Consultation document: 17.03.04 - Kits and packages

This section focuses on the patentability of claims to kits and packages in the context of medical inventions.

In the interest of clarity, the following definitions for "package" and "kit" are provided. These definitions are based on the plain and ordinary meaning of these terms and reflect how they are generally understood by a person skilled in the art working in the medical field. It is well established that an applicant may act as their own lexicographer. However, when an applicant creates a definition for a term that is contrary to the usual meaning ascribed to that term in the art, this may unnecessarily cause confusion or ambiguity, particularly when another term could easily provide the same information (see MOPOP 9.05.03).

A "package" is generally understood as one or more discrete components that are contained within conventional packaging material, such as a box, paper or plastic wrapping, or the like. A package may contain a single component, a plurality of the same component, one or more different components, or any combination of these without limitation. Where appropriate, an applicant may choose to define a package more particularly as, for example, a commercial package or a pharmaceutical package.

A "kit" is generally understood as a specific type of package that contains two or more discrete components, and those components work together for a specific purpose, or to achieve a specific result. A kit may be regarded as a "disassembled invention"Footnote 1. In some cases the components of a kit may be assembled to produce a composition or product, such as an unstable composition that is to be prepared immediately prior to use, and so the individual ingredients are packaged in separate containers. In other cases, the components may be used together, either simultaneously or in sequence, to achieve a specific result. An example would be a pharmaceutical composition that is formulated for administration and is ready-to-use, and an applicator for its administration. The two are used simultaneously to administer the composition. Another example would be a test kit containing different reagents that are to be used in a certain sequence to test a sample.

When a kit contains a composition, such as a unit dosage form, which is composed of two or more active ingredients that are formulated together, that single formulated product is considered as one component in the kit. Even if the ingredients contained within the unit dose work together to achieve a specific result, they are formulated as a single unit. One unit dose would not reasonably be considered as two separate components in a kit. The skilled person would understand that there is a difference between a "composition" and a "kit", based on the plain and ordinary meaning of those terms.

When a pharmaceutical composition comprising an active ingredient is a component in a medical kit, the following is a non-exhaustive list of examples of what the second component may be: an instrument for administration, e.g., an applicator, empty syringe or graduated cup; a separate formulating excipient, adjuvant or potentiator; a separate activating agent, reagent, or buffer; an antiseptic wipe; a test strip; or a separate product comprising a second active ingredient.

Conventional packaging material is not included in the above list because such packaging material would not work together with the other components of the kit. Alternatively, the packaging material associated with a package or kit may be unconventional, and in some cases unconventional packaging may be regarded as a component that works together with the other components of a kit. However, for medical kits this is generally the exception, rather than the rule.

Likewise, a set of instructions is not included in the above list because instructions would not generally be considered as a component that works together with the other components of a kit to achieve a specific purpose or result. See 17.03.04c below for a more detailed discussion of instructions.

17.03.04a - Claims of indefinite scope or lacking clarity

The subject-matter of a claim must be defined distinctly and in explicit terms, in accordance with subsection 27(4) of the Patent Act, because the claims define the subject-matter of the monopoly. The scope of a claim must be clear and definite from the perspective of the person skilled in the art.

The terms "package" and "kit" are used interchangeably at times, even though they are not synonymous. In some cases this leads to a lack of clarity or creates avoidable ambiguity within a claim or set of claims, contrary to subsection 27(4) of the Patent Act.

A kit would be understood as a specific type of package comprising at least two components that work together for a specific purpose or to achieve a specific result and so a minimum of two components should be defined, at least broadly.

If a kit claim defines only one component, and as a result the scope of the claim would be indefinite or unclear to the skilled person when the claim is read from their perspective in view of the specification as a whole, the claim would not comply with subsection 27(4) of the Patent Act. The lack of clarity may be avoided by defining a second component, at least in broad terms, or by directing the claim to a package, instead of a kit.

If a package claim defines two or more components that work together to achieve a specific result, there would be no lack of clarity even though the subject-matter could have been claimed as a kit. There are no restrictions on the number of components a package may contain.

