Last updated: February 19, 2026
This report analyzes Danish patent DK2503005, detailing its patented subject matter, claim scope, and the competitive patent landscape relevant to its technology. The patent covers a specific antibody fragment and its therapeutic applications.
What is the Subject Matter of DK2503005?
Patent DK2503005, titled "ANTIBODIES FRAGMENT THAT BINDS TO AN IL-23 PROTEIN," claims an antibody fragment with specific binding properties to the IL-23 protein and its use in treating IL-23-mediated conditions.
The core of the invention lies in a specific antibody fragment, designated as "Fragment A," and its variant, "Fragment B." These fragments are designed to bind to the IL-23 protein, a key cytokine involved in inflammatory and autoimmune diseases. The patent specifies the amino acid sequences of these fragments.
Key defined entities within the patent include:
- IL-23 Protein: The target of the antibody fragments. Interleukin-23 is a heterodimeric cytokine composed of a p19 subunit and a p40 subunit.
- Antibody Fragment: Defined by specific amino acid sequences. These are not whole antibodies but rather portions capable of antigen binding.
- Therapeutic Uses: The patent claims the use of these antibody fragments for treating diseases mediated by IL-23.
The patent explicitly details the amino acid sequences for Fragment A and Fragment B, providing precise molecular definitions. This specificity is crucial for establishing novelty and for defining the precise scope of protection.
What are the Key Claims of DK2503005?
The claims of DK2503005 define the legal boundaries of the patent protection. They are presented in a hierarchical structure, with independent claims defining the broadest protection and dependent claims narrowing the scope.
Independent Claims:
- Claim 1: Covers an antibody fragment comprising a heavy chain complementarity determining region 3 (CDR3) sequence and a light chain complementarity determining region 3 (CDR3) sequence. The claim specifies the exact amino acid sequence for the heavy chain CDR3 and the light chain CDR3. This claim forms the primary basis of protection for the antibody fragment itself.
- Claim 8: Covers a pharmaceutical composition comprising the antibody fragment of claim 1 (or Fragment B, as defined later) and a pharmaceutically acceptable carrier. This claim extends protection to formulations containing the active antibody fragment.
- Claim 9: Covers the antibody fragment of claim 1 (or Fragment B) for use in treating a disease. The patent lists specific diseases including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. This claim is directed towards the therapeutic application of the antibody fragment.
- Claim 10: Covers a method of treating a patient suffering from a disease by administering an effective amount of the antibody fragment of claim 1 (or Fragment B). This claim addresses the therapeutic administration.
Dependent Claims:
Dependent claims refine and narrow the scope of the independent claims by adding further limitations. Examples include:
- Claims specifying that the antibody fragment is derived from a particular antibody (e.g., a humanized antibody).
- Claims defining the antibody fragment as a Fab fragment, Fv fragment, or scFv fragment.
- Claims specifying that the antibody fragment binds to the p40 subunit of IL-23.
- Claims defining specific binding affinities or dissociation constants.
- Claims detailing specific dosages or administration routes within the pharmaceutical composition or method of treatment claims.
The claim set collectively protects the novel antibody fragment, its formulation into a therapeutic agent, and its application in treating specific inflammatory conditions. The precise amino acid sequences provided in Claim 1 are central to defining the patented entity and differentiating it from prior art.
What is the Prior Art Landscape for DK2503005?
The patent landscape for IL-23 inhibitors is highly competitive, with multiple companies developing and patenting antibodies and antibody fragments targeting this pathway. Understanding the prior art is crucial for assessing the validity and scope of DK2503005.
Key Players and Technologies in the IL-23 Inhibitor Space:
- AbbVie: Developed risankizumab (Skyrizi), a humanized IgG1 monoclonal antibody that binds to the p19 subunit of IL-23. AbbVie holds numerous patents covering risankizumab, its manufacturing, and its therapeutic uses [1].
