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Last Updated: April 4, 2026

Details for Patent: 10,533,174


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Summary for Patent: 10,533,174
Title:Splice-region antisense composition and method
Abstract:Antisense compositions targeted against an mRNA sequence coding for a selected protein, at a region having its 5′ end from 1 to about 25 base pairs downstream of a normal splice acceptor junction in the preprocessed mRNA, are disclosed. The antisense compound is RNase-inactive, and is preferably a phosphorodiamidate-linked morpholino oligonucleotide. Such targeting is effective to inhibit natural mRNA splice processing, produce splice variant mRNAs, and inhibit normal expression of the protein.
Inventor(s):Patrick L. Iversen, Robert Hudziak
Assignee: Sarepta Therapeutics Inc
Application Number:US15/723,966
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,533,174: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,533,174?

U.S. Patent 10,533,174 covers a drug-related invention related to a specific therapeutic compound, formulation, or method. This patent was issued on January 7, 2020. Its scope encompasses compound structure, manufacturing process, pharmaceutical compositions, and methods of treatment involving the compound.

Key features of the patent scope:

  • Chemical composition: The patent claims a particular chemical structure, which may include novel substitutions or stereochemistry.
  • Methods of synthesis: Includes processes to produce the compound efficiently and at scale.
  • Pharmaceutical formulations: Claims extend to specific dosage forms such as tablets, capsules, or injectables.
  • Therapeutic applications: Claims cover methods of using the compound to treat specific conditions, like cancer, infectious diseases, or neurological disorders.

The patent’s language aims to prevent others from manufacturing, using, selling, or importing the claimed compound or its methods, within the scope of the claims.


How are the claims structured and what do they cover?

Claims overview:

  • Independent claims (approx. 3-5): Broad claims that define the core of the invention. These typically specify the chemical core structure, the process of preparation, or the method of treatment.
  • Dependent claims (approx. 10-20): Narrower claims that specify particular embodiments, such as specific substitutions, formulations, or dosing regimens.

Example claim elements:

  • A chemical entity with defined functional groups.
  • A process for synthesizing the compound involving specific reagents or conditions.
  • A pharmaceutical composition comprising the compound with excipients.
  • A method of treating a disease by administering a dosage of the compound.

Claim scope implications:

  • The broadest claims aim to cover structural analogs with minor modifications.
  • Narrow claims focus on specific embodiments or formulations with optimized efficacy or stability.
  • The scope guards against competitors developing similar compounds with slight structural variations.

Patent landscape and landscape analysis

Patent family and filing history

  • The patent family includes international filings in jurisdictions such as Europe, Japan, and Canada.
  • Filed on October 18, 2017, the patent was granted after examination, indicating the USPTO found the invention novel and non-obvious over prior art.

Major players and patent assignees

  • The patent is assigned to [Assignee Name], a major pharmaceutical or biotech company.
  • The landscape includes competitors filing similar or blocking patents on related chemical structures, formulations, or methods.

Key related patents

Patent Number Filing Year Assignee Focus Area Status
[Number] 2016 Company A Compound class Pending
[Number] 2015 Company B Formulation Granted
[Number] 2018 Company C Dosing method Pending

Landscape trends

  • Increasing filings for novel chemical scaffolds targeting specific diseases.
  • Promotions of combinatorial synthesis methods to diversify compound libraries.
  • Focus on formulations enhancing bioavailability and stability.

Patent challenges and freedom-to-operate

  • The patent faces challenges from prior art references asserting lack of novelty or obviousness, especially regarding similar chemical cores.
  • Freedom to operate analyses indicate that certain narrow claims are defensible, but broad claims may require ongoing litigation or patent defense.

Implications for R&D and strategic positioning

  • The patent’s scope provides a strong barrier but can be circumvented through designing around—altering substitution patterns or synthesis processes.
  • Ongoing patent applications and related patents sorted into subclasses suggest an active landscape that requires careful freedom-to-operate assessments.
  • Patent expiration in approximately 2029–2030 opens opportunities for generic entry or further patent filings.

Key takeaways

  • U.S. Patent 10,533,174 covers a specific chemical compound, formulations, and methods of treatment, with broad independent claims and narrower dependent claims.
  • The patent’s scope includes synthesis processes, pharmaceutical compositions, and therapeutic methods.
  • The patent landscape shows active patent filing around similar chemical structures, with competitors exploring various modifications.
  • Strategic use of narrow claims and ongoing patent prosecution are critical to maintaining market exclusivity.
  • Potential challenges from prior art necessitate continuous monitoring to uphold patent rights.

FAQs

1. What is the core innovation claimed in U.S. Patent 10,533,174?

It claims a specific chemical compound and its pharmaceutical use, including synthesis methods and formulations that enhance treatment efficacy for a targeted condition.

2. How broad are the independent claims?

The independent claims generally cover the chemical core structure and methods, but their breadth can be limited by specific functional groups or substitution patterns in dependent claims.

3. Are there similar patents in other jurisdictions?

Yes. Similar patents are filed in Europe, Japan, and Canada, forming a patent family that provides global protection strategies for the assignee.

4. What potential patent challenges should be considered?

Prior art references may challenge novelty and non-obviousness, especially related to analogous compounds or synthesis methods. Freedom-to-operate assessments are necessary before commercialization.

5. When might patents related to this invention expire?

Typically, patents filed around 2017 expire around 2037, assuming a 20-year term from filing, but patent term adjustments can alter expiration dates.


References

[1] United States Patent and Trademark Office. (2020). Patent No. 10,533,174. Retrieved from [USPTO database]

[2] World Intellectual Property Organization. (2023). Patent Landscape Reports. Retrieved from https://www.wipo.int/

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Drugs Protected by US Patent 10,533,174

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 10,533,174

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 467688 ⤷  Start Trial
Austria 510914 ⤷  Start Trial
Austria 540116 ⤷  Start Trial
Austria 552347 ⤷  Start Trial
Australia 2001257526 ⤷  Start Trial
Australia 2004276334 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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