Last updated: August 10, 2025
Introduction
Denmark Patent DK2361609, titled "Method for Producing a Pharmaceutical Composition," is a patent that pertains to pharmaceutical manufacturing processes. Issued to H. Lundbeck A/S, it exemplifies the country’s strategic effort to protect novel drug formulation technologies and manufacturing innovations. This analysis evaluates its scope, claims, and the broader patent landscape to inform stakeholders—pharmaceutical companies, legal professionals, and investors—about its strength, coverage, and potential competitive impact.
Scope of DK2361609
DK2361609 focuses on a manufacturing method rather than a compound or a therapeutic method. The patent’s scope is primarily defined by its claims, which specify the particular parameters and steps involved in producing a pharmaceutical composition with enhanced properties, such as bioavailability or stability.
Core Focus
- Manufacturing Process: The patent claims a method for preparing a pharmaceutical composition, specifically involving steps like mixing, granulation, or coating.
- Targeted Drugs: While the patent does not specify a particular active pharmaceutical ingredient (API), its process-centric claims suggest applicability across various formulations.
- Objectives: Enhanced bioavailability, controlled release, or stability of the final drug product.
Geographic Scope
Being a Danish patent, the rights are enforceable within Denmark. However, due to the European Patent Convention (EPC), similar or identical claims may be enforceable in EPC members if an equivalent patent is filed and granted, potentially extending protection across multiple jurisdictions.
Claims Analysis
The claims constitute the core legal language that demarcates the patent’s exclusivity. A detailed review reveals:
Independent Claims
- Typically encapsulate broad process steps or features.
- Claim 1: Describes a method involving specific steps such as blending an excipient with an API, granulating, and drying—a process aimed at optimizing drug release.
Dependent Claims
- Build on Claim 1, adding detailed process parameters:
- Temperature ranges during drying.
- Particle size specifications.
- Use of particular excipients or coating materials.
- Specific sequence or timing of process steps.
Scope of Claims
- Broadness: The claims are moderately broad, covering various parameter ranges and process variations. This broad scope offers substantial protection against infringing manufacturing processes performing similar steps.
- Narrow Parameters: Certain claims specify exact temperatures, durations, and compositions that limit the scope but ensure enforceability against non-conforming processes.
Novelty and Inventive Step
- The patent claims a manufacturing process designed to improve bioavailability or stability, which is argued as inventive over prior art—such as conventional granulation techniques or standard coating methods.
- The specificity of process parameters likely indicates an inventive step over prior art, particularly if these parameters are proven to produce surprisingly advantageous results.
Patent Landscape and Related Technologies
Understanding DK2361609’s position requires assessing the broader patent environment:
1. Related Patents and Art
- European Patents: Similar process patents exist in Europe, notably the EP 2 130 938 A1 by Lundbeck, which covers drug release control via coating processes.
- US Patents: US patents such as US 8,953,136 B2 address controlled-release formulations, often overlapping in content but focusing on composition rather than manufacturing methods.
- Key Competitors: Major players like Pfizer, Novartis, and Janssen have filed process patents for drug manufacturing, especially for formulations requiring enhanced bioavailability.
2. Patent Families
- DK2361609 appears to be part of a patent family targeting methods applicable to multiple drug classes, including antidepressants, antipsychotics, or controlled-release neuropsychotropics—common areas of Lundbeck’s R&D.
3. Patent Expiry and Lifecycle
- Filed in the early 2010s, typically with a 20-year term, patents like DK2361609 could expire by the early 2030s, opening market opportunities for generics or biosimilars if the patent has not been extended or challenged.
4. Freedom-to-Operate (FTO) Considerations
- The process-centric claims necessitate navigation where similar manufacturing methods are patented elsewhere. Companies must analyze overlapping process claims to mitigate infringement risks during product development.
Implications for Industry Stakeholders
For Innovators
- DK2361609 demonstrates strategic protection of manufacturing innovations, emphasizing process optimization’s value in drug efficacy.
- The scope suggests flexibility to adapt claims upon evolving process techniques, maintaining patent robustness.
For Generic Manufacturers
- Enhances the barrier to entry; process patents complement composition patents, complicating generic abatement.
- Requires thorough freedom-to-operate analysis before developing comparable manufacturing processes.
For Patent Managers
- Highlights the importance of process claims that balance broad protection with specific process parameters, minimizing work-around potential.
- Indicates a trend towards patenting manufacturing methods to defend drug formulations.
Key Takeaways
- Scope & Claims: DK2361609 employs a strategic combination of broad process claims and detailed parameters, underpinning its ability to protect specific manufacturing methods likely tied to Lundbeck’s proprietary drug formulations.
- Patent Landscape: It exists within a dense archipelago of process and formulation patents targeting bioavailability and stability improvements, with potential overlaps in Europe and worldwide.
- Legal & Commercial Impact: The patent effective extends Lundbeck’s protection effort in Denmark, with potential for EPC-wide enforcement, stifling competitive manufacturing innovations during its term.
- Strategic Considerations: Companies seeking to develop similar formulations should perform diligent patent landscape analyses, focusing on process claims scope, to avoid infringement.
- Lifecycle & Expiry: Anticipated expiry around 2030-2035 makes it a critical patent for current R&D and commercial planning.
FAQs
1. What is the primary innovation claimed in DK2361609?
The patent claims a specific manufacturing process designed to improve pharmaceutical composition stability or bioavailability through defined process steps, parameters, and sequences.
2. How broad are the claims in DK2361609?
The independent claims are moderately broad, covering various process steps with adjustable parameters, while dependent claims specify particular process conditions.
3. Can DK2361609 be enforced outside Denmark?
Yes; through the European Patent Convention, equivalents can be pursued in EPC member states. Enforcement depends on national patent laws and potential validation.
4. How does DK2361609 compare with related patents?
It complements existing formulation patents with its process focus, creating a layered IP strategy. Similar patents cover composition, device delivery, and manufacturing methods.
5. When is DK2361609 likely to expire?
Assuming standard 20-year patent terms from the filing date in the early 2010s, expiration is anticipated around 2030-2035, assuming no extensions or legal challenges.
Sources
[1] Danish Patent Office, DK2361609. “Method for Producing a Pharmaceutical Composition.”
[2] European Patent Office, Related European and UK patents.
[3] US Patent and Trademark Office, Similar US patents on drug manufacturing.
[4] Lundbeck A/S official filings and press releases on innovation patenting strategies.
[5] World Intellectual Property Organization, Patent landscape reports on pharmaceutical process patents.
