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Patent landscape, scope, and claims: |
United States Patent 11,597,720 (Breast cancer) scope, claim coverage, and US patent estate risk map
Patent 11,597,720 is drafted as a broad breast-cancer treatment patent centered on three related elements: (i) a “compound” defined in claims 1/12/23/34 (and later tied to “a pharmaceutically acceptable salt” in claim 34), (ii) pharmaceutical compositions containing that compound, and (iii) combination regimens in which the compound is administered with a wide menu of additional anti-cancer agents and targeted therapies. The claims are structured to capture both monotherapy and multi-agent combinations, with method-of-treatment claims written to be indifferent to mechanism of the “additional anti-cancer agent” category, so long as the agent falls within the enumerated list or within the functional class set (e.g., FLT-3 inhibitor, VEGFR inhibitor, EGFR TK inhibitor, PARP inhibitor, checkpoint inhibitor).
Critically, the provided claim text shows a portfolio-like strategy: the same combination coverage appears repeatedly in claims 3-11 and 14-22 and 25-33 and 36-44 and is then reinforced by a consolidated “method” claim 45 that explicitly recites administration of the compound plus administration of an additional anti-cancer agent. This repetition increases enforcement options against different infringement theories (composition use vs. method, compound vs. salt, and monotherapy vs. combination).
What does US Patent 11,597,720 claim cover for breast cancer treatment?
Direct answer: The patent claims (a) the core compound (and salts), (b) compositions comprising it, (c) methods of treating breast cancer by administering those compositions, and (d) methods that further include an additional anti-cancer agent either from an explicit list or from defined target/functional inhibitor classes.
Core compound claims: what is protected in claims 1, 12, 23, and 34?
From your claim excerpt:
- Claim 1 / Claim 12 / Claim 23 / Claim 34: “A compound that is:” (and claim 34 further includes “or a pharmaceutically acceptable salt thereof”).
- The excerpt does not include the chemical structure or chemical definition that would normally appear after “A compound that is:”. Without the actual compound definition, the scope can only be described at the structural level of claim drafting (not the chemical boundaries).
Claim strategy observed in the excerpt
- Multiple independent compound claims (1, 12, 23, 34) are used to anchor different downstream claim sets: composition, method, and later a salt-focused anchor.
- The excerpt repeats the same functional scaffolding across multiple blocks, consistent with claim sets derived from different claims sets in prosecution (or multiple “compound variants” that are tied together via different claim labels).
Composition coverage: claims 2, 13, 24, 35
- Claim 2: “A pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.”
- Claim 13: composition with the compound of claim 12.
- Claim 24: composition with the compound of claim 23.
- Claim 35: composition with the compound of claim 34.
Enforcement implication: Any product sold as a pharmaceutical composition containing the claimed compound (or salt, via claim 34) can be positioned for product-based infringement and for method-of-use infringement if administered for breast cancer.
Method-of-treatment baseline: claims 3, 14, 25, 36
- Claim 3: method of treating breast cancer by administering an effective amount of a composition comprising the compound of claim 1.
- Claim 14: same for compound of claim 12.
- Claim 25: same for compound of claim 23.
- Claim 36: same for compound of claim 34.
Key drafting detail: The claims are “treating breast cancer” in a subject “in need thereof,” and the active compound is defined by the claim chain (compound → composition → method). This is standard broad method-of-use structure.
Combination therapy expansion: claims 4-11, 15-22, 26-33, 37-44
Each block adds a second therapeutic element:
- Claim 4: method includes at least one additional anti-cancer agent.
- Claim 5: specifies that the additional anti-cancer agent is one from a large enumerated list.
- Claim 6: subset narrowed to everolimus, capecitabine, docetaxel, paclitaxel, or abraxane.
- Claim 7: additional anti-cancer agent is chosen from target class categories (FLT-3 inhibitor, VEGFR inhibitor, EGFR TK inhibitor, aurora kinase inhibitor, etc., including checkpoint-1/2 inhibitors, anti-HGF antibody, VEGF trap antibody).
- The same structure reappears as claims 8-11 (additional anti-cancer agent administered as an additional step) and again in claims 15-22 and 26-33 and 37-44.
Consolidated combination method: claim 45
- Claim 45: “A method of treating breast cancer… comprising administering… a pharmaceutical composition comprising… a compound… and… a pharmaceutically acceptable carrier, and comprising administering… an additional anti-cancer agent.”
Enforcement implication: Claim 45 is the most direct “compound + additional anti-cancer agent” method that does not require you to rely on narrower dependent claim formatting; it expressly includes both administrations and a carrier.
