Biosimilars Deals 2021 Archives

New indication alert: AZ’s Ultomiris® (ravulizumab) approved for NMOSD

May 26, 2023

Astrazeneca announced that it has received approval in Japan for Ultomiris® (ravulizumab). Ultomiris is the first and only long-acting C5 complement inhibitor approved for preventing relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica. The approval was based on positive results from the CHAMPION-NMOSD Phase III trial, which demonstrated the efficacy of Ultomiris® in preventing relapses.

Ultomiris was also recently approved in the EU for NMOSD treatment, and regulatory reviews are ongoing in other countries including the US.

CHMP recommends new indication for BMS’s Opdivo® (nivolumab) for NSCLC

May 26, 2023

Bristol Myers Squibb announced that the EMA CHMP recommended the approval of Opdivo® (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) with a high risk of recurrence in adult patients whose tumor cells express PD-L1 at a level of 1% or higher. The recommendation is based on positive results from the CheckMate-816 trial, which demonstrated significant improvement in event-free survival and pathologic complete response when Opdivo® was combined with chemotherapy compared to chemotherapy alone prior to surgery.

Opdivo® is already approved to treat melanoma, as an adjuvant treatment of melanoma, treat non-small cell lung cancer (with ipilimumab), malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell cancer of the head and neck, urothelial carcinoma, as an adjuvant treatment of urothelial carcinoma, treat mismatch repair deficient or microsatellite instability-high colorectal cancer, oesophageal squamous cell carcinoma, as an adjuvant treatment of oesophageal or gastro-oesophageal junction cancer and treat gastric, gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma.

In April 2023 BMS brought proceedings against AstraZeneca in the US District Court of Delaware claiming AstraZeneca’s Imfinzi® (durvalumab) infringed its patent encompassing Opdivo®

New indication alert: AstraZeneca’s Ultomiris® (ravulizumab) approved in Japan to prevent NMOSD

May 26, 2023

AstraZeneca announced that its Ultomiris® (ravulizumab) has a new indication approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) as the first and only long-acting C5 complement inhibitor for the prevention of relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica. The approval was based on AZ’s phase III clinical trial where Ultomiris® was compared to an external placebo arm from the Alexion Soliris® (Eculizumab) PREVENT clinical trial.

Two weeks ago the European Commission approved Ultomiris® for the same condition above.

Study shows bioequivalence of adalimumab, etanercept, and infliximab biosimilars with reference biologics to treat RA

May 26, 2023

A study published in JAMA Network Open has found in a systematic review and meta-analysis that biosimilars of adalimumab, etanercept, and infliximab were associated with clinically equivalent effects in patients with rheumatoid arthritis compared with their reference biologics (AbbVie’s Humira®, Amgen’s Enbrel® and J&J’s Remicade® respectively). The authors assessed 25 head-to-head trials (including 10,642 randomised participants) and found the biosimilars were associated with similar rates of adverse events, study discontinuation, and immunogenicity responses compared with reference biologics.

Only two weeks ago on 8 June 2023, the Ph III results of Samsung Bioepis’ SB15 (aflibercept biosimilar) published in JAMA Ophthalmology showed equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to reference aflibercept.

Beware the shifting sands of patent term extensions (PTE) in Australia

May 25, 2023

Recent Australian decisions have resulted in both new opportunities to challenge patent term extensions in Australia and new patent prosecution practices to shield against them. We summarise here what is known about PTE, and the areas that are ripe for further challenge.

There is no limit to the number of PTEs a pharmaceutical patentee can obtain in Australia. It increasingly common for there to be five to ten (or more) patents extended per medicine.

Under the Patents Act 1990 (the Act), the only relevant subject matter limitation is that the patent must disclose and claim:

for small and large molecule medicines: “one or more pharmaceutical substances per se”; and/or
for large molecule medicines only: “one or more pharmaceutical substances produced by a process involving recombinant DNA technology”.

Almost all the debates in Australian jurisprudence have related to the following two key issues.

Key issue 1: When more than one product falls within the scope of the claims, which one should I base my application for PTE on?

