MOPOP chapter 17- Kits Training Dec 2017 Josée Pharand Riley Brandt, University of Calgary Building a prosperous and innovative Canada

Medical Kits Practice Established following: a public consultation extensive collaborative drafting and discussion by: members of the Practice Group the PAB Chemical division Biotechnology division

Reasons for update = unnecessary uncertainty MOPOP update

Package vs Kit A package is one or more components that are contained within conventional packaging material Vs A kit is a specific type of package that contains two or more components

Clarity and Kits two components do not need to interact The kit must have at least two components But kit claims can define only one component

Dictionary Definition of Kit A kit is: A set of articles, equipment, documents or clothing needed for a specific purpose A container for such a set The clothing, gear, etc. needed for any activity A set of all the parts needed to assemble an item (from Canadian Oxford Dictionary 2nd Ed)

Interacting components? Recognizing that: applicant can act as their own lexicographer; the plain (dictionary) meaning does not require interaction between the components of the kit; and, no explicit jurisprudence The practice does not require that the components of a kit interact No clarity defects for kits whose components do not appear to interact After the text: However, depending on the specific facts of the case, a lack of interaction may render claims more susceptible to defects based on obviousness or anticipation. In the most extreme situations it may be possible to view such kits as aggregations though again that will depend on the specific facts of the case

Two components in a kit The definition of kit is a set of something which implies more than one item → The practice states that a kit must have at least 2 components. However there is no clarity 27(4) ?requirement that both of the components be identified in the claim

Compositions = 1 component Unless A composition It is a composition in parts

Two components: the low-down consisting comprising

Two components: the low-down Comprising 1 component: No description of the components of the kit AND construe the kit with only one component? b) All other cases Note: claim must still be analysed for obviousness etc

Two components: example Claims:  A kit comprising a pharmaceutical composition. The kit according to claim 2, further comprising an instrument for administering the pharmaceutical composition. Look and Know, added following bio input after initial training

Claim analysis: For Claim 2: it is immediately evident that there is more than one component so For Claim 1: the composition does not appear to be “in parts” so it is only a single component → The claim comprises 1 component → The description must be consulted Discuss composition in parts with the reference to the description

Example Description 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 and an empty syringe may be packaged together within a kit. 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. Also described is an embodiment where compound A is packaged together with a second compound for treating disease Y.

Example Description 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 and an empty syringe may be packaged together within a kit. 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. Also described is an embodiment where compound A is packaged together with a second compound for treating disease Y.

Claim analysis: claim 2 contd. Thus the second component may be: the syringe; or, the additional compound for treating disease Y Consequently, the claim understood as comprising at least 2 components Note other requirements of patentability may force the introduction of other components to the claim e.g. prior art disclosing a kit comprising same composition

Instructions affect what prior art can be used A kit with instructions is construed as a kit for use with the use taken from the instructions: A kit comprising A and B and instructions for using A and B to treat disease Y Is equivalent to A kit for treating disease Y comprising A and B affect what prior art can be used Statutory subject-matter if Medical use or DM

Instructions example Claims: Prior Art 1. A kit comprising: a) a first pharmaceutical formulation comprising levetiracetam; and b) 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. Prior Art D1 discloses the combined use of levetiracetam and carbamazepine in epileptic patients as well as a kit comprising both components

Instructions example analysis Claim 1 is claim to a kit per se D1 discloses a kit comprising the two formulations and so anticipates claim 1 Claim 2 contains instructions for using the components to treat pain associated with diabetic neuropathy is construed as a claim to a kit for use in treating pain associated with diabetic neuropathy D1 discloses a kit but does not the new use of the kit and so does not anticipate claim 2 Still must be evaluated for other considerations of patentability

Intersection of kits and DMs The update to MOPOP does not affect our current practice vis-à-vis kits and DMs Therefore Kits for use; or, Kits comprising instructions for use where the use is a DM Must follow DM practice; and Must be included in the DM purposive construction analysis

Acknowledgements I’d like to thank the following for their hard work helping to put together this practice and training: Katrina Campsall Christine Teixeira Cara Weir The GSLF Jeremy McLean Gertrude Major