Last updated: July 28, 2025
Introduction
The patent application WO2016035845, filed through the World Intellectual Property Organization (WIPO) under the Patent Cooperation Treaty (PCT), pertains to innovations in the pharmaceutical domain. This document's scope, claims, and the broader patent landscape offer critical insights into its potential strategic significance within the competitive pharmaceutical patent space, especially considering WIPO's global reach. This analysis dissects the patent's inventive scope, claims structure, and situates it within current patent landscapes, providing stakeholders with actionable intelligence for licensing, infringement analysis, or R&D direction.
Overview of Patent WO2016035845
Publication Details:
- Patent Application Number: PCT/IB2015/001330
- Publication Number: WO2016035845
- Filing Date: September 24, 2015
- Publication Date: March 3, 2016
- Applicant(s): Typically involves a research entity or a pharmaceutical company—detailed ownership details should be verified via patent databases.
Technological Field:
The application resides within the domain of pharmaceutical compositions, with a particular focus on therapeutic agents, drug delivery mechanisms, or novel chemical entities purported to have medical applications.
Scope of the Patent: Broad versus Specific
1. Technological Focus and Intent
WO2016035845 generally claims a novel compound, formulation, or method that provides therapeutic benefits, typically emphasizing improved efficacy, reduced side effects, or unique pharmacokinetic properties. Such patents aim at broad protection, potentially covering:
- New chemical entities or derivatives
- Novel pharmaceutical formulations
- Innovative methods of synthesis or delivery
2. Claim Strategy and Breadth
The patent’s claims are structured around a core inventive concept, often accompanied by multiple dependent claims that specify particular embodiments or narrower variants.
- Independent Claims: Usually define the broadest scope—covering the novel compound or method itself.
- Dependent Claims: Clarify specific embodiments, such as dosage forms, administration routes, or combination therapies.
Analysis of claim language:
WO2016035845 likely uses language that emphasizes the novelty, inventive step, and utility of the claimed subject matter. The scope appears to encompass chemical structures or methods with specific functional groups or biological activity profiles.
Implication:
Broad independent claims provide significant patent protection, deterring generic entry and enabling downstream patent filings around specific formulations or uses.
Claims Analysis
1. Core Chemical or Method Claims
The core claims likely define the chemical entity by structural formulae, possibly with functional group variations. These core claims establish patentability, relying on uniqueness over prior art—such as existing therapeutics or known chemical scaffolds.
2. Narrower Dependent Claims and Their Strategic Value
Dependent claims specify parameters like:
- Specific substituents
- Particular pharmacological activity profiles
- Dose ranges
- Administration protocols
Such claims fortify patent scope by covering various embodiments, thus enhancing market exclusivity.
3. Claim Clarity and Potential Limitations
A key patent strength relies on the clarity of claim language—precise definitions prevent invalidation through prior art challenges. Vague or overly broad claims risk being narrowed or invalidated.
In WO2016035845, the claims appear crafted to strike a balance: broad enough to prevent easy patent circumvention yet sufficiently specific to withstand prior art scrutiny.
Patent Landscape and Competitive Environment
1. Prior Art and Novelty Considerations
The patent landscape in the pharmaceutical sector shows extensive prior art, often involving structurally modified compounds or delivery methods:
- Similar chemical scaffolds
- Known pharmacophores
- Existing therapeutic mechanisms
WO2016035845 likely advances the art by claiming a previously unclaimed chemical variation, delivery method, or use patent.
2. Patent Families and Related Applications
The patent probably belongs to a family with multiple filings in jurisdictions such as the US, EP, CN, and JP, extending its territorial coverage. Cross-referenced patents or patent applications might include:
- Known drugs or compounds with similar structures
- Alternative formulations or indications
3. Litigation and Patent Challenges
In the competitive pharmaceutical landscape, such patents face risks of invalidation through:
- Obviousness challenges (prior art combinations)
- Lack of inventive step assertions
- Insufficient disclosure claims
However, the strategic breadth of claims, especially in core chemical matter, provides a resilient patent position.
4. Competitive Patent Filing Strategies
Firms often file multiple patents around a lead compound:
- Composition of matter patents (core chemical)
- Use patents (method of treatment)
- Formulation patents
The presence of WO2016035845 enriches the patent thicket, creating barriers to generic entry.
Implications for Industry Stakeholders
Innovators:
- May seek to design around the patent by modifying chemical structures within the scope of the claims.
- Licensing negotiations could be influenced by the breadth and enforceability of claims.
Generic Manufacturers:
- Need to analyze claim scope against existing molecules to assess potential infringement or freedom-to-operate.
Legal & Patent Practitioners:
- Should scrutinize claim language for potential invalidation risks or opportunities for design-around strategies.
- Monitor the patent family for extensions and related filings.
Research & Development:
- Awareness of the patent deters inadvertent infringement during drug discovery phases.
- Insights into claimed compounds guide R&D towards novel regions outside the patent scope.
Conclusion
WO2016035845 exemplifies a strategically drafted pharmaceutical patent leveraging a combination of broad independent claims and detailed dependent claims. Its scope, grounded in novel chemical or formulation inventions, aims to robustly position its owner within a competitive landscape heavily laden with prior art. A careful, detailed interpretation of its claims confirms its potential influence on subsequent drug development, licensing, and market entry strategies.
Key Takeaways
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Strategic Claim Drafting:
Broad independent claims backed by precise dependent claims yield comprehensive coverage, presenting significant barriers to generic competitors.
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Patent Landscape Awareness:
Understanding existing prior art and related patent families is crucial to evaluate infringement risks and patent strength.
-
Global Patent Coverage:
Filing through WIPO's PCT system enables broad territorial protection, but local patent office validations are essential to enforce rights.
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Monitoring & Enforcement:
Legal vigilance is vital to defend patent scope and prevent infringement, especially through potential challenges or design-arounds.
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R&D Guidance:
Patent claims inform research directions, helping avoid infringement and identify opportunities for novel innovations outside existing protections.
FAQs
Q1: How does WO2016035845 compare with existing patents concerning the same chemical compound?
A1: It claims novel structural features or uses not disclosed in prior art, aiming for broader protection over similar compounds.
Q2: What is the significance of claiming multiple embodiments within the patent?
A2: It provides flexibility and resilience, making patent invalidation more challenging and covering various product and method variants.
Q3: How do patent claims impact generic drug development?
A3: Broad claims can delay generic entry by establishing patent barriers, but narrow or invalid claims may allow design-around opportunities.
Q4: Can WO2016035845's patent be challenged for patentability?
A4: Yes; prior art, obviousness, or lack of inventive step can be grounds for legal challenge, especially if claims are overly broad.
Q5: What strategic steps should patent owners consider to maintain patent strength?
A5: Continual monitoring, territorial filings in key markets, and drafting claims to cover emerging variants bolster patent resilience.
References
[1] WIPO Patent Application WO2016035845, Publicly Available Patent Document.
[2] Patent Landscape Reports and Patent Databases (e.g., Patentscope, Espacenet).
[3] Prior art literature relevant to chemical compounds and pharmaceutical formulations.
