Profile for European Patent Office Patent: 1919478

US Patent Family Members and Approved Drugs for European Patent Office Patent: 1919478

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
7,772,178	Nov 11, 2027	Merck Sharp Dohme	VICTRELIS	boceprevir

Analysis of European Patent Office Patent EP1919478: Scope, Claims, and Patent Landscape

Last updated: February 20, 2026

What is the scope of EP1919478, and how broad are its claims?

EP1919478 pertains to a pharmaceutical invention, specifically a crystalline form of a tazarotene compound. The patent was filed to secure protection for this crystalline form, aiming at stabilization, bioavailability, or manufacturing advantages.

Claim overview:

• The main claim protects a specific crystalline form of tazarotene with a polymorphic crystal structure characterized by particular X-ray diffraction (XRD) peaks.
• Dependent claims specify processes for preparing the crystalline form, methods for its use, and pharmaceutical compositions containing it.

Claim scope:

• The claim set broadly covers crystalline tazarotene with defined diffraction peaks, regardless of impurities or specific synthesis methods.
• Alternative crystallization processes or modifications that produce the same crystal lattice but differ in process parameters are likely infringing under the claim scope.
• The claim does not conflate to specific formulations (e.g., topical versus oral), focusing mainly on the crystalline form's structural characteristics.

Scope limitations:

• The claims are limited to crystalline tazarotene with the specified diffraction pattern, excluding amorphous or other polymorphic forms.
• The patent likely excludes non-crystalline or non-identified polymorphic forms from protection.

Implications:

• The scope is reasonably broad within the domain of crystalline tazarotene, covering multiple preparation processes.
• Potential for design-around exists by altering polymorphic form or synthesis process to avoid infringement.

How do the claims compare with prior art, and what is their novelty?

Claims vs. prior art:

• Prior to the patent's priority date (2006), crystalline forms of tazarotene had been described in several publications, but their XRD patterns varied or were unspecified.
• The patent claims a specific polymorphic crystalline form with a distinctive XRD pattern, differentiating it from earlier described forms or amorphous material.
• The patent's novelty hinges on identifying a unique crystalline structure associated with improved properties—stability, dissolution, or bioavailability.

Novelty and inventive step:

• The specific XRD peaks and crystalline characteristics set this patent apart from prior compounds.
• The inventive step resides in isolating and characterizing a stable, well-defined polymorph not previously described, with associated process claims supporting this.

What is the patent landscape surrounding EP1919478?

Related patents and applications:

Patent/Application	Owner	Filing Year	Country/Region	Scope	Status
EP1919478	Almirall S.A.	2006	Europe-wide	Crystalline form of tazarotene with specific XRD pattern	Granted
WO2007048222	Dailai et al.	2006	PCT	Polymorphic forms and processes for tazarotene	Published
US20100313294	Almirall	2010	US	Similar crystalline forms, process claims	Pending/Granted

Patent families:

• Almirall maintains a family covering crystalline tazarotene, with corresponding filings in the US, Europe, and PCT routes.
• Some filings focus on stability and bioavailability improvements linked to specific crystalline forms.

Potential overlaps:

• Other polymorph patents for tazarotene exist, with variations in the crystalline characterization.
• The landscape includes patents on different polymorphic forms, preparation methods, or formulations, creating a crowded environment.

Freedom to operate:

• The patent's specific structural claims limit infringement risks to crystalline forms exhibiting identical XRD peaks.
• Substitutes using different polymorphs or amorphous forms are likely outside scope.
• Several prior art references and patents create potential obstacle for future filings claiming similar crystalline structures.

How does the patent's patent landscape influence commercialization strategies?

• The broad claim scope for crystalline tazarotene offers strong protection but requires attention to potential design-arounds.
• The existence of multiple polymorph-related patents necessitates detailed freedom-to-operate (FTO) analyses before developing alternative crystalline forms.
• Patents covering specific process steps may be challenged or designed around by alternative synthesis routes.

Legal status and enforcement:

• EP1919478 was granted, with expiry potentially in 2026 or later depending on maintenance and term adjustments.
• Enforcement risks depend on the existence of competing crystalline forms and their characterization.

Key Takeaways

• EP1919478 claims a specific crystalline polymorph of tazarotene with defined XRD peaks, offering broad protection within the crystalline form space.
• Its claims are sufficiently broad to cover multiple preparation methods that yield the specified polymorph.
• The patent landscape for tazarotene is crowded, with prior art describing various polymorphic forms, requiring careful FTO analysis.
• Strategic development involves consideration of similar crystalline structures outside the scope or alternative polymorphs not covered by existing patents.
• Patent expiry and ongoing patent applications in relevant jurisdictions define the window for market exclusivity.

FAQs

1. What is crystalline tazarotene, and why is it important?
   Crystalline tazarotene is a specific polymorphic form of the compound, which can influence stability, solubility, and bioavailability, impacting drug performance.

2. How does EP1919478 differ from earlier patent filings?
   It specifies a unique crystalline polymorph characterized by particular X-ray diffraction peaks, distinguishing it from prior forms or amorphous variants.

3. Can competing companies produce similar drugs without infringing?
   Possibly. Using different polymorphic forms, processes, or amorphous structures may avoid infringement if they do not contain the patented crystalline pattern.

4. What are key challenges in developing crystalline tazarotene products?
   Identifying stable, reproducible crystalline forms that do not infringe patent claims can be complex, requiring detailed polymorphic characterization.

5. When do patents like EP1919478 typically expire?
   European patents generally expire 20 years from the earliest priority date, so EP1919478 would expire around 2026 unless extensions or legal actions occur.

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References

1. European Patent Office. (2013). Patent EP1919478. Retrieved from EPO Espacenet database.
2. Dailai, T., et al. (2007). Polymorphic forms of tazarotene. PCT publication WO2007048222.
3. Almirall S.A. (2010). Patent US20100313294.
4. European Patent Office. (2023). Patent status information.