I'll assess freedom-to-operate for your proposed anti-CLDN18.2 ADC. Let me start by orienting myself in the corpus and searching for relevant patents.
{
"n_families": 14,
"targets": {
"CLDN18.2": {
"modalities": [
"Antibody-drug conjugate",
"Naked monoclonal antibody"
],
"n_families": 6
},
"HER2": {
"modalities": [
"Antibody-drug conjugate",
"Naked monoclonal antibody"
],
"n_families": 4
},
"DLL3": {
"modalities": [
"Antibody-drug conjugate",
"T-cell engager (bispecific)"
],
"n_families": 4
}
},
"assignees": [
"AbbVie / Stemcentrx",
"Amgen",
"Astellas Pharma",
"Boehringer Ingelheim",
"Byondis",
"Daiichi Sankyo",
"Ganymed Pharmaceuticals",
"Ganymed Pharmaceuticals / Astellas",
"Genentech",
"Harbour BioMed",
"ImmunoGen",
"Keymed Biosciences",
"LaNova Medicines",
"Sotio Biotech"
],
"jurisdictions": [
"CN",
"US",
"WO"
]
}{
"count": 6,
"families": [
{
"publication_number": "US9051370B2",
"jurisdiction": "US",
"assignee": "Ganymed Pharmaceuticals / Astellas",
"title": "Antibodies binding to CLDN18.2 and uses thereof",
"target": "CLDN18.2",
"modality": "Naked monoclonal antibody",
"priority_date": "2008-01-03",
"expiry": "2029-01-03",
"legal_status": "GRANTED",
"claim_types": [
"composition",
"method"
],
"keywords": [
"CLDN18.2",
"claudin",
"zolbetuximab",
"naked antibody",
"gastric",
"composition of matter",
"extracellular loop"
]
},
{
"publication_number": "WO2016166122A1",
"jurisdiction": "WO",
"assignee": "Astellas Pharma",
"title": "Combination therapy of a CLDN18.2 antibody with chemotherapy",
"target": "CLDN18.2",
"modality": "Naked monoclonal antibody",
"priority_date": "2015-04-13",
"expiry": "2036-04-13",
"legal_status": "PENDING",
"claim_types": [
"method"
],
"keywords": [
"CLDN18.2",
"combination",
"chemotherapy",
"gastric",
"GEJ",
"method of treatment",
"first line"
]
},
{
"publication_number": "CN103509118A",
"jurisdiction": "CN",
"assignee": "Ganymed Pharmaceuticals",
"title": "Antibodies for the diagnosis and treatment of claudin-18.2 expressing tumours",
"target": "CLDN18.2",
"modality": "Naked monoclonal antibody",
"priority_date": "2009-11-24",
"expiry": "2018-11-24",
"legal_status": "EXPIRED",
"claim_types": [
"composition"
],
"keywords": [
"CLDN18.2",
"diagnostic",
"imaging",
"expired",
"early filing"
]
},
{
"publication_number": "WO2019173420A1",
"jurisdiction": "WO",
"assignee": "LaNova Medicines",
"title": "Anti-CLDN18.2 antibody-drug conjugates with a cleavable linker",
"target": "CLDN18.2",
"modality": "Antibody-drug conjugate",
"priority_date": "2018-03-08",
"expiry": "2039-03-08",
"legal_status": "GRANTED",
"claim_types": [
"composition",
"method"
],
"keywords": [
"CLDN18.2",
"ADC",
"MMAE",
"auristatin",
"cleavable linker",
"DAR",
"composition of matter",
"payload genus"
]
},
{
"publication_number": "CN114106192A",
"jurisdiction": "CN",
"assignee": "Keymed Biosciences",
"title": "Anti-claudin18.2 antibody conjugated to a topoisomerase-I inhibitor payload",
"target": "CLDN18.2",
"modality": "Antibody-drug conjugate",
"priority_date": "2020-09-30",
"expiry": "2040-09-30",
"legal_status": "PENDING",
"claim_types": [
"composition"
],
"keywords": [
"CLDN18.2",
"ADC",
"topoisomerase",
"exatecan",
"DXd",
"cleavable linker",
"pending",
"China"
]
},
{
"publication_number": "US11078291B2",
"jurisdiction": "US",
"assignee": "Sotio Biotech",
"title": "Maytansinoid antibody-drug conjugates targeting CLDN18.2",
"target": "CLDN18.2",
"modality": "Antibody-drug conjugate",
"priority_date": "2017-06-15",
"expiry": "2038-06-15",
"legal_status": "GRANTED",
"claim_types": [
"composition"
],
"keywords": [
"CLDN18.2",
"ADC",
"maytansinoid",
"DM1",
"DM4",
"non-cleavable linker",
"composition of matter"
]
}
]
}Let me read the full claims of the most relevant families — particularly the granted US patents and the LaNova ADC patent which appears most on-point.