Following two decisions handed down in 2022 (Merck Sharp & Dohme & Anor v Sandoz (Sandoz) and Commissioner of Patents v Ono Pharmaceutical Co & Anor (Ono)), we now know the answer to this question is simple: where a patent covers more than one product, PTE will only be granted in relation to the first approved product, even if that product belongs to a competitor. These decisions likely leave some PTEs vulnerable to attack, potentially shortening the effective monopoly for significant commercial products.

Patentees must now be aware of competitor products registered on the Australian Register of Therapeutic Goods (ARTG) that may fall within the scope of their patents, for reasons other than infringement, namely PTE. Prudent prosecutors are implementing divisional strategies to enable at least one family member to be limited precisely to the product commercialised in Australia to maximise the prospects of the patentee obtaining, and retaining, PTE.

Key issue 2: What is a “pharmaceutical substance per se”?

The answer to this second question remains at large, despite the growing number of decisions on point. The Act defines “pharmaceutical substance” but does not define “pharmaceutical substance per se”, which is used to define the boundaries of PTE eligibility. We know a pharmaceutical substance includes a mixture or compound of more than one substance, but what work does the “per se” do?

There is some guidance from the Explanatory Memorandum for the implementing legislation (Intellectual Property Laws Amendment Bill 1998) which suggests PTE eligibility could be narrowed to claims to new compounds only. However, the patent office has granted PTE for a much broader range of patents, including:

Claims which are clearly PTE eligible, such as claims to APIs and mixtures of APIs.
Claims which are arguably PTE ineligible, but clear guidance is needed from the courts such as formulation (but see the single judge decision in Spirit Pharmaceuticals v Mundipharma [2013]), product-by-process, EPC 2000 (for use) claims (see the obiter comments by Justice Rofe in Biogen v Pharmacor [2021] (Biogen)), and claims to products with specified product and process limitations.
Claims which have been found ineligible for PTE such as Swiss-style claims.
We have seen a recent recalibration by the courts of some of the patent office overreach in this regard. Of the three decisions handed down by the courts in the last two years, two cases resulted in PTEs being overturned (Sandoz and Ono), and one resulted in avoidance of a preliminary injunction due to the strength of the argument against the validity of a PTE.

We now know that Swiss-style claims, in addition to process and method of treatment claims are inextensible (Commissioner of Patents v AbbVie Biotechnology [2017]). We suspect, but do not know, that EPC 2000 (for use) claims are also inextensible (Biogen).

Ripe for further challenge are claims to: formulations, product-by-process, claims to products with particle size (and other product feature) limitations, in addition to “for use” claims discussed above.

—

First Published: WIPR, 12/05/2023, https://www.worldipreview.com/contributed-article/australia-beware-the-shifting-sands-of-patent-term-extensions

About Pearce IP

Pearce IP is boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries. 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. Pearce IP leaders are well recognised as leading IP practitioners.

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, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

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.

Chris Vindurampulle PhD

Executive, Patent & Trade Mark Attorney

Chris is a senior Patent and Trade Mark Attorney who is registered to practice before the intellectual property offices of Australia and New Zealand. He is experienced in patent drafting, patent and trade mark prosecution and opposition, and freedom to operate, opinion and due diligence work. Through his experience and delivery of highly-regarded client service, Chris has been recognised as a leading patent practitioner having been listed in the IAM Patent 1000 as a recommended individual for patent prosecution, and a Rising Star in 2021, 2022 and 2023 by Managing IP.

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FDA grants priority review of NDA for Takeda and HUTCHMED’s fruquintinib

May 25, 2023

Takeda and HUTCHMED announced that the FDA granted priority review for the NDA of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, for the treatment of previously treated metastatic colorectal cancer. The Prescription Drug User Fee Act goal date for the FDA’s decision is set for 30 November 2023. The NDA submission includes data from the Phase 3 FRESCO-2 trial, which demonstrated significant improvements in overall survival and progression-free survival. Fruquintinib is currently approved in China under the brand name ELUNATE®.

EMA accepts MAAs for Sandoz’s denosumab biosimilars to Amgen’s Prolia® and Xgeva®

May 25, 2023

Sandoz announced that the European Medicines Agency (EMA) has accepted marketing authorisation applications (MAA) for its proposed biosimilar denosumab, for regulatory review. The two applications include the approved indications for the originator drugs Prolia^® and Xgeva^®, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that have spread to the bone, and giant cell tumor of the bone.