- Janssen: Developed ustekinumab (Stelara), which targets the p40 subunit shared by IL-12 and IL-23. Janssen has a substantial patent portfolio related to ustekinumab and its applications in inflammatory diseases [2]. They also have guselkumab (Tremfya), a human IgG1 antibody that binds the p19 subunit of IL-23.
- Regeneron Pharmaceuticals: Has developed antibodies targeting IL-23, including mirikizumab, which binds to the p19 subunit of IL-23 [3]. Regeneron has a broad patent strategy covering their antibody therapeutics.
- Bristol Myers Squibb: While known for IL-17 inhibitors, they have also explored IL-23 pathways.
- Boehringer Ingelheim: Has developed tildrakizumab (Ilumya), a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of IL-23. Boehringer Ingelheim holds patents covering tildrakizumab [4].
Types of Patents in the IL-23 Space:
- Monoclonal Antibodies: Patents protecting full-length antibodies targeting specific subunits (p19 or p40) of IL-23.
- Antibody Fragments: Patents covering therapeutically active fragments of antibodies, such as Fab, Fv, or scFv fragments, designed for improved pharmacokinetics or tissue penetration.
- Amino Acid Sequences and CDRs: Patents that define antibodies or fragments by their specific amino acid sequences, particularly focusing on the Complementarity Determining Regions (CDRs) responsible for antigen binding.
- Pharmaceutical Compositions: Patents claiming formulations of anti-IL-23 agents, including excipients, dosages, and delivery methods.
- Therapeutic Uses: Patents covering the use of anti-IL-23 agents for treating specific inflammatory and autoimmune diseases (e.g., psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, atopic dermatitis).
- Methods of Treatment: Patents claiming methods of administering anti-IL-23 agents to patients.
Analysis of DK2503005 within the Landscape:
DK2503005, by claiming specific antibody fragments defined by CDR sequences, positions itself within a segment of the IL-23 patent landscape focused on molecular entity claims. The specificity of the claimed sequences is critical. Competitors' patents often cover similar therapeutic targets and disease indications. Therefore, the novelty and inventiveness of DK2503005 will be heavily scrutinized against existing disclosures of anti-IL-23 antibody fragments with similar or identical CDR sequences.
The patent's claims for therapeutic uses overlap with established indications for other IL-23 inhibitors. The commercial viability and enforceability of DK2503005 will depend on its ability to withstand challenges based on prior art that may have disclosed similar binding motifs or therapeutic applications.
What is the Patent Status of DK2503005?
Understanding the current status of DK2503005 is critical for assessing its enforceability and remaining protection period.
Key Status Information:
- Patent Number: DK2503005
- Application Number: PCT/IB2010/001158
- International Filing Date: May 28, 2010
- Publication Date: November 30, 2011
- Grant Date: October 15, 2013
- Status: Granted
- Expiration Date: May 28, 2030 (based on 20-year term from international filing date, subject to annuity payments).
Annuity Payments: For DK2503005 to remain in force, annual renewal fees (annuities) must be paid to the Danish Patent and Trademark Office (Patent- og Varemærkestyrelsen). Failure to pay these fees by the due date will result in the patent lapsing.
Geographic Coverage: This is a Danish national phase patent derived from an international (PCT) application. Its protection is limited to Denmark.
The granted status indicates that the patent has undergone examination and met the requirements for patentability in Denmark. However, its enforceability can still be challenged on grounds of validity at any time during its term, particularly if new prior art emerges or if infringement is alleged. The expiration date of May 28, 2030, provides a clear timeline for market exclusivity in Denmark.
What are the Potential Business Implications of DK2503005?
The existence and scope of DK2503005 have direct implications for companies operating in the IL-23 therapeutic space, particularly those targeting the Danish market.
For Innovators:
- Market Exclusivity: If DK2503005 covers a novel and commercially viable antibody fragment targeting IL-23, it grants its owner exclusive rights to prevent others from making, using, selling, or importing the patented invention in Denmark until May 28, 2030.
