Details for Patent: 5,496,804

Summary for Patent: 5,496,804

Title:	Method for treating taxol side-effects with G-CSF
Abstract:	A method of treating a host using taxol comprising administering granulocyte colony-stimulating factor to the host being treated with taxol. The present inventive method allows for increased levels of taxol to be administered to the host in the treatment of various conditions, particularly with respect to ovarian tumors.
Inventor(s):	Eddie Reed, Elise Kohn, Gisele Sarosy
Assignee:	US Department of Health and Human Services
Application Number:	US08/342,797
Patent Claim Types: see list of patent claims	Use;

Patent 5,496,804 scope and claims: Taxol (paclitaxel) + G-CSF methods to prevent myelosuppression, mucositis, and peripheral neuropathy

US Patent 5,496,804 claims method-of-treatment use of granulocyte colony-stimulating factor (G-CSF) to alleviate or prevent taxol-associated side effects in a host undergoing taxol chemotherapy. The core claim set is narrow to (i) taxol-treated hosts, (ii) specific side-effect categories (myelosuppression, mucositis, peripheral neuropathy), and (iii) administration of G-CSF at specified dose and timing parameters in dependent claims. The strongest enforceable leverage typically sits in combinations tied to high-dose, q3-week paclitaxel regimens and specific post-dose G-CSF dosing windows.

What is US Patent 5,496,804 and what does it claim about Taxol side effects treated with G-CSF?

Direct claim thesis. The independent claim is a single-combination method: administer G-CSF to a host being treated with Taxol in an amount sufficient to alleviate or prevent at least one side effect selected from:

• myelosuppression
• mucositis
• peripheral neuropathy

This is a classic “indication-and-association” claim that binds together the drug regimen (taxol exposure) with the prophylactic/therapeutic supportive intervention (G-CSF) and the clinical outcome targeted (specific toxicity domains).

Claim 1 key limitations (scope-defining elements)

Claim 1 requires all of the following to be present in the accused method:

1. A host is “being treated with Taxol” (paclitaxel).
2. The Taxol is given “in an amount sufficient to cause” a targeted side effect.
3. The side effect is one of the enumerated three categories (myelosuppression, mucositis, peripheral neuropathy).
4. The method “comprises administering granulocyte colony-stimulating factor” in an effective amount to alleviate or prevent that side effect.

Scope impact:

• The claim is not limited to a particular cancer type in Claim 1.
• The claim is not limited to a specific G-CSF brand, but it is limited to “granulocyte colony-stimulating factor” (interpretation typically covers G-CSF molecules used clinically, such as filgrastim and related forms, to the extent they qualify as G-CSF).
• The claim hinges on the side-effect relationship: the Taxol regimen must be sufficient to cause the specified side effect, and G-CSF must be administered to prevent/alleviate it.

Dependent claims as “knobs” that narrow infringement

Dependent claims add:

• Taxol dose thresholds (e.g., exceeding ~175 mg/m²/21 days; and 200–250 mg/m²/21 days)
• Side-effect selection (myelosuppression or mucositis, excluding neuropathy for those dependents)
• G-CSF dose in µg/kg/day (≥ about 5 µg/kg/day; and 10–20 µg/kg/day)
• Timing pattern: taxol once every three weeks with daily G-CSF for at least seven days following taxol

These dependents reduce design-around flexibility for parties using the specific taxol regimens and supportive dosing patterns.

Which side effects are covered, and how do the claims treat neuropathy vs mucositis vs myelosuppression?

Does the patent cover peripheral neuropathy from Taxol?

Yes in Claim 1 only. Peripheral neuropathy is included in the independent claim’s side-effect selection group. There are no dependent claim text you provided that expressly limits neuropathy to a separate dosing regimen. The narrower dependents you supplied route to myelosuppression or mucositis.

Enforcement implication:
If an accused regimen targets neuropathy with G-CSF, Claim 1 is the direct hook. If the accused method is closer to classic G-CSF indications (neutropenia/myelosuppression), then Claims 3–5 and 11–13 provide tighter dependent support.

Does the patent cover mucositis and myelosuppression with G-CSF?

Yes with tighter claim structure.

• Claim 3 limits side effect to myelosuppression or mucositis.
• Claim 4–5 specify G-CSF dose parameters once Claim 3 is selected.
• Claim 6 and 14 specify timing after q3-week Taxol.
• Claim 11–13 mirror the ovarian tumor + high-dose Taxol + dose window pattern.

Enforcement implication:
If the accused party uses G-CSF for toxicity management in the mucositis/myelosuppression domain during paclitaxel therapy, it is more likely to land on the dependent claim structure that includes measurable dosing thresholds.

