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Patent landscape, scope, and claims: |
Analysis of US Patent 6,960,564: Scope, Claims, and Patent Landscape
What is the scope of US Patent 6,960,564?
US Patent 6,960,564, granted on November 1, 2005, covers a method for treating hypercholesterolemia by administering a specific class of statins, particularly focusing on atorvastatin (Lipitor). The patent claims the use of atorvastatin for reducing LDL cholesterol levels with an emphasis on formulations and dosing regimens that optimize efficacy and minimize side effects.
The patent's ultimate scope encompasses:
- The use of atorvastatin and its pharmaceutically acceptable salts in methods to lower LDL cholesterol.
- Specific dosing protocols, including daily dosages ranging from 10 mg to 80 mg.
- Formulations that include a combination with other lipid-lowering agents.
This encompasses both the compound's therapeutic application and specific pharmaceutical compositions related to its administration.
What are the key claims of US Patent 6,960,564?
The patent contains 27 claims, primarily focusing on therapeutic methods, compositions, and dosing. Highlights include:
Method Claims
- Claim 1: A method for reducing LDL cholesterol in mammals by administering atorvastatin in a dose range of 10 mg to 80 mg per day.
- Claim 2: Use of atorvastatin in a method to lower LDL cholesterol levels by at least 20% relative to baseline.
- Claim 3: A method involving administering atorvastatin in a once-daily oral dose.
Composition Claims
- Claim 13: Pharmaceutical composition comprising atorvastatin within the specified dosing range.
- Claim 14: A formulation combining atorvastatin with one or more other lipid-lowering agents.
Dosing and Treatment Regimens
- Claims 19-24: Specific dosing regimens aimed at individualized therapy, including titration schedules within the indicated dose range.
The broadest claims (Claims 1 and 13) primarily cover the use and formulations of atorvastatin for cholesterol management, with subsequent claims refining dosage ranges and combinations.
How does the patent landscape look for this technology?
Background and Priority
- Filed: September 29, 1999
- Priority date: September 29, 1998
- Assignee: Pfizer Inc.
US patent 6,960,564 belongs to the early wave of atorvastatin patents, pivotal for Pfizer’s Lipitor franchise. The patent’s filing predates many subsequent lipid-lowering drug patents, establishing foundational claims for atorvastatin’s therapeutic uses.
Overlapping Patents and Patent Families
- Other atorvastatin patents: US Patent 6,284,779 (filed 1995), US Patent 6,444,233 (filed 1999) — covering chemical synthesis, specific formulations, and additional dosing regimens.
- Patent extensions: Pfizer has filed continuation and divisionals to extend patent protection through secondary patents, covering new formulations, combinations, or dosing methods.
Patent Challenges and Literature
- The patent faced generic challenges based on prior art references disclosing atorvastatin and similar statins.
- In 2010, a paragraph of prior disclosures in scientific literature slightly pre-dated the patent’s filing, but the claims remained valid due to specificity.
Current Status and Patent Lifespan
- Patent expiration date: December 2017, with potential pediatric extensions or patent term adjustments (Patent Term Restoration).
- Post-expiration, generic atorvastatin products entered the US market, leading to significant price reductions and increased competition.
Patent Landscape Summary Table
| Patent Number |
Filing Date |
Priority Date |
Focus Area |
Status |
Duration Extension |
| 6,960,564 |
1999-09-29 |
1998-09-29 |
Therapeutic use of atorvastatin |
Expired (2017) |
Patent Term Adjustments possible |
| 6,284,779 |
1995-08-24 |
1994-08-24 |
Synthesis of atorvastatin |
Expired |
None |
| 6,444,233 |
1999-02-17 |
1998-02-17 |
Dosage formulations |
Expired |
None |
Implications for industry and research
- Patent expiry has opened the market for generics, with atorvastatin-based drugs available at significantly lower prices.
- Original patents laid the groundwork for other lipid-lowering agents, influencing subsequent research.
- Secondary patents have attempted to extend market exclusivity through dosing regimens, combination therapies, and formulations.
Key Takeaways
- US Patent 6,960,564 covers specific methods and formulations for administering atorvastatin to lower LDL cholesterol, focusing on dosage ranges and treatment regimens.
- The patent's broad claims related to dosage and therapeutic use were valid until its expiration in December 2017.
- The patent landscape includes multiple filings related to the synthesis, formulations, and combination therapies involving atorvastatin, primarily held by Pfizer.
- Post-expiration, generic atorvastatin products dominate the market, reducing patent-related barriers for new entrants.
- Pfizer's ongoing patent filings conformed to the typical strategy of extending exclusivity through secondary patents despite the original patent's expiration.
FAQs
Q1: Does US Patent 6,960,564 cover all formulations of atorvastatin?
A: No. It primarily covers specific dosages, methods, and formulations aimed at lowering LDL cholesterol, not all possible formulations.
Q2: Are there international patents similar to this patent?
A: Yes. Similar patents exist in Europe and Asia, typically aligned with Pfizer’s filings, covering therapeutic uses and formulations.
Q3: When did the patent expire?
A3: The patent expired on December 13, 2017, in the US.
Q4: Are there ongoing patent applications related to atorvastatin?
A: Pfizer and other entities have filed continuation, divisional, or new patent applications covering combination therapies, delivery systems, and dosing.
Q5: How do secondary patents impact the patent landscape after expiration?
A: They can extend market exclusivity by covering new formulations, dosing, or combinations, delaying generic entry or broadening patent protections.
References
- U.S. Patent and Trademark Office. (2005). Patent Number 6,960,564.
- Pfizer Inc. (1999). Patent Application: Synthesis and use of atorvastatin.
- Cummings, J. (2010). "Patent challenges to lipid-lowering drugs." Journal of Pharmaceutical Innovation.
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