| Abstract: | The present invention relates to novel hydroxyl compounds, compositions comprising hydroxyl compounds, and methods useful for treating and preventing a variety of diseases and conditions such as, but not limited to aging, Alzheimer's Disease, cancer, cardiovascular disease, diabetic nephropathy, diabetic retinopathy, a disorder of glucose metabolism, dyslipidemia, dyslipoproteinemia, hypertension, impotence, inflammation, insulin resistance, lipid elimination in bile, obesity, oxysterol elimination in bile, pancreatitis, pancreatitius, Parkinson's disease, a peroxisome proliferator activated receptor-associated disorder, phospholipid elimination in bile, renal disease, septicemia, metabolic syndrome disorders (e.g., Syndrome X), thrombotic disorder. Compounds and methods of the invention can also be used to modulate C reactive protein or enhance bile production in a patient. In certain embodiments, the compounds, compositions, and methods of the invention are useful in combination therapy with other therapeutics, such as hypocholesterolemic and hypoglycemic agents. |
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Patent landscape, scope, and claims: |
Executive summary
US Patent 7,335,799 claims a highly configurable small-molecule scaffold (formula I) with variable ring/side-chain substitution parameters, covering individual compounds, pharmaceutically acceptable salts/hydrates/solvates, and formulations including combination therapy with a statin. The claim set you provided is broad at the “genus” level (parameter ranges for m (0–5), n (3–7), X (benzyl/phenyl or (CH2)z), Y1/Y2 (alkyl or acid/ester or sulfonic acid), and R1/R2/R11/R12 (broad C1–C6 alkyl through phenyl/benzyl)) while also adding narrower dependent claim pick-offs (examples include m = 0, m = 1, n = 4, n = 5, z = 0, z = 1, and selected Y1/Y2 combinations such as Y1 = methyl and Y2 = OH).
From a patent-landscape and freedom-to-operate (FTO) standpoint, the practical scope hinges on: (1) whether US7,335,799 is tied to a specific active ingredient class (the missing printed formula embodiments matter for identifying the exact covered “core”), (2) how many related patents in the same family also claim alternative parameter sets or specific species, and (3) whether later continuation/divisional filings or formulation/combo patents capture the clinically relevant salt/form/combination regimen.
Because your prompt provides only claim text, not the publication/application family, drug name, title, assignee, priority date, specification, or the exact structural depictions, a complete, accurate US landscape map (expiry, other patents, litigation, and competitor design-arounds) cannot be produced from the information in the record you supplied.
What does US Patent 7,335,799 claim at the genus level (formula I)?
Core claim 1 is a genus claim to “a compound of the formula I” with multiple independent variable parameters. Scope is defined by five main buckets:
Parameter map in claim 1
(a) m: integer 0–5
- Independent per occurrence, meaning the scaffold can support up to five repeating units in the relevant substructure positions.
(b) n: integer 3–7
- Controls length/spacing (typically a tether count) in the scaffold.
(c) X: either (CH2)z or phenyl (Ph)
- If (CH2)z: z = 0–4 (so includes the “z = 0” edge case, effectively turning that segment into a direct bond equivalent).
- If Ph: phenyl is substituted at positions 1,2- or 1,3- or 1,4- (so not meta/para restricted; the claim allows three distinct substitution patterns).
(d) R1, R2, R11, R12: each independently selected from a broad menu
- Options: H, C1–C6 alkyl, C2–C6 alkenyl, C2–C6 alkynyl, phenyl, benzyl
- Constraint: “R1,R2,R11,R12 are not each simultaneously H”
- This eliminates the single fully-unsubstituted configuration but still leaves an enormous number of substituted variants.
(e) Y1 and Y2: each independently selected from acids/esters/sulfonic acid/alkyl
- Options: (C1–C6)alkyl, OH, COOH, COOR3, SO3H
- Constraints:
- Y1 and Y2 are not each simultaneously (C1–C6)alkyl
- Ensures at least one position is a hydroxy/acid/ester/sulfonic functionality when alkyl appears.
- R3 (in COOR3): (C1–C6)alkyl, C2–C6 alkenyl, C2–C6 alkynyl, phenyl, or benzyl, with optional substitution: halo, OH, alkoxy, or phenyl.
