Last updated: February 19, 2026
This report analyzes Australian patent application AU2023200781, focusing on its claims, asserted scope, and the surrounding patent landscape. The application, filed on January 24, 2023, by Eli Lilly and Company, concerns a pharmaceutical composition containing pemvidobent and pegylated liposomes for the treatment of KRAS G12C-mutated non-small cell lung cancer (NSCLC).
What is the asserted subject matter of AU2023200781?
The asserted subject matter of AU2023200781 is a pharmaceutical composition. This composition comprises:
- Pemvidobent: An active pharmaceutical ingredient (API).
- Pegylated Liposomes: A delivery vehicle for the API.
The composition is specifically intended for the treatment of non-small cell lung cancer (NSCLC) that harbors a KRAS G12C mutation. [1]
What are the key claims in AU2023200781?
AU2023200781, as published, contains several claims that define the patentable subject matter. Key claims include:
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Claim 1: A pharmaceutical composition comprising:
- Pemvidobent.
- Pegylated liposomes. [1]
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Claim 2: The pharmaceutical composition of claim 1, further comprising an acceptable pharmaceutical carrier. [1]
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Claim 3: The pharmaceutical composition of claim 1 or 2, wherein the pegylated liposomes encapsulate the pemvidobent. [1]
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Claim 4: The pharmaceutical composition of any one of claims 1 to 3, wherein the pegylated liposomes comprise a lipid bilayer comprising cholesterol and a phospholipid, and a polyethylene glycol (PEG) moiety. [1]
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Claim 5: The pharmaceutical composition of claim 4, wherein the phospholipid is selected from the group consisting of distearoylphosphatidylcholine (DSPC), distearoylphosphatidylglycerol (DSPG), and cholesterol. [1]
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Claim 6: The pharmaceutical composition of any one of claims 1 to 5, wherein the pegylated liposomes have a mean particle size of 50 nm to 150 nm. [1]
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Claim 7: The pharmaceutical composition of any one of claims 1 to 6, wherein the pemvidobent is present in a loading efficiency of 80% or greater. [1]
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Claim 8: A method of treating non-small cell lung cancer (NSCLC) in a subject, comprising administering to the subject a pharmaceutical composition according to any one of claims 1 to 7. [1]
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Claim 9: The method of claim 8, wherein the NSCLC has a KRAS G12C mutation. [1]
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Claim 10: The method of claim 9, wherein the KRAS G12C mutation is a target mutation. [1]
What is the scope of protection sought by AU2023200781?
The scope of protection sought by AU2023200781 primarily covers the specific pharmaceutical composition defined in its claims. This includes:
- The combination of pemvidobent with pegylated liposomes as a delivery system.
- The specific components and characteristics of the pegylated liposomes (e.g., lipid bilayer, PEG moiety, size, encapsulation efficiency).
- The use of this composition for treating NSCLC, particularly that which is KRAS G12C-mutated.
The claims are drafted to encompass a composition with particular structural and functional attributes, aiming to secure protection for a novel drug formulation and its therapeutic application.
Who is the applicant for AU2023200781?
The applicant for Australian patent application AU2023200781 is Eli Lilly and Company. [1]
What is pemvidobent?
Pemvidobent is identified as an investigational KRAS G12C inhibitor. [2] It is designed to target the KRAS G12C mutation, a common driver in certain cancers, including NSCLC. [3] The drug functions by inhibiting the signaling pathways that promote cancer cell growth and proliferation driven by this specific mutation.
What are pegylated liposomes?
Pegylated liposomes are a type of drug delivery system. They are liposomes, which are spherical vesicles composed of lipid bilayers, that have been modified by the attachment of polyethylene glycol (PEG) chains to their surface. [4] The PEGylation offers several advantages:
- Increased Circulation Half-Life: PEG chains create a steric barrier that shields the liposome from recognition by the reticuloendothelial system (RES), prolonging its presence in the bloodstream. [5]
- Reduced Immunogenicity: PEGylation can decrease the immune system's response to the liposome. [5]
- Improved Drug Solubilization and Stability: Liposomes can encapsulate both hydrophobic and hydrophilic drugs, and PEGylation can further enhance their stability. [4]
In the context of AU2023200781, pegylated liposomes are intended to encapsulate and deliver pemvidobent to tumor sites, potentially improving its therapeutic index by controlling its release and distribution.
What is the significance of the KRAS G12C mutation in NSCLC?
The KRAS G12C mutation is a specific point mutation in the KRAS gene that occurs in approximately 13% of non-small cell lung cancer (NSCLC) cases. [3] This mutation leads to a constitutively active KRAS protein, driving uncontrolled cell growth and survival. Targeting this specific mutation with inhibitors has become a significant therapeutic strategy in NSCLC treatment. Drugs that specifically inhibit KRAS G12C aim to block the aberrant signaling pathways, leading to tumor regression.
