Details for Patent: 8,791,097

Which drugs does patent 8,791,097 protect, and when does it expire?

Patent 8,791,097 protects TORISEL and is included in one NDA.

Protection for TORISEL has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has forty-one patent family members in twenty-three countries.

Summary for Patent: 8,791,097

Title:	Anti-tumor activity of CCI-779 in papillary renal cell cancer
Abstract:	This invention provides the method or use of CCI-779 in the treatment of papillary renal cell carcinoma.
Inventor(s):	Gary Dukart, James Joseph Gibbons, Jr., Anna Berkenblit, Jay Marshall Feingold
Assignee:	Wyeth LLC
Application Number:	US12/099,394
Patent Claim Types: see list of patent claims	Use; Delivery;

United States Patent 8,791,097 (CCI-779) for Metastatic Papillary Renal Cell Carcinoma: Scope of Claims and US Patent Landscape

US Patent 8,791,097 is a treatment-method patent centered on CCI-779 (temsirolimus; marketed as Torisel) for papillary renal cell carcinoma (PRCC) in a metastatic setting. The claims are built around (i) PRCC patient subgrouping (hereditary type I, hereditary type II, sporadic; previously untreated; advanced), (ii) dosing and administration controls (intravenous; weekly 1 to 24 months; 1 to 250 mg/week; exemplary 25 mg/week), and (iii) regimen composition limitations (CCI-779 as the sole anti-neoplastic or sole active agent; or addition of another agent that is not interferon), plus (iv) a specific negative limitation: treatment “in the absence of interferon alpha.”

The claim set indicates the patent’s practical infringement risk is highest for providers and trial protocols using temsirolimus IV schedules in metastatic PRCC, including combination use that avoids interferon alpha and still uses CCI-779 as a regimen component.

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What is US Patent 8,791,097 and what does it claim for CCI-779 (temsirolimus) in papillary RCC?

Core invention theme: a method of treating PRCC with CCI-779 where the PRCC is metastatic. The independent claim anchors on the disease state and drug identity, while dependent claims carve out clinically and operationally distinct practice settings.

Independent claim scope (Claim 1)

Claim 1 requires all of the following:

• Subject: “a mammal in need thereof”
• Disease: papillary renal cell carcinoma
• Disease stage: metastatic
• Therapy: “providing… an effective amount of CCI-779”

Implication for coverage: Any therapeutic regimen that administers temsirolimus (CCI-779) IV (even if IV is only in dependent claims) could still fall under Claim 1 if the method “provid[es]… an effective amount” in metastatic PRCC. Dependent claims then narrow to particular administration and dosing parameters.

Disease subtype and treatment-naïve carve-outs (Claims 2–6)

Dependent claims specify PRCC subgroup and presentation:

• Claim 2: hereditary type I PRCC
• Claim 3: hereditary type II PRCC
• Claim 4: sporadic PRCC
• Claim 5: previously untreated PRCC
• Claim 6: advanced PRCC

Implication for scope: These claims reinforce that infringement is not limited to one PRCC etiologic class. If “papillary renal cell carcinoma” is metastatic and the prescriber treats with CCI-779, Claim 1 already covers. Claims 2–6 add layered coverage for scenarios where treatment records or trial inclusion criteria specify subtype or prior-treatment status.

Administration and dosing constraints (Claims 7–10)

• Claim 7: CCI-779 administered intravenously
• Claim 8: administered weekly for one to 24 months
• Claim 9: IV dose 1 to 250 mg per week
• Claim 10: IV dose 25 mg per week

Implication for coverage:

• Claim 1 is broader on route (does not require IV).
• Claims 7–10 are narrower but track standard temsirolimus administration patterns and typical dosing bands used in clinical protocols.
  If a payer-approved regimen includes weekly IV dosing within these bands for metastatic PRCC, dependent claims create a strong “protocol-matching” infringement pathway.

Regimen composition limitations (Claims 11–13)

• Claim 11: CCI-779 is the sole anti-neoplastic agent
• Claim 12: CCI-779 is the sole active agent
• Claim 13: may further comprise another active agent, but the further active agent is not an interferon

Implication for coverage:
The patent draws a regimen boundary around interferon. A combination regimen that includes an interferon alpha would be outside Claim 13’s explicit allowance. However, Claims 11 and 12 show coverage for CCI-779 as the lone anti-neoplastic or lone active agent. Claim 14 then tightens the negative requirement around interferon alpha.

Negative limitation on interferon alpha (Claim 14)

Claim 14 requires treatment:

• “in the absence of interferon alpha”

Implication for coverage:
Claim 14 gives the patent a specific factual hook that can be litigated using medical records and regimen component lists. If interferon alpha is part of the regimen, Claim 14 does not read. If it is absent, Claim 14 expands enforcement leverage beyond those using interferon-free monotherapy, capturing interferon-free combinations as well.