- R4 and R5 define further substituent layers:
- R4: H/alkyl/alkenyl/alkynyl with up to one or two substituents (halo, OH, alkoxy, or phenyl)
- R5: H/alkyl/alkenyl/alkynyl
Read-across consequence
Claim 1 is written as a broad coverage of a chemical genus, not as a narrow “one molecule” patent. The limiting factors are mainly the scaffold parameter ranges and the requirement that at least one of R1/R2/R11/R12 is not H and that Y1/Y2 cannot both be purely alkyl.
How broad are the claims in practice (what combinations are literally covered)?
Using the claim structure as provided, the set of literally covered compounds is combinatorial. Examples of literal coverage included by the claim logic:
- Backbone lengths:
- n can be 3,4,5,6,7.
- m can be 0–5.
- Linker choice:
- X can be substituted phenyl (with specified substitution patterns) or a polymethylene segment (CH2)z with z ranging 0–4.
- Terminal functional group set:
- Y1/Y2 can be OH/COOH/COOR3/SO3H/alkyl under the “not both alkyl” constraint.
- Substitution density on R positions:
- Each of the four R groups can vary across aliphatic, unsaturated, aromatic, or benzyl substituents.
The practical implication for IP scope: many analogs that preserve the same formula framework but vary substituents within the listed ranges are within claim 1 unless they fall outside one of the enumerated parameter categories or violate the specific negative limitations.
What do the dependent claims do (which “species” are called out explicitly)?
Claims 2–15 carve out narrower selections from the genus, increasing enforceability for specific embodiments.
Key dependent claim selections
- Claim 2: Y1 and Y2 each independently are OH / COOR3 / COOH
- Eliminates alkyl and SO3H in those positions.
- Claim 3–4: m is specifically:
- Claim 3: m = 0
- Claim 4: m = 1
- Claim 5–6: n is specifically:
- Claim 5: n = 4
- Claim 6: n = 5
- Claim 7–8: z is specifically:
- Claim 7: z = 0
- Claim 8: z = 1
- Claim 9–10: Y1/Y2 specifically:
- Claim 9: Y1 is (C1–C6)alkyl and Y2 is OH
- Claim 10: Y1 = methyl and Y2 = OH
Species/structure claims (11–15)
Claims 11–15 are directed to “a compound according to claim 1” with specific structure depictions. Your prompt does not include the actual drawn structures in text form, but these claims typically:
- Provide specific enumerated exemplars from the specification (or closely related ones).
- Strengthen infringement positions by covering named or pictured species, even if the broad genus is challenged.
Composition claims (16–18)
- Claim 16: pharmaceutical composition containing a compound from claims 1/15/11/12/13/14 plus a pharmaceutically acceptable vehicle.
- Claim 17: composition including a second therapeutic agent.
- Claim 18: composition administered in combination with a statin.
This matters because even if a competitor avoids the exact compound, combination regimens can still trigger infringement if they use a covered compound in a statin combination regimen.
Which parts of the claim are most likely to control claim construction in litigation?
From the text you provided, the high-friction elements for claim construction are:
- The “formula I” scope
- Without the actual definition of the core scaffold and where each variable plugs into the molecule, claim construction will be anchored to the specification. In practice, courts interpret variable substitutions using the specification’s description of formula I.
- Negative limitations
- “R1,R2,R11,R12 are not each simultaneously H”
- “Y1 and Y2 are not each simultaneously (C1–C6)alkyl”
These can narrow an “edge” compound that otherwise fits the enumerations.
- The role of R3, R4, R5 substitutions
- Claim 1 includes layered substitution allowances for ester alkyl groups (COOR3) and substituents on R4/R5. This affects both literal coverage and potential “design-around” attempts.
How does US7,335,799’s scope compare with typical pharma patent estates (genus + specific species + combo)?
The structure of US7,335,799 is consistent with a common estate pattern:
- Genus coverage (claim 1) to catch broad chemical analogs.
- Dependent claim embodiments to preserve validity/infringement options and to help handle prior-art attacks.
- Specific structure claims (11–15) to lock down key species.
- Formulation and combination claims (16–18), including a statin combination.
This adds a clinical-use adjacency that often survives if the core compound claim is narrowed.
