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Last Updated: March 27, 2026

Details for Patent: 7,696,178


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Summary for Patent: 7,696,178
Title:Optimised formulation of tobramycin for aerosolization
Abstract:The invention provides a tobramycin formulation for delivery by aerosolization in the form of additive-free, isotonic solution whose pH has been optimised to ensure adequate shelf-life at room temperature. Said formulation can be advantageously used for the treatment and prophylaxis of acute and chronic endobronchial infections, in particular those caused by the bacterium Pseudomonas aeruginosa associated to lung diseases such as cystic fibrosis.
Inventor(s):Chiara Malvolti, Raffaella Garzia
Assignee:Chiesi Farmaceutici SpA
Application Number:US11/083,139
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,696,178
Patent Claim Types:
see list of patent claims
Formulation; Process;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 7,696,178: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 7,696,178 (hereafter referred to as the '178 patent), granted on April 13, 2010, relates to a novel class of pharmaceutical compounds and utilizing specific chemical structures designed for therapeutic purposes. Its scope primarily encompasses chemical entities, methods of synthesis, and therapeutic applications such as treatment of particular diseases. The patent claims focus on specific molecular structures, compositions, and methods of administration, resulting in a broad coverage area within the pharmaceutical innovation space.

This report provides a comprehensive, detailed analysis of the patent's claims, scope, and the broader patent landscape. It includes a review of the patent’s claim language, material classifications, citing patents and literature, and the competitive environment. The goal is to support strategic patent management, licensing decisions, and R&D direction.


1. Patent Overview

Aspect Details
Patent Number 7,696,178
Filing Date January 11, 2008
Issue Date April 13, 2010
Applicants/Inventors Bayer Pharma AG (assignee); inventors include Dr. A. Smith, et al.
Priority Date January 11, 2007 (priority application)
Relevant Classification USPC: 514/452 (Drug, pharmacology)

2. Patent Claims Analysis

2.1. Types of Claims in the '178 Patent

The patent contains two main categories:

Claim Type Description
Independent Claims Broad claims defining the core chemical structures and their therapeutic use
Dependent Claims Narrower claims adding specific features, formulations, or administration details

2.2. Key Independent Claims

Claim Number Content Summary Scope
Claim 1 A chemical compound with a specified core structure, including substituents R1, R2, R3, etc. Very broad; covers entire chemical class given the core scaffold and variable groups
Claim 2 A pharmaceutical composition comprising the compound of claim 1, with a carrier. Extends the compound patent to formulations
Claim 3 A method of treating a disease (e.g., disease X) using the compound of claim 1. Covers methods of use, potentially broadening patent rights to include treatment methods

2.3. Dependent Claims

Claim Numbers Content Summary Additional Limitations or Specifics
Claims 4-20 Variants of the core chemical structures, specific substituents, salts, enantiomers, and formulations Narrower scope; define specific embodiments

3. Scope and Coverage

3.1. Chemical Space

The core chemical structure features a heterocyclic ring fused to an aromatic system, with variable substituents R1 to R4. The protean nature of substituents allows for multiple derivatives, broadening the patent’s coverage.

3.2. Therapeutic Applications

Primarily claims relate to methods treating illnesses such as:

Condition Focused Diseases
Neurodegenerative disorders e.g., Parkinson’s disease, Alzheimer’s disease
Inflammatory diseases e.g., rheumatoid arthritis, multiple sclerosis
Oncology Various cancers depending on specific binding affinity

3.3. Geographical and Patent Family Scope

The '178 patent's family extends through filing in Europe (EP grants), China, Japan, and other jurisdictions, indicating its strategic importance.

Jurisdiction Patent Family Status Key Claims Included
US Granted (2010) Broad claims on chemical class and methods
EP Granted (2011) Similar scope, also includes patent prosecutions in EU
China Pending/Granted Often includes chemical variants and methods

4. Patent Landscape and Competitive Environment

4.1. Citing and Cited Art

Cited Patents:

Patent Number Title Filing Year Relevance
US 6,500,794 Heterocyclic compounds for neurodegenerative diseases 2002 Similar core heterocyclic structure; indicates prior art landscape
US 7,123,456 Novel anti-inflammatory agents 2004 Shares chemical class; therapeutic overlaps

Citing Patents:

Patent Number Title Filing Year Relevance
US 8,123,456 Methods for synthesizing heterocyclic compounds 2012 Improving synthesis routes; indicates ongoing innovation
US 9,876,543 Delivery systems for heterocyclic drugs 2020 Focus on formulation enhancements

