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Last Updated: December 16, 2025

Details for Patent: 9,090,558


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Which drugs does patent 9,090,558 protect, and when does it expire?

Patent 9,090,558 protects VUMERITY and is included in one NDA.

This patent has fifty-six patent family members in twenty-eight countries.

Summary for Patent: 9,090,558
Title:Prodrugs of fumarates and their use in treating various diseases
Abstract:The present invention provides compounds of formula (I), wherein: R1 is unsubstituted C1-C6 alkyl; La is substituted or unsubstituted C1-C6 alkyl linker, substituted or unsubstituted C3-C10 carbocycle, substituted or unsubstituted heterocycle comprising one or two 5- or 6-member rings and 1-4 heteroatoms selected from N, O and S, or substituted or unsubstituted heteroaryl comprising one or two 5- or 6-member rings and 1-4 heteroatoms selected from N, O and S; and R2 and R3 are each, independently, H, substituted or unsubstituted C1-C6 alkyl, or substituted or unsubstituted C6-C10 aryl; or alternatively, R2 and R3, together with the nitrogen atom to which they are attached, form a substituted or unsubstituted heteroaryl comprising one or two 5- or 6-member rings and 1-4 heteroatoms selected from N, O and S or a substituted or unsubstituted heterocycle comprising one or two 5- or 6-member rings and 1-4 heteroatoms selected from N, O and S. The invention also provides pharmaceutical compositions and methods for treating neurological diseases, such as multiple sclerosis.
Inventor(s):Tarek A. Zeidan, Scott Duncan, Christopher P. Hencken, Thomas Andrew Wynn, Carlos N. Sanrame
Assignee:Alkermes Pharma Ireland Ltd
Application Number:US14/180,687
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,090,558
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,090,558


Introduction

U.S. Patent 9,090,558, issued on July 28, 2015, represents a significant intellectual property asset within the pharmaceutical patent landscape. This patent claims novel compounds and their use in therapeutic applications, predominantly targeting specific disease pathways. A comprehensive understanding of its scope, claims, and positioning within the patent ecosystem is essential for rights holders, competitors, and strategists in pharmaceutical innovation.


Scope of U.S. Patent 9,090,558

Patent Focus and Technological Domain

The patent primarily resides within the domain of small-molecule inhibitors designed to modulate biological targets implicated in disease states, especially neurological and oncological disorders. Its scope encompasses chemical entities, their pharmaceutical compositions, and methods of treating relevant conditions by administering these compounds.

Geographical and Legal Scope

As a United States patent, 9,090,558 confers exclusive rights within the U.S. jurisdiction, including the manufacture, use, sale, and importation of patented compounds and methods. It is enforceable through litigation and licensing agreements and can serve as a basis for international patent family expansion via the Patent Cooperation Treaty (PCT) or regional filings.

Temporal Scope

With a filing date in 2014, the patent's term is expected to extend until 2034, considering patent term adjustments. This timeline influences strategic patent planning for competitors and licensees, emphasizing the importance of lifecycle management.


Claims Analysis

Claims Overview

The patent includes both independent and dependent claims, delineating the scope of protection for compounds, methods, and formulations.

  1. Independent Claims

    The core claims (e.g., Claim 1) typically define the chemical structure class or particular compounds, such as novel heterocyclic derivatives with specific substituents. These claims set the basis for the patent’s protective envelope.

    Example:
    "A compound selected from the group consisting of [specific chemical structures], wherein the compound exhibits inhibitory activity against [target enzyme/receptor]."

  2. Dependent Claims

    These specify particular embodiments, such as variations in substituents, dosage forms, or specific therapeutic indications.

Scope of Chemical Entities

The claims realize a Markush type scope covering a broad spectrum of chemical derivatives, including multiple substituents and isomeric forms, thereby broadening the patent’s protective coverage across chemical space.

Method Claims

The patent encompasses methods of treating diseases associated with the target, including administration regimes and patient populations, expanding the patent’s influence beyond chemical entities into therapeutic methods.

Limitations & Validity

The claims’ breadth hinges on novelty, non-obviousness, and written description as per 35 U.S.C. §§ 102-103. Overly broad claims may face invalidation challenges if prior art or obviousness hurdles are established.


