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The European Commission submits its views in an important case for SPCs to biologics

06 February 2015

News & Views
Author: Mike Snodin

Pharmaq v Intervet (E-16/14) is a case being heard by the EFTA Court that is potentially of huge importance to those seeking (or holding) supplementary protection for biological active ingredients in European Union (EU) or EFTA Member States. This is because it raises fundamental questions relating to the breadth of protection provided by an SPC to a biological product, and may well lead to an opinion from the court that could influence the extent to which such SPCs can be enforced against the producers of “copycat” (i.e. biosimilar or “me too”) biological products.

Whilst the opinion of the EFTA Court will be important (and potentially persuasive for future cases in the EU), the most interesting aspect of the case is the fact that observations have been submitted to the Court by parties that include the European Commission (EC) and the Government of the United Kingdom.

Significantly, the EC has proposed answers that may have profound (and, in part, undesirable) implications. For example, those proposed answers could lead to both harsh results for innovators and/or prolonged uncertainty for producers of “copycat” biological products. Parties having a stake in either innovative or “copycat” biological products may therefore wish to develop, and advocate to national governments and the European Commission, alternative solutions to the problem of SPC scope for biological products that lead to:

- a fairer result for innovators; and
- more (and earlier) certainty on freedom to operate.

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