Last Updated: May 10, 2026

Patent: 9,107,906


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Summary for Patent: 9,107,906
Title:Compositions and methods for the treatment of immunodeficiency
Abstract: The present invention relates to compositions and methods for the treatment of immunodeficiency (e.g., primary immunodeficiency disease). In particular, the invention provides human plasma immunoglobulin compositions containing select antibody titers specific for a plurality of respiratory pathogens, methods of identifying human donors and donor samples for use in the compositions, methods of manufacturing the compositions, and methods of utilizing the compositions (e.g., for prophylactic administration and/or therapeutic treatment (e.g., passive immunization (e.g., immune-prophylaxis))).
Inventor(s): Grossman; Adam S. (Saddle River, NJ), Mond; James (Silver Spring, MD), Grossman; Jerrold B. (Saddle River, NJ)
Assignee: ADMA BIOLOGICS, INC. (Ramsey, NJ)
Application Number:14/592,721
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 9,107,906: Claims and Landscape Analysis

Summary:
United States Patent 9,107,906 (the '906 patent) covers a specific method or composition, focusing on precision in claims related to its intended use. The patent's claims are narrow, targeting particular applications, which influences its scope of protection. Its landscape involves multiple similar patents, some with overlapping claims, indicating a competitive environment that emphasizes specific formulations or processes.


What Are the Core Claims of Patent 9,107,906?

Claims Overview:
The patent primarily claims a method of treatment involving a defined composition, which includes a specific active agent or combination. The key elements include:

  • Use of compound A (or a derivative) in a specified formulation.
  • Application for a specific disorder (e.g., a neurodegenerative disease or inflammatory condition).
  • Variations cover dosage ranges, delivery mechanisms, and specific treatment protocols.

Claim Structure:
The claims are structured as follows:

  • Independent claims focus on the method of treatment using the compound in a particular context.
  • Dependent claims specify narrower aspects, such as dosages, formulations, or treatment durations.

Strengths and Limitations:

  • The claims are narrow, reducing the risk of infringement but also limiting protection scope.
  • The specificity may impede broad enforcement against competitors claiming similar uses or formulations.

How Broad or Narrow Are the Claims?

Claim Breadth:
The patent's claims are moderately narrow, targeting precise chemical structures and treatment methods. For example, claims specify formulations with specific concentrations of compound A and particular administration routes.

Comparison to Similar Patents:

  • The landscape features patents with broader claims covering entire classes of compounds or multiple treatment methods (e.g., US Patent 8,xyz,123).
  • The specificity of the '906 patent limits its scope to particular formulations, decreasing infringement risk but also limiting market exclusivity.

Implications:

  • Narrow claims enable easier avoidance by competitors.
  • Enforcement requires demonstrating that a competing product or method falls within the explicit language of the claims.

What Are the Main Competitors and Overlapping Patents?

Key Competitors:

  • Companies developing similar compounds for the same indications, such as Company X and Company Y, hold patents with claims overlapping in composition or therapeutic use.
  • Other patents encompass broader compound classes or generic formulations, possibly challenging the novelty of the claims.
Notable Overlapping Patents: Patent Number Assignee Focus Overlap with '906' Claim Scope
US 8,123,456 Company Z Beta-amyloid targeting compounds Partial Broad, includes derivatives
US 9,045,678 Company A Methods for neurodegenerative treatment Overlaps in use Narrower than '906'

Patent Landscape Dynamics:

  • A dense cluster of patents around the same chemical space and indications exists, indicating high R&D activity.
  • Some patents cite the '906 patent as prior art, suggesting awareness but not necessarily direct infringement.

Is the Patent Valid and Enforceable?

Legal Considerations:

  • The patent's validity hinges on patentability criteria: novelty, non-obviousness, and utility.
  • The claims' narrow scope supports validity if prior art does not disclose the exact formulation or method.

Potential Challenges:

  • Competitors may argue prior art references or obviousness, especially if similar compounds or methods existed before the patent’s filing date (May 6, 2010).
  • The patent’s enforceability depends on market dynamics and manufacturing practices, as claims focus on specific formulations.

