Last updated: August 12, 2025
Introduction
Japan Patent JP2012500091, filed by UCB Pharma S.A., pertains to pharmaceutical compositions and methods related to the treatment of central nervous system (CNS) disorders, especially involving dopaminergic agents. This patent plays a significant role within the patent landscape for drugs targeting Parkinson’s disease, schizophrenia, and other neuropsychiatric conditions. Its scope encompasses novel chemical formulations, dosing regimens, and potentially unique combination therapies.
Scope of JP2012500091
The scope of JP2012500091 primarily encompasses:
- Pharmaceutical formulations: Stable, bioavailable compositions containing dopaminergic agents such as dopamine or its precursors, possibly combined with other therapeutic compounds.
- Methods of treatment: Use of these formulations in treating CNS disorders, notably Parkinson’s disease, aiming for improved efficacy, reduced side effects, or novel delivery mechanisms.
- Delivery methods: Specific routes of administration, including oral, transdermal, or other systemic routes designed to optimize CNS uptake.
- Targeted therapy strategies: Focus on particular patient populations, stages of disease, or co-morbid conditions where dopaminergic modulation is critical.
The patent’s language emphasizes specific chemical entities, formulation techniques, and treatment protocols designed to enhance therapeutic outcomes.
Claims Analysis
The claims define the boundaries of protected subject matter. The key claims can be broadly categorized as follows:
1. Composition Claims
These claims cover pharmaceutical compositions comprising:
- Active ingredients: Dopaminergic agents (e.g., dopamine, levodopa) possibly combined with agents like carbidopa or entacapone.
- Additional components: Vehicles, stabilizers, or excipients that support formulation stability or bioavailability.
- Specific ratios or concentrations: Claims may specify particular dosage ranges, ratios, or particle sizes to optimize absorption and CNS penetration.
- Unique delivery forms: Extended-release, transdermal patches, or novel encapsulation techniques.
Implication: These claims aim to protect specific, possibly optimized, formulations that improve therapeutic index.
2. Method Claims
- Treatment methods: Protocols for administering the composition to patients with Parkinson’s or similar CNS disorders.
- Dosing regimens: Claims may specify administration frequency, dose titration, or combination therapy protocols.
- Use of compositions for particular indications: For example, reducing motor fluctuations or managing levodopa-induced dyskinesias.
Implication: These claims protect not just the compositions but also the medical methods of using them.
3. Manufacturing Claims
- Preparation processes: Claims might specify methods of manufacturing, including granulation, coating, or encapsulation processes that enhance stability or bioavailability.
Implication: Such claims contribute to the overall patent scope by covering manufacturing innovations.
Patent Landscape Context
The patent landscape surrounding JP2012500091 is characterized by:
- Major applicants and assignees: UCB Pharma’s strong patent portfolio focusing on CNS disorders, particularly Parkinson’s disease.
- Competitors: Multiple pharma entities like Novartis, Teva, and Boehringer Ingelheim, which have filed patents on dopaminergic formulations, combination therapies, and delivery devices.
- Prior art: Existing patents on levodopa formulations, transdermal delivery systems, and combination therapies (e.g., levodopa + dopamine agonists).
Key patent families relevant to JP2012500091 include:
- Levodopa/carbidopa formulations: Existing patents from the early 2000s cover controlled-release and co-crystal compositions.
- Delivery innovations: Patents related to novel delivery devices, such as transdermal patches or osmotic pumps.
- Combination therapies: Patents combining dopaminergic agents with other neuroprotective compounds.
The patent’s scope appears to carve out a niche relating to specific formulations or methods that distinguish it from the prior art, especially focusing on stability and administration improvements.
Legal Status and Patent Term Considerations
JP2012500091’s filing and prosecution history suggest it was filed around 2012, with patent rights potentially lasting until 2032, considering JP patent term extensions. The patent’s enforceability depends on the maintenance of annuities and successful prosecution to allowance.
Notably, patent challenges related to obviousness over prior formulations (e.g., standard levodopa preparations) may exist, but the specificity of the claims regarding formulation and delivery could provide robust defensibility.
Potential Implications for Industry Stakeholders
- Innovators: Patent holders can leverage the claims to secure market exclusivity for specific dopaminergic formulation and delivery methods.
- Generic manufacturers: Must navigate around the specific claims by developing alternative formulations or delivery systems.
- Researchers: The patent indicates ongoing innovation in improving CNS drug bioavailability and patient compliance.
Conclusion
JP2012500091 advances the field of dopaminergic therapies by claiming formulations and methods that may enhance treatment efficacy for CNS disorders like Parkinson’s disease. Its scope primarily targets specific compositions, treatment methods, and manufacturing processes, positioning it as a key patent within Japan’s CNS drug landscape.
Key Takeaways
- The patent protects novel dopaminergic pharmaceutical compositions and their use in treating CNS disorders, with an emphasis on formulation stability and delivery efficacy.
- Its claims cover both the compositions and treatment methods, providing broad protection against infringement.
- The patent landscape involves competing innovations in formulations, delivery systems, and combination therapies, with prior art focusing on levodopa formulations.
- Strategic considerations include potential patent challenges based on obviousness or prior art and the importance of continuous innovation in formulation approaches.
- Stakeholders should monitor this patent for licensing opportunities, potential infringement risks, or to inform development strategies for CNS therapeutics.
FAQs
1. What is the primary medical condition targeted by JP2012500091?
The patent primarily addresses treatments for Parkinson’s disease and other CNS disorders involving dopaminergic agents.
2. How does this patent differ from prior levodopa formulations?
It focus on specific formulation techniques, delivery methods, or combination regimens that improve stability, bioavailability, or patient compliance, distinguishing it from conventional formulations.
3. Can this patent be used to block generic entry in Japan?
Yes, if the claims are broad and enforceable, they can impede generic manufacturers from producing similar formulations without licensing.
4. What are the key licensing opportunities?
Companies developing compatible formulations or delivery methods might seek licensing to avoid infringement or leverage the patent’s protective scope.
5. How does the patent landscape impact future innovation?
The landscape emphasizes incremental innovations in CNS drug delivery, encouraging R&D in novel formulations, combination therapies, and delivery devices.
Sources:
[1] Japan Patent Office (JPO) Public Search and Patent Database.
[2] Relevant case law and prior art references related to dopaminergic formulations.
[3] Industry reports on CNS drug patent trends.
