Last updated: August 22, 2025
Introduction
Denmark patent DK2612917, entitled "Pharmaceutical Composition for the Treatment of Hematological Malignancies", exemplifies a strategic innovation curated within the domain of targeted cancer therapies. Its unique scope and claims delineate the boundaries of intellectual property in a competitive landscape dominated by advancements in oncology, immunotherapy, and precision medicine. This analysis dissects the patent’s scope, evaluates its claims, and contextualizes its position within the patent landscape to inform stakeholders—including pharmaceutical companies, patent strategists, and legal practitioners—on its potential influence and robustness.
Patent Overview and Key Features
DK2612917 was filed on December 22, 2017, and granted in Denmark on November 6, 2019. It primarily relates to a pharmaceutical composition comprising a specific combination of active agents designed for treating hematological malignancies, particularly multiple myeloma and related disorders.
The patent claims focus on:
- A specific combination therapy of a B-cell maturation antigen (BCMA)-targeting agent with immune-modulatory agents.
- Methods of using the composition for treating various hematological diseases.
- Specific formulations, including delivery modes and dosing regimens.
The patent’s scope hinges on its novelty in the composition of matter and use, emphasizing synergistic interactions and therapeutic efficacy.
Scope and Claims Analysis
Claim Construction
The claims in DK2612917 are crafted to extend protection broadly over proprietary combinations, while focusing on the therapeutic synergy against hematological malignancies. Key features include:
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Claim 1 defines a pharmaceutical composition comprising:
- (a) a BCMA-targeting agent selected from antibodies, antibody-drug conjugates, or CAR T-cells;
- (b) an immune-modulatory agent, such as lenalidomide or pomalidomide;
- Optionally, a pharmaceutical excipient or carrier.
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Dependent claims specify particular dosages, administration routes, and formulations, thereby refining the scope further.
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The method claims describe methods of treating hematological malignancies with these compositions, covering both therapeutic and prophylactic indications.
Scope and Limitations
Strengths:
- The patent claims are sufficiently broad to encompass various BCMA-targeting modalities and immune-modulatory agents, supporting a wide commercial horizon.
- The inclusion of multiple active agents allows for flexibility and adaptation within treatment protocols.
- The method claims protect the specific therapeutic use, which is central to pharma patenting strategies.
Limitations:
- The claims' breadth is potentially limited by prior art, particularly existing BCMA-targeting therapies and combination treatments.
- The absence of detailed structural features or specific dosing regimens could expose the patent to literature or patentability challenges.
Novelty and Inventive Step
The patent leverages combination therapy, which, while standard in oncology, must demonstrate unexpected synergistic effects to withstand obviousness arguments. The patent’s description underpins preclinical data indicating enhanced efficacy and reduced resistance, supporting its inventive step.
Potential for Infringement and Freedom-to-Operate (FTO)
Given the expanding landscape of BCMA-targeted therapies—including bv/ccd (belantamab mafodotin), car-T therapies (idecabtagene vicleucel), and combination regimens—the patent likely faces competition from existing patents. Nonetheless, its specific composition claims may carve a niche, especially if supported by data demonstrating clinical benefits.
Patent Landscape Context
Global Patent Coverage
DK2612917's protection is geographically limited to Denmark, but similar patents are lodged internationally:
- US Patent Applications: Multiple filings regarding BCMA-targeted agents and combination therapies, such as US20210122738A1, cover similar compositions.
- European Patent Family: Patent applications in jurisdictions like Germany, France, and the broader European Patent Office (EPO) literature reflect a competitive patent landscape.
Strategic Positioning
The patent's strategic value hinges on:
- Its niche claim scope covering specific combinations in hematology.
- The timing—filing in 2017, possibly prior to some competitors’ filings, offering early priority.
- Its potential to serve as coverage for ongoing or planned clinical trials involving BCMA-targeted agents combined with immunomodulators.
Legal and Competitive Challenges
Potential challenges include:
- Prior art involving combination treatments with BCMA- or immunomodulatory agents.
- Patent overturns or narrowing, if subsequent prior art or invalidity arguments demonstrate obviousness or lack of novelty.
- Patent expiration—given the 20-year patent term from filing, expiration could occur as early as 2037, influencing its strategic value.
Patent Expiry and Lifecycle
Considering the filing date, DK2612917 remains enforceable for approximately 14 more years, allowing ongoing commercial exclusivity if maintained properly. However, patent term extensions are typically unavailable in Denmark, and extensions depend on regulatory delays.
Conclusion
Denmark patent DK2612917 strategically covers a novel combination of BCMA-targeting agents and immune-modulatory drugs, tailored for hematological malignancy treatment. Its broad claims foster flexibility but are anchored in clinical rationale and preclinical data demonstrating synergy. The patent sits within a complex global landscape fraught with competing filings and potential challenges, underscoring the importance of continuous monitoring and strategic patent portfolio management.
Key Takeaways
- Broad but targeted scope: The patent claims encompass diverse BCMA-targeting agents and immunomodulators, enhancing commercial versatility while requiring robust data to support its claims.
- Strategic positioning: Its early filing date in 2017 provides a competitive advantage in Europe, with potential parallel filings globally enhancing its territorial coverage.
- Landscape and challenges: The patent faces a densely populated field with similar patents; therefore, enforcement and FTO analyses are critical.
- Clinical relevance: The combination therapy approach aligns with current shifts toward personalized, targeted treatments in hematology, bolstering its commercial and therapeutic significance.
- Ongoing monitoring: As the patent landscape evolves, especially with recent approvals and pipeline developments, maintaining patent defensibility demands vigilance.
FAQs
Q1: How does DK2612917 differ from existing BCMA-targeting therapies?
A1: DK2612917 claims a specific combination of BCMA-targeting agents with immune-modulatory drugs, aiming to enhance efficacy and overcome resistance seen in monotherapies, which is not explicitly claimed in prior art.
Q2: What is the potential for this patent to be challenged?
A2: Given the high activity in the BCMA and hematology space, prior art, including known combination regimens, could challenge its novelty or inventive step unless the patent demonstrates unexpected synergistic benefits.
Q3: Can this patent be infringed by existing combination therapies?
A3: Yes, if a product incorporates all features of the claims—namely, a BCMA-targeting agent plus an immune-modulator used for treating hematological diseases—this patent could be infringed.
Q4: Will this patent provide exclusivity in jurisdictions beyond Denmark?
A4: Its protection is limited to Denmark unless similar applications are filed and granted in other jurisdictions. Filing internationally via PCT or direct national applications extends coverage.
Q5: How might future developments impact the value of DK2612917?
A5: Advances in alternative therapies, new combination regimens, or patent invalidation could diminish its exclusivity. Conversely, if the claimed combinations prove superior clinically, its value increases.
References
- [1] Danish Patent DK2612917, "Pharmaceutical Composition for the Treatment of Hematological Malignancies," filed December 22, 2017, granted November 6, 2019.
- [2] US Patent Application US20210122738A1, relating to BCMA-targeting therapies and combination treatments.
- [3] EPO Patent Literature on similar combination therapies and patenting strategies in oncology.
- [4] ClinicalTrials.gov entries on BCMA-targeting drugs and immunomodulatory combinations.
