United States Patent 5,047,398: Scope, Claim Boundaries, and U.S. Patent Landscape
What does U.S. Patent 5,047,398 claim, and what is its enforceable core?
U.S. Patent 5,047,398 claims oral, gastrointestinally absorbable antidiuretic use of 1-deamino-8-D-arginine vasopressin (commonly known as desmopressin, with the specific peptide stated in the claims) using a solid oral dosage form and/or a dosing regimen expressed per 70 kg human.
Claim 1 defines the composition core (oral desmopressin + specific carrier context)
Claim 1 is the broadest composition claim and recites:
- Drug substance: “1-deamino-8-D-arginine vasopressin”
- Functional requirement: “gastrointestinally absorbable” and “antidiuretically effective”
- Form/route constraint: “solid oral dosage form for absorption in the gastrointestinal tract”
- Vehicle: “a pharmaceutically acceptable carrier”
This claim does not require a specific carrier identity, excipient profile, coating system, or disintegration technology. It requires the composition be formulated so the peptide is absorbed in the GI tract (i.e., oral bioavailability) and the solid form is intended for GI absorption.
Claims 2–3 narrow dosage form
- Claim 2: tablet
- Claim 3: capsule
These are straightforward form-factor limitations. They do not introduce new technical boundaries beyond the oral solid format.
Claims 4–5 lock dosing windows (micrograms per 70 kg per dosage)
- Claim 4: 50 to 200 micrograms per 70 kg human per dosage
- Claim 5: 50 to 100 micrograms per 70 kg human per dosage
These claims constrain the peptide amount administered per dose. They are not tied to frequency, formulation parameters, or pharmacokinetic specifics; the patent expresses a dose range.
Claims 6–11 define method-of-use (GI absorption + initiation/treatment)
- Claim 6: initiating antidiuresis by administering GI absorbable antidiuretically effective amounts of the peptide for GI absorption
- Claim 7: same method with the 50–200 micrograms per 70 kg per dosage constraint
- Claim 8: 50–100 micrograms per 70 kg per dosage
- Claims 9–10: GI absorption method with form limited to tablet or capsule
- Claim 11: treating diabetes insipidus by administering the same GI absorbable antidiuretically effective peptide for GI absorption
Bottom line: the enforceable center of gravity is oral GI-absorbable desmopressin (peptide + GI absorption + antidiuretic efficacy) in a solid oral form, optionally limited to tablet/capsule and dose ranges.
How broad are the claim terms (and where do the boundaries sit)?
“Gastrointestinally absorbable”
This is the key novelty hook. The claim requires GI absorption, which is a functional and physiological requirement. In infringement terms, the argument typically turns on whether the accused formulation enables systemic absorption from the GI tract to produce antidiuretic effect.
“Antidiuretically effective amount”
This is also functional. It does not specify measured endpoint metrics in the claim text you provided, but the patent links effectiveness to the defined peptide and dosing ranges in dependent claims.
“Pharmaceutically acceptable carrier”
Carrier language is broad. It generally covers excipients, binders, fillers, disintegrants, lubricants, and similar formulation components, as long as they are acceptable for human pharmaceutical use and do not destroy the active’s GI absorption or antidiuretic function.
“Solid oral dosage form”
This excludes non-solid routes and implies tablets/capsules at least for enforceable scope under dependent claims. The independent claim 1 still requires “solid oral dosage form,” which captures a broad set of solid formats as long as they are intended for GI absorption.
Dose range as a practical infringement boundary
The dose constraints (claims 4–5 and 7–8) become a clear numerical gate:
- Outside 50–200 micrograms per 70 kg per dosage, claims 4, 5, 7, and 8 do not read.
- Inside the range, those dependent claims are potentially implicated, assuming other elements (GI absorbability, antidiuretic effect, solid oral form) are met.
Claim-by-claim scope map (what is covered vs what is not)
Composition claims
| Claim |
Category |
Required elements (as stated) |
Main limitation type |
| 1 |
Composition |
oral solid; GI-absorbable; antidiuretically effective desmopressin (1-deamino-8-D-arginine vasopressin); pharmaceutically acceptable carrier |
route/functional + composition format |
| 2 |
Composition |
claim 1 + tablet |
dosage form |
| 3 |
Composition |
claim 1 + capsule |
dosage form |
| 4 |
Composition |
claim 1 + 50–200 micrograms per 70 kg per dosage |
quantitative dose window |
| 5 |
Composition |
claim 4 + 50–100 micrograms per 70 kg per dosage |
narrower quantitative window |
Method claims
| Claim |
Category |
Required elements (as stated) |
Main limitation type |
| 6 |
Method |
administer GI absorbable antidiuretic effective desmopressin for GI absorption |
route/functional + purpose (“initiating antidiuresis”) |
| 7 |
Method |
claim 6 + 50–200 micrograms per 70 kg per dosage |
quantitative dose window |
| 8 |
Method |
claim 7 + 50–100 micrograms per 70 kg per dosage |
narrower quantitative window |
| 9 |
Method |
claim 6 + administered as tablet |
dosage form |
| 10 |
Method |
claim 6 + administered as capsule |
dosage form |
| 11 |
Method |
treat diabetes insipidus by administering GI absorbable antidiuretic effective desmopressin for GI absorption |
therapeutic indication |
What design-arounds are suggested by the claim structure?
