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Healthcare & Life Sciences

11 December 2019
Abigail Smith PMPRB releases draft guidelines operationalising amended Patented Medicines Regulations

Canada - Smart & Biggar

The Patented Medicines Prices Review Board recently released new draft guidelines for consultation and a backgrounder. The new guidelines aim to operationalise the amended Patented Medicines Regulations, which come into force on 1 July 2020, and provide a number of circumstances in which categories or price ceilings may be reassessed.

Authors: Abigail Smith, Nancy Pei, Daphne Lainson
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Ina vom Feld Recent case law on compulsory licences and use-up periods

Germany - Simmons & Simmons LLP

According to Section 24(1) of the German Patent Act, a compulsory licence can be granted to a patent infringer. Recent case law suggests that this possibility is becoming increasingly relevant. Further, in a recent originator-originator pharma case, the enforcement of a recall obligation was for the first time suspended for a certain period for public health reasons.

Authors: Ina vom Feld, Behyad Hozuri
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Jonas Löfgren Marketing authorisation holder lacks standing to challenge off-label prescription for unlicensed products

Sweden - Westerberg & Partners Advokatbyrå Ab

The Swedish system for medicinal products is generally product based. Prescriptions as such are product based (ie, by brand name or generic product name) and the indication for which the product is intended cannot be filled in anywhere by the prescriber. Off-label prescriptions are therefore not generally possible in the 'official' prescription system. However, when it comes to accessing unlicensed medicinal products, the system for licences on a named-patient basis works differently.

Author: Jonas Löfgren
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Recent updates

Andreas Wildi Court annuls FOPH order limiting medicinal product price increase

Switzerland - Walder Wyss

Author: Andreas Wildi
José Alberto Campos Vargas Vaping prohibition on grounds of health risk deemed unconstitutional

Mexico - Sanchez DeVanny Eseverri SC

Author: José Alberto Campos Vargas
Rainer Herzig 'Medical meets Beauty' – recent decision on dental sector advertising

Austria - Preslmayr Attorneys at Law

Author: Rainer Herzig
Katie Lee Federal Court issues two interlocutory decisions in Section 8 pregabalin case

Canada - Smart & Biggar

Author: Katie Lee
Armand Aviges French Administrative Supreme Court cancels Ministry of Health decision on assessment of public health interests

France - Altana

Authors: Armand Aviges, Delphine Lapillonne
Scott D Stein Ninth Circuit invited to weigh in on public disclosure bar falsity

USA - Sidley Austin LLP

Authors: Scott D Stein, Joseph LoCascio