Details for Patent: 5,212,155

Scope, Claims, and Patent Landscape for US Drug Patent 5,212,155

What does US Patent 5,212,155 claim, in plain scope terms?

US Patent 5,212,155 is a method-of-use patent for inhibiting organ or tissue transplant rejection in a mammal by administering rapamycin and a cyclosporin together at an effective dose for rejection inhibition. The claims are drafted as a method in which the combination regimen is the core invention, with scope tightened by dependent dose, route, and duration limits.

Core independent claim (Claim 1)

Claim 1:
A method of inhibiting organ or tissue transplant rejection in a mammal in need thereof, comprising:

• administering to the mammal in combination rapamycin and a cyclosporin, and
• administering the combination in an amount effective to inhibit transplant rejection, including an effective amount of rapamycin and cyclosporin.

Scope drivers in Claim 1

• Use type: “method of inhibiting rejection” (not a composition, not a device).
• Activity target: “organ or tissue transplant rejection.”
• Population: “mammal.”
• Treatment structure: “rapamycin and a cyclosporin” in combination.
• Sufficiency standard: “amount effective to inhibit transplant rejection.”

Dependent claims that narrow dosage and administration details

Claims 2-10 add quantitative and operational limits around rapamycin, and timeline/route features.

How do the dependent claims narrow rapamycin dose?

The patent provides multiple rapamycin dosing windows that can overlap, creating a dose-range ladder that broadens coverage around the independent concept.

Dose ranges recited (mg/kg/day)

Net dose coverage result

• The patent spans 0.25 to 50 mg/kg/day for rapamycin via Claims 9 and 2.
• It also explicitly covers 0.25 to 5 mg/kg/day (Claim 10), plus two narrower windows (0.5 to 5 and 1 to 5) (Claims 4 and 3).
• Because Claims 3 and 4 are nested in Claim 2, they become “sub-regimens” inside the broader 0.5 to 50 framework.
• Practically, if an accused regimen uses rapamycin within 0.25 to 5 mg/kg/day, it can be mapped to multiple dependent claims (10 and, depending on the exact lower bound and upper bound, also Claims 2-4 via the nested structure).

Does the patent require oral or parenteral administration?

No. Route is optional, but explicitly claim-captured.

• Claim 5: rapamycin administered orally.
• Claim 6: rapamycin administered parenterally.

Because Claim 5 and Claim 6 are separate dependents from Claim 1, the patent covers both route modalities when paired with cyclosporin and effective rejection inhibition.

Is there a treatment duration requirement?

Yes for one claim; another claim covers ongoing dosing.

• Claim 7: combination administered between about 1 to about 180 days.
• Claim 8: rapamycin administered for an indefinite period of time to maintain inhibition of transplant rejection.

Net duration coverage result

• The patent covers short-to-medium fixed courses (1 to 180 days).
• It also covers indefinite maintenance therapy.

What does “in combination” mean for infringement scope?

The claims recite “administering … in combination rapamycin and a cyclosporin,” without specifying a simultaneous administration time window, formulation, or co-dosing interval.

As drafted, “in combination” is broad enough to capture regimens where the two drugs are given as part of the same rejection-inhibiting course, including sequences or schedules that still constitute combination therapy under claim interpretation. The risk point for any competitor is that the method claim does not require a single composition; it requires the combination administration as a regimen.

What is the legal and technical scope of the claim set?

This is a regimen method claim family. Coverage is keyed to:

1. Indication: organ/tissue transplant rejection in a mammal.
2. Therapeutic pairing: rapamycin + cyclosporin together.
3. Effective amount standard: dosing that inhibits rejection.
4. Operational parameters (dependent claims):
   • rapamycin dose ranges (0.25-50; 0.25-5; 0.5-50; 0.5-5; 1-5 mg/kg/day)
   • route (oral or parenteral)
   • duration (1-180 days; indefinite maintenance)

Practical scope map (what must be true in an accused regimen)

How does this patent fit within the broader rapamycin immunosuppression landscape?

Rapamycin (sirolimus) and cyclosporin have long been core immunosuppressants in transplant medicine. A regimen patent like 5,212,155 seeks to protect a specific combination therapy concept with explicit rapamycin dosing, route, and duration parameters.

Competitor design-around pressure points

A product developer or trial designer attempting to avoid literal read-across to this patent would focus on removing at least one required element:

• Removing cyclosporin (using a different calcineurin inhibitor, or a different immunosuppressant entirely).
• Using rapamycin without cyclosporin (switching maintenance strategy).
• Avoiding the specific rapamycin dose windows (relevant for dependent claims; Claim 1 still relies on “effective amount” so dose shifting may not fully eliminate risk).
• Avoiding the claimed duration structure (Claim 7 and Claim 8 cover defined windows and indefinite maintenance; practical clinical regimens often look like maintenance, increasing exposure).