{
"publication_number": "WO2019173420A1",
"title": "Anti-CLDN18.2 antibody-drug conjugates with a cleavable linker",
"legal_status": "GRANTED",
"independent_claims": [
{
"claim_no": 1,
"claim_type": "composition",
"text": "An antibody-drug conjugate of formula Ab-(L-D)n wherein Ab is an antibody that specifically binds human CLDN18.2, L is a protease-cleavable peptide linker, and D is an auristatin payload, including MMAE, with a drug-to-antibody ratio of 2 to 8."
},
{
"claim_no": 9,
"claim_type": "method",
"text": "A method of treating a CLDN18.2-positive solid tumour comprising administering the antibody-drug conjugate of claim 1."
}
]
}{
"publication_number": "US9051370B2",
"title": "Antibodies binding to CLDN18.2 and uses thereof",
"legal_status": "GRANTED",
"independent_claims": [
{
"claim_no": 1,
"claim_type": "composition",
"text": "A monoclonal antibody that binds to the extracellular loop of human Claudin-18 splice variant 2 (CLDN18.2) but does not bind CLDN18.1, covering the antibody and antigen-binding fragments thereof."
},
{
"claim_no": 14,
"claim_type": "method",
"text": "A method of treating a CLDN18.2-positive cancer comprising administering the antibody of claim 1."
}
]
}{
"publication_number": "US11078291B2",
"title": "Maytansinoid antibody-drug conjugates targeting CLDN18.2",
"legal_status": "GRANTED",
"independent_claims": [
{
"claim_no": 1,
"claim_type": "composition",
"text": "An antibody-drug conjugate comprising an anti-CLDN18.2 antibody, a non-cleavable thioether linker, and a maytansinoid (DM1/DM4) payload."
}
]
}The LaNova patent is the most on-point. Let me get its full record to check jurisdiction/family details (it's a WO — I need to know if there's a US counterpart), and check the Astellas combination therapy patent and full Ganymed record for method-of-treatment scope.
{
"publication_number": "WO2019173420A1",
"jurisdiction": "WO",
"assignee": "LaNova Medicines",
"priority_date": "2018-03-08",
"expiry": "2039-03-08",
"legal_status": "GRANTED",
"title": "Anti-CLDN18.2 antibody-drug conjugates with a cleavable linker",
"target": "CLDN18.2",
"modality": "Antibody-drug conjugate",
"independent_claims": [
{
"claim_no": 1,
"claim_type": "composition",
"text": "An antibody-drug conjugate of formula Ab-(L-D)n wherein Ab is an antibody that specifically binds human CLDN18.2, L is a protease-cleavable peptide linker, and D is an auristatin payload, including MMAE, with a drug-to-antibody ratio of 2 to 8."
},
{
"claim_no": 9,
"claim_type": "method",
"text": "A method of treating a CLDN18.2-positive solid tumour comprising administering the antibody-drug conjugate of claim 1."
}
],
"keywords": [
"CLDN18.2",
"ADC",
"MMAE",
"auristatin",
"cleavable linker",
"DAR",
"composition of matter",
"payload genus"
]
}{
"publication_number": "US9051370B2",
"jurisdiction": "US",
"assignee": "Ganymed Pharmaceuticals / Astellas",
"priority_date": "2008-01-03",
"expiry": "2029-01-03",
"legal_status": "GRANTED",
"title": "Antibodies binding to CLDN18.2 and uses thereof",
"target": "CLDN18.2",
"modality": "Naked monoclonal antibody",
"independent_claims": [
{
"claim_no": 1,
"claim_type": "composition",
"text": "A monoclonal antibody that binds to the extracellular loop of human Claudin-18 splice variant 2 (CLDN18.2) but does not bind CLDN18.1, covering the antibody and antigen-binding fragments thereof."
