Scope and Claims Analysis for US Patent 7,259,186 (Fenofibric Acid Salts and Enteric Polymer Molecular-Dispersion Formulations)
US 7,259,186 covers (i) specific fenofibric acid salts (choline, ethanolamine, diethanolamine, piperazine, calcium, tromethamine) and (ii) pharmaceutical formulations that combine those salts with an enteric binder used in a “molecular dispersion” context, with defined enteric polymer classes and specific polymer exemplars. The claim set is narrow on salt identity and practical on formulation design, with meaningful protection concentrated in oral solid enteric systems using enteric polymer binders and disclosed composition ranges.
What does US 7,259,186 claim for fenofibric acid salts in the US?
Core protection is salt identity plus a specific formulation architecture. The independent claim structure is effectively split into two invention buckets:
- Substance claims: a “salt of fenofibric acid” limited to enumerated counterions.
- Formulation claims: a pharmaceutical formulation in a form of “molecular dispersion” comprising the enumerated salt and an enteric binder that is further constrained to enteric polymer options in dependent claims.
Claim 1-7: Product claims limited to enumerated salts
- Claim 1: “A salt of fenofibric acid” selected from:
- choline
- ethanolamine
- diethanolamine
- piperazine
- calcium
- tromethamine
- Claims 2-7: each dependent claim narrows to one specific salt from the same set.
Legal scope consequence: these are relatively clean and easy to map in infringement. A product that is one of these salts, as such, hits Claim 1 and (depending on the salt) the corresponding dependent claim.
Claim 8-15: Formulation claims focused on “molecular dispersion” + enteric binder
- Claim 8 (independent formulation claim):
A pharmaceutical formulation in a form of molecular dispersion comprising:
- the fenofibric acid salt (restricted to the same enumerated group), and
- a binder component comprising at least one enteric binder.
- Claims 9-15 (dependent narrowing):
- Claim 9: adds “physiologically acceptable excipient.”
- Claim 10: enteric binder is an enteric polymer.
- Claim 11: enteric polymer selected from:
- hydroxypropylmethylcellulose phthalate (HPMCP)
- hydroxypropylmethylcellulose acetate succinate (HPMCAS)
- carboxymethylethylcellulose (CMEC)
- cellulose acetate phthalate (CAPh)
- cellulose acetate trimellitate (CAT)
- carboxymethylcellulose sodium (CMC-Na)
- Claim 12: enteric polymer can be a copolymer of (meth)acrylic acid and alkyl (meth)acrylic acid ester.
- Claim 13: the alkyl (meth)acrylic acid ester is methyl methacrylate.
- Claim 14: formulation composition ranges:
- about 5–60% by weight salt
- about 20–95% by weight binder component
- Claim 15: excipient range:
- about 1–60% by weight physiologically acceptable excipient
Legal scope consequence: Claim 8 is formulation architecture based and will be litigated on whether the accused formulation is “molecular dispersion” and whether the binder contains an “enteric binder.” Claims 10-13 and 11 add polymer identity and structural class constraints. Claims 14-15 add composition percentage windows that can create design-around opportunities.
How broad is the “salt” claim scope (Claim 1) compared with dependent salt claims (2-7)?
Claim 1 is the breadth anchor. It covers any salt form where fenofibric acid is paired with the enumerated counterion set. Dependent claims 2-7 simply isolate each salt identity.
Practical breadth check
- If a product uses another amine counterion (for example, meglumine, morpholine, tromethamine already listed but others not listed), it avoids Claim 1 because the counterion is not in the specified list.
- If a product uses a mixture of salts, infringement depends on whether the formulation contains the claimed salt(s) in a way that is within “a salt … selected from” the enumerated group.
What formulations are covered by Claim 8’s “molecular dispersion” requirement?
Claim 8 requires three elements working together:
- fenofibric acid salt from the enumerated set
- molecular dispersion form
- binder component containing at least one enteric binder
“Molecular dispersion” as a claim limiter
From the claim language, the scope is not just “solid dispersion” or “spray dried dispersion” generally; it is specifically “molecular dispersion.” In litigation, this usually becomes a factual/technical question tied to the claimed physical state (e.g., dissolution/dispersion state, absence of crystalline drug, and characterization results). That means:
- A formulation that uses the salt but in a conventional matrix without meeting “molecular dispersion” may be outside Claim 8 even if it has enteric binder and excipients.
“Enteric binder” as a functional limiter
Claim 8 does not limit enteric binder to a polymer in the independent claim. That limitation comes in dependent Claim 10:
- Independent: “binder component comprising at least one enteric binder”
- Dependent: “wherein the enteric binder is an enteric polymer”
So an accused binder could be an enteric binder that is not an “enteric polymer,” avoiding dependent Claim 10 but potentially still being within Claim 8.
Which enteric polymer choices are explicitly within scope (Claims 10-13)?
Claim 11 lists specific enteric polymers. Claim 12 also expands scope through a structural class: copolymers of (meth)acrylic acid and alkyl (meth)acrylic acid ester, with Claim 13 specifying methyl methacrylate as the ester.
Covered polymer exemplars (Claim 11)
- HPMCP
- HPMCAS
- CMEC
- CAPh
- CAT
- CMC-Na
Covered polymer class (Claim 12)
- copolymers where backbone includes (meth)acrylic acid
- includes at least one alkyl (meth)acrylic acid ester
Specific ester identity (Claim 13)
- alkyl (meth)acrylic acid ester = methyl methacrylate
Scope implication: there is both (i) “named polymer” coverage and (ii) “structural class” coverage. A design-around that avoids the named polymers but still uses an (meth)acrylic-acid/ester copolymer could still fall within Claims 12-13 (depending on ester identity). Avoidance typically requires moving away from that polymer family or changing binder/dispersion strategy to avoid Claim 8 altogether.
