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Details for Patent: 5,866,581
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Summary for Patent: 5,866,581
| Title: | Penciclovir for the treatment of post therapeutic neuralgia |
| Abstract: | A method for the treatment of PHN in mammals, including humans, which method comprises administering an effective amount of a compound of formula (A), or a pharmaceutically acceptable salt thereof. ##STR1## |
| Inventor(s): | Ronald James Boon, David Ronald John Griffin |
| Assignee: | Novartis Pharmaceuticals Corp |
| Application Number: | US08/624,466 |
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Patent Claim Types: see list of patent claims | Use; |
| Patent landscape, scope, and claims: | Scope and Patent Landscape for US Patent 5,866,581 (Famciclovir/Penciclovir for Post-Herpetic Neuralgia, US Claims 1–21) US Patent 5,866,581 covers specific therapeutic and prophylactic uses of famciclovir or penciclovir for post-herpetic neuralgia (PHN), including treatment timing windows after rash onset, duration (7 days), and treatment in older age strata. The claims are directed to method-of-treatment and method-of-prophylaxis with particular dosing regimens (including famciclovir 250 mg/500 mg/750 mg and multiple daily frequency options). From a freedom-to-operate and litigation-risk perspective, the most infringement-relevant claim elements are: (i) PHN indication, (ii) drug identity (famciclovir or penciclovir), (iii) timing relative to rash onset (≤72 hours, ≤48 hours), and (iv) specified dosing/frequency combinations for famciclovir. What is US Patent 5,866,581 and what PHN uses does it claim?Short answer: The patent claims methods for treating PHN in mammals (including humans) using famciclovir or penciclovir, and prophylactic treatment methods in humans, with additional limitations for early treatment timing, treatment duration, patient age, and specific famciclovir dosing regimens. Core claim structure (independent and dependent claims)Claim 1 (treatment method, broad baseline)
Claim 15 (prophylactic method, baseline)
Claims 2–4 (timing and duration)
Claims 5–7 (age-limited subgroups)
Claims 8–14 (famciclovir-specific dosing configurations)
Claim 14
Immediate technical read-acrossThese are classic “use/indication” and “method” claims around an antiviral in a neuropathic complication setting (PHN). The claim language narrows risk in two ways:
What is the real scope of protection: treatment vs prophylaxis, and what counts as PHN “treatment”?Short answer: The patent covers both therapeutic treatment of PHN and prophylactic administration to prevent PHN in humans. The protection attaches to PHN management, not directly to the management of acute zoster pain unless the claimed method is framed and executed as PHN treatment/prophylaxis. Infringement-relevant distinctions for enforcement
What “in need of such treatment” tends to operationalizeEven without additional claim wording, these phrases typically track clinical determination that the patient has PHN (for treatment claims) or is at risk / needs prevention (for prophylaxis claims). From an enforcement lens, any contest usually turns on:
How do the timing limits (72 hours, 48 hours) narrow infringement risk?Short answer: Timing windows are key claim elements. Methods performed outside the “within 72 hours” (Claim 2) or “within 48 hours” (Claim 3) frames do not meet those dependent limitations. Claim dependency and “gating” effect
Practical enforcement implications
How does the 7-day treatment period limit matter for design-around?Short answer: Claim 4 limits infringement for that dependent claim to “treatment period is 7 days,” which can create a pathway to avoid that dependent claim by varying treatment duration. Claim interaction
What age thresholds are protected, and can competitors escape by treating other subgroups?Short answer: The patent includes dependent claims for older age groups (>50, >60, >70). Methods outside those thresholds avoid those dependent claims. Age-gated claim set
Design-around logicEven if a physician treats PHN with famciclovir/penciclovir in younger populations, the older-age dependent claims are not met. However, the baseline Claim 1 and Claim 15 remain broader without age limitations. Which famciclovir dose and frequency regimens are explicitly claimed?Short answer: The patent explicitly claims multiple famciclovir dose-frequency configurations, plus a broader dose/frequency matrix. Claim 9 matrix (breadth with controlled dimensions)Claim 9 limits famciclovir dosing to:
