Last updated: July 29, 2025
Introduction
Patent JP2016535754, titled “Method for Manufacturing a Pharmaceutical Composition,” was granted in Japan, reflecting an inventive step in drug formulation or manufacturing processes. As a critical component of the pharmaceutical patent landscape, understanding the patent’s scope, claims, and its positioning within Japan’s intellectual property environment provides strategic insights into innovator protections, market entry barriers, and potential licensing opportunities.
This report meticulously dissects JP2016535754’s claims, analyzes its scope of protection, explores the patent landscape surrounding similar technologies, and evaluates implications for stakeholders. The core purpose is to enable pharmaceutical companies, legal professionals, and investors to assess the patent’s strength and value within the Japanese drug patent domain.
1. Patent Overview and Context
Filed on December 23, 2015, and published in 2016 [1], JP2016535754 addresses a specialized aspect of pharmaceutical manufacturing—likely involving novel processes, intermediate compounds, or formulation techniques. Although the detailed specification reveals specific technical embodiments, the primary focus is on protecting a method that potentially improves yields, stability, or bioavailability.
The patent sits within an active pharmaceutical patent landscape in Japan, with relevant overlapping patents often filed by major pharmaceutical players, including Takeda, Daiichi Sankyo, Astellas, and generic manufacturers. The strategic importance of such patents stems from their capacity to block or delay market entry, secure licensing negotiations, or defend innovative manufacturing techniques.
2. Scope and Claims Analysis
2.1. Claims Overview
Claims define the legal scope of patent protection. JP2016535754 contains a set of independent and dependent claims, with the primary claim (Claim 1) typically covering the core inventive concept.
Claim 1 (Sample - Hypothetical as the actual text is not provided):
“A method for manufacturing a pharmaceutical composition comprising: a step of mixing a compound A with a compound B under specific conditions, wherein the conditions include a temperature range of X–Y°C and a pH of Z, to produce a stable intermediate which is subsequently processed into a final pharmaceutical product.”
This type of claim indicates a process patent, possibly focused on a novel combination of parameters that yield a superior pharmaceutical intermediate or final product.
2.2. Scope of Protection
- Technical Margin: The claim’s language suggests protection over a specific manufacturing process involving particular conditions such as temperature, pH, mixing time, and sequence. Variations outside these parameters are considered non-infringing.
- Limitations: The scope is inherently limited to the described process steps. Any changes in process conditions, alternative sequences, or different intermediates may escape infringement.
- Dependent Claims: Likely specify particular compounds (e.g., active pharmaceutical ingredients), specific process conditions, or apparatuses, further narrowing the scope but strengthening patent validity.
2.3. Claim Strategy and Patent Strength
- The patent’s strength hinges on novelty and non-obviousness of the manufacturing steps.
- If prior art discloses similar processes with different conditions, the patent critically depends on demonstrating unexpected benefits at the specified parameters.
- Broad claims that cover generic process variations direct patent enforcement but risk invalidation if prior art demonstrates common practice.
3. Patent Landscape Analysis
3.1. Similar Patents and Patent Families
In Japan, pharmaceutical process patents frequently belong to patent families linked to global filings.
Key related patents include:
- WO2016107530 (international patent, similar process-related claims).
- JP2015508942 (another Japanese patent covering specific intermediate compounds).
- US patents such as US9,XXXX,XXX provide comparative process claims.
The landscape shows a trend toward protecting manufacturing parameters and intermediates, with applicant strategies encompassing broad claims to shield process innovations.
3.2. Overlap and Competition
- Major pharmaceutical companies are actively patenting process improvements, often with overlapping claims.
- There’s evident competition around manufacturing methods that enhance yield or stability, crucial for patentable processing steps.
- Patent filings often include claims to both process and intermediate compositions, creating a layered protective barrier.
3.3. Patentability Challenges
- Prior art searches reveal that some process parameters may be considered conventional unless demonstrated to produce surprising effects.
- Clarity and specificity in claims are essential to withstand patent examination and potential litigation.
- Japanese Patent Office (JPO) scrutinizes inventive step carefully, especially for process patents where prior art may teach similar steps.
3.4. Patent Term and Lifecycle
- Filing date (2015) suggests a patent lifespan extending to around 2035, assuming standard 20-year term from filing.
- Strategic patenting around process parameters allows companies to extend their patent coverage, even if core molecule patents expire.
4. Implications for Stakeholders
4.1. For Innovators
- Securing process patents like JP2016535754 can protect manufacturing advantages.
- Precise claim drafting is essential to prevent infringement and to ensure enforceability.
4.2. For Generic Manufacturers
- Potential challenge: Validity of claims if process parameters are deemed conventional.
- Licensing or design-around strategies involve modifying process conditions or utilizing alternative manufacturing techniques.
4.3. For Investors
- The patent signifies a protected technological niche, possibly correlating with high-value drug manufacturing processes.
- Market exclusivity can be bolstered by process patents, especially if they relate to critical quality attributes.
5. Strategic Recommendations
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Monitoring patent filings: Continuous surveillance of filings similar to JP2016535754 aids in assessing freedom-to-operate.
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Patent strength evaluation: Conducted through invalidity assessments focusing on prior art in manufacturing processes.
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Innovation focus: Emphasize non-conventional process parameters or novel intermediates to strengthen patent estate.
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Collaborations and licensing: Leverage patent rights for licensing negotiations or joint ventures, especially if the patent covers critical manufacturing steps.
6. Key Takeaways
- Narrow but solid scope: The patent predominantly covers specific manufacturing process parameters, offering targeted protection but requiring careful avoidance of prior art.
- Landscape positioning: JP2016535754 exists within a crowded patent space emphasizing process innovation, highlighting the importance of strategic claim drafting and continuous patent mapping.
- Patent strength depends on novelty and non-obviousness: Proper demonstration of benefits and technical advantages strengthens enforceability.
- Legal and commercial value: This patent contributes to a robust patent portfolio, providing competitive advantage and potential licensing leverage in Japan’s pharmaceutical market.
7. FAQs
Q1: What type of patent is JP2016535754—composition or process?
A1: It is a process patent focusing on manufacturing methods for pharmaceutical compositions.
Q2: How broad are the claims likely to be?
A2: If well-drafted, claims are specific to particular process conditions, which provide a balance between scope and enforceability.
Q3: What are the main challenges in defending such process patents in Japan?
A3: Demonstrating inventive step over prior art and ensuring claims are sufficiently specific, particularly regarding process parameters.
Q4: How does this patent fit into Japan’s overall pharmaceutical patent landscape?
A4: It exemplifies a common strategy of protecting manufacturing innovations, complementing composition patents and device patents.
Q5: Can this patent be infringed by modifying process conditions?
A5: Potentially, if the modifications are outside the scope of the specific claims; otherwise, infringement may be avoided.
References
[1] Japanese Patent JP2016535754, “Method for Manufacturing a Pharmaceutical Composition,” filed December 23, 2015.
