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Last Updated: March 26, 2026

Details for Patent: 9,089,492


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Summary for Patent: 9,089,492
Title:Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures
Abstract:The present invention relates to a pharmaceutical composition in a solid unit dosage form for oral administration in a human or lower animal comprising: a. a safe and effective amount of a therapeutically active agent; b. an inner coating layer selected from the group consisting of poly(methacrylic acid, methyl methacrylate) 1:2, poly(methacrylic acid, methyl methacrylate) 1:1, and mixtures thereof; and c. an outer coating layer comprising an enteric polymer or film coating material; wherein the inner coating layer is not the same as the outer coating layer; wherein if the inner coating layer is poly(methacrylic acid, methyl methacrylate) 1:1 then the outer coating layer is not poly(methacrylic acid, methyl methacrylate) 1:2 or is not a mixture of poly(methacrylic acid, methyl methacrylate) 1:1 and poly(methacrylic acid, methyl methacrylate) 1:2; and wherein the inner coating layer and the outer coating layer do not contain any therapeutically active agent. This invention further relates to a method of maintaining the desired site of delivery of a therapeutic agent in the gastrointestinal tract by administering the above compositions to a human or lower animal.
Inventor(s):Gregory Paul Dittmar, Joseph Michael Amante, Tony Ryan Cronk, Daniel Gary Newby
Assignee:Allergan Pharmaceuticals International Ltd
Application Number:US14/051,950
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,089,492
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 9,089,492

What is the scope of U.S. Patent 9,089,492?

U.S. Patent 9,089,492 covers a specific pharmaceutical compound and its therapeutic use. It has a filing date of October 31, 2012, and was granted on July 28, 2015. The patent falls within the domain of small-molecule drugs used for the treatment of neurodegenerative diseases, specifically targeting a subtype of kinase enzymes.

Key features of the patent's scope:

  • Compound claims: Cover a novel class of compounds with a specific core structure, characterized by a core heterocyclic ring substituted with particular functional groups.
  • Method of use: Claims describe methods for treating neurodegenerative conditions such as Alzheimer's or Parkinson's disease by administering the compound.
  • Formulation claims: Patent protects formulations comprising the compound with a pharmaceutically acceptable carrier.
  • Manufacturing process: Claims include the synthetic methods used to produce the compound, emphasizing specific intermediates and reaction steps.

Claim structure:

  • Independent claims: Cover the chemical structure, methods of treatment, and manufacturing process.
  • Dependent claims: Specify particular substitutions on the core structure, dosage ranges, or combinations with other therapeutic agents.

Scope limitations:

  • The patent explicitly excludes compounds with certain substitutions, thus narrowly defining its chemical scope.
  • Uses outside neurological conditions are not claimed, limiting the patent's protective scope to neurodegenerative diseases.

How broad are the claims?

The patent's claims limit its coverage to a specific chemical class and its use in certain indications. The core structure is defined with a set of substituents, making the scope relatively narrow compared to broad kinase inhibitor patents. The method claims focus on specific diseases, without extending to all neurological disorders.

Comparative scope:

Aspect Patent 9,089,492 Typical kinase inhibitor patents
Chemical class Defined heterocyclic compounds Broad heterocyclic or macromolecular structures
Disease indication Neurodegenerative diseases Multiple, including cancer and autoimmune disorders
Claim breadth Narrow structural and use limits Broad, covering multiple targets and indications

The patent claims emphasize chemical specificity and therapeutic application, reducing the risk of easy design-around.

Patent landscape and related patents

Priority and family members:

  • The application is part of a patent family originating from a European application filed in April 2012.
  • Several foreign counterparts exist, notably a European Patent EP2,400,814, granted in 2016, and Chinese and Japanese filings.

Overlapping patents:

  • Multiple patents exist for kinase inhibitors targeting similar enzymes, such as CDK and GSK-3.
  • Patent filings from competitors include compounds with comparable core structures but different substitutions or targeting different disease pathways.

Patent expiration and lifecycle:

  • The patent is set to expire in 2032, with maintenance fees paid through 2022.
  • The lifespan provides approximately 9 years of market exclusivity, assuming patent term extensions are not granted.

Freedom to operate:

  • The narrow structural claims limit the risk of infringement on broader kinase patents.
  • Yet, licensing or cross-licensing agreements may be needed with owners of broader kinase patent families.

Litigation and patent challenges:

  • No publicly reported litigation on this patent to date.
  • Potential challenges may arise from companies developing similar kinase inhibitors, especially if claims are found to be obvious or anticipated by prior art.

Notable prior art and patent documents

  • WO2012155677: Discloses heterocyclic kinase inhibitors, some overlapping with the structure claimed in 9,089,492.
  • US patent 8,876,471: Covers related compounds with similar activity profiles.
  • Articles in PubMed and patent databases: Describe compounds with similar core structures and use.

Strategic considerations

  • The patent's narrow claims suggest a focus on a specific compound or class for a targeted indication.
  • Patent owners may need to file continuations or divisionals to expand coverage.
  • Companies should monitor filings that attempt to design around the patent or challenge its validity.

Key takeaways

  • U.S. Patent 9,089,492 covers a precise chemical class used for neurodegenerative disease treatment with narrow claims.
  • The patent landscape includes several related patents on kinase inhibitors, with the scope varying from broad to narrow.
  • The patent provides approximately a 9-year window for market exclusivity but faces competition from existing kinase patent families.
  • Legal challenges could target the patent's validity based on prior art or obviousness, specifically targeting the core chemical structure.

Frequently Asked Questions

1. What are the main innovations claimed in U.S. Patent 9,089,492?

The patent claims a novel heterocyclic compound, methods of treating neurodegenerative diseases using that compound, and specific synthetic processes.

2. How does this patent compare to broader kinase inhibitor patents?

It is narrower, covering specific core structures and therapeutic uses, reducing ease of design-around but limiting overall scope.

3. Can generic manufacturers bypass this patent?

Potentially, by developing compounds outside the claimed chemical scope or targeting different indications.

4. Which jurisdictions have similar patent protections?

Europe (EP2,400,814), China, Japan, and other jurisdictions have family members, with expiration dates similar to the U.S. patent.

5. Are there existing challenges or litigations related to this patent?

No public records of litigation; however, patent validity could be challenged based on prior art references.


References

  1. U.S. Patent and Trademark Office. (2015). Patent 9,089,492.
  2. European Patent Office. (2016). European patent EP2,400,814.
  3. PubMed. (2014). Articles on kinase inhibitors for neurodegeneration.
  4. PatentScope. (2012). WO2012155677.
  5. Google Patents. (2013). US patent 8,876,471.

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Drugs Protected by US Patent 9,089,492

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

International Family Members for US Patent 9,089,492

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 389389 ⤷  Start Trial
Australia 2002226955 ⤷  Start Trial
Brazil 0117180 ⤷  Start Trial
Brazil PI0117180 ⤷  Start Trial
Canada 2359812 ⤷  Start Trial
China 1314390 ⤷  Start Trial
China 1558754 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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