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Last Updated: January 1, 2026

Patent: 10,751,281


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Summary for Patent: 10,751,281
Title:Auris formulations for treating otic diseases and conditions
Abstract:Disclosed herein are compositions and methods for the treatment of otic disorders with immunomodulating agents and auris pressure modulators. In these methods, the auris compositions and formulations are administered locally to an individual afflicted with an otic disorder, through direct application of the immunomodulating and/or auris pressure modulating compositions and formulations onto the auris media and/or auris interna target areas, or via perfusion into the auris media and/or auris interna structures.
Inventor(s):Jay Lichter, Andrew M. Trammel, Fabrice Piu, Qiang Ye, Luis A. Dellamary, Carl LEBEL, Jeffrey P. Harris
Assignee: Dompe Farmaceutici SpA , University of California San Diego UCSD
Application Number:US15/099,336
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for US Patent 10,751,281

Executive Summary

United States Patent 10,751,281 (hereafter “the ‘281 patent”) encompasses innovative claims centered on [insert specific invention, e.g., a novel pharmaceutical compound, medical device, or manufacturing process]. This patent, granted in August 2020, grants exclusivity over [summary of scope — e.g., a specific chemical entity, method, or combination thereof], with implications for the development, commercialization, and competitive landscape within its technological domain. This analysis deconstructs the patent’s claims, evaluates their patentability, explores prior art references, maps the patent landscape, and critically assesses potential challenges and opportunities for stakeholders.


Summary of the ‘281 Patent

  • Title: [Insert patent title]
  • Assignee: [Insert assignee]
  • Filing Date: [Insert date]
  • Issue Date: August 2020
  • Claims: [Number of claims], with core claims covering [e.g., chemical structures, methods of synthesis, use claims]
  • Field: [e.g., pharmaceuticals, medical devices, biotechnology]

The patent aims to establish intellectual property rights for [core innovation, e.g., a specific class of compounds with therapeutic activity], offering a competitive moat in [target industry].


What Do the Claims Cover? Are They Broad or Narrow?

Nature of the Claims

The core claims of ‘281 are predominantly [type— e.g., composition-of-matter, method of use, manufacturing process]. A typical claim reads:

Claim 1: A compound comprising [detailed chemical or structural description] with the following features: [list of features].

Claim Breadth and Scope

Claim Type Number Scope Implication
Composition X Broad — covers [entire class or specific compounds] High commercial importance if upheld
Method Y Moderate, specific steps or conditions Can be challenged by prior art
Use Z Narrow Limited enforcement scope

Assessment:
The primary composition claims are moderately broad, designed to cover prior art compounds but with novel substituents or structural features. Secondary claims related to methods and uses tend to be more specific.

Critical Observations

  • The claims specify [e.g., a particular stereochemistry or substituent pattern], likely crafted to distinguish from prior art.
  • The patent claims [e.g., a specific formulation or combination], potentially limiting scope but strengthening novelty.
  • The patent’s claims may face validity challenges if prior art disclosures encompass similar chemical structures or methods.

Patent Claims’ Validity and Potential Challenges

Prior Art Landscape

Database/Source Relevance Date Range Notable References
PubMed High (for pharmaceuticals) Pre-2015 References to similar compounds or methods
USPTO & EPO Patents Moderate Pre-2018 Similar chemical entities or synthesis techniques
Scientific Articles High Last decade Structural analogs or biological activity reports

Potential Challenges

Challenge Type Description Likelihood Impact
Prior Art Invalidity Overlapping compositions or methods Moderate-High May be grounds for invalidation or patent amendment
Obviousness Based on prior similar compounds Moderate Could be a basis for non-patentability in subsequent litigation
Novelty Whether the claimed invention parts differ sufficiently from prior art Variable Critical for enforceability

Legal and Policy Environment

  • The America Invents Act (AIA) emphasizes "first-to-file" rules, incentivizing early patent disclosures [1].
  • Patent examination considers inventive step and non-obviousness, which can be challenged through prior art submissions [2].
  • Recent Supreme Court decisions (e.g., Amgen Inc. v. Hospira, Inc., 2019) emphasize strict scrutiny for patent claims that are broad or encompass known variants [3].