What taxol dosing parameters define infringement under US 5,496,804?

The provided claim set uses paclitaxel (“Taxol”) exposure levels to narrow the relevant regimen.

Taxol amount exceeding about 175 mg/m²/21 days (Claims 2, 11)

• Claim 2: side-effect treatment method of Claim 1 where taxol dose exceeds ~175 mg/m²/21 days
• Claim 11: ovarian tumor version of Claim 10 with taxol dose exceeding ~175 mg/m²/21 days

Scope impact:
This is a quantifiable threshold. Regimens at or below ~175 mg/m²/21 days may try to argue non-infringement against these dependents, but Claim 1 could still apply if “in an amount sufficient to cause” the side effect is met.

Taxol amount about 200 to about 250 mg/m²/21 days (Claims 7, 15)

• Claim 7: Claim 6 method where taxol is about 200–250 mg/m²/21 days
• Claim 15: Claim 14 method where taxol is about 200–250 mg/m²/21 days

Scope impact:
These are narrower than the ~175 threshold. They create strong factual anchors for claim construction and infringement analyses in litigation: dosing records, cycle documentation, and protocol schedules.

What G-CSF dose and schedule does the patent require?

Minimum daily dose parameter (Claims 4 and 12)

• Claim 4: G-CSF at at least about 5 µg/kg/day
• Claim 12: same threshold in the ovarian tumor + high-dose taxol context

Dose range (Claims 5 and 13)

• Claim 5: G-CSF at about 10 to about 20 µg/kg/day
• Claim 13: same range in the ovarian tumor + high-dose taxol context

Scope impact:
The dose window creates a measurable infringement test for typical product labels. If the accused G-CSF dosing falls outside 10–20 µg/kg/day but still meets ≥5 µg/kg/day, Claims 4/12 may be implicated even if Claim 5/13 are argued around.

Timing: q3-week Taxol with daily G-CSF for at least seven days (Claims 6 and 14)

• Claim 6: Taxol once every three weeks; G-CSF administered daily for at least seven days following Taxol
• Claim 14: same limitation in the cancer/treatment-dependent chain (as written, Claim 14 depends on Claim 13)

Scope impact:
This is a scheduling limitation. If a protocol uses a shorter course of G-CSF after paclitaxel or uses non-daily schedules, it may attempt a design-around against Claims 6 and 14, while still facing Claim 1 depending on whether the method “alleviates or prevents” the side effect within the meaning of the independent claim.

What cancer types and tumor sites are specifically covered?

Taxol used to treat a cancerous tumor (Claim 8)

Claim 8 links Claim 1 to “a cancerous tumor” without restricting tumor type.

Breast, lung, or ovarian tumor (Claim 9)

Claim 9 restricts the tumor to breast, lung, or ovarian.

Ovarian tumor (Claims 10, 11–15 path)

Claim 10 specifies ovarian tumor. Claims 11–15 then layer additional constraints:

• Claim 11: ovarian tumor + taxol > ~175 mg/m²/21 days
• Claim 12: add G-CSF ≥ about 5 µg/kg/day
• Claim 13: add G-CSF about 10–20 µg/kg/day
• Claim 14: add timing (q3-week taxol; daily G-CSF ≥ seven days after)
• Claim 15: add taxol about 200–250 mg/m²/21 days

Scope impact:
The ovarian-specific branch is the most constrained and therefore the easiest to map to a particular clinical protocol. If competitors treat ovarian cancer with paclitaxel and supportive G-CSF under a comparable schedule and dosing, the infringement risk is higher for the dependent claims 11–15.

How many distinct claim “families” exist within the provided claim set?

Within the text provided, the claim architecture splits into three practical enforceability clusters:

1. Baseline method-of-treatment for taxol toxicity support (Claim 1)

   • Any tumor type
   • Side-effect set includes neuropathy, mucositis, myelosuppression
   • G-CSF “effective amount” (no numeric dose or schedule)

2. General toxicity support with measurable G-CSF dosing (Claims 3–5)

   • Side effect restricted to myelosuppression or mucositis
   • Numeric G-CSF dose limits: ≥5 µg/kg/day and 10–20 µg/kg/day

3. Protocol-specific branch for q3-week Taxol regimens and ovarian cancer (Claims 10–15)

   • Ovarian tumor only
   • Taxol dose thresholds and ranges: >~175 and 200–250 mg/m²/21 days
   • G-CSF numeric range: ≥5 and 10–20 µg/kg/day
   • Timing: daily for ≥7 days post-taxol

The ovarian branch has the highest specificity. It also provides the most “litigation-ready” elements for a claim charts: tumor type, dose per cycle, daily schedule, and mg/kg/day values.

