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Healthcare & Life Sciences

16 October 2019
Eleanor Wilson Innovators commence court challenges regarding recent amendments to Patented Medicines Regulations

Canada - Smart & Biggar

The recent amendments to the Patented Medicines Regulations have been the subject of two court challenges launched by groups of innovative pharmaceutical companies – one in the Quebec Superior Court and the other in the Federal Court. The applicants before the Quebec court brought a constitutional challenge to the Patented Medicine Prices Review Board provisions of the Patent Act and the regulations, while the applicants before the Federal Court challenged the validity of the amending regulations.

Authors: Eleanor Wilson, Nancy Pei, Daphne Lainson
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Katie Lee Amended PMNOC Regulations: second anniversary update

Canada - Smart & Biggar

The amended Patented Medicines (Notice of Compliance) Regulations, which came into force in 2017, heralded significant changes to the landscape for pharmaceutical companies in Canada. Among other changes, the amendments ended dual litigation and provided innovators with a right of appeal. This article provides an update as of the second anniversary of the amendments.

Authors: Katie Lee, Urszula Wojtyra
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Riccardo Fruscalzo Milan court sets precedent on second medical use invention plausibility

Italy - Hogan Lovells

Few Italian precedents have considered the plausibility of a second medical use invention as a potential requirement for patent validity. However, a recent decision has clearly stated for the first time and as a matter of principle that the plausibility of an invention does not need the support of experimental data; rather, credible information based on a sound scientific and technical rationale is sufficient.

Author: Riccardo Fruscalzo
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Recent updates

Jaime L M Jones DOJ defends Medicare Advantage upcoding claims against Sutter

USA - Sidley Austin LLP

Authors: Jaime L M Jones, Scott D Stein, Jennifer M Haney
José Alberto Campos Vargas Challenges of providing telemedicine services

Mexico - Sanchez DeVanny Eseverri SC

Author: José Alberto Campos Vargas
Andreas Wildi New measures to combat rising costs in public healthcare sector

Switzerland - Walder Wyss

Author: Andreas Wildi
Rainer Herzig Alternative medical treatments and compassionate use

Austria - Preslmayr Attorneys at Law

Author: Rainer Herzig
Urszula Wojtyra Market access: biosimilars no longer reviewed by CADTH

Canada - Smart & Biggar

Author: Urszula Wojtyra
Fabian Huber MDR and medical software: liability under German law

Germany - Simmons & Simmons LLP

Authors: Fabian Huber, Caroline von Nussbaum