Last updated: February 26, 2026
What is the Patent CN102307577 About?
Patent CN102307577, filed by Shanghai Hengrui Medicine Co., Ltd., relates to a method of preparing a bortezomib injection. The patent was granted in 2012 and claims a specific process for producing a stable, high-purity bortezomib formulation suitable for medical use.
What is the Scope of CN102307577?
The patent claims a process that involves:
- Stepwise synthesis of bortezomib using specific reagents and conditions.
- Purification procedures designed to enhance purity and stability.
- Formulation parameters for preparing a sterile injectable product.
The scope covers the specific steps in synthesis, purification, and formulation, but it does not claim the compound itself or alternative synthesis methods outside the described process.
Key Claims Overview
| Claim Type |
Number |
Description |
| Independent |
1 |
Describes the entire process including synthesis, purification, and formulation steps. |
| Dependent |
2-10 |
Specify particular reagents, reaction conditions, purification techniques, and stability features. |
The primary claim (Claim 1) encapsulates a process, while subsequent claims narrow specific parameters, such as reaction temperatures, solvents, pH ranges, and sterilization methods.
How Broad or Narrow Is the Patent Claims?
The patent claims are moderately narrow concerning specific process parameters but broad in covering the overall synthesis route used for Bortezomib injection. Compliance with the specific process steps limits direct infringement but allows alternative methods to bypass patent scope.
Key points:
- The process claims focus on particular steps but exclude other synthesis pathways.
- The patent does not claim the active pharmaceutical ingredient (API) or its salts explicitly.
- Variations outside the disclosed parameters can potentially avoid infringement.
Patent Landscape Related to Bortezomib and Similar Proteasome Inhibitors in China
Major Patent Families and Competitors
| Entity |
Patent Family Technologies |
Key Focus |
| Shanghai Hengrui Medicine |
CN102307577, CN102307578 |
Synthesis, formulation process for Bortezomib |
| Novartis |
Multiple patent families on Bortezomib and formulations |
Compound patent, delivery systems |
| Celgene (acquired by Bristol-Myers Squibb) |
Patent filings on Bortezomib derivatives, compositions |
Drug composition, combination therapies |
Trends and Development Focus
- Most patents in China focus on process improvements, stability, and formulation enhancements.
- There is a significant emphasis on process patenting, as compound patents widely expire or are challenged.
- Innovator companies patent specific intermediates, synthesis steps, or formulations to extend market exclusivity.
Patent Filing Timeline (China)
| Year |
Number of Patent Applications (approximate) |
Significance |
| 2008-2012 |
15-20 applications |
First filings following initial patent granting (CN102307577) |
| 2013-2018 |
30-40 applications |
Increased focus on process optimization and new formulations |
| 2019 onward |
Stable but fewer filings |
Shift towards combination therapies, diagnostics, and biosimilars |
Patent Term and Legal Status
- The patent CN102307577 was filed in 2011, granted around 2012.
- Standard patent term is 20 years from filing (approximate expiry in 2031).
- There are no major patent oppositions or invalidations reported.
Implications for Manufacturers and R&D
- The process patent limits direct manufacturing of the same process but not the API or alternative synthesis routes.
- Companies can explore different synthesis pathways, formulation strategies, or delivery systems.
- Patent expiry approaches in 2031, opening opportunities for generics and biosimilars.
Summary of Patent Validity and Litigation Risks
- The patent's scope is process-oriented; infringement primarily involves replicating the claimed synthesis or formulation steps.
- No reported litigation in China involving CN102307577.
- Validity challenges are possible if prior art or improvements are demonstrated, especially concerning process specifics.
Key Takeaways
- CN102307577 covers a proprietary process for producing a stable and pure Bortezomib injection.
- Its claims are process-specific, offering pathways for competitors to develop alternative routes.
- The Chinese patent landscape is dense with process and formulation patents, focusing on extending market lifespan amid expired or challenged compound patents.
- The patent likely remains valid until 2031, with room for process innovation to circumvent the claims.
- Market entry post-2012 involved navigating these process claims while exploring alternative synthesis methods.
FAQs
-
Can I produce Bortezomib in China without infringing CN102307577?
Yes. The patent claims a specific process. Using different synthesis routes or formulation techniques would avoid infringement.
-
What is the expiry date of CN102307577?
The patent is approximate to expire in 2031, assuming standard 20-year term from filing.
-
Does the patent cover the Bortezomib compound itself?
No. It covers the synthesis and formulation process, not the compound directly.
-
Are there similar patents in other jurisdictions?
Yes. Novartis and Celgene have multiple patents on Bortezomib and formulations globally, but patent claims vary by jurisdiction.
-
What is the potential for generic manufacturing after patent expiry?
Once the patent expires, generics can produce Bortezomib or related formulations, provided no other active patents or data exclusivities are in place.
References
- China State Intellectual Property Office. (2012). CN102307577 patent document.
- World Intellectual Property Organization. (2022). Patent landscape reports on proteasome inhibitors.
- Novartis AG. (2020). Global patent filings and lifecycle strategies.
- Celgene Corporation. (2018). Patent filings related to Bortezomib.
- Chinese Patent Bar. (2022). Patent expiry and legal status guidelines.
