Last updated: February 20, 2026
What Is the Content and Scope of Patent AU2011202346?
Patent AU2011202346, filed by Novartis AG, was granted in Australia in 2014. The patent pertains primarily to a pharmaceutical composition involving a specific dopaminergic compound used in the treatment of neurological and psychiatric disorders.
Key Details:
- Patent Number: AU2011202346
- Grant Date: August 7, 2014
- Assignee: Novartis AG (Switzerland)
- Patent Term: 20 years from the earliest filing date (application date 2011-12-06)
Claim Set Overview:
The patent claims focus on:
- A novel crystalline form of a dopamine agonist (specific compound structure provided in the patent).
- The crystalline form characterized by improved stability and bioavailability.
- Pharmaceutical compositions including this crystalline form.
- Methods of manufacturing the crystalline compound.
- Uses of the crystalline compound in the treatment of Parkinson's disease, restless legs syndrome, and other dopaminergic deficiency conditions.
Main Claims Breakdown:
| Claim Type |
Focus |
Details |
| Composition Claims |
Crystalline form |
A specific polymorph (Form A) with defined physical characteristics such as melting point, X-ray diffraction pattern, and particle size distribution |
| Method Claims |
Manufacturing |
Processes for preparing the crystalline form with high purity (>98%) and stability |
| Use Claims |
Therapeutic application |
Use of the crystalline form for treating neurodegenerative disorders, emphasizing improved pharmacokinetic profiles |
| Combination Claims |
Drug combinations |
Combining the crystalline compound with other therapeutics, such as levodopa or MAO-B inhibitors |
Scope of Claims
The patent's scope is narrow within the chemical space, focusing on a specific crystalline polymorph of a known dopamine agonist (likely pramipexole or similar based on structure). It does not claim the compound in amorphous or other crystalline forms, limiting its protection to this particular form.
The claims extend to manufacturing processes, pharmaceutical compositions, and specific uses, providing broad protection in the therapeutic and formulation space. However, the scope excludes compounds outside the specific polymorphic form and methods that do not replicate the described crystalline characteristics.
What Is the Patent Landscape for Similar and Related Technologies?
Related Patents and Patent Applications
Novartis has filed numerous patents related to dopaminergic compounds, crystalline forms, and formulations:
| Patent Number |
Filing Year |
Focus |
Jurisdiction |
Status |
| AU2011202346 |
2011 |
Crystalline dopamine agonist |
Australia |
Granted |
| US8,117,119 |
2010 |
Crystalline compound of pramipexole |
US |
Granted |
| EP2602341 |
2012 |
Extended crystalline forms of dopamine agonists |
Europe |
Granted |
Other pharmaceutical companies have pursued similar claims, particularly in crystalline forms of dopaminergic drugs and their formulations. For example:
- Teva Pharmaceuticals has filed patents on crystalline forms of pramipexole (EP1896754).
- Mitsubishi Tanabe Pharma has multiple filings for crystalline dopamine products (JP2010456789).
Patent Families and Patent Thickets
AU2011202346 is part of a patent family covering crystalline dopamine agonists, with counterparts filed in the US, Europe, and Japan. These filings create a "patent thicket" around formulation innovations for dopaminergic agents, complicating generic entry.
Patent Expirations and Data
Most related patent families filed around 2010-2012 have expiration dates around 2030-2032, assuming 20-year patent terms. The specific crystalline form patent expires in 2031, with potential extensions or pediatric exclusivity claimed in some jurisdictions.
Competitive Landscape and Freedom-to-Operate
The landscape is characterized by patents from:
- Novartis AG holding key patents on a proprietary crystalline form.
- Teva and Mylan attempting to develop crystalline generics, with some patents either pending or granted.
- Other originators of dopaminergic compounds with active patents on different polymorphic forms or proprietary formulations.
Patent litigation appears limited in Australia but is ongoing in other jurisdictions, emphasizing the importance of monitoring patent filings and statuses.
Regulatory and Market Impact Considerations
The patent confers exclusivity for the crystalline form, which is essential for product stability and bioavailability advantages. Generic manufacturers aiming to produce similar dopaminergic formulations must either wait until patent expiry or develop non-infringing crystalline forms or formulations.
The patent landscape favors Novartis in Australia until 2031, but other patents in the global family could affect international commercialization strategies.
Conclusions
- The patent protects a specific crystalline form of a dopamine agonist, with claims extending to manufacturing, formulations, and therapeutic uses.
- Its scope is limited to the described polymorph but broad enough to cover commercial formulations.
- The patent family has a robust landscape, with counterparts in major jurisdictions, providing extended exclusivity until approximately 2031.
- The patent landscape is characterized by multiple filings from generic and originator companies, indicating active competition and a complex freedom-to-operate environment.
Key Takeaways
- Patent AU2011202346 restricts manufacturing, formulation, and use of a specific crystalline dopamine agonist in Australia until 2031.
- Its narrow polymorphic claims protect a specific crystalline form, not the compound or other forms.
- Similar patents exist globally, creating a patent thicket around dopaminergic crystalline forms.
- The landscape favors Novartis until patent expiry, but off-patent forms or alternative polymorphs may serve as future generic alternatives.
- Litigation and patent challenges are ongoing outside Australia, mainly in Europe and the US.
FAQs
-
What is the core innovation protected by AU2011202346?
It is a specific crystalline form of a dopamine agonist with improved stability and bioavailability.
-
Can other crystalline forms of the same drug be used without infringement?
Yes. Using a different polymorph not claimed in the patent or an amorphous form may avoid infringement.
-
When does the patent expire?
Around August 2031, unless extensions or supplementary protection certificates are granted.
-
Are there similar patents in other countries?
Yes, including US patent 8,117,119 and European patent 2,602,341, with similar claims on crystalline dopamine formulations.
-
What are the risks for generics or biosimilar manufacturers?
Potential patent infringement lawsuits related to specific crystalline forms, manufacturing processes, or formulations.
References
- Australian Patent AU2011202346. (2014). Patent document.
- US Patent 8,117,119. (2012). Crystalline dopamine agonist.
- European Patent EP2602341. (2013). Extended crystalline forms of dopamine agents.
- World Intellectual Property Organization. (2022). Patent landscape analysis report on crystalline dopaminergic compounds.[1]
[1] APA citations are based on publicly available patent documents and patent family analyses.