How broad are the “additional anti-cancer agent” combinations covered by US 11,597,720?
Direct answer: The additional anti-cancer agent set is very broad because it includes (i) a long enumerated list of named agents and (ii) large functional target class categories. This makes it easier to argue infringement for many standard-of-care combination regimens used in breast cancer.
Enumerated additional anti-cancer agent list (claims 5, 9, 16, 20, 27, 31, 38, 42, 46)
The excerpt includes the following named agents (as “additional anti-cancer agent is [X]”):
- Cytotoxics / chemotherapies & related small molecules: docetaxel, paclitaxel, abraxane, carboplatin, cisplatin, oxaliplatin, vincristine, etoposide, gemcitabine, doxorubicin, 5′-deoxy-5-fluorouridine, topotecan, pemetrexed, camptothecin, capecitabine, temozolomide, epithilone B
- Hormonal agents / SERMs/SERDs: goserelin acetate, triptorelin, buserelin, flutamide, bicalutamide, nilutamide, tamoxifen, toremifene, anastrazole, letrozole, raloxifene, fulvestrant, acolbifene, lasofoxifene, idoxifene
- Targeted small molecules: PD0325901, pazopanib, erlotinib, vorinostat
- Biologics: bevacizumab, trastuzumab
- Other agents in the list: ticilimumab, ipilimumab
- Bone-targeted agents: pamidronate, zolendronate
- mTOR/PI3 pathway: everolimus
- Checkpoint inhibitors included via named antibodies: ticilimumab (IL-? CTLA-4 class as written), ipilimumab (CTLA-4)
Scope effect: If the accused regimen uses the claimed compound together with any of these named agents in the claimed combination framing, the patentee has a clean dependent-claim pathway to assert.
Narrow subset explicitly called out (claims 6, 10, 17, 21, 28, 32, 39, 43, 47)
Each block narrows to one of these five, repeated across the claim sets:
- everolimus, capecitabine, docetaxel, paclitaxel, abraxane
Scope effect: This subset is likely included to support easier proof and to capture commercially common combinations even if the defendant argues the additional agent must match only the broader classes.
Functional target class categories (claims 7, 11, 18, 22, 29, 33, 40, 44, 48)
The excerpt defines additional anti-cancer agents by class, including:
- FLT-3 inhibitor
- VEGFR inhibitor
- EGFR TK inhibitor
- aurora kinase inhibitor
- PIK-1 modulator
- Bcl-2 inhibitor
- HDAC inhibitor
- c-MET inhibitor
- PARP inhibitor
- Cdk inhibitor
- anti-HGF antibody
- PI3 kinase inhibitor
- AKT inhibitor
- mTORC1/2 inhibitor
- JAK/STAT inhibitor
- checkpoint-1 inhibitor
- checkpoint-2 inhibitor
- focal adhesion kinase inhibitor
- Map kinase kinase inhibitor
- VEGF trap antibody
Scope effect: This is materially broader than the enumerated list because many breast cancer regimens can be mapped to these classes even if the exact named drug is not present.
How the “additional anti-cancer agent” is introduced matters (claims 4 vs 8 vs 5 vs 6 vs 7)
There are two ways the dependent claims frame the combination:
- Inline composition/method recitation: e.g., Claim 4 “wherein the composition further comprises…”
- Add-on administration step: e.g., Claim 8 “further comprising the administration… of an additional anti-cancer agent”
Scope effect: This allows infringement theories whether:
- the additional agent is co-formulated in the same composition, or
- the additional agent is administered separately during the treatment course.
What is the practical claim-to-product map for infringement risk?
Direct answer: The patent can be asserted on either product composition infringement (composition containing the claimed compound) or method-of-use infringement (breast cancer treatment in a subject with that composition), with combination coverage materially expanding the asserted scenarios.
Infringement pathways created by the claim structure
- Pathway A: compound-in-composition
- If a generic or licensee product contains the claimed compound in a pharmaceutically acceptable carrier, composition claims 2/13/24/35 are implicated.
- Pathway B: treating breast cancer
- If the composition is used to treat breast cancer, method claims 3/14/25/36 are implicated.
- Pathway C: combination therapy
- If used with an additional anti-cancer agent from the enumerated list, dependent claims 5/9/16/20/27/31/38/42/46 apply.
- If used with an agent that fits one of the functional target classes, dependent claims 7/11/18/22/29/33/40/44/48 apply.
- Claim 45 consolidates a direct “administer compound + administer additional anti-cancer agent” method.
What does the scope imply for patent estate strength, based on claim breadth alone?
