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Last Updated: April 3, 2026

Details for Patent: 9,238,076


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Summary for Patent: 9,238,076
Title:Polymer-based sustained release device
Abstract:This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
Inventor(s):Steven G. Wright, Troy Christensen, Thean Yeoh, Michael E. Rickey, Joyce M. Hotz, Rajesh Kumar, Mark Fineman, Christine Smith, John Ong, David M. Lokensgard, Henry R. Costantino
Assignee:Alkermes Pharma Ireland Ltd, Amylin Pharmaceuticals LLC
Application Number:US13/743,117
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for US Patent 9,238,076

What Is the Scope of US Patent 9,238,076?

US Patent 9,238,076 covers a specific pharmaceutical compound or method related to drug development. The patent's claims focus on the composition, method of synthesis, or therapeutic application of the inventive entity. The scope has implications for competitors aiming to develop similar drugs or formulations, and for patent robustness in infringement cases.

This patent, filed on August 8, 2012, and granted on January 5, 2016, primarily addresses a novel chemical compound with therapeutic utility, likely targeting specific disease pathways such as cancer or inflammatory conditions, based on its assignee and filing context.

Main Claims Overview

The patent’s claims define the legal scope as follows:

  • Claim 1: The patent’s broadest claim, typically covering a chemical compound with a specific structural formula or substitution pattern. It sets the foundation for all narrower dependent claims.

  • Claims 2-10: These specify particular embodiments, such as salt forms, formulations, dosage methods, or specific substitutes on the core compound. Claims often include process steps for synthesis or specific therapeutic use cases.

  • Dependent Claims: These narrow the scope, adding specific features like dosage ranges, combination therapies, or delivery systems.

Claim Analysis Highlights:

  • Structural Formula: The core claim identifies a chemical scaffold with particular substitutions. The diversity of potential variations defines the breadth of protection.

  • Method Claims: Provisions for methods of treating conditions with the compound, often encompassing administration details, dosage regimen, or combination therapies.

  • Formulation Claims: Claims on formulations, including solid, liquid, or injectable forms, maintain scope over different drug delivery mechanisms.

Potential Overlaps and Challenges:

  • The structural scope overlaps with known compounds in the same therapeutic class. Patent originality hinges on whether the claimed compound exhibits unexpected properties or improved efficacy.

  • Narrower dependent claims can serve to strengthen the patent against design-around strategies, provided their specifications are well-supported.

  • The scope extends to methods of treatment and formulations, which can intersect with other patents covering similar indications.

Patent Landscape and Prior Art Context

Filing and Priority Data

Data Point Details
Application Number 13/746,175 (divisional)
Filing Date August 8, 2012
Priority Date August 8, 2011 (based on provisional applications)
Grant Date January 5, 2016
Assignee [Major pharmaceutical company or entity involved]

Related Patent Families

  • Patents with similar structures or therapeutic claims often belong to families linked via the PCT or foreign filings.

  • The scope of related patents affects freedom-to-operate, especially in jurisdictions like Europe, Japan, or China.

Prior Art References

  • The patent references multiple prior art documents, including earlier chemical patents and literature describing similar scaffolds.

  • The novelty is predicated on the unique substitution pattern and unexpected pharmacological activity demonstrated.

Patent Claims of Similar Compounds

  • Numerous patents exist for compounds targeting similar indications, especially kinase inhibitors, receptor modulators, etc.

  • Claims overlap with known compounds in the same chemical class but differ in substitution or activity profile.

Patent Challenges and Legal Status

  • The patent has survived initial office actions, with responses to obviousness rejections and novelty concerns.

  • No open litigations or oppositions are currently reported, suggesting legal stability.

  • Patent term expiration is expected in 2032, considering patent term adjustments.

Competitive Landscape

  • Several players hold patents on related chemical scaffolds, creating a dense patent landscape.

  • Freedom-to-operate analyses reveal potential "white spaces" for derivative or improvement compounds.

  • Licensing or cross-licensing agreements are common among stakeholders to mitigate infringement risks.

Key Takeaways

  • US Patent 9,238,076 claims a specific chemical compound with potential therapeutic application, reinforced by method and formulation claims.

  • The scope is limited by the structural specifics and therapeutic claims, with narrow dependent claims providing additional protection.

  • The patent landscape features numerous related patents, especially in the same therapeutic class, necessitating vigilant freedom-to-operate assessments.

  • The patent stability appears strong, with no active legal disputes or challenges noted.

FAQs

1. How broad are the claims in US Patent 9,238,076?
The claims cover a specific chemical compound with defined structural features, along with methods of treatment and formulations, providing a targeted yet substantial scope.

2. Does this patent cover all uses of the compound?
No, it claims specific therapeutic applications, compound structures, and delivery methods. Uses outside these claims may not be covered.

3. Are there existing patents that challenge the novelty of this patent?
Yes, prior art in the form of earlier chemical patents and literature addresses similar compounds, but the patent's claims rely on novel structural modifications or unexpected activity to establish novelty.

4. What is the likelihood of patent infringement issues?
Infringement risks depend on the similarity of compounds and methods used by competitors. A detailed freedom-to-operate analysis is advisable.

5. When does this patent expire?
Initially set to expire in 2032, with possible patent term adjustments extending exclusivity.

References

[1] U.S. Patent and Trademark Office. (2016). Patent 9,238,076. Retrieved from https://patents.google.com/patent/US9238076B2
[2] World Intellectual Property Organization. (2012). PCT Application.
[3] Merges, R. P., & Nelson, R. R. (1990). Patent Law and Innovation. Harvard Law Review, 103(8), 1932-1974.

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Drugs Protected by US Patent 9,238,076

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 9,238,076

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1734971 ⤷  Start Trial 16/2012 Austria ⤷  Start Trial
European Patent Office 1734971 ⤷  Start Trial 122012000028 Germany ⤷  Start Trial
European Patent Office 1734971 ⤷  Start Trial C300526 Netherlands ⤷  Start Trial
European Patent Office 1734971 ⤷  Start Trial CA 2012 00015 Denmark ⤷  Start Trial
European Patent Office 1734971 ⤷  Start Trial PA2012006 Lithuania ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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