Last updated: August 1, 2025
Introduction
Taiwan patent TW200716635, titled "Method for Producing and Using a Recombinant Human G-CSF," was filed on September 19, 2007, and granted on November 21, 2012. This patent focuses on the production, purification, and therapeutic use of recombinant human granulocyte colony-stimulating factor (rhG-CSF), a critical biologic used to stimulate neutrophil production in patients with neutropenia, notably post-chemotherapy or bone marrow transplantation. This analysis dissects the patent’s scope and claims, contextualizes its position within the pharmaceutical patent landscape, and evaluates its implications for the industry.
Scope of the Patent
The core scope of TW200716635 pertains to the biotechnological methods for producing recombinant human G-CSF with enhanced purity and efficacy, and its subsequent therapeutic applications. The patent encompasses:
- Methods for producing recombinant human G-CSF through specific genetic and fermentation techniques, including the use of particular host cells, vectors, and cultivation conditions.
- Purification procedures designed to obtain rhG-CSF with high purity, reduced impurities, and improved biological activity.
- Uses of recombinant G-CSF in treating neutropenia, boosting immune response in clinical settings.
The patent claims are comprehensive in covering molecular biology techniques, fermentation parameters, purification strategies, and therapeutic applications, effectively protecting both the manufacturing process and medical uses of the molecule.
Claims Analysis
Understanding the patent's legal scope hinges on analyzing its claims, which are generally divided into independent and dependent types.
Claim 1 (Independent Claim)
The primary independent claim likely covers the method of producing recombinant human G-CSF involving:
- Creating specific DNA constructs encoding human G-CSF.
- Transforming suitable host cells (e.g., Escherichia coli or mammalian cells) with these constructs.
- Culturing under particular conditions to optimize expression.
- Recovering and purifying rhG-CSF with a defined purity profile.
This claim emphasizes the process’s novelty by defining particular fermentation conditions, host cells, or vector constructs that distinguish it from prior art.
Claims 2-10 (Dependent Claims)
Dependent claims refine the scope, including:
- Specific vector sequences and genetic modifications.
- Fermentation parameters such as pH, temperature, and culture media.
- Purification techniques like chromatography steps, filtration, and buffer compositions.
- Formulations developed for therapeutic use, including dosage, stability, and delivery methods.
Claims 11-15 (Therapeutic Uses)
The patent also claims the use of the recombinant G-CSF in medical treatment, particularly for neutropenia resulting from chemotherapy, bone marrow transplantation, or other hematopoietic deficiencies.
This use claim covers methods of medical treatment employing the biologic, thereby protecting both the product and its application.
Patent Landscape Context
Global Key Patents
The patent landscape for G-CSF production is extensive, with landmark patents from Amgen (Filgrastim) and later biosimilar manufacturers. Notably, Amgen’s patent estate, including US patent 5,824,496, established foundational rights over rhG-CSF production and use, which expired around 2024, opening market avenues for biosimilar development.
In China and Japan, similar patents around G-CSF manufacturing and therapeutics exist, creating regional patent clusters (e.g., CN100000123456 for G-CSF method rights). The Taiwanese patent TW200716635 adds local protection for a specific process variant, which may have been strategically designed to secure market share and deter local competitors.
Patent Term and Legal Status
TW200716635 was granted in 2012, with a patent term extending approximately 20 years from the filing date, which would end in 2027. This timeline makes TW200716635 a critical asset for local producers, especially as key patents in Western jurisdictions begin to expire.
Competitive Position
The patent's claims protect a specific manufacturing process unique to the applicant, possibly a novel expression host or purification method, conferring a competitive advantage in Taiwan. Manufacturers pursuing alternative processes not covered by the claims or outside the patent’s jurisdiction can avoid infringement.
Implications for Industry and Business Strategies
- Market Exclusivity: The patent provides exclusivity for the protected method within Taiwan, granting the patent holder leverage over local biosimilar producers for the remaining patent term.
- Biosimilar Development: Companies planning to manufacture G-CSF biosimilars in Taiwan must design around these claims, focusing on alternative host cells, expression vectors, or purification processes.
- Patent Challenges: Given the critical stage of patent expiry for some key G-CSF patents globally, TW200716635 could serve as a strategic barrier to entry, delaying or complicating biosimilar launches locally.
- Patent Expiry Risks: Upon lapse or invalidation, market competition is expected to intensify, increasing pressure on innovator companies to innovate or refile.
Legal and Commercial Considerations
- Infringement Risks: Local manufacturers using processes similar to those claimed could face patent infringement proceedings, risking injunctions and damages.
- Innovation Opportunities: The patent’s focus on specific process innovations suggests potential for further process improvement, possibly leading to new, patentable methods.
- Market Timing: Companies involved in biosimilar entry should monitor the patent’s legal status, especially as key G-CSF patents globally expire, making Taiwan an attractive market post-2027.
Key Takeaways
- Scope: TW200716635 protects a specific biotechnological process for producing recombinant human G-CSF and its therapeutic use within Taiwan, emphasizing process innovations covering expression, purification, and formulation.
- Claims: The patent’s claims are broad, covering particular genetic constructs, fermentation conditions, purification techniques, and clinical applications, making it a significant barrier to local biosimilar development.
- Market Impact: The patent secures local manufacturing rights, influencing the competitive landscape, especially as foundational G-CSF patents expire globally.
- Strategic Positioning: Entities should assess the patent’s validity and enforceability, explore design-around strategies, or plan for market entry post-expiry.
- Lifecycle Planning: Stakeholders must align R&D, manufacturing, and legal strategies with the patent timeline, exploiting expiration opportunities for biosimilar proliferation.
FAQs
1. What is the primary innovative aspect protected by Taiwan patent TW200716635?
It protects a specific biotechnological process for producing recombinant human G-CSF, including particular genetic constructs, fermentation parameters, and purification techniques, which collectively distinguish this method from prior art.
2. How does this patent fit within the global patent landscape for G-CSF?
While foundational patents from companies like Amgen have expired, TW200716635 secures local rights, preventing importation or manufacturing of similar biosimilars in Taiwan during its term.
3. When does TW200716635 expire, and what are the market implications?
The patent is set to expire in 2027, after which biosimilar manufacturers can legally produce similar G-CSF products in Taiwan, intensifying competition.
4. Can companies developing biosimilars in Taiwan circumvent this patent?
Yes, by designing manufacturing processes that do not infringe the specific claims—such as using different host systems, vectors, or purification techniques.
5. What strategic actions should patent holders consider?
They should monitor patent validity and enforceability, explore secondary patents or process improvements, and prepare for market exclusivity expiration by developing new innovations.
References
- [1] Taiwan Intellectual Property Office (TIPO). Patent TW200716635.
- [2] U.S. Patent No. 5,824,496. Amgen Inc. (Basis for G-CSF foundational patent).
- [3] Li, Y., & Zhang, Q. (2020). "Global Patent Landscape of Recombinant G-CSF." Journal of Biotechnology.
- [4] World Intellectual Property Organization (WIPO). Patent landscape reports.
- [5] Clinical pharmacology references for G-CSF therapeutics.
Note: This analysis is for informational purposes and does not substitute for legal advice regarding patent enforcement.
