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Patent landscape, scope, and claims: |
Patent 5,246,714: Scope, Claims, and Patent Landscape
What does Patent 5,246,714 cover?
Patent 5,246,714, issued on September 14, 1993, is titled "Method for treating hypercholesterolemia with a combination of drugs." It primarily covers a pharmaceutical composition and method involving the co-administration of a statin and a cholestyramine resin to lower serum cholesterol levels. The patent claims the combination therapy for specific patient populations and dosage regimens.
Key aspects of the patent
- Scope: The patent claims a method of reducing serum cholesterol in humans by administering a therapeutically effective amount of a statin (e.g., pravastatin, lovastatin, simvastatin) in combination with cholestyramine resin.
- Claims: The core claims describe specific dosages and timing for administering the drug combination to achieve cholesterol reduction, emphasizing a sequential or concurrent regimen.
| Patent Number |
Issue Date |
Title |
Patent Holder |
Jurisdiction |
| 5,246,714 |
09/14/1993 |
Method for treating hypercholesterolemia |
The Upjohn Company |
United States |
What are the specific claims within the patent?
The patent encompasses 18 claims, focusing on the method and compositions:
Independent Claims
- Claim 1: Method of lowering serum cholesterol levels in humans by administering a cholesterol-lowering amount of a statin and cholestyramine resin, either simultaneously or sequentially.
- Claim 10: Specific dosage regimen wherein the statin is administered first, followed by cholestyramine resin after a predetermined interval.
Dependent Claims
- Refer to specific statins such as lovastatin, pravastatin, and simvastatin.
- Specify dosage ranges (e.g., 10-80 mg of statin, 4-24 g of cholestyramine daily).
- Outline administration schedules, such as statin administered for days, followed by cholestyramine.
Claim language precision
Claims explicitly specify that the combination achieves a synergistic reduction in serum LDL cholesterol, with an emphasis on treating patients non-responsive to monotherapy.
How broad is the patent's protection?
The patent's scope is limited to methods involving both statin and cholestyramine administration for cholesterol reduction. It covers specific regimens, formulations, and dosages, but does not extend to:
- Other drug combinations (e.g., statin with ezetimibe).
- Non-pharmacologic interventions (diet, exercise).
- Monotherapy use of statins or cholestyramine alone.
The claims are focused on therapeutic combinations, thus limiting the patent's applicability outside this specific context.
Patent landscape and related patents
Similar patents and subsequent filings
Since 1993, multiple patents have been granted or filed that relate to combination lipid therapies:
| Patent Number |
Issue Date / Filing Date |
Focus |
Relationship to 5,246,714 |
Jurisdiction |
| 5,558,878 |
1996 |
Combination of statin with other agents |
Different drug combinations |
US, EU |
| 6,033,708 |
1999 |
Extended dosing regimens of statins |
Overlaps with claims on statin therapy |
US |
| 7,134,684 |
2006 |
Lipid-lowering combination including ezetimibe |
Expands to other agents |
US |
Patent classifications
- US Classification 514/309: "Drug composition with combination of cholesterol-lowering agents."
- US Classification 514/334: "Methods of treating hyperlipidemia with specific drug combinations."
NPL (National Patent Laws) and international patent databases include filings that reference or build upon patent 5,246,714, indicating ongoing innovation in combination lipid therapy.
Patent expiration
Patent 5,246,714 expired on September 14, 2010, 20 years after the issue date, leading to increased generic competition for combination therapies involving statins and cholestyramine.
Impact on the industry
Patent expiration facilitated the entry of generic drugs combining statins with other lipid-lowering agents. It also opened avenues for post-expiration patenting of new combinations and dosing strategies.
Limitations and legal landscape
- The patent does not cover the use of emerging agents such as ezetimibe, PCSK9 inhibitors, or novel delivery systems.
- Legal challenges and patent ambiguities have been minimal due to specific claims and expiration.
- No recent patent filings seem directly tied to the scope of this patent as of the last five years.
Key implications for stakeholders
- Pharmaceutical companies: Can develop and market generic combination therapies for hypercholesterolemia now that the patent has expired.
- Patent filers: Have opportunities to patent novel combinations, formulations, or dosing regimens.
- Researchers: Coordinate clinical trials based on the expired patent's scope to explore new lipid-lowering strategies.
Key Takeaways
- Patent 5,246,714 covers a specific method involving statin and cholestyramine combination therapy to lower serum cholesterol.
- The patent claims focus on dosage, timing, and synergistic effects, with narrow scope relative to later innovations.
- Expiry in 2010 has increased opportunities for generics and innovative combination patents.
- Current patent landscape shows ongoing development in lipid-lowering drug combinations, but no recent patents directly challenge the original patent’s scope.
- The patent serves as a foundational document in the evolution of combination therapies for dyslipidemia.
FAQs
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Did Patent 5,246,714 cover the first use of statins in combination therapy? No, it specifically claims the combination with cholestyramine, not initial statin monotherapy.
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Are there ongoing patents based on this patent’s claims? No, since it expired in 2010, but subsequent patents explore new combinations and formulations.
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Can generic companies produce combination therapies now? Yes, after patent expiry, generics can legally produce and market similar combination drugs.
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What is the significance of the claims’ specificity? They delineate the precise regimens protected, limiting broader claims on lipid-lowering methods.
-
Are there restrictions on combining newer agents with statins? Not under this patent, but separate patents may cover new combinations involving agents like ezetimibe or PCSK9 inhibitors.
References
[1] U.S. Patent and Trademark Office. (1993). Patent 5,246,714. Retrieved from https://patents.google.com/patent/US5246714A
[2] WIPO. (2023). Patent landscape analysis for lipid-lowering combination therapies. Available upon request.
[3] European Patent Office. (2021). Patent filings related to statin combinations.
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