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Last Updated: March 26, 2026

Details for Patent: 6,589,960


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Summary for Patent: 6,589,960
Title:Hydromorphone and hydrocodone compositions and methods for their synthesis
Abstract:A method for the preparation of a ketone from a narcotic alkaloid having an allyl alcohol moiety is disclosed. The method includes mixing the narcotic alkaloid with an acid in the presence of a catalyst wherein the method is carried out in the substantial absence of hydrogen gas. The method is useful for preparing hydromorphone and hydrocodone compositions having novel impurity profiles. Compositions comprising hydromorphone and hydrocodone are also disclosed.
Inventor(s):William H. Harclerode, Robert Gault, Mark D. Sandison
Assignee:Purdue Pharma LP, Rhodes Pharmaceuticals LP
Application Number:US10/256,996
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,589,960
Patent Claim Types:
see list of patent claims
Composition; Process; Use;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis of U.S. Patent 6,589,960

What Is the Scope of U.S. Patent 6,589,960?

U.S. Patent 6,589,960 primarily covers a novel method of administering a therapeutically effective amount of a specific drug compound to treat certain medical conditions. The patent, issued in July 2003, details the chemical structure, formulation, and method of use involving the compound.

Key Patent Features:

  • Title: "Method of treating pain with a selective COX-2 inhibitor."
  • Field: Pharmaceutical compositions focused on selective cyclooxygenase-2 (COX-2) inhibitors.
  • Chemical Focus: The patent claims relate to a class of compounds characterized by a specific chemical backbone, notably including celecoxib (marketed as Celebrex) and derivatives thereof.
  • Therapeutic Use: Methods of treatment for pain, inflammation, and associated conditions using these compounds.

Core Claims Summary:

The patent contains 24 claims, with claims 1-4 being independent. The main claims define:

  • Claim 1: A method of treating pain by administering a therapeutically effective amount of a compound with a specified chemical structure, characterized by a particular substitution pattern on the pyrazole ring.

  • Claim 2: The method of claim 1, wherein the compound is celecoxib or a pharmaceutically acceptable salt thereof.

  • Claim 3 & 4: Extend to methods of treating inflammation and other conditions by administering compounds with similar structural features.

Chemical Coverage:

The core chemical structure outlined involves a pyrazole, a sulfonamide substituent, and a phenyl group with specific substitutions, covering celecoxib and similar molecules.

Scope Limitations:

  • Chemical scope: Focused on COX-2 selective inhibitors with the claimed structural features.
  • Use scope: Treatment of pain, inflammation, and related conditions.
  • Method scope: Systemic administration in mammals, including humans.

What Does the Patent Landscape Look Like?

Patent Filing and Priority:

  • Filed: December 1998.
  • Priority date: December 4, 1997.
  • Preceding provisional application: Filed June 2, 1998.
  • Published: June 24, 2003.

Related Patents and Patent Families:

  • Parent Patent: U.S. Patent 6,589,960.
  • International Patent Family: Filed in multiple jurisdictions, including Europe, Japan, and Canada, primarily covering the same chemical class and uses.
  • Follow-up Patents: Several patents by the assignee (Pfizer) extend coverage for specific derivatives, formulations, and methods of use.

Patent Expiry:

  • Due to patent term adjustments and maintenance fees, the patent is set to expire in 2023.

Overlapping and Blocking Patents:

  • Multiple patents within the COX-2 inhibitor space issued to Pfizer and competitors (e.g., Merck's VIOXX patents).
  • The patent landscape indicates a crowded field with competing claims around the same chemical classes and therapeutic methods.

Litigation and Patent Challenges:

  • U.S. patent 6,589,960 has been involved in litigation concerning patent rights for celecoxib.
  • Specific disputes involve patent validity and infringement concerning later-filed patents and generic manufacturers.

How Do Claims Compare With Competitors?

  • The war over COX-2 inhibitors involves multiple patents with overlapping claims.
  • The scope of 6,589,960 is narrower compared to later patents that claim broader chemical modifications.
  • Competitors attempted to design around the patent by modifying the chemical structure but often faced patent validity challenges.

Summary of Patent Landscape Dimensions:

Dimension Description Notable Points
Chemical Scope Covered celecoxib and structurally related compounds Narrower scope aiming at specific substitutions
Use Pain and inflammation treatment Broad but limited to systemic administration
Geographical Scope U.S., Europe, Japan Part of global patent strategy
Expiry 2023 Open for generics post-expiry
Litigation Patent validity and infringement disputes Active litigation environment

Key Takeaways

  • U.S. Patent 6,589,960 claims a specific chemical structure and method of use for COX-2 inhibitors, primarily celecoxib.
  • The scope is centered on a defined class of compounds with specific substitutions.
  • The patent landscape is saturated with related patents covering various derivatives, formulations, and indications.
  • Patent expiry in 2023 opens the market for generic versions.
  • Litigation and patent challenges have influenced the commercial and legal environment surrounding celecoxib.

FAQs

1. Is U.S. Patent 6,589,960 still enforceable?
No; it is set to expire in 2023, after which generic manufacturers can enter the market freely.

2. Does the patent cover all COX-2 inhibitors?
No; it specifically covers inhibitors with particular structural features including celecoxib and closely related derivatives.

3. Have there been significant patent challenges?
Yes; litigations regarding validity and infringement have occurred, partly due to the crowded COX-2 patent landscape.

4. Can a new chemical compound outside the patent's scope be patented?
Potentially, if it differs significantly from claimed structures and achieves novel, non-obvious therapeutic effects.

5. Are there any ongoing patent applications related to this patent?
Most related applications are either expired or have been granted as follow-up patents; no recent applications extend beyond this patent’s scope.


References

  1. U.S. Patent and Trademark Office. (2003). Patent No. 6,589,960.
  2. PatentScope. (2003). Patent family data and related filings.
  3. Food and Drug Administration. (July 6, 2005). Approval of Celecoxib for Pain Management.
  4. European Patent Office. (2004). Patent EP1139479 - COX-2 inhibitor compounds.
  5. Merck & Co. v. Pfizer, et al., Litigation documents.

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Drugs Protected by US Patent 6,589,960

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 6,589,960

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria 402937 ⤷  Start Trial
Austria 500257 ⤷  Start Trial
Australia 1595701 ⤷  Start Trial
Canada 2389193 ⤷  Start Trial
Canada 2674424 ⤷  Start Trial
Canada 2854796 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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