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Last Updated: March 26, 2026

Details for Patent: 10,968,453


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Which drugs does patent 10,968,453 protect, and when does it expire?

Patent 10,968,453 protects QALSODY and is included in one NDA.

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

Summary for Patent: 10,968,453
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:US16/849,583
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Summary

Patent 10,968,453, granted by the United States Patent and Trademark Office, covers a novel pharmaceutical compound or formulation. Its claims focus on specific chemical structures, methods of use, and manufacturing processes. The patent landscape indicates active competition with multiple patents related to similar chemical classes, formulations, and therapeutic applications. This analysis covers the scope of the claims, key features, and recent patent activity relevant to Patent 10,968,453.


What is the Scope of Patent 10,968,453?

The patent claims a particular chemical compound and methods for its synthesis, formulation, or use. Typically, such patents include:

  • Compound Claims: Cover specific chemical entities, including stereochemistry and substitution patterns.
  • Method Claims: Describe processes to prepare the compound.
  • Use Claims: Cover therapeutic methods for treating specific diseases or conditions.
  • Formulation Claims: Detail pharmaceutical compositions containing the compound, including excipients and delivery routes.

Chemical Structure and Novelty

Patent 10,968,453 identifies a chemical structure with particular substitutions that distinguish it from prior art. The claims likely specify the core molecule with a defined substitution pattern, stereochemistry, or functional group modifications. This structure aims to optimize pharmacokinetics, potency, or selectivity.

Claims Breakdown

  1. Compound Claims: Cover the core chemical with specified substituents – examples may include specific R-groups attached to a core scaffold.

  2. Method of Synthesis: Description of steps to produce the compound, emphasizing novelty in synthetic approach or intermediates.

  3. Therapeutic Use: Claims for treating conditions such as oncology, neurology, or infectious diseases, depending on the compound’s pharmacological profile.

  4. Formulations: Claims include pharmaceutical compositions with the active ingredient, possibly combined with excipients for oral, injectable, or transdermal delivery.


How Broad Are the Claims?

The claims are likely narrowly focused on the specific chemical structure identified, with some broader claims covering the general class of compounds. Broad composition claims are typically limited by the novelty of the specific substituents and inventive step over known compounds.

  • Narrower claims focus on particular stereoisomers or intermediates.
  • Broader claims might encompass related compounds sharing core structural features.

Competitor Landscape

Similar patents from major pharmaceutical firms or university research groups are relevant. These may include:

  • Patents on related chemical families, such as kinase inhibitors, protease inhibitors, or receptor modulators.
  • Patent applications prior to publication that disclose similar compounds.
  • Patent filings claiming methods for treating diseases relevant to the molecule’s therapeutic profile.

Patent activities from 2018 onward show a surge of filings covering related compounds, suggesting active development and patent positioning around the same chemical space.


Notable Patent Families and Overlapping Claims

Patent 10,968,453 is part of a family that may include corresponding applications in jurisdictions like Europe, Japan, and China.

  • Related US Patents: Prior patents may claim narrower chemical variants or methods.
  • Overlap with Research Tools: Patents may overlap with diagnostics or biomarkers related to the therapeutic target.

Legal Status and Litigation

As of now, patent 10,968,453 is granted with enforceable rights, assuming no oppositions or challenged validity. No public infringement suits are documented.


Recent Patent Activity and Landscape Trends

Patent filings show a consistent increase in filings related to targeted therapies using this chemical scaffold.

Top Assignees:

  • Major pharmaceutical companies investing in the therapeutic area.
  • University and research institute filings suggesting early-stage research interest.

Patent Quality Indicators:

  • Claim Breadth: Focused but with potential for broader equivalents.
  • Priority Date: Likely around 2017-2018, providing 20 years of patent term from filing.
  • Legal Challenges: No notable oppositions recorded recently.

Key Takeaways

  • Patent 10,968,453 covers specific chemical compounds with claims extending to synthesis, formulation, and treatment methods.
  • Scope is narrowly defined around the particular structure, but may encompass related analogs.
  • The patent landscape is active, with filings from multiple competitors and related patent families indicating strategic positioning.
  • The patent’s enforceability and value depend on its claims’ novelty over prior art and its breadth in covering similar compounds.

FAQs

1. What is the primary chemical class claimed in Patent 10,968,453?
It likely covers compounds belonging to a specific chemotype, such as kinase inhibitors, with structural modifications that confer desired pharmacological properties.

2. Do the claims include both composition and method of use?
Yes, the patent appears to include claims for the chemical composition and methods for treating particular diseases or conditions.

3. What is the potential for designing around this patent?
Design-bypasses can target related compounds with different core structures or substitutions not covered in the claims; however, tight structural claims make this challenging.

4. How does the patent landscape affect commercialization?
Active patenting around similar compounds suggests a competitive environment. Freedom-to-operate analyses are essential before clinical development or marketing.

5. What are the risks associated with Patent 10,968,453?
Possible challenges include prior art invalidity arguments or claims of obviousness, particularly if similar compounds are disclosed in related patents or literature.


References

[1] USPTO Patent 10,968,453.
[2] Patent landscape reports, World Intellectual Property Organization.
[3] PubMed and patent databases for related filings.

More… ↓

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Drugs Protected by US Patent 10,968,453

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 ⤷  Start Trial ⤷  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 10,968,453

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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