While the EU decision on supplementary protection certificates might be good news for drug companies that find new uses for 'old' active ingredients, it raises more questions than it answers and leaves lingering uncertainty for many other companies.  

On 19 July 2012, the Court of Justice of the European Union (CJEU) delivered a judgement that is binding upon all EU patent offices and courts and should significantly liberalise the system of supplementary protection in Europe.

In the case in question, Neurim Pharmaceuticals (C-130/11), the CJEU upheld the validity of a Supplementary Protection Certificate (SPC) for a new medical use of a known pharmaceutically active ingredient. The ruling should allow SPCs to be based upon patents on (and marketing authorisations for) such new medical uses, regardless of the existence of earlier authorisations of the compound for different uses.

It is not yet clear whether the ruling allows SPCs for "old" active ingredients in other situations, for example based upon patents for new formulations. However, the logic of the ruling provides new hope that such SPCs might now also be allowable.

The opinion of Advocate-General Verica Trstenjak in the case of Neurim Pharmaceuticals (C-130/11) has the potential to greatly increase the number of medical innovations that will qualify for supplementary protection in Europe.

On 3 May 2012, Advocate-General Verica Trstenjak delivered her opinion in the Neurim Pharmaceuticals case (C-130/11) that is pending before the Court of Justice of the EU (CJEU).

The opinion delivered by A-G Trstenjak is non-binding but will be taken into consideration by the CJEU when it reaches its final decision later this year. If confirmed by the CJEU, the conclusions would have a profound, liberalising effect on SPC practice in Europe for new medicinal products that contain previously authorised active ingredients.

SPCs

Supplementary Protection Certificates (SPCs) are national rights in Europe that protect authorised uses of a "product" (an active ingredient or a combination of actives) that has been subject to patent protection. The protection provided by SPCs is particularly valuable, as it can provide an effective barrier to generic competition for up to five (or even five and a half) years beyond patent expiry.

A new European court decision completes a new model of how both availability and breadth of protection under supplementary protection certificates are to be assessed. Its confirmation of an earlier decision means SPCs will be afforded a broader scope than some had previously appreciated, report Mike Snodin and Michael Pears.

Following hot on the heels of important SPC decisions issued in late 2011, the Court of Justice of the European Union (CJEU) has now issued a reasoned order in the Novartis v Actavis case (C-442/11).

On 24 November 2011, the Court of Justice of the European Union issued decisions in two cases that have important and far-reaching consequences for the application of the law relating to the Supplementary Protection Certificates (‘SPCs')

On 25 November 2011, the Court of Justice of the European Union (CJEU) decided three cases relating to Supplementary Protection Certificates (SPCs) by reasoned order (i.e. without a hearing). The orders follow judgements already handed down in the Medeva (C-322/10) and Georgetown University et al (C-422/10) cases that we previously reported in our IP Update No. 165. The following are further points of note.

The Court of Justice of the European Union (CJEU) ruled yesterday in an important case (C-125/10, Merck Sharp & Dohme Corp. v Deutsches Patent- und Markenamt), relating to Supplementary Protection Certificates (SPCs). The decision of the CJEU is binding upon all national patent offices and courts, and dictates how the term of an SPC is calculated, especially in view of a 6-month extension of term that may be available.

In essence, the CJEU has approved "Model A" of an article published on 7 July 2007 by Mike Snodin and John Miles of this firm, which introduced the revolutionary concept of zero and negative term SPCs.

That is, the CJEU has decided that SPCs can be granted even if they initially have a zero or negative term, i.e. if less than 5 years and 1 day has elapsed between patent filing and Marketing Authorisation (MA) issuance. This is because, provided that at least 4 years, 6 months and 1 day has elapsed from between patent filing and MA issuance, a zero or negative term SPC can serve as the basis for an extended SPC with a positive term.

The particular factual background to this case is discussed in our IP Update no. 153 (relating to the opinion of the Advocate-General that has effectively been confirmed by the Court). However, the essential points of the case, as well as possible actions that you may wish to take, are outlined below.

On 24 November 2011, the Court of Justice of the European Union (CJEU) delivered its judgement in two seminal cases relating to Supplementary Protection Certificates (SPCs). Potter Clarkson represented Georgetown University, University of Rochester and Loyola University of Chicago in one case and the party in the other case was Medeva. Our IP Update No 155 discusses the corresponding Advocate General's opinion, which opinion is superseded by the present judgement. The ruling provides significant clarity and is binding on all EU national patent offices and courts.

Mike Snodin, a member of our SPC & Regulatory group, has published an article in the journal Scrip Regulatory Affairs that challenges the manner in which many patent offices in Europe calculate the terms of Supplementary Protection Certificates (SPCs) that are based upon a centralised (European Commission / European Medicines Agency) marketing authorisation.