A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Monday, 3 September 2012

Casualty of Law: will SPC legislation be the next victim after Neurim?

After Neurim many
people view sheep
in a completely
different light ...

Following on from their article published in Life Science IP Review relating to the Opinion of the Advocate-General, Mike Snodin and Michael Pears (Potter Clarkson LLP) have published another article in the September edition of Scrip Regulatory Affairs on the ruling  of the Court of Justice of the European Union (CJEU) in Case C-130/11 Neurim Pharmaceuticals.

Mike and Michael's article, "Neurim wins the battle but not (yet) the war for innovators", notes that the Court of Justice's decision 
"significantly diverges from the opinion of the Advocate-General in a way that, through (arguably) focusing upon the need for a new therapeutic application / indication of an active substance, may just avoid some of the undesirable side-effects that could have arisen from strict adherence to the proposals in that opinion".
Nevertheless, Mike and Michael highlight the difficulties that national patent offices and courts are likely to have in interpreting the CJEU's decision, and especially in understanding how it fits in with its own earlier case law, such as Pharmacia Italia (C-31/03) and Yissum (C-202/05).  They also note the uncertainty for the pharmaceutical industry that arises from these interpretive difficulties.

In this respect, the article concludes with the following comments. 
"Various further questions from national courts are now almost certain to be referred to the CJEU, if only to obtain clarification as to what the decision in Neurim actually means.  In this respect, although the Neurim decision has improved the situation for the innovative pharmaceutical industry, the war is still far from won. The hardest battle yet to be faced relates to how to the CJEU can reach a clear and consistent interpretation of the SPC legislation that provides an appropriate reward for innovators. Although the current SPC legislation has survived the battle in Neurim, it is still perfectly possible that the legislation itself may become a casualty of future battles, especially if the CJEU fails to square the circle between Neurim and earlier case law such as Yissum".
A copy of the full article can be viewed here.


Anonymous said...

Yissum and Pharmacia Italia (two judgements adopted by only 3 judges) have been obvisouly abandonned in Neurim by 5 judges'chamber.

Mike S said...

That is an interesting thought, Anonymous. It would have been great if the CJEU had clarified the situation by saying what you have asserted. As they did not, it seems that we are left with lingering uncertainty as to whether you are correct or not...