SPCs outlive patent protections in 91% of cases, new report reveals

Supplementary protection certificates (SPCs) outlive medicinal patents in more than nine in ten cases, a new report has found.

The study, Pharma and Life Sciences Patent Extensions in Europe, published by law firm Mewburn Ellis yesterday, June 23, analyses five years of data on SPCs to provide insights into filing patterns and strategies.

The data was drawn from the UK Intellectual Property Office’s publication of SPC applications over a five year period from 2016 to 2021, which showed that 344 UK SPC applications were filed. Of this number, 94% related to medicinal products.

Among pending and granted SPCs, the study revealed that the projected SPC term would outlive the standard ten-year regulatory protection period of patents in 91% of cases. If all the relevant SPCs benefitted from a further six-month paediatric extension, that figure would nudge up to 92%, said the report.

The pandemic does not seem to have had any obvious impact on the pace of SPC filings up to the end of 2020 with 73 filings in 2020 compared to 72 in 2019, the report revealed.

“It remains to be seen whether the loss of research time due to the pandemic will eventually feed through to fewer approved drugs and lower SPC numbers,” said the report.

Commenting on the findings, Sam Bailey, partner at Mewburn Ellis, said: “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.”

According to the research, more traditional small molecule medicines still dominate the approved drugs market with 56% of the SPCs filed in the UK, despite the rise of biologics therapies.

Therapies classified as “antibodies” fell into second place at 23%, while the next largest category was “nonantibody proteins”, accounting for 8% of SPC filings.

The research provides insights 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.

The report’s  analysis of SPC applicants suggests that at least two-thirds of the approved medicinal products started their life outside of the world’s “pharma top 20’” underscoring the importance and success of smaller players in the sector, and the relevance of acquisitions and licensing.

The report also looks at the different forms of medicinal technology being protected, and how the length of protection varies with different technology types.

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