CJEU AG’s Opinion in Santen referral proposes to abandon Neurim

On 23 January 2020, AG Giovanni Pitruzzella provided his Opinion on the interpretation of Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products ("SPC Regulation"). In doing so, AG Pitruzzella makes two proposals to the CJEU. His favoured proposal would significantly curtail the availability of SPCs for second medical uses of known and previously authorised compounds, as it strictly interprets the meaning of "product" under Article 1(b) and precludes an interpretation of Neurim according to which a marketing authorisation (“MA”) for a “different and new application of an old active ingredient” could be considered as the first MA of a previously authorised active ingredient. His alternative proposal permit SPCs in a wider set of circumstances by interpreting Neurim as allowing an SPC to be granted if the new MA “covers a new therapeutic indication of said active ingredient or relates to a use of it in which this active ingredient exerts a new pharmacological, immunological or metabolic action of its own”. Read more

Data issues in innovation and collaborations

Businesses in every sector are under pressure to innovate to stay ahead of the competition. ‘’Open innovation’’ is a term that has come to describe innovation which extends beyond the traditional R&D department of a business and embraces a broader pool of talent and ideas within the whole business and frequently also extends to an external partnership with a third party collaborator to assist with and accelerate the process. In our second publication Data issues in innovation and collaborations, following on from our Open Innovation: Collaborate To Innovate report, we take a more detailed look at how data frequently plays a central role in the drive towards ‘’open’’ innovation and the significant value attached to it. Data can be used to generate new products or services and revenue streams, to identify efficiencies within an organisation and reduce costs, and to inform strategic decision-making. Read more