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Herbert Smith Freehills LLP | Australia | 29 Apr 2020
Commonwealth fails in its claim for compensation for PBS expenditure
Justice Nicholas’ long-awaited decision in Commonwealth v Sanofi is an Australian first. Of the 4 cases in Australia in which the Commonwealth has…
Peksung Intellectual Property Ltd | China | 20 Apr 2020
中国仿制药的发展现状分析
仿制药是指与原研药在剂量、安全性、效力、质量、药效以及适应症上均相同的一种仿制药品。现代仿制药起源于1984…
Peksung Intellectual Property Ltd | China | 20 Apr 2020
从《我不是药神》看中国的仿制药
一部意外走红的电影《我不是药神》让治癌神药"格列卫"家喻户晓，同时也再次让仿制药成为了大众关注的焦点。同样的药效，为何来自印度的仿制药格列卫价格如此低廉，而进口的正品格列卫价格却这么昂贵？为何我们要从印度买仿制格列卫而没有国产的仿制格列卫呢？接下来，我们就从以下几个方面来探讨这些问题。 一、什么是…
Westerberg & Partners Advokatbyrå Ab | Sweden | 8 Apr 2020
Biosimilars still not subject to mandatory substitution
Both the Medical Products Agency and the Dental and Benefits Agency (the authority which decides on reimbursement) have long held the position that…
PRO Compliance | USA | 3 Mar 2020
DOJ reaches deferred prosecution deal with Sandoz
Sandoz has agreed to pay $195 million as part of a deferred prosecution agreement with the Department of Justice to resolve a four-count felony charge of conspiring to fix prices, rig bids and allocate customers for certain generic drugs.
PRO Compliance | European Union, United Kingdom | 30 Jan 2020
ECJ: potential competition exists between originators and generics
The European Court of Justice has held that competition can exist between a pharmaceutical patent-holder and generic drugmakers that are in a patent dispute.
Bardehle Pagenberg | European Union, Germany | 30 Jan 2020
CJEU on the assessment in terms of antitrust law of pay-for-delay agreements between the holder of pharmaceutical patents and the manufacturers of generic medicines - Generics (GB), GSK et al. vs. Competition and Markets Authority
According to the CJEU, pay-for-delay agreements between the holder of pharmaceutical patents and manufacturers of generic medicines have the object…
Westerberg & Partners Advokatbyrå Ab | Sweden | 11 Dec 2019
Marketing authorisation holder lacks standing to challenge off-label prescription for unlicensed products
The Swedish system for medicinal products is generally product based. Prescriptions as such are product based (ie, by brand name or generic product…
De Berti Jacchia Franchini Forlani Studio Legale | European Union | 13 Nov 2019
Diritto di accesso, studi clinici e studi tossicologici. L’Avvocato Generale Hogan si pronuncia sulla presunzione generale di riservatezza e sull’eccezione relativa alla tutela degli interessi commerciali secondo il Regolamento 1049/2001
In data 11 settembre 2019, l'Avvocato Generale Hogan si è pronunciato nelle Cause C-175/18 P, PTC Therapeutics International Ltd contro…
PRO Compliance | France | 30 Oct 2019
Sanofi escapes €116 million damages claim in France
A French court has dismissed as time-barred a follow-on damages claim against Sanofi, as the claimant’s role in the competition authority’s investigation showed it knew about the drugmaker’s illegal conduct before an infringement decision was issued.
