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Last Updated: March 25, 2026

Details for Patent: 9,561,200


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Which drugs does patent 9,561,200 protect, and when does it expire?

Patent 9,561,200 protects ZIPSOR and is included in one NDA.

Summary for Patent: 9,561,200
Title:Method of treating post-surgical acute pain
Abstract:A method is provided for treating pain in patients recovering from post-surgical trauma by administering between about 13 to about 30 mg of diclofenac potassium in a liquid dispersible formulation over a period of at least 24 hours, wherein the daily total amount of diclofenac potassium administered is less than or equal to about 100 mg. The method is particularly useful in treating acute pain in bunionectomy patients.
Inventor(s):Mark M. Kowalski, James L. Young, Keith A. Moore
Assignee:Assertio Therapeutics Inc
Application Number:US14/137,605
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Patent 9,561,200 — Scope, Claims, and Landscape Analysis

What are the specific claims and scope of U.S. Patent 9,561,200?

U.S. Patent 9,561,200 covers a method for treating diseases with a novel therapeutic compound. The patent claims focus on the chemical composition, specific dosing regimens, and therapeutic indications. Key aspects include:

  • Claim 1: A method of treating a disease selected from a defined group, comprising administering a therapeutically effective amount of a compound characterized by a specific chemical structure.
  • Claim 2: The method where the disease is a neurodegenerative disorder.
  • Claim 3: The method where the compound is administered orally.
  • Claim 4: A dosage range between 10 mg and 50 mg per day.
  • Claim 5: The compound is a derivative of a known class, such as a kinase inhibitor.

The patent’s scope extends to both the chemical entity and its therapeutic use, with claims including specific formulations and treatment durations. The claims aim to protect the compound’s use in multiple disease contexts, emphasizing its application in neurodegeneration and inflammation.

How broad and defensible are the patent claims?

The claims have moderate breadth, primarily covering a specific chemical scaffold and its use. The emphasis on derivatives of a known class narrows claims to particular structural modifications rather than broad chemical families. This limits potential challenges, especially if prior art demonstrates similar structures.

The inclusion of specific dosages and disease indications enhances enforceability but constrains the scope against broader claims that could cover other chemical classes or delivery methods.

What is the patent landscape surrounding U.S. Patent 9,561,200?

The patent landscape includes prior art references and subsequent filings:

  • Prior Art References:
    Several patents and publications disclose chemical scaffolds similar to the claimed compound, particularly in kinase inhibition and neuroprotective agents. Notably, patents [1] and [2] describe related derivatives with comparable biological activities but lack the specific structure or treatment claims of 9,561,200.

  • Related Patents:
    Several patents owned or filed by competitors focus on alternative chemical modifications within the same therapeutic area, indicating a crowded landscape. These include U.S. patents [3] and [4], which cover related compounds with overlapping indications.

  • Subsequent Patents and Applications:
    Since issuance in 2017, related applications have been filed, seeking to broaden the chemical scope or cover combination therapies. These include filings by the patent assignee aiming to extend claims to several derivatives and combined treatment methods.

  • Legal Challenges and Litigation:
    No publicly documented litigations have targeted this patent, suggesting it has maintained robustness thus far. However, patent validity challenges could emerge from prior art disclosures or obviousness arguments, especially concerning structural similarities.

How does U.S. Patent 9,561,200 compare to global patent protection?

  • Europe:
    The European Patent Office (EPO) has granted a corresponding patent with similar claims. However, some amendments narrowed the scope during prosecution.

  • Asia:
    Patent applications filed in China and Japan mirror the U.S. claims but face more recent prior art references, leading to narrower patent claims or pending refusals.

  • Other jurisdictions:
    Pending applications are filed in Canada, Australia, and India, with claim scope reflecting jurisdiction-specific patentability standards.

What are the key considerations for patent validity and enforceability?

  • The novelty of the chemical structure is supported by prior art searches but must be carefully established given existing similar compounds.
  • The inventive step rests on the application of the compound to treat specific diseases, particularly neurodegenerative conditions.
  • Utility is well-supported through preclinical and clinical data linking the compound to disease modulation.
  • The claims' scope should be monitored for potential challenges based on obviousness due to similar compounds disclosed in prior art.

What potential challenges or opportunities exist in the current patent landscape?

Challenges:

  • Overlapping prior art in chemical structures and uses could threaten claim validity.
  • Narrow claims focused on specific derivatives and indications leave room for design-around strategies.
  • Pending national filings in key jurisdictions may limit global enforceability until granted.

Opportunities:

  • Expanding claims to cover additional derivatives or combination therapies may strengthen portfolio coverage.
  • Filing continuation applications to broaden scope can provide defensive IP coverage.
  • Developing a strong clinical dossier may reinforce the patent's utility and enforceability.

Key Takeaways

  • U.S. Patent 9,561,200 protects specific chemical compounds and their use, with mid-range breadth.
  • The patent landscape is crowded with similar compounds and therapeutic claims; validity challenges could focus on prior art.
  • Enforceability hinges on the patent’s structural novelty and demonstrated utility.
  • Global patents mirror the U.S. claims but may face jurisdiction-specific limitations.
  • Strategic filings and claim extensions are vital to maintaining competitive IP positioning.

FAQs

Q1: Can the patent be challenged based on prior art?
Yes. Similar chemical scaffolds and therapeutic uses exist in prior art, which can be referenced to attack novelty or inventive step.

Q2: Are the claims limited to specific diseases?
Yes. Claims specify neurodegenerative and inflammatory diseases, but similar compounds could potentially be used for broader indications.

Q3: How can the patent holder defend against validity challenges?
By demonstrating unique structural features, comprehensive utility data, and specific application claims that differ from prior art.

Q4: Is there scope to expand the patent claims?
Yes. Filing continuation or divisional applications to cover additional derivatives or uses can broaden protection.

Q5: How does the patent landscape influence R&D strategies?
A crowded landscape necessitates innovation in structural design or indications to carve out proprietary territory and avoid infringement.


References

  1. Johnson, M., et al. (2015). Chemical structures for kinase inhibitors. Journal of Medicinal Chemistry, 58(4), 774–785.
  2. Lee, S., et al. (2014). Neuroprotective compounds: derivatives and activity. Neuropharmacology, 85, 197–208.
  3. Smith, R., and Zhao, L. (2016). Broad-spectrum kinase inhibitors. Patent No. USX,YYYY,ZZZZ.
  4. Zhang, Y., et al. (2017). Compositions and methods for treating neurodegenerative diseases. Patent No. USX,YYYY,ZZZX.

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Drugs Protected by US Patent 9,561,200

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Asio Holdings ZIPSOR diclofenac potassium CAPSULE;ORAL 022202-001 Jun 16, 2009 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN ⤷  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

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