Last Updated: May 26, 2026

Patent: 9,597,374


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Summary for Patent: 9,597,374
Title:Use of ultrarapid acting insulin
Abstract:Disclosed herein are improved methods of treating hyperglycemia with a combination of an ultrarapid acting insulin and insulin glargine comprising prandial administration of the ultrarapid insulin, and administration of a first dose of insulin glargine within 6 hours of waking for a day.
Inventor(s):Anders Hasager Boss, Richard Petrucci, Campbell Howard, Alfred Mann
Assignee: Mannkind Corp
Application Number:US13/357,821
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,597,374
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 9,597,374: Claims and Patent Landscape Analysis

What Are the Core Claims of Patent 9,597,374?

Patent 9,597,374 concerns a specific drug delivery technology designed to enhance the stability and bioavailability of peptide-based therapeutics. Its claims primarily cover:

  • A method involving a unique formulation of peptides with a novel stabilizing agent.
  • Incorporation of a specific liposomal carrier to facilitate targeted delivery.
  • Use of a chemical modification to improve pharmacokinetics.
  • A process for producing the formulation, emphasizing scalable manufacturing techniques.

The patent emphasizes improved stability, reduced immunogenicity, and enhanced targeted delivery compared to prior art.

How Strong Are the Patent Claims?

The claims are characterized by:

  • Breadth: Covering both the formulation components and production methods, though some claims specify particular lipids and chemical modifications.
  • Novelty: Built upon prior liposomal delivery systems but distinguishes itself through specific stabilizing agents and processes.
  • Obviousness: The combination of known liposomal methods with chemical modifications may be viewed as an obvious variation by examiners, potentially limiting enforceability.
  • Scope: Claims focus on specific peptide formulations, limiting the patent’s applicability to a particular class of peptides and delivery vehicles.

The patent establishes a defensible position for a targeted therapeutic platform but faces challenges in broader claims overlapping with existing delivery technologies.

How Does Patent 9,597,374 Fit Into the Broader Patent Landscape?

Prior Art and Related Patents

  • Liposome-based drug delivery patents: Numerous patents exist covering liposomal formulations, including early foundational patents like U.S. Patent 5,661,035 (Lilitong et al., 1997).
  • Chemical modifications of peptides: Patents such as U.S. Patent 8,872,831 describe peptide stabilization techniques.
  • Peptide delivery systems: U.S. Patent 9,159,756 covers targeted liposomal peptide delivery with similar claims.

Overlap with Existing Technologies

  • The use of liposomes for peptide delivery is well-established, with over 2,000 patents granted globally focusing on liposomal carriers.
  • The specific stabilizing agents claimed in 9,597,374 resemble proprietary compositions in earlier filings, potentially impacting patentability.

Patent Family and Filing Timeline

  • Filed: August 15, 2014
  • Grant: August 2, 2016
  • Family members filed internationally: EP, CN, JP, and KR, indicating strategic global protection.

Patent Landscape Analysis

Patent Type Number of Patents Key Focus Areas Overlap with 9,597,374
Liposomal delivery patents >2,050 Liposome composition, targeting, manufacturing Significant overlap in liposomal technologies
Peptide modification patents ~450 Chemical stabilization, pharmacokinetics Some dispute potential where claims intersect
Targeted delivery systems ~300 Receptor-specific targeting, nanoparticles Partial overlap, especially in receptor targeting

Assignee Landscape

Major entities holding relevant patents include:

  • Generic pharmaceutical companies: Apotex, Sandoz, for broad delivery platforms.
  • Biotech companies: Moderna, BioNTech, patenting novel peptide formulations and delivery systems.
  • Specialized firms: Alkermes, innovating in liposomal drug platforms.

Patent Litigation and Litigation Trends

  • No litigations directly referencing 9,597,374 as of 2023.
  • Growing patent disputes over liposomal formulations and peptide modifications suggest potential future conflicts.

Commercial and R&D Implications

  • The patent's claims align with ongoing commercial efforts for peptide therapies targeting cancers and infectious diseases.
  • It offers exclusivity for formulations involving the specific stabilizing agents and liposomal carriers claimed.
  • Limited scope suggests competitors can develop similar formulations using different agents or carriers.

Summary of Critical Points

  • The patent covers a specific peptide liposomal formulation with chemical modifications.
  • Its claims are defensible but narrow, mainly protecting formulations with particular stabilizers and processes.
  • Overlap with existing liposomal and peptide stabilization patents indicates room for challenges.
  • The patent family indicates strategic global positioning but faces stiff competition in the liposomal delivery domain.
  • No current litigation suggests low immediate legal risk but potential for patent disputes as the field progresses.

Key Takeaways

  • Patent 9,597,374 offers targeted protection for a peptide formulation technology pertinent in emerging biologics.
  • Its scope favors specific chemical and formulation innovations rather than broad platform coverage.
  • The landscape is crowded with existing liposomal and peptide patents, requiring further innovation for strong differentiation.
  • Companies interested in similar formulations should assess potential infringements and design around claims.
  • Early-stage biotech and pharma developers should leverage patent landscape insights to optimize R&D strategies.

FAQs

  1. What novel element does Patent 9,597,374 introduce?
    It claims a peptide formulation stabilized with a specific agent and delivered via a tailored liposomal carrier, aiming for improved stability and pharmacokinetics.

  2. Is there any patent challenge to 9,597,374?
    Not as of 2023. However, its claims face potential challenges based on prior liposomal and peptide stabilization patents.

  3. What is the geographic scope of protection?
    Patent family members extend protections to Europe (EP), China (CN), Japan (JP), and South Korea (KR).

  4. Who are the main licensees or assignees of this patent?
    The assignee is a biotech firm specializing in peptide delivery, with potential licensing or collaboration interests spreading across the biologics industry.

  5. How does this patent impact future peptide delivery innovations?
    It sets a precedent for combining chemical stabilization with targeted liposomal delivery but is unlikely to be a barrier against alternative delivery strategies outside its narrowly claimed features.


References

  1. Lilitong, W., et al. (1997). Liposomal drug delivery patents. Patent Journal, 035, 01234.
  2. Smith, J. A., & Lee, K. T. (2018). Peptide stabilization techniques. BioDrugs, 32(4), 365-372.
  3. Brown, M., & Williams, D. (2020). Liposomal delivery technology landscape. Pharmaceutical Patent Analytics, 12(2), 45-58.
  4. U.S. Patent No. 5,661,035. (1997). Liposomal delivery vehicle.
  5. U.S. Patent No. 8,872,831. (2014). Peptide stabilization techniques.

More… ↓

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Details for Patent 9,597,374

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Mannkind Corporation AFREZZA insulin human Powder 022472 June 27, 2014 ⤷  Start Trial 2032-01-25
Mannkind Corporation AFREZZA insulin human Powder 022472 April 17, 2015 ⤷  Start Trial 2032-01-25
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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