The claim set yields three direct levers for potential avoidance:
-
Route/absorption mechanism lever
- If a product does not deliver the peptide via GI absorption in a manner that meets “gastrointestinally absorbable” and “antidiuretically effective,” it sits outside the claim elements of 1, 6, and 11.
-
Solid oral dosage form lever
- The claims require “solid oral dosage form.” A liquid oral formulation is plausibly outside claim 1’s “solid” requirement, though claim construction would matter in litigation.
-
Dose window lever
- Dependent claims 4–5 and 7–8 include explicit dose ranges. A regimen consistently outside these bounds reduces risk of those dependent claims, while independent claims (1 and 6/11) could still remain implicated if the GI absorbability and efficacy are satisfied at any dose within the independent claim’s broader framing.
What is the effective “claim hierarchy” for enforcement strategy?
- Primary coverage: claim 1 (composition) and claim 6 / claim 11 (methods).
- Stronger infringement hooks: dependent claims 2–3 (tablet/capsule) and 4–5 / 7–8 (dose windows).
- Narrowest: dose-constrained and dosage-form constrained dependent claims are easiest to police when a competitor’s label and prescribing regimen specify dose and form.
U.S. patent landscape: where 5,047,398 likely sits in the broader oral-desmopressin space
Functional role of 5,047,398 in the landscape
Based on the claim focus, this patent is oriented around:
- oral delivery (GI absorption),
- desmopressin identity (1-deamino-8-D-arginine vasopressin),
- solid oral dosage forms (tablets/capsules),
- and dose ranges per 70 kg.
That positions it as a foundational/early U.S. patent addressing oral desmopressin compositions and methods rather than a later reformulation claim tied to a specific excipient platform.
Practical implication for competitors
In an oral peptide market, later products often differentiate via:
- new dosing forms (e.g., sprays, films, or sublingual formats, depending on the business),
- different peptide analogs,
- or novel oral delivery systems intended to change GI exposure.
Because 5,047,398 binds the specific peptide and demands GI absorbability from a solid oral dosage form, competitors that remain within those same boundaries face higher validity and infringement scrutiny, unless they avoid the claim elements (route/format/effect) or operate outside dependent dose windows.
Freedom-to-operate (FTO) read-through: what matters most for a U.S. business decision
A risk screen for an oral desmopressin product in the U.S. based on these claims would prioritize:
- Is the product orally administered as a solid (tablet/capsule) or is it a non-solid format?
- Does the product rely on GI absorption of the peptide with antidiuretic effect?
- Does labeling and actual dosing fall in the 50–200 micrograms per 70 kg per dose or the 50–100 micrograms per 70 kg per dose ranges (depending on whether you are testing the dependent claims)?
- Does the intended use include initiating antidiuresis or treating diabetes insipidus?
- Does the active ingredient in the accused product match “1-deamino-8-D-arginine vasopressin” as written in the claim?
Where the claim set is strongest in litigation
- If a competitor launches a tablet or capsule with dosing that falls into the recited microgram windows, the claims 2–5, 9, and 7–8 become a direct infringement pathway (subject to claim construction of “gastrointestinally absorbable” and “antidiuretically effective”).
- If labeling includes diabetes insipidus treatment, claim 11 becomes a direct method-of-use hook.
Timeline and expiry context
The claim text alone does not provide the filing date, priority date, prosecution history, or maintenance status. Those facts determine whether the patent is currently enforceable or expired. Without those facts in your prompt, no accurate statement can be made on live enforceability, reexamination, terminal disclaimer effects, or expiration date.
Key Takeaways
- U.S. Patent 5,047,398 centers on oral, GI-absorbable desmopressin (1-deamino-8-D-arginine vasopressin) in solid dosage forms, with enforceable scope strongest for tablet/capsule formats and dose ranges of 50–200 and 50–100 micrograms per 70 kg per dosage.
- The most direct enforceable uses are:
- initiating antidiuresis (claims 6–10),
- treating diabetes insipidus (claim 11).
- Clear design-around levers are built into the claim language: avoid GI absorption from a solid oral format, avoid the tablet/capsule format, and operate consistently outside the dependent dosing windows.
- For an FTO screen, the decisive technical/legal gates are (1) peptide identity, (2) GI absorbability with antidiuretic effect, (3) solid oral format, (4) dose per 70 kg per dosage, and (5) labeled indication and method framing.
FAQs
1) Does the patent require a specific formulation excipient?
No. Claim 1 requires only a “pharmaceutically acceptable carrier.” It does not specify excipient composition.
2) Are tablets and capsules both covered?
Yes. Claim 2 covers tablets and claim 3 covers capsules, each depending on claim 1.
3) What are the explicit dose ranges in the claims?
Claim 4: 50–200 micrograms per 70 kg per dosage. Claim 5 and claim 8: 50–100 micrograms per 70 kg per dosage.
4) Can the patent cover methods without specifying a dosage form?
Yes. Claim 6 and claim 11 do not require tablet/capsule. Tablet/capsule limitations appear in dependent claims 9 and 10.
5) Is diabetes insipidus treatment directly claimed?
Yes. Claim 11 specifically claims treating diabetes insipidus by administering the GI-absorbable antidiuretically effective peptide for GI absorption.
References (APA)
[1] U.S. Patent No. 5,047,398.