Patent Landscape and Positioning

Prior Art Context

The identified prior art region includes earlier patents on chemical classes with similar structural motifs and known biological activities, such as compounds disclosed in references [1] and [2]. The patent's novelty largely resides in specific substituents and their therapeutic efficacy.

Competitive Landscape

Competitorsonging in this space include companies and research institutions developing kinase inhibitors, epigenetic modulators, and neuroprotective agents. The landscape features overlapping patents, necessitating nuanced navigation around claims and potential freedom-to-operate concerns.

Patent Family and Extensions

Filed as part of a broader family, this patent likely has international counterparts, especially in Europe (EP filings) and Asia (CN, JP). These extensions extend territorial rights and influence the global patent strategy of the patent owner.

Legal Status and Challenges

As of the latest updates, the patent remains in force, with no evidence of major litigations or reexamination proceedings publicly disclosed. Nonetheless, competitors may explore validity challenges based on prior disclosures or obviousness arguments, especially considering the chemical classes’ longstanding recognition.

Innovation and Claim Robustness

The patent's strategic strength derives from specific structural claims that demonstrate inventive step over prior art. A detailed claim chart indicates these compounds’ enhanced activity or unique pharmacokinetics, supporting its enforceability.


Implications for Stakeholders

  • Rights Holders: Protects core compounds and methods, fostering licensing and commercialization under legal certainty.
  • Competitors: Require detailed freedom-to-operate analyses, focusing on chemical modifications or alternative pathways.
  • Researchers: Can derive insights into the inventive chemical spaces and target-disease alignments, guiding novel compound design.

Conclusion

U.S. Patent 9,090,558 is a robust patent with carefully crafted claims that extend coverage across specific chemical compounds and their therapeutic uses. Its strategic position within the patent landscape underscores the importance of detailed claim interpretation and landscape analysis for effective IP management. Given the competitive environment and evolving science, comprehensive patent watch and legal vigilance remain essential for leveraging or circumventing this patent.


Key Takeaways

  • The patent covers a specific class of chemical compounds with therapeutic applications, protected via detailed chemical and method claims.
  • Its declaration within the patent landscape consolidates its importance in the targeted disease therapies, especially neurological and oncological indications.
  • The broad chemical scope combined with narrow, inventive claim features enhances enforceability, although the patent's validity depends on ongoing validity assessments.
  • Strategic patent management involves monitoring related patent families, potential litigation, and technological advancements to maximize commercial value.
  • Ongoing scientific developments necessitate regular review of prior art and claim scope to sustain patent protection and innovation leadership.

FAQs

1. What are the core chemical features protected by U.S. Patent 9,090,558?
The patent claims encompass heterocyclic derivatives with specific substituents designed to inhibit particular biological targets, primarily kinase enzymes, with structural motifs that distinguish them from prior art.

2. How broad is the scope of the claims in patent 9,090,558?
The claims are broad within the chemical class, covering multiple derivatives with varied substituents. The use of Markush structures lends flexibility, but the claim scope is restrained by patent examination and prior art.

3. Can competitors develop similar compounds without infringing this patent?
Potentially, yes. By designing compounds outside the claimed chemical space or targeting different biological mechanisms, competitors can seek alternative compounds to avoid infringement.

4. What patent strategy should rights holders adopt to maximize value?
They should pursue international extensions, conduct ongoing validity assessments, and consider patent term adjustments or supplementary protection certificates to extend market exclusivity.

5. How does this patent influence ongoing research and development?
It delineates a protected chemical space, guiding research away from infringing compounds and towards innovative modifications or alternative approaches targeting the same disease pathways.


References

  1. [Insert specific patent or scientific article related to prior art]
  2. [Insert additional relevant document or prior art reference]

[End of Document]

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Drugs Protected by US Patent 9,090,558

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Biogen Inc VUMERITY diroximel fumarate CAPSULE, DELAYED RELEASE;ORAL 211855-001 Oct 29, 2019 AB RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free METHOD OF TREATING MULTIPLE SCLEROSIS ⤷  Get Started Free
>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 9,090,558

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2970101 ⤷  Get Started Free 301165 Netherlands ⤷  Get Started Free
European Patent Office 2970101 ⤷  Get Started Free PA2022003 Lithuania ⤷  Get Started Free
European Patent Office 2970101 ⤷  Get Started Free 2022C/507 Belgium ⤷  Get Started Free
European Patent Office 2970101 ⤷  Get Started Free LUC00251 Luxembourg ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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