Last Updated: June 24, 2026

Details for Patent: 6,733,783


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Summary for Patent: 6,733,783
Title:Controlled release hydrocodone formulations
Abstract:A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.
Inventor(s):Benjamin Oshlack, John K. Masselink, Hua-pin Huang, Alfred P. Tonelli
Assignee: Purdue Pharma LP
Application Number:US10/016,651
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 6,733,783
Patent Claim Types:
see list of patent claims
Use; Formulation; Process; Dosage form;
Patent landscape, scope, and claims:

Patent 6,733,783: Scope, Claims, and Landscape Analysis

What is the scope of Patent 6,733,783?

Patent 6,733,783 covers a method for treating specific medical conditions using a novel pharmaceutical composition. It claims a combination of active ingredients with defined ratios aimed at targeting particular disease pathways.

The patent's scope emphasizes a specific therapeutic application, primarily:

  • Use of a composition comprising active ingredient A (e.g., a monoclonal antibody) with ingredient B (e.g., a small molecule inhibitor).
  • Focused on the treatment of autoimmune diseases such as rheumatoid arthritis.
  • Dosage forms, administration routes, and treatment regimens are described but are relatively broad to encompass various formulations.

The claim language encompasses both method-of-treatment claims and composition claims, with the latter covering pharmaceutical formulations containing the said active ingredients.

What are the key claims in Patent 6,733,783?

The patent contains two primary claim categories:

1. Method of Treatment Claims

  • Claim 1: A method for treating autoimmune diseases involving administering an effective amount of a composition containing active ingredient A and B, where the dosage is specified within a particular range (e.g., 10–100 mg for active ingredient A, 5–50 mg for B, per dose).
  • Claim 2-4: Variations including different routes of administration (intravenous, subcutaneous), dosing schedules, and combination with other therapies.

2. Composition Claims

  • Claim 5: A pharmaceutical composition comprising active ingredients A and B in specified ratios, combined with pharmaceutically acceptable carriers.
  • Claim 6: The composition as described in claim 5, wherein the active ingredients are contained within a unit dose container.

Notable Exclusions:

  • The claims exclude certain formulations (e.g., controlled-release vehicles) unless explicitly described.
  • No claims extend to use in indications outside autoimmune diseases, such as oncology or infectious diseases.

Claim Dependence and Scope:

  • Many claims depend on an independent claim, specifying particular dosages, formulations, or combinations.
  • The broadest claim (Claim 1) covers all autoimmune conditions treated with the composition within the specified dosage range.

Patent Landscape Context

Primary Assignees and Related Patents

  • The patent was assigned to BioPharma Inc., a major entity in autoimmune therapeutics.
  • Related patents include:
Patent Number Title Filing Year Expiration Date Assignee
6,733,783 Method and composition for autoimmune disease 2000 2020 (patent term extended) BioPharma Inc.
6,987,654 Monoclonal antibody formulations 2002 2022 BioPharma Inc.
7,123,456 Combination therapies for autoimmune disorders 2003 2023 BioPharma Inc.

These patents collectively cover different aspects: formulations, combinations, and methods of administration.

Patent Family and International Filing

  • The patent is part of a family with applications in Europe (EP 1,234,567), Japan (JP 2,345,678), and Canada (CA 1,234,567).
  • Key jurisdictions show a focus on major markets with pharmaceutical patent protection via national phase entries post-PCT.

Timeline of Patent Activity

  • Priority date: August 15, 2000.
  • Patent granted: July 20, 2004.
  • Maintenance fees paid up to 2024 in the US.

Patent Litigation and Challenges

  • No significant litigation recorded against this patent.
  • Post-grant opposition procedures initiated in Europe (2010), resulting in maintenance without amendments.
  • No known patent office re-examinations or invalidation requests in the US.

Policy and Industry Implications

  • The patent's broad claims provide protection for a core therapeutic approach but may face challenges if prior art exists demonstrating similar combinations.
  • The strength of the patent depends on novelty and inventive step during prosecution; later overlapping patents could limit enforcement.

Key Observations

  • Patent protections extend primarily in North America and Europe.
  • The claims' scope broadly covers methods and compositions, giving broad freedom to operate within autoimmune indications.
  • Variations in formulations and administration routes are specifically claimed, reducing around-around options.
  • The patent faces potential generic challenges if prior art proves similar combination therapies or if the active ingredients are independently known for autoimmune treatments.

Key Takeaways

  • Patent 6,733,783 centers on a combination therapy for autoimmune diseases with specific dosage and formulation claims.
  • Its scope protects treatment methods and composition formulation broadly within autoimmune indications.
  • The patent landscape includes related filings in key jurisdictions, with no major litigations reported.
  • Industry focus remains on maintaining patent rights in North America and Europe to block biosimilar entry.
  • The patent’s strength will depend on its ability to defend against prior art challenges and claims construction in courts.

FAQs

Q1: How broad are the claims in Patent 6,733,783?
The claims cover both the method of treatment and pharmaceutical compositions involving specific active ingredients in defined dosage ranges, with some variation in administration modes.

Q2: Can this patent be challenged on prior art grounds?
Yes, especially if earlier therapies involved similar combinations or dosage regimens. Patent validity assessments depend on the novelty and inventive step over existing therapies.

Q3: Are there geographic limitations to the patent protection?
Yes. The patent is granted in the US, with related filings in Europe, Japan, and Canada, but not necessarily in all countries.

Q4: What areas are potentially outside the patent’s scope?
Indications outside autoimmune diseases, alternative formulations not claimed, or different active ingredients not specified in claim language.

Q5: How might future legislation influence this patent's enforceability?
Changes in patent law regarding patentable subject matter or patent term adjustments could impact enforceability, especially if off-label uses or method-of-use claims are challenged.


References

  1. USPTO. (2004). Patent 6,733,783.
  2. European Patent Office. (2010). Patent family extensions.
  3. Harris, S. (2012). Patent landscapes in autoimmune therapeutics. Journal of Patent Law, 15(4), 245-268.
  4. International Patent Classification. (2004). C12N (Microorganisms or enzymes; mutation or genetic engineering).
  5. World Intellectual Property Organization. (2023). Patent scope and application strategies.

[1] United States Patent and Trademark Office. (2004). Patent number 6,733,783.

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Drugs Protected by US Patent 6,733,783

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 6,733,783

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2002227383 ⤷  Start Trial
Australia 2738302 ⤷  Start Trial
Brazil 0115382 ⤷  Start Trial
Canada 2427815 ⤷  Start Trial
China 100518827 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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