Because Claim 1 is not limited to a specific dose, route, or duration beyond “effective amount,” avoiding dependent claims may not be sufficient if the regimen still meets Claim 1’s combination and effective rejection inhibition requirements.

What does a “US drug patent” number imply for landscape mapping?

US 5,212,155 is treated in practice as a US patent in the immunosuppression/regimen domain, not necessarily tied to a modern Orange Book entry or a specific currently marketed product label. The operational consequence: freedom-to-operate analysis must focus on method-of-use and regimen claims rather than only composition claims or formulation patents.

Patent landscape: what is likely the nearest prior art category?

Even without reprinting the entire file history or citing specific earlier documents, the claim structure indicates the relevant landscape includes:

• rapamycin/sirolimus as an immunosuppressant in transplant settings
• cyclosporin-based immunosuppression regimens
• combination regimens combining rapamycin with calcineurin inhibitors or other immunosuppressants
• dosage and route of administration strategies for rapamycin in transplant management
• duration and maintenance therapy approaches in transplant rejection inhibition

The strongest landscape overlap risk is that earlier publications or patents may already disclose some form of rapamycin-containing transplant immunosuppression, and the contested novelty likely focused on the rapamycin + cyclosporin combination and/or regimen parameters.

Where are the “strongest” and “weakest” claim edges for enforcement?

Strongest edge

• Claim 1: it is broad in dosing (effective amount), broad in duration, broad in route, and covers any mammal needing rejection inhibition with organ or tissue transplants.

Tightest edges

• The dependent claims are narrow on:
  • rapamycin dose windows
  • route
  • duration

These dependents are useful when an accused regimen matches a specific dose/route/time course. But even if a regimen misses one dependent range, it may still land in Claim 1.

Claim-by-claim scope summary

Claim 1

• Broad method: rapamycin + cyclosporin combination for inhibiting organ/tissue transplant rejection in a mammal, using an effective amount.

Claim 2

• Rapamycin dose 0.5 to 50 mg/kg/day.

Claim 3

• Rapamycin dose 1 to 5 mg/kg/day.

Claim 4

• Rapamycin dose 0.5 to 5 mg/kg/day.

Claim 5

• Oral rapamycin.

Claim 6

• Parenteral rapamycin.

Claim 7

• Combination administered 1 to 180 days.

Claim 8

• Rapamycin for an indefinite period to maintain inhibition.

Claim 9

• Rapamycin dose 0.25 to 50 mg/kg/day.

Claim 10

• Rapamycin dose 0.25 to 5 mg/kg/day.

What should an investor or R&D team conclude about scope risk?

1. The patent is built around a combination immunosuppression method with rapamycin and cyclosporin.
2. The independent claim is not constrained to specific dose, route, or time, which makes Claim 1 the primary risk vector for any regimen that uses cyclosporin alongside rapamycin for rejection inhibition.
3. Dependent claims offer a secondary set of “exact matches” for dose and operational parameters, improving enforcement leverage when the clinical regimen falls within the ranges.

Key Takeaways

• US 5,212,155 is a method patent covering rapamycin + cyclosporin combination therapy to inhibit organ or tissue transplant rejection in a mammal.
• Claim 1 is broad: it requires combination administration and an effective amount to inhibit rejection, without a specific dose, route, or duration limit.
• Dependent claims add enforceable limits on rapamycin dose (0.25-50 and 0.25-5 mg/kg/day; plus 0.5-50 and 0.5-5; plus 1-5), route (oral or parenteral), and duration (1-180 days; indefinite maintenance).
• The central design-around lever is to avoid co-administration with cyclosporin; adjusting dose or route alone may not eliminate exposure because Claim 1 remains effective-amount based.

FAQs

1. Is US 5,212,155 about a formulation or a treatment method?
   It is a method of inhibiting transplant rejection by administering rapamycin plus cyclosporin.

2. Does the patent require a specific rapamycin dose to meet the independent claim?
   No. Claim 1 requires an “effective amount” but does not fix a dose range. Dose ranges appear in dependent claims.

3. Can a regimen be covered if rapamycin is oral?
   Yes. Claim 5 covers oral administration of rapamycin with cyclosporin in the combination regimen.

4. Does the patent cover both short and long duration regimens?
   Yes. Claim 7 covers 1 to 180 days, while Claim 8 covers indefinite rapamycin use for ongoing rejection inhibition.

5. What is the most direct way to reduce literal infringement risk?
   Avoid the claimed rapamycin + cyclosporin combination in the rejection-inhibition method (since cyclosporin is required in Claim 1).

References

[1] US Patent 5,212,155: Claims as provided in the prompt.