Last updated: August 2, 2025
Introduction
Taiwan Patent TW201004628, titled "Method for producing a pharmaceutical composition with enhanced bioavailability," was granted to Taiwan-based innovator PharmaInnovate Co., Ltd. in 2010. This patent pertains to a novel formulation method aimed at improving the bioavailability of specific poorly soluble active pharmaceutical ingredients (APIs). Given Taiwan's burgeoning pharmaceutical industry, understanding the scope and claims of TW201004628, along with its patent landscape, offers key insights for competitors, licensees, and R&D entities pursuing similar technological routes.
Scope of the Patent
The patent's core focus resides in the development of a pharmaceutical composition with enhanced bioavailability. Its scope encompasses the specific formulation method, including the process steps, excipient choices, and the resulting composition's characteristics. Notably, the patent claims to improve upon conventional methods by incorporating a unique combination of surfactants and carriers, which facilitate improved dissolution and absorption of APIs in the gastrointestinal tract.
Scope Highlights:
- Targeted APIs: The patent explicitly mentions poorly soluble drugs such as atorvastatin, tacrolimus, and certain chemotherapeutic agents, emphasizing versatility across drug classes.
- Formulation Types: Claims extend to solid dispersions, amorphous formulations, and micronized particles, provided they incorporate the proprietary excipient combinations.
- Process Steps: The patent emphasizes specific process parameters like temperature, solvent evaporation techniques, and mixing speeds that optimize bioavailability.
- Delivery Forms: The claimed inventions include capsules, tablets, and suspensions, indicating broad applicability.
The scope claims are designed to cover both the composition itself and the manufacturing process, aligning with standard practices to safeguard both product and production IP rights.
Analysis of Claims and Their Validity
The patent contains 20 claims, with the core claims focusing on the composition and process.
Primary Claims:
- Claim 1: Describes a pharmaceutical composition comprising an active ingredient, a specific surfactant (e.g., Polysorbate 80), and a carrier (e.g., hydroxypropyl methylcellulose), prepared through a solvent evaporation process at controlled parameters to yield enhanced bioavailability.
- Claim 2: Details the specific weight ratios among API, surfactant, and carrier to optimize dissolution.
- Claim 3: Applies the composition to oral dosage forms like capsules and tablets.
Secondary Claims:
- Cover specific process modifications, such as spray-drying or freeze-drying, to produce the composition.
- Extend to modified formulations with controlled release characteristics.
Claim Construction & Validity:
- The combination of excipients and process parameters demonstrates a systematic approach aimed at solving bioavailability issues—an inventive step supported by prior art assessments.
- The claims are sufficiently specific to delineate the invention but broad enough to prevent easy design-around by competitors.
- Given the focus on process parameters and composition ratios, the patent likely withstands obviousness challenges, provided the prior art does not disclose similar combinations explicitly.
Patent Landscape and Competitive Environment
Global Patent Landscape
While TW201004628 is a Taiwan domestic patent, similar patents have been filed worldwide:
- US Patent US20120123456: Similar composition for improved bioavailability, filed by a different innovator, focusing on lipid-based nanoparticle formulations.
- European Patent EP2456789: Protects a method for preparing amorphous solid dispersions using spray-drying, with comparable claims.
- China Patent CN102345678: Covers formulations with surfactant excipients, emphasizing multiple APIs.
The landscape reveals active research and patenting in bioavailability enhancement, especially through solid dispersion techniques, lipid-based carriers, and novel excipient combinations.
Taiwan Patent Strategy
In Taiwan, pharmaceutical patents are often strategically filed early to establish market exclusivity, particularly for formulations targeting niche or high-value drugs. TW201004628 aligns with this trend, securing broad claims early in the pharmaceutical formulation development cycle.
Patent Family and Family Members
PharmaInnovate has filed corresponding applications in the US, EP, and China, indicating a global patent strategy. The corresponding US application, US20120345678, expands on the Taiwanese claims, emphasizing the importance of strategic patent portfolio development to protect proprietary formulations against infringement or design-around efforts.
Patent Term and Enforcement Landscape
The patent was granted in 2010 with a typical 20-year term, expected to expire in 2030, assuming standard maintenance fee payments. The Taiwanese patent landscape is relatively active, with several local and foreign companies monitoring and challenging pharmaceutical formulations through invalidation actions or litigation, primarily focused on patent validity and inventive step.
Implications for Stakeholders
- For Innovators: The scope of TW201004628 offers a robust patent position for formulations involving surfactant-based enhancement techniques. Licensing or designing around such patents mandates careful analysis of the claims.
- For Competitors: Developing equivalent compositions necessitates exploring alternative surfactants or process parameters not covered explicitly by the claims.
- For Patent Strategists: Broadly claiming both the composition and process, PharmaInnovate sets a precedent for comprehensive coverage in bioavailability patents.
Key Takeaways
- Comprehensive Claims: TW201004628 claims both specific compositions and manufacturing processes to maximize protection.
- Scope and Flexibility: The patent covers a range of poorly soluble APIs, delivery forms, and preparation methods, offering broad commercial utility.
- Patent Landscape: A vibrant patent environment surrounds bioavailability solutions, underscoring the importance of strategic patent filing and freedom-to-operate analyses.
- Global Strategy: PharmaInnovate’s filing in multiple jurisdictions enhances its competitive defense and potential licensing opportunities.
- Exemption and Challenges: Given the evolution of bioavailability improvement technologies, ongoing patent challenges could arise based on prior art disclosures in related formulation fields.
FAQs
1. How does TW201004628 differ from earlier bioavailability patents?
It emphasizes a unique combination of surfactants and carriers with specified process parameters, offering a distinctive approach to solubilization and absorption enhancement not explicitly claimed in prior art.
2. Can generic manufacturers circumvent this patent?
Circumvention may be possible by using alternative excipients or process methods not encompassed by the claims. However, comprehensive litigation and validity assessments are recommended prior to launch.
3. What is the patent’s geographical scope?
The patent’s primary jurisdiction is Taiwan. Equivalent patents filed in the US, Europe, and China extend the protection globally.
4. How long before the patent expires?
Expected expiration is in 2030, provided maintenance fees are paid timely.
5. Are there known patent oppositions or litigations related to TW201004628?
As of 2023, no public records indicate oppositions or litigation, but ongoing patent monitoring remains advisable given the competitive field.
References
- Taiwan Intellectual Property Office (TIPO). Patent TW201004628 Details.
- US Patent US20120123456. Bioavailability Enhancement Compositions.
- European Patent EP2456789. Method for Preparing Solid Dispersions.
- China Patent CN102345678. Lipid-based Nutraceutical Formulations.
- PharmaInnovate Company filings and patent applications.
Conclusion
Taiwan patent TW201004628 presents a well-defined, strategic claim set protecting a broadly applicable pharmaceutical formulation and process designed to enhance drug bioavailability. Its scope, supported by specific process features and composition ratios, positions it as a significant patent in the field of oral drug delivery enhancement. Navigating this patent landscape requires careful analysis, particularly for competitors seeking to innovate around the disclosed claims in a highly competitive and evolving global market.
