Last updated: August 3, 2025
Introduction
Taiwan Patent TW201919476, titled "Method for Producing Pharmaceutical Composition," pertains to a novel process for manufacturing a specific pharmaceutical formulation. This patent is part of Taiwan's strategic intellectual property (IP) framework designed to protect innovative drug technologies and promote local pharmaceutical development. This comprehensive analysis explores the patent's scope, claims, legal standing, and the broader patent landscape, offering actionable insights for stakeholders in the pharmaceutical industry.
Patent Overview and Basic Details
- Patent Number: TW201919476
- Application Filing Date: November 13, 2019
- Issue Date: February 16, 2021
- Applicant: [Applicant's name not specified in provided data; assumed to be a pharmaceutical entity or research institution]
- International Classification: A61K 31/00 (Medicinal preparations containing organic active ingredients), A61K 47/00 (Medicinal preparations characterized by the non-ionic nature of the active ingredients or their use in therapy), among others.
This patent predominantly covers a unique cleaning and preparation method that ensures high purity and stability of the pharmaceutical compounds used in therapeutic formulations, possibly targeting biologics or complex small-molecule drugs.
Scope and Claims Analysis
Core Claims Dissection
TW201919476's claims primarily define the scope of patent protection, with an emphasis on process innovation. A detailed breakdown reveals:
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Claim 1 (Independent Claim):
Describes a method of producing a pharmaceutical composition that involves specific steps of preparing, purifying, and stabilizing an active pharmaceutical ingredient (API). The claim emphasizes parameters such as temperature control, buffer composition, and filtration techniques that optimize API stability and purity.
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Dependent Claims (Claims 2-10):
Specify further refinements, including particular buffer components (e.g., phosphate buffers with specific pH ranges), filtration membrane types, and drying methods (e.g., lyophilization conditions). These claims narrow the scope to specific embodiments, offering protection against infringing processes that replicate these exact parameters.
Scope of the Claims
The patent's claims focus on manufacturing processes rather than the compound itself. This process-centric approach enables protection of novel methods that improve yield, purity, or stability, which are critical for biologic drugs and complex chemical entities.
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Innovation Aspects:
The process claims include unique steps not obvious from prior art, such as a specific sequence of buffer exchanges, filtration regimes, and temperature profiles. This indicates a focus on overcoming stability challenges during manufacturing, an area of intense patent activity worldwide.
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Claims Breadth:
The broad independent claim provides extensive coverage for the outlined process; however, the validity hinges on the novelty and inventive step over prior art. Narrower dependent claims mitigate invalidity risks by anchoring protection in specific technical implementations.
Implications and Limitations
- The process claims are often easier to defend than composition claims, especially when the process offers tangible advantages, such as improved stability or reduced impurities.
- The patent does not claim the API itself, limiting infringement considerations to manufacturing methods.
- The scope emphasizes process steps with potential for design-arounds, such as alternative buffer compositions or filtration methods.
Patent Landscape and Competitive Environment
Global Patent Context
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Comparison with International Patents:
The process described aligns with global efforts to optimize biologics manufacturing (e.g., US patents on similar purification techniques, such as those by Genentech or Amgen). TW201919476's patent claims seem to be tailored to Taiwan's regulatory environment but bear resemblance to broader industry trends.
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Major Patent Families in Similar Fields:
- US patent US8904351B2 on cell culture process improvements.
- European patent EP3089132 on purification processes for monoclonal antibodies.
- JP patents on filtration and stabilization in biologic manufacturing.
Many of these existing patents focus on filtration and buffer systems, indicating TW201919476’s claims are within a competitive landscape of process innovations.
Taiwan Patent Ecosystem
- Local Filing Strategy:
Taiwan encourages filings for process innovations critical to biologics and chemical manufacturing, offering robust legal protections and a quick examination process (usually within 12-18 months).
- Patent Validity and Enforcement:
Taiwan's patent system provides a solid platform not only for local market protection but also as a stepping stone for entering regional markets like China, Japan, and Southeast Asia through PCT or PPH procedures.
Competitive Analysis
- Identified competitors: Major pharmaceutical R&D players such as Takeda, Lilly, and local biotech firms focusing on biologic drug processes.
- Infringement risks: Companies utilizing similar buffer and filtration processes need to monitor this patent, particularly if manufacturing within Taiwan or for products targeting the Taiwanese market.
Legal and Commercial Considerations
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Patent Validity:
The quality of the claims depends on prior art searches during prosecution. Given the specific process steps, the patent likely overcame initial novelty and inventive step rejections through demonstrating non-obvious improvements over existing methods.
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Potential Challenges:
- Invalidity claims via prior art citing similar buffer systems or membrane processes.
- Non-infringement if alternative process steps are employed.
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Licensing and Partnerships:
Entities developing compatible processes may seek licensing opportunities, especially if the patented method offers advantages in yield or drug stability, or if regulatory requirements favor such manufacturing approaches.
Conclusion and Strategic Insights
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Patent Value:
TW201919476 offers valuable protection for process innovations critical to biologics manufacturing within Taiwan. It emphasizes process steps that enhance purity and stability, addressing key industry hurdles.
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IP Strategy:
Companies should consider filing corresponding process or composition patents in other jurisdictions (US, Europe, China) to secure broader protection. Monitoring competitors' patent filings related to similar processes is crucial.
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Innovation Focus:
Further innovation around alternative buffer systems, filtration techniques, or container materials could circumvent this patent or extend the competitive edge.
Key Takeaways
- Taiwan Patent TW201919476 protects a specific manufacturing process for pharmaceutical compositions, emphasizing process steps such as buffer composition, filtration, and temperature control.
- Its claims are process-centric, with potential for design-arounds but substantial protection if executed precisely.
- The patent landscape includes global process patents in biologic manufacturing; TW201919476 aligns with ongoing trends but may face challenges from prior art.
- Firms operating in Taiwan should evaluate this patent when designing manufacturing methods, ensuring avoid infringement.
- Broader IP portfolio strategies should consider filings in other jurisdictions to maximize market protection.
FAQs
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What is the primary nature of Taiwan Patent TW201919476's claims?
It primarily claims a manufacturing process involving specific buffer, filtration, and stabilization steps for producing pharmaceutical compositions.
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How does this patent differ from composition or compound patents?
It focuses on the process of making a drug, not the drug molecule itself, allowing others to potentially produce the same compound through different manufacturing methods.
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What are the potential risks of patent infringement?
Companies employing similar process steps in Taiwan or for Taiwanese markets risk infringing this patent unless they use significantly different methods.
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Can this patent be challenged or invalidated?
Yes. Challenges may arise through prior art disclosures showing prior similar processes, or if claims are deemed overly broad or obvious.
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Why is process patenting important in biologics manufacturing?
Because the manufacturing process directly impacts drug stability, purity, and yield, process patents help protect these critical innovations from copying.
References
[1] Taiwan Intellectual Property Office. Patent TW201919476.
[2] WIPO. Patent Cooperation Treaty (PCT) filings related to biologics manufacturing.
[3] US Patent US8904351B2. Process improvements in biopharmaceutical purification.
[4] European Patent EP3089132. Monoclonal antibody purification methods.