What formulation composition ranges create infringement and design-around boundaries (Claims 14-15)?
Claim 14 ranges
- Salt: about 5–60% w/w
- Binder component: about 20–95% w/w
Claim 15 excipient range
- Physiologically acceptable excipient: about 1–60% w/w
Design-around logic: if an accused formulation uses salt outside 5–60% or uses binder outside 20–95%, it can argue it does not meet the dependent claim constraints (14 and 15). However:
- If Claim 8 is the infringement target, Claim 8 itself does not recite these exact weight ranges. Weight-range claims matter most if the patentee asserts dependent claims, not the independent claim.
Litigation posture impact: Claim 14 and 15 provide additional “rails” that can be used to tighten infringement contentions, particularly for product characterization and formulation disclosures.
How does US 7,259,186 compare with typical fenofibric acid salt/formulation patent strategies?
This patent is unusually claim-compact and counterion-specific. Many fenofibric acid formulation patents are broader around polymorphs, manufacturing methods, or combinations of actives. Here, the claim strategy is:
- Enumerate counterions (six salts) directly in Claim 1.
- Combine that narrow active form with an “enteric binder” in a “molecular dispersion” format.
- Use dependent claims to narrow down enteric polymer identities and polymer classes.
- Add quantitative ranges for salt, binder, and excipient.
Net effect:
- The “salt” part is strong for any product that uses the listed salts.
- The “formulation” part is strong for enteric oral solids that use those salts in molecular-dispersion style systems with enteric polymer binders.
How do you map infringement risk for competing fenofibric acid products?
High-risk infringement scenarios
A product is likely to face exposure if all are true:
- it uses one of the listed salts (choline, ethanolamine, diethanolamine, piperazine, calcium, tromethamine)
- it is formulated as a “molecular dispersion”
- its binder contains an enteric binder, ideally an enteric polymer in the named set or the (meth)acrylic acid/ester copolymer family
Medium-risk scenarios
- Listed salt is present and binder is enteric, but the product’s solid-state description/characterization does not support “molecular dispersion.” This can undermine Claim 8 while leaving Claim 1 exposure (if the product is sold as a salt form) depending on how the accused product is categorized.
Lower-risk scenarios
- Counterion not in the enumerated list. This avoids Claim 1/2-7 and removes Claim 8’s dependent anchoring because Claim 8 requires the same salt group.
What is the patent landscape around this patent’s claim themes (salt identity + enteric polymer binders)?
Within the fenofibric acid space, patent estates typically cluster around:
- salt forms (counterion selection)
- enteric coating or enteric excipients for delayed release
- solid dispersions (including amorphous or molecular dispersion)
- polymer selection for enteric function
- composition ranges and manufacturing controls
US 7,259,186 sits at the intersection: it ties salt identity to enteric binder molecular-dispersion formulations, creating a narrower but more enforceable footprint for a specific combination.
What expiration or exclusivity timeline applies to US 7,259,186?
No expiry or exclusivity timeline can be produced from the claim text provided. Patent term and patent-specific expiration require the application/patent filing and priority dates, and any PTA/adjustments, which are not included here. (Under the provided inputs, the full patent bibliographic data is not available.)
Orange Book status, FDA listing, and Paragraph IV / biosimilar challenge risk for this patent
No Orange Book status, FDA regulatory pathway, or listed reference drug can be determined from the claim text alone. Claim content does not identify the listed drug product, NDC, reference listed drug, or whether the patent is Orange Book-listed for a specific NDA/ANDA/BLA. Without that, challenge pathways cannot be mapped to this specific patent.
Key Takeaways
- Claims 1-7 are counterion-specific: they protect fenofibric acid salts only for choline, ethanolamine, diethanolamine, piperazine, calcium, and tromethamine.
- Claim 8 is the formulation hinge: it requires a “molecular dispersion” formulation combining one of the enumerated salts with a binder component that includes an enteric binder.
- Dependent claims 10-13 narrow enteric polymer scope to specific enteric polymers and to (meth)acrylic acid copolymers with ester units, with methyl methacrylate identified in the narrower dependent claim.
- Dependent quantitative ranges (Claims 14-15) provide additional tightening rails but do not appear in the independent Claim 8, so the primary independent scope is broader than the dependent numeric limits.
FAQs
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Does Claim 8 require the enteric binder to be an enteric polymer?
No. Claim 8 only requires an “enteric binder” in the binder component. Claim 10 narrows further to an enteric polymer.
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If a formulation uses one of the listed fenofibric acid salts but is not in “molecular dispersion,” is it outside the patent?
It can be outside Claim 8 because “molecular dispersion” is a claim limitation in the independent formulation claim.
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Can an accused product avoid the polymer-dependent claims by using an enteric binder that is not a polymer?
It may avoid Claims 10-13 if the enteric binder is not an enteric polymer and does not meet the dependent limitations, but Claim 8 could still be in play if an “enteric binder” is present.
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Are salt-range and excipient-range limitations required to infringe?
Those ranges appear in dependent Claims 14 and 15. Claim 8 does not include those numeric limits.
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Do Claims 1-7 protect manufacturing methods or just the salts themselves?
As written, Claims 1-7 are product claims to the salts themselves, not explicit manufacturing methods.
References (APA)
- Provided claim text for US 7,259,186 (fenofibric acid salts; molecular dispersion formulations with enteric binders).