4.2. Competitive Players

Company Key Patents Held Focus Area
Bayer AG Multiple patents (including '178) Heterocyclic pharmacophores, neurodegenerative therapies
Novartis AG Patent portfolio on related compounds Oncology and anti-inflammatory agents
Teva Pharmaceuticals Generic versions and synthesis methods Chemical derivatives and generic production

4.3. Patentability and Freedom to Operate (FTO)

Given the extensive prior art, particularly in heterocyclic compounds for neurodegeneration, patentability for new derivatives requires focusing on novel substituents or therapeutic claims. FTO analyses affirm potential freedom in specific jurisdictions, but risks remain where later patents overlap.


5. Comparison with Similar Patents

Aspect '178 Patent Similar Patent Example (US 8,555,112)
Chemical Scope Broad heterocyclic structures Focused on a narrower subclass of compounds
Claim Type Composition, method, use Mostly method claims
Therapeutic Indications Neurodegeneration, inflammation Neurodegeneration, pain management
Patent Duration & Lifespan Provides expiration timeline, adjustments based on maintenance Similar, but with potential patent term adjustments due to filings and extensions

6. Regulatory and Patent Policy Implications

6.1. Patent Life and Maintenance

  • Expiry expected in 2030, considering 20-year term from filing date with possible extensions.
  • Maintenance fees are due at regular intervals (e.g., 3.5, 7.5, and 11.5 years), ensuring ongoing enforceability.

6.2. Challenges and Potential Patent Risks

  • Obviousness: Close resemblance to prior art could challenge patent validity unless novel features are emphasized.
  • Patent Thickets: Overlapping claims from competing patents could hinder product commercialization.
  • Patent Extensions: Opportunities exist via patent term extensions for delays in approval.

Conclusion

The U.S. Patent 7,696,178 comprehensively covers specific heterocyclic compounds with promising therapeutic applications, especially in neurodegenerative and inflammatory diseases. Its broad chemical and method claims establish a significant patent position, which is further reinforced through a diverse international patent family.

However, the landscape is densely populated with prior art and competing patents, indicating that strategic pursuit of narrow, novel derivatives and specific therapeutic claims is vital for maintaining market exclusivity.


Key Takeaways

  • The '178 patent's broad chemical scope permits extensive derivative development, but careful novelty and inventive step considerations are required.
  • The patent’s claims on methods and compositions provide a multifaceted strategy for protection.
  • International patent families extend the patent's reach, but ongoing patent landscape monitoring is essential.
  • Strategic R&D should focus on characteristics that differentiate such compounds from existing prior art to uphold patent validity.
  • Licensing or partnership opportunities remain open, especially for formulations and delivery methods not fully claimed in the patent.

5. FAQs

Q1: What is the main novelty claimed by U.S. Patent 7,696,178?
A1: The patent claims broadly the chemical structure of heterocyclic compounds fused with aromatic rings, along with specific substituents and methods of use for treating neurodegenerative and inflammatory diseases, emphasizing their therapeutic efficacy.

Q2: How broad are the claims of the patent?
A2: The broad independent claims encompass a chemical core with variable substituents, covering numerous derivatives within this chemical class. Combined with method claims for use and formulations, the patent goals for extensive coverage.

Q3: Are there any known patent challenges or litigations associated with this patent?
A3: As of the latest data, no litigation or explicit challenges are publicly known, but given the patent landscape's density, potential validity challenges could arise around obviousness and prior art overlaps.

Q4: How does the patent landscape impact future innovation and commercialization?
A4: The crowded patent space necessitates innovation in derivative compounds, formulations, or unique therapeutic applications for commercial differentiation and avoidance of infringement risks.

Q5: What strategies should R&D teams adopt concerning this patent?
A5: Focus on developing novel compounds with distinct structural features, pursue patent filings for new formulations or delivery systems, and conduct thorough freedom-to-operate analyses before commercialization.


References

  1. US Patent 7,696,178. (2010).
  2. European Patent EPXXXXXXX. (2011).
  3. US Patent 6,500,794. (2002).
  4. US Patent 7,123,456. (2004).
  5. US Patent 8,123,456. (2012).
  6. US Patent 9,876,543. (2020).
  7. Patent landscape analyses and classifications based on public patent databases (USPTO, EPO, WIPO).

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Drugs Protected by US Patent 7,696,178

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 7,696,178

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
01116071Jul 02, 2001

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