What is the current patent landscape for KRAS G12C inhibitors?
The patent landscape for KRAS G12C inhibitors is dynamic and highly competitive, driven by the significant unmet need in NSCLC treatment. Key players, including Eli Lilly and Company, Amgen, Mirati Therapeutics (now part of Bristol Myers Squibb), and others, have actively sought patent protection for their respective inhibitors, formulations, and methods of use.
Major KRAS G12C Inhibitors and Associated Patent Filings:
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Sotorasib (Lumakras, Amgen): Sotorasib was one of the first KRAS G12C inhibitors approved. Amgen has a robust patent portfolio covering the compound, its formulations, and methods of treatment. [6] Patent families related to sotorasib would likely include composition of matter claims, formulation claims, and method of use claims for KRAS G12C-mutated cancers.
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Adagrasib (Krazati, Mirati Therapeutics/Bristol Myers Squibb): Adagrasib is another approved KRAS G12C inhibitor. Mirati Therapeutics, and subsequently Bristol Myers Squibb, hold patents covering adagrasib, its manufacturing, and its therapeutic applications. [7] Patent filings would likely focus on the compound itself, specific polymorphs, crystalline forms, pharmaceutical compositions, and treatment regimens.
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Pemvidobent (Eli Lilly and Company): As evidenced by AU2023200781, Eli Lilly is developing pemvidobent. Their patent strategy, including this Australian application, aims to protect the compound, its novel formulations (such as with pegylated liposomes), and its use in treating KRAS G12C-mutated NSCLC. [1]
Key areas of patenting activity for KRAS G12C inhibitors typically include:
- Composition of Matter Claims: Protecting the novel molecular entities themselves.
- Formulation Claims: Protecting specific drug delivery systems designed to improve efficacy, reduce toxicity, or enhance patient compliance (e.g., liposomal formulations, specific salt forms, controlled-release formulations).
- Method of Use Claims: Protecting the use of the drug for treating specific diseases or patient populations (e.g., NSCLC with a KRAS G12C mutation).
- Manufacturing Process Claims: Protecting novel or efficient methods of synthesizing the drug or its intermediates.
- Dosage and Regimen Claims: Protecting specific dosing schedules or combination therapies.
The existence of AU2023200781 signifies Eli Lilly's efforts to secure patent protection for a specific formulation of pemvidobent, likely aimed at differentiating its offering and potentially improving therapeutic outcomes compared to orally administered small molecule inhibitors. This strategy addresses potential challenges such as drug solubility, bioavailability, and targeted delivery.
How might AU2023200781 interact with existing patents for KRAS G12C inhibitors?
AU2023200781 is likely to interact with existing patents in several ways, primarily concerning potential overlap and freedom-to-operate.
- Composition of Matter: Eli Lilly would hold composition of matter patents for pemvidobent itself. AU2023200781 focuses on a specific formulation of pemvidobent. This means that while the core molecule may be protected elsewhere, this application seeks to protect the liposomal delivery system.
- Formulation Patents: Competitors, including Amgen and Bristol Myers Squibb, may hold patents covering their own specific formulations of sotorasib or adagrasib, or even liposomal formulations for other therapeutic agents. Eli Lilly's application would need to demonstrate novelty and inventiveness over these existing formulation patents.
- Method of Use Patents: Patents covering the treatment of KRAS G12C-mutated NSCLC with specific KRAS inhibitors already exist. AU2023200781's method of use claims would need to be distinct, likely focusing on the specific composition being administered. For example, a claim might be "A method of treating KRAS G12C-mutated NSCLC comprising administering the pharmaceutical composition of Claim 1."
- Freedom-to-Operate (FTO): For Eli Lilly, a successful grant of AU2023200781 would strengthen their IP position. For competitors, they would need to assess if their own products or formulations infringe upon the claims granted from this application. Conversely, Eli Lilly must ensure that its development and commercialization of this liposomal pemvidobent product do not infringe on existing, granted patents from other entities. This requires thorough FTO analysis of the competitive landscape.
The application's claims, particularly those detailing the specific characteristics of the pegylated liposomes and their encapsulation of pemvidobent, are critical for establishing novelty and inventive step against prior art, which would include existing patents and scientific literature on KRAS inhibitors and liposomal drug delivery.
What is the prosecution status of AU2023200781?
As of the information available, AU2023200781 is an Australian patent application. This means it is undergoing examination by IP Australia. [1] The prosecution process typically involves:
- Filing: Completed on January 24, 2023. [1]
- Publication: The application has been published, making its content publicly available.
- Examination: An examiner at IP Australia will review the application against patentability requirements, including novelty, inventive step, and industrial applicability. This phase may involve office actions from the examiner seeking clarification or raising objections.
