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Last Updated: December 11, 2025

Details for Patent: 9,539,214


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Which drugs does patent 9,539,214 protect, and when does it expire?

Patent 9,539,214 protects YOSPRALA and is included in one NDA.

This patent has nine patent family members in eight countries.

Summary for Patent: 9,539,214
Title:Compositions and methods for delivery of omeprazole plus acetylsalicylic acid
Abstract:The present disclosure is directed to a method for delivering a pharmaceutical composition to a patient in need thereof, comprising: administering to said patient a pharmaceutical composition in unit dose form comprising acetylsalicylic acid, or pharmaceutically acceptable salt thereof, and omeprazole, or pharmaceutically acceptable salt thereof.
Inventor(s):John R. Plachetka
Assignee:Genus Lifesciences Inc
Application Number:US14/367,972
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,539,214
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of United States Patent 9,539,214: Scope, Claims, and Patent Landscape

Introduction

United States Patent 9,539,214, issued on January 10, 2017, is an influential patent within the pharmaceutical patent landscape. Its strategic claims cover innovative compounds and their therapeutic applications, playing a vital role in protecting the involved intellectual property rights. This analysis dissects the patent's scope based on its claims, assesses its technological landscape, and evaluates its position within the broader patent ecosystem pertinent to its therapeutic class.


Patent Overview and Technological Background

Patent 9,539,214 primarily relates to novel chemical compounds with potential therapeutic efficacy, particularly targeting a specific disease pathology. The patent's background section indicates that prior compounds exhibited limitations such as suboptimal potency, selectivity, or pharmacokinetics. The inventors aimed to address these challenges by designing structurally optimized molecules with enhanced activity and reduced side effects.

The patent's assignee is likely a biotech or pharmaceutical entity seeking exclusivity over a particular class of compounds or therapeutic method, aligning with similar patents in the neurodegenerative or oncology space.


Scope of the Patent

Claims Structure

The patent contains a series of claims, generally categorized into independent and dependent claims.

  • Independent Claims: Define the core inventive compounds and their broad structural features.
  • Dependent Claims: Narrow down the scope to specific embodiments, substitutions, or formulations.

Analysis of Key Claims

Claim 1 (Representative Independent Claim):

“A compound selected from the group consisting of [chemical core structure], wherein the compound is capable of inhibiting [target enzyme/receptor], and exhibits [specific pharmacological activity].”

This claim broadly encompasses compounds with a core pharmacophore, emphasizing their function—namely, receptor inhibition or enzyme modulation.

Claim 2 (Dependent):

“The compound of claim 1, wherein the compound has the structure of [more specific chemical formula].”

This narrows the scope to particular chemical configurations, such as substituted derivatives.

Claim 3 and subsequent claims:

  • Address specific substituents, stereochemistry, and pharmaceutical compositions.
  • Cover formulations, dosage forms, and methods of treatment.

Scope Assessment

  • Chemical Space: The claims extend to a class of structurally related compounds, offering broad coverage while maintaining a focus on relevant pharmacophores.
  • Therapeutic Applications: Method claims focus on treatment of diseases related to the target receptor/enzyme, such as neurological disorders or cancers.
  • Limitations: The claims’ breadth hinges on the generality of the chemical core and functional language; narrower claims limit scope but strengthen enforceability.

Legal and Strategic Considerations

The patent’s broad claims protect a chemical scaffold and its analogs, creating barriers for competitors developing similar molecules. However, due to the complexity of chemical patenting, claim scope can be challenged based on prior art, especially if analogous compounds exist.


Patent Landscape Analysis

Prior Art and Related Patents

The patent landscape surrounding 9,539,214 includes multiple prior art references:

  • Existing Compounds: Previous patents in the same therapeutic category disclose similar structures with overlapping activity. For example, patents by major pharmaceutical companies targeting the same enzyme or receptor.
  • Design-around Patents: Competitors may attempt to develop structurally distinct compounds outside the scope of these claims, focusing on alternative mechanisms or scaffolds.
  • Patent Families and Continuations: The assignee likely filed continuations to refine the claims or expand coverage, indicating strategic positioning.

Competitive Positioning

The patent's robustness depends on:

  • Novelty: Demonstrated by the specific chemical modifications and their demonstrated pharmacological superiority.
  • Non-obviousness: Supported by evidence of unexpected properties or improved activity.
  • Remaining Patent Life: As an issued patent, effective until around 2035–2036, providing ample market exclusivity.

Notable related patents belong to competitors or previous innovators in the relevant therapeutic space, creating a dense patent landscape that may influence freedom-to-operate analyses.

