Evidence For Establishing Sound Prediction And The Use Of Trial And Error Experimentation To Establish An Enabling Disclosure

The Federal Court of Appeal's (FCA) recent decision in Teva v. Leo Pharma1 addresses important issues related to the doctrines of sound prediction and sufficiency. At first instance, Locke J granted Leo Pharma's application for an order of prohibition, rejecting Teva's obviousness, utility and sufficiency allegations. Gauthier JA wrote for a unanimous Court of Appeal and dismissed Teva's appeal.

The patent at issue related to ointment compositions comprising two active ingredients, calcipotriol and a corticosteroid, along with a solvent. The prior art taught that calcipotriol and corticosteroids were both useful for the treatment of psoriasis. However, an instability problem had prevented these ingredients from being formulated together. The claimed compositions overcame that compatibility problem.

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