This is still fairly specific because it excludes other doses and other schedules (and it anchors on the named doses). Explicit dependent dosing options
Enforcement mapInfringement of Claims 10–13 typically turns on:
Does the patent cover penciclovir dosing, or only famciclovir?Short answer: The provided claim text explicitly lays out famciclovir dosing embodiments, while penciclovir appears in the baseline treatment and prophylaxis claims without the same dose-frequency detail. Claim language implications
Result: Penciclovir exposure risk is higher for broader dependent coverage only where the baseline claims are asserted, and lower for specific dose-frequency attacks absent penciclovir-specific dependent claim limitations. What is the US patent expiration and exclusivity outlook for 5,866,581?Short answer: The patent’s lifespan in the US is governed by its patent term and any applicable adjustments/extensions, but those dates require the actual application/filing and patent-publication timeline. Without those bibliographic facts present here, a precise expiration date cannot be stated from the information provided. What other US patents likely affect PHN methods with famciclovir/penciclovir?Short answer: Without the underlying bibliographic record (application number, assignee, continuation set, and citing/related patents), a complete landscape cannot be enumerated. The claims you provided are method-of-use claims anchored to famciclovir/penciclovir for PHN with timing, age, and dosing limits, so the most relevant adjacent IP classes are:
How strong is the patent estate for infringement cases: what would a Paragraph IV or non-infringement argument target?Short answer: For method-of-use claims, typical defenses center on (i) absence of PHN indication evidence, (ii) absence of timely administration, and (iii) mismatch of dosing regimen and/or intended prophylaxis vs treatment. Infringement elements most likely litigated
Claim construction pressure points
What is the most likely “generic entry” or competitive risk pattern?Short answer: A generic of famciclovir or penciclovir typically does not face product-claim exclusivity barriers for method-of-use patents unless the generic product is launched with label or promotional use that aligns with the patented method. The key issue is alignment between real-world prescribing practices and the patented method constraints (PHN indication, prophylaxis framing, timing, dosing regimen, and patient cohort). Real-world launch risk drivers
How does 5,866,581 compare with other method-of-use antivirals in PHN?Short answer: Compared with broader PHN prevention method patents, this one is unusually claim-dense on operational variables: early treatment windows, a specific treatment period (7 days), age thresholds, and enumerated famciclovir dose-frequency options. That structure can both (i) narrow the infringement target and (ii) strengthen enforcement where clinical evidence matches the specific regimen. Relative positioning
Key Takeaways
FAQs1) Does US 5,866,581 require treatment within 72 hours of rash onset? 2) Can a competitor avoid infringement of the 7-day limitation? 3) Are famciclovir dosing regimens the same for prophylaxis claims as treatment claims? 4) Is age >70 a strict requirement for any infringement risk? 5) Does the patent cover prophylactic treatment only for humans? References (APA)
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Drugs Protected by US Patent 5,866,581
| 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 |
Foreign Priority and PCT Information for Patent: 5,866,581
| Foriegn Application Priority Data | ||
| Foreign Country | Foreign Patent Number | Foreign Patent Date |
| United Kingdom | 9320485 | Oct 05, 1993 |
| United Kingdom | 9321255 | Oct 14, 1993 |
| PCT Information | |||
| PCT Filed | October 04, 1994 | PCT Application Number: | PCT/GB94/02156 |
| PCT Publication Date: | April 13, 1995 | PCT Publication Number: | WO95/09632 |
International Family Members for US Patent 5,866,581
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| African Regional IP Organization (ARIPO) | 616 | ⤷ Start Trial | |||
| African Regional IP Organization (ARIPO) | 9400684 | ⤷ Start Trial | |||
| Austria | 216885 | ⤷ Start Trial | |||
| Australia | 1383495 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
