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ARTICLE · 14 SEPTEMBER 2023

Does An SPC For A Biological Product Cover A Biosimilar?

J A Kemp
J A Kemp
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J A Kemp

J A Kemp

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To what extent will a Supplementary Protection Certificate (SPC) for a biological product be considered to encompass closely-related alternatives such as biosimilars?

United KingdomIntellectual Property
Graham Lewis
Graham Lewis
Chris Milton
Chris Milton
Ravi Srinivasan
Ravi Srinivasan
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To what extent will a Supplementary Protection Certificate (SPC) for a biological product be considered to encompass closely-related alternatives such as biosimilars? This question will become increasingly important as more and more biological medicinal products, and their competing biosimilars, enter the marketplace. We expect to see the issue arise before the national courts of the EU and the UK, and ultimately – at least for EU member states – the question is likely to require a referral to the CJEU. Until that happens, however, arguably the best available guidance is that provided by the EFTA court in 2015, in its judgment E-16/14 (Pharmaq v Intervet), subsequently applied in 2016 by the Norwegian Court of Appeal. This briefing provides an analysis of Pharmaq v Intervet as well as our conclusions and recommendations for those seeking SPCs for biological products across Europe.

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