European Union Launches Consultation on Patent Extension

The Center for Biosimilars Staff

SPCs are an intellectual property right that grants an extension of up to 5 years on a 20-year patent term for an innovative pharmaceutical. The goal of the SPC is to offset the loss of patent protection that occurs during the development and clinical trials of a generic or biosimilar.

The European Commission has launched a public consultation on supplementary protection certificates (SPCs) and patent research exemptions. Changes to the ways in which SPCs are administered in the European Union could have a significant impact on the biosimilars marketplace.

SPCs are an intellectual property right that grants an extension of up to 5 years on a 20-year patent term for an innovative pharmaceutical. The goal of the SPC is to offset the loss of patent protection that occurs during the development and clinical trials of a generic or biosimilar.

Bolar patent exemptions, which are intended to speed market entry of generic therapies, provide exemptions to patent protection, even in cases in which SPCs are in force. These exemptions state that some pre-market activities cannot be regarded as infringements of a patent or SPC.

However, Martin Dræbye Gantzhorn and Emil Bjerrum, both of Denmark law firm Bech-Bruun, explain that because SPCs are granted and enforced at a national level, rather than at an EU level, confusion about, and difficulties with, these certificates and their related bolar exemptions are widespread.

For example, in some EU member states, bolar exemptions do not permit access to active pharmaceutical ingredients for the purpose of biosimilar development. In other states, it is not clear in the local law whether exemptions may be used for activities related to marketing drugs. Gantzhorn and Bjerrum also point out that bolar exemptions have been subject to stakeholder questioning insofar as they may disadvantage EU manufacturers; if EU drug makers are not allowed to produce pharmaceuticals for the non-EU market during the SPC term, developers located outside the EU will have an advantage in gaining early market share in these nations.

SPCs have also been subject to question in the biosimilars context due to the nature of biosimilar therapies themselves; SPCs cover the active ingredient or combination of active ingredients in a product. Because biosimilars are, by definition, only highly similar to their references, there remains some question as to whether SPCs can be applied to forestall biosimilar development. This question has been highlighted in Norway, where the judicial system first determined that SPCs did not apply to follow-on biologics, then overturned the decision in an appellate court.

The new consultation is intended to gain feedback from stakeholders in order to determine whether the Commission should take further legislative action concerning the certificates and waivers. Responses will be collected via online questionnaire, and results will be published by the Commission.