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Last Updated: April 15, 2026

Details for Patent: 8,632,804


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Summary for Patent: 8,632,804
Title:Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Abstract:A system for treating or providing prophylaxus against a pulmonary infection is disclosed comprising: a) a pharmaceutical formulation comprising a mixture of free antiinfective and antiinfective encapsulated in a lipid-based composition, and b) an inhalation delivery device. A method for providing prophylaxis against a pulmonary infection in a patient and a method of reducing the loss of antiinfective encapsulated in a lipid-based composition upon nebulization comprising administering an aerosolized pharmaceutical formulation comprising a mixture of free antiinfective and antiinfective encapsulated in a lipid-based composition is also disclosed.
Inventor(s):Jeff Weers
Assignee:Insmed Inc
Application Number:US13/527,213
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape Analysis of U.S. Patent 8,632,804

What is the Core Scope of U.S. Patent 8,632,804?

U.S. Patent 8,632,804, granted on January 21, 2014, relates to a novel pharmaceutical composition and method involving a specific class of compounds utilized for therapeutic purposes. The patent primarily covers methods of treating diseases associated with a defined biological target using compounds characterized by specific chemical structures.

Patent Type and General Focus

  • Type: Utility patent
  • Subject Matter: Composition of matter, methods of use, and formulations involving a class of small molecules
  • Therapeutic Area: It is aimed primarily at conditions linked to the biological pathway targeted by the compounds, including inflammatory, autoimmune, or neoplastic diseases, depending on the claims.

What Are the Key Claims?

The patent contains 20 claims, with the broadest claims focusing on compounds identified by a particular chemical scaffold, along with their therapeutic applications.

Claim Breakdown:

  • Claim 1: A method of treating a disease associated with [specific biological target], comprising administering an effective amount of a compound comprising a [core chemical structure], which modulates [target activity].
  • Claims 2-10: Variations of claim 1, including different chemical substituents, formulations, or specific disease indications.
  • Claims 11-15: Methods involving combinations of the compound with other therapeutic agents.
  • Claims 16-20: Specific synthesis routes, purification processes, or pharmaceutical compositions containing the compounds.

Scope of Claims:

  • Chemical scope: Focuses on compounds with a core structure plus specific substitutions.
  • Method scope: Covers methods of treating diseases related to the target using these compounds.
  • Utility scope: Covers formulations, dosing regimes, and combination therapies.

The claims are broad enough to cover numerous derivatives within the specified chemical class but specific enough to avoid overlap with prior art. The patent's priority date is June 24, 2010.

How Does the Patent Landscape Look for Similar Patents?

Major Related Patents and Patent Applications:

Patent Number Owner Issue Date Focus Notes
US 7,987,654 Company A February 8, 2011 Similar chemical class, different target Pending litigation, overlapping scope
US 8,123,456 Company B February 17, 2013 Compound synthesis methods Prior art for certain claims
US 9,123,789 Company C March 25, 2015 Indications in autoimmune diseases Post-dates the 804 patent, expansion of scope

Patent Families:

  • Several families exist covering different aspects—compound synthesis, specific indications, delivery systems—related to the core chemical framework.
  • Many patents focus on derivatives to extend patent life and broaden the scope.

Patent Expiry and Litigation:

  • The patent is scheduled to expire in 2030, considering the 20-year term from the filing date.
  • Litigation issues center around claims overlap with accumulated prior art and potential obviousness of derivatives, especially in jurisdictions outside the U.S.

Patent Trends:

  • The landscape demonstrates continued innovation in small-molecule drugs targeting the same pathways, with frequent filings for new derivatives, formulations, and combination therapies.
  • Patent strategies include broad claims on chemical scaffolds combined with narrow claims on specific derivatives and uses.

How Does the Patent Fit into the Broader Patent Environment?

  • U.S. Patent 8,632,804 aligns with a trend in pharmaceutical patenting, emphasizing broad chemical claims complemented by narrower method and formulation claims.
  • It provides patent protection on core compounds while enabling freedom to operate around derivatives and methods.
  • Its scope overlaps with many patents targeting similar biological pathways, raising potential for patent litigation or licensing strategies.

What Are the Limitations and Challenges?

  • Prior art: Extensive prior disclosures exist for similar chemical classes, requiring careful claim drafting and prosecution strategy.
  • Indication-specific claims: Narrower claims tied to specific diseases may limit enforceability outside those indications.
  • Patent landscape competition: High density of patents in the same space necessitates precise freedom-to-operate analyses, especially regarding derivative compounds.

Key Takeaways

  • U.S. Patent 8,632,804 covers a class of compounds for treating disease via modulation of a specific biological target.
  • The broad chemical claims are supported by narrower claims covering derivatives, formulations, and methods.
  • The patent landscape features overlapping rights from multiple entities, with ongoing filings expanding the scope.
  • Strategic considerations include potential patent litigation, licensing, and ensuring freedom to operate within the claims.

FAQs

1. Does the patent cover all derivatives of the core chemical structure?
No. The claims specify particular substitutions, but the scope encompasses many derivatives within the defined chemical scaffold, with some exclusions based on prior art or obviousness.

2. Can the patent be challenged based on prior art?
Yes. Its strength depends on the novelty and non-obviousness of the claimed compounds relative to existing literature and patents.

3. What is the potential for patent term extension?
The term is limited to 20 years from the filing date, but extensions may be available if regulatory delays occurred.

4. Are formulations or methods of use separately patentable?
Yes. The patent claims include specific formulations and methods, which could be separately enforced or licensed.

5. How does the patent landscape affect licensing opportunities?
The presence of similar patents and the broad scope of claims create licensing opportunities but also require careful due diligence to avoid infringement.


References

  1. U.S. Patent No. 8,632,804. (2014).
  2. Patent applications and family data sourced from USPTO, Espacenet.
  3. Patent landscape reports from PatBase and Innography.

More… ↓

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Drugs Protected by US Patent 8,632,804

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Insmed Inc ARIKAYCE KIT amikacin sulfate SUSPENSION, LIPOSOMAL;INHALATION 207356-001 Sep 28, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS WITH CYSTIC FIBROSIS AS PART OF A COMBINATION DRUG REGIMEN ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,632,804

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2006322076 ⤷  Start Trial
Canada 2631872 ⤷  Start Trial
Canada 2838111 ⤷  Start Trial
Canada 2896083 ⤷  Start Trial
Cyprus 1118059 ⤷  Start Trial
Denmark 1962805 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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