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[IP NEWS-PATENTS] Protecting medications and Supplementary Protection Certificate: what to learn from the Court of Justice of the European Union! (Decision C-650/17 from the 30th of April 2020)

Even a medication, which is a simple and perfectly characterised chemical molecule, can be protected by a series of patents filed one after the other, mimicking the development of the product.

Here is an example of what could happen:

• A first patent protecting the molecule by its function through claims, as “Product for its use in treating disease X, characterised by its link to the Y receptor”.
• A second patent, filed a few years afterwards, covering the chemical formula of a molecule linked with the Y receptor”. This molecule would be the one going through the marketing authorization process.
• A third patent covering a single enantiomer from the above-mentioned molecule.

For various reasons, the applicant will sometimes only need to get patents such as the first one, meaning with claims protecting the molecule’s function but not the molecule – which is discovered later – itself. If this protection works perfectly for 20 years, some issues may arise at the end of that period when the patent owner wishes to obtain a Supplementary Protection Certificate (SPC) in the European Union.

Indeed, the EU laws enable the owner of the base patent covering the medication to apply for an additional five years maximum of protection as a compensation for the time required to obtain the marketing authorization. This SPC does not really lengthen the patent’s life: it is a separate protection that only affects the product that went through the marketing authorization process.

So what happens when the base patent does not precisely describe the product that was subjected to a market authorization but only its use, or even when the product was discovered only later, requiring the use of inventive activity? These questions had to be answered by the Court of Justice of the European Union in its judgment from the 30^th of April 2020.

The Court stated that even if a patent does not present specifically a product in its text or its claims, a SPC can, theoretically, be granted. However, when the product is not explicitly divulged in the base patent’s claims, but comes from a general functional definition, the person of skill in the art needs to be able to immediately deduced and without ambiguity in the patent as filed that the product benefiting from a SPC is protected by the patent.

However, a product benefiting from a SPC or a SPC request, which was developed after the filing date or priority date of the base patent, after an autonomous inventive activity, could not be considered as benefiting from the protection of this patent.

To conclude, when a product that goes through a marketing authorization does not directly come from the patent’s development, this patent can not be used as a base to obtain a SPC. In such a case, the medication will only be protected for 20 years and will be benefit from the additional 5 years of protection.