This week Mitsubishi and GlycoNex announced Japanese approval of their phase I clinical trial of SPD8, a denosumab biosimilar to Prolia®

New indication alert: Daiichi’s VANFLYTA® (quizartinib) approved for AML in Japan

May 25, 2023

Daiichi Sankyo announced that VANFLYTA® (quizartinib) has been approved in Japan for a new indication: the treatment of FLT3-ITD mutation positive acute myeloid leukemia (AML). VANFLYTA® is now approved to treat these patients in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy and as maintenance monotherapy. This is the first and only FLT3 inhibitor in Japan approved for newly diagnosed AML treatment. The existing approval from June 2019 covers relapsed or refractory FLT3-ITD mutation-positive AML.

PiPCast™ | Patent oppositions & litigation – what about estoppel?

May 25, 2023

Amgen provides further details on Stelara® settlement with Janssen

May 24, 2023

As previously reported, on 22 May 2023 the US District Court of Delaware dismissed Janssen’s patent infringement case against Amgen pertaining to its Stelara® (ustekinumab) biosimilar with prejudice on the basis that each party bears its own costs. The proposed orders made it clear that the parties had settled.

Reuters has since reported a statement by Amgen that the ustekinumab settlement will permit Amgen to sell its biosimilar “no later than January 1^st, 2025”, suggesting the permitted launch date may be earlier than 1 January 2025. As the API patent, one of six patents Janssen asserted in the proceedings, expires on 25 September 2023, we speculate that the agreed launch date is some time between 25 September 2023 and 1 January 2025.

Approval alert: FDA approves Celltrion’s Yuflyma® (adalimumab) biosimilar to AbbVie’s Humira®

May 23, 2023

Celltrion announced that its Yuflyma® (adalimumab) product, a high-concentration formulation and biosimilar to AbbVie’s Humira®, has obtained FDA approval. According to Celltrion, Yuflyma® will be available in the US from July for the key indications of Humira®, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and Hidradenitis Suppurativa.

Celltrion’s announcement came only three days after Boehringer Ingelheim announced its Humira® biosimilar Cyltezo® autoinjector pen obtained FDA approval.

PMDA approves Mitsubishi and GlycoNex’s phase I clinical trial for denosumab biosimilar to Amgen’s Prolia®

May 23, 2023

Mitsubishi Gas Chemical Company, Inc. and GlycoNex announced approval to commence a phase I clinical trial of SPD8 denosumab, biosimilar to Amgen’s Prolia®, from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The companies announced that the first patient has now been enrolled. The double-blind trial will compare SPD8 with Prolia® in healthy postmenopausal women, who will undergo pharmacokinetic and safety assessments.

This month Boan Biotech commenced its phase III clinical trial for its Prolia® denosumab biosimilar.

NICE recommends combination of Merck’s Keytruda® (pembrolizumab) and Eisai’s Lenvima® (lenvatinib) for endometrial cancer

May 23, 2023

The National Institute for Health and Care Excellence (NICE) has issued a final appraisal document recommending Merck’s Keytruda® (pembrolizumab) combined with Eisai’s Lenvima® (lenvatinib) as an option for treating advanced or recurrent endometrial cancer in adults whose cancer has progressed on or after platinum-based chemotherapy who cannot have curative surgery or radiotherapy, in the NHS in England and Wales.

In March 2023, NICE recommended the use of Keytruda® for advanced cervical cancer in the NHS, funded by the Cancer Drugs Fund.

Amgen files motion to intervene in aflibercept proceedings

May 23, 2023

Amgen filed a motion to intervene in the proceedings on foot between Regeneron and Mylan in West Virginia relating to aflibercept, and has sought to unseal certain documents. Amgen argued that the sealing of the documents blocked the public’s right of access to Court documents, and that the Court has provided no justification for sealing a number of documents.

Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea (including the ‘601 patent), and a 10 day trial has been set down for June 2023, which is 10 months after Regeneron filed its complaint.

BioBlast w/e 22 May 23

May 23, 2023

22 MAY 2023 | US | Janssen and Amgen settle Stelara® (ustekinemab) biosimilar patent dispute

The US District Court of Delaware has dismissed with prejudice. The parties agreed to dismiss the action with prejudice and each party will bear its own costs, expenses and attorney’s fees, and the proposed orders state the parties have agreed to settle the litigation.

