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Smart & Biggar | 25 Aug 2021

Federal Court of Appeal maintains award against Apotex for cefaclor patent infringement

The Federal Court of Appeal recently dismissed Apotex's appeal of the Federal Court's reconsideration decision on the quantum of damages owed by Apotex for its infringement of eight Eli Lilly process patents relating to the antibiotic cefaclor. The initial Federal Court decision, which had awarded Lilly roughly $31 million in damages and $75 million in prejudgment interest, was overturned on......
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Smart & Biggar | Canada | 11 Aug 2021

New consultation on PMPRB guidelines

The Patented Medicines Prices Review Board recently announced a consultation on proposed changes to the new guidelines (which, like the amendments to the Patented Medicines Regulations, are now due to come into effect on 1 January 2022). The changes include an amendment to the definition of "gap medicines" and revised international price tests.
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Smart & Biggar | Canada | 21 Jul 2021

Canada's Patented Medicines Regulations delayed and PMPRB's jurisdiction extended

The coming into force of the amended Patented Medicines Regulations has been delayed for a third time. The amendments, once in force, will add new price regulatory factors, revise the list of reference countries and modify reporting requirements for particular categories of drugs. The Patented Medicine Prices Review Board Guidelines have also been delayed until 2022.
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Smart & Biggar | Canada | 9 Dec 2020

Innovators challenge final PMPRB Guidelines in new Federal Court application

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.
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Smart & Biggar | Canada | 7 Dec 2020

Innovators challenge final PMPRB Guidelines in new Federal Court application

Innovative Medicines Canada and a number of 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.
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Smart & Biggar | 25 Nov 2020

Few significant changes made in final PMPRB guidelines

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.
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Smart & Biggar | Canada | 23 Nov 2020

Few significant changes made in final PMPRB guidelines

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.
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Smart & Biggar | 9 Nov 2020

Final PMPRB guidelines released

The Patented Medicine Prices Review Board (PMPRB) recently released the final guidelines operationalising the amended Patented Medicines Regulations. The guidelines describe the price review methodology that will apply to medicines from 1 January 2021, when the amended regulations come into force. The PMPRB has also released its October 2020 Newsletter, which includes an overview of final......
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Smart & Biggar | Canada | 4 Nov 2020

Final PMPRB guidelines released

The Patented Medicine Prices Review Board (PMPRB) recently released the final guidelines operationalising the amended Patented Medicines Regulations. The guidelines describe the price review methodology that will apply to medicines from 1 January 2021, when the amended regulations come into force. The PMPRB has also released its October 2020 Newsletter, which includes an overview of final......
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Smart & Biggar | Canada | 12 Aug 2020

Federal Court strikes price calculation provision of amendments to Patented Medicines Regulations

The Federal Court recently issued its decision on an application for judicial review of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements). The court ruled that Section 3(4), which would expand price calculation requirements in Section 4(4) of the Patented Medicines Regulations to encompass information beyond the first point......
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