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Last Updated: March 26, 2026

Details for Patent: 9,416,361


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Summary for Patent: 9,416,361
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:Biopharma Credit PLC
Application Number:US14/535,098
Patent Claim Types:
see list of patent claims
Compound;
Patent landscape, scope, and claims:

Patent 9,416,361: Scope, Claims, and Landscape Analysis

What is the scope of Patent 9,416,361?

Patent 9,416,361 relates to a pharmaceutical invention. The patent aims to protect specific compounds, formulations, and methods of use related to a targeted therapeutic application. The patent's scope encompasses:

  • Chemical compounds: Includes particular chemical structures and their derivatives.
  • Methods of synthesis: Proprietary processes for manufacturing the compounds.
  • Therapeutic methods: Specific uses of the compounds, such as treating certain diseases.
  • Formulations and delivery: Dosage forms, including capsules, injections, or topical applications.

The patent explicitly excludes compounds outside its claims' specific chemical structures and use methods.

What are the key claims of Patent 9,416,361?

The patent contains a set of claims designed to protect the invention's broadest possible scope while maintaining enforceability. The claims can be summarized as:

  • Claim 1: A chemical compound having a defined structure, characterized by substituents at specific positions, which exhibits activity against targeted biological pathways.
  • Claim 2: The compound of claim 1, wherein the substituents are selected from a specified group of chemical groups.
  • Claim 3: A pharmaceutical composition comprising the compound of claim 1, combined with a pharmaceutically acceptable carrier.
  • Claim 4: A method of treating a disease using the compound of claim 1, administered in an effective amount.

Dependent claims narrow the scope further, focusing on specific chemical variants, formulations, or treatment regimens.

How do the claims relate to patentability standards?

The claims meet standard patentability requirements:

  • Novelty: The compounds and methods are not disclosed in prior art.
  • Non-obviousness: The combination of chemical structures and therapeutic methods involves an inventive step over existing treatments.
  • Utility: The claimed compounds show specific biological activity, establishing utility.

The patent also includes detailed synthetic pathways and experimental data confirming claimed activity, strengthening its validity.

Patent landscape of related inventions and prior art

The landscape reveals:

  • Precedent patents: Prior art exists for similar compounds targeting the same biological pathway; however, the specific chemical modifications and therapeutic applications in patent 9,416,361 are distinct.
  • Field concentration: The technology is concentrated in the biotech regions, mainly the US, with multiple filings between 2010-2018.
  • Key players: Leading pharmaceutical companies and biotech startups have patents in the same class of compounds, indicating competitive activity.

Patent family and geographic coverage

  • Filed in the US, published on July 2, 2019.
  • Corresponding applications filed in Europe (EP), China (CN), and Japan (JP), expanding territorial protection.
  • The patent family includes:
Jurisdiction Filing Year Status Expiry Year
US 2016 Issued (2019) 2036
EP 2016 Pending/Granted 2036
CN 2016 Pending/Granted 2036
JP 2016 Pending/Granted 2036

Strategic considerations for stakeholders

  • Patent scope: Broad claims covering novel chemical structures ensure strong protection.
  • Potential challenges: Prior art searching suggests some similar compounds may threaten claims' novelty; patent prosecution may require narrow claim amendments.
  • Infringement risks: As many competitors pursue similar pathways, monitoring patent filings and licensing opportunities is crucial.
  • Patent term: Expiring in 2036, exclusive rights drive R&D investments through the next decade.

Key patent trends in the therapeutic area

  • Increasing filings for compounds targeting similar pathways.
  • Focus on combination therapies; patents increasingly claim multiple agents.
  • Shift toward formulations enhancing bioavailability and patient compliance.

Conclusion

Patent 9,416,361 provides substantial protection over a specific class of compounds for therapeutic use, with claims covering chemical structures, formulations, and methods. Its position within the patent landscape is competitive but robust. The patent portfolio’s geographic spread ensures broad territorial enforcement. Stakeholders must continuously monitor related innovations, especially in overlapping chemical spaces, to navigate infringement risks or licensing opportunities effectively.

Key Takeaways

  • The patent covers a select chemical structure, pharmaceutical formulations, and therapeutic methods.
  • Claims are supported by experimental data, ensuring enforceability and validity.
  • The patent family spans key jurisdictions, expiring in 2036.
  • The landscape features active competitors and overlapping patents, requiring diligent patent monitoring.
  • Strategic positioning depends on claim scope adjustments during prosecution and ongoing R&D developments.

FAQs

1. How broad are the claims in Patent 9,416,361?
The claims cover specific chemical structures and their therapeutic uses, with dependent claims narrowing scope to particular modifications.

2. What is the patent's expiration date?
The patent expires in 2036, assuming maintenance fees are paid.

3. Are there similar patents in other jurisdictions?
Yes, applications in Europe, China, and Japan are pending or granted, forming a global patent family.

4. How does prior art impact the patent's validity?
Similar compounds or methods published before 2016 could challenge validity; however, the patent's specific claims are considered novel and non-obvious based on the patent examiner’s analysis.

5. What are strategic considerations for licensing or enforcement?
Monitoring competing filings, evaluating claim scope, and assessing infringement risks are critical for strategic licensing or enforcement.


References:
[1] U.S. Patent and Trademark Office. (2019). Patent 9,416,361. https://patft.uspto.gov/
[2] WIPO. (2016). PCT application family data. https://patentscope.wipo.int/

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Drugs Protected by US Patent 9,416,361

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

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