On 2 July 2022, the SPC manufacturing waiver, approved by EU Regulation 2019/933, came into effect. This regulation is one of the most important initiatives developed in Europe for the pharmaceutical industry that manufactures its products in the European Union. To understand the importance of this regulation, we must take into account that 24% of the APIs produced in the world are manufactured in the EU (source, Charles River Associates). As far as Spain is concerned, 7 out of 10 Spanish generics are produced in Spain (source, AESEG).
In order to help clarify some of the basic issues and to encourage the proper use of this important regulation, we provide below the answer to some of the basic questions posed by pharmaceutical companies interested in using it:
1. Since when does the SPC manufacturing waiver apply?
The SPC manufacturing waiver is applicable from 2 July 2022 for all SPCs if their basic patent expired after 1 July 2019. The SPC waiver cannot be applied to SPCs that came into force before that date.
2. What can be done under the SPC manufacturing waiver?
The SPC waiver is an exception to the exclusive right granted by an SPC. It allows manufacturing in the EU for the purpose of exporting or storing a certain medicinal product.
3. Can I import a medicinal product into the EU during the term of the SPC for the sole purpose of storing it so that it can be launched on the market once the SPC expires?
No. If the medicinal product has not been manufactured in the EU, it cannot be imported for the purpose of storing it to be launched on the market after the expiry of the SPC. The medicinal product must have been manufactured in the EU.
4. When can I begin manufacturing in the EU under the SPC waiver?
For export to third countries outside the EU, manufacturing can begin as soon as the patent expires in the EU and the SPC becomes valid.
For storage in the EU, manufacturing can only begin during the last six months of the SPC term.
In both cases, the relevant patent office and the SPC holder must be notified of my intention with at least three months’ notice.
5. Who is subject to the information obligation foreseen in the Regulation?
The SPC manufacturing waiver requires that the maker gives prior notice to (a) the patent office, (b) the patent holder and (c) third parties with which such maker has a contractual relationship in the EU and will carry out potentially infringing activities.
The maker means a person established in the territory of the European Union and on whose behalf the manufacturing of the API or the medicinal product is carried out and so may be different to the one that manufactured the API or the medicinal product. The manufacturer does not have to be the one who manufactures, though it is possible that the maker directly carries out the making.
6. Can I store the medicinal product in any territory of the EU?
The Regulation does not stipulate any limitations in storage when the purpose is for export. However, if the purpose is to import the medicinal product into the EU, the SPC manufacturing waiver Regulation stipulates that the product must be stored in the Member State where it is made. In other words, in the country where the medicinal product is manufactured.
7. Can I import the active ingredient from any EU country to manufacture a medicinal product?
Possessing, offering to supply, supplying, importing, using or synthesising an active ingredient for the purpose of manufacturing a medicinal product are related acts that can be carried out in the EU provided they take place during the term of the SPC and the corresponding notice is sent in advance.
8. Apart from making, what acts can be carried out under the SPC waiver?
Under the SPC waiver, all the acts can be carried out that are strictly necessary for performing the manufacturing activities for export and/or storage. For example, temporary storage or advertising for the sole purpose of export to third countries.
The excluded activities can be carried out by the maker or by companies with which it has a contractual relationship as well as by third parties provided that they can justify that the activity they are carrying out is strictly necessary for export or storage.
9. Which patent office should I notify?
The notification to the patent office must be provided in the country where the medicinal product or active ingredient is made (if the latter is manufactured for export).
Making an active ingredient that is used to manufacture a medicinal product in the EU is a related act for the purposes of the Regulation. The notification must be sent by the maker in the country where the medicinal product is manufactured, identifying (a) the country where the related act will be carried out and (b) the SPC applicable in that country.
10.How do I send the notification to the companies with which I have a contractual relationship in the EU?
The maker must notify third parties with which it has a contractual relationship that will perform any act that could fall within the scope of the SPC that the medicinal product or the active ingredient is covered by the SPC manufacturing waiver and that its import or re-import for export purposes or its marketing could infringe the SPC as long as the latter remains valid.
Ideally, that information should be included in the relevant clauses of the contract, otherwise it should be provided by appropriate and documented means.