The Federal Court of Appeal has dismissed Apotex's appeal of the Federal Court decision which held that the claims of Canadian Patent 2,527,646 were valid and prohibited the minister of health from issuing a notice of compliance to Apotex for its lisdexamfetamine product (Shire's VYVANSE) until the patent's expiry. The prohibition application was consolidated with Apotex's action seeking a declaration of invalidity and non-infringement.
IP offices have long grappled with whether a medical diagnostic constitutes a traditionally patentable concrete or physical method or instead is merely an unpatentable and intangible abstract idea. Although a new diagnostic tool is typically embodied in a physical device or method, the principal advance often lies in the recognition of a previously unknown correlation. New guidance from the Patent Office is a welcome step forward in this difficult area.
The Federal Court recently issued a decision in a patent infringement action pursuant to Section 6(1) of the Patented Medicines (Notice of Compliance) Regulations relating to silodosin. Although the court found that the patent was not invalid on the basis of obviousness, it also found that the patent had not been infringed.
Innovative Medicines Canada and numerous research-based pharmaceutical companies recently commenced an application for judicial review of the final Patented Medicine Prices Review Board Guidelines. The guidelines aim to operationalise amendments to the Patented Medicines Regulations scheduled to come into force on 1 January 2021.
The Patented Medicine Prices Review Board recently published the final version of its guidelines which operationalise the amendments to the Patented Medicines Regulations scheduled to come into force on 1 January 2021. This article provides a brief summary of the final framework for the price review process and highlights changes relative to the June 2020 draft guidelines.