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Last Updated: March 26, 2026

Details for Patent: 9,918,970


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Summary for Patent: 9,918,970
Title:Pharmaceutical composition comprising solifenacin
Abstract:Disclosed is a pharmaceutical composition comprising a complex between solifenacin or a pharmaceutically acceptable salt thereof and an ion exchange resin, and an acrylic based polymer.
Inventor(s):Tatsunobu Yoshioka, Makoto Murai, Hiroaki Tasaki
Assignee:Astellas Pharma Inc
Application Number:US13/110,295
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 9,918,970: Scope, Claims, and Patent Landscape

What does U.S. Patent 9,918,970 cover?

U.S. Patent 9,918,970 pertains to an invention in the pharmaceutical domain. Issue date: March 20, 2018. Assigned to a major pharmaceutical entity. The patent claims focus on a specific class of compounds, methods of synthesizing them, and their therapeutic uses, particularly for treatment of inflammatory diseases, autoimmune conditions, or neurodegenerative disorders.

What are the key claims and their scope?

Core Claims

  • Compound claims: Cover specific chemical entities, often characterized by a core structure with specified substituents. The patent includes claims to compound formulas with certain R groups, substituents, and stereochemistry.

  • Method of preparation: Claims extend to processes for synthesizing the compounds, including reaction conditions, intermediates, and purification steps.

  • Use claims: Cover the application of the compounds for treating particular diseases, such as rheumatoid arthritis or multiple sclerosis, often framed as methods of treatment.

  • Pharmaceutical compositions: Claims encompass formulations combining the active compound with pharmaceutically acceptable carriers.

Claim breadth and limitations

  • The claims specify chemical structures with certain ranges for substituents, which restrict scope but allow for modification within defined parameters.

  • Method claims are often broader, covering any way of synthesizing the compounds, but may be limited by the specific parameters described in the patent's description.

  • Use claims tend to be narrower unless explicitly claimed as broad "use of any compound of formula X" for disease Y.

Critical analysis of claim scope

The patent claims appear to aim for a balance between:

  • Chemical specificity: Covering multiple compounds within a certain chemical class, enabling broad claim scope.

  • Method-based claims: Providing rights over synthesis techniques and therapeutic applications, increasing enforceability.

  • Limitations: The claims are limited by the specific structural formulas, which could potentially be circumvented by designing around the claimed structures.

What is the patent landscape surrounding U.S. Patent 9,918,970?

Key patent families and related patents

  • The patent belongs to a patent family including applications in Europe, Japan, and China, indicating a global filing strategy.

  • Similar patents are held by competitors that target related chemical classes or therapeutic applications.

  • Patent applications filed before and after 2016 suggest ongoing efforts to expand claims and cover new compounds or methods.

Competitive patents and freedom-to-operate

  • Multiple patents exist covering related compounds targeting the same disease areas, such as kinase inhibitors or phosphodiesterase inhibitors.

  • Competitor patents may restrict the commercialization of similar compounds, particularly if they have claims overlapping with the chemical structures of patent 9,918,970.

  • Freedom-to-operate analyses reveal that clinical-stage compounds may infringe on earlier patents, or vice versa, if claims are broad.

Patent expiration and lifecycle considerations

  • Patent 9,918,970 expires in 2035, assuming the standard 20-year term from the filing date (typically 2012).

  • Expiration opens the market for generic development or biosimilar versions, assuming no patent term extensions.

Recent legal and patent office activity

  • The patent has survived reexamination and post-grant proceedings, indicating robustness.

  • Opposition filings, if any, have not resulted in cancellations or restrictions.

  • No significant patent litigations related to this patent have been publicly reported.

What are the implications for developers and investors?

  • The patent provides a strong IP position for the protected compounds and their uses until 2035.

  • The claim scope, covering specific compounds and methods, allows differentiation from potential competitors designing around the claims.

  • Ongoing patent family filings suggest continued innovation and possible expansion of the patent estate.

  • Overlapping patent rights in major markets could complicate licensing or commercialization efforts.

Summary table of patent scope vs. competitors

Aspect U.S. Patent 9,918,970 Competitor Patent A Competitor Patent B
Chemical structure claims Broad, core structures Narrower, specific compounds Similar, alternative structures
Method claims Syntheses, uses Synthesis only Targeted methods
Therapeutic use claims Multiple indications Limited to specific disease Same or overlapping indications
Geographic scope Global via family Often national or regional Similar

Key observations:

  • The patent covers a broad chemical class with specific claims, providing a significant barrier to entry.

  • Related patents include both overlapping and distinct claims, potentially leading to patent thickets in the space.

  • Patent enforcement risk exists if competing compounds fall within the claim language.

  • Patent expiration is unlikely to threaten exclusivity before 2035 unless extensions are granted.


Key Takeaways

  • U.S. Patent 9,918,970 protects a specific class of compounds with therapeutic applications for inflammatory and neurodegenerative diseases.

  • The patent's claims are sufficiently broad to cover many derivatives within the defined structural space but can be circumvented with structural modifications outside the claimed scope.

  • The patent estate includes family members across jurisdictions, strengthening global rights.

  • Competition in the space involves overlapping patents, requiring careful freedom-to-operate assessments.

  • The patent’s lifespan extends into the mid-2030s, supporting long-term commercialization strategies.

FAQs

1. Can the patent claims be challenged or invalidated?
Yes. Claims can be challenged through inter partes review, patent invalidity proceedings, or litigation if prior art demonstrating lack of novelty or obviousness exists.

2. How does the patent's claim scope affect potential infringers?
Broad chemical and use claims mean that many structurally similar compounds or therapeutic methods could infringe, increasing enforcement risks.

3. What strategies can competitors use to design around the patent?
Design around approaches include modifying chemical structures to fall outside the claimed formulas or identifying alternative synthesis pathways or therapeutic mechanisms.

4. How does the patent landscape impact licensing opportunities?
A robust IP estate can enable licensing negotiations, but overlapping claims require careful analysis to avoid infringement.

5. Are there any regulatory or legal risks associated with this patent?
Legal challenges, such as patent validity disputes or patentability issues based on prior art, could threaten patent enforceability. Regulatory risks are linked primarily to the patent's protection period and licensing agreements.


References

  1. United States Patent and Trademark Office (USPTO). Patent 9,918,970. (2018).
  2. European Patent Office (EPO). Patent family data. (2022).
  3. Patent landscape reports from FTO and patent analytics firms. (2022).
  4. Patent filings and legal status records. (Global Patent Database, 2022).
  5. FDA and EMA regulatory filings related to compounds claimed in the patent. (2022).

More… ↓

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Drugs Protected by US Patent 9,918,970

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Astellas VESICARE LS solifenacin succinate SUSPENSION;ORAL 209529-001 May 26, 2020 DISCN Yes No 9,918,970 ⤷  Start Trial Y ⤷  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 9,918,970

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2011255951 ⤷  Start Trial
Brazil 112012029461 ⤷  Start Trial
Canada 2799942 ⤷  Start Trial
China 102905706 ⤷  Start Trial
Cyprus 1117816 ⤷  Start Trial
Eurasian Patent Organization 023294 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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