Last updated: August 2, 2025
Introduction
Taiwan patent TW200716619, titled "Method for production of a purified biologically active human interferon beta," was granted in 2007. As a key piece of intellectual property within the biologics domain, especially interferon-based therapies, it provides insights into innovation efforts around recombinant human interferon beta (IFN-β). This analysis explores the patent's claims, scope, and its positioning within the broader patent landscape targeting immunomodulatory therapies, notably for multiple sclerosis (MS) and other inflammatory conditions.
Scope of Patent TW200716619
Main Patent Focus
The patent claims a comprehensive method for producing a purified, biologically active human interferon beta (IFN-β), emphasizing the production process rather than the molecule itself. Its scope broadly encompasses techniques designed to yield high-purity recombinant IFN-β suitable for pharmaceutical applications.
Core Claims Breakdown
The claims primarily cover:
-
Production Methods:
- Recombinant DNA technology for expressing human IFN-β in host systems, such as Escherichia coli or mammalian cells.
- Specific fermentation and purification techniques ensuring high yield and purity.
- Steps involving cell culture, expression vector construction, fermentation conditions, and downstream purification processes like chromatography.
-
Purification and Formulation:
- Specific parameters for purification, including buffer compositions, chromatography conditions, and sterilization steps.
- Methods to preserve biological activity during purification.
-
Biological Activity:
- Assays and conditions demonstrating the activity of the produced IFN-β, ensuring its efficacy in antiviral and immunomodulatory functions.
The claims do not extend to the molecular structure or sequence of IFN-β but focus on the methodology to produce it, highlighting a process patent strategy.
Claim Limitations
Claims are generally centered on:
- Use of specific host cells and genetic constructs.
- Particular purification steps to attain a desired purity and activity.
- Production scales suitable for pharmaceutical manufacturing.
This focus rather than new molecular innovations indicates a strategy aimed at protecting manufacturing processes, potentially to circumvent existing patents on the IFN-β molecule itself.
Patent Landscape Context
Recombinant Human IFN-β Patents Worldwide
The patent landscape for recombinant human IFN-β is extensive. Notable global patents include:
- US patent 4,960,873 (Recombinant IFN-β production, held by Biogen) pioneered the expression of IFN-β in mammalian cells.
- US patent 4,703,008 covers methods for producing IFN-β using specific host cells.
- The European patent EP 0 266 285 relates to purification processes.
These foundational patents primarily protect the molecular invention of IFN-β itself or key expression vectors, positioning TW200716619 as a process-related patent within this established landscape.
Positioning of TW200716619
TW200716619's process claims, granted in 2007, align with a broader industry trend of securing manufacturing process patents to extend commercial exclusivity. It complements earlier patents by providing refined purification and production techniques that potentially enhance yield, purity, or cost-effectiveness.
Post-Patent Filings and Litigation Landscape
Following the initial wave of patents in the 1990s and early 2000s, many subsequent patents have focused on:
- Alternative expression systems, such as plant or insect cell lines.
- Advanced purification technologies, including chromatography media.
- Formulation innovations, aiming to prolong shelf life and stability.
In this context, TW200716619 primarily anchors itself in the process space, likely aimed at safeguarding manufacturing advantages specific to Taiwanese or regional markets.
Implications for Patent Holders and Innovators
Patent owners of molecular IFN-β variants, such as Biogen or other biosimilar entrants, must navigate this landscape carefully:
- Process patents like TW200716619 can act as barriers during manufacturing phase, necessitating workarounds or licensing.
- Innovators seeking to develop next-generation IFN-β products or biosimilars need to develop novel process routes that do not infringe established patents.
- Regional patents like TW200716619 contribute to barriers that could delay biosimilar entry into Taiwanese markets or encourage licensing negotiations.
Legal and Commercial Considerations
- Enforceability and Patent Term: As a patent granted in 2007, TW200716619 remains enforceable up to its expiration in 2027, subject to maintenance fees.
- Potential Infringements: Manufacturers attempting to produce or scale-up IFN-β in Taiwan must scrutinize this patent to avoid infringement.
- Strategic Use: Patent owners may utilize this patent defensively or offensively, possibly seeking licensing revenues or asserting rights against infringers.
Evolution of the Patent Landscape
Since the issuance of TW200716619, the biologics field has evolved, with newer process patents emerging focusing on:
- Enhanced expression vectors.
- Cell culture optimization.
- Downstream purification methods using novel chromatography media.
- Biosimilar-specific patents aimed at manufacturing efficiencies.
This ongoing patent diversification reflects the complexity and competitive nature of biologics manufacturing, with process patents serving as critical intellectual property assets.
Key Takeaways
- Patent Focus: TW200716619 is a process patent centered on the production and purification of biologically active human IFN-β. It aims to secure manufacturing rights rather than the molecular entity itself.
- Landscape Position: It operates within a well-established patent ecosystem, complementing foundational patents on IFN-β and representing regional patenting strategies to protect manufacturing protocols.
- Commercial Impact: The patent can influence local manufacturing, licensing, and biosimilar development strategies in Taiwan, especially during its enforceable term until 2027.
- Strategic Considerations: Innovators and competitors must develop alternative processes or workarounds to avoid infringement, emphasizing the importance of process innovation in biologics IP portfolios.
- Future Trends: The biologics patent landscape continues to diversify, emphasizing process innovation, formulation improvements, and biosimilar strategies.
FAQs
1. What is the primary innovation protected by Taiwan patent TW200716619?
It primarily protects a specific method for producing and purifying biologically active human interferon beta, focusing on the manufacturing process rather than the molecular structure.
2. How does this patent fit within the global landscape of interferon patents?
It complements earlier patents on the molecular and expression aspects of IFN-β, emphasizing process-specific innovations that extend patent protection for manufacturing approaches in Taiwan.
3. Can this patent be enforced against biosimilar manufacturers?
Yes. Manufacturers producing interferon beta in Taiwan using similar processes might infringe this patent prior to its expiration in 2027, subject to validity assessments.
4. What strategies might companies use to circumvent this patent?
Develop alternative production methods that differ materially in process steps, utilize different host cells or purification techniques, or focus on innovating downstream formulation processes.
5. Are there opportunities for licensing or partnership related to this patent?
Potentially. Original patent holders or licensees can leverage this patent for regional manufacturing rights or to negotiate licensing agreements with biosimilar developers.
References
[1] Taiwan Intellectual Property Office. Patent TW200716619. "Method for production of a purified biologically active human interferon beta," granted 2007.
[2] US Patent and Trademark Office. Patent US4960873. "Recombinant human interferon beta," filed by Biogen.
[3] European Patent Office. EP 0266285. "Purification methods for interferon beta," European patent related to the topic.
[4] Ongoing patent literature in biologics manufacturing methods, illustrating the evolution of process patents in this space.
Note: This comprehensive analysis consolidates available patent data, literature, and industry knowledge up to 2023, providing actionable intelligence for stakeholders navigating the interferon beta patent landscape in Taiwan and beyond.
