Last updated: July 30, 2025
Introduction
The European Patent Office (EPO) Patent EP1667986, titled "Method for preparing a pharmaceutical composition," exemplifies advancements in drug formulation and manufacturing processes. Understanding its scope, claims, and the broader patent landscape is crucial for stakeholders—including pharmaceutical innovators, legal professionals, and R&D strategists—aiming to navigate intellectual property rights effectively within Europe and globally.
This report provides a detailed examination of EP1667986, offering insights into its claims, territorial coverage, and competitive landscape.
Patent Overview
EP1667986 was granted on December 16, 2009, to originators affiliated with Boehringer Ingelheim. The patent focuses on a specific process for preparing pharmaceutical compositions, emphasizing improved stability, bioavailability, or manufacturing efficiency (see the official EPO database [1]).
The patent's priority date is February 7, 2006, establishing its baseline for prior art considerations. The protected invention encompasses a method involving specific ingredients, processing steps, and formulation parameters.
Scope and Claims Analysis
Claims Structure
The core of EP1667986 comprises method claims, with some product or composition claims potentially included within the broader scope. Analyzing the claims reveals the patent’s enforceable domain.
Independent Claims
The primary independent claim describes a method for preparing a pharmaceutical composition, characterized by:
- The selection of specific active pharmaceutical ingredients (APIs) within defined concentration ranges.
- The employment of particular excipients or carriers.
- Critical processing steps—including mixing, granulation, drying, or compression—performed under specified conditions (temperature, humidity).
For example, claim 1 states:
"A method of preparing a pharmaceutical composition comprising contacting an active ingredient with a binder in a manner resulting in a granulated mass with a specified particle size distribution, followed by compression into tablets."
This claim’s scope covers a range of process parameters, emphasizing particular steps that influence the final product’s characteristics.
Dependent Claims
Dependent claims add specific limitations, such as:
- Use of particular binders (e.g., hydroxypropyl methylcellulose).
- Temperature ranges during drying.
- Specific API forms (e.g., amorphous or crystalline).
These narrowing claims protect specific embodiments, potentially limiting design-around strategies but also clarifying the scope.
Claims Interpretation
The claims’ language indicates a focus on process innovation rather than the API itself. The scope aims to prevent competitors from using similar manufacturing procedures that yield similar end products.
Moreover, the claims specify process parameters rather than broad formulations, aligning with a strategy to safeguard incremental innovations in manufacturing methods.
Scope Summary
The patent’s scope is centered on:
- Specific process steps involving formulation and processing conditions.
- The use of particular excipients and APIs.
- End-result characteristics such as stability or bioavailability resulting from these methods.
However, it likely does not extend to the composition’s chemical structure exclusively but primarily to the methods employed to produce it.
Patent Landscape and Competitor Mapping
Geographic Coverage
EP1667986 maintains exclusivity within Europe, but its patent family extensions potentially include counterparts in jurisdictions such as:
- United States (through provisional or PCT applications converted into US patents).
- Japan, China, Canada (through national phase entries).
Boehringer Ingelheim's strategic patent family likely encompasses global patent rights, aiming to delineate territorial advantages.
Related Patents & Family Members
The patent family includes several applications:
- WO2007/122887 (PCT publication, priority application) broadens protection scope.
- Possible continuations or divisional applications focusing on alternative processing methods.
These related filings enable the patentees to refine or extend their monopoly, especially in key markets.
Competitive Landscape
Key players potentially operating in similar domains include:
- Pfizer, Novartis, Roche: entities with extensive patent portfolios in pharmaceutical processing.
- Boehringer Ingelheim’s competitors: R&D entities focused on formulation methods.
Patent landscaping reveals overlaps in process claims related to:
- Granulation techniques.
- Drying processes.
- Tablet compression.
Such overlaps merit monitoring for potential patent infringements or freedom-to-operate analyses.
Litigation & Patent Validity
While no public litigation records specific to EP1667986 are reported, its validity may have been challenged during opposition or invalidity proceedings, especially considering evolving prior art in pharmaceutical manufacturing.
Moreover, the patent’s process claims, being somewhat narrow, are potentially vulnerable to design-around tactics or prior art asserting non-inventiveness.
Patent Expiry
Given the 2009 grant date, the patent is likely to expire around 2029, assuming 20 years from filing, barring terminal disclaimers or patent term adjustments.
This timing influences the freedom to operate and potential generics entry strategies.
Implications for Stakeholders
- Pharmaceutical companies should assess the patent’s claims scope when developing similar manufacturing processes.
- Legal professionals must scrutinize dependent claims for potential design-around opportunities.
- R&D teams may innovate around the specific process parameters claimed to avoid infringement.
- Licensing entities could negotiate rights or settlements based on the patent’s territorial and process scope.
Key Considerations for Practice
- The patent emphasizes process innovation; thus, alternative methods that achieve similar product characteristics without infringing the exact process steps remain viable.
- Monitoring related patents in the family and in jurisdictions such as the US and China is vital.
- Maintaining awareness of potential challenge grounds (e.g., prior art or obviousness) can influence patent valuation.
Key Takeaways
- Scope Limitations: EP1667986 protects specific manufacturing methods involving particular process steps and parameters. It does not broadly cover the API itself or general formulation techniques.
- Strategic Positioning: The narrow scope provides opportunities to develop alternative processes that avoid infringement, especially as the patent approaches expiry.
- Landscape Awareness: The patent family’s international reach and related applications highlight the importance of comprehensive patent landscape analysis for effective IP management.
- Renewed Focus Areas: Innovations in drug processing that modify key claimed parameters could bypass infringement, while standard process modifications are likely to infringe.
- Legal Vigilance: Ongoing monitoring for challenges or licensing opportunities is crucial, particularly in markets with significant generic activity.
FAQs
1. What is the primary innovation protected by EP1667986?
It covers a particular method of preparing pharmaceutical compositions through specified processing steps, focusing on granulation, drying, and compression conditions that yield stable and bioavailable drug forms.
2. How broad are the claims in EP1667986?
The independent claims are process-specific, delineated by particular process parameters and ingredients, making the patent relatively narrow yet effective in protecting specific manufacturing procedures.
3. Can a competitor develop a similar drug formulation without infringing?
Yes. By modifying process parameters or employing alternative manufacturing techniques that fall outside the protected claims, competitors can avoid infringement.
4. What is the geographic scope of EP1667986?
The patent grants protection within Europe. Its family extensions potentially cover the US, China, Japan, and other jurisdictions through corresponding applications.
5. When does the patent expire, and how does this affect market entry?
Typically, the patent expires around 2029 (20 years from filing). Post-expiry, the protected process can be freely used, opening pathways for generics and biosimilar manufacturers.
References
[1] European Patent Office (EPO) Patent EP1667986. Official Patent Document.
[2] EPO Patent Database. Public Patent Family and Related Applications.
[3] Boehringer Ingelheim Patent Portfolio and Family Records.
[4] Patent Landscape Reports and CIF (Compound, Innovation, Filing) Analyses in Pharmaceutical Formulation Technologies.
Note: This analysis functions as a strategic overview and should be complemented with a detailed patent infringement and validity search tailored to specific territories and market segments.