Direct answer: Based on drafting breadth (monotherapy + composition + breast-cancer method + expanded combination lists + functional target classes + repeated dependent claim nesting), the estate is designed to cover many standard combination regimens and to reduce design-around opportunities.
Areas where the excerpted claims increase enforceability
- Target-agnostic combination inclusion via functional classes.
- Broad agent list crossing chemotherapies, hormonals, targeted agents, biologics, checkpoint antibodies, and bone agents.
- Multiple redundant claim blocks that recreate the same combination concept, improving the ability to plead alternative theories in litigation.
- Salt coverage via claim 34 (and downstream chain).
Areas where the excerpted claims provide fewer specifics
- The excerpt does not include the chemical definition after “A compound that is:”. Without the specific chemical definition, you cannot determine whether the compound claim is limited to a single structure, a formula, a Markush genus, or a salt set, which would drive actual chemical coverage.
How might these claims be used in US patent litigation (strategic angles)?
Direct answer: The claim layout supports multiple litigation theories that track commercial development: product composition, method of use, and combination regimens. The combination language is likely to be central because it captures wide treatment standards.
Pleading and proof themes the claims support
- Method claims aligned to clinical trial designs: Breast cancer treatment regimens using the claimed compound plus a common oncology partner can be framed under dependent claims 4-11 and claim 45.
- Partner drug matching reduces disputes: The enumerated list offers a direct mapping for many regimens. The class categories offer a second route when a partner drug name is not in the list but still falls within a target class.
- Separate vs co-formulated dosing: Claims 4/5/6/7 and claims 8/9/10/11 create coverage whether the additional anti-cancer agent is combined in the same composition or administered as a separate regimen step.
What are the main “design-around” risks created by the broad combination coverage?
Direct answer: To avoid infringement, a product must typically avoid (i) the claimed compound/salts altogether, or (ii) using the compound in a breast-cancer treatment context with an additional anti-cancer agent that falls into the enumerated list or functional class categories captured by the dependent claims.
Design-around pressure points
- If the accused regimen uses the same additional agent list or target class categories, combination-dependent claims become difficult to avoid.
- If the regimen uses a new agent outside enumerated and outside the defined classes, the patentee’s class-based dependent claims may be harder to apply; however, claim 4/8 still require “at least one additional anti-cancer agent,” so the patentee can fall back to other dependent combinations only if they cover the substituted partner.
Key takeaways
- US 11,597,720 claims compound(s), compositions, and breast-cancer methods using a common compound basis across multiple claim sets.
- Combination therapy coverage is extensive: an enumerated list of many named anti-cancer agents plus functional class categories spanning major oncology targets (FLT-3, VEGFR, EGFR TK, PARP, PI3K, AKT, mTORC1/2, JAK/STAT, checkpoint-1/2, etc.) and includes checkpoint antibodies by at least ipilimumab in the excerpt.
- The claims cover both co-formulated compositions and add-on administration steps, increasing infringement surface area across dosing modalities.
- Claim 45 is a consolidated “compound + additional agent” breast-cancer method, likely the most straightforward asserted claim during litigation for combination regimens.
- Salt coverage exists via claim 34 in the excerpt, strengthening capture of salt-form commercial products.
FAQs
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Can US 11,597,720 be asserted for combination regimens where the additional anti-cancer agent is dosed separately rather than in the same composition?
Yes. The excerpt includes dependent method claims that add an additional anti-cancer agent via “further comprising the administration” (e.g., claim 8 and mirrored claims), covering separate dosing.
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Does the patent cover both monotherapy and combination therapy?
Yes. The baseline method/composition claims are independent (e.g., claim 3, 14, 25, 36), and dependent claims add combination therapy (e.g., claims 4-11 and mirrored sets).
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How does the patent broaden coverage beyond named drugs?
Through functional categories defining additional anti-cancer agents by target class (claims like 7, 11, 18, 22, 29, 33, 40, 44, 48), not only by enumerated drug names.
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What role does claim 34’s “pharmaceutically acceptable salt” play?
It expands the protected subject matter to salts of the claimed compound, which can matter for commercial formulation choices and generic/salt switching arguments.
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Which claims are most likely to be the litigation focus for combination therapy infringement?
Dependent combination method claims tied to the additional anti-cancer agent lists and classes (claims 4-11, 15-22, 26-33, 37-44) and the consolidated method claim 45.
References
No external sources were cited because the prompt provides only the claim text excerpt and does not include bibliographic details (publication number, filing date, assignee, specification, prosecution history, or any Orange Book or litigation records).
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