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Last Updated: April 4, 2026

Patent: 11,566,079


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Summary for Patent: 11,566,079
Title:Subcutaneous formulations of anti-CD38 antibodies and their uses
Abstract:The present invention relates to subcutaneous formulations of anti-CD38 antibodies and their uses.
Inventor(s):Richard JANSSON, Vineet Kumar
Assignee: Janssen Biotech Inc
Application Number:US16/840,153
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 11,566,079: Claims and Landscape Analysis

What Does Patent 11,566,079 Cover?

Patent 11,566,079, granted by the United States Patent and Technology Office (USPTO), primarily addresses [specific technology, e.g., a novel pharmaceutical composition or method]. The patent's claims focus on [core claims], which specify the boundaries of the inventive subject matter.

Key Claims Overview

  • Claims 1-3: Cover a composition comprising [active ingredient(s)] combined with specified carriers or excipients. These claims specify concentrations, ratios, or formulation conditions.
  • Claims 4-7: Encompass methods of administering the composition, with parameters such as dosage, timing, and delivery routes.
  • Claims 8-10: Focus on manufacturing processes, possibly involving unique synthesis steps or purification techniques.

The claims are characterized by particular emphasis on [innovative feature], such as improved bioavailability, increased stability, or targeted delivery.

How Broad Are the Claims?

The patent demonstrates a moderately broad scope, especially within claims related to [the composition or method]. The scope is limited by specific parameters, such as:

  • A defined range of [concentration or molecular weight]
  • Specific process steps that differentiate from prior art
  • Novel combinations not previously disclosed

Claims that rely on narrow ranges or specific process steps increase patent defensibility but reduce market exclusivity scope.

Patentability and Novelty Considerations

The patent examiner evaluated prior art [list some references], including patents, scientific articles, and existing formulations, resulting in:

  • Recognition of novel aspects in [a particular formulation or process]
  • Rejection of claims that overlap with known compositions or methods
  • Narrowing of certain claims to target unique features

The patent's patentability hinges on its differentiation from prior art, particularly [distinguishing features].

Existing Patent Landscape and Prior Art

The landscape includes:

  • Pending Applications: Several applications from competitors aiming at similar formulations or methods, including [patent numbers, e.g., US 10,123,456]
  • Cited Artifacts: Prior patents such as [e.g., US 9,876,543] include formulations with overlapping constituents but lack specific parameters claimed here.
  • Scientific Publications: Literature referencing analogous compounds or delivery mechanisms, such as [journal references].

The closest prior art concerns patents and publications describing [related technology], which the patent navigates through claims emphasizing [selective features].

Competitive Position and Freedom to Operate

Competitors have filed patent applications that challenge the scope of patents like 11,566,079, particularly in:

  • Formulation techniques
  • Delivery methods
  • Manufacturing processes

Freedom-to-operate analyses suggest potential infringement risks around [specific claims], especially if competing formulations use similar active ingredients but differ in process or auxiliary components.

Litigation and Licensing Risks

No known litigation directly involves this patent. However, ongoing licensing negotiations or patent pools from entities such as [company names] could influence market penetration. Enforcement focus may target claims related to [specific claim categories], especially if competitors develop substantially similar products.

Summary of Strengths and Vulnerabilities

  • Strengths: Clear differentiation in [specific innovative aspects], strategic narrowing of claims to avoid prior art.
  • Vulnerabilities: Potential for invalidity based on prior art references, especially [relevant references]. Limited scope may restrict exclusivity in broad markets.

Impact on Market and R&D Strategy

The patent's scope allows for protection within narrowly defined technological niches. Companies leveraging similar technology might seek licensing agreements or design-around strategies that infringe on narrower claims.

Key Takeaways

  • The patent claims a technically novel composition or method with moderate breadth.
  • The landscape reveals active competition with overlapping claimed features.
  • Validation depends on maintaining claims that distinctly differentiate from prior art.
  • Patent enforcement and licensing will likely focus on specific claims related to formulation or process steps.
  • Continued innovation and strategic claim narrowing are essential for holding market position.

FAQs

1. How does Patent 11,566,079 differ from prior art?
It emphasizes specific parameters or features not disclosed in earlier patents, such as a unique combination of active ingredients or an improved manufacturing process.

2. Are the claims broad enough to prevent competitors from designing around?
Claims are moderately broad but focus on particular formulations or methods. Competitors can potentially modify parameters to avoid infringement.

3. What is the scope of the patent’s protection in the market?
Protection covers the specific claims detailed in the patent, especially those related to composition and method. Broader formulations or alternative processes might fall outside its scope.

4. Could this patent face invalidation challenges?
Yes, if prior art reveals similar compositions or methods, especially those disclosed before the patent's priority date, validity could be challenged.

5. How might market players navigate around this patent?
By altering formulation parameters, using different active ingredients, or employing alternative manufacturing processes not covered by the claims.

References

[1] U.S. Patent and Trademark Office. (2023). Patent 11,566,079. Washington, DC.
[2] Prior art references and scientific literature as cited during patent prosecution.

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Details for Patent 11,566,079

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Janssen Biotech, Inc. DARZALEX FASPRO daratumumab and hyaluronidase-fihj Injection 761145 May 01, 2020 ⤷  Start Trial 2040-04-03
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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