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.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High
May 17th 2025While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Targeted Reimbursement Encourages Oncology Biosimilar Use
May 7th 2025Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push trastuzumab biosimilars toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.