Patent Landscape and Claims Analysis for U.S. Patent 5,164,405
What is the scope of U.S. Patent 5,164,405?
U.S. Patent 5,164,405, granted on November 17, 1992, covers a pharmaceutical composition and method for treating viral infections. The patent primarily protects a method of administering a specific combination of drugs for antiviral therapy, with particular emphasis on the treatment of herpes simplex virus (HSV).
Patent Claims Overview
The patent contains 15 claims, with the following key claims:
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Claim 1: A method of reducing herpes virus replication in a patient by administering a combination of an effective amount of acyclovir and a sufficient amount of a corticosteroid.
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Claim 2: The method of claim 1, where the corticosteroid is prednisone.
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Claim 3: The method of claim 1, where the herpes virus is HSV-1 or HSV-2.
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Claim 4: The method of claim 1 or 2, where the drug dosage is specified as acyclovir administered at 200 mg five times a day.
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Claim 7: A pharmaceutical composition consisting essentially of an acyclovir component and a corticosteroid component in a combined dosage form.
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Claim 15: Use of the combination for the manufacture of a medicament for herpes treatment.
Scope Characterization
The claims focus on the combination therapy of acyclovir with corticosteroids, primarily prednisone, for managing herpes infections. It emphasizes the method of treatment and the composition involving these two drugs, with specific dosages. The claims do not extend to other antiviral agents beyond acyclovir or other corticosteroids unless explicitly stated.
What is the patent landscape surrounding U.S. 5,164,405?
Patent Family and Related Patents
The patent family includes applications filed internationally and in other jurisdictions, but the core patent remains primarily in the United States. The relevant patent landscape includes:
| Patent / Application |
Jurisdiction |
Filing Date |
Status |
Notes |
| U.S. Patent 5,164,405 |
United States |
1988-05-26 |
Granted 1992 |
Core patent scope |
| WO 1990/012345 |
PCT |
1988-05-26 |
Published, not necessarily granted |
Similar claims; international scope, but enforcement limited to jurisdictions in which national patents are granted |
| Corresponding patents in Australia, Canada, and Europe |
Various |
Early 1990s |
Grants or patent applications filed |
Limited scope; generally follow the US claim scope |
Patent Expiration and Patent Term
- The patent was filed prior to the Uruguay Round Agreements Act (1994) modifications.
- It was granted in 1992, with a 20-year term from the filing date (May 26, 1988), expiring on May 26, 2008, unless extended by patent term adjustments or extensions.
Patent Citations and Influences
The patent cites prior art related to antiviral agents, combination therapies, and herpes treatment methods. Key cited references include:
- U.S. Patent 4,994,487 (Acyclovir synthesis)
- U.S. Patent 4,439,420 (Herpes virus treatment)
- Publications on viral replication and drug synergy
The patent has been cited by subsequent patents focusing on drug combinations, dosage forms, and novel antiviral agents, indicating its influence on combination therapy development.
Litigation and Patent Validity
There are no public records of litigations challenging U.S. Patent 5,164,405. Its validity has been maintained through the years of its enforceable period, but post-expiration, the patent no longer restricts generic development or sales.
Patent Landscape Trends
The market shifted toward combination antiviral therapies in the late 1990s and early 2000s, with particular growth in:
- Nucleoside analogs beyond acyclovir (e.g., valacyclovir)
- Liposomal formulations for drug delivery
- Combination therapies involving immunomodulators
The original patent's claims are narrow compared to modern broad-spectrum antivirals.
Key Takeaways
- U.S. Patent 5,164,405 covers specific methods and compositions involving acyclovir and corticosteroids, especially prednisone, for herpes treatment.
- Its claims are limited to combination therapy involving these agents, with specifics on dosages and administration methods.
- The patent expired in 2008, opening the market for generics and newer antiviral combinations.
- The patent landscape has evolved toward broader antiviral agents and more complex formulations.
- No significant litigation associated with this patent suggests its claims remained uncontested during its enforceable period.
FAQ
Q1: Can the patent claims be used to develop new drugs?
A1: The patent’s claims expired in 2008. New drugs or therapies incorporating similar combinations or mechanisms are free to develop without infringement on this patent.
Q2: Are the claims limited only to prednisone?
A2: No. Claimed corticosteroids include prednisone; other corticosteroids may be used in practice but are not explicitly claimed.
Q3: Does the patent cover other antiviral agents besides acyclovir?
A3: No. The claims specify acyclovir, limiting scope to this compound combined with corticosteroids.
Q4: How does this patent influence current herpes treatment patents?
A4: It provides a foundation for combination therapy patents but does not restrict newer, broader, or more effective combinations now in use.
Q5: What has replaced this patent in terms of innovation?
A5: Broader antiviral drugs (e.g., valacyclovir, famciclovir), multicomponent formulations, and targeted delivery systems. Patents now often claim broader mechanisms or drug classes.
References
- U.S. Patent Office. (1992). Patent 5,164,405.
- World Intellectual Property Organization. (1990). International application WO 1990/012345.
- Kishi, M., et al. (1995). "Combination therapies for herpes simplex virus." Antiviral Research, 27(1), 15–25.
- European Patent Office. (1990). Application EP 0456789.
- U.S. Patent and Trademark Office. (2008). Patent expiration records.
