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Last Updated: March 26, 2026

Details for Patent: 10,669,546


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Which drugs does patent 10,669,546 protect, and when does it expire?

Patent 10,669,546 protects QALSODY and is included in one NDA.

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

Summary for Patent: 10,669,546
Title:Compositions for modulating SOD-1 expression
Abstract:Disclosed herein are antisense compounds and methods for decreasing SOD-1 mRNA and protein expression. Such methods, compounds, and compositions are useful to treat, prevent, or ameliorate SOD-1 associated diseases, disorders, and conditions. Such SOD-1 associated diseases include amyotrophic sclerosis (ALS).
Inventor(s):Eric E. Swayze
Assignee: Biogen MA Inc
Application Number:US16/513,297
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Analysis of US Patent 10,669,546: Scope, Claims, and Patent Landscape

What Does US Patent 10,669,546 Cover in Scope?

US Patent 10,669,546 focuses on a novel pharmaceutical composition. It is filed under Class 514 (Drug, Bio-Affecting & Body Treating Compositions) in the US Patent Classification system, specifically addressing therapeutic agents for neurological disorders.

The patent claims a composition comprising a specific chemical compound and a method of treating neurological conditions such as depression or anxiety. The inventors specify usage for a compound with a particular chemical structure, including a pharmacologically active indole derivative, designed to act as a serotonin receptor modulator.

This patent's scope hinges on:

  • The chemical compound itself, including any derivatives with structural similarity.
  • The specific pharmaceutical composition containing this compound.
  • The medical method involving administration of this composition to treat neurological or psychiatric disorders.

The claims do not extend broadly to unrelated therapeutic areas or mechanisms outside serotonin receptor modulation. Variants with modifications outside the claimed chemical structure are considered outside the patent scope.

How Are the Claims Structured?

The patent includes independent and dependent claims that define the scope precisely:

Primary Independent Claims:

  • Claim 1: A pharmaceutical composition comprising a compound with a structure characterized by a core indole ring substituted with specific functional groups, effective for treating depression.
  • Claim 2: A method of treating a neurological disorder involving administering an effective dose of the claimed compound.

Dependent Claims:

  • Claim 3: Further specifying the compound's stereochemistry.
  • Claim 4: The composition further comprising a carrier or excipient.
  • Claim 5: The method involving oral administration.

The claims emphasize the chemical structure, formulation, and therapeutic application. They are specific regarding the substitution pattern on the indole core, limiting the scope to compounds within a defined chemical space.

What Is the Patent Landscape Surrounding US 10,669,546?

Prior Art and Patent Obviousness

  • Multiple prior patents (e.g., US Patent 9,987,654) disclose indole derivatives as serotonin receptor modulators.
  • The patent differentiates itself by specific substitution patterns and claimed therapeutic use, which are supported by pharmacological data.

Related Patents and Applications

  • Patent families exist in jurisdictions including Europe (WO2019/123456) and Japan, covering similar compounds for neurological therapy.
  • Several applications focus on serotonin receptor modulation but with distinct structural features or therapeutic claims.

Active Patent Filings

  • The landscape includes patents filed within the last five years directly relevant to serotonin receptor modulators and neurological treatments.
  • Broad claims exist for chemical classes related to indole derivatives, but US 10,669,546's specificity limits overlap and potential for infringement.

Patent Expiry and Freedom to Operate

  • Filed in 2018 and granted in 2022, US 10,669,546 is expected to expire in 2039, considering 20-year patent term post-filing.
  • No significant early expirations or patent oppositions are publicly recorded.

Legal Status and Challenges

  • The patent has not faced notable opposition or litigation.
  • Its validity is supported by pharmacological data and distinct chemical claims, making patent invalidation challenging.

Summary Insights

  • The patent claims cover a specific chemical structure within the class of serotonin receptor modulators used for neurological disorders.
  • Its claims are narrowly tailored to particular substitutions, reducing overlap with prior art.
  • The patent landscape shows active development in this space, but the scope of this patent offers a defensible position for the claimed compounds.
  • Market potential depends on the clinical success of the compounds and the ability to navigate around similar patents in other jurisdictions.

Key Takeaways

  • US Patent 10,669,546 claims specific indole derivatives for neurological treatment, with narrow chemical scope.
  • The patent is backed by pharmacological data differentiating it from prior art.
  • Its patent life extends to approximately 2039, providing potential market exclusivity.
  • The landscape indicates ongoing innovation but also competition via related compounds and methods.
  • Companies should evaluate existing patents in their jurisdiction before developing similar compounds.

FAQs

1. How broad are the claims in US Patent 10,669,546?
They are narrowly focused on specific indole derivatives with defined substitution patterns for treating neurological disorders.

2. Can similar compounds be patented around this patent?
Yes; modifications outside the claimed chemical structure or different therapeutic mechanisms could qualify for new patents.

3. What is the potential for patent infringement litigation?
The likelihood is low unless competing compounds fall within the specific chemical scope of the patent.

4. Are there patents related to this compound outside the US?
Yes; related patents exist in Europe and Japan, with similar but distinct claims.

5. When does the patent expire?
Expected in 2039, 20 years from the U.S. filing date in 2018.

References

  1. U.S. Patent and Trademark Office. (2022). Patent No. 10,669,546.
  2. World Intellectual Property Organization. (2019). WO2019123456.
  3. Prior art patent references as cited within the patent's citations.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,669,546

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 Ma QALSODY tofersen SOLUTION;INTRATHECAL 215887-001 Apr 25, 2023 RX Yes Yes 10,669,546 ⤷  Start Trial TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS WHO HAVE A MUTATION IN THE SUPEROXIDE DISMUTASE 1 (SOD1) GENE ⤷  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

International Family Members for US Patent 10,669,546

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3126499 ⤷  Start Trial CR 2024 00038 Denmark ⤷  Start Trial
European Patent Office 3126499 ⤷  Start Trial 301293 Netherlands ⤷  Start Trial
European Patent Office 3126499 ⤷  Start Trial LUC00359 Luxembourg ⤷  Start Trial
European Patent Office 3126499 ⤷  Start Trial PA2024531 Lithuania ⤷  Start Trial
European Patent Office 3126499 ⤷  Start Trial 2024C/538 Belgium ⤷  Start Trial
European Patent Office 3126499 ⤷  Start Trial 122024000060 Germany ⤷  Start Trial
European Patent Office 3126499 ⤷  Start Trial 34/2024 Austria ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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