This combination of coverage layers means the enforceable set can be more resilient than a single-species-only patent, even though genus validity can be contested.
What is the likely commercial value of the patent estate for statin combination therapy?
Claim 18 creates a licensing and litigation hook: if the covered compounds are used alongside statins in a regimen, infringement can be argued even with partial chemical changes.
Commercially, this raises two value dimensions:
- Regimen lock-in: combination prescribing patterns create more “stickiness” than pure single-agent use.
- Incentive for competitors: competitors must consider both the chemical structure and the combination regimen. A competitor can sometimes avoid compound coverage, but statin combo claims increase the cost of that avoidance.
When does US Patent 7,335,799 lose exclusivity (patent term timeline)?
Not computable from the data provided. A correct exclusivity/term analysis requires:
- application filing date,
- patent issue date confirmation,
- any terminal disclaimers,
- possible patent term adjustment (PTA),
- and whether there are later continuation patents with later expiration.
No such bibliographic data is included in your prompt.
What patents protect the same formula family around US 7,335,799?
Not computable from the data provided. A complete landscape requires:
- the patent’s assignee,
- priority/continuation links,
- related US published applications,
- and family member patents in other jurisdictions.
The claim text alone does not identify the family.
What generic entry risks exist for compounds covered by US 7,335,799?
Not computable from the data provided. A real risk assessment depends on:
- whether the claimed compounds map to a marketed drug,
- Orange Book listing status,
- FDA approval status and whether the drug is covered by listed patents,
- and whether any generic applicant filed Paragraph IV challenges.
No FDA/Orange Book data is included in your prompt.
What is the Orange Book status of US 7,335,799?
Not computable from the data provided.
How strong is the patent estate for US 7,335,799 (enforceability levers and vulnerability points)?
Claim-strength indicators you can derive from the claim text:
Strengths
- Breadth within genus parameters: wide ranges for m/n/z and substituent classes.
- Multiple claim layers: genus (claim 1) plus species/structure-dependent claims (11–15) and compositions (16–18).
- Combination claim: claim 18 adds an additional infringement theory tied to a statin combination.
Vulnerabilities
- Genus validity risk: genus claims of this breadth can face enablement/adequate written description and indefiniteness arguments depending on specification support. Those determinations require specification content.
- “Not all H” and “not both alkyl” negative limitations: they can help avoid an exact prior-art match but may also create edge-case interpretive disputes on what counts as “simultaneously” for variable positions.
A litigation strength ranking cannot be produced without:
- prosecution history,
- claim construction history (if any),
- and the specification’s actual disclosure breadth.
Key takeaways
- US7,335,799 claim 1 is a broad genus defined by variable integers m (0–5), n (3–7), z (0–4) and enumerated substitution classes for X, R1/R2/R11/R12, and Y1/Y2.
- Dependent claims add specific parameter lock-ins (examples: m = 0 or 1, n = 4 or 5, z = 0 or 1) and selected functional group pairings (notably Y1 methyl, Y2 OH).
- Claims 11–15 (structure embodiments) and claims 16–18 expand enforcement beyond a single compound to pharmaceutical compositions and statin combination regimens.
- Exclusivity timelines, Orange Book status, family members, litigation posture, and generic entry risk are not determined from the claim text alone.
FAQs
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Do US7,335,799 claims cover salts, hydrates, and solvates?
Yes. Claim 1 expressly includes pharmaceutically acceptable salt, hydrate, solvate, or mixture forms.
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Can a competitor avoid infringement by changing only Y1/Y2 to two alkyl groups?
Claim 1 prohibits Y1 and Y2 being simultaneously (C1–C6)alkyl. If both positions are alkyl, the compound falls outside that limitation.
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Is a statin co-administration required to infringe claim 18?
Claim 18 is a composition regimen administered in combination with a statin, so infringement theory hinges on statin combination use.
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Which parameters are explicitly constrained in dependent claims?
Dependent claims pick specific values for m, n, and z, and specific combinations for Y1/Y2 (including methyl/OH).
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Does claim 1 require that all four R positions are substituted?
No. It only requires that R1,R2,R11,R12 are not each simultaneously H, meaning at least one of the four must differ from H.
References
- United States Patent 7,335,799, claims 1–18 (as provided in prompt).
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