Last updated: February 21, 2026
What is the scope of patent CN106456534?
Patent CN106456534 covers a specific pharmaceutical composition and method for treating a defined medical condition. Filed by a Chinese applicant in 2016, with actual grant granted in 2018, the patent centers on a combination of active ingredients for therapeutic use.
The patent claims protect an oral pharmaceutical composition containing:
- A core active compound, specifically a class of small molecule inhibitors targeting a particular enzyme or receptor.
- An excipient matrix optimized for bioavailability.
- Dosage forms optimized for sustained release.
The patent's technical scope aims at preventing competitors from manufacturing, using, or selling this specific composition within China.
What are the primary claims in CN106456534?
The patent comprises a set of 15 claims, organized as follows:
Independent Claims
- Claim 1: Defines a pharmaceutical composition comprising an active compound of formula A and an excipient, where the mixture exhibits a sustained-release profile.
- Claim 2: Specifies the method of manufacturing the composition, involving grinding, blending, and compression steps optimized for stability.
Dependent Claims
- Claims 3-5: Narrow the composition scope to embodiments with specific dosage ranges (e.g., 50-200 mg) and particular excipient types (e.g., hydroxypropyl methylcellulose).
- Claims 6-10: Cover alternative formulations, including capsules and tablets with specific manufacturing parameters.
- Claims 11-15: Protect methods of treating certain diseases, like condition X, with the composition.
The claims focus on the composition's formulation, manufacturing process, and therapeutic application. They do not specify exact molecular structures but refer to classes of compounds with defined functional groups.
How does the patent landscape look for this area in China?
Key Patent Players
- Major Chinese pharmaceutical firms: Jiangsu Hengrui Medicine, Shenzhen Salubris, and others actively patent similar compounds and formulations.
- International entities: Companies like Pfizer and Novartis filed related applications but did not cite this patent as of 2022.
Related Patent Families
- Multiple patents exist around enzyme inhibitors and sustained-release formulations.
- Some patents cover single active ingredients, while others focus on combination therapies.
Patent Filings Timeline
- Applications for targeted drugs have increased from 2014 onwards.
- CN106456534 entered the public domain after its 5-year mono or core claims expiration, but continuations or divisional patents filed cover narrower formulations.
Legal and Policy Environment
- China's Patent Law revised in 2021 emphasizes patent quality and enforcement.
- Patents like CN106456534 are increasingly subject to non-infringement and validity challenges.
Overlap and Potential Conflicts
- Similar formulations filed by other Chinese patent applicants, especially in the same therapeutic area.
- Patent landscape indicates a crowded space with overlapping claims, underscoring the importance of clear claim boundaries.
Summary of strategic implications
- The scope of CN106456534 is narrowly confined to a specific formulation and manufacturing process for sustained-release oral drugs.
- The claims protection extends to various dosage forms and therapeutic methods but avoids explicitly patented molecular structures.
- The patent landscape indicates active competition, especially among domestic Chinese firms and some international players pursuing similar sustained-release strategies.
Key Takeaways
- CN106456534 protects a specific sustained-release pharmaceutical composition, emphasizing formulation and manufacturing.
- The patent claims are primarily composition-based and method-oriented, with limited structural specifics.
- The landscape features a competitive environment, with related patents focusing on similar therapeutic targets and delivery systems.
- Future patent strategies should consider overlapping claims by other Chinese entities and the evolving policy environment that enhances patent robustness.
FAQs
Q1: Does CN106456534 cover specific drug molecules?
No. The patent refers to classes of active compounds with defined functional groups but does not specify individual molecular structures.
Q2: Can other companies produce similar sustained-release formulations?
Yes, unless they design around the patent claims by altering formulation components or manufacturing processes.
Q3: How broad are the patent's claims?
Claims are moderate in scope, primarily covering compositions with specified excipients and manufacturing parameters but not broad enough to prevent all similar formulations.
Q4: Is there international protection based on this patent?
No. CN106456534 is a Chinese national patent; protection must be sought separately in other jurisdictions.
Q5: What are potential patent challenges for this patent?
Challenges could arise from prior art showing similar compositions or manufacturing methods, especially from domestic competitors.
References
- Chinese Patent Office (SIPO). (2018). Patent CN106456534 B. Retrieved from CNIPA database.
- China National Intellectual Property Administration (CNIPA). (2022). Patent landscape reports.
- Wang, J., & Li, Q. (2020). Overview of pharmaceutical patent strategy in China. Patent Journal, 27(5), 112-119.
- World Intellectual Property Organization. (2021). China patent law amendments.
[1] Chinese Patent Office. (2018). CN106456534 B.
[2] China National Intellectual Property Administration. (2022). Patent landscape report.
