US Patent 11,976,068: What Is Claimed, Where It Sits in the Landscape, and How Competitors Can Design Around
What is US 11,976,068 claiming at the core?
US 11,976,068 claims a pharmaceutical composition defined by (i) a specific active compound of Formula (1) (or a pharmaceutically acceptable salt) and (ii) a defined salt form plus (iii) a dosing range tied to free-base weight. The claims are composition-level, not method-of-treatment-level.
Claim 1 (independent)
Claim 1 requires all of the following elements:
- A pharmaceutical composition comprising:
- Active ingredient:
- “a compound of formula (1) or a pharmaceutically acceptable salt thereof”
- dose amount: “between about 100 mg to about 1000 mg”
- basis: “based on the free base weight”
- Formulation:
- “one or more pharmaceutically acceptable carrier”
- Salt requirement:
- “wherein the pharmaceutically acceptable salt is a di-salt.”
Claim 2 (dependent)
Claim 2 narrows Claim 1 by specifying salt identity:
- The di-salt is a hydrochloride di-salt.
What is the practical scope of the claims?
The scope is constrained by three distinct claim-limiting features:
1) The active is limited to Formula (1)
The active ingredient is not named in the claim excerpt, but it is restricted to “a compound of formula (1).” Any competitor composition that does not contain a compound matching Formula (1) (or an equivalent pharmaceutically acceptable salt of that compound) falls outside the literal language.
2) Salt must be a “di-salt”
Claim 1 is explicitly limited to a di-salt form. That term is a structural/ionic definition: it implies two salt-forming equivalents relative to the free base (as written in the claim). If a competitor uses a mono-salt (single counterion equivalent), or a salt that does not meet the “di-salt” characterization, it is outside Claim 1.
3) Claim 2 locks in hydrochloride di-salt
Claim 2 is even narrower: it requires the di-salt to be hydrochloride. That gives clear design-around leverage around the counterion (e.g., non-hydrochloride di-salts).
4) Dose window: 100 mg to 1000 mg based on free base weight
Claim 1 specifies a dosing amount “between about 100 mg to about 1000 mg” calculated on “free base weight.” This matters because competitors can change:
- the salt molecular weight and stoichiometry, and
- the amount of salt used to deliver the targeted free-base equivalent.
Even when delivering the same active, claim coverage depends on how the formulation is dosed and how “free base weight” maps to the exact administered amount.
How broad is coverage across formulation types?
Claim 1 is framed as a “pharmaceutical composition” with “one or more pharmaceutically acceptable carrier.” That is a very common and typically broad formulation hook, and it generally captures:
- solid dosage forms (tablets, capsules, granules),
- powders,
- dry blends,
- and liquid formulations,
provided they contain:
1) the Formula (1) compound as a di-salt, and
2) the required dose amount range, and
3) carriers.
Unless the specification adds additional constraints (not provided in your excerpt), the independent claim does not require a specific excipient list or particular dosage form. That means the practical scope is likely to cover many routine formulations so long as the salt and dose window requirements are met.
What does the claim structure imply about infringement triggers?
Literal infringement targets
To infringe Claim 1, a product must, in a single accused composition:
- contain the Formula (1) compound (or its pharmaceutically acceptable salt),
- where the salt is specifically a di-salt,
- and be dosed so that the amount of compound delivered is “between about 100 mg to about 1000 mg” on a free base weight basis,
- together with pharmaceutically acceptable carriers.
Claim 2 infringement requires the hydrochloride di-salt
If the product uses a different di-salt counterion (not hydrochloride), Claim 2 should not read on it, even if Claim 1 might.
Where does this sit in the US patent landscape?
Based only on the claim excerpt you provided, the invention class is best characterized as:
- salt-form + dose-range + composition coverage for a defined API structure (Formula 1),
- with counterion specificity at least for hydrochloride di-salt in the dependent claim.
This pattern usually clusters with other patents in the same family that cover one or more of:
- the compound itself (process and/or composition),
- polymorphs/solid-state forms,
- specific salts and preparation processes,
- unit dosage forms and/or dosing regimens.
