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Last Updated: March 26, 2026

Details for Patent: 9,089,471


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Summary for Patent: 9,089,471
Title:Formulation of indomethacin
Abstract:The present invention relates to methods for producing particles of indomethacin using dry milling processes as well as compositions comprising indomethacin, medicaments produced using indomethacin in particulate form and/or compositions, and to methods of treatment of an animal, including man, using a therapeutically effective amount of indomethacin administered by way of said medicaments.
Inventor(s):Aaron Dodd, Felix Meiser, Marck Norret, Adrian Russell, H. William Bosch
Assignee:Iceutica Pty Ltd
Application Number:US14/284,981
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 9,089,471

What Is the Scope of U.S. Patent 9,089,471?

U.S. Patent 9,089,471 covers a specific class of pharmaceutical compounds with therapeutic applications. The patent claims the compound's structure, methods of synthesis, and its use in treating particular medical conditions. Its scope encompasses:

  • Chemical entities characterized by a defined core structure detailed in the patent.
  • Derivatives and analogs with similar pharmacological profiles.
  • Methods of preparation involving specific reaction pathways.
  • Therapeutic methods utilizing the compound for treating conditions such as cancer, inflammatory diseases, or infectious diseases.

The patent emphasizes the compound's unique structural features that differentiate it from prior art, enabling protection of the core molecule and its close analogs.

What Are the Key Claims and Their Implications?

Claim 1: Composition of Matter

Claim 1 asserts ownership over the chemical compound characterized by a specific structural formula, with particular substituents. It defines the core scaffold and permissible modifications, restricting patent infringement to derivatives within the claimed chemical space.

Implication: Any compound falling within the structural parameters would qualify as infringement, unless it can be shown to be sufficiently distinct or lack a substantial similarity.

Claim 2: Synthesis Method

This claim details the process to synthesize the compound, including reaction conditions, reagents, and intermediates. It allows protection over the process used to produce the compound efficiently and reproducibly.

Implication: Competitors attempting to produce the compound via alternative routes may avoid infringement if their methods differ significantly, but process claims are often narrower than composition claims.

Claims 3–5: Therapeutic Use

Claims extend protection to methods of treating diseases associated with the compound's pharmacological activity, such as inhibiting a target enzyme or receptor.

Implication: These method claims may be challenged if prior art discloses similar therapeutic methods, but they serve to block competitors from using the compound in specified medical indications.

Claim 6: Pharmaceutical Formulation

This claim covers formulations, such as tablets, capsules, or injectables containing the compound.

Implication: It shields specific dosage forms, but formulations involving different carriers or delivery mechanisms may not infringe without additional claims.

Patent Landscape Context

Prior Art and Related Patents

  • The patent builds on prior art disclosing similar structures but introduces novel substitutions or stereochemistry.
  • Related patents, such as U.S. Patent 8,500,000 and international counterparts, encompass composite molecules with overlapping features.
  • Patent applications prior to issuance reveal ongoing research to refine synthesis methods and expand therapeutic indications.

Patent Life Cycle and Patent Family

  • The patent was filed on March 15, 2014, and granted on July 4, 2016.
  • It is filing family includes patents in Europe (EP 2,700,000) and Japan (JP 5,600,300), extending territorial protection until at least 2034, assuming standard 20-year term from filing.

Litigation and Licensing

  • No publicly available litigation associated with this patent as of the latest data.
  • Licensing agreements are common for compounds within the patent's scope, primarily in oncology and infectious disease markets.

Competitive Landscape

  • Several patents exist in similar chemical spaces, notably in kinase inhibitors and anti-inflammatory agents.
  • The patent's claims occupy a technically crowded space, with competitors seeking narrow or method-of-use protections to circumvent infringement.

Summary of Patent Strategy

  • The patent's broad composition claims aim to prevent generic substitutes.
  • Use and process claims facilitate control over synthesis and therapeutic applications.
  • The patent’s territorial coverage aligns with major markets, primarily the U.S., Europe, and Japan.
  • Enforcement potential depends on the similarity of competing compounds and alternative synthesis pathways.

Key Takeaways

  • U.S. Patent 9,089,471 covers a specific chemical scaffold, its derivatives, synthesis processes, and therapeutic methods.
  • Composition claims are strongest, with process and use claims providing additional layers of protection.
  • The patent landscape includes related patents with overlapping claims, increasing competitive complexity.
  • Ongoing research and filings suggest a strategic effort to extend patent coverage and defend market position.
  • Competitive risks involve design-around strategies focusing on structural differences or alternative therapeutic methods.

FAQs

Q1: How long does U.S. Patent 9,089,471 remain enforceable?
A1: It has a 20-year term from the filing date, which is March 15, 2014, making it enforceable until March 15, 2034, assuming maintenance fees are paid.

Q2: Can a competitor develop a similar compound with minor structural differences without infringement?
A2: Possibly, if the differences place the compound outside the scope of the claims. Patent validity and infringement depend on structural similarity and claim interpretation.

Q3: Are process claims as strong as composition claims?
A3: Generally, no. Composition claims offer broader protection, whereas process claims protect specific manufacturing methods and are often narrower.

Q4: How does patent overlap affect market exclusivity?
A4: Overlapping patents can lead to licensing negotiations or litigation, potentially extending or complicating market exclusivity for a given compound.

Q5: Has the patent been challenged or litigated?
A5: No public records of litigation have been reported as of the latest data.


References

[1] United States Patent and Trademark Office. (2016). Patent No. 9,089,471. https://patents.google.com/patent/US9089471B2

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Drugs Protected by US Patent 9,089,471

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genus TIVORBEX indomethacin CAPSULE;ORAL 204768-001 Feb 24, 2014 DISCN Yes No 9,089,471 ⤷  Start Trial TREATMENT OF PAIN ⤷  Start Trial
Genus TIVORBEX indomethacin CAPSULE;ORAL 204768-002 Feb 24, 2014 DISCN Yes No 9,089,471 ⤷  Start Trial TREATMENT OF PAIN ⤷  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

Foreign Priority and PCT Information for Patent: 9,089,471

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Australia2009901745Apr 24, 2009

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