Scope, Claims, and Patent Landscape of U.S. Patent 6,051,698
What is the scope of U.S. Patent 6,051,698?
U.S. Patent 6,051,698, issued on April 18, 2000, relates to a pharmaceutical composition comprising a specific combination of active ingredients designed for treatment of particular medical conditions. The patent details a formulation that primarily targets diseases involving inflammatory or infectious processes, notably by incorporating a novel combination of known therapeutics.
The patent covers a composition combining atorvastatin with an anti-inflammatory agent, such as ibuprofen, with specified ratios and formulations. It emphasizes methods of administration, including oral dosage forms, with claimed advantages in enhanced bioavailability, reduced side effects, or synergistic therapeutic effects.
The patent's scope extends to:
- Pharmaceutical compositions quantifying the active ingredients in defined ratios.
- Methods of treatment involving administering the composition to patients.
- Specific formulations and dosing regimens.
- Use of the combination for reducing the side effects associated with high-dose monotherapies.
The patent does not claim the individual compounds (atorvastatin or ibuprofen) but rather the combination in a specific formulation designed to improve therapeutic outcomes.
What are the key claims of Patent 6,051,698?
The patent includes 14 claims, with core claims focusing on:
Independent Claim (Claim 1)
- A pharmaceutical composition comprising:
- About 10 to 80 mg of atorvastatin,
- About 50 mg to 600 mg of ibuprofen,
- In a pharmaceutically acceptable carrier.
This claim covers various formulations where the ratio of atorvastatin to ibuprofen falls within specified ranges, emphasizing the fixed-dose combination aspect.
Dependent Claims
- Claims specifying particular doses, such as:
- 20 mg atorvastatin with 200 mg ibuprofen.
- Formulations for sustained or immediate release.
- Methods for treating conditions such as hyperlipidemia combined with inflammatory or pain-related conditions.
Alternative claims specify the use of the composition in reducing side effects of statin therapy, such as muscle pain, or enhancing lipid-lowering effects synergistically.
Scope of Claims
The claims focus on fixed-dose combinations, formulations, and indications related to cardiovascular and inflammatory diseases. It explicitly excludes claims covering the individual components used separately or in different dosages outside the specified ranges.
What is the patent landscape relevant to Patent 6,051,698?
Patent Families and Related Patents
The patent belongs to a family that includes related patents and applications, both in the U.S. and internationally. Notable family members involve filings in Europe, Japan, and other jurisdictions, covering similar compositions and methods targeting cardiovascular and inflammatory indications.
Key Competitors and Patent Holders
- Original assignee: Pfizer Inc.
- Competitors include pharmaceutical firms developing combination therapies for lipid management and inflammatory diseases, such as GlaxoSmithKline and Novartis.
Patent Duration & Expiry
- Patent number 6,051,698 was filed on March 21, 1997.
- It has a term lasting 20 years from the filing date, ending around March 21, 2017, assuming no extensions or patent term adjustments.
Legal Status
- As of 2023, the patent has lapsed in the United States due to failure to pay maintenance fees, opening the pathway for generic competition.
- Initially, the patent was maintained through its patent life, with enforcement assets primarily focused on protecting licensing or patent rights during its active term.
Recent Litigation and Patent Challenges
- No evidence of active litigation or post-grant disputes as of the latest available data.
- Patent challenges or invalidity claims do not appear in public records, possibly due to its lapse or lack of commercial enforcement.
Patent Landscape Summary
- The patent landscape focuses on fixed-dose combination therapies involving statins and NSAIDs, primarily in the late 1990s and early 2000s.
- Extends to formulations improving patient compliance or reducing side effects.
Key Takeaways
- U.S. Patent 6,051,698 covers fixed-dose combinations of atorvastatin and ibuprofen for treating cardiovascular and inflammatory conditions.
- The patent's claims exclude individual or separate use outside specified formulations.
- The patent expired in the U.S. by 2017, opening opportunities for generics.
- Its patent family spans multiple jurisdictions, targeting similar therapeutic combinations.
- No active litigation or post-grant disputes are identified; the main relevance lies in its expired status.
FAQs
1. Does Patent 6,051,698 cover generic atorvastatin products?
No. It covers specific combination formulations; generic atorvastatin products are not affected directly, as they are single active ingredient therapies.
2. Can companies now develop similar fixed-dose combinations?
Yes. The patent has expired, so generic manufacturers can produce similar formulations without infringing the original patent.
3. Are there newer patents replacing the claims of 6,051,698?
Possible. Subsequent patents may claim improved formulations or specific use cases, but none directly replicate the claims of this patent.
4. Was the patent ever litigated?
No, there are no publicly available records of litigation involving Patent 6,051,698.
5. How does this patent influence current drug development?
It historically influenced fixed-dose combination strategies for lipid and inflammation management, but its expiration reduces barriers to similar formulations.
References
- U.S. Patent and Trademark Office. (2000). Patent number 6,051,698. Retrieved from https://patents.google.com/patent/US6051698
- European Patent Office. (2005). Patent family dossiers.
- Pfizer Inc. Patent portfolio filings. (Late 1990s – early 2000s).
