Pharma IP – European Update on SPCs and Litigation
In the pharmaceutical field, SPCs, supplementary protection certificates, are extremely valuable intellectual property rights. An SPC extends the duration of the exclusive rights conferred by a patent and usually covers the period during which the medicinal product reaches peak sales and profitability. SPCs were introduced as compensation for the loss of effective patent term due to the lengthy time required to research and gain market approval for new medicinal products.
An SPC is a sui generis right that does not operate as a simple extension, in the same way as, e.g., a patent term extension in the US does. With the 2011 Medeva judgement, the CJEU addressed specific weaknesses in the system, which created uncertainty for all stakeholders. While numerous judgements have been handed down by the CJEU, following Medeva, key questions regarding SPC requirements have not been fully answered and new questions of interpretation have arisen.
This report will cover the some of the key questions and zoom in on national practices on the basis of specific examples. In addition the report will cover best approaches regarding the SPC Manufacturing Waiver, and also briefly cover the new Unitary Patent System. This report reflects the opinions from three industry experts: Jurgen Dressel, Patent Litigator and former Head of Patent Litigation Strategy at Novartis Pharma, Jaap Mannaerts, European Patent Attorney and Partner at NLO, and Judith Krens, Partner at Pinsent Masons.
It is beneficial to consider the context for these topics, and their complexities: the main goal of the EU legislation on SPCs and the SPC Manufacturing Waiver, was intended to stimulate and take away competitive disadvantages for pharmaceutical industries within the EU.