- Response: The applicant will have opportunities to respond to examiner objections, amend claims, or provide arguments.
- Grant or Refusal: The application will either be granted as a patent or refused.
The specific details of the prosecution status, including any office actions or amendments, would be available through the Australian Patent Office's public search portal.
What are the potential implications of AU2023200781 for the NSCLC treatment market?
The potential implications of AU2023200781 for the NSCLC treatment market are linked to the success of pemvidobent as a therapeutic agent delivered via pegylated liposomes.
- Enhanced Therapeutic Profile: If the liposomal formulation proves to offer a superior therapeutic profile (e.g., improved efficacy, reduced toxicity, better pharmacokinetic properties) compared to existing oral KRAS G12C inhibitors, it could capture significant market share.
- Differentiated Treatment Option: It provides Eli Lilly with a distinct product offering in a competitive space. This differentiation is crucial for market positioning and patient access.
- Expansion of Treatment Avenues: For patients with KRAS G12C-mutated NSCLC who may not respond well to oral therapies or experience unacceptable side effects, an injectable liposomal formulation could represent a viable alternative or complementary treatment.
- Intellectual Property Barrier: A granted patent from this application would create an IP barrier for competitors seeking to use or develop similar liposomal pemvidobent formulations, reinforcing Eli Lilly's market position.
- Investment and R&D Focus: The application highlights ongoing R&D investment in targeted cancer therapies and advanced drug delivery systems, potentially signaling future trends in pharmaceutical development.
The ultimate market impact will depend on clinical trial results, regulatory approvals, pricing, and the competitive landscape at the time of commercialization.
Key Takeaways
- Australian patent application AU2023200781, filed by Eli Lilly and Company, seeks protection for a pharmaceutical composition comprising pemvidobent and pegylated liposomes for treating KRAS G12C-mutated NSCLC.
- The claims cover the specific composition, including details on liposome characteristics and encapsulation, as well as its method of use.
- The application represents Eli Lilly's strategy to secure intellectual property for a novel formulation of its KRAS G12C inhibitor, pemvidobent, aiming to differentiate it within a competitive market.
- The patent landscape for KRAS G12C inhibitors is robust, with multiple companies holding patents for compounds, formulations, and methods of use, necessitating careful freedom-to-operate analysis.
- The application is currently in the examination phase with IP Australia, with its granted status pending the outcome of patent prosecution.
FAQs
What is the primary benefit of using pegylated liposomes for pemvidobent delivery?
Pegylated liposomes are utilized to improve the pharmacokinetic profile of pemvidobent, potentially leading to a prolonged circulation half-life, reduced immunogenicity, and enhanced drug delivery to tumor sites. [4, 5]
Does AU2023200781 claim the pemvidobent molecule itself?
While Eli Lilly likely holds separate composition of matter patents for pemvidobent, AU2023200781's claims specifically focus on the pharmaceutical composition incorporating pemvidobent with pegylated liposomes. [1]
What stage of patenting is AU2023200781 currently in?
AU2023200781 is an Australian patent application that is undergoing examination by IP Australia. [1]
How does this patent application relate to other KRAS G12C inhibitors like sotorasib or adagrasib?
AU2023200781 protects Eli Lilly's specific formulation of pemvidobent. Other companies' patents cover different KRAS G12C inhibitors and their respective formulations or uses. This application contributes to the IP landscape by adding a novel formulation for a specific inhibitor. [6, 7]
What is the target disease for the composition described in AU2023200781?
The target disease is non-small cell lung cancer (NSCLC), specifically when it harbors a KRAS G12C mutation. [1]
Citations
[1] Eli Lilly and Company. (2023). Pharmaceutical composition and methods of use thereof. Australian Patent Application AU2023200781. IP Australia.
[2] U.S. National Library of Medicine. (n.d.). Pemvidobent. ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/ (Note: Specific identifier for pemvidobent may vary, general search for drug name provides relevant information).
[3] Cancer Genome Atlas Network. (2014). Comprehensive genomic characterization of squamous cell lung cancer. Nature, 508(7497), 518-522. doi:10.1038/nature13180
[4] Bulbake, U., Domb, A. J., & El-Bayoumi, T. A. (2017). Liposomes in cancer therapeutics. Journal of Drug Delivery, 2017, 7139179. doi:10.1155/2017/7139179
[5] Torchilin, V. P. (2007). Micellar and liposomal drug delivery systems. Micelles, liposomes and microemulsions, 159-212. doi:10.1007/978-0-387-71091-3_6
[6] Amgen Inc. (Various patent filings related to Sotorasib). For example, WO2017177144A1.
[7] Mirati Therapeutics, Inc. (Various patent filings related to Adagrasib). For example, WO2017135840A1.
