Originally published November 24, 2011
Keywords: Court of Justice, EU rules, Supplementary Protection Certificates, SPCs, Hatch-Waxman Act, patent term extensions
Summary and implications
The Court of Justice of the European Union ("CJEU", the new name for the ECJ) has today delivered its highly anticipated judgments on the grant of EU-wide Supplementary Protection Certificates ("SPCs") for medicinal products.1 Broadly, SPCs are the EU equivalent to patent term extensions under the US Hatch-Waxman Act.
These judgments are of great importance for life science companies, who are facing much-publicised patent expiries for high-value drugs, and for competitors and manufacturers of generic medicines who are keen to enter the market. These judgments bring some welcome harmonisation to EU law on SPC applications, and have a potentially strategically significant effect on the position across the EU.
Whilst these judgments give life science companies welcome clarification that it is legitimate to have SPCs for combination products and multiple active ingredients, these judgments strictly limit SPCs to what the underlying patents cover – and no more. The CJEU has given life science companies an unequivocally stark reminder that there can be only one SPC for each relevant patent. This cuts directly across current patent office and industry practice in Europe, where multiple SPCs are being granted out of the same basic patent despite the prohibition against doing so from the earlier 1997 ECJ Biogen decision2. The effect of reiterating that such multiple SPCs are impermissible is that existing multiple SPCs can now be invalidated by competitors, life science companies with such SPCs stand to lose valuable monopolies (with potentially significant stock market and market share implications), and competitors will be aggressively seeking to enter the market. The consequence of the "there can be only one SPC per basic patent" rule will potentially be an increase in litigation in national courts seeking to cancel existing multiple SPCs. This could lead to continued uncertainty and divergent opinions from national courts across Europe as they set about working out the boundaries and implications of this rule – which will inevitably be a very fact-specific exercise. In the longer term these cases will have a significant effect on how life science companies craft their patent life cycle strategies. Life science companies should now be giving much attention at the granular level to how patents are written to maximise the types of SPCs that may subsequently follow, to the choice that has to be made between keeping or abandoning active ingredients or combinations for SPCs, and to how marketing authorisations can be best deployed to boost the position. Legal summary of today's decision by the CJEU
An SPC can only be granted for active ingredients that are specified in the claims of the basic patent.
An SPC may be granted even if the medicinal product in question (e.g. a multi-disease vaccine) contains not only an active ingredient or a combination of two active ingredients...