Details for Patent: 7,192,938

United States Patent 7,192,938: Scope, Claims, and US Landscape for Monthly Oral Bisphosphonate Regimens

US Patent 7,192,938 is directed to an osteoporosis treatment regimen defined by (i) orally administering a bisphosphonic acid (or pharmaceutically acceptable salt), (ii) a specific per-dose exposure window (about 100 mg to about 150 mg), and (iii) a dosing frequency of once monthly on a single day, after an initial first dose that is also administered orally as a one-day dose.

At the claim level, the patent’s “scope engine” is dosing schedule plus dose range plus identity of the bisphosphonic acid (explicitly including risedronic acid). The practical claim boundary is method-of-treatment language that is tightly tied to how the drug is administered rather than to formulation specifics beyond a broad “solid pharmaceutical composition” fallback.

What is the claimed dosing regimen under US 7,192,938?

Core independent claim concept

Claim 1 (and substantially claim 16) define the regimen as follows:

• Start: commence treatment by orally administering to a subject in need of such treatment
• First dose: a single day first dose of a pharmaceutical composition comprising:
  • about 100 mg to about 150 mg of a bisphosphonic acid (or a pharmaceutically acceptable salt equivalent to that amount)
• Continue: continuing treatment by
  • orally administering once monthly on a single day
  • a pharmaceutical composition with the same about 100 mg to about 150 mg dose window (or equivalent salt)

Claim 16 is a slightly tightened version that reads as a direct “consisting of” framework for:

• orally administering once monthly
• a pharmaceutical composition with about 100 mg to about 150 mg bisphosphonic acid (or equivalent salt)

Schedule structure that matters

Even without any explicit pharmacokinetic performance elements, the claims embed a treatment workflow:

• a first dosing day (explicitly “on a single day”)
• then a monthly dosing cadence (explicitly “once monthly on a single day”)

This makes the regimen difficult to design around by minor changes in patient compliance or by splitting doses across days, because the claim language requires “on a single day” at each dosing event.

What is the dose range and how narrowly is it defined?

Dose window in the independent claim

• About 100 mg to about 150 mg per monthly dosing event
• Equivalent salt is included: “pharmaceutically acceptable salt thereof that is equivalent to about 100 mg to about 150 mg”

Literal claim fallbacks

The dependent claims lock in specific endpoints within that same window:

• Claims 2, 4, 17, 19: composition comprises about 100 mg (or equivalent)
• Claims 3, 5, 18, 20: composition comprises about 150 mg (or equivalent)

Because the dependent claims are “about 100 mg” and “about 150 mg,” the patent does not only cover the range; it expressly covers the likely commercial dose points if a product maps to those values.

Key consequence: a product positioned at a dose materially below 100 mg or above 150 mg per monthly event is outside these explicit dependent claim anchor points, and likely outside independent claim 1/16 if the “about” interpretation does not bridge to the off-range dose. The “about” term introduces some interpretive leeway, but the claim structure still centers on the 100 to 150 mg exposure window.

Which bisphosphonic acid is covered?

Identity of the active

• Independent claims 1 and 16: any “bisphosphonic acid” (or acceptable salt) within the stated dose range and schedule

Explicit risedronic acid limitation

• Claims 6, 7, 8, 21, 22, 23, 24: the bisphosphonic acid is risedronic acid (or pharmaceutically acceptable salt)

Scope implication: even if the independent claim language is broader, the patent contains explicit dependent claims that target risedronic acid. This matters for enforcement and for design-around analysis, because risedronate-based osteoporosis products are structurally aligned with that active.

How is dosage form treated in the claim set?

A formulation fallback appears in multiple dependent claims:

• Claims 10, 11, 12, 13, 14: the pharmaceutical composition is a solid pharmaceutical composition
• Claims 25, 26, 27, 28, 29, 30: the same “solid pharmaceutical composition” limitation appears again across the dependent set

Scope implication:

• The solid-form limitation is not in the independent claims you provided, so it is not required to land within the independent regimen scope.
• However, for prosecution history or enforcement, these dependent claims supply additional coverage if a competitor argues non-solid delivery forms, or if the product’s core claim strategy includes a solid dosage form.

What do claim 1 and claim 16 likely cover in practice?

Activity-to-regimen mapping

The claims, read as a treatment method, cover an osteoporosis regimen in a subject that follows:

1. A first oral dosing event on day 1
2. Continued oral dosing at monthly intervals, each on a single day
3. Each dosing event includes a bisphosphonic acid at 100 to 150 mg (or salt equivalent)

What is not required

Based on the claim text provided, there is no requirement for:

• a specific patient subgroup (e.g., postmenopausal only)
• a specific biomarker response
• co-administration of calcium, vitamin D, or other agents
• a specific duration (number of months)

So enforcement, in principle, focuses on the dosing instructions and administration pattern rather than on treatment outcomes or additional regimen components.

How does the “consisting of” language in claim 16 affect scope?

Claim 16 states: “A method for treating or inhibiting osteoporosis consisting of orally administering…”

That can limit additional steps in a way that differs from “comprising.” If a court construes “consisting of” strictly, then extra method steps outside the defined administration could be argued to fall outside claim 16.

