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
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
The outcome is still awaited of the constitutional case objecting to a ratification of the UPCA by Germany, which was listed to be decided in 2019. In a recent interview, Judge Huber of the German Federal Constitutional Court (which is the court due to decide the case) denied that the delay had anything to do with Brexit, rather that other important cases were also waiting to be decided and took precedence. He suggested that the case might be decided in the early part of 2020. Read more
Hear the latest developments in European pharmaceutical patent law from France, Italy and the UK. Now available on demand. Key topics included: The situation of provisional damages in PI proceedings and the consequences in terms of damages of a wrongly awarded PI in France and Italy The implications of the above with respect to involving … Read more
Jeremy Corbyn, Leader of the Labour Party, recently announced a report entitled “Medicines For the Many: Public Health before Private Profit”, which sets out a proposed set of policies on access to medicines in the UK, which are reflected in the Labour Party’s manifesto launched last week. An accompanying press release described the report as … Read more
On Thursday 7 November, our London IP team hosted a panel discussion and roundtable session on 'Harnessing the power of diversity in IP'. This was part of an ongoing campaign with World IP Review (WIPR), to celebrate the achievements of influential women in IP and to improve gender diversity in the profession.Read more
Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector In this issue we provide updates from the CJEU on SPCs: in one case the CJEU has declined to consider a referral from the UK while in another the Advocate General has issued his opinion on the interpretation of Article 3(a) … Read more
In our recent report on our clients’ perspectives on managing innovation in their organisations “Open Innovation: Collaborate To Innovate” we shared our insights into the world of open collaboration assisted by contributions from a wide range of our clients. As part of our analysis we highlighted the main legal considerations that arise in restructuring a collaboration arrangement. In our first publication following on from the report – Getting the IP right in collaborations – we take a more detailed look at some of the principal intellectual property issues and set out practical steps to consider when embarking on collaboration projects. Read more
On 5 September 2019, the Ninth Chamber of the CJEU refused a request for referral in relation to the interpretation of Article 3(b) 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'). Read more
