept.

Approval Alert: Celltrion’s Vegzelma® Biosimilar Bevacizumab Approved By TGA

The Therapeutic Goods Administration (TGA) approved Celltrion’s Vegzelma®, biosimilar to Genentech’s Avastin® (bevacizumab) for a range of indications, including metastatic colorectal cancer, locally recurrent or metastatic breast cancer, advanced, metastatic or recurrent non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell cancer, grade IV glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and cervical cancer.

Although Celltrion is yet to announce its latest approval, it has been reported by Korean news media including the JoongAng Daily and KoreaBioMed.

Celltrion now has six biopharma products approved in Australia: Vegzelma® (bevacizumab, biosimilar to Genentech’s Avastin®) approved 5 September 2023; Yuflyma® (adalimumab, biosimilar to AbbVie’s Humira®) approved on 25 March 2022; Remsima® SC (infliximab “biobetter” to Janssen’s Remicade®) approved on 12 November 2020; Herzuma® (trastuzumab, biosimilar to Genentech’s Herceptin®) approved on 17 July 2018; and Truxima® (rituximab, biosimilar to Genentech/Biogen’s Rituxan®) approved on 14 April 2018.  The TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) to treat COVID-19 on 6 December 2021.

Celltrion To Expand South Korean Facility

The Korea Economic Daily reported that Celltrion, Inc. announced plans to enlarge its finished pharmaceuticals manufacturing facility at its Songdo campus in Incheon, and has allocated about ₩126B (US$95M) for the project.  The expansion is scheduled to be completed by early 2026 and production to begin in 2027, with an annual production capacity of around 8 million liquid vials.

New Indication Alert: NMPA Approves AZ’s Calquence® (Acalabrutinib) For CLL & SLL

AstraZeneca announced that the Chinese National Medical Products Administration (NMPA) has approved its Calquence® (acalabrutinib) to treat a new indication: chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy.

On 24 August 2023 AstraZeneca had Soliris® (eculizumab) approved in Japan for a new indication to treat paediatric patients with gMG.

No Anshun Estoppel in Fourth VMS Validity Challenge

Orikan Group Pty Ltd v Vehicle Monitoring Systems Pty Limited [2023] FCA 1031

Date:

Court:

Judge:

29 August 2023

Federal Court of Australia

O’Bryan J

Highlight

The Federal Court considered for the first time post-RTB, whether Anshun estoppel operates to prevent a cross-claimant for patent revocation raising arguments it did not raise in a previous opposition to grant of the same patent, or in subsequent Federal Court appeals.  In finding that no Anshun estoppel exists, the Court placed significance on the fact that that the revocation challenge was in defence to infringement proceedings, but it left open whether the answer would be different if the revocation suit was not by cross-claim.

Background

Orikan Group Pty Ltd (Orikan), is the registered owner of the patent in suit AU2013213708 titled “Vehicle Detection” (Patent), assigned to it from SARB (a related entity) in 2022.

Orikan alleged infringement by Vehicle Monitoring Systems Pty Ltd (VMS) in connection with the manufacture, sale and use of in ground vehicle detection sensor units dating back to 2013.  VMS denied infringement and filed a cross-claim for revocation of the patent.  This decision concerns an interlocutory application by Orikan for a stay of the cross-claim on the basis of Anshun estoppel or strikeout as an abuse of process in light of the fact that VMS did not (but could have) raised the same invalidity grounds in earlier opposition proceedings or subsequent Federal Court appeals.

The dispute is part of a longstanding and multipronged commercial dispute between the parties relating to several patents to vehicle monitoring devices, including:

  1. 2011 VMS Infringement Proceedings: The first spat between the parties occurred in 2011, when VMS sued SARB for infringement of a VMS patent titled “Method, apparatus and system for parking overstay detection”, and SARB cross-claimed for revocation. Judgment was delivered in May 2013 in favour of VMS.
     
  2. 2012 SARB Innovation Patent Proceedings: Infringement proceedings commenced by SARB against VMS for infringement of an innovation patent titled “Vehicle detection”. Both that innovation patent and the Patent claim priority to the same 2008 parent application, and the claims overlap considerably.  VMS cross-claimed for revocation.  The dispute settled in 2014.
     
  3. 2016 VMS Opposition Proceedings: Unsuccessful VMS pre-grant opposition filed in 2016 against the Patent. VMS’s 2018 appeal to the Federal Court was decided in March 2020 to the same effect.  VMS appealed again to the Full Federal Court and its decision delivered in December 2021 again rejected the opposition. We reported on that decision in our 2021 Patent Case Summary.  The patent granted in January 2022 and was assigned to Orikan in May that year.
     
  4. 2022 Orikan Infringement Proceedings: The same year the Patent was granted and then assigned to Orikan by SARB, Orikan brought proceedings against VMS for infringement of the Patent, and VMS cross- claimed for revocation.

