Technology and Life Sciences | New clarifications from CJEU on the conditions for obtaining an SPC for medicinal products

The SPC Regulation provides extended protection for patented medicinal products in Europe, due to the lengthy process of placing medicinal products on the market. The regulation is implemented in Norway through Section 62a of the Norwegian Patents Act. There are four conditions for obtaining an SPC, and the CJEU judgment contains interpretations regarding two of these, namely that the product cannot already have been the subject of an SPC (Article 3 (c)) and that the product must be protected by a basic patent (Article 3 (a)). The judgment contains several clarifying statements regarding the interpretation of the conditions for obtaining an SPC.
Article 3 (c) states that an SPC may only be granted if “the product has not already been the subject of a certificate”. The first question addressed by the CJEU was whether Article 3 (c) should be interpreted to permit that a product composed of two active ingredients (A+B) could be granted an SPC if one of those active ingredients (A) had already been the subject of an SPC alone and was the only ingredient disclosed by the basic patent, while the other ingredient (B) was known at the patent’s filing or priority date.
The CJEU stated that whether two products are identical or different depends solely on a comparison of their active ingredient(s), irrespective of their therapeutic applications. Specifically, if one product is a combination of active ingredients (A+B), it is distinct from a product which only contains one of the ingredients (A or B). Thus, an SPC application with two active ingredients (A+B) cannot be refused simply because a product with only one of the ingredients (A or B) has previously been the subject of a SPC certificate.
The CJEU further emphasized that given the separate and cumulative conditions required by Article 3, whether only one active ingredient (A or B) in a combination (A+B) has been disclosed by the basic patent, which is the topic of Article 3 (a), is not relevant in the context of Article 3 (c).
Turning to its interpretation of Article 3 (a), the CJEU examined whether an express mention in the claims of the basic patent is sufficient for a product to be considered as being “protected by a basic patent”, as is required by Article 3 (a).
Referring to its previous assessment in case C-121/17 (Teva v Gilead), the CJEU confirmed that two criteria must be met to determine if a product is protected by a basic patent: First, from the point of view of a person skilled in the art, considering the description and drawings of the patent, the product must necessarily fall under the invention covered by the patent. Second, the product must be expressly mentioned in the claims or be specifically identifiable (the “two-stage test”).
The CJEU further concludes that this also applies to situations in which the product has been expressly mentioned in the patent claims. An express mention in the claims is insufficient for a product to be protected by the patent; the product must also necessarily fall under the invention covered by that patent from the point of view of a person skilled in the art. The mere mention of the possibility of combining active ingredients disclosed by that patent is insufficient to satisfy this condition. For a product to “fall under the invention covered by the patent”, the patent must disclose how this combination is required for solving the technical problem outlined in the patent.
Furthermore, the CJEU stated that the fact that one of the active ingredients is known and in the public domain does not necessarily disqualify the product from falling under the invention covered by the patent. If the basic patent shows that their combination produces a synergistic effect beyond their individual effects and contributes to solving the technical problem, it may be concluded that the combination of those two active ingredients necessarily falls under the invention covered by that patent.
Key Takeaways:
- A combination of active ingredients (A+B) can be granted an SPC even if one of the ingredients (A) has already been the subject of an SPC.
- The conditions for obtaining an SPC in Article 3 are cumulative, meaning all must be satisfied independently. The content of the basic patent is not relevant when interpreting Article 3 (c).
- For a product to be protected under Article 3(a), it must necessarily fall under the invention covered by the patent and be expressly mentioned in the patent claims or be specifically identifiable.
- Merely mentioning a combination in the patent claims is insufficient; the combination must contribute to solving the technical problem disclosed by the patent.
BAHR’s view
The judgment provides welcome clarifications regarding the possibility to ensure extended protection by way of SPC certificates, especially for combination products consisting of one active ingredient that was previously known in the art, such as was the case in the two national litigations for which the referrals to the CJEU were made.