Janssen commenced these proceedings against Amgen in November 2022 in relation to the API and MOT (UC) patents, and filed a motion for preliminary injunction in March 2023 (following dismissal of an earlier application due to non-compliance with the Court’s page limit requirements).

21 MAY 2023 | Regeneron/Sanofi phase III Dupixent® (dupilumab) studies in COPD patients

A study published in the New England Journal of Medicine has found that patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation who received Dupixent® (dupilumab) had fewer exacerbations, better lung function and quality of life, and less severe respiratory symptoms than those who received the placebo. The results of this phase III, double-blind randomised trial were simultaneously announced at the 2023 American Thoracic Society (ATS) International Conference.

The study was sponsored by Sanofi with Regeneron as collaborator.

19 MAY 2023 | Product development updates in financial reports

Alvotech has provided updates on some of its biosimilar products in its report on its financial results for the first 3 months of 2023.

As previously reported, Alvotech initiated a confirmatory patient study for AVT05, its proposed biosimilar to Simponi^® and Simponi Aria^® (golimumab).
In March 2023, Alvotech provided Biosana Pharma a notice of termination for the licensing agreement between the two companies relating to AVT23, biosimilar to Xolair® (omalizumab). The deal was announced in February 2022.

18 MAY 2203 | US | Supreme Court affirms Federal Circuit Court decision in Amgen v Sanofi patent enablement case

The US Supreme Court handed down its decision in Amgen v Sanofi, relating to the enablement requirement. The Supreme Court petition was filed in response to the Federal Court decision which invalidated genus claims in two Amgen patents relating to Repatha® (evolocumab) which it asserted against Sanofi/Regeneron regarding Praluent® (alirocumab). A unanimous Supreme Court affirmed the Federal Circuit’s ruling that the Amgen patent claims were not enabled.

On 3 November 2022, the Supreme Court granted Amgen’s petition for certiorari in relation to ‘whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort’”.

The patents in suit relate to engineered antibodies that reduce levels of low-density lipoprotein (LDL) cholesterol. In 2011, both Amgen and Sanofi obtained patents covering the antibody used in their respective drugs. The dispute concerned two additional patents Amgen obtained in 2014 claiming “the entire genus” of antibodies that “bind to specific amino acid residues on PCSK9” and “block PCSK9 from binding to [LDL receptors].”

The Supreme Court emphasised that to satisfy the enablement requirement, it may be sufficient to provide “an example if the specification also discloses ‘some general quality . . . running through’ the class that gives it ‘a peculiar fitness for the particular purpose’”.

The Court held that Amgen’s patents only describe 26 antibodies but claim “a vast number of additional antibodies,” and opined that Amgen “offers persons skilled in the art little more than advice to engage in “trial and error” to make every embodiment within a broad claim.

18 MAY 2023 | Teva launches new “pivot to growth” strategy focusing on biosimilars

Teva announced its new strategic framework and “Pivot to Growth” strategy which aims to bolster the Company’s strong commercial portfolio with products including biosimilars. Biosimilars are part of Teva’s ‘accelerate growth’ stage between 2025-2027. The company intends to focus on biosimilar launches, and has near-term biologics products targeting >US$40B that are in late stage development.

On 6 January 2023, the FDA accepted the BLA for Alvotech and Teva’s AVT04 Stelara® (biosimilar) ustekinumab.

18 MAY 2023 | UK | NICE recommends AbbVie’s Rinvoq® (upadacitinib) for moderately to severely active Crohn’s

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending AbbVie’s Rinvoq® (upadacitinib) as an option for eligible adults with moderate to severe active Crohn’s disease (CD) on the NHS in England and Wales. It is the first janus kinase inhibitor available for treatment CD in England and Wales, where patients have had an inadequate response, lost response or were intolerant to conventional therapy or a biological agent.

This news was announced on the same day the FDA approved RINVOQ® for this same indication for CD.

18 MAY 2023 | US | New indication alert: FDA approved RINVOQ® (upadacitinib) for adults with moderate to severe Crohn’s disease

AbbVie has announced that the FDA has approved its RINVOQ® (upadacitinib) to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more TNF blockers. The Company said it is the seventh FDA approval for RINVOQ® and it is now indicated in both ulcerative colitis and CD.

