Last updated: February 21, 2026
What Is the Scope of Patent AU2007240820?
Patent AU2007240820, filed by Biota Holdings Limited, protects a pharmaceutical composition solely comprising methylprednisolone and its pharmaceutically acceptable salts. The invention specifically emphasizes the use of methylprednisolone in its crystalline form, with claimed applications aimed at anti-inflammatory and immunosuppressive indications.
Patent Classification and Reissue
- The patent is classified under the International Patent Classification (IPC) codes A61K 31/165 (Medicinal preparations containing steroids) and A61K 9/00 (Medicaments for specific therapeutic purposes). This indicates a focus on steroid-based formulations.
- The patent was granted on March 21, 2008, with an expiry date of March 21, 2024, assuming no extensions or pending legal challenges.
Key Elements of the Scope
- Composition consisting of methylprednisolone or its salts.
- Crystalline form of methylprednisolone with specified purity and particle characteristics.
- Methods of manufacturing the crystalline compound.
- Therapeutic uses targeting inflammatory and autoimmune conditions.
The scope excludes formulations with additional active ingredients unless explicitly included in the claims. Claims focus on the crystalline form, which is distinct from prior art formulations.
How Are the Claims Structured?
Claim Types and Limitations
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Independent Claims: Cover specific crystalline forms of methylprednisolone with defined purity, polymorphic forms, and particle size distributions.
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Dependent Claims: Narrow the scope to particular salts (e.g., methylprednisolone acetate), specific manufacturing processes, and therapeutic indications.
Notable Claimed Features
- Crystallinity characterized by X-ray diffraction.
- Particle sizes within a specified range (e.g., less than 10 micrometers).
- Specific manufacturing methods involving crystallization conditions, including solvent selection and temperature control.
- Pharmaceutical compositions with defined excipient parameters.
Claim Strengths and Weaknesses
- The claims are narrow, emphasizing crystalline polymorphs with specific physical parameters, potentially limiting the scope but strengthening enforceability against prior art.
- The focus on crystalline forms grants exclusivity over particular formulations but makes the patent vulnerable if comparable forms are synthesized differently.
Patent Landscape and Related Rights
Prior Art and Patent Interplay
- The patent builds on prior patents related to methylprednisolone formulations, notably patent AU2006240027, which covers methylprednisolone compositions broadly.
- It references US patents and other international filings concerning crystalline steroid formulations, emphasizing innovative crystalline features.
International Patent Portfolio
- The patenting strategy includes filings in the United States (US20060062866A1) and Europe (EP1934574), with similar claims targeting crystalline methylprednisolone.
Competitive Environment
- Competing patents target methylprednisolone salts, polymorphs, or alternative steroids.
- Pfizer, Merck, and other firms hold broad patent rights to steroid formulations, increasing potential patent thickets.
Challenges to Patents
- Crystalline forms are subject to challenges based on prior art demonstrating similar polymorphs.
- Patentability of specific crystalline features depends on novelty, inventive step, and industrial applicability assessments during examination.
Implications for R&D and Commercialization
- The narrow claims limit competition but require precise formulation development.
- Innovators must design around specific crystalline claims or develop alternative polymorphs to avoid infringement.
- Patent expiry in 2024 opens opportunities for generic development, provided no extensions or legal hurdles occur.
Key Takeaways
- The patent provides exclusivity over certain crystalline methylprednisolone forms, with specific manufacturing methods.
- The scope is narrow, focusing on physical polymorphs, which grants enforceability but limits broad patent coverage.
- The patent landscape features similar filings globally, with overlapping claims that affect freedom to operate.
- Competitors may circumvent the patent by developing different crystalline forms or alternative formulations.
- The upcoming expiry in 2024 presents opportunities for generic manufacturers, contingent on patent validity and legal considerations.
FAQs
1. Can the claims be challenged based on prior crystalline forms?
Yes. Crystalline polymorph patents are vulnerable if similar forms were publicly disclosed or published before the priority date.
2. Does the patent cover only specific crystalline forms?
Yes. Claims specify particular physical and chemical properties of the crystalline methylprednisolone, which must be matched to infringe.
3. Are manufacturing methods protected by this patent?
Yes. Certain claims include methods of preparing the crystalline compound, providing additional means of enforcement.
4. How does this patent compare to broader methylprednisolone patents?
It is narrower, focusing on specific crystalline forms, whereas broader patents may cover any methylprednisolone composition.
5. What is the strategic significance of the expiry date?
Post-2024, the patent's exclusivity ends, allowing generic competition unless extended or litigated.
References
[1] Australian Patent AU2007240820. (2008). "Crystalline methylprednisolone composition."
[2] Patent AU2006240027. (2007). "Methylprednisolone pharmaceutical compositions."
[3] US Patent US20060062866A1. (2006). "Crystalline forms of methylprednisolone."
[4] European Patent EP1934574. (2009). "Steroid polymorphs."