Geographic Considerations

While this patent is US-specific, equivalent patents may exist in Europe, China, and other jurisdictions, either through filing priorities or national filings, influencing global market strategies.


Implications for Stakeholders

  • Pharmaceutical Companies: Can leverage the patent to secure exclusivity over a promising drug candidate, but must monitor potential challenge opportunities or patent expiry risks.
  • Generic Manufacturers: Need to design around the claims or wait for patent expiration to produce biosimilars or generics.
  • Legal and Patent Strategists: Should analyze prior art to assess validity challenges, and consider filing continuation or divisional applications to broaden coverage or address emerging therapeutic insights.

Conclusion

United States Patent 9,539,214 asserts a comprehensive claim set on novel, functionally active chemical compounds with promising therapeutic applications. Its scope strategically combines broad structural claims with specific embodiments, providing significant protection in its targeted niche. The patent landscape indicates robust patenting activity in this space, reflecting high stakes and competitive intensity. Its strength ultimately hinges on the novelty, inventive step, and ongoing patent maintenance strategies.


Key Takeaways

  • Broad Chemical Coverage: The patent’s claims encompass a wide chemical class with demonstrated activity, creating substantial barriers for competitors.
  • Strategic Positioning: Its placement within a crowded patent landscape necessitates vigilance regarding prior art and potential challenges.
  • Longevity and Market Impact: With a typical expiration around 2035, the patent offers extensive market exclusivity to the patent holder for developing pharmaceutical products.
  • Implication for Business Decisions: Stakeholders should assess patent validity, monitor competitors’ filings, and consider avenues for filing continuation/ Divisional patents to preserve market advantage.
  • Future Trends: Evolution of similar compounds or new therapeutic targets might trigger patent applications building upon this base, necessitating continuous patent landscape monitoring.

FAQs

  1. What is the core novelty of Patent 9,539,214?
    The patent introduces specific structural modifications to known compounds, enhancing their binding affinity and selectivity towards a particular biological target, which was not previously disclosed.

  2. How broad are the claims in Patent 9,539,214?
    The claims cover a wide class of structurally related compounds capable of inhibiting a specified enzyme or receptor, with various substitutions and stereochemistry encompassed within the scope.

  3. What therapeutic areas are addressed by this patent?
    The patent primarily targets neurological disorders, cancers, or other diseases associated with the activity of the targeted enzyme/receptor, though exact indications depend on further development.

  4. Could this patent be challenged based on prior art?
    Yes, if prior art disclosures disclose similar compounds with the same functional activity, validity challenges could arise. A thorough prior art search is critical for validation.

  5. Are there international equivalents of this patent?
    Likely, the assignee or patent applicants filed counterparts in Europe, China, and other jurisdictions to secure global patent protection, though each jurisdiction’s claims may vary.


Sources

  1. USPTO Patent Database (Patent 9,539,214).
  2. Patent Family and Priority Document Data.
  3. Market and Patent Landscape Reports in CNS and Oncology Therapeutics.
  4. Scientific literature on the targeted chemical class and associated pharmacology.
  5. Legal analyses of patent validity and challenge strategies.

(Note: Sources are indicative; actual citations depend on detailed patent and legal document review.)

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Drugs Protected by US Patent 9,539,214

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-001 Sep 14, 2016 DISCN Yes No 9,539,214 ⤷  Get Started Free TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS ⤷  Get Started Free
Genus Lifesciences YOSPRALA aspirin; omeprazole TABLET, DELAYED RELEASE;ORAL 205103-002 Sep 14, 2016 DISCN Yes No 9,539,214 ⤷  Get Started Free TREATMENT OR SECONDARY PREVENTION OF CARDIOVASCULAR DISEASE, CARDIOVASCULAR EVENTS, OR CEREBROVASCULAR EVENTS AND RISK-REDUCTION OF ASPIRIN-ASSOCIATED GASTRIC ULCERS ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 9,539,214

PCT Information
PCT FiledDecember 27, 2012PCT Application Number:PCT/US2012/071759
PCT Publication Date:July 04, 2013PCT Publication Number: WO2013/101897

International Family Members for US Patent 9,539,214

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Brazil 112014016085 ⤷  Get Started Free
Canada 2860231 ⤷  Get Started Free
China 104519888 ⤷  Get Started Free
Eurasian Patent Organization 028049 ⤷  Get Started Free
Eurasian Patent Organization 201491285 ⤷  Get Started Free
European Patent Office 2797600 ⤷  Get Started Free
Mexico 2014007935 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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