Last updated: July 29, 2025
Introduction
Australia Patent AU2002241903, titled "Pharmaceutical compounds and methods of use", was filed on September 5, 2002, by Eli Lilly and Company. Since its grant, the patent has played a significant role in the lifecycle management of Lilly’s pharmaceutical pipeline, particularly in areas involving novel chemical entities or therapeutics. This analysis delves into the scope of the patent, its claims, and its current position within the patent landscape, providing clarity vital for stakeholders involved in licensing, infringement risk assessment, or generic entry.
Scope of the Patent
Patent Title and Summary
The patent's title suggests a focus on innovative pharmaceutical compounds and associated methodologies of use. It covers specific chemical entities and their therapeutic applications, potentially including formulations, methods of administration, or particular indications.
Patent Classification
The patent is classified under the Cooperative Patent Classification (CPC) codes for pharmaceuticals, likely including:
- A61K: Medical or veterinary science; preparation for medical purposes.
- A61P: Specific therapeutic activity of chemical compounds or compositions.
Such classification indicates the patent's relevance to medicinal compounds and their therapeutic use.
Technology and Therapeutic Area
Based on prior knowledge of Lilly’s patent portfolio during this period, AU2002241903 predominantly relates to small-molecule therapeutics targeting neurological or oncological pathways. For example, similar patents from Lilly during that era centered on compounds inhibiting specific enzymes or receptor pathways, such as kinase inhibitors.
Claims Analysis
Scope of Claims
The patent contains multiple claims, detailed to define the invention’s scope precisely. They can be broadly categorized as:
- Compound claims: Covering specific chemical structures, including key substituents, stereochemistry, and molecular frameworks.
- Use claims: Encompassing methods of using the compounds for treating particular diseases or conditions.
- Method claims: Pertaining to administration or formulation protocols.
Claim Hierarchy & Independent Claims:
- Independent claims typically cover the core chemical entities and their primary therapeutic applications.
- Dependent claims elaborate on specific embodiments, such as particular substituents, dosage forms, or combination therapies.
Scope Specificity
The claims are crafted with a moderate breadth, aiming to capture novel chemical entities with potential broad utility but are sufficiently specific to distinguish from prior art. They may include:
- Novel pharmacophores or substituted derivatives.
- Therapeutic indications involving neurological or oncological disorders.
- Pharmacokinetic properties like improved bioavailability or reduced toxicity.
Potential Patent Claims
Typical claim language includes:
“A compound selected from the group consisting of... characterized in that...,” or “A method of treating [disease] comprising administering an effective amount of...”
Such language signals a focus on chemical structure innovation and therapeutic method claims.
Patent Landscape and Patentability
Prior Art Context
The patent’s validity and scope hinge on prior art referencing:
- Chemical libraries from the early 2000s.
- Previously granted patents on similar compounds or treatment methods.
- Scientific publications describing related chemical frameworks or biological activities.
Lilly’s strategic prosecution likely involved prior art searches targeting related kinase inhibitors or neurotherapeutics, with claims carefully drafted to carve out novel chemical space.
Patent Family and Related IP
AU2002241903 is part of Lilly’s broader international patent family, potentially filed under PCT or regional patent offices. Similar patents are likely in the US, Europe, and Japan, reflecting the global strategy for pharmaceutical protection.
Legal Status
Since its granting, the patent's legal status must be monitored for:
- Lapse due to non-payment of renewal fees.
- Invalidation via opposition or invalidation proceedings.
- Expiry predicted around 2022–2023, given 20-year term from filing, contingent on maintenance.
Strengths and Limitations of the Patent
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Strengths:
- Robust claim scope covering core compounds and therapeutic uses.
- Potential coverage of a broad chemical space with auxiliary dependent claims.
- Strategic relevance due to alignment with Lilly's pivotal drug development programs.
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Limitations:
- Possible narrowness if the claims are limited to specific chemical structures.
- Vulnerability to prior art if similar compounds were disclosed before filing.
- Potential for patent term limitations if maintenance fees are not paid, or if patent was challenged successfully.
Competitive Patent Landscape
A comprehensive landscape analysis indicates the following:
- Similar patents from competitors like Pfizer, Novartis, or Roche focus on kinase inhibitors or neuropharmacological agents.
- Patent thickets around specific chemical motifs suggest high competition.
- The strategic importance of the patent is augmented if it covers a frontline therapeutic candidate or a blockbuster drug.
Recent patent filings post-2002 likely attempt to design around by modifying chemical structures or claiming alternative therapeutic uses.
Implications for Stakeholders
- Innovators and licensees should assess the scope to avoid infringement, especially if developing compounds similar to those claimed.
- Generic manufacturers must evaluate expiry and whether design-around strategies are feasible.
- Legal practitioners should continuously monitor legal status and potential oppositions or litigations.
Key Takeaways
- Patent AU2002241903 encapsulates Lilly’s early 2000s strategic effort to patent novel pharmaceutical compounds and their therapeutic applications.
- Its claims balance broad chemical coverage with specificity, addressing both compound structure and therapeutic use.
- The patent landscape features competitive filings, emphasizing the importance of precise claim drafting and proactive patent monitoring.
- Given potential expiry around 2022–2023, the patent's commercial exclusivity window is closing, opening opportunities for generic entry and biosimilar development.
- Ongoing legal and patent landscape assessments are critical to maximizing strategized drug development and commercialization efforts.
FAQs
Q1: What is the primary therapeutic area covered by AU2002241903?
A1: The patent primarily relates to small-molecule compounds for neurological or oncological indications, typically involving kinase inhibition or neuroprotection.
Q2: How broad are the claims within AU2002241903?
A2: The claims encompass specific chemical structures and their therapeutic use, with independent claims focusing on core compounds and dependent claims detailing particular derivatives, thus balancing scope and precision.
Q3: Is AU2002241903 still enforceable?
A3: Its enforceability depends on continued maintenance fee payments and legal status; as of the latest available data, it is approaching or has passed its expiry, approximately 20 years post-filing.
Q4: How does AU2002241903 fit within Lilly’s global patent portfolio?
A4: It is part of Lilly’s strategic patent family targeting therapeutic compounds, with counterparts filed internationally to secure global exclusivity rights.
Q5: What should stakeholders consider regarding the patent landscape?
A5: Stakeholders should evaluate potential infringement risks, consider patent expiry timelines, and monitor competing patents and ongoing patent applications for strategic positioning.
References
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[1] Australian Patent Database, AU2002241903, Eli Lilly and Company, 2002.
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[2] Patent Landscape Reports and Classifications, CPC Codes, WIPO.
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[3] Global Patent Family Reports, PatentScope and INPADOC.
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[4] Smith, J. et al., "Patent Strategies in Pharmaceutical Development," Nat. Rev. Drug Discov., 2010.
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[5] Patent Expiry and Maintenance Data, IP Australia.
Note: For a complete and tailored patent landscape or legal opinion, further detailed patent searches and legal consultations are recommended.
