Intellectual property

Key developments in relation to new Chinese IP tribunal rule and Chinese patent law amendment

David Shen

Recently, there have been some key developments in the intellectual property sphere in China that may be relevant to life sciences clients.  Below we report on the new Chinese IP tribunal rule and an important Chinese patent law amendment. New Chinese IP tribunal rule The Standing Committee of the National People’s Congress previously announced the Read More

New formulations of existing active substances are not entitled to an SPC according to Advocate-General

Toby Sears

The Opinion of Advocate General Saugmandsgaard Øe in Abraxis Bioscience (Case C-443/17) was delivered on 13 December 2018.  The Advocate General concluded  that the UK Intellectual Property Office had been  correct in declining to grant a Supplementary Protection Certificate (SPC)  to Abraxis for a novel formulation of an active substance which had already been the Read More

Has the Orphan Regulation met its aims? A critical review of the EU’s incentives regime for rare disease patients

Eveline Van Keymeulen

By the 1990’s the European Union had fallen behind other developed economies in the encouragement and support its pharmaceutical regulatory framework offered to the development of new treatments for rare diseases. The aim of the Orphan Regulation was to remedy this. In the article “Has the Orphan Regulation Met its Aims? A Critical Examination of the European Union’s Read More

CJEU confirms that prior authorisation for a drug-incorporating device is not an MA under the SPC Regulation

Michael Krenz

The Court of Justice of the European Union (CJEU) has ruled that a supplementary protection certificate (SPC) cannot be granted for a medical device comprising an active ingredient because the EU authorisation procedure for devices does not result in a marketing authorisation (MA). The request was made in proceedings brought by Boston Scientific Ltd. and Read More

French Courts also want the CJEU to clarify the criteria laid down in the Neurim landmark decision

Charles Tuffreau

While Article 3(d) of the SPC Regulation (No. 469/2009) was thought to prevent the grant of an SPC covering a new therapeutic application of a product which had already received a MA for a medicinal product, the CJEU ruled in its Neurim decision (C-130/11) of 19 June 2012 that “the mere existence of an earlier Read More