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Details for Patent: 4,870,105
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Summary for Patent: 4,870,105
| Title: | Phosphorus binder | ||||||||||||||||||||||||||||||||||||
| Abstract: | A composition for oral administration to an individual for the purpose of inhibiting gastrointestinal absorption of phosphorous, which includes calcium acetate. A method of inhibiting gastrointestinal absorption of phosphorous, comprising administering orally the composition, preferably close in time to food and beverage consumption. | ||||||||||||||||||||||||||||||||||||
| Inventor(s): | John S. Fordtran | ||||||||||||||||||||||||||||||||||||
| Assignee: | Fresenius Medical Care Holdings Inc | ||||||||||||||||||||||||||||||||||||
| Application Number: | US07/035,341 | ||||||||||||||||||||||||||||||||||||
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Patent Claim Types: see list of patent claims | Use; Dosage form; | ||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | United States Patent 4,870,105: Scope, Claims, and US Landscape for Calcium Acetate to Inhibit Phosphate AbsorptionWhat does US 4,870,105 claim, and what is the practical scope?US Patent 4,870,105 claims an oral dosing method using calcium acetate to inhibit gastrointestinal absorption of phosphorous (phosphate) in an individual. The claim set is a tight, method-of-treatment scope: it does not claim a formulation beyond dosing vehicle (tablet vs. gelatin capsule) and does not claim specific patient populations, kidney stages, disease labels, or administration duration. The independent claim concept appears in claim 1 and is repeated in claim 5 with “at mealtimes” as the key scheduling limitation. Dependent claims add (i) a dosing range framed as milliequivalents (mEq) of calcium and (ii) solid oral form as tablet or gelatin capsule. Claim-by-claim scope map (as provided)
Functional claim center: “bind with phosphorous in the gastrointestinal tract”The “sufficient to bind” functional language drives scope beyond fixed mg amounts. Even where dependent claims impose a numeric range, the independent claims still hinge on achieving phosphate binding in the GI tract. That typically captures calcium acetate products that deliver bioavailable calcium ions in the GI environment to complex dietary phosphate. How broad is “calcium acetate,” and how limiting are the dose and timing terms?1) Active ingredient and “chemical identity” boundaryThe claims require calcium acetate as the ingested compound. That is a hard boundary. Substituting another calcium salt (e.g., calcium carbonate) or other phosphate binders (sevelamer, lanthanum carbonate, ferric-based binders) is outside the literal scope because the claim language is specific. However, if an alternative product is chemically calcium acetate (or a salt/hydrate that is treated as calcium acetate in practice), it may still map. The claim set does not say “anhydrous” or “specific hydrate.” 2) Dose boundary: “between 10 to 200 milliequivalents of calcium”The dose range is expressed as mEq calcium, not mg calcium or mg calcium acetate. That matters for infringement analysis because product labels and prescriber instructions often state mg per tablet/capsule, not mEq. Operationally, the dose range creates a measurable infringement trigger:
3) Timing boundary: “at mealtimes”Only claims 5 to 8 require meal-time dosing. That creates two layers:
4) Vehicle boundary: tablet vs. gelatin capsuleClaims 3-4 and 7-8 limit the dosage form to tablet or gelatin capsule.
What is the infringement logic if someone commercializes a calcium acetate phosphate binder?The claim structure suggests infringement exposure is driven by prescribing and use instructions as well as actual use patterns. Likely literal mapping patterns
Key design-around levers implied by the claimsBecause claim language is restrictive, design-arounds typically target one of these elements:
How does this patent sit within the broader US phosphate-binder landscape?Market context the claims align withUS 4,870,105 is directed to a classic approach for chronic hyperphosphatemia management: oral calcium-based phosphate binding. In the US market, calcium acetate appears alongside other phosphate binders. While the claim set is narrow to calcium acetate dosing methods, the landscape competition usually includes:
Landscape impact: what this patent is and is not protecting
That positioning affects freedom-to-operate:
Scope boundaries that affect claim interpretation in practice1) “Phosphorous” vs “phosphorus/phosphate”Claims use “phosphorous.” Practically, phosphate binding methods target dietary phosphate. In infringement analysis, courts often interpret based on the substance intended in the method. The claim language also uses “bind with phosphorous in the gastrointestinal tract,” consistent with phosphate binding in GI. 2) “Inhibiting gastrointestinal absorption”The method requires an effect: inhibiting absorption by binding in GI. That still typically maps to phosphate binders used with meals. It is not a systemic pharmacokinetic claim; it is tied to GI binding and functional inhibition. 3) “Quantity sufficient”For claims 1 and 5, the “quantity sufficient” wording is open-ended. Dependent claims 2 and 6 narrow by numeric mEq range. This is the typical structure: broad independent + narrower dependent. What is known from the information provided about claim scope vs. typical product instructions?The claims are compatible with standard phosphate-binder use patterns:
US patent landscape implications for developers and investorsIf you are evaluating calcium acetate product IP risk
If you are evaluating competing chemistry (non-acetate binders)
Key Takeaways
FAQs1) Does US 4,870,105 claim a specific patient population or disease stage?No. Based on the claim text provided, it is framed as a method for “an individual” without kidney stage or diagnosis limitations. 2) Are the claims limited to tablets only?No. Tablet and gelatin capsule are specified only in dependent claims (3-4 and 7-8). Independent claim coverage (1 and 5) is not limited by dosage form in the text provided. 3) How critical is the “10 to 200 mEq calcium” range?It is critical for dependent claim coverage (2 and 6) and forms a measurable dosing boundary for infringement analysis. The independent claims still require a “quantity sufficient” to bind phosphate. 4) If dosing is not at mealtimes, is the patent avoided?It may avoid claims requiring mealtime dosing (5-8), but it does not eliminate potential exposure to claims 1-4, which do not require mealtime scheduling. 5) Can alternative calcium salts be used to avoid literal scope?Based on the “calcium acetate” identity requirement in the claims, substituting other calcium salts is outside literal coverage, unless the substituted product is calcium acetate in substance. References
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Drugs Protected by US Patent 4,870,105
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
International Family Members for US Patent 4,870,105
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Canada | 1333884 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
