This is a decision of the Court of Appeal in respect of a decision of the Court determining that the patent at issue is not eligible for listing on the Patent Register. Our summary of the case is found here.
COMPLERA contains three medicinal ingredients. The Patent claims two of those three medicinal ingredients, together with a third unnamed anti-viral agent. The third medicinal ingredient found in COMPLERA is not mentioned in the claims.
The Court of Appeal found, contrary to the Court’s finding, that the claims do not claim a formulation because a formulation must contain both medicinal and non-medicinal ingredients. Thus, the Court of Appeal found that the patent falls under paragraph 4(2)(a) as the relevant claims consist of chemically stable combinations of medicinal ingredients. Gilead noted that the Guidance Document relating to the NOC Regulations states that a claim to one medicinal ingredient is eligible for listing in respect of a product which contains the medicinal ingredient in combination with other medicinal ingredients. The Court of Appeal found that the wording of the Regulations themselves suggest that the product specificity requirement is a high threshold and, therefore, the three medicinal ingredients in the product must be set out in the patent claims for the patent to be eligible for listing on the Register.
The Court of Appeal therefore upheld the Court’s conclusion that the patent claims fail the requirement for product specificity and therefore cannot be listed. The Court of Appeal that success was divided and therefore both parties bore their own costs in the present appeal.