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How do the claims read as a set: what practice scenarios fall inside vs outside 8,791,097?

Most direct “within-the-lines” scenario

• Diagnosis: metastatic papillary RCC
• Drug: temsirolimus (CCI-779)
• Route: IV
• Schedule: weekly
• Duration: 1 to 24 months
• Dose: within 1–250 mg/week, including 25 mg/week
• Regimen: CCI-779 alone, or CCI-779 + non-interferon agents

Scenario that still fits Claim 1 but may miss dependent claims

• Metastatic PRCC treated with effective amount of CCI-779, but:
  • route is non-IV (would not satisfy Claim 7)
  • weekly duration or dose band differs (would not satisfy Claims 8–10) Even so, Claim 1 may still capture treatment if route/dosing limitations are not required by the asserted claim.

Scenario that can avoid Claim 13 and Claim 14

• Combination regimen that includes interferon alpha
  • may still be captured by Claim 1 (no interferon exclusion in Claim 1), but it would not satisfy the interferon-absence or interferon-nonuse-dependent limitations in Claims 13 and 14.

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What patent estate surrounds US 8,791,097 (CCI-779 in papillary RCC) in the US?

Expected landscape structure

For a treatment-method patent tied to CCI-779 (temsirolimus), the US estate typically splits into:

1. Compound or composition patents for temsirolimus (active ingredient)
2. Medical use patents (methods of treating specific cancers or patient populations)
3. Combination regimens or specific exclusions/requirements (e.g., interferon alpha absence)
4. Dosing/administration patents (route, schedule, mg/week ranges)
5. Related dosing or formulation process patents (less likely to be central to the claims you provided, but common nearby)

US 8,791,097 is positioned in bucket (2) and (3)/(4): it reads as a tailored medical-use method with regimen constraints.

Claim-anchored enforcement focus

Given the claim language, the most litigated questions in an enforcement posture would be:

• Is the treated malignancy papillary RCC and metastatic?
• Was CCI-779 provided in an effective amount?
• Was administration IV, weekly, and within the stated dose and duration (for dependent claim assertions)?
• Was the regimen interferon alpha-free (Claim 14) or “no interferon” under Claim 13’s dependent allowance?
• Were other active agents used, and were they interferons?

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What Orange Book status issues matter for temsirolimus (CCI-779) and generic entry risk?

US medical-use method claims like 8,791,097 can constrain generic entry only if the generic product labeling or intended use triggers infringement for the covered indication and the statutory framework for use-code listings applies.

Key commercial/legal mechanics:

• If temsirolimus is approved via a brand NDA, the Orange Book may list patents tied to the indication(s) in the NDA, often including method-of-use patents for specific cancer types and settings.
• Paragraph IV certifications typically target expiring patents listed for the referenced indication.
• A medical-use method patent can be asserted against generic manufacturers or purchasers if the generic’s ANDA-labeling carve-outs do not avoid the patented use.

Because the provided prompt includes only the claims text for 8,791,097 and not the Orange Book listing details or ANDA/labeling history, the patent’s exact Orange Book enforcement posture cannot be determined from the available information.

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When does US 8,791,097 expire and how does that affect generic or biosimilar timelines?

Patent term usually hinges on:

• filing date (utility patent term from earliest effective non-provisional filing, plus any adjustments)
• potential terminal disclaimers
• patent-specific expiration calculation
• any pediatric exclusivity (if applicable)

However, the provided content does not include the patent’s filing, priority, grant, or adjustment data. Without those inputs, an accurate US exclusivity/expiration timeline cannot be produced.

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Is US 8,791,097 limited to metastatic PRCC or can it cover broader papillary RCC settings?

Claim 1 is explicit on metastatic PRCC. That does two things:

• It narrows the “must be metastatic” fact pattern required for Claim 1 infringement.
• It creates a relatively clean “workaround” at the level of indication design and prescribing evidence for non-metastatic PRCC.

Dependent claims retain the metastatic foundation through dependency, but add further specificity (hereditary type I/II, sporadic, previously untreated, advanced). “Advanced” may overlap with “metastatic” in clinical parlance but is not substitutable as a legal requirement for Claim 1’s explicit “metastatic” element.

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What does the interferon alpha limitation do for freedom to operate in combination regimens?

Claims 13 and 14 create an enforceable regimen boundary:

• Claim 14: absence of interferon alpha
• Claim 13: any further active agent must not be an interferon

Practical effect:

• Regimens incorporating interferon alpha can be designed to avoid the “interferon alpha absent” dependent limitations.
• If interferon is part of standard-of-care in a particular timeframe or protocol, the patent’s interferon-specific dependent claims may be harder to assert for that protocol. Still, Claim 1 remains unaffected by these specific interferon limitations if asserted as the independent claim.

