The claims of each patent in the Orange
Book have been examined, and we have provided our opinion of the
category
that a claim should fall into. As we went through the patents, we kept
adding new categories, finally arriving at the following nineteen:
Claim Type | Explanation |
Compound | Just the chemical, usually delineated by its structure |
Composition | One or more active ingredients and a pharmaceutically acceptable carrier |
Formulation | Any combination of one or more active ingredients where something in addition to the presence of the active ingredients and the carrier is specified. This can be a specific excipient, or it can be the ratio of two active ingredients, or it can be any other claim limitation that we feel distinguishes the claim from a composition claim. |
Impurity content limitation |
Compound-ish claim that recites
a compound and an impurity. The maximum level of the impurity is
usually a limitation. |
Method of use | A method of using the active ingredient to treat a disease |
Process | Method of making something. E.g., method of making the active ingredient; method of making a dosage form; method of preparing a formulation. |
Product-by-process | Anything where a product (including an intermediate or excipient) is described by its method of preparation |
Device | Anything with “parts,” e.g., walls, chambers, etc., such as an osmotic pump dosage form. It of course also includes more traditional devices, such as spray pumps, syringes, etc. |
Device part |
An individual part of a device,
e.g., a dosage counter for an asthma inhaler, a rubber tip for a
syringe plunger. |
Kit | Mainly defined in the claim, itself, e.g., “a kit comprising . . .” |
Intermediate | A chemical used to make another chemical. DNA is an intermediate when the final product is a protein or polypeptide. |
Method of administration | A way of getting the drug into the patient |
Excipient | An inactive part of a dosage form |
Packaging or device material | Material from which the packaging or device is constructed |
Diagnostic or surgical method | Self-explanatory |
Method of improving a formulation | E.g., “a method of improving the stability of formulations containing compound X.” |
Drug in a container | E.g., “an article of manufacture comprising drug X in a container” |
New polymorph, salt or hydrate | A new form of a previously approved compound |
Method of improving a treatment | E.g., “a method of reducing the side effects due to the administration of drug X” |
Functional tablet design | Tablets that are easy to break into equal-size pieces |
Ornamental appearance of a device | A design patent |