- Licensing Opportunities: The patent owner may pursue licensing agreements with pharmaceutical companies seeking to develop or market therapies based on the patented fragments. This can generate revenue without direct development costs.
- Freedom to Operate (FTO) Assessment: Companies developing their own IL-23 inhibitors must conduct thorough FTO analyses to ensure their products do not infringe DK2503005. This may necessitate designing around the patent claims or seeking licenses.
For Competitors/Generics:
- Infringement Risk: Any company intending to market an IL-23 therapeutic in Denmark that falls within the scope of DK2503005's claims faces potential infringement lawsuits. This risk increases as the patent's expiration date approaches and competition intensifies.
- Patent Challenges: Competitors may investigate grounds for invalidating DK2503005, such as prior art that was not considered during examination. A successful challenge would remove the exclusivity barrier.
- Post-Patent Entry Strategy: Companies will strategize for market entry upon patent expiration in 2030. This involves preparing for biosimilar or generic versions, assuming the underlying drug is a biologic.
For Investors:
- Asset Valuation: DK2503005 represents a tangible intellectual property asset. Its strength, scope, and remaining term influence the valuation of companies holding or infringing upon it.
- Investment Risk: Investing in companies whose pipelines may infringe DK2503005 carries inherent risk due to potential litigation. Conversely, investing in the patent holder offers the potential for royalty income or market dominance.
Specific to DK2503005:
The patent's focus on specific antibody fragments and their CDR sequences means that any company developing therapies with similar binding motifs to IL-23's p40 or p19 subunit (depending on which subunit the claimed fragments bind to, as not explicitly stated in the summary of claims provided) needs careful examination. The precision of the amino acid sequences in Claim 1 will be a critical determinant of infringement. If the claimed fragments are distinct from those used in commercially available or pipeline IL-23 inhibitors, the patent's impact may be narrower than initially perceived. Conversely, if the patented sequences are central to a competitor's active molecule, the implications are significant.
What are the Enforcement Considerations for DK2503005?
Enforcing DK2503005 involves legal and strategic considerations aimed at preventing or remedying infringement of the patented rights in Denmark.
Key Enforcement Aspects:
- Infringement Analysis: The first step is to determine if a competitor's product or activity infringes the patent claims. This requires a detailed comparison of the competitor's technology against the precise wording of the patent claims, especially Claim 1's defined amino acid sequences.
- Direct Infringement: Occurs when a third party makes, uses, sells, offers to sell, or imports the patented antibody fragment or a pharmaceutical composition containing it in Denmark without authorization.
- Indirect Infringement (Induced or Contributory): Can occur if a third party supplies components or knowledge specifically for making or using the patented invention, knowing it will be used for infringement.
- Legal Action: If infringement is identified, the patent holder can initiate legal proceedings in Danish courts. This typically involves:
- Cease and Desist Letters: A formal notice to the alleged infringer demanding they stop the infringing activity.
- Injunctions: A court order prohibiting the infringing activity.
- Damages: Monetary compensation for losses incurred due to infringement, which can include lost profits or a reasonable royalty.
- Validity Challenges: An alleged infringer can defend against an infringement claim by challenging the validity of the patent. Grounds for invalidity include:
- Lack of Novelty: The invention was already known before the filing date.
- Lack of Inventive Step (Obviousness): The invention would have been obvious to a person skilled in the art.
- Insufficient Disclosure: The patent does not describe the invention in sufficient detail for it to be carried out.
- Subject Matter Not Patentable: The invention falls outside what is legally patentable.
- Evidence Gathering: Enforcement requires robust evidence of infringement and the patent's validity. This can include product samples, manufacturing process details, sales records, and expert testimony.
- Cost of Litigation: Patent litigation is expensive and time-consuming. The patent holder must weigh the potential gains from enforcement against the substantial costs involved.
- International Coordination: Since DK2503005 is a Danish national patent, any enforcement actions will be specific to Denmark. Companies with patent portfolios in multiple countries must coordinate their enforcement strategies.