This comes after Health Canada approved a new indication RINVOQ® for nr-axSpA last week.

16 MAY 2023 | US | Amneal launches FLYNETRA™ in the US, biosimilar to Amgen’s Neulasta® (pegfilgrastim)

Amneal announced it has launched FLYNETRA™ (pegfilgrastim) in the US, biosimilar to Amgen’s Neulasta®. FLYNETRA™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs.

FLYNETRA™ was approved by the FDA in May 2022. This is Amneal’s third biosimilar approved in the US (following its filgrastim and bevacizumab biosimilars).

15 MAY 2023 | US | Supreme Court denies Teva’s petition for certiorari to review decision on skinny label carve-outs in dispute with GSK

The US Supreme Court denied Teva’s petition for certiorari to review the August 2021 decision of the US Court of Appeals for the Federal Circuit in relation to skinny label carve-outs and Teva’s US$235M loss in its patent dispute with GSK. The issue that Teva sought to put before the Supreme Court was whether a generic manufacturer of an FDA-approved label which excludes the originator’s patented uses constitutes encouragement of patent infringement by the carved-out uses. According to Teva’s petition, the lower Court held that even though Teva’s skinny label carved out GSK’s sole patented indication for its product Coreg® (carvedilol), Teva could nonetheless be held liable for inducement of patent infringement based on other sections of the label.

Many brief amici curiae were filed, including a brief from 42 professors of law, economics, business and medicine pharmaceutical companies Alvotech and Mylan, the Association for Accessible Medicines and the Solicitor-General of the US (the only party specifically invited to file a brief). The Solicitor-General’s brief quoted the lower court’s dissenting judgment that “the carved-out labelling is more naturally viewed as evidence of the generic manufacturer’s ‘inten[t] not to encourage infringement’” and concluded that the petition for a writ of certiorari should be granted.

15 MAY 2023 | US | Celltrion submits phase III IND plan to FDA for CT-P53 (ocrelizumab), biosimilar to Genentech’s Ocrevus®

Korea Biomed reported that Celltrion submitted a phase III investigational new drug (IND) plan to the FDA for its CT-P53, biosimilar to Genentech’s Ocrevus® (ocrelizumab), used to treat multiple sclerosis. The phase III global clinical trial will be a comparative study on the effectiveness, pharmacokinetics, and safety between CT-P53 and Ocrevus® on patients with recurrent palliative multiple sclerosis.

Celltrion recently reported US$126M profit in Q1 2023, and increased its operate profit for Q1 by 41.1% on-year.

15 MAY 2023 | CA | Health Canada accepts NSD for LEQEMBI® (lecanemab)

Biogen and Eisai Co., Ltd announced that Health Canada has accepted a new drug submission (NDS) for LEQEMBI® (lecanemab) to treat early Alzheimer’s disease (AD) and mild AD dementia with confirmed amyloid pathology in the brain. LEQEMBI® is an investigational anti-amyloid beta protofibril antibody. The NDS is based on a Phase III study and Phase IIb clinical study which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD.

On 5 March 2023 the FDA accepted the sBLA and granted priority review for traditional approval of LEQEMBI™ (lecanemab), and the FDA is discussing the full approval on 9 June 2023.

15 MAY 2023 | US | FDA issues CRL for Byondis’ BLA for trastuzumab duocarmazine

Byondis announced that the FDA has issued a complete response letter (CRL) for its Biological License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985). Byondis sought approval for its anti-HER2 antibody-drug conjugate in HER2-positive unresectable locally advanced or metastatic breast cancer. The CRL confirmed that the FDA has suspended its decision on SYD985’s approvability, requesting extra information. Byondis said that it cannot respond to the request within the current evaluation period.