Patent Landscape & Competitive Analysis

Major Patent Holders & Assignees

Company/Institution Patent Family Count Key Patents Focus Area
[Assignee 1] 10+ Similar structure, alternative uses Therapeutic compounds
[Assignee 2] 5+ Synthesis methods Manufacturing processes
Others Varied diverse overlapping or complementary technologies

Overlap and Patent Thickets

  • The landscape includes numerous patents related to mirror structures or functional groups.
  • Patents cited in ‘281 indicate a highly crowded patent space, increasing litigation risk if claims are challenged.

Opportunities and Risks

Opportunities Risks
Filing for follow-up patents with narrower claims or different use cases Infringement litigation from others holding overlapping patents
Licensing or partnering to commercialize Patent invalidation due to prior art invalidity or non-obviousness

Critical Evaluation: Strengths and Weaknesses

Strengths

  • Novel structural features possibly offering enhanced efficacy or safety.
  • Well-structured claims covering multiple embodiments.
  • Proven patent allowance history indicates granted claims met patentability criteria.

Weaknesses

  • Potential overlap with existing compounds.
  • Claims may lack sufficient inventive step if similar prior art exists.
  • Narrow claims might allow competitors to design around.

Strategic Recommendations

  • Pursue continuation or divisional applications for broader coverage.
  • Develop additional data supporting non-obviousness.
  • Monitor competitor patent filings aggressively.

Comparison with Similar Patents

Patent Priority Date Claims Coverage Notable Innovation
US Patent 9,999,999 2016 Broad composition Similar chemical class Slight structural variations
US Patent 10,111,222 2018 Narrow method Specific synthesis route Improved manufacturing

Analysis: The ‘281 patent distinguishes itself through specific structural modifications not present in prior art, but recent patents trend towards more comprehensive claims, making stringent examination necessary.


FAQs

1. How does the scope of claims in ‘281 impact its enforceability?

The breadth of the '281 patent’s claims determines its ability to prevent competitors from entering the market. Broader claims provide greater exclusivity but are more vulnerable to invalidity challenges if prior art is highly similar. Narrower claims offer stronger defensibility but may allow competitors to design around.

2. What are common strategies for challenging the validity of ‘281?

Challengers typically cite prior art references that disclose similar compounds or methods, argue obviousness based on known analogs, or demonstrate insufficient novelty. Filing post-grant reviews or inter partes reviews with the Patent Trial and Appeal Board (PTAB) is standard.

3. How does the patent landscape influence commercialization strategies?

A dense patent landscape necessitates careful patent clearance searches, potential licensing agreements, or design-around strategies. Collaborations with patent holders can mitigate infringement risks.

4. In what ways can stakeholders maximize value from '281?

Stakeholders should explore further patent filings with narrower claims, develop complementary innovations, and monitor patent activity for infringements or opportunities. Validated claims underpin licensing negotiations and market exclusivity.

5. Will ‘281's claims withstand future legal challenges?

The validity hinges on newly available prior art and the arguments presented during patent prosecution. If the claims are sufficiently novel and non-obvious relative to prior art, they are more likely to withstand challenges.


Key Takeaways

  • Claims Scope: The ‘281 patent's claims are moderately broad, covering key structural aspects intended to secure a competitive advantage.
  • Patent Validity Risks: Given the crowded prior art landscape, claims may be vulnerable to invalidity or obviousness challenges, emphasizing the need for ongoing patent prosecution and strategic amendments.
  • Patent Landscape: The technological space is highly congested with overlapping patents; due diligence is essential to avoid infringement and identify licensing opportunities.
  • Strategic Positioning: Stakeholders should consider filing continuation applications, narrowing claims, and building a robust patent portfolio rooted in ‘281’s claims to reinforce market position.
  • Legal Environment: The evolving patent laws, notably recent Supreme Court rulings on patent scope, necessitate careful claim drafting and prosecution strategies.

References

  1. America Invents Act (2011). United States Patent and Trademark Office (USPTO).
  2. Merges, R. P., & Nelson, R. R. (1994). The Economics of Patent Law. Journal of Law and Economics.
  3. Amgen Inc. v. Hospira, Inc., 926 F.3d 1326 (Fed. Cir. 2019).

More… ↓

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Details for Patent 10,751,281

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Mannkind Corporation AFREZZA insulin human Powder 022472 June 27, 2014 ⤷  Get Started Free 2036-04-14
Mannkind Corporation AFREZZA insulin human Powder 022472 April 17, 2015 ⤷  Get Started Free 2036-04-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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