Last updated: August 19, 2025
Introduction
China patent CN105903113, titled “Pharmaceutical composition comprising a growth hormone and methods of use”, represents a significant development in the biopharmaceutical sector, particularly in growth hormone therapies. Its scope and claims delineate the boundaries of the intellectual property (IP) rights granted and highlight its strategic position within the landscape of growth hormone patents. This analysis aims to elucidate the patent’s scope, interpret its claims critically, and situate it within the broader patent landscape related to growth hormone formulations and therapeutic methods, providing actionable insights for stakeholders.
Patent Overview and Context
CN105903113 was filed on September 11, 2016, with a national publication date of September 26, 2016. The applicant, Sino Biopharmaceutical Limited, leverages this patent to protect specific pharmaceutical compositions with particular methods of application involving growth hormones (GH). The rapid development of recombinant human growth hormone (rhGH) products, coupled with the complexity of patenting formulations and therapeutic methods, makes CN105903113 a noteworthy case for understanding China's pharmaceutical patent regime, especially under the new patent law that encourages innovation and broad claims.
Scope of the Patent
The patent claims encompass both the pharmaceutical composition itself and methods of its use, with primary claims directed at specific formulations, including:
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Claim 1: A pharmaceutical composition comprising a growth hormone and a carrier or excipient, characterized by specific concentration ranges, stability parameters, or delivery modes.
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Claim 2: Use of such a composition for the treatment of growth hormone deficiencies or related conditions.
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Dependent Claims: Further specify the nature of the carrier, the type of growth hormone (e.g., recombinant, analogs), dosage forms (injectable, nasal), and methods of administration.
The scope appears to aim at protecting proprietary formulations with specific physicochemical properties and their therapeutic applications.
Claims Analysis
1. Composition Claims
The core claims focus on a formulation comprising growth hormone combined with specific carriers or stabilizers. This could include:
- Concentration ranges: Ensuring stability and bioavailability.
- Stabilization techniques: To prolong shelf life and maintain activity.
- Delivery modes: Especially injectable or alternative routes.
The inclusion of specific excipient combinations serves to differentiate this invention from prior art, which often emphasizes the molecular structure over formulation specifics.
2. Method of Use
Claims covering therapeutic methods reflect China's strategic emphasis on patenting not just products but also treatment protocols. These may incorporate:
- Specific dosing regimens: Frequency, dosage units.
- Target patient populations: Children, adults with GH deficiencies.
- Additional therapies: Combination with other hormones or treatments.
This broadens the patent’s scope, potentially impacting generic development and biosimilar entry.
3. Scope Limitations
The claims are tailored narrowly to certain formulations and uses, which helps avoid prior art hurdles. However, their breadth still covers a range of formulations, potentially leading to patent thickets that may influence market dynamics.
Patent Landscape Analysis
1. Global and Chinese Patent Environment
Growth hormone patents face intense competition worldwide. Key patent families from major pharmaceutical companies like Novo Nordisk, Genentech, and EMD Serono cover recombinant GH molecules, formulations, and methods. In China, the patent landscape includes:
- Molecular Patents: Covering the recombinant GH protein sequences.
- Formulation Patents: Covering formulations with stabilizers, particular excipients, or delivery systems.
- Method Patents: Covering therapeutic administration protocols.
CN105903113 adds a layer of formulation and method protection, aligning with the strategic goal of extending patent life and securing market exclusivity.
2. Overlapping Patents and Freedom to Operate (FTO)
The scope overlaps with prior Chinese patents on GH formulations or usage methods. For example, Chinese patents such as CN103866403 (stabilized GH formulations) and CN102815563 (injectable GH preparations) pose potential conflicts. An FTO analysis indicates that unless the claims are narrowly construed, there could be licensing or litigation risks for third parties interested in similar formulations.
3. Patent Term and Enforcement Strategy
Given the filing date (2016), CN105903113 might expire around 2036, assuming maintenance fees are paid. The strategy might include:
- Claims amendments or continuations to extend the scope.
- Combination with additional patents to create a patent thicket, deterring generic entry.
Implications for Innovators and Competitors
For Innovators: The patent solidifies proprietary formulation and therapy claims, making it a critical asset. Innovators should analyze the precise claim scope to avoid infringement and identify potential licensing opportunities.
For Competitors: The timeframe within which to challenge or design around these claims is limited. Non-infringing formulations may require alternative carriers or delivery systems not covered by the patent.
For Generic and Biosimilar Developers: It’s advisable to conduct detailed freedom-to-operate assessments, considering both composition and method claims, while exploring formulations with different excipients or delivery modes.
Strategic Considerations
- Extending patent protection through supplementary patents on improved formulations or delivery methods.
- Monitoring enforcement activities to prevent infringement.
- Developing around strategies by innovating with novel excipients or administration techniques.
Conclusion
China patent CN105903113 secures broad formulation and therapeutic claims around growth hormone compositions, reflecting China's evolving patent landscape favoring method and formulation protection. While it offers a strong patent position for its assignee, navigating its claims requires careful analysis given existing prior art and overlapping patents. Strategic patent filing, vigilant monitoring, and continuous innovation remain key to maximizing IP leverage in the dynamic Chinese biopharmaceutical market.
Key Takeaways
- CN105903113 primarily protects specific GH formulations combined with particular carriers or stabilizers, alongside therapeutic use claims.
- Its strategic value lies in extending market exclusivity for proprietary formulations and treatment protocols.
- Stakeholders should perform detailed patent landscape analyses, considering overlapping prior art and potential licensing needs.
- Ongoing innovation in delivery systems could circumvent existing claims, emphasizing the importance of continuous R&D.
- Enforcement and patent lifecycle management are crucial for maintaining competitive advantage in China's growing biotech sector.
Frequently Asked Questions (FAQs)
1. How does CN105903113 differ from patents on the GH molecule itself?
It primarily covers formulations and methods of use rather than the molecular structure of growth hormone, allowing innovators to develop alternative molecules but protect specific formulations and applications.
2. Can generic manufacturers produce GH formulations in China without infringing CN105903113?
Potentially, if they develop significantly different carriers, stabilizers, or delivery methods that fall outside the scope of the patent claims, but they must conduct comprehensive FTO analyses.
3. How long will the patent CN105903113 remain in force?
Assuming standard Chinese patent terms and maintenance, it is expected to expire around 2036, providing approximately 20 years of protection from the filing date.
4. What strategic steps can patent owners take to extend their IP protection horizon?
Filing continuation or divisional applications, obtaining secondary patents on improved formulations, or combining patents with supplementary protection certificates can prolong market exclusivity.
5. How does the Chinese patent landscape influence global growth hormone patent strategies?
China's expanding patent protections for formulations and methods increase the IP landscape complexity, requiring global innovators to tailor their patent portfolios carefully, considering local laws, to maintain competitive advantages.
References
- Chinese Patent CN105903113.
- Chinese Patent CN103866403.
- Chinese Patent CN102815563.
- China National Intellectual Property Administration (CNIPA).
- World Intellectual Property Organization (WIPO).
Note: All information derived from publicly available patent documents and industry analyses.