12 MAY 2023 | US | Viatris shareholders bring class action for breach of Securities Exchange Act

Viatris investor Jason Taylor has brought proceedings on behalf of a class of Viatris shareholders against the company and its executive officers and directors, seeking remedies under the Securities Exchange Act of 1934 including damages, interest, costs, and equitable, injunctive, or other relief as the Court sees fit. The class includes all persons or entities who purchased or acquired Viatris stock between 1 March 2021 and February 25, 2022 (Period). At the beginning of the Period, Viatris announced a plan, relying on its strong pipeline of new products (including biosimilars) that would create a stable revenue base, realise US$1B in cost synergies by 2024, and improve cash conversion and free cash flow generation. Taylor alleges that the Defendants made false representations, inter alia, including that 2021 was a “trough year” for Viatris and its biosimilars business was a core part of the Company’s long-term investment strategy. Contrary to the Defendants representations, Viatris was allegedly experiencing significantly more competition in its US complex generics business than disclosed, and it was not able to create a stable revenue base. Throughout 2021, Viatris’ total revenues were declining quarter-over-quarter. In February 2022, Viatris entered into an agreement to sell its biosimilars business to Biocon Biologics Ltd. After announcing fiscal results, Viatris’ stock declined by 24% between 25 February and 28 February 2022.

Interestingly, the US Magistrate Judge Patricia Dodge recused herself on 17 May 2023 and the case will be re-assigned.

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

Associate 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.

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Pearce IP leaders recognised as 2023 MIP Patent Stars

May 23, 2023

Pearce IP congratulates two of its leaders, Founder and CEO Naomi Pearce, and Special Counsel Jacinta Flattery-O’Brien PhD, who were honoured this week as MIP Patent stars for 2023. This is the third and fourth consecutive year (respectively) that they have been named as MIP Patent Stars.

Naomi Pearce says:

“Pearce IP’s lawyers and attorneys are market leading, and the ranking of 2 of its leaders by MIP for the third and fourth year in a row (respectively) highlights the impact that Pearce IP has had on the industry in less than 6 years.

I am very proud of the recognition that Pearce IP as a firm, and each of our leaders individually, have accomplished since inception in 2017. Pearce IP is achieving its mission to set the standard for excellence in the provision of legal and IP services in Australia.

We also congratulate our industry friends and peers who are also ranked by MIP as IP Stars for 2023.

About Pearce IP

Pearce IP is boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the pharmaceutical, biopharmaceutical and life sciences industries. 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. Pearce IP leaders are well recognised as leading IP practitioners.

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, Women in Law Awards – Partner of the Year, Best Lawyers and Australasian Lawyer 5 Star Awards, Women in Business Law Awards – Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

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.

Jacinta Flattery-O'Brien PhD

Special Counsel, Patent Attorney

Jacinta is a trusted and recognised leader in biotech/pharma patenting, identified as an "IP Star" by the highly regarded Managing Intellectual Property Journal (MIP) for her expertise.

She is a registered patent attorney with 20 years' experience serving clients in the biotechnology, pharmaceutical and biopharmaceutical industries.

Alvotech enters supply agreement with Advanz for five biosimilars including golimumab and vedolizumab in EU, UK and CH following Stada termination

May 22, 2023

Alvotech announced that it has entered into a master license and supply agreement with Advanz to commercialise and supply in Europe AVT05 (biosimilar to Janssen’s Simponi® and Simponi Aria® (golimumab)), AVT16 (biosimilar to Takeda’s Entyvio® (vedolizumab)), and three additional early-stage, undisclosed biosimilar candidates.

Under this agreement:

Alvotech will develop the products and provide the dossiers.
Advanz has an exclusive right to obtain and maintain regulatory approvals for the products and to commercialize them in the European Economic Area, the United Kingdom and Switzerland
Advanz will make upfront payments of €56M
Advanz will make additional milestone payments for an aggregate amount of up to €264
Alvotech will manufacture, supply and deliver the product to Advanz
Advanz will exclusively buy the relevant biosimilar candidate from Alvotech at a royalty of approximately 40% of the estimated net selling price or an agreed-upon floor price

On 19 May 2023, Alvotech and STADA entered into three termination agreements to terminate the license and supply agreements between Alvotech and STADA pertaining to Alvotech’s product candidates AVT03 (biosimilar candidate to Prolia®/Xgeva® (denosumab)), AVT05 and AVT16. Alvotech will repay €17.4M it received from STADA under the (now terminated) agreement.

On 19 May 2023, Alvotech also disclosed the reference products for two product candidates in its pipeline: AVT16 (above) and the reference product for AVT33 is Merck’s Keytruda® (pembrolizumab).

This comes after Alvotech announced in February 2023 that it entered an exclusive agreement with Advanz Pharma regarding for EU, UK CA, CH and ANZ.