However:

• claim 1 uses “comprising,” which is typically more tolerant of additional steps.
• claim 16 still centers on the oral once-monthly administration and dose range; other steps may or may not be excluded depending on claim construction.

Practical read: claim 1 is the broader enforcement anchor; claim 16 is a narrower variant that can matter if a defendant adds step(s) to the dosing protocol.

Claim-by-claim scope summary (based on the text provided)

Where does the patent sit in the US osteoporosis bisphosphonate landscape?

Landscape structure

For US osteoporosis, bisphosphonates typically exist in:

• daily oral regimens (for some actives)
• weekly oral regimens
• monthly oral regimens (for certain actives)
• injectable schedules (not targeted by these method claims due to the “orally administering” requirement)

This patent is specifically engineered to a monthly oral dosing cadence with a 100 to 150 mg exposure window, and includes risedronic acid as a dependent active.

Competitive vectors most likely to intersect claim scope

1. Monthly oral risedronate products at doses mapping to 100 to 150 mg per monthly administration day
2. Monthly oral bisphosphonate products (other than risedronic acid) if their labeling supports a dosing event with the same 100 to 150 mg exposure window and the regimen matches the “first day then once monthly on a single day” pattern

Design-around levers embedded in the claim text

The claims provide several straightforward levers for competitors:

• change the monthly dose to be materially outside about 100 mg to about 150 mg
• administer the monthly dose across more than one day (the claims require “on a single day”)
• avoid “bisphosphonic acid” identity (move to a non-bisphosphonate mechanism)
• switch from oral administration to an injectable route (claims require “orally administering”)
• shift away from “solid pharmaceutical composition” only matters for dependent claims; it does not necessarily avoid independent claim coverage unless the product strategy also attempts to address the independent regimen elements

Freedom-to-operate implications: what is the key collision with others?

The collision is regimen-based

Because the claims are method-of-treatment claims tied to dosing instructions, the biggest litigation exposure for a competitor is where:

• the FDA label or physician instructions effectively induce the same dosing pattern; and
• the product’s dose matches the 100 to 150 mg monthly exposure window; and
• the active is a bisphosphonic acid (and especially risedronic acid)

If a competitor can show:

• a different dosing schedule (e.g., weekly rather than monthly), or
• a different dose range, or
• administration not “on a single day,” then claim 1/16 elements become easier to attack.

Patent landscape mapping around this specific claim theme

Enforcement strength points

• Independent claim 1 includes comprising language, so additional steps do not automatically eliminate coverage.
• Dependent claims include both specific dose endpoints and risedronic acid identity, increasing enforcement pathways against close variants.
• The “solid pharmaceutical composition” dependent claims cover a common manufacturing reality for monthly oral regimens.

Enforcement weakness points

• If a competing product uses a different active that still is a bisphosphonic acid but targets a dose outside the range, the core dose window becomes the key barrier.
• If a competitor’s dosing instructions do not follow “once monthly on a single day,” method claims become harder to map.

Business implications for R&D and licensing

Where to focus for compound development or product positioning

• Keep monthly oral exposure aligned with the claims only if the risk is accepted.
• If avoiding infringement is necessary, the highest-leverage change is usually the combination of:
  • dosing frequency (not monthly) and/or
  • dose per monthly event (outside the 100 to 150 mg window) and/or
  • dosing across multiple days.

If acquiring rights or pursuing a license

The patent’s claim architecture suggests licensing is most relevant for:

• monthly oral regimens with 100 to 150 mg exposure and
• risedronic acid-based products in particular, given the explicit dependent claim set.

Key Takeaways

• US 7,192,938 claims a method for osteoporosis defined by oral bisphosphonic acid dosing with about 100 mg to about 150 mg per dosing event.
• The dosing schedule requires a first single-day dose, followed by once monthly administration on a single day.
• Dependent claims lock in 100 mg and 150 mg endpoints, and explicitly cover risedronic acid.
• “Solid pharmaceutical composition” appears as dependent fallback but does not need to be present to fall within the independent regimen scope.
• For landscape and infringement risk, the key collision variables are monthly frequency, single-day administration, dose window, and bisphosphonic acid identity.

FAQs

1) Does US 7,192,938 cover injectable osteoporosis therapy?

No. The independent claims recite “orally administering.”

2) Is risedronic acid required to practice the independent claims?

No. Claims 1 and 16 cover “bisphosphonic acid” generally. Risedronic acid is required only in the dependent risedronic-acid claims.

3) What dosing frequency is required for claim coverage?

The regimen requires once monthly dosing, with each monthly dose on a single day.

4) What dose range is the critical exposure window?

The claims require about 100 mg to about 150 mg bisphosphonic acid (or salt equivalent) per dosing event.

5) Do solid dosage forms matter for coverage?

Solid dosage form is a dependent limitation in multiple claims. Independent claim coverage does not require “solid” as written in the text provided.

References

[1] US Patent 7,192,938 (claims text provided in prompt).