Last updated: November 19, 2025
Introduction
Taiwan Patent TW201946625, titled "Method for manufacturing pharmaceutical composition containing protein or peptide", was filed by a major pharmaceutical entity to secure intellectual property rights over a novel manufacturing process for protein- or peptide-based therapeutics. This patent plays a crucial role within the rapidly evolving biotech landscape, especially as protein and peptide drugs constitute a significant portion of emerging therapies for various complex diseases.
This analysis provides an in-depth review of the patent’s scope, claims, and its position within the current patent landscape, with implications for industry stakeholders, licensees, and potential competitors.
Scope of Patent TW201946625
TW201946625 broadly aims to safeguard a proprietary method for producing stable, high-purity pharmaceutical compositions comprising proteins or peptides. The scope emphasizes:
- An innovative manufacturing process involving specific steps, such as controlled solubilization, refolding, purification, and stabilization.
- The resultant pharmaceutical compositions with enhanced stability, bioavailability, and reduced immunogenicity.
- Use of particular excipients, stabilizers, or buffers optimized during synthesis to improve therapeutic efficacy.
The patent’s claims protect both the process and the composition, covering methods to manufacture the therapeutic proteins/peptides with improved characteristics. Its scope aligns well with industry trends seeking methods that improve yield, stability, and safety profile of biologics.
Claims Analysis
Patent claims form the cornerstone of statutory protection, defining the legal boundaries. TW201946625 contains a mixture of independent and dependent claims, aim to cover both the manufacturing process and the resultant pharmaceutical formulations.
Independent Claims
The primary independent claims (most likely Claims 1 and 10) generally encompass:
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Claim 1: A method comprising steps such as solubilizing a protein or peptide using specific conditions (e.g., pH, temperature), refolding under controlled parameters, and purifying with particular chromatography techniques, culminating in a stable pharmaceutical composition.
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Claim 10: The composition itself, characterized by specific features such as a defined concentration, buffer composition, and stability parameters, resulting from the method claimed earlier.
Dependent Claims
Dependent claims specify particular embodiments, such as:
- Use of particular excipients like amino acids or sugars.
- Specific pH ranges or temperature controls.
- Process parameters like dialysis conditions or spray-drying methods.
- Composition features such as viscosity, isotonicity, or crystallinity.
Scope of Claims
The claims are structured to strike a balance between broad coverage—protecting a generalized manufacturing approach—and narrow claims that specify particular process parameters, thus providing legal fallback positions. The breadth, particularly of independent claims, signifies an intent to deter competitors from easily designing around this patent.
Patent Landscape Context
1. Global Patent Environment
While TW201946625 is a Taiwan national patent, related international patent applications are likely filed via the Patent Cooperation Treaty (PCT) or through regional filing strategies, especially in key markets like the U.S., E.U., China, and Japan.
Notably:
- Major biologics manufacturers have been increasingly patenting manufacturing methods for complex biologics, including refolding and stabilization techniques.
- Similar patents tend to cluster around refolding processes, stabilizers, and composition-specific features, aiming to cover proprietary manufacturing conditions.
2. Competitive Landscape
Over the past decade, large pharma firms such as Pfizer, Roche, and Novartis have aggressively patented protein manufacturing processes, often focusing on:
- Innovative refolding techniques to reduce aggregation.
- Methods to improve yield and reduce immunogenicity.
- Novel stabilizing excipients and buffer systems.
This patent seems to enter a mature landscape, yet its specific process steps and composition details may carve out unique patentability grounds.
3. Legal and Commercial Importance
Such patents are critical in the biologics space because:
- They provide exclusivity, delaying generic or biosimilar entry.
- They underpin continued innovation in biologic manufacturing.
- They can serve as blocking patents in licensing negotiations.
Given Taiwan’s strategic position in the Asian biotech market, protection via TW201946625 potentially deters local and regional copycats, especially when integrated into a broader patent portfolio.