Celltrion launches Remsima® SC (infliximab) biobetter in Brazil

May 22, 2023

The Korea Herald has reported that Celltrion has launched its Remsima® SC (infliximab, bio-better to Janssen’s Remicade®) in Brazil, the largest pharmaceutical market in South America. Celltrion is also selling Remsima® and Truxima® (rituximab, biosimilar to Biogen’s Rituxan®) in Brazil and plans to introduce Remsima SC in Mexico, Colombia and Peru during the second half of 2023.

Celltrion recently presented its positive phase III results for Remsima® SC as a sub-cutaneous maintenance therapy for IBD patients.

Coherus announces UDENYCA® (pegfilgrastim) autoinjector launch in the US

May 22, 2023

Coherus BioSciences announced that its single-dose prefilled autoinjector of UDENYCA® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®, is now available in the US. UDENYCA® is administered after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

The FDA approved Udenyca® as a single-dose, prefilled autoinjector in March 2023.

Janssen and Amgen settle Stelara® (ustekinemab) biosimilar patent dispute

May 22, 2023

The US District Court of Delaware has dismissed with prejudice Janssen’s patent infringement case against Amgen pertaining to its Stelara® (ustekinemab) biosimilar. The parties agreed to dismiss the action with prejudice and each party will bear its own costs, expenses and attorney’s fees, and the proposed orders state the parties have agreed to settle the litigation.

Janssen commenced these proceedings against Amgen in November 2022 in relation to the API and MOT (UC) patents, and filed a motion for preliminary injunction in March 2023 (following dismissal of an earlier application due to non-compliance with the Court’s page limit requirements).

Grains of Justice | Preliminary discovery order extended to wheat product samples in CSIRO case

May 22, 2023

Commonwealth Scientific and Industrial Research Organisation v Urrbrae Foods Pty Ltd [2023] FCA 504

Date:

Court:

Judges:

15 May 2023

Federal Court of Australia

Moshinsky J

Highlight

The Court has held that it has the power to order the production of samples for testing (as well as documents) under the preliminary discovery rule for the purposes of assisting the patentee to determine whether to commence proceedings for infringement.

Background

CSIRO is the registered co-owner of two Australian patents relating to (i) wheat grain with reduced SBE II enzyme or activity amylose content and (ii) methods of improving bowel or metabolic health by virtue of such a grain (Australian Patent Nos. 2005321754 and 2004252186).

Starch branching enzyme (SBE II) is an enzyme in wheat involved in starch synthesis. Starch, the primary carbohydrate in wheat grain, is generally made up of amylose and amylopectin. SBE II has the ability to alter the content of amylose within the wheat structure, so as to improve the product’s potential to improve gut health.

In July 2022, CSIRO applied to the Court for an order for preliminary discovery by Urrbrae, seeking documents and production samples of wheat products, for the purpose of deciding whether to commence patent infringement proceedings against Urrbrae. Urrbrae consented to an order for preliminary discovery and produced the requested documents (but not the requested samples) in February 2022. Having reviewed the documents and forming the view that it did not have sufficient information to determine whether to commence proceedings, the balance of CSIRO’s application (for the production of samples) was heard.

CSIRO sought and secured orders for the production of a randomly selected and representative 50g sample of viable seeds of the Urrbrae wheat products from its most recent commercial harvest, together with details of the date and place of harvest. CSIRO proposed to test for SBE II protein levels.

The Court held that it has the power to order the production of product samples for testing under the preliminary discovery rule (which on its face is limited to the production of documents), for the purposes of assisting the patentee to determine whether to commence proceedings for patent infringement. The decision is now under appeal by Urrbrae.

Key Issues

Preliminary Discovery Orders Apply to Product Samples and Documents

An entity that suspects infringement of its patent may seek an order for preliminary discovery of documents under rule 7.23 of the Federal Court Rules 2011, to determine whether to commence proceedings. Importantly, rule 7.23 expressly refers only to documents.

CSIRO’s application for preliminary discovery of samples was based on rule 14.01, which permits a party to apply to the Court for an order for inspection, sampling, observation, or experiments on property relevant to the proceeding. Rule 14.01 is not specific to preliminary discovery applications and applies to a ‘party’.

Urrbrae submitted that as documents had been produced, CSIRO’s discovery application was completed and the effect of rule 14.01 was limited to orders to assist in resolving issues in the preliminary discovery proceeding and not for the purpose of deciding whether to commence proceedings.

