The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption.

Background

In the EU, SPCs, which apply to innovative pharmaceutical and plant protection products and have been increasingly used since 1993, are a unique intellectual property right that can the extend the 20-year term of a patent by up to five years.

An innovator can apply for an SPC on a product’s “basic” patent within six months of obtaining marketing authorization in any EU member state. 

In essence, SPCs aim to offset the loss of effective patent protection that occurs due to testing and clinical trials that products require prior to obtaining regulatory marketing approval.

The differences in SPCs across EU member states, which is related to differences in patenting as well as litigation, result in a complicated IP landscape, though there “is no clear geographic bias in the use of SPCs by the location of patent holders,” study by Margaret Kyle of Mines ParisTech says.

“Almost 44% of SPC applicants are US-based, while the EU has close to 30%, followed by Japan and Switzerland at roughly 7% and 6%, respectively,” the study says.

Meanwhile, the EC notes that so-called Bolar patent exemption or research exemption, which is only for the pharmaceutical industry, aims to speed up the market entry of generic medicines by allowing early preparatory development on generics to obtain premarket regulatory approval even if the SPC of the reference medicine is still in force.

The scope of the exemption has been updated in some EU countries to meet new pharmaceutical-related requirements, according to the EC.

Consultation

The EC’s Single Market Strategy, adopted in October 2015, announced that the Commission will consult, consider and propose improvements to the patent system in Europe, notably for pharmaceutical and other industries whose products are subject to regulatory authorizations.

In particular, the strategy said this recalibration could comprise the following 3 elements:

• the creation of a European SPC title
• an update of the scope of EU patent research exemptions
• the introduction of an SPC manufacturing waiver 

The EC, from now until 4 January 2018, is seeking stakeholder comments, which the Commission says it will analyze before deciding whether and to what extent it should take further action.

Industry group Medicines for Europe has already put its weight behind the idea of an SPC manufacturing waiver.

Adrian van den Hoven, Director General at Medicines for Europe, noted a recent study showing "the huge benefits that the SPC Manufacturing Waiver and Bolar harmonisation offer Europe in terms of jobs, manufacturing and a lower overall medicines bill."

Public consultation on supplementary protection certificates (SPCs) and patent research exemptions