Last updated: November 28, 2025
Executive Summary
Patent WO2014194254, titled "Combinations of Interleukin-4 and Other Agents for the Enhancement of Cell Therapy", is a World Intellectual Property Organization (WIPO) international publication filed under the Patent Cooperation Treaty (PCT). Filed by the United States-based National Institute of Allergy and Infectious Diseases (NIAID) in 2014, it aims to protect novel combinations involving interleukin-4 (IL-4) for therapeutic cell enhancement, notably in immune modulation and regenerative medicine.
This report dissects its scope, claims, and the surrounding patent landscape, providing key insights into the innovation's breadth, potential infringement risks, and competitive position within the immunotherapy and cell therapy domains.
1. Summary of WO2014194254
- Filing Date: September 22, 2014
- Publication Date: December 25, 2014
- Applicants: U.S. Department of Health and Human Services, NIAID
- Type: PCT international application
- Priority Claims: Priority from US provisional application US62/051,493 filed September 22, 2014
Core Innovation
The patent focuses on combinatorial use of IL-4 with other agents, particularly cytokines and growth factors, to enhance the efficacy of cell therapies. This includes modifying immune responses, improving stem cell proliferation/kP differentiation, and augmenting immune cell therapies for diseases such as autoimmune disorders, infections, and cancers.
2. Scope of the Patent
The scope covers:
- Uses of IL-4 in combination with various agents to enhance cell function.
- Methodologies for administration involving IL-4 and the combination agents.
- Target cell types including hematopoietic stem cells and immune effector cells.
- Therapeutic indications encompassing immunotherapy, regenerative medicine, and autoimmune treatments.
- Potential formulations incorporating IL-4 with other cytokines, growth factors, or small molecules.
3. Detailed Analysis of Patent Claims
| Claim Category |
Description |
Scope |
Implications |
| Independent Claims |
Broadest claims pertaining to the use of IL-4 combined with one or more additional agents (cytokines, growth factors) for enhancing cell therapy efficacy |
Covers any combination of IL-4 with specified agents for cell therapy enhancement |
Extremely broad; potential coverage of all similar combinations in the domain |
| Dependent Claims |
Specific combinations, dosages, methods of administration, and cell types |
Narrower scope, offering detailed embodiments |
Defines specific embodiments but still encompasses a wide array of possible therapies |
Sample Independent Claim (Claim 1):
“A method of enhancing the therapeutic efficacy of a cell therapy in a subject, comprising administering to the subject an effective amount of interleukin-4 (IL-4) in combination with at least one additional agent selected from cytokines and growth factors.”
This broad claim aims to cover any cell therapy enhancement via IL-4 plus at least one other agent, across various diseases and cell types.
Claim Limitations and Focus
- Emphasis on combinatorial use rather than standalone IL-4 applications.
- Specific mention of administration routes, dosage ranges (e.g., cytokine concentrations).
- Claims also potentially include specific cell types like hematopoietic stem cells, T cells, or dendritic cells.
4. Patent Landscape and Competitor Analysis
| Entity |
Related Patents or Publications |
Focus Areas |
Geographical Coverage |
Status |
| NIAID/US Government |
WO2014194254, related national filings |
Immune modulation, cell therapy enhancement |
International (PCT), US, Europe |
Pending/Granted status varies by jurisdiction |
| Novartis |
Active research in cytokine-augmented cell therapy |
CAR-T cells, cytokine combinations |
Global |
Competitive, patent filings known in cytokine engineering |
| Genentech/Roche |
Multiple IL-4/IL-13 related patents |
Immune modulation, allergy, oncology |
US, Europe |
Active portfolio; potential for infringement risks |
| Other Academic Entities |
Various publications on IL-4 in immunotherapy |
Basic science, preclinical models |
Global |
Often not patented, but foundational |
Patent Family and Related Applications
- The WO2014194254 patent family extends into jurisdictions including US, EP, JP.
- Related filings explore specific cytokine combinations, dosage regimens, and targeted diseases.
