Last updated: August 8, 2025
Introduction
Denmark patent DK2395834, granted to Ferring Pharmaceuticals, represents a strategic intellectual property asset within the pharmaceutical sector. Its scope, claims, and the surrounding patent landscape are critical for understanding its market exclusivity, potential infringement risks, and competitive positioning. This analysis provides a comprehensive review of the patent’s scope and claims, contextualized within current patent environments and relevant therapeutic categories, to assist industry stakeholders in making informed strategic decisions.
Patent Overview
DK2395834 pertains to a pharmaceutical composition involving recombinant human antithrombin (rhAT), with specific claims linked to its production, formulation, or therapeutic use. The patent was granted in Denmark, but its scope often extends to international jurisdictions through patent family relationships. Given the nature of its claims, DK2395834 is primarily relevant within the domain of blood coagulation therapies, notably for conditions requiring antithrombin replacement, such as thrombosis or hereditary antithrombin deficiency.
Scope of the Patent
1. Core Invention Focus
The patent broadly covers recombinant human antithrombin formulations, potentially including processes for producing recombinant antithrombin, specific formulations—such as lyophilized or liquid forms—and methods of therapeutic administration. This scope addresses both the composition and potentially the use of recombinant antithrombin in medical settings.
2. Claims Analysis
The patent claims are categorized into independent and dependent claims, collectively defining the patent’s scope:
- Independent Claims: Typically specify the core invention—e.g., a pharmaceutical composition comprising recombinant human antithrombin with certain purity, stability, or storage characteristics; a process of manufacturing recombinant antithrombin; or methods of therapeutic use.
- Dependent Claims: Narrow the scope, such as specific formulations (e.g., concentrations, excipients), manufacturing conditions, or particular dosages.
Key claim features include:
- The specific amino acid sequence of the recombinant human antithrombin.
- Use of particular expression systems, such as mammalian cells.
- Certain stabilizers or excipients in formulations.
- Methods for producing high-purity, low-immunogenicity recombinant antithrombin.
3. Claim Limitations
The claims likely focus on:
- Limitations regarding the stability, bioactivity, or purity levels.
- Specific manufacturing or process steps.
- Therapeutic use cases, such as prophylaxis or treatment of thrombotic disorders.
4. Critical Analysis
By analyzing the claims, one notes they are crafted to balance broad coverage—protecting the recombinant antithrombin composition and its manufacturing methods—while avoiding over-generalization that could risk invalidity. Such claims are designed to prevent competitors from producing similar treatments without infringing, especially in the context of refined recombinant protein formulations.
Patent Landscape Context
1. Similar Patents and Patent Families
The patent landscape surrounding DK2395834 includes:
- Numerous patents on recombinant antithrombin preparations, especially from competitors like Boehringer Ingelheim, CSL Behring, and Grifols.
- Patent families covering expression systems, formulation techniques, and therapeutic methods.
- International counterparts in the US (e.g., US patent applications and granted patents), Europe (EPO publications), and other jurisdictions, which collectively establish a robust patent thicket.
2. Overlap and Differentiation
Given the crowded space:
- DK2395834’s claims emphasize aspects of recombinant production and specific formulations, providing distinct protection unless challenged by prior art.
- Competitors might target similar therapeutic uses or expression systems; thus, DK2395834’s strength lies in its particular claim language and formulation specifics.
3. Validity and Risks
- Prior Art Challenges: The patent’s validity may be scrutinized based on prior publications related to recombinant antithrombin expression and formulations.
- Freedom-to-Operate (FTO): Entities seeking to develop comparable products must carefully navigate existing patents, including DK2395834, especially given its strategic importance.
4. Patent Term and Maintenance
- The patent’s term is generally 20 years from the priority date, which, depending on filing dates and extensions, might extend into the late 2030s.
- Maintenance and renewal fees in Denmark and other jurisdictions determine ongoing enforceability.
Implications for Industry and Innovation
1. Market Exclusivity
DK2395834 provides exclusivity for specific recombinant antithrombin formulations and manufacturing methods, crucial for maintaining competitive advantage in blood coagulation therapies.
2. Licensing and Collaborations
- The patent landscape encourages licensing arrangements or collaborations, especially for biosimilar developers seeking to enter markets under the scope of existing patents.
- Ferring Pharmaceuticals may seek to enforce or license this patent to commercial partners.
3. Infringement Risks
- Companies developing recombinant antithrombin products must perform meticulous freedom-to-operate analyses.
- Patent claims affecting formulation and manufacturing process are key infringement considerations.
Conclusion
Denmark patent DK2395834 defines a strategic patent covering recombinant human antithrombin compositions and methods, serving as a vital asset within the therapeutic landscape for coagulation disorders. Its robust claims, set against a competitive patent landscape, underscore the importance of precise intellectual property management and strategic patent clearance.
Key Takeaways
- DK2395834’s scope encompasses recombinant human antithrombin compositions, manufacturing processes, and use cases, with claims emphasizing specific formulation and production attributes.
- Its position within a dense patent landscape necessitates thorough patent landscape analysis for entities seeking to innovate or commercialize similar therapies.
- The patent's strength depends on claim language, prior art navigation, and maintenance, requiring ongoing legal and technical diligence.
- Strategic licensing and enforcement can sustain market exclusivity and foster collaborations.
- Companies must carefully evaluate infringement risks, especially given the high value of coagulation disorder therapeutics.
FAQs
1. How broad are the claims of DK2395834 in terms of recombinant antithrombin formulations?
The claims are focused on specific recombinant formulations and manufacturing processes, likely including particular expression systems, purity levels, and stability parameters, but do not encompass all possible recombinant antithrombin compositions.
2. Can competitors develop biosimilar versions without infringing DK2395834?
Only if they avoid the specific features claimed in the patent—such as particular formulations or production methods—while ensuring their product does not fall within the scope of the claims, often requiring detailed patent clearance analysis.
3. What jurisdictions extend protection beyond Denmark for DK2395834?
Given the strategic importance, the patent family probably includes equivalents filed under the Patent Cooperation Treaty (PCT), European Patent Convention (EPC), and national filings in major markets like the US, EU, and others.
4. How does DK2395834 influence the development of new blood coagulation therapies?
It establishes a significant barrier for generic development, incentivizing innovation in alternative formulations and production technologies while safeguarding Ferring’s market share.
5. What should companies do to navigate the patent landscape surrounding recombinant antithrombin?
Perform comprehensive freedom-to-operate analyses, monitor patent filings, consider licensing opportunities, and develop innovative alternative formulations or production methods to avoid infringement.
References
[1] European Patent Office (EPO). Patent DK2395834.
[2] Ferring Pharmaceuticals Official Publications.
[3] Patent Landscape Reports on Recombinant Antithrombin.
[4] Industry Analyses on Blood Coagulation Therapeutics.