A patent application may contain multiple independent product claims within the same claim set, such as claims to a package, a kit, and a package containing the kit. This is permissible provided the distinction between the claims would be clear to the skilled person based on the specification as a whole.

Example

An application discloses that compound A, a known herbicide, has therapeutic utility for treating disease Y in humans. The description states that compositions comprising compound A may be formulated for a variety of routes of administration, but focuses on subcutaneous and intravenous injectable formulations and liquid oral formulations. In one embodiment the formulation may be packaged with an empty syringe. The description also discloses using the formulation in combination with a second compound that also treats disease Y, and refers to a number of compounds well known for treating Y. An embodiment where compound A is packaged together with a second compound for treating disease Y is also described.

Claims

  1. A pharmaceutical composition comprising compound A and a pharmaceutically acceptable formulating excipient.
  2. A package comprising the pharmaceutical composition of claim 1.
  3. A kit comprising the pharmaceutical composition of claim 1.
  4. The kit according to claim 3, further comprising an instrument for administering the pharmaceutical composition.
  5. A package comprising the kit of claim 3.

Analysis: Claim 1 complies with subsection 27(4) of the Patent Act. The claim is directed to a pharmaceutical composition comprising at least two components, compound A and a pharmaceutically acceptable formulating excipient. The excipient is defined in broad terms, but the nature and scope of the excipient would be clear to the skilled person, based on their common general knowledge and in view of the specification as a whole, based on the terms "pharmaceutically acceptable" and "formulating".

Claim 2 also complies with subsection 27(4) of the Patent Act. The claim is directed to a package comprising the pharmaceutical composition of claim 1. The scope of the claim would be understood as a package containing at least the pharmaceutical composition component of claim 1 within conventional packaging material.

Claim 3 is indefinite in this case and does not comply with subsection 27(4) of the Patent Act. The claim is directed to a kit, and so the claim would be understood as any kit comprising two or more components that work together for a specific purpose, or to achieve a specific result, where one of the components is the pharmaceutical composition of claim 1. There is a basis in the description for what the second component may be, but there are no indications in the claim relating to the nature of the second component or the specific purpose or result the components achieve when used together, and so these are not limited. A second component is implicitly present but has not been defined distinctly and in explicit terms, contrary to subsection 27(4) of the Patent Act.

Claim 4 complies with subsection 27(4) of the Patent Act. The claim is directed to a kit comprising the pharmaceutical composition of claim 1, and an instrument for administering the composition. It would be clear to the skilled person that the instrument works together with the composition by facilitating its administration so it can be used in therapy. The instrument is defined in broad terms, but the nature and scope would be clear to the skilled person, based on their common general knowledge and in view of the specification as a whole. Notably, claiming a second compound for treating disease Y as the second component of the kit would also have been accepted.

Claim 5 is indefinite and does not comply with subsection 27(4) of the Patent Act. The claim is directed to a package comprising the kit of claim 3. Since the kit of claim 3 is indefinite, claim 5 is also indefinite. Notably, the claim would be compliant with subsection 27(4) if it referred to claim 4 instead of claim 3.

17.03.04b - Other patentability requirements

While a kit or package claim may be compliant with subsection 27(4) of the Patent Act, it does not automatically mean the claim is patentable. A claim is only patentable when all of the requirements of patentability are satisfied.

A claim to a kit or a package will be non-statutory and fail to satisfy section 2 of the Patent Act where an essential element of the claim is an element that points to a limitation of a physician’s skill or judgment (e.g., a dosing schedule encompassing a range), see PN2015-01 – Revised Examination Practice Respecting Medical Uses.

When considering whether a kit or package comprising known components satisfies the patentability requirements of novelty and obviousness, it may be necessary to consider whether packaging known components together as a kit or package is an aggregation, or if there is invention in their combination. See MOPOP 15.01.02 and 15.02.04 for more information on combinations and aggregations.

