Understanding Supplementary Protection Certificates (SPCs) and Pediatric Extensions (SPC-PEs) in Norway

The role of SPCs in pharmaceutical protection

SPCs are designed to compensate for the time lost during the lengthy process of obtaining regulatory approval for new pharmaceutical products. In Norway, as in the EU, the European Economic Area (EEA) and UK, SPCs can extend the protection of a patented product by up to five years beyond the original patent expiry. This extension is crucial for pharmaceutical companies, allowing them to maximize the return on investment for their innovations.

Pediatric extensions: Encouraging child-specific research

Pediatric Extensions of SPCs (SPC-PEs) can provide an additional six-month extension to the SPC term. Pediatric exclusivity may be granted to companies that conduct research specifically aimed at understanding the effects of their products on children. By encouraging pediatric studies, SPC-PEs aim to ensure that medicines are safe and effective for younger populations, addressing a critical gap in pharmaceutical research.

Navigating the SPC and SPC-PE application process in Norway

SPC and SPC-PE applications are filed and granted nationally, however they are based on the framework established by EU Regulation No. 469/2009 , commonly referred to as the SPC Regulation. In Norway, this regulation is implemented through Sections 62a and 62b of the Norwegian Patents Act.

The process of obtaining SPCs and SPC-PEs in Norway involves a thorough understanding of both national and European regulations. Applicants must demonstrate that their product is protected by a basic patent in force, validated in Norway, and which has received marketing authorization in Norway. Furthermore, an SPC may only be granted if the product has not already been the subject of a certificate. An SPC application must be filed within six months from the grant of the marketing authorization or from the patent grant, whichever is later. An SPC-PE application must be filed at latest two years prior to the expiry of the SPC term.

Bryn Aarflot: Expertise in SPC and SPC-PE applications

Bryn Aarflot, as a leading intellectual property firm in Norway, has extensive experience in drafting and prosecuting both SPC and SPC-PE applications. With a team of skilled professionals, we offers comprehensive services that guide clients through the complex landscape of intellectual property and regulatory exclusivity, related to these application processes. By staying updated on interpretations of the SPC Regulation and case law, the team maintains solid in-house knowledge of best practices aligned with the EU’s regulation. Our expertise ensures that applications are meticulously prepared, increasing the likelihood of successful outcomes.

Conclusion

In the ever-evolving field of medicines, SPCs and SPC-PEs are indispensable for extending the lifecycle exclusivity of patented products, being business critical for pharmaceutical and biotech companies. These legal instruments provide essential protection, encouraging innovation and ensuring that new medicines reach the market. With our proven track record in handling SPC and SPC-PE applications, you can confidently entrust us with your questions and applications for these exclusive rights. Please contact us if you have any questions in relation to SPCs or SPC-PEs or want to learn how we can support your SPC and SPC-PE application process.