By way of introduction, a Supplementary Protection Certificate (CCP) (in English SPC – Supplementary Protection Certificate) is an industrial property title that extends, for a maximum period of 5 years, the protection conferred by a patent on an active ingredient or combination of active ingredients, present in a pharmaceutical or phytosanitary product, after the patent has expired. This title was devised in the 1990s with the aim of compensating for the time elapsed until a product obtains the relevant health permits to be marketed. In fact, for the calculation of the useful time of the SPC, both the filing date of the patent and the date of marketing authorization of the product in question are taken into account, and if the difference between these two dates is greater than 5, it is set then to that maximum of 5 years. It should be noted that in the event that the product may have a pediatric purpose, this 5-year extension can be extended for another 6 months if a Pediatric Research Plan (PIP) is provided that supports its application in children. Again, these additional 6 months are intended to offset any additional research time that may be required for its study in children.
The CCP will be issued in the country, by the National Patent Office, in which the application for the certificate is submitted if a series of requirements are met on the date of application. In summary, they are the following:
– The product is protected by a basic patent in force.
– The product, as a medicine or as a phytosanitary product, has obtained a Marketing Authorization which is the first of the product as a medicine or phytosanitary product.
– The product has not already been the subject of a certificate.
The CCP enters into force once the patent has expired and only for the authorized product. It should be noted that supplementary protection certificates basically exist in the European Economic Area, since beyond the European Union (EU), supplementary protection certificates can be obtained in countries such as the United Kingdom, Norway, Iceland, Liechtenstein, Switzerland. Although they do not have to follow the European directive in this regard, their national laws are practically a copy of it.
From the foregoing, it is clear that the title of CCP is intended to favour those innovative product companies trying to “punish” in a certain way a part of the pharmaceutical industry as important as that dedicated to generic products, that is, those products whose composition is already in the public domain and that are biosimilar to a product whose patent has already expired.
However, the existence of this part of the pharmaceutical industry cannot be denied and, in this way, on July 1, 2019, Regulation 2019/933 came into force, amending Regulation 469/2009 regarding CCP. This modification arises as a response to the growing demand for generic medicines with the involvement of a large number of pharmaceutical companies, and to the search for greater competitiveness of the manufacturers of generic and biosimilar medicines established in the EU. In this way, the new Regulation 2019/933 (whose modifications have also been called the SPC waiver) modifies the old Regulation of 2009 in some of its most conflictive sections. For example, a new section (2) of Article 5 indicates that the CCP will not confer protection against certain related acts for which the consent of the certificate holder was required:
(i) the manufacture of a product/medication for export to third countries,
(ii) any related act that is strictly necessary for manufacturing in the Union referred to (i) or for export, or
(iii) the manufacture, not earlier than the six-month period prior to the expiration of the SPC, of the product/medication, for storage in order to market said product/medication in the Member States after the expiration of the SPC,
(iv) all related acts that are strictly necessary for (iii), provided that said act is carried out not earlier than the six-month period prior to the expiration of the SPC, and not earlier than that period.
These exceptions are applicable as long as certain conditions are met for the manufacturer. Briefly:
(i) that the manufacturer has provided the required information to the authorities of the member state where manufacturing takes place and to the SPC holder at least three months before the start of manufacturing:
(ii) the manufacturer ensures that a logo appears on the outer packaging of the product/drug.
Section 10 of this same article refers to the application of these exceptions. In this way, the modifications will only apply to the SPCs requested as of the entry into force of this new regulation, that is, on July 1, 2019. Likewise, as of July 2, 2022, these exceptions will apply in the same way to SPCs applied for before the date of July 1, 2019 but that take effect from that date. They will not apply to certificates that take effect before July 1, 2019.
Ultimately, the aim of this amendment to the regulation is to remove a major competitive disadvantage for EU-based manufacturers compared to manufacturers based in non-EU countries (where SPC-type protection is not available or not available). can be met) and ensure better treatment for patients. The review strikes a balance between ensuring Europe’s attractiveness to innovative pharmaceutical companies and allowing EU-based generics and biosimilars to compete in the global market.
At the national level, it should be remembered that the majority of generic medicines (it is said that 7 out of 10) that are marketed in Spain are produced at the national level. Consequently, this “SPC waiver” will allow Spanish companies dedicated to generic products to recover their competitiveness in the business that was clearly affected by the existence of the title of supplementary protection certificate.
Finally, it is worth mentioning that there may be more important changes in relation to CCPs coming soon. As is already vox populi in this world of patents, the entry into force of the Unitary Patent and the Unified Patent Court, which is expected for the second half of 2022 or the first half of 2023, will make it possible to obtain a patent valid for many countries (with its advantages and disadvantages). As a result of this, the logical idea of transferring the concept of a unitary patent to the concept of a single supplementary protection certificate valid for many countries was raised. However, things are not that simple, as the scope of SPC protection is limited to the product for which a marketing authorization has been granted and it is currently unclear how the issue of SPC protection in territories will be addressed. not covered by a marketing authorisation. In fact, the European Commission closed a proposal period in April in order to prepare an impact assessment and the necessary legislation in order to introduce a single procedure for granting supplementary protection certificates throughout the European Union. We are waiting for new changes in the not too distant future…
Article by Rafael Moreno