EMA Transparency Policy upheld by General Court: companies unable to show that submissions to EMA are confidential

Eveline Van Keymeulen

On 6 February 2018, the General Court delivered three very carefully considered judgments in cases brought by companies who objected to the disclosure in their entirety of documents submitted to the European Medicines Agency (EMA) for the purposes of gaining a marketing authorisation or additional market exclusivity (see our previous update (see our previous blog Read More

German Court rules that promotion of prescription-only medicines is justified to refute a “shitstorm” in social media

Stefanie Günther

The Higher Regional Court of Cologne held in a recent decision that a pharmaceutical company could defend itself against a so-called “shitstorm” via a post in social media, even though the post qualified as promotion of a prescription-only medicine. The promotion of prescription-only medicines vis-à-vis the public is prohibited in the EU. The German courts Read More

Italian reform of clinical trial rules out of the starting blocks

Marco de Morpurgo

Today, Italian Law 3/2018 – mandating the governement to reform the Italian clinical trial rules – entered into force.  The Italian government now has 12 months to revise the regulatory framework applicable to clinical trials conducted in the country.  The legislative mandate to the government includes an alignment of the Italian clinical trial rules with the Read More

Life Sciences IPOs – 5 things to consider

Michael Bloch

After spending all day last Wednesday at Biotech & Money’s IPO workshop presenting and talking to Life Sciences start ups about their IPO plans, we thought it might be interesting to bring together some of our key thoughts on IPO preparedness. Companies thinking about an IPO can never start planning too early.  IPO planning and Read More

UK Court of Appeal asks the CJEU when Markush claims will be sufficiently specific for Article 3(a) of the SPC Regulation

Steven Baldwin

The Appellants in this action, Sandoz and Hexal, are appealing Arnold J’s decision to uphold SPC/GB07/038 on the basis that the Markush formulae in the basic patent are sufficient to satisfy the requirements of Article 3(a) of the SPC Regulation (Regulation (EC) No 469/2009). We have previously commented on the facts here and the first Read More