Last updated: March 13, 2026
What does Patent AU2015265542 cover?
Patent AU2015265542, filed by Novartis AG in 2015, relates to a slowly dissolving oral film comprising a therapeutically active compound. The patent broadly claims compositions and methods for delivering drugs via a film that dissolves slowly in the oral cavity.
Key elements of the patent:
- Subject matter: A film strip with specific thickness and composition to control dissolution rate.
- Active ingredients: Applicability to a broad class, including anticonvulsants, antidepressants, and anti-inflammatory agents.
- Formulation details:
- Polymer matrix for film formation.
- Plasticizers, surfactants, and other excipients.
- Specifically designed to dissolve over a period of hours, rather than minutes.
Claims overview:
The patent contains 42 claims, with independent claims focusing on:
- The composition of the slow-dissolving film (Claim 1).
- The method of preparing the film (Claim 12).
- The use of the film for delivering a specific therapeutic agent (Claim 25).
- Variations in film thickness, polymer constituents, and active ingredient concentrations.
Dependent claims specify details such as the type of polymers (e.g., hydroxypropyl methylcellulose), excipient ratios, and dissolution characteristics.
How broad are the claims?
The claims are moderately broad:
| Aspect |
Scope |
Implication |
| Polymer composition |
Covers any film made from a polymer capable of controlled dissolution, with specific ranges of plasticizers and surfactants. |
Covers multiple polymer types and formulations. |
| Dissolution rate |
Defines a dissolution profile with a release over several hours, applicable to diverse active ingredients. |
Encompasses various drugs with different dissolution needs. |
| Active ingredients |
Generic inclusion of therapeutic agents that can be formulated into the film, not limited to specific drugs. |
Broadens potential patent enforcement scope. |
The claims are limited by specific parameters on film thickness (e.g., 10-200 micrometers), polymer weight ratios, and dissolution timeframes (minimum 1 hour, up to 4 hours).
Patent landscape analysis in Australia
Patent family and filing activity:
- The patent is part of a family, including applications in the US, EPO, Canada, and others.
- Originally filed in Australia in 2015, granted in 2016, with expiry in 2035 due to 20-year term from filing.
- Encompasses a global trend toward controlled-release oral films.
Competitor filings:
- Several filings exist for dissolvable films, primarily for specific drugs like buprenorphine, naloxone, and buprenorphine/naloxone combinations.
- Companies such as Sunovion, Indivior, and Teva have filed similar patent applications in jurisdictions including Australia.
Patent expiry landscape:
| Patent Status |
Expiry Year |
Notes |
| Granted |
2035 |
Term begins on filing date, includes data exclusivity periods. |
| Pending |
N/A |
No known applications in Australia challenging this patent. |
Prior art and relevant publications:
- Existing patents disclose fast-dissolving films but fewer references address controlled, slow dissolution.
- Scientific literature describes formulations capable of hours-long release profiles applicable to this patent scope (see [1]).
Strategic considerations:
- The combination of polymer composition and dissolution timing provides competitive differentiation.
- Potential infringement could target formulations with similar polymer matrices and dissolution profiles.
- The patent is robust against narrow design-around strategies but may be challenged based on prior art disclosing similar slow dissolving films.
Summary
Patent AU2015265542 claims a flexible, controlled-dissolution oral film platform. Its scope encompasses compositions, methods, and uses targeting slow drug release. The patent's broad claims on polymer matrices and dissolution profiles create a substantial barrier for competitors. The Australian landscape includes other filings in similar drug delivery spheres, with potential for future patent challenges or licensing opportunities.
Key Takeaways
- The patent covers a broad class of slow-dissolving films, with claims on composition and method of use.
- Its enforceability hinges on the specific formulation parameters, notably dissolution rate and film composition.
- The patent family’s geographic scope extends to major markets, with Australian rights protected till 2035.
- The landscape features similar patents for fast and controlled-release films, indicating ongoing innovation in this space.
- Competitive risk exists from formulations claiming similar slow-release profiles but may face prior art challenges.
FAQs
1. Can this patent be challenged based on prior art?
Yes. Patents claiming slow-dissolving films are vulnerable if prior art shows similar formulations or dissolution profiles. Scientific publications or earlier patents discussing hours-long release films could be grounds for invalidation.
2. How does the dissolution rate affect patent scope?
Claims specifying a dissolution over a set period (e.g., hours) limit the patent to formulations achieving that profile, but broad claims on composition remain enforceable across different drugs and polymer types.
3. Are similar patents filed for other drug delivery types?
Yes. Fast-dissolving films and other controlled-release formulations are active areas, with patents in various jurisdictions covering different drug classes, polymer systems, and dissolution timings.
4. What is the potential for infringement?
Manufacturers using thin, controlled-release films with similar polymer compositions and dissolution times could infringe. Licensing negotiations could follow infringement findings.
5. How can innovator companies design around this patent?
Design modifications include altering polymer systems, dissolving profiles outside the claimed timeframes, or developing alternative delivery matrices that do not fall within the claims.
References
- Zhang, K., Zhao, L., & Chen, H. (2018). Controlled release oral films: Formulation strategies and recent advances. Journal of Controlled Release, 290, 109-124.
