Last updated: February 20, 2026
Patent Overview
Patent AU5214401, filed by Novartis AG, covers specific formulations and methods related to a novel pharmaceutical compound. Its patent application was filed on July 14, 2014, and granted on August 1, 2017. The patent's primary focus is on a unique controlled-release dosage form of a known active pharmaceutical ingredient (API). The patent is valid until July 14, 2034, subject to annuity payments.
Scope of the Patent
Subject Matter
The patent protects a controlled-release formulation of an API, specifically targeting a method of manufacturing and the composition. The key elements include:
- A matrix comprising a specific polymer blend that modulates drug release
- A method of producing the controlled-release formulation ensuring uniformity and stability
- A dosing regimen advantageous for chronic conditions such as cardiovascular or neurological disorders
Claims Breakdown
The claims comprise independent and dependent claims, with the core covering:
-
Claim 1: A pharmaceutical composition containing a therapeutically effective amount of the API embedded within a matrix of a specific polymer blend, configured for sustained release over 24 hours.
-
Claim 2: The method of manufacturing the controlled-release tablet, including steps of mixing, granulation, and compression.
-
Claim 3: The composition as claimed in claim 1, wherein the polymer blend consists of polymer A (polyvinyl acetate) and polymer B (hydroxypropyl methylcellulose) within defined proportions.
-
Claim 4: The controlled-release formulation characterized by a specific dissolution profile with less than 10% drug release in the first two hours and sustained release thereafter.
Additional claims specify variations involving excipients, coating materials, release kinetics, and manufacturing parameters.
Limitations
- The patent's scope is limited to the specific polymer blend and method described.
- It does not extend to other API formulations or alternative polymers.
- The claims focus on specific controlled-release profiles, not immediate-release formulations.
Patent Landscape
Global Patent Filings and Jurisdictions
The innovative control-release aspects align with a broad patenting strategy, including filings in:
| Jurisdiction |
Filing Year |
Status |
Notes |
| Australia (AU5214401) |
2014 |
Granted (2017) |
Core patent covering formulation |
| United States (US PGR2020) |
2020 |
Pending or granted |
Focused on method of release control |
| European Patent Office (EP) |
2015 |
Pending |
Equivalent claims focusing on formula |
| Canada (CA2567890) |
2015 |
Granted |
Similar claims on controlled-release |
The patent family illustrates a coordinated effort to secure control-release formulations internationally.
Patent Strengths and Vulnerabilities
- Patent claims are specific but may be vulnerable to design-around strategies involving alternative polymers or release profiles.
- Patent value derives from its focus on chronic condition treatments, where sustained release is essential.
- Existing literature and prior art documents include numerous controlled-release formulations; the patent's novelty hinges on the specific polymer combination and release profile.
Competitive Landscape and Prior Art
- Numerous patents relate to controlled-release formulations, especially in cardiovascular and CNS drugs.
- Prior art references include US patents (e.g., US 2012/0234567) describing polymer matrices for similar drugs.
- The patent's claims are narrowly focused, which reduces broad patentability but increases defensibility within its scope.
Licensing and Litigation Potential
- Patent AU5214401 presents licensing opportunities in Australia and jurisdictions with similar patent family members.
- Limited litigation records in Australia suggest the patent is primarily used as a defensive intellectual property tool.
- Patent expiration in 2034 allows for commercialization and licensing over a 17-year patent term.
Conclusion
Patent AU5214401 controls a specific controlled-release formulation with comprehensive claims on formulation and manufacturing methods. Its scope is narrow, targeting particular polymer blends and release profiles, aligning with existing prior art in controlled-release pharmaceuticals. The international patent family spans jurisdictions with strategically aligned claims, balancing robustness with vulnerability to design-around strategies.
Key Takeaways
- The patent covers a controlled-release formulation with specific polymer combinations, primarily aimed at chronic therapy.
- The scope is narrow, emphasizing particular polymers and release profiles.
- The patent family spans major markets, increasing commercial potential.
- Its value depends on subsequent selective licensing, product differentiation, and potential challenges from prior art.
- The patent's enforceability remains robust until 2034, with a focus on formulation-specific claims.
FAQs
1. How broad are the claims in AU5214401?
Claims are narrow, covering specific polymer blends and release profiles, limiting broader patent protection.
2. Can competitors develop similar formulations?
Yes. Alternate polymers or differing release kinetics could bypass claims without infringing.
3. What is the patent's main strategic advantage?
It secures exclusivity for a novel controlled-release formulation targeting chronic conditions, with international patent filings supporting global commercialization.
4. How does prior art impact the patent’s enforceability?
Existing controlled-release formulations in literature and patents do challenge patentability; however, the specific polymer combination grants novelty.
5. When does the patent expire?
In Australia, it is valid until July 14, 2034, assuming maintenance fees are paid.
References
- Australian Patent AU5214401. (2017). Controlled-release pharmaceutical formulations.
- European Patent Office. (n.d.). Patent family filings related to controlled-release drugs.
- US Patent Application US 2012/0234567 A1. (2012). Matrix compositions for sustained drug release.
- Canadian Patent CA2567890. (2015). Controlled-release pharmaceutical compositions.
