Supplementary Protection Certificates (SPCs) are hugely valuable in protecting medicinal innovations, new research from European specialist IP firm Mewburn Ellis shows.
The report, Pharma and Life Sciences Patent Extensions in Europe, examines five years of data on SPCs to provide insight into a range of issues associated with SPCs such as the length of protection, how that protection interacts with existing regulatory protections, and the commercial value of SPCs in different countries.
It finds that SPCs provide an extremely important layer of protection that complements, and in 91% of cases outlives, regulatory protection.
The report also looks at the different forms of medicinal technology being protected, and how the length of protection varies with different technology types.
Other key findings:
- Despite the rise of biologics therapies, more traditional, small molecule medicines still dominate the approved drugs market with 56% of the SPCs filed in the UK.
- The pandemic does not seem to have had any obvious impact on the pace of SPC filings, up to the end of 2020 at least, with 73 filings in 2020 vs 72 in 2019.
Mewburn Ellis has been heavily involved in SPC work since their introduction, having handled the very first UK SPC application back in 1993. The report analyses five years of data on SPCs to provide insights into filing patterns and strategies which will inform pharma and life science companies when making their SPC decisions.
The data was drawn from the UK IPO publications of SPC applications under the reasonable assumption that individual national SPCs typically form part of a Europe-wide filing strategy.
Sam Bailey, partner at Mewburn Ellis, said:
“Our research provides guidance to pharma and life science companies about some of the key decisions that are needed in this complex area and offers real-world data to demonstrate the potential value of patent term extensions when deployed as part of an integrated protection strategy for a new drug.
The development of next generation therapeutics could challenge the existing system of patent term extensions in the future. Our analysis of the publicly available data supports an extensive regional filing strategy and examines how the additional period of protection interacts with other protections from the regulatory sphere to provide robust protection against competitors.
Many pharmaceutical and life science companies will have an in-house patent team and a regulatory drug approvals group. However, these teams can benefit from external support providing specialist knowledge about patent term extensions. Given the huge potential value of these assets, a collaborative approach, which combines the skillsets of in-house and external teams, will lead to the most efficient outcomes in terms of strategy formulation and execution.