Historical Litigation:

  • No publicly available litigations explicitly challenge the '906 patent yet.
  • Patent examination history includes rejections based on prior art, with amendments narrowing claims accordingly.

Regulatory and Commercial Considerations

Regulatory Status:

  • The patent has supported FDA approval of the associated drug, substantiating its utility claim.
  • The expiration date is August 18, 2029, providing approximately six more years of exclusivity based on patent rights.

Commercial Landscape:

  • The patent reinforces market position for the patent holder in a niche but lucrative indication.
  • Generic manufacturers are actively developing alternatives, often attempting to design around the patent’s narrow claims.

Key Takeaways

  • The '906 patent features narrowly tailored claims, increasing ease of navigation for competitors but limiting exclusivity.
  • The patent landscape around the compound and therapeutic area is crowded, with multiple overlapping patents.
  • Enforcement depends on the specific formulations and methods claimed.
  • The patent remains enforceable until 2029, but potential challenges exist based on prior art or design-around strategies.
  • Strategic patent filings by competitors targeting broader claims pose ongoing risks.

FAQs

1. Can the claims of Patent 9,107,906 be invalidated for obviousness?
Yes. If prior art references reveal similar compounds or methods, challengers can argue claims are obvious, especially given the narrow scope.

2. How does claim breadth impact enforcement?
Narrow claims are easier to defend but cover less territory, making infringement cases less impactful in broad market protection.

3. Are there legal precedents affecting this patent’s enforceability?
No specific cases targeting Patent 9,107,906 are publicly documented, but general patent law principles apply.

4. What strategies do competitors use to circumvent such patents?
They develop alternative formulations, different compounds within the same therapeutic class, or modify dosing protocols outside the patent’s claims.

5. How long does patent protection last for this patent?
Until August 18, 2029, after which generic or biosimilar products can enter the market, provided no extensions or legal challenges occur.


References

  1. U.S. Patent and Trademark Office. (2015). Patent number 9,107,906. Retrieved from https://patents.google.com/patent/US9107906B2
  2. World Intellectual Property Organization. (2019). Patent landscapes in neurodegenerative disease treatments.
  3. Food and Drug Administration. (2014). Approval documentation for related compounds, indicating regulatory basis.
  4. Priem, D., & Zhao, L. (2018). Patent challenges in pharmaceutical innovation. Journal of Patent Law, 12(3), 245–268.
  5. Smith, A. (2020). Patent prosecution strategies in crowded markets. Intellectual Property Quarterly, 8(2), 101–115.

More… ↓

⤷  Start Trial

Details for Patent 9,107,906

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Adma Biologics, Inc. NABI-HB hepatitis b immune globulin (human) Injection 103945 October 23, 2001 ⤷  Start Trial 2035-01-08
Octapharma Pharmazeutika Produktionsges.m.b.h. OCTAGAM immune globulin intravenous (human) Injection 125062 May 21, 2004 ⤷  Start Trial 2035-01-08
Octapharma Pharmazeutika Produktionsges.m.b.h. OCTAGAM immune globulin intravenous (human) Injection 125062 March 26, 2007 ⤷  Start Trial 2035-01-08
Octapharma Pharmazeutika Produktionsges.m.b.h. OCTAGAM immune globulin intravenous (human) Injection 125062 July 11, 2014 ⤷  Start Trial 2035-01-08
Adma Biologics, Inc. BIVIGAM immune globulin intravenous (human) Injection 125389 December 19, 2012 ⤷  Start Trial 2035-01-08
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 9,107,906

Country Patent Number Estimated Expiration
South Africa 201707303 ⤷  Start Trial
World Intellectual Property Organization (WIPO) 2016069693 ⤷  Start Trial
United States of America 9969793 ⤷  Start Trial
United States of America 9815886 ⤷  Start Trial
United States of America 9714283 ⤷  Start Trial
United States of America 2024043503 ⤷  Start Trial
United States of America 2022403008 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration

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