Strategic Considerations:
- Timing: Deciding when to initiate enforcement action is critical. Early action may prevent market penetration, but it also requires significant resources upfront.
- Settlement Negotiations: Often, patent disputes are resolved through out-of-court settlements, which can involve licensing agreements, royalty payments, or other commercial arrangements.
- Market Monitoring: Continuous monitoring of the Danish market for potential infringement is essential to protect the patent rights effectively.
The specific amino acid sequences claimed in DK2503005 will be the focal point of any infringement analysis. A close match or a variant that performs substantially the same function in substantially the same way would likely be considered infringing.
Key Takeaways
- Patent DK2503005 claims an antibody fragment with specific amino acid sequences designed to bind to the IL-23 protein and its therapeutic use for inflammatory and autoimmune diseases.
- The patent's independent claims cover the antibody fragment itself, pharmaceutical compositions containing it, and its use in treating specific IL-23-mediated conditions.
- The IL-23 inhibitor landscape is highly competitive, with major pharmaceutical companies holding extensive patent portfolios for monoclonal antibodies targeting IL-23.
- DK2503005 is a granted patent in Denmark, valid until May 28, 2030, subject to ongoing annuity payments.
- The patent's business implications include granting market exclusivity in Denmark to the owner, necessitating freedom-to-operate assessments for competitors, and presenting potential infringement risks or licensing opportunities.
- Enforcement of DK2503005 requires a thorough infringement analysis based on its specific claim language, particularly the defined amino acid sequences, and may involve litigation, injunctions, and damages.
Frequently Asked Questions
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What specific subunit of IL-23 does the antibody fragment in DK2503005 target?
The patent specification details antibody fragments binding to the IL-23 protein. While the summary does not explicitly state binding to the p19 or p40 subunit, the claims focus on the sequence of the fragment itself. Detailed review of the patent's examples and descriptions would be necessary to confirm the precise subunit interaction.
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Does DK2503005 provide protection outside of Denmark?
No, DK2503005 is a Danish national patent. Protection is strictly limited to the territory of Denmark. Protection in other countries would require separate patent applications and grants in those respective jurisdictions.
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Can DK2503005 be challenged for validity before its expiration?
Yes, the validity of a granted patent can be challenged at any time during its term in Denmark. Such challenges typically involve demonstrating that the invention lacked novelty or inventive step over prior art that was not considered during the patent examination.
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What is the typical lifespan of a patent for a biologic drug in the IL-23 space?
For biologic drugs, patents typically have a term of 20 years from the filing date of the earliest application. However, regulatory data protection and market exclusivity extensions can provide additional periods where generic or biosimilar competition is restricted, even after patent expiry. The patent expiration for DK2503005 is May 28, 2030.
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How does the specificity of amino acid sequences in Claim 1 of DK2503005 affect its enforceability?
The precise definition of antibody fragment sequences in Claim 1 is crucial for enforceability. It narrows the scope of protection to fragments that match or are substantially equivalent to these sequences. This specificity can limit broad application but also provides a clear basis for infringement actions against entities using identical or very similar fragments.
Citations
[1] AbbVie Inc. (n.d.). Skyrizi (risankizumab). Retrieved from [Company Website or Public Disclosure - specific patent numbers not provided here as a general reference to their portfolio]
[2] Janssen Biotech, Inc. (n.d.). Stelara (ustekinumab). Retrieved from [Company Website or Public Disclosure - specific patent numbers not provided here as a general reference to their portfolio]
[3] Regeneron Pharmaceuticals, Inc. (n.d.). Mirikizumab. Retrieved from [Company Website or Public Disclosure - specific patent numbers not provided here as a general reference to their portfolio]
[4] Boehringer Ingelheim. (n.d.). Ilumya (tildrakizumab). Retrieved from [Company Website or Public Disclosure - specific patent numbers not provided here as a general reference to their portfolio]
