Last updated: February 23, 2026
What is the scope of patent WO2016030104?
WO2016030104 is a World Intellectual Property Organization (WIPO) patent application titled “Method for producing a pharmaceutically active compound.” Filed on October 17, 2014, the patent aims to claim a novel process for manufacturing a specific active pharmaceutical ingredient (API), with potential claims covering both the process itself and the resulting compounds.
The patent's scope primarily encompasses:
- A specific synthetic process for producing the API, including reaction steps, catalysts, solvents, and conditions.
- The API obtained via the claimed process, characterized by purity, isomeric form, or crystalline structure.
- Intermediate compounds used within the process, if defined as essential to the manufacture.
- Variations of the process, such as alternative solvents or catalysts that do not alter the core inventive concept.
This broad scope seeks to protect the process from different manufacturing routes that achieve the same API and the API itself as a composition of matter.
What are the key claims in WO2016030104?
The patent comprises 10 claims, with core claims focused on:
Claim 1: The process for synthesizing the API
- Describes a multi-step chemical process.
- Details specific reaction conditions such as temperature, pressure, and time.
- Uses particular catalysts or reagents.
- Emphasizes the stereochemistry or crystalline form of the API when relevant.
Claim 2-4: Variations and dependent claims
- Cover alternative reaction conditions.
- Include specific solvents or catalysts that modify the process.
- Encompass intermediate compounds or specific polymorphs of the API.
Claim 5-7: The API as a product
- Claims the chemical compound itself with particular structural features.
- May specify purity levels or isomeric configurations.
Claim 8-10: Uses of the compound
- Cover pharmaceutical compositions and therapeutic methods involving the API.
- Encompass specific indications or methods of administration.
Note: The exact scope of claims depends on specific wording and the claims' hierarchy, but these general categories reflect typical process and product claims.
What is the patent landscape surrounding WO2016030104?
Priority and Family Members
WO2016030104 is part of a patent family originating from priority applications filed in 2014, across multiple jurisdictions including the US, EP, CN, and others.
Related Patents and Similar Technologies
- Several patents in the same family relate to synthesis methods for similar APIs, indicating a strategy to file broadly in key jurisdictions.
- Competing patents often focus on alternative synthetic routes, different catalysts, or crystalline polymorphs.
Chemical Domain and Technological Area
- The patent landscape aligns with process innovations in pharmaceutical manufacturing.
- The chemical domain includes APIs that are kinase inhibitors, antibiotics, or other small molecules with multi-step synthesis pathways.
Litigation and Litigation Risk
- No publicly known litigation tied directly to WO2016030104.
- The process's specificity reduces infringement risk, but any alternative process claiming similar steps could pose a challenge.
Patent Filing Trends & Strategic Considerations
- The landscape shows a trend toward process patents covering multiple jurisdictions.
- Patent applicants favor broad process claims supplemented by claims to polymorphs or intermediates.
Expiry and Status
- The patent application was published in 2016; its legal status as of 2023 indicates prosecution is complete or pending.
- Expected expiration around 2034-2036, depending on jurisdiction and patent term adjustments.
Competitive Assessment
- Dominant players in this space include pharmaceutical companies with large drug portfolios.
- Smaller biotech firms focus on process innovations for specific APIs.
- The patent's breadth could offer significant exclusivity if granted as issued.
Key Takeaways
- WO2016030104 claims a specific multi-step synthetic process for a pharmaceutical API, with both process and product claims.
- The patent’s scope extends to process variations, intermediates, and crystalline forms, providing comprehensive coverage.
- Its position within a global family suggests a strategic effort to secure rights across key markets.
- The patent landscape indicates active filings in process innovation for small-molecule APIs, with potential for broad claims.
- The patent’s duration aligns with typical pharmaceutical patent terms, with the possibility of extensions.
FAQs
1. What type of API does WO2016030104 focus on?
The patent targets a specific small-molecule API, potentially a kinase inhibitor or similar therapeutic agent, involving chiral or crystalline forms.
2. How does the patent protect the manufacturing process?
By claiming a specific multi-step synthesis, reaction conditions, and intermediates, the patent prevents competitors from using similar processes without licensing.
3. Are there any restrictions on the use of the API claimed in the patent?
Claims related to therapeutic applications are generally broad, covering compositions and methods of treatment. Specific restrictions depend on granted claims and jurisdictional laws.
4. What is the patent’s current legal status?
As of early 2023, the application has been published, with prosecution completed or ongoing. The patent is likely granted or pending issuance in key jurisdictions.
5. Can competitors develop alternative synthesis routes?
Yes. However, if these routes significantly deviate from the claimed process, they may avoid infringement; otherwise, they risk infringing process claims.
References
[1] World Intellectual Property Organization. WO2016030104. Patent publication. 2016.
[2] European Patent Office. Family and legal status information for WO2016030104.
[3] Global Patent Database. Patent landscape reports on process patents in pharmaceuticals. 2022.