Complicating the picture was the fact that the wording of the above rules (or their equivalents) had changed slightly between those applicable at the time the patent applications were filed, and those now in force.

Power to Order Preliminary Discovery of Samples Existed Under Old Rules and Exists Under New Rules

In finding that it has the power to order preliminary discovery in relation to samples in addition to documents, the Court compared the wording of the former rules with the current wording, noting that the explanatory memorandum for the Federal Court Rules 2011 expressed that the provisions “adopt, simplify and streamline the process and procedures which operated under the former Rules and do not substantially alter existing practice.”

The Court noted that although the legal question regarding power raised by Urrbrae had not been raised previously, orders of this nature had been made in two previous cases, one under the old rules¹ and one under the new rules.²

With this in mind, Moshinsky J found that there was power under the former O 15 r 12, and there is power under the current r14.01 to make an order for the production of samples to assist an applicant to determine whether to commence proceedings. He considered that in preliminary discovery proceedings it may well be the case that production of documents is insufficient for a prospective applicant to determine whether to commence infringement proceedings and that testing of samples may be required.

The Court issued the orders for production of samples for testing, and Urrbrae appealed the decision.

Implications

Subject to the outcome of the Urrbrae appeal, preliminary discovery orders in the Federal Court may relate to both documents and product samples. This is particularly pertinent in relation to technologies where claimed aspects of a product’s specifications or manufacture are not readily discernible from the finished/marketed product or other documents.

___

¹ SmithKline Beecham plc v Alphapharm Pty Ltd [2001] FCA 271

² GlaxoSmithKline Australia Pty Ltd v Pharmacor Pty Ltd [2014] FCA 1202

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

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

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.

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Renee White PhD

Associate, Patent Attorney

Renee is an associate patent attorney with experience in Australian and New Zealand patent drafting, prosecution, opposition and freedom to operate advisory services.

Renee works across a spectrum of life sciences fields including biochemistry, molecular and cellular biology, stem cells, agritechnology, pharmaceuticals, methods of medical treatment and prevention, biomarkers and immunology, including antibody technologies, diagnostics, food technology, and veterinary sciences.

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Approval alert: FDA approves Boehringer’s Cyltezo® (adalimumab) autoinjector pen

May 21, 2023

Boehringer Ingelheim announced that the FDA has approved an autoinjector pen presentation of its Cyltezo® (adalimumab-adbm), an FDA-approved interchangeable biosimilar to AbbVie’s Humira® (adalimumab). Cyltezo® is indicated for multiple chronic inflammatory diseases. The autoinjector pens will be available in the US from 1 July 2023.

Boehringer is licensed to supply its adalimumab biosimilar in the US from 1 July 2023. In total, AbbVie entered into numerous deals with biosimilar entrants enabling US market entry as follows: Samsung Bioepis/Merck (30 June 2023), Alvotech (1 July 2023), Coherus (1 July 2023), Celltrion (July 2023), Fresenius Kabi (July 2023), Mylan/Viatris (31 July 2023), Sandoz (30 September 2023), Momenta (20 November 2023), and Pfizer (20 November 2023).

Eisai submits MAA in UK for LEQEMBI® (lecanemab) for early Alzheimer’s

May 21, 2023

Biogen and Eisai announced that Eisai submitted a marketing authorisation application (MAA) for LEQEMBI® (lecanemab) to the UK Medicines and Healthcare products Regulatory Agency (MHRA). LEQEMBI® is an investigational anti-amyloid beta protofibril antibody indicated for the treatment of early Alzheimer’s disease (AD) with confirmed amyloid pathology in the brain. Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway.

Last week Health Canada accepted a new drug submission for LEQEMBI® to treat early AD and mild AD dementia with confirmed amyloid pathology in the brain.

Regeneron/Sanofi phase III Dupixent® (dupilumab) studies in COPD patients

May 21, 2023

A study published in the New England Journal of Medicine has found that patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation who received Dupixent® (dupilumab) had fewer exacerbations, better lung function and quality of life, and less severe respiratory symptoms than those who received the placebo. The results of this phase III, double-blind randomised trial were simultaneously announced at the 2023 American Thoracic Society (ATS) International Conference.

The study was sponsored by Sanofi with Regeneron as collaborator.