17.03.04c - Instructions

Instructions are generally understood as information printed or displayed on a substrate. In the context of medical inventions, this information often suggests actions or directions that can be taken, such as how an active agent can be administered or used in treatment. The skilled person would understand that the instructions themselves are merely printed matter with solely intellectual or aesthetic significance unless the information printed or displayed on the substrate imparts a new functionality to the substrate itself (see Chapter 12 for a discussion of printed matter).

It is recognized that in most cases instructions would not be considered a discrete component that works together with at least one other component to achieve a specific result. Therefore, instructions that simply provide directions for using the contents of a kit and nothing more would not be considered a component of the kit. For example, in a claim to "a kit comprising drug X and instructions for use" it is clear that one of the components is drug X. Given that the recited instructions do not work together with drug X to achieve a specific result, the instructions are not considered a component in a kit. The claim lacks compliance with subsection 27(4) of the Patent Act because there is no indication in the claim as to the nature of a second component that would work together with drug X to achieve a specific result.

In contrast, it is generally understood that a package is one or more discrete components contained within conventional packaging and there is no requirement that the discrete components work together for a specific purpose. Therefore, instructions may be a second discrete component of a package recognizing that in most cases the instructions would constitute printed matter with solely intellectual or aesthetic significance.

Where a use is defined in the preamble or body of a kit or package claim (e.g., a kit for treating disease Y comprising…), such a claim may be construed as a "kit for use" or "package for use", which is distinct from a claim to a kit or package per se. However, a claim is not regarded as a "kit for use" or "package for use" if it is only the instructions that provide information relating to a use (e.g., a kit comprising drug X and instructions for using X to treat disease Y).

The distinction above may become pertinent when assessing the novelty and/or inventiveness of the claimed subject-matter. For instance, the recitation of a particular use in the preamble of the claim may bring novelty and/or inventiveness to the claimed kit or package if the components thereof had not been used for that particular purpose prior to the claim date. In contrast, where only the instructions provide information relating to the use of the claimed kit or package, the claimed kit or package would be anticipated and/or obvious in view of prior art that discloses the use of its components for any purpose. In other words, the recitation of information about a use within the instructions does not pose a limitation on the use of the kit or package.

Example

An application discloses there is a need for improved treatment of painful diabetic neuropathy in patients. The description states that the inventors have surprisingly discovered that levetiracetam and carbamazepine (known anti-epileptic drugs), when used in combination, are effective for reducing pain associated with diabetic neuropathy.

Claims:

  1. A kit comprising:
    1. a first pharmaceutical formulation comprising levetiracetam; and
    2. a second pharmaceutical formulation comprising carbamazepine.
  2. The kit of claim 1 further comprising instructions for using levetiracetam and carbamazepine to treat pain associated with diabetic neuropathy.
  3. A kit for reducing pain associated with diabetic neuropathy comprising:
    1. a first pharmaceutical formulation comprising levetiracetam; and
    2. a second pharmaceutical formulation comprising carbamazepine.

A search of the prior art identified patent document D1, which discloses the combined use of levetiracetam and carbamazepine in epileptic patients. An embodiment of D1 includes a kit comprising both levetiracetam and carbamazepine as well as instructions for preventing seizures in patients.

Analysis: Claims 1-3 comply with subsection 27(4) of the Patent Act. The claims recite a kit comprising at least two discrete components, namely a first pharmaceutical formulation comprising levetiracetam and a second pharmaceutical formulation comprising carbamazepine. It would be clear to the skilled person, in view of the specification, that levetiracetam and carbamazepine are components in a kit that work together to achieve the specific purpose of reducing pain in diabetic patients.

In regard to the requirement for novelty, both of claims 1 and 2 are anticipated by D1 because D1 discloses and enables a kit comprising levetiracetam, carbamazepine and instructions. It is noted that although claim 2 includes instructions providing information about a use of levetiracetam and carbamazepine that differs from D1; the informational content of the instructions does not pose a limitation on the actual use of the claimed kit and, therefore, does not bestow novelty. In contrast, claim 3 is not anticipated by D1 because claim 3, which defines the use in the preamble, is regarded as a new use of a kit comprising levetiracetam and carbamazepine over D1.