Legal Robustness and Potential Challenges
1. Novelty and Inventive Step
- The patent claims are likely to hinge on specific process parameters (e.g., temperature ranges, buffer compositions).
- Given the high level of existing prior art for protein refolding and stabilization, the novelty of TW201946625 depends on the specific combination of steps or composition features introduced.
2. Obviousness
- The claims must demonstrate an inventive step over existing refolding and stabilization methodologies.
- If the patent’s process steps mirror prior art with slight modifications (e.g., a different buffer pH), they risk being challenged as obvious.
3. Enablement and Written Description
- The patent must adequately disclose the manufacturing steps and composition details.
- Given the technical complexity, whether the disclosure fully enables practitioners to reproduce the process would influence validity.
4. Enforcement and Infringement Risks
- Competitors can attempt design-around strategies: modifying process parameters or changing excipient compositions.
- Active patent claims that are narrowly tailored may be vulnerable, whereas broader claims provide stronger deterrence.
Implications for Industry Stakeholders
- Innovators and patent holders should evaluate the scope to prevent infringement and to establish freedom-to-operate.
- Generic manufacturers may seek to engineer around the claims, especially if process modifications do not infringe on specific parameters.
- Licensing opportunities may arise through negotiations with patent owners, especially if the patent covers key manufacturing steps for critical biologics.
Conclusion: Strategic Value of TW201946625
Taiwan patent TW201946625 secures intellectual property rights over a specific, potentially high-value manufacturing process for protein and peptide pharmaceuticals. Its claims target crucial steps for improving stability and purity, the parameters of which are pivotal in biologics development. The patent’s strength relies on the novelty of the process steps and composition specifics, positioning it as a significant asset within its patent landscape.
Industry players must conduct continuous freedom-to-operate assessments and monitor ongoing patent filings in this domain. The patent’s protective scope, combined with Taiwan’s strategic geographic location, makes TW201946625 a vital component of a comprehensive regional patent strategy for biologics developers.
Key Takeaways
- Scope and Claims: Cover a specific, multi-step manufacturing process and resultant stable pharmaceutical compositions, with claims strategically balanced for broad protection yet defensible against prior art.
- Patent Landscape: Embedded within a competitive biotech domain, it complements existing patents on protein refolding and stabilization, emphasizing process-specific innovations.
- Legal Considerations: Validity hinges on demonstrated novelty and inventive step; process modifications could challenge enforceability.
- Strategic Use: Protects key manufacturing technologies, enabling exclusivity and licensing opportunities in Taiwan and potentially in broader Asian markets.
- Market Impact: Supports the development of robust biologic formulations, with implications for biosimilar competition and innovation.
FAQs
1. How does TW201946625 compare to international patents in the biologics manufacturing space?
It aligns with global endeavors to patent refolding and stabilization processes, but its novelty depends on specific process parameters and compositions not disclosed in prior art, providing regional exclusivity in Taiwan.
2. Can this patent prevent competitors from developing similar protein manufacturing processes?
Yes, within Taiwan, the patent can serve as a barrier against infringing manufacturing methods that fall within its claims. Outside Taiwan, equivalent protections depend on corresponding international filings.
3. What are the strategic advantages of securing patents like TW201946625 in Taiwan?
Taiwan’s robust biotech sector and strategic geographical position make such patents critical for regional market entry, licensing, and establishing a foothold in Asia’s growing biologics industry.
4. How vulnerable are these patents to invalidation or design-around strategies?
They are potentially vulnerable if challengers identify prior art or develop alternative processes that do not infringe on claim specifics. Regular patent landscape monitoring is essential.
5. What should biologics manufacturers do to navigate this patent landscape?
They should conduct thorough freedom-to-operate analyses, consider designing around specific process claims, and pursue their own innovations to secure alternative IP rights.
Sources:
[1] Taiwan Intellectual Property Office (TIPO): Official patent database.
[2] Recent patent publications on biologics manufacturing processes.
[3] Industry reports on biologics patent trends and litigation cases.
[4] Scientific literature on protein refolding and stabilization methodologies.