Orikan’s interlocutory application for stay (based on Anshun estoppel) or strike (based on abuse of process) which we report on here was based on VMS’s cross-claim for revocation raising invalidity grounds in the 2022 Orikan Infringement Proceedings (these proceedings) which it had not previously raised in the 2016 opposition proceedings or the two subsequent appeals, in which it challenged the same Patent.  Importantly, there was substantial overlap between the invalidity grounds raised in this revocation cross-claim and that in the 2012 innovation patent proceedings.

Orikan’s application was unsuccessful and it did not appeal the decision.

Key Issues

Anshun estoppel is a common law principle that precludes a party from raising an issue of fact or law in a subsequent proceeding, if the later proceeding was “so connected with the earlier proceeding that it would have been unreasonable” not to raise the issue in that earlier proceeding.  Anshun estoppel will only apply if the issue could have and should have been raised in the earlier proceeding.  The question for the Court is whether it was “unreasonable to defer” the challenge, which depends “not so much on legalities, but on practicalities” (paragraph 27).

VMS accepted that it could have raised the current particulars of invalidity in the 2016 opposition proceedings, but not that it should have.  VMS submitted that employing the various avenues to challenge validity made available under the Patents Act 1990 (Cth) should not count against it.  VMS argued that it was not unreasonable to have relied on more limited grounds in the initial opposition before the Patent Office, as compared to the more ‘expansive approach’ taken in the cross-claim in both these proceedings and the 2012 innovation patent proceedings, submitting this was in fact an efficient use of judicial resources.

The Court has power under r16.21(1)(f) of the Federal Court Rules 2011 (Cth) to strike out proceedings for an abuse of process.  The Court made clear that there is no hard and fast rule; rather a broad, merits-based judgment is required, taking into account public and private interests and all the facts of the case and facilitating efficient resolution of disputes.

Orikan’s application for the strikeout was based on the time, cost and inefficiencies arising from the invalidity cross-claim in these proceedings being the fourth challenge to the validity of the Patent, and having already challenged the validity of the same subject matter in the 2012 innovation patent proceedings.  VMS submitted that the Patent assignment from SARB to Orikan occurring between the Federal Court decision in the 2016 opposition proceedings and these proceedings meant that neither had suffered harassment or unjustifiable oppression.  It again made the argument that it was not unreasonable to rely on different statutory routes to challenge the validity of a patent.

Outcome

The Court held that no Anshun estoppel operated to prevent VMS running its invalidity cross-claim.  First, there was no risk of inconsistent judgments, since if VMS were to succeed in the cross-claim, it would be on a different basis to any decision in the 2016 opposition proceedings.  Further, any cost relating to the additional particulars was not in fact additional, since Orikan’s position was essentially that they should have been raised anyway, only earlier.

The Court held there was no abuse of process for the same reasons.

Implications

The question of whether Anshun estoppel operates to prevent a subsequent validity challenge following a failed opposition under the pre-RTB Act was answered in the negative by the Full Court in Genetics Institute Inc v Kirin-Amgen Inc [1999] FCA 742.

The pre-RTB standard of proof required for oppositions and appeals to the Federal Court (‘practically certain’) then differed from that required in revocation cases (‘balance of probabilities’).  But the standard of proof required in oppositions and appeals post-RTB (‘balance of probabilities’) is now aligned with that required in a revocation suit.  Therefore, notwithstanding Genetics Institute, the question of whether Anshun estoppel would operate post- RTB has been one for Australian patent lawyers to debate since the RTB reforms came into effect.

In this case, a single judge of the Federal Court considered – for the first time post-RTB – whether Anshun estoppel operates to prevent a party raising in a revocation cross-claim arguments not raised in a previous opposition or Federal Court appeal from the opposition decision.  In finding that no Anshun estoppel exists, and despite the same standard of proof applying, it was significant that the revocation challenge was in defence to an infringement allegation.  Anshun estoppel did not prevent a revoker holding back arguments from an opposition and any subsequent appeals, keeping them “up its sleeve” for a subsequent revocation challenge as a “shield” to an infringement suit.

The Court left open whether the answer would be different for a revocation suit other than by cross-claim.  Because VMS had not previously raised these substantive arguments, legal questions relating to the applicability of issue estoppel and res judicata (in short, “asked and answered”) were saved for another day.

The distinction the Court drew between a revocation challenge initiated by the revoker (which remains an open question) and a revocation case as a “shield” to an infringement suit (which the Court addressed here) seems, with respect, to be splitting hairs.

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.

Kate Legge

Kate Legge

Special Counsel, Lawyer

Kate is an experienced IP and patent lawyer, providing IP leadership for pharmaceutical product development and commercialisation in global markets – from initial scoping through to post-launch.

She has developed and implemented global IP strategies over more than 15 years at multi-national pharmaceutical companies. She is an Australian qualified and registered legal practitioner, and has a Master’s degree in IP Law and a BSc in biochemistry.