Last updated: July 28, 2025
Introduction
China Patent CN102149717, filed and granted to Hoffmann-La Roche Inc., relates to innovations in pharmaceutical compositions and methods of use, primarily targeting cancer therapy. As part of a strategic review of global drug patent landscapes, understanding the scope, claims, and broader patent trends of CN102149717 is critical for pharmaceutical companies, patent professionals, and strategic IP planners. This report provides a detailed, technical, and strategic analysis of this patent, focusing on its claims, scope, and position within the Chinese pharmaceutical patent landscape.
Patent Overview
- Patent Number: CN102149717
- Application Filing Date: September 10, 2010
- Grant Date: February 29, 2012
- Assignee: Hoffmann-La Roche Inc.
- Title: "Use of a BRAF Inhibitor in the Manufacture of a Medicament for the Treatment of BRAF-mutant Cancers"
The patent is primarily directed toward the use of BRAF inhibitors, such as vemurafenib, in the treatment of cancers characterized by BRAF mutations, especially malignant melanoma.
Scope and Core Claims
1. Core Innovation and Main Claims
Claim 1 (Use claim):
The broadest independent claim specifies the use of a BRAF inhibitor, notably vemurafenib, for the manufacture of a medicament intended for the treatment or prevention of BRAF-mutant cancers. Such claims target the indication-specific use rather than a new compound, aligning with a "second medical use" or "indication patent" strategy.
Claim 2 onward (Method claims):
These claims expand on specific methods of administering the BRAF inhibitors, dosage regimens, or combinations with other therapies. For example, claims specify certain doses, treatment cycles, or concurrent therapeutic agents.
Dependent Claims:
They specify particular BRAF inhibitors, such as vemurafenib or dabrafenib, specific cancer types, and combination therapies, providing a layered scope to the patent's protection.
2. Scope Analysis
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Indication-specific protection:
CN102149717 primarily claims the use of BRAF inhibitors for treating BRAF-mutant cancers. This scope offers protection for a specific therapeutic application but does not necessarily cover the compounds themselves or alternative uses outside this indication.
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Compound protection:
The patent does not assert a novel chemical entity but utilizes known compounds like vemurafenib in a new therapeutic context, which is typical for second medical use patents.
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Methodology and dosage claims:
Claims extend protection to specific treatment protocols, but they are often narrower and more susceptible to design-around strategies.
3. Claim Breadth and Limitations
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The use of the "Swiss-type" or "purpose" claim format is consistent with China's practice for second medical use patents, focusing on specific therapeutic purposes.
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The claims are narrow enough to be enforceable but potentially vulnerable to challenges based on inventive step or prior art.
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The protection is mainly over the method of use within the BRAF-mutant cancer indication, not directly over the chemical compounds, unless combined with other claims.
Patent Landscape Context
1. Global Comparisons
- Similar patents exist worldwide, notably the US patent US8,586,116 and European Patent EP2,100,678, covering the use of BRAF inhibitors in cancer therapies.
- The Chinese patent landscape aligns with global trends, focusing on second medical use patents for targeted cancer therapies where the active compound itself is known.
2. Patent Families and Related Patents
- This patent forms part of a patent family covering BRAF inhibitors with specific claims for oncological indications.
- It's typically accompanied by composition patents or method-of-treatment patents in different jurisdictions, creating a layered IP portfolio.
3. Challenges and Opportunities
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As BRAF inhibitors like vemurafenib are well-established, patent protection hinges on specific claims related to novel therapeutic indications and methods rather than the compound itself.
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Patent expiry is looming for global patents (e.g., 2027–2029), emphasizing the importance of maintaining robust protection through improvements or combination therapies.
4. Potential Infringements and Challenges
- The scope could be challenged on grounds of lack of inventive step if prior art demonstrates comparable use; however, the indication-specific claims can still retain enforceability.
- The monopolistic advantage remains effective for the specific use in BRAF-mutant cancers within China's market.
Strategic Implications
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The patent provides Roche with exclusive rights to market BRAF inhibitors for the specified indication in China, with enforceable claims limited to use and methods.
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The narrow scope suggests that competitors may seek alternative compounds, combination therapies, or broader composition claims to circumvent patent barriers.
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Patent protection in China complements global IP strategies, especially for targeted oncology drugs where indication-specific patents dominate the landscape.
Conclusion
China patent CN102149717 robustly claims the use of BRAF inhibitors, notably vemurafenib, for treating BRAF-mutant cancers. Its scope encompasses specific therapeutic methods, dosage protocols, and uses, aligning with global trends in second medical use patenting. While it offers valuable market exclusivity within China, its narrow scope necessitates strategic patent planning to prevent infringement or design-around by competitors.
Key Takeaways
- CN102149717 strategically covers indication-specific use of known BRAF inhibitors, securing exclusive rights to Roche's oncology treatments in China.
- The patent's scope is primarily limited to therapeutic methods, emphasizing the importance of breadth in claims and ongoing patent filings for comprehensive protection.
- The landscape indicates increasing global convergence in patenting targeted cancer therapies, with similar indications protected via second medical use patents.
- Enforceability depends on clear demonstration of the patented use; competitors may develop alternative molecules or combination approaches to circumvent claims.
- Ongoing patent expiry dates highlight the importance of preparing new patents covering novel formulations, combinations, or improved methods to sustain market exclusivity.
FAQs
Q1: What is the main protection offered by China patent CN102149717?
A1: The patent offers exclusive rights to the use of BRAF inhibitors, such as vemurafenib, in treating BRAF-mutant cancers, specifically covering the method of treatment and specific dosing regimens within China.
Q2: How does this patent compare with global patents for BRAF inhibitors?
A2: Similar patents worldwide, like US8,586,116 and EP2,100,678, also protect the use of BRAF inhibitors in cancer treatment. CN102149717 aligns with these by focusing on indication-specific claims rather than structural compounds.
Q3: What are the vulnerabilities of the claims in CN102149717?
A3: Its narrow scope centered on specific indications and methods may be vulnerable to challenges related to inventive step or prior arts demonstrating similar uses; design-around strategies may also be employed.
Q4: What strategic actions should patent holders consider for such indication patents?
A4: To strengthen market exclusivity, patent holders should pursue claims covering broader indications, formulations, combination therapies, or new delivery methods, and file corresponding patents in other jurisdictions.
Q5: When is the expected expiration of CN102149717?
A5: Patents filed in 2010, with a 20-year term from the filing date, generally expire around 2030, assuming maintenance fees are paid; thus, protection in China extends roughly until 2030.
Sources
- CN102149717 patent documentation and claims analysis.
- Hoeffmann-La Roche's global patent portfolio on BRAF inhibitors.
- Comparative patent analyses from the WIPO Patentscope and Espacenet databases.
- Literature on second medical use patents and their enforceability strategies in Chinese patent law.
