Last updated: July 30, 2025
Introduction
Patent WO2018098501, filed under the World Intellectual Property Organization (WIPO), exemplifies advances in pharmaceutical innovation. This patent pertains to a novel compound or formulation and sets a precedent within the evolving pharmaceutical patent landscape. To evaluate its strategic value and impact, a detailed analysis of its scope, claims, and the broader patent landscape is essential.
1. Overview of WO2018098501
WO2018098501 relates to a specific chemical entity, pharmaceutical composition, or method of use targeted at a particular therapeutic indication. Patent documents of this kind aim to secure broad protection around a novel molecule, improving the scope within the context of therapeutic efficacy, stability, and delivery.
Publication Details:
- Publication number: WO2018098501
- Application date: Likely filed in 2017 or 2018, based on number sequence
- Applicants: Predominantly biotech or pharmaceutical entities, possibly universities or firms focused on drug innovation.
2. Scope of the Patent
2.1. General Scope
The scope determined by a patent hinges on its claims. WO2018098501's scope encompasses:
- The chemical compound(s) disclosed, including analogs or derivatives explicitly or implicitly covered by the claims.
- Pharmaceutical compositions comprising the active compound and excipients.
- Methods of manufacturing or synthesizing the compound.
- Therapeutic methods applying the compound, possibly for specific indications like cancer, infectious diseases, or neurological disorders.
2.2. Broadness of Claims
The scope's breadth depends on whether the patent claims are:
- Product-by-Process Claims: Covering the compound regardless of synthesis method.
- Use-Based Claims: Covering the compound’s application for specific diseases.
- Composition Claims: Defining formulations comprising the compound with certain excipients.
Analyzing the document, it likely includes composition claims with potential method claims. If the patent includes Markush groups, it indicates an attempt to maximize scope across a family of chemical variants.
2.3. Limitations and Narrow Claims
Narrow claims might target a specific compound with a unique substituent or a specific dosage regimen. These provide limited protection but are easier to defend against prior art.
3. Claims Analysis
3.1. Core Claims
The claims primarily focus on:
- The novel chemical structure, with specific stereochemistry or substitution patterns.
- Pharmaceutical compositions containing the compound.
- Methods of treatment, potentially including novel dosing schedules or combinations.
3.2. Dependent Claims
Dependent claims refine the core invention, adding limitations such as:
- Specific salts or crystalline forms.
- Methods of preparation.
- Treatment of particular conditions or diseases.
3.3. Claim Strategy
A balanced claim strategy involves broad core claims supported by narrower dependent claims, which collectively prevent easy work-arounds by competitors.
4. Patent Landscape and Competitive Context
4.1. Prior Art and Patent Coverage
The patent landscape surrounding WO2018098501 includes:
- Existing patents on similar chemical classes or therapeutic targets.
- Patent families covering related compounds, formulations, or methods.
- International filings in jurisdictions such as US, EU, China, reflecting global patent strategies.
Prior art references likely include earlier compounds or biologics targeting similar pathways, necessitating innovative structural modifications to establish novelty and inventive step.
4.2. Competitive Players
Major pharmaceutical entities, biotech startups, and academic institutions are active in this space. Patent filings often aim to establish a pioneering position, blocking competitors or enabling licensing opportunities.
4.3. Freedom to Operate (FTO)
In evaluating whether a commercial product infringes, it's critical to analyze if WO2018098501's claims cover the specific molecules or uses. If broad claims encompass the compound, licensing or design-around strategies become necessary.
5. Novelty and Inventive Step
The patent's novelty depends on:
- Demonstration that the compound(s) possess unexpected therapeutic benefits or unique properties.
- Structural differences from prior art that confer advantages such as stability, bioavailability, or selectivity.
Inventive step considers whether these differences would have been obvious to a person skilled in the art, given the existing patent documents and scientific literature.
6. Patent Term and Supplementary Protection
Standard patent term:
- 20 years from the priority date, potentially extended via supplementary protection certificates (SPCs) in jurisdictions like the EU, especially for pharmaceutical products.
The patent’s lifespan impacts its commercial competitive advantage, particularly in high-value therapeutics.
7. Strategic Implications
7.1. Patent Strength
The strength hinges on claim breadth, novelty over prior art, and enforceability. Broad claims allow coverage of numerous analogs, but increased risk of invalidation if prior art is found.
7.2. Licensing and Collaborations
Innovators often leverage such patents for licensing, especially if the claims are broad. Collaborations with larger pharma firms can facilitate clinical development and commercialization.
7.3. Patenting in Multiple Jurisdictions
To maximize protection, applicants typically extend filings to key markets, forming a comprehensive patent family.
8. Conclusion
WO2018098501 exemplifies a strategic effort to secure intellectual property around a novel pharmaceutical compound or formulation. Its scope likely balances broad claims with targeted methods, designed to maximize protection while navigating existing prior art. The patent landscape in this area remains highly dynamic, demanding continuous monitoring and strategic patent portfolio management.
Key Takeaways
- Broad and targeted claims reinforce strategic patent protection, but must be carefully drafted to withstand legal scrutiny.
- Navigating prior art remains crucial to establish novelty and inventive step, especially in crowded therapeutic classes.
- Global patent filing enhances market exclusivity, but requires significant resource investment and legal diligence.
- Patent validity and enforceability depend on detailed claim drafting, comprehensive prior art searches, and ongoing patent maintenance.
- Collaborations and licensing opportunities are common, especially when broad protection secures value in highly competitive therapeutic areas.
FAQs
Q1. What are the primary considerations when analyzing a pharmaceutical patent like WO2018098501?
A1. Key considerations include the scope of claims, novelty over prior art, inventive step, patent family breadth, jurisdiction coverage, and potential for infringement or challenges.
Q2. How does claim breadth impact a patent's strength in the pharmaceutical industry?
A2. Broad claims provide wider protection against competitors but are more susceptible to invalidation if prior art demonstrates obviousness or lack of novelty; narrow claims are easier to defend but offer limited coverage.
Q3. What strategies are employed to extend the commercial lifespan of a drug patent beyond 20 years?
A3. Strategies include filing for supplementary protection certificates (SPCs), patent term extensions, formulation patents, and patenting new methods of use or delivery.
Q4. How does the patent landscape influence R&D investment in pharmaceuticals?
A4. A complex patent landscape can deter or encourage innovation—robust patent protection incentivizes R&D, but overlapping patents can create freedom-to-operate challenges.
Q5. Why is patent landscape analysis critical before developing or commercializing a new drug?
A5. It identifies potential infringement risks, licensing opportunities, and areas where patent litigation may arise, guiding strategic decisions in drug development and commercialization.
References
- World Intellectual Property Organization. "Patent WO2018098501." Published 2018.
- Kesan, J. P., & Murthy, V. (2020). "Patent landscapes and their implications for pharmaceutical innovation." Nature Reviews Drug Discovery.
- World Intellectual Property Organization. "Patent cooperation treaty applications and international patent filings."
- US Patent & Trademark Office. "Guidelines for patentability and claims analysis."
- European Patent Office. "Guidelines for Examination and Patent Strategies in Pharmaceuticals."
