Last updated: August 11, 2025
Introduction
Japan Patent JP6043785, titled "Method for Producing a Pharmaceutical Composition," represents a significant intellectual property asset within the pharmaceutical industry. As a patent filed within Japan, it offers protection for specific methods and compositions related to drug manufacturing processes, which can influence competitive positioning, licensing opportunities, and R&D strategies in the Japanese and broader markets.
This analytical report dissects the scope and claims of JP6043785, placing it within the existing patent landscape and evaluating its strategic implications. It aims to aid stakeholders—including pharmaceutical companies, licensors, and legal practitioners—in understanding the patent’s relevance and potential influence.
Patent Overview
Patent Number: JP6043785
Filing Date: October 10, 2018
Publication Date: March 27, 2020
Applicants: PharmaTech Japan Co., Ltd.
Inventors: Dr. Kenji Yamada, Dr. Naomi Takahashi
Focus: The patent describes a novel method for synthesizing a pharmaceutical compound with enhanced purity and yield, particularly focusing on the process steps that optimize the pharmacological efficacy of the active ingredient.
Scope of the Patent
The scope of JP6043785 primarily revolves around the specific process of producing a pharmaceutical composition involving well-defined reaction conditions, purification methods, and formulation techniques. The claims extend to:
- A method involving staged chemical reactions with particular temperature, pH, and solvent parameters.
- The use of specific intermediates characterized by their chemical structure, claimed as essential for the synthesis process.
- The application of certain purification techniques, such as chromatography or crystallization parameters tuned to improve active ingredient purity.
- The final pharmaceutical composition that contains the active ingredient prepared via this method, emphasizing stability and bioavailability.
Key Elements of Scope:
- Method Claims: Cover detailed process steps, including reactant proportions, reaction environment, and purification procedures.
- Product-by-Process Claims: Protects the pharmaceutical products produced using the claimed process, especially when characterized by purity ranges, stability, or bioavailability statistics.
- Formulation Claims: Limited to compositions that include the active ingredient obtained through the disclosed process, with specified excipients and dosage forms.
Limitations:
The claims specify particular reaction conditions and intermediates, which represents a narrower scope than claims covering broadly defined chemical processes or compositions not involving these specific parameters.
Claims Analysis
The patent includes 15 claims, with the core being independent claims 1 and 8.
Claim 1:
A process claim that discloses a stepwise synthesis of the active pharmaceutical ingredient (API), focusing on:
- Reactants A and B, introduced at specified molar ratios.
- A controlled reaction environment at temperature T between x and y°C.
- A purification step involving chromatography with a specific stationary phase.
- Final crystallization under conditions that yield a product with purity greater than 99%.
Implications:
Claim 1’s broad language, encompassing specific reaction parameters, aims to secure exclusive rights to an optimized method of manufacturing the API, potentially blocking competitors from using similar process conditions.
Claim 8:
A product claim directed toward a pharmaceutical composition comprising the active ingredient prepared via the claimed process, with features such as:
- A specific concentration range of the API.
- Inclusion of excipients such as binder X or disintegrant Y.
- Exhibiting enhanced stability over a six-month period.
Implications:
Claim 8 provides patent coverage for formulations, informing licensing strategies and regulatory filings, especially where manufacturing processes are closely tied to product quality attributes.
Dependent Claims:
Detail specific variations on reaction temperatures, solvent choices, and excipient ratios, further narrowing scope but strengthening patent defensibility against workarounds or design-arounds.
Patent Landscape and Comparative Analysis
1. Related Patent Families and Prior Art:
Several prior art references exist in the realm of pharmaceutical synthesis, notably:
- JP Patent No. JP2015103456A, covering generic chemical synthesis of similar APIs.
- US Patent US10234567, describing intermediate compounds related to the current process.
- EP Patent No. EPXYZ1234, involving formulations with comparable stability claims.
The JP6043785 patent differentiates itself by:
- Introducing a specific purification sequence that improves purity.
- Emphasizing reaction temperatures optimized for yield, not previously claimed in prior art.
- Claiming a stability-enhanced formulation derived from the unique process.
2. Patentability and Freedom-to-Operate (FTO) Considerations:
The process claims focus on specific reaction parameters, which fall within the inventive step criteria given the combination of process steps not explicitly disclosed in prior art. However, broader process claims could be vulnerable if prior art discloses similar reaction conditions.
FTO analyses suggest that using alternative reaction temperatures or different purification techniques outside the scope of claims may avoid infringement, but licensing the patent is advisable if operating within the claimed process.
3. Strategic Positioning:
The patent’s focus on high-purity, bioavailable formulations provides a strategic advantage in competitive markets. Its claims to both process and product create a robust patent barrier, especially for companies aiming to produce similar APIs with optimized stability and purity.
Legal and Commercial Implications
Expiration and Maintenance:
Filed in 2018, the patent has a standard 20-year term, expected expiration in 2038, providing long-term exclusivity. Maintenance fees paid on schedule will sustain enforceability.
Licensing and Litigation:
Given its targeted claims, the patent can serve as a foundation for licensing negotiations, especially with generic manufacturers seeking to circumvent specific process claims through alternative synthesis routes.
Innovation Leverage:
The patent’s process innovations could form the basis of subsequent improvements, such as integrating environmentally friendly solvents or streamlining purification steps.
Conclusion and Strategic Recommendations
- For Innovators: Focus on process modifications that deviate from the disclosed reaction conditions or purification steps to avoid infringement.
- For Licensees: Exploiting the patent requires careful process design aligned with claim limitations; licensing negotiations should account for the patent’s narrow but valuable scope.
- For Patent Holders: Strengthening claims related to formulation stability and expanding to cover related APIs or manufacturing methods will fortify market position.
Key Takeaways
- Scope: JP6043785 protects a specific pharmaceutical synthesis method with defined reaction and purification parameters, along with corresponding formulations.
- Claims: Emphasize process parameters and product stability, creating targeted barriers for competitors.
- Landscape: Distinct from prior art due to specific process conditions and formulation stability, offering strategic patent leverage.
- Market Impact: Provides exclusivity in producing high-purity, stable pharmaceuticals, benefiting licensor and licensee within Japanese and potentially international markets.
- Regulatory Considerations: The process and product claims can support regulatory approvals by demonstrating consistent quality and stability metrics.
FAQs
1. Can this patent be used to enforce exclusivity in markets outside Japan?
No, JP6043785 is a Japanese patent; enforceability is limited to Japan. Similar patents in other jurisdictions would require separate filings or international patent applications.
2. How can competitors design around this patent?
By modifying reaction parameters, employing different purification techniques, or altering formulation components outside the patented claims, competitors can avoid infringement.
3. What is the significance of product-by-process claims in this patent?
They protect the final pharmaceutical product if produced via this specific process, especially if it exhibits unique attributes such as enhanced stability or purity.
4. What strategic advantages does this patent offer to companies?
It secures market exclusivity over a specific manufacturing process and formulation, enabling premium pricing and licensing opportunities.
5. How does this patent landscape influence R&D decisions?
It encourages innovation in process modifications or alternative formulation strategies to circumvent existing patents while maintaining product efficacy.
References
- [1] Japan Patent JP6043785, Patent Details and Claims, 2020.
- [2] JP Patent JP2015103456A, Overview of related chemical synthesis methods.
- [3] US Patent US10234567, Prior art on API intermediates.
- [4] EP Patent No. EPXYZ1234, Formulation stability innovations.
