US Patent 11,643,397: scope, claim coverage, and US patent landscape for anemia treatment compounds
US Patent 11,643,397 is directed to (1) a broad genus of substituted compounds defined by a generic formula (I) with specific constraints on substituents and heteroatoms, and (2) method-of-treatment claims for anemia using the genus compound, with narrower dependent coverage to a single named active (N-[(1,3-dicyclohexyl-6-hydroxy-2,4-dioxo-1,2,3,4-tetrahydro-5-pyrimidinyl)carbonyl]glycine) and its salts. Claim scope is primarily driven by the formula (I) scaffold and the R1/R4 and R2 substitution definitions, while potency/biomarkers are not stated in the independent claim set you provided, making coverage hinge on chemical structure rather than clinical endpoints.
What is US Patent 11,643,397 claim scope for anemia treatment compounds?
Answer (scope snapshot). The patent covers a chemical genus defined by formula (I) (claim 1), plus US method-of-use claims for treating anemia in humans via administering the compound (claims 2-4). The only expressly singled-out chemical entity in the claim text you provided is the N-[(1,3-dicyclohexyl-6-hydroxy-2,4-dioxo-1,2,3,4-tetrahydro-5-pyrimidinyl)carbonyl]glycine structure in claims 3-4.
Claim 1: formula (I) genus coverage and structural limits
Claim 1 requires all of the following, as shown in your excerpt:
- Core scaffold: “A compound according to formula (I)” with:
- X = O and Y = O
- R2 = —OR9
- R3 = H
- R1 and R4 are each independently selected from a defined substituent group:
- hydrogen; C1-C10 alkyl; C2-C10 alkenyl; C2-C10 alkynyl; C3-C8 cycloalkyl; cycloalkyl-C1-C10 alkyl; C5-C8 cycloalkenyl; cycloalkenyl-C1-C10 alkyl
- C3-C8 heterocycloalkyl and heterocycloalkyl-C1-C10 alkyl
- aryl, aryl-C1-C10 alkyl
- heteroaryl, heteroaryl-C1-C10 alkyl
- Substitution constraint: “any carbon or heteroatom of R1, and R4 is unsubstituted”
- Salt coverage: includes pharmaceutically acceptable salts
- R9: H or a cation (meaning the —OR9 can be a free hydroxyl (R9=H) or an ionic ether/alkoxy form depending on R9 definition)
- Unsubstituted requirement is a narrowing element: If R1 or R4 is selected as “aryl” or “heteroaryl,” the claim text as provided also says any carbon or heteroatom of R1/R4 is unsubstituted. That can exclude substituted aromatic rings (even if not obvious from the substituent list).
Practical implication for competitors. To design around claim 1, a structural change has to break at least one required element: X and Y both O, R3 = H, R2 = —OR9, the allowed R1/R4 substituent classes, and the “unsubstituted” constraint on those R1/R4 groups.
Claims 2-4: method-of-use scope
- Claim 2 is a method-of-treatment claim: treating anemia in a human in need thereof by administering a therapeutically effective amount of the claim 1 compound.
- Claim 3 is a direct method claim using the specific named compound (same compound as in claim 1’s genus but explicitly recited).
- Claim 4 is the same as claim 3 without the salt alternative.
Practical implication. Even if a competitor avoids the genus by changing substituents, claim 3-4 may still capture marketing/infringement if they use the exact named active.
How broad are the R1/R4 substitutions under US 11,643,397?
Answer. Broad on paper for R1/R4 (many aliphatic and aromatic substituent categories) but narrowed by the phrase requiring that any carbon or heteroatom of R1 and R4 is unsubstituted.
Substitution categories that are potentially included
From the claim text:
- Hydrogen (R1 or R4 can be H)
- Straight chain alkyl C1-C10
- Alkenyl C2-C10 and alkynyl C2-C10
- Cycloalkyl C3-C8 and cycloalkyl-C1-C10 alkyl (for example cyclohexyl-methyl type patterns)
- Cycloalkenyl C5-C8 and cycloalkenyl-C1-C10 alkyl
- Heterocycloalkyl C3-C8 and heterocycloalkyl-C1-C10 alkyl
- Aryl and heteroaryl
- Aryl-C1-C10 alkyl and heteroaryl-C1-C10 alkyl
Key narrowing language
- “where any carbon or heteroatom of R1, and R4 is unsubstituted”
- This text is often used to avoid substitution on the ring or on the substituent itself.
- It likely eliminates aryl/heteroaryl rings bearing additional substituents (other than the attachment point to the core), and it may eliminate substituted alkyl/alkenyl substituents where an internal carbon bears substituents.
Design-around focus. A competitor should treat that sentence as a meaningful structural constraint. Changes such as installing substituents on the aromatic ring (if that is within the R1/R4 “any carbon or heteroatom” definition) are the most obvious path to avoid this narrowing phrase, but the actual claim construction depends on the patent’s full specification and definitions.
What are the key non-compound elements: X, Y, R2, and R3 constraints?
Answer. These are hard “fixed” elements that limit the genus.
Hard-coded heteroatoms
- X = O
- Y = O
If a competitor can change these positions (for example converting an oxygen to sulfur or carbon), claim 1 would not read.
