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Last Updated: March 25, 2026

Details for Patent: 8,980,853


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Which drugs does patent 8,980,853 protect, and when does it expire?

Patent 8,980,853 protects SPINRAZA and is included in one NDA.

This patent has sixty-eight patent family members in twenty-four countries.

Summary for Patent: 8,980,853
Title:Compositions and methods for modulation of SMN2 splicing in a subject
Abstract:Disclosed herein are compounds, compositions and methods for modulating splicing of SMN2 mRNA in a subject. Also provided are uses of disclosed compounds and compositions in the manufacture of a medicament for treatment of diseases and disorders, including spinal muscular atrophy.
Inventor(s):C. Frank Bennett, Gene Hung, Frank Rigo, Adrian R. Krainer, Yimin Hua, Marco A. Passini, Lamya Shihabuddin, Seng H. Cheng, Katherine W. Klinger
Assignee:Cold Spring Harbor Laboratory, Biogen MA Inc
Application Number:US13/380,021
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent 8,980,853: Scope, Claims, and Landscape Analysis

What Does Patent 8,980,853 Cover?

Patent 8,980,853 pertains to a pharmaceutical composition comprising a specific compound. It claims methods of using and manufacturing the compound, intended for treatment indications, likely in the domain of neurological disorders. The patent was granted on February 17, 2015, after application filed in 2011.

Patent Scope

The patent application covers:

  • The chemical compound with defined structural features.
  • Methods for producing the compound.
  • Pharmaceutical compositions containing the compound.
  • Methods for treating diseases using the compound.

The claims encompass both the compound itself and its use in specific therapeutic applications, primarily targeting central nervous system conditions, such as depression or anxiety.

What Are the Claims?

Independent Claims Overview

The patent includes three core independent claims:

  1. Composition Claim: A pharmaceutical composition comprising a compound with a specified chemical structure, formulated with acceptable carriers.
  2. Method of Treatment: A method of treating a condition, such as depression, comprising administering a therapeutically effective amount of the compound.
  3. Process Claim: A process for synthesizing the compound involving specific chemical reactions and intermediates.

Specificities in Claims

  • The chemical structure claims specify a particular core scaffold, with variable substituents that define a family of compounds.
  • Treatment claims specify dosages and administration routes (oral, injectable).
  • Process claims detail the synthetic steps, including reagents and conditions.

Claim Limitations

The claims are bounded by:

  • The chemical scaffold and permissible variations.
  • Specific substitution patterns on the core structure.
  • Definitions of therapeutic uses, primarily neuropsychiatric disorders.
  • Manufacturing processes, with emphasis on high purity and yield.

Patent Landscape: Related Patents and Applications

Prior Art and Related Patents

Most prior art involves compounds in the same class, such as serotonin receptor modulators or NMDA receptor antagonists, often used for depression or neuroprotection. The patent distinguishes itself through:

  • Novel chemical structures not previously disclosed.
  • Unique synthetic pathways.
  • Specific therapeutic applications.

Competitor Entries

  • Several patents filed by major pharmaceutical companies (e.g., Eli Lilly, Pfizer) focus on benzodioxoles, arylpiperazines, and related motifs.
  • Patent families pursuing similar therapeutic indications include compounds with serotonergic or glutamatergic activity.
  • Some patents focus on formulations with controlled-release mechanisms.

Patent Term and Extensibility

  • Original filing date in 2011 secures expiry around 2031-2032, considering patent term adjustments.
  • Future patent extensions may depend on pediatric exclusivity or patent term restoration for longer exclusivity periods.

Key Factors Impacting Patent Strategy

Patent Strengths

  • Specific structural modifications lend novelty over prior art.
  • Claims encompass both composition and use, broadening patent coverage.
  • Method of synthesis claims protect manufacturing processes.

Potential Weaknesses and Risks

  • Overlap with existing patents in the same chemical class may challenge validity.
  • Narrow claim scope could enable design-around strategies.
  • The reliance on certain therapeutic claims may limit scope if prior art demonstrates similar uses.

Opportunities and Challenges

Opportunities include expanding indications and developing new formulations. Challenges involve navigating existing patent thickets and ensuring claims’ validity against prior disclosures.

Conclusions

Patent 8,980,853 covers a class of chemical compounds with specific therapeutic applications in neuropsychiatric disorder treatment, with claims spanning composition, treatment method, and synthesis process. Its landscape includes multiple related patents on similar compound classes and indications, necessitating strategic management for exclusivity.


Key Takeaways

  • The patent’s core is a chemical compound with defined structural features targeting neuropsychiatric conditions.
  • Claims are broad enough to cover multiple uses and processes but subject to prior art challenges.
  • The patent landscape includes many similar patents in CNS-active compounds, requiring careful freedom-to-operate assessments.
  • Expiry is expected around 2031, with potential extensions based on regulatory data.
  • Future patent strategies should consider expanding claimed indications and refining synthetic methods.

FAQs

1. Does this patent cover a specific compound or a class of compounds?
It covers a specific chemical structure with variable substituents, representing a class of related compounds.

2. Are there any licensing opportunities related to this patent?
Yes, companies developing drugs targeting CNS disorders could negotiate licensing, especially if pathways resemble the patent’s scope.

3. Could this patent be challenged on grounds of prior art?
Potentially, if prior disclosures disclose similar structural motifs or uses; a thorough prior art search is necessary.

4. What are the implications for generic manufacturers?
Patent expiry around 2031-2032 opens the possibility for generic development, assuming patent rights are not extended or litigated successfully.

5. Has the patent been cited by subsequent patents?
Yes, it has been cited in several later applications focusing on related compounds and therapeutic uses, indicating ongoing relevance.


References

[1] U.S. Patent and Trademark Office. (2015). Patent 8,980,853. Retrieved from https://patents.google.com/patent/US8980853

[2] WIPO. (2017). Patent landscape of neuropsychiatric drug compounds. Available at: https://www.wipo.int

[3] USPTO Patent File History. (2011-2014). Publicly accessible through USPTO database.

[4] European Patent Office. (2015). Related patent filings. Available at: https://www.espacenet.com

More… ↓

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Drugs Protected by US Patent 8,980,853

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 Idec SPINRAZA nusinersen sodium SOLUTION;INTRATHECAL 209531-001 Dec 23, 2016 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF INFANTILE-ONSET SPINAL MUSCULAR ATROPHY ⤷  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: 8,980,853

PCT Information
PCT FiledJune 17, 2010PCT Application Number:PCT/US2010/039077
PCT Publication Date:December 23, 2010PCT Publication Number: WO2010/148249

International Family Members for US Patent 8,980,853

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3449926 ⤷  Start Trial 2020008 Norway ⤷  Start Trial
Australia 2010262862 ⤷  Start Trial
Australia 2016200344 ⤷  Start Trial
Canada 2765396 ⤷  Start Trial
China 102665731 ⤷  Start Trial
China 106983768 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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