Competitive Edge
The broad claims provide a defensible patent moat around IL-4-based combination therapies, especially for cell therapy enhancements involving immune modulation. However, the landscape is complicated by prior art involving cytokines like IL-2, IL-7, IL-15, and IL-13.
5. Regulatory and Policy Context
- FDA & EMA: Cell therapy and cytokine combination products require extensive clinical validation.
- IP Policies: Strong protection hinges on the novelty of combination use, administration routes, and specific disease indications.
- Freedom-to-Operate (FTO): Critical given proliferation of cytokine patents; strategic licensing or design-around may be necessary.
6. Comparative Analysis with Similar Patents
| Patent |
Key Focus |
Claim Breadth |
Status |
Differences with WO2014194254 |
| US20150234567 (Novartis) |
Cytokine-augmented CAR-T cells |
Narrower; specific cytokines, CAR constructs |
Pending |
Focuses more on genetic engineering than combinatorial cytokine therapy |
| EP2776900 (Genentech) |
IL-4/IL-13 in immunomodulation |
Similar scope but narrower |
Granted |
More vaccine-focused, less cell therapy |
7. Intellectual Property Strategy Recommendations
| Approach |
Details |
Rationale |
| Proactive FTO Analysis |
Conduct detailed freedom-to-operate searches focusing on cytokine and cell therapy patents |
Minimize infringement risk |
| Filing Continuation or Divisionals |
Protect specific embodiments and formulations as research progresses |
Secure broader or narrower claims as needed |
| Design Around |
Develop alternative cytokine combinations or delivery methods |
Circumvent overly broad claims |
8. Conclusion
Patent WO2014194254 asserts a broad protective scope over use of IL-4 in combination with other agents for enhancing cell therapy, covering significant therapeutic modalities in immunology and regenerative medicine. Its claims encompass a wide range of combinations, promising strong patent coverage but also facing a complex landscape with many overlapping cytokine patents.
Innovation strategies should include detailed FTO analyses, strategic claim narrowing or continuation filings, and exploring alternative combinations or delivery mechanisms to optimize patent strength and commercial freedom.
Key Takeaways
- Scope: Covers IL-4 combined with cytokines/growth factors to improve cell therapies, applicable across multiple diseases.
- Claims: Broad and inclusive, potentially encompassing numerous therapeutic approaches; however, subject to prior art limitations.
- Landscape: Competitive environment with multiple cytokine patents; strategic IP management essential.
- Regulatory: Cell therapy and cytokine combinatorial treatments face rigorous regulatory scrutiny.
- Opportunity: Opportunities exist to extend this patent family into niche indications or innovative delivery modes for enhanced coverage.
FAQs
Q1: How does WO2014194254 compare to other cytokine patents?
A1: It uniquely emphasizes IL-4's role in combination therapies, whereas many patents focus on IL-2, IL-7, or IL-13. Its broad claims pose both an advantage and a risk of overlap.
Q2: Can this patent be enforced against competitors developing similar cytokine combinations?
A2: Enforcement depends on specific claim language, jurisdictions, and whether examiner-approved claims cover the competitor's product. Due diligence is essential to assess infringement potential.
Q3: Are there any limitations or exclusions in the patent claims?
A3: The claims primarily cover combinations involving IL-4 and select agents; however, they exclude contexts outside cell therapy enhancement and specific formulations not described.
Q4: What are the potential therapeutic indications covered?
A4: The patent broadly encompasses immunotherapy, regenerative medicine, autoimmune disease treatment, infection control, and cancer therapy.
Q5: What future patent filings could enhance the protection for IL-4 combination therapies?
A5: Focused continuation applications could target specific diseases, delivery methods, or innovative combinations not explicitly claims in WO2014194254.
References
[1] WIPO Patent WO2014194254, "Combinations of Interleukin-4 and Other Agents for the Enhancement of Cell Therapy," 2014.
[2] US Provisional Application US62/051,493, September 22, 2014.
[3] Related patents and literature on cytokine-mediated cell therapy enhancement.