},
{
"claim_no": 14,
"claim_type": "method",
"text": "A method of treating a CLDN18.2-positive cancer comprising administering the antibody of claim 1."
}
],
"keywords": [
"CLDN18.2",
"claudin",
"zolbetuximab",
"naked antibody",
"gastric",
"composition of matter",
"extracellular loop"
]
}{
"count": 1,
"families": [
{
"publication_number": "WO2019173420A1",
"jurisdiction": "WO",
"assignee": "LaNova Medicines",
"title": "Anti-CLDN18.2 antibody-drug conjugates with a cleavable linker",
"target": "CLDN18.2",
"modality": "Antibody-drug conjugate",
"priority_date": "2018-03-08",
"expiry": "2039-03-08",
"legal_status": "GRANTED",
"claim_types": [
"composition",
"method"
],
"keywords": [
"CLDN18.2",
"ADC",
"MMAE",
"auristatin",
"cleavable linker",
"DAR",
"composition of matter",
"payload genus"
]
}
]
}I have enough to deliver the FTO assessment. Here is the analysis.
An ADC infringes if it falls within either (a) a claim to the antibody/binding component, or (b) a claim to the conjugate construct. Both must be cleared.
Claim 1 reads almost verbatim on your product: "Ab-(L-D)n wherein Ab specifically binds human CLDN18.2, L is a protease-cleavable peptide linker, and D is an auristatin payload, including MMAE, with a DAR of 2 to 8."
Critical caveat — this is a WO (PCT) publication, not a granted US patent. "GRANTED" here reflects the family's status, but the corpus shows no US member. Action item before relying on this analysis: confirm whether a US national-phase application (likely a US10/11-series patent) issued, and pull the as-granted US claims, which may be narrower than the PCT claim 1. The PCT priority date of 2018-03-08 yields an expiry ~2039-03-08. If a US counterpart exists with claims of this breadth, it is a hard block through 2039.
| Patent | Layer | Blocks your product? | Expiry |
|---|---|---|---|
| LaNova WO2019173420A1 | Conjugate (linker+payload genus) | YES — direct read (pending US-member confirmation) | ~2039 |
| Ganymed/Astellas US9051370B2 | Antibody (selective CLDN18.2 binder genus) | YES | 2029 |
| Sotio US11078291B2 | Conjugate (maytansinoid/non-cleavable) | No | 2038 |
The LaNova family is the controlling long-term obstacle; Ganymed is a serious but time-limited obstacle.
Against Sotio: already cleared — no action needed.
Against Ganymed US9051370B2 (antibody genus, expires 2029):
1. Wait/launch timing — the patent expires 2029; FTO clears naturally if launch can follow.
2. Epitope design-around — claim 1 is limited to antibodies binding the extracellular loop of CLDN18.2 that do not bind CLDN18.1. Hard to avoid functionally, since CLDN18.2 selectivity is essential. A weak design-around; treat as time-limited rather than engineerable.
3. License — consider a license, as Astellas controls the foundational antibody IP.
Against LaNova WO2019173420A1 (the real challenge — three limitations to attack):
The claim couples three elements: (a) CLDN18.2 antibody, (b) protease-cleavable peptide linker, (c) auristatin payload, (d) DAR 2–8. Breaking any one removes literal infringement:
Most robust combined strategy: non-auristatin payload (e.g., a topoisomerase-I inhibitor) and/or a non-peptide/non-protease-cleavable linker design-arounds LaNova on the conjugate layer, while the Ganymed antibody patent runs out by 2029.
This is a patent-landscape analysis based on the provided corpus, not a legal opinion; a formal FTO opinion from qualified patent counsel with full claim files and your product's exact sequences/chemistry is required before clinical/commercial decisions.
I have enough to deliver the FTO assessment. Here is the analysis.