What does the patent landscape likely look like for paclitaxel + G-CSF supportive care in the US?

A complete US landscape requires Orange Book and patent bibliographic extraction for 5,496,804 plus related assignee/patent families; however, the claim text provided already indicates the competitive IP focus: supportive cytokine use to manage chemotherapy-associated toxicity rather than tumor-targeting.

Where enforcement leverage typically concentrates in this kind of claim set

For method claims like these, enforceable leverage often concentrates around:

• Protocol-anchored supportive care: “once every three weeks” taxol with post-dose daily G-CSF at a defined duration
• Quantified dose parameters: thresholds (≥5 µg/kg/day) and ranges (10–20 µg/kg/day)
• Indication narrowing: ovarian tumor branch provides a clearer clinical mapping and can increase litigation relevance for oncology-focused defendants

Design-around vectors implied by the claim structure

Given the limitations in dependents, a competitor might attempt to avoid specific dependent claims by changing one or more measurable elements:

• Use a taxol regimen at or below the cited thresholds to weaken Claims 2/7/11/15
• Use a different G-CSF dose outside the cited window to weaken Claims 5/13
• Shorten or alter the post-dose schedule so daily G-CSF is under 7 days to weaken Claims 6/14
• Avoid claiming use for mucositis or exclude the neuropathy targeting approach to weaken reliance on different branches

However, Claim 1’s broad “effective to alleviate or prevent” language still creates risk if the accused regimen can be shown to alleviate/prevent one of the side-effect categories in a taxol-treated host.

What is the practical claim-chart mapping for likely US infringement theories?

Theory A: Myelosuppression/mucositis prevention in taxol regimens

Most straightforward mapping uses the Claim 3–5 dependents:

• Paclitaxel regimen consistent with Taxol “amount sufficient to cause” myelosuppression/mucositis
• G-CSF administered at ≥5 µg/kg/day (and possibly 10–20 µg/kg/day)
• No need for ovarian-specific protocol limitations unless seeking the stronger dependents

Theory B: Ovarian cancer q3-week paclitaxel protocol with daily G-CSF

This targets Claims 10–15:

• Ovarian tumor
• Paclitaxel dosing: >~175 mg/m²/21 days and/or 200–250 mg/m²/21 days
• G-CSF dosing: ≥5 µg/kg/day and/or 10–20 µg/kg/day
• Schedule: once every three weeks with daily administration for at least seven days after taxol

Theory C: Peripheral neuropathy alleviation with G-CSF

This relies primarily on Claim 1:

• Taxol-treated host
• Peripheral neuropathy among the side effects alleviated/prevented by G-CSF
• No numerical dosing or schedule required in the text provided for neuropathy within Claim 1

Key takeaways

• US 5,496,804 claims a taxol + G-CSF method-of-treatment linking paclitaxel-induced toxicities to G-CSF administered to prevent/alleviate them.
• The independent claim (Claim 1) covers three toxicity categories: myelosuppression, mucositis, and peripheral neuropathy, without tumor restriction.
• Dependent claims add quantifiable enforcement anchors: taxol dose thresholds (≈175 mg/m²/21 days; and 200–250 mg/m²/21 days), G-CSF daily dose (≥5 µg/kg/day; and 10–20 µg/kg/day), and timing (daily for ≥7 days after q3-week taxol).
• The ovarian cancer branch (Claims 10–15) is the most specific and likely the most litigation-relevant, because it layers all measurable dosing and scheduling limitations into a single protocol template.

FAQs

1. Does US 5,496,804 require a specific G-CSF molecule (filgrastim) or only “granulocyte colony-stimulating factor”?
The claim language requires “granulocyte colony-stimulating factor,” not a specific brand or molecule in the text provided.

2. Can the patent be infringed if G-CSF is given for myelosuppression but the side effect is not explicitly documented as mucositis?
Claim 1 and Claims 3–5 cover myelosuppression as a targeted side-effect category; the claim chain depends on which side-effect selection is proven in the method.

3. Does the patent protect only ovarian cancer protocols?
No. Claim 1 covers any tumor type; ovarian-specific dependents create a narrower additional enforceability layer.

4. What dosing changes most directly reduce risk against dependent claims 5 and 13?
Adjusting G-CSF dose outside the about 10–20 µg/kg/day range targets the dependent claim dose limitation.

5. Is the timing limitation only relevant to claims that specify “once every three weeks”?
Yes. The “daily for at least seven days following the taxol treatment” limitation appears in Claims 6 and 14 as written.

References

1. US Patent 5,496,804 (claims as provided in prompt).

Drugs Protected by US Patent 5,496,804

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 5,496,804

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2092271