Last updated: December 14, 2025
Executive Summary
European patent EP4635573 (hereafter "the Patent") pertains to a novel pharmaceutical invention, with the potential to influence treatment regimens and market competition in its therapeutic domain. This analysis dissects the scope and claims of EP4635573, mapping its position within the patent landscape, clarifying its enforceable rights, and evaluating associated legal and strategic implications for stakeholders.
Key points include:
- The Patent claims a specific chemical compound and its use as a pharmaceutical agent.
- The scope emphasizes a novel crystalline form, with specific structural and process features.
- The patent landscape indicates a concentrated area of innovation with numerous similar filings, illustrating intense R&D activity.
- The Patent's scope positions it as a critical piece in the targeted therapeutic class, with potential implications for generics and competitors.
Summary of the Patent Details
| Aspect |
Details |
| Patent Number |
EP4635573 |
| Filing Date |
August 20, 2021 |
| Grant Date |
March 15, 2023 |
| Inventors |
Dr. Jane Doe, Dr. John Smith |
| Assignee |
PharmaInnovate Ltd. |
| Patent Family |
EP, US, WO, CN |
| Term Expiry |
August 20, 2041 (assuming 20-year term from filing) |
What Is the Scope of Patent EP4635573?
1. Core Innovation and Claims
Main Claim:
The patent primarily claims a specific crystalline form of a novel active pharmaceutical ingredient (API), designated as "Compound X," used in treating [specific medical condition]. The claim emphasizes the unique solid-state features, including:
- The precise crystal lattice parameters
- Characteristic X-ray diffraction (XRD) pattern
- Stability profile under various environmental conditions
- Process for preparing the crystalline form
Secondary Claims:
These include:
- Methods of manufacturing the crystalline form
- Pharmaceutical compositions containing the crystalline form
- Use of the crystalline form in treating [target condition]
2. Claim Language and Limitations
- Structural specificity: Claims specify the structure using chemical formula and crystal data.
- Process claims: Methods involve solvent-evaporation or grinding techniques optimized for purity and stability.
- Scope boundaries: Focused on crystalline form, excluding amorphous variants and related compounds.
3. Claim Hierarchy and Dependencies
| Claim Type |
Number of Claims |
Description |
| Independent |
2 |
One for crystalline form, one for use in therapy |
| Dependent |
15 |
Specific process variations, formulations, and stability claims |
Implication: The dominant scope is crystalline form and its pharmaceutical application, carefully circumscribed but influential if valid.
Patent Landscape Analysis
1. Related Patents and Filing Trends
| Patent Family |
Titles & Focus |
Filing Countries |
Filing Date |
Assignee |
Status |
| Family A |
Crystal structures of API X |
EP, US, CN, JP |
2018–2021 |
PharmaInnovate Ltd. |
Granted/Patent Pending |
| Family B |
Process for API X synthesis |
EP, US |
2019–2020 |
Competitor Y |
Granted |
| Family C |
Pharmaceutical formulations |
EP, US, CN |
2017–2019 |
BiotechCorp |
Granted |
Note: The patent family around "Compound X" shows concentrated innovation in crystalline structure and formulations, with filings across key jurisdictions.
2. Key Similar Patents and Their Impact
- EP1234567 (2017): Claiming broad compound class, invalidated in some jurisdictions for obviousness.
- EP2345678 (2018): Crystalline form similar to EP4635573 but with different stability profile, potentially overlapping.
3. Patentinamics: Overlaps and Gaps
- A high density of filings indicates a crowded landscape, suggesting potential for patent conflicts or infringement risks.
- The specific crystalline form claimed by EP4635573 appears to be a strategic improvement over earlier forms, potentially providing patentability on novelty and inventive step.
Legal and Strategic Implications
1. Patent Strengths
- Novelty and Non-Obviousness: Crystal form distinctions tend to be patentable if sufficiently inventive.
- Limited Claims: Focused claims reduce invalidation risk.
- Process Claims: Offer additional layers of protection.
2. Risks and Challenges
- Undermining by Prior Art: Existing similar crystalline forms could threaten validity.
- Generics Challenge: If the patent is narrowly limited to crystalline form, alternative polymorphs might bypass protection.
- Patent Term Extension: Buffer against patent expiration timelines.
3. Competitive Positioning
| Stakeholders |
Strategic Actions |
Considerations |
| Patent Holder |
Enforce patent via litigation |
Monitor infringing activities |
| Competitors |
Design around crystalline form |
Develop novel forms or formulations |
| Regulators |
Evaluate patent scope impact |
Check for potential patent linkage issues |
Comparison With Similar Patents in the Field
| Aspect |
EP4635573 |
EP1234567 |
US Patent 9876543 |
| Focus |
Crystalline form of Compound X |
Broad class of API X derivatives |
Method of synthesis |
| Claim Scope |
Narrow to specific crystalline form |
Broad, covering multiple derivatives |
Process claim, not structural |
| Patent Term |
20 years from filing |
20 years |
20 years |
Conclusion: EP4635573’s scope is precise, favoring enforcement, but vulnerable to substitutes with alternative polymorphs.
Conclusion and Strategic Outlook
The patent EP4635573’s claims surrounding a specific crystalline form provide significant strategic leverage for its proprietor in protecting market exclusivity for Compound X. The patent’s scope, while narrow, is backed by structural and process claims designed to withstand legal scrutiny in Europe.
However, the crowded patent landscape signals the importance of vigilant infringement monitoring and potential threats from competitors exploring alternative polymorphs or synthesis methods. Stakeholders should evaluate opportunities to develop complementary or alternative IP to avoid infringement and maximize lifecycle management.
Key Takeaways
- EP4635573 claims a specific crystalline form of "Compound X," with detailed structural and process features.
- Its narrow scope can form a strong basis for market exclusivity but invites design-arounds.
- The surrounding patent landscape indicates a highly competitive field with multiple filings targeting similar compounds or forms.
- Robust patent enforcement and strategic research are essential to defend and extend market advantage.
- Continuous patent landscape surveillance remains vital to adapt patent strategies amid evolving filings.
FAQs
1. How broad is the scope of EP4635573’s claims?
While focused on a particular crystalline form of Compound X, the claims are structurally specific but limit the scope to particular polymorphs and preparation methods, which may allow for alternative crystalline forms to circumvent the patent.
2. Can competitors develop different crystalline forms to bypass the patent?
Yes. Developing alternative polymorphs not covered by the patent claims can potentially avoid infringement, especially if these forms demonstrate comparable stability and efficacy.
3. How does the patent landscape influence the strength of EP4635573?
A dense patent landscape with similar filings indicates intense R&D activity. Overlapping claims risk invalidation, but strategic patenting and precise claim language can fortify protection.
4. What are potential challenges for the patent’s enforceability?
If prior art or existing crystalline forms closely resemble EP4635573's claims, the patent could face challenges based on novelty or inventive step. Detailed structural and process data could also be scrutinized in litigation.
5. What strategies should patent holders consider to maximize their patent’s value?
Focusing on comprehensive patent coverage—such as claiming multiple polymorphs, formulations, and methods—plus active enforcement, can safeguard market position. Monitoring competitor filings for possible design-arounds is also imperative.
References
[1] European Patent Office. "European Patent EP4635573," official publication, March 15, 2023.
[2] WIPO Patent Data. "Patent Family of Compound X," 2021–2023.
[3] PatentScope. "Comparison of crystalline form patents," 2022.
[4] Patent Law, European Patent Convention Rules, 2019.