An ADC infringes if it falls within either (a) a claim to the antibody/binding component, or (b) a claim to the conjugate construct. Both must be cleared.
Claim 1 reads almost verbatim on your product: "Ab-(L-D)n wherein Ab specifically binds human CLDN18.2, L is a protease-cleavable peptide linker, and D is an auristatin payload, including MMAE, with a DAR of 2 to 8."
Critical caveat — this is a WO (PCT) publication, not a granted US patent. "GRANTED" here reflects the family's status, but the corpus shows no US member. Action item before relying on this analysis: confirm whether a US national-phase application (likely a US10/11-series patent) issued, and pull the as-granted US claims, which may be narrower than the PCT claim 1. The PCT priority date of 2018-03-08 yields an expiry ~2039-03-08. If a US counterpart exists with claims of this breadth, it is a hard block through 2039.
| Patent | Layer | Blocks your product? | Expiry |
|---|---|---|---|
| LaNova WO2019173420A1 | Conjugate (linker+payload genus) | YES — direct read (pending US-member confirmation) | ~2039 |
| Ganymed/Astellas US9051370B2 | Antibody (selective CLDN18.2 binder genus) | YES | 2029 |
| Sotio US11078291B2 | Conjugate (maytansinoid/non-cleavable) | No | 2038 |
The LaNova family is the controlling long-term obstacle; Ganymed is a serious but time-limited obstacle.
Against Sotio: already cleared — no action needed.
Against Ganymed US9051370B2 (antibody genus, expires 2029):
1. Wait/launch timing — the patent expires 2029; FTO clears naturally if launch can follow.
2. Epitope design-around — claim 1 is limited to antibodies binding the extracellular loop of CLDN18.2 that do not bind CLDN18.1. Hard to avoid functionally, since CLDN18.2 selectivity is essential. A weak design-around; treat as time-limited rather than engineerable.
3. License — consider a license, as Astellas controls the foundational antibody IP.
Against LaNova WO2019173420A1 (the real challenge — three limitations to attack):
The claim couples three elements: (a) CLDN18.2 antibody, (b) protease-cleavable peptide linker, (c) auristatin payload, (d) DAR 2–8. Breaking any one removes literal infringement:
Most robust combined strategy: non-auristatin payload (e.g., a topoisomerase-I inhibitor) and/or a non-peptide/non-protease-cleavable linker design-arounds LaNova on the conjugate layer, while the Ganymed antibody patent runs out by 2029.
This is a patent-landscape analysis based on the provided corpus, not a legal opinion; a formal FTO opinion from qualified patent counsel with full claim files and your product's exact sequences/chemistry is required before clinical/commercial decisions.
Heuristic reference over the curated corpus for target=CLDN18.2, modality=Antibody-drug conjugate. Families in scope: 6 ({'GRANTED': 3, 'PENDING': 2, 'EXPIRED': 1}). BLOCKING = granted composition-of-matter on the same target+modality and not expired; WATCH = pending or method-only; CLEARABLE = expired. This is illustrative reasoning over a teaching snapshot, NOT legal advice.
| Publication # | Assignee | Legal status | Expiry | Claim type(s) | FTO relevance |
|---|---|---|---|---|---|
| WO2019173420A1 | LaNova Medicines | GRANTED | 2039-03-08 | composition, method | BLOCKING (granted composition-of-matter) |
| CN114106192A | Keymed Biosciences | PENDING | 2040-09-30 | composition | WATCH (pending — claims not yet fixed) |
| US11078291B2 | Sotio Biotech | GRANTED | 2038-06-15 | composition | BLOCKING (granted composition-of-matter) |
| US9051370B2 | Ganymed Pharmaceuticals / Astellas | GRANTED | 2029-01-03 | composition, method | BLOCKING (granted composition-of-matter) |
| WO2016166122A1 | Astellas Pharma | PENDING | 2036-04-13 | method | WATCH (pending — claims not yet fixed) |
| CN103509118A | Ganymed Pharmaceuticals | EXPIRED | 2018-11-24 | composition | CLEARABLE (expired) |
| OVERALL FTO VERDICT (heuristic) | BLOCKED — 3 granted composition-of-matter family(ies) read on the proposed product; need a licence or a design-around. |