However, a complete landscape requires bibliographic and family data (priority date, assignee, related publications, continuation history, and other claims in the patent). The claim excerpt alone does not provide that.
Given the constraint not to add missing data, the landscape below is limited to claim-driven positioning rather than citing other patents, because you have not supplied the patent’s bibliographic record, publication family, or the specification text.
What design-arounds are most directly suggested by the claim text?
Design-around 1: switch away from di-salt forms
If a competitor uses a salt form that is not a di-salt (for example, mono-salt forms), it avoids the di-salt limitation in Claim 1.
Design-around 2: keep the di-salt but change the counterion
If the competitor uses a di-salt that is not hydrochloride, it avoids Claim 2 while potentially still falling within Claim 1 depending on the di-salt characterization and counterion. The claim language does not restrict di-salt counterion in Claim 1 other than “di-salt,” so changing from hydrochloride to another di-salt can evade Claim 2 and potentially preserve freedom to operate for any claim dependent solely on hydrochloride.
Design-around 3: adjust administered amount relative to free-base equivalents
Claim 1 uses a dosing range “between about 100 mg to about 1000 mg” based on free base weight. If the competitor’s unit-dose or daily dose falls outside that free-base equivalent band, it can avoid literal infringement. Because the claim says “about,” there is some tolerance, but the key is that the dosing must be outside the defined range on the claimed basis.
Design-around 4: alter carriers/dosage form
Claim 1 requires “one or more pharmaceutically acceptable carrier.” That is typically hard to avoid if the product is an ordinary dosage formulation. A competitor would not gain much from changing excipients unless the claims/specification introduce additional restrictions beyond what you provided.
What is the likely claim priority and validity posture?
No priority dates, prosecution history, or claim amendments were provided in your excerpt. Without those, any analysis of patentability posture (novelty, non-obviousness, enablement, written description, indefiniteness) cannot be done accurately.
What can investors and R&D teams do with this scope right now?
1) Map your product attributes to claim elements
For any candidate product (or competitor product) assess:
- Does it use the API matching “compound of formula (1)”?
- Is the active present as a di-salt (not a mono-salt)?
- If di-salt, is it hydrochloride di-salt?
- Does the unit dose fall within 100 mg to 1000 mg based on free base weight?
2) If you are developing around it, prioritize salt selection and dosing calculation
Salt selection (di-salt identity) and free-base equivalent dosing calculations are the two clearest levers created directly by the claim language.
Key Takeaways
- US 11,976,068 is a composition claim that requires a Formula (1) API delivered as a di-salt with carriers, and dosed 100 mg to 1000 mg based on free base weight (Claim 1).
- Hydrochloride di-salt is mandatory only in Claim 2.
- The strongest design-arounds are salt form (di-salt vs non-di-salt) and counterion (non-hydrochloride di-salt), plus dosing outside the free-base equivalent window.
- Formulation carriers alone likely do not avoid infringement because the claim does not specify carrier identity.
FAQs
1) Does Claim 1 require hydrochloride specifically?
No. Claim 1 requires a di-salt, not a specific counterion. Hydrochloride di-salt is only in Claim 2.
2) If a product uses the same API but as a mono-salt, does it infringe Claim 1?
The claim requires the salt to be a di-salt. A mono-salt product should fall outside Claim 1 on the salt limitation.
3) If a product uses a di-salt but not hydrochloride, does it infringe Claim 2?
Claim 2 requires hydrochloride di-salt. A different di-salt counterion should avoid Claim 2.
4) How does the “based on free base weight” dosing affect infringement risk?
The claim defines the dose range using free base weight. A competitor can change how much salt corresponds to the same free-base equivalent, so the mapping from administered salt amount to “free base weight” matters for whether the product falls within 100 mg to 1000 mg.
5) Are method-of-treatment claims included based on the excerpt?
No. The provided claims are composition claims (pharmaceutical composition with carriers and defined active/salt/dose).
References
No sources were provided in your prompt, and no patent bibliographic data or full text was supplied beyond the two claim excerpts. Therefore no APA citations can be produced without inventing information.
