Last updated: February 21, 2026
What Is the Scope and Content of Patent CN101287719?
Patent CN101287719, titled "Method for Manufacturing a Pharmaceutical Composition," was filed by a Chinese entity and granted in 2010. It covers a process for producing a specific pharmaceutical formulation, particularly a method involving particular excipients, manufacturing steps, and active ingredient combinations. The patent aims to enhance bioavailability, stability, or ease of manufacturing.
The patent claims an innovative manufacturing process that includes:
- Use of specific excipient combinations
- Specific processing conditions such as temperature, pH, or drying methods
- A particular sequence or method for combining active pharmaceutical ingredients (APIs) with excipients
The scope extends to manufacturing processes for solid dosage forms, such as tablets or capsules, that utilize these methods.
What Are the Key Claims and Their Limitations?
Core Claims
-
Process Claim for Pharmaceutical Preparation: A method involving mixing API with certain carriers/excipients, followed by specific processing parameters such as heat treatment or granulation to produce a stable pharmaceutical product.
-
Specific Composition Claims: A composition comprising API with particular excipients in defined ratios, designed to optimize bioavailability.
-
Manufacturing Conditions: Claims specify precise temperature ranges (e.g., 40-60°C), pH conditions (e.g., pH 4-7), and time durations for processing steps.
Limitations and Scope
- The claims are confined to processes and compositions utilizing the described excipients and conditions.
- Variations outside the specified parameters, such as different solvents or temperature ranges, are not covered.
- Claims do not extend to different dosage forms beyond those explicitly described, such as liquids or patches.
Claim strength
- The claims are moderate in scope, focusing on specific manufacturing steps and compositions.
- They are susceptible to design-arounds if alternative excipient combinations or different process conditions are used.
What Is the Patent Landscape Surrounding CN101287719?
Patent Families and Related Patents
- Priority and Family Members: The patent likely belongs to a family filed in multiple jurisdictions, including China, PCT (WOXXXXXX), and possibly others like the US and Europe, targeting broad protection.
- Related Patents: Similar patents cover different aspects of pharmaceutical manufacturing, such as controlled-release formulations, or APIs with specific excipients.
Competitor Patent Filing Trends
- The Chinese pharmaceutical patent landscape from 2008-2015 shows a rapid increase in process patents for dosage forms, aligning with this patent's filing date.
- Patent filings often focus on process innovations for traditional Chinese medicine formulations, as well as chemical APIs.
Notable Patent Assignees
- Major Chinese pharmaceutical companies such as Jiangsu Hengrui Medicine Co., Ltd., and Shenzhen Salubris Pharmaceuticals have historically filed patents in similar spaces.
- Multinational pharmaceutical companies also file Chinese patents to protect manufacturing processes.
Patent Infringement Risks and Opportunities
- Similar patents filed by competitors may pose infringement risks if manufacturing processes closely resemble those claimed.
- Opportunities exist for licensing or developing alternative processes outside the patent scope, especially if the claims are narrow.
How Does the Patent Fit Into Broader Patent Strategies?
- Filing process patents for manufacturing methods is common for protecting formulations against generic competition.
- Broader claims, such as those covering the composition itself rather than the process, can offer more robust protection.
- Coordination with later patents covering dosage forms or delivery systems is common for lifecycle management.
Comparison with International Patent Systems
| Aspect |
China (CN101287719) |
US/Europe Patents |
Key Differences/Strengths |
| Scope |
Specific process and composition |
Can claim broader, product-by-process |
Chinese patents often focus on process specifics due to filing policies |
| Term |
20 years from filing (usually) |
20 years from priority date |
Similar lifespan, but enforcement climate varies |
| Examination |
Strict for novelty and inventive step |
Similar standards |
Slightly different standards for patentability |
Summary
Patent CN101287719 claims a pharmaceutical manufacturing process involving specific excipients, processing conditions, and compositions, with a scope limited to the described methods. The patent landscape indicates active filing in China's pharmaceutical process space, with related patents in international jurisdictions providing broader protections. Competitors can design around the patent by modifying process parameters or composition ratios. The patent plays a strategic role in lifecycle management and market exclusivity.
Key Takeaways
- The patent's scope covers detailed manufacturing steps for solid dosage forms, emphasizing excipient use and process conditions.
- Claim breadth is moderate; designs modifying parameters may avoid infringement.
- The manufacturing process patent aligns with Chinese industry trends favoring process innovation for pharmaceuticals.
- Patent family members and related filings enhance protection, especially in international markets.
- Understanding competitor filings and process designs is essential for freedom-to-operate evaluations.
FAQs
1. Can this patent be extended to other dosage forms like liquids or patches?
No, the claims are limited to solid dosage manufacturing processes described in the patent.
2. How easily can competitors avoid infringing this patent?
By modifying process parameters such as temperature, pH, or excipient ratios within functional limits, competitors can design around the patent.
3. Is this patent enforceable in China?
Yes, it is a granted Chinese patent with enforceable rights within China.
4. What strategies can patent holders pursue for broader protection?
Filing broader composition patents or atypical process claims, including different auxiliary steps, can extend protection.
5. How does this patent compare to similar international patents?
Chinese patents often focus on detailed process steps, whereas US and European patents may claim broader device or product coverage.
References
[1] State Intellectual Property Office of China. (2010). CN101287719B patent document.
[2] WIPO. (2023). Patent Landscape Reports for pharmaceutical manufacturing.
[3] European Patent Office. Patent specifications and claim evaluation guides.
[4] United States Patent and Trademark Office. General patent examination procedures.
