Read our IP Brochure on supplementary protection certificates.
Today, we will discuss some recent developments regarding Supplementary Protection Certificates or, in short: SPCs. An SPC is a discrete protective right that prolongs the protection conferred by a patent for a medicinal product or a plant protection product for a certain period of time in view of the marketing authorization procedure that these products need to undergo prior to their marketing. SPCs have been hotly debated since their introduction in the 1990s by an EU regulation. Why is that? Because many medicinal products yield their profit only at the end of the patent term and beyond that - which is then subject to protection by an SPC. Many questions, particularly regarding granting requirements were referred, over the years, to the European Court of Justice. Among all, the seemingly simple question of "Is the product which forms the subject matter of the SPC protected by the basic patent?" Right. And here, the European Court of Justice recently provided some further guidance in its Teva and Royalty Pharma decisions explaining that a structural definition of the product in the claims of the basic patent is not necessary. In other words, a functional definition of the product can do. However, if the definition is only a functional one, then a two-stage test needs to be passed. Right. Step one is the question "Does the product to be covered by the SPC fall under the invention of the basic patent - in view of the person skilled in the art, taking into account the whole disclosure of the basic patent?" Step two: "Can the person skilled in the art identify the specific product from the complete disclosure of the basic patent - taking into account his common general knowledge, so everything he knows from the prior art about how to obtain such products and what to do with them?" The second requirement is what will spark discussions. But the take home message certainly is that a general structural, or also functional definition of the product in the basic patent can do and is not a showstopper. Apart from case law, further defining and developing the application of the SPC law, there was a new development in 2019, namely the amendment to the SPC regulation by a manufacturing waiver. The problem the EU authorities saw was that biosimilar engineering companies would move their manufacturing sites outside the EU in order to be able to supply markets which were never patent-protected, or which became patent-free - SPC-free - outside the EU, and to start marketing within the EU, from day one of the expiry of the SPC. Under the manufacturing waiver, an SPC no longer protects against the manufacturing of active ingredients or corresponding medicinal products for the purpose of export to countries outside of the EU, nor against the manufacturing and stockpiling of products for day-1 market entry into the EU, following the expiry of the relevant SPC. Right. Now, while the export exemption applies from day one of the SPC, that means during the whole duration of the SPC, the stockpiling exemption only applies during the last six months of the life of the SPC. In order to be able to enjoy such an exemption, a party needs to give a notification to the respective patent office as well as to the holder of the SPC. And, products which shall be offered and sold outside the EU must be clearly marked on their outer packaging to that end. Notably, there is also a relatively complex transitional period regime with the consequence that we will still see SPCs coming into force to which no manufacturing waiver applies. Absolutely. The devil is in the detail.
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