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European Commission Launches Public Consultation on Supplementary Protection Certificates

AUTHOR(S): Deirdre Kilroy
PRACTICE AREA GROUP: Intellectual Property, Life Sciences
DATE: 20.12.2017

The European Commission (the “Commission”) launched a public consultation on 12 October 2017 (the “Consultation”) seeking views on proposed reforms on certain aspects of patent and supplementary protection certificate (“SPC”) protection.  SPCs are a unique EU intellectual property right that extends the term of a patent right by up to five years.

The Consultation deals with the following three topics of possible reforms of the patent system in Europe:

  • The creation of a European SPC right: Existing SPCs, although created and regulated by EU laws, are granted and enforced at Member State level. The discussion of the creation of a European-wide SPC arises because the laws laying the ground for the creation of a Unitary Patent system in the EU do not currently contemplate the creation of a Unitary SPC.  Also some are of the view that differences in practices across Member States in operating the current SPC regime are not ideal. The Commission seeks views regarding whether the current SPC system suffices, or should a new Unitary SPC be created.

  • An update of the scope of EU patent research exemptions: The current patent research exemption was introduced through Directive 2011/83/EC on the Community code relating to medicinal products for human use (as amended by Directive 2004/27/EC) and Directive 2004/28/EC relating to veterinary medicinal products (the “Bolar Directives”) and is commonly called the Bolar exemption.  The Bolar Directives have been implemented in different ways across EU Member States, particularly in relation to the scope of the exemption available in certain specific pharmaceutical-related fields.  The Commission seeks views on the impact of the current Bolar exemption regime within the EU, and what (if any) changes should be considered in terms of the Bolar exemption regime.

  • The introduction of an SPC manufacturing waiver: The Commission seeks views on the creation of an SPC “manufacturing waiver”. This waiver would allow manufacturing of generics / biosimilars within the EU during the term of an SPC, with a view to exporting products to countries with no SPC protection.

    In its Inception Impact Assessment (published in February 2017), the Commission provides that one of the key drivers for introducing an SPC manufacturing waiver is that “[it] could allow EU based medicines manufacturers to seize net export opportunities of several billion Euros in the coming years [which] in turn would generate increased investment in manufacturing activities in the EU and create new jobs”. This is not a view held by many in the industry, who view this possible development as a threat to innovation and investment in R&D in the EU, as it would erode the value of a SPC. The Commission seeks views on the economic and social impact of the introduction of such a waiver in the EU.

The deadline for responses to the Commission’s Consultation is 4 January 2018. The Commission is seeking contributions from established stakeholders (eg, originators, EU-based generic and biosimilar suppliers, active pharmaceutical ingredients suppliers), those in the innovative sectors whose products require pre-market regulatory authorisation but are not currently eligible for SPC protection, national authorities and consumer/patient organisations. The Consultation is likely to draw responses from those operating in the pharmaceutical industry and in other industries whose products are subject to regulated market authorisations.

If you require further information or assistance with responding to this Consultation, please contact Deirdre Kilroy, Head of Intellectual Property at Matheson.

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