As part of the intended reform of EU pharmaceutical legislation, the EU Commission has published a proposal for a recast of SPC Regulation (EC) No 469/2009, namely draft Regulation COM(2023)231. In addition to the suggested introduction of a centralized procedure for SPCs, two paragraphs have been added to Article 3, which lists the conditions for obtaining an SPC.
Further additions concerning Article 3 have been made to the recitals by (partially) including CJEU decisions on Article 3 lit. a and d SPC Regulation (EC) No 469/2009. Also, new Article 6 (2) adds a granting condition for cases in which the patent owner is not the holder of the marketing authorization relevant to the SPC application.
Revised wording of articles 3 and 6 SPC Regulation
Conditions for obtaining a certificate
- A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application, all of the following conditions are fulfilled:
(a) the product is protected by a basic patent in force;
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC
or Directive 2001/82/EG,Regulation (EC) No 726/2004, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.
- By way of derogation from paragraph 1, a certificate shall not be granted under this Chapter, in a Member State, on the basis of a national application where the requirements of Article 20(1) are fulfilled for the filing of a centralised application in which that Member State would be designated.
- The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for that product may be issued to each of those holders, where they are not economically linked.
Entitlement to the certificate
- The certificate shall be granted to the holder of the basic patent or
his to the successor in title of that holder.
- Notwithstanding paragraph 1, where a basic patent has been granted in respect of a product that is the subject of an authorisation held by a third party, a certificate for that product shall not be granted to the holder of the basic patent without the consent of that third party.
Impact of proposed modifications to Articles 3 and 6
Article 3 (2)
- aligns granting conditions with proposed centralized application
Article 3 (3), 1st sentence
- clarifies concept of “one SPC per product per patent holder”
- reasoning formerly derived from Article 3 (2), 1st sentence and recital (17) of the Plant Protection Regulation (EC) No 1610/96
Article 3 (3), 2nd sentence, 1st half-sentence
- clarifies concept that different patent holders may obtain an SPC each for the same product
- previously held in Biogen/Smithkline (C-181/95) and AHP Manufacturing (C-482/07)
Article 3 (3), 2nd sentence, 2nd half-sentence
- adds additional requirement that different patent holders relying on Article 3, 2nd sentence, 1st half-sentence may not be “economically linked”.
- No definition of “economically linked” provided
Article 6 (2)
- consent of MA holder required for SPC application if MA is not held by patent holder
- Does this serve the intent of protecting the innovator?
- Potential bidding war in Article 3 (3), 2nd sentence-cases?
- intends to incorporate Teva v Gilead (C‑121/17) on Article 3 (1) a
- fails to mention the subsequent decision in Royalty Pharma (C-650/17)
- incorporates Santen (C-673/18) on Article 3 (1) d
- incorporates the ruling in Farmitalia (C-392/979) and recital (13) of the Plant Protection Regulation (EC) No 1610/96, further explicitly listing ethers, isomers, mixtures of isomers, complexes or biosimilars
- describes Article 3 (3), 1st sentence as a further measure to ensure that no more than one certificate may protect the same product in any Member State.
- also refers to Article 6 (2)
- clarifies that SPC protection based on a biological medicinal product extends to all therapeutically equivalent products having the same International Nonproprietary Name, including biosimilars having “minor differences” compared to the authorized product.
With the wealth of CJEU rulings on Article 3 SPC Regulation, improved consistency and clarity would be most welcome. However, including CJEU decisions on the interpretation of Article 3 SPC Regulation in the recitals per se requires regular updates. As mentioned in footnote 16 of the Explanatory Memorandum, further decisions are expected in two referrals made in 2022 (C-119/22, C-149/22). In the proposed recast, only a limited number of the relevant decisions has been included.
Notoriously, for every ounce of clarity CJEU rulings provide, they simultaneously add levels of complexity to the legal issues supposedly solved. Therefore, selecting individual decisions for inclusion in the recitals does not necessarily ensure consistency.
For those seeking SPC protection, the proposed amendments to Article 3 (3), 2nd sentence, 2nd half-sentence and Article 6 (2) would pose further hurdles. On the other hand, those challenging SPCs may obtain additional grounds for successfully challenging SPC validity.