Functional group constraints
- R2 = —OR9
- If R2 must be an alkoxy (ether) substituent, then alternative direct hydrogen bonding groups or different linkers may fall outside.
- R3 = H
- Eliminates substitution at the R3 position.
R9 options
- H or a cation
If R9 being a cation means a salt-like form beyond a “pharmaceutically acceptable salt,” then claim coverage may extend to certain ionic forms. Still, claim 1 expressly also covers pharmaceutically acceptable salts.
How many patent claims are potentially implicated by a product using the named active?
Answer. At least two method claims (claims 3 and 4) and the overarching genus claim (claim 1) depending on structural identity.
Infringement pathways if the named active is used
- If a drug’s API is exactly N-[(1,3-dicyclohexyl-6-hydroxy-2,4-dioxo-1,2,3,4-tetrahydro-5-pyrimidinyl)carbonyl]glycine (or a salt thereof), then claims 3 and 4 are directly implicated (with claim 3 expressly including salts).
- If the product’s API is a structural variant within formula (I), claim 1 and claim 2 are implicated.
What is the Orange Book status of US 11,643,397 and which FDA products map to it?
Answer. Nothing in the information provided includes Orange Book listings, FDA NDA/BLA numbers, applicant/holder, or Orange Book patent identifiers tied to US 11,643,397. Without those mappings, a product-level Orange Book status determination cannot be produced from the claim text alone.
When does US 11,643,397 lose exclusivity for anemia drugs?
Answer. The information provided does not include the issuance date, earliest priority date, patent term adjustments, or patent term adjustment schedules. Without those data, an exclusivity and expiration timeline cannot be calculated from claim text alone.
What patent expiration and litigation risks exist for generic or biosimilar entry?
Answer. This patent set appears to be directed to a small-molecule compound and small-molecule method-of-use, not a biologic. Biosimilar frameworks and 351(k) are not implicated from claim text alone. For generics, the relevant risk is ANDA Paragraph IV exposure if the ANDA references an approved product for anemia and includes certifications against any listed patent(s) that correspond to US 11,643,397.
No litigation docket numbers, settlement dates, or ANDA references are provided, so the landscape cannot be quantified here.
What other patents typically cover the same anemia active scaffold as US 11,643,397?
Answer. In a typical chemical-genus pattern, a patent estate covering an anemia small molecule often includes:
- additional composition-of-matter patents on alternate substituents (different R1/R4 sets),
- process/method-of-manufacture patents,
- formulation patents (tablet, capsule, controlled release),
- additional method-of-use patents (different anemia subtypes, dosing regimens, combination therapies).
However, no co-cited patent numbers, related applications, assignees, or family members were provided, so the actual US and global landscape for US 11,643,397 cannot be enumerated here.
How does claim 1 compare with the narrower specific-entity claims (3-4)?
Answer. Claim 1 is a genus; claims 3-4 are a specific species.
Scope hierarchy
- Claim 1 (genus): covers formula (I) compounds where R1 and R4 fall into defined sets with “unsubstituted” constraint, X and Y are O, R3 is H, and R2 is —OR9.
- Claims 3-4 (species): cover one specific member of the genus, with the exact substituent pattern implied by the named chemical (including “1,3-dicyclohexyl” and “6-hydroxy”).
Design-around implications
- Avoiding the named compound does not necessarily avoid claim 1 if another genus member is used.
- Avoiding the genus might still not avoid claims 3-4 if the formulation includes or enables use of the named active, or if the named active is present in combination.
What formulations are protected by US 11,643,397?
Answer. The claims provided are for compound structure and method of use. No formulation-specific limitation (dosage form, excipients, polymorphs, particle size, release kinetics) is included in claims 1-4 as provided.
What manufacturing/IP barriers exist for compounds within formula (I)?
Answer. The provided claim text does not include manufacturing methods or process limitations. Structural infringement analysis therefore dominates rather than process infringement.
Key Takeaways
- US 11,643,397 is structured around a small-molecule genus (claim 1) plus anemia method-of-use (claims 2-4).
- Claim 1 is constrained by fixed heteroatoms (X=O, Y=O), R3=H, R2=—OR9, allowed R1/R4 substituent categories, and a narrowing requirement that any carbon or heteroatom of R1 and R4 is unsubstituted.
- Claims 3-4 target a specific named active: N-[(1,3-dicyclohexyl-6-hydroxy-2,4-dioxo-1,2,3,4-tetrahydro-5-pyrimidinyl)carbonyl]glycine (and optionally its salts).
- The provided information is insufficient to map the patent to Orange Book listings, FDA product(s), expiration dates, or litigation/Paragraph IV events.
FAQs
- Does US 11,643,397 cover anemia treatment for specific anemia subtypes or only “anemia” broadly?
- If a compound matches formula (I) but changes the ether group at R2, does claim 1 still apply?
- Can a product avoid infringement by using a different R1/R4 substitution pattern while keeping X=O and Y=O?
- Do claims 3-4 require administration of the free base or also cover salts in practice?
- Is this patent likely to be asserted against ANDAs via Paragraph IV certifications, and on which claim types?
References
No external sources were provided or cited in the prompt, and none can be generated accurately from the claim excerpt alone.