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How strong is the claim set for litigation: what are the key elements that must be proven?

For a patentee, strong points in 8,791,097 include:

• Clear identification of drug: CCI-779
• Clear disease: papillary renal cell carcinoma
• Clear stage: metastatic
• Clear administration/dose parameters in dependent claims (IV; weekly; 1–250 mg/week; 25 mg/week)
• Clear interferon exclusion in dependent claims (interferon alpha absence; no interferons in the add-on active agent)

Key evidentiary elements in enforcement:

• Medical records or protocol docs establishing diagnosis subtype and metastatic status
• Evidence of CCI-779 administration and dosage
• Evidence of regimen composition, specifically presence or absence of interferon alpha
• Trial inclusion criteria or prescribing information if labeling/medical practice is used to establish “providing an effective amount”

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What would a generic “design-around” attempt look like under the claim structure?

Given the claim architecture, design-around levers include:

• Avoiding the metastatic PRCC indication in labeling or intended use (where possible)
• Avoiding CCI-779 use in that indication (not feasible for a generic temsirolimus product marketed for other indications but relevant for PRCC strategies)
• If pursuing protocol-level workarounds: including interferon alpha in a combination regimen can move practice outside Claims 13 and 14 (though not necessarily outside Claim 1)
• Using non-IV routes or non-weekly schedules could reduce or avoid dependent claim coverage (Claims 7–10), but again Claim 1 could remain at issue

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What patent comparisons matter: how does 8,791,097 compare with typical temsirolimus method-of-use claims?

Typical method-of-use claim patterns in oncology estates fall into three clusters:

1. Disease specificity (type of cancer)
2. Patient population specificity (hereditary vs sporadic; treatment-naïve; advanced)
3. Treatment operationalization (dose, schedule, route; regimen composition)

US 8,791,097 combines all three:

• disease: PRCC
• population: hereditary type I/II, sporadic, previously untreated, advanced
• operationalization: IV weekly dosing; mg/week bounds; 25 mg/week; sole active/sole anti-neoplastic; interferon exclusions

That combination increases “claim fit” against real-world prescribing and trial protocols, which often specify regimen details.

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Key patent risk points for developers and investors tied to this claim text

• Clinical-trial inclusion criteria for PRCC that are metastatic, especially when the regimen includes IV weekly temsirolimus (1–250 mg/week, including 25 mg/week).
• Interferon-free combinations: regimens that avoid interferon alpha align strongly with Claim 14.
• Monotherapy and “sole active agent” regimens: Claim 11 and Claim 12 map to protocols where temsirolimus is used without other active agents.
• Labeling and REMS not required to be identical to practice: infringement can be proven through actual treatment practices or protocol documents, not only marketing language.

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Key Takeaways

• US 8,791,097 is a metastatic papillary renal cell carcinoma treatment method patent tied to CCI-779 (temsirolimus).
• The claim set is built to match real-world oncology protocols: IV administration, weekly dosing, defined dose range (1–250 mg/week) and exemplary 25 mg/week, and defined duration window (1–24 months) in dependent claims.
• The regimen restrictions around interferon alpha (absence required in Claim 14; interferons prohibited for add-on active agents in Claim 13) create specific evidentiary hooks and design-around paths.
• The independent claim (Claim 1) is broader than interferon-dependent claims, so an “interferon workaround” may avoid dependent coverage but not necessarily independent claim exposure.
• Without the patent’s filing/priority and Orange Book listing details, an exact exclusivity/expiration and US generic entry timing cannot be computed from the provided record.

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FAQs

1. Does US 8,791,097 require IV administration to infringe?
   Claim 1 does not require IV, but dependent Claim 7 does.

2. Is the patent limited to hereditary papillary RCC or does it cover sporadic cases?
   It covers both: hereditary type I (Claim 2), hereditary type II (Claim 3), and sporadic (Claim 4).

3. How does adding interferon alpha affect infringement risk?
   It targets dependent claims: Claim 14 requires absence of interferon alpha, and Claim 13 requires that any additional active agent not be an interferon.

4. What dosing elements are explicitly covered?
   Dependent Claims 8–10: weekly for one to 24 months; IV dose 1 to 250 mg/week; including 25 mg/week.

5. Can a protocol that uses temsirolimus for advanced PRCC avoid the patent by arguing “not metastatic”?
   Claim 1 requires PRCC to be metastatic, so “advanced” alone does not replace the metastatic requirement.

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References

1. United States Patent No. 8,791,097.

Drugs Protected by US Patent 8,791,097

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pf Prism Cv	TORISEL	temsirolimus	SOLUTION;INTRAVENOUS	022088-001	May 30, 2007	AP	RX	Yes	Yes	8,791,097*PED				Y

International Family Members for US Patent 8,791,097

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008236621
Brazil	PI0809322
Canada	2681451
Chile	2008001009