By Sarah Gabriele
In line with the European Union’s efforts to strengthen the single market and as part of the Single Market Strategy presented by the European Commission in 2015, the European Commission has presented a proposed regulation regarding the Unitary Supplementary Protection Certificate (“USPC”). The proposed regulation will extend patent protections across the Union, creating a stronger right for brand-name pharmaceutical companies. However, the proposed regulation, in line with the most recent case law of the European Court of Justice, further strengthens the limit for pharmaceutical companies to obtain only one certificate per product per patent holder.
The Current Supplementary Protection Certificate Framework
Supplementary Protection Certificates (SPCs) are sui generis intellectual property rights that serve as an extension to a patent right. Although an SPC is an independent right, it can extend the patent right for a period of a maximum of five years, with the possibility of extending it for an additional six months if a pediatric extension is obtained. The rationale for the existence of SPCs is to help companies offset the loss of effective patent protection due to the regulatory requirements for obtaining marketing approval.
Currently, SPCs are being regulated by Regulation 469/2009. Article 3 of said regulation currently sets the conditions for obtaining a certificate. These conditions include: (a) the product is protected by a basic patent in force; (b) a valid authorization to place the product on the market has been granted; (c) the product has not yet been the subject of a certificate and (d) the authorization referred under point (b) is the first authorization placing the product on the EU market.
Article 3(c), the requirement of no prior certificate, sets one of the most debated conditions of this regulation. This condition aims at the prohibition of double issuance of SPCs for a company that holds multiple patents related to the same product. However, as history has shown, it is possible for different patentees to independently own different patents relating to the same active ingredient and product. In this case, if Article 3(c) were to be applied literally, this condition would result in the rejection of a second SPC application filed on the basis of different patents owned by different patentees. To resolve this problem, in 2009 the European Court of Justice has ruled that a second SPC for the same product can be granted on the basis of a different patent owned by a different patentee. This rule is also known as one certificate per product per patent per patent holder. Since its ruling, the European Court of Justice has been called to adjudicate different interpretations of the one certificate per product per patent per patent holder rule, including the possibility to obtain a second certificate for a combination product (their answer was no), or the possibility to obtain multiple certificates on the basis of the same basic patent if the certificate relates to different products with different terms (their answer was yes).
One open question, however, that scholars have been debating is whether holders of different basic patents, which are legally separate entities but which are factually economically linked, are prevented from obtaining multiple SPCs.
The Proposed Unitary Supplementary Protection Certificate Framework
On June 1, 2023, the unitary patent regime entered into force across the European Union. The new regime allows for a single patent to be enforceable in a unitary manner. In April, the European Commission proposed a similar system regarding SPCs, with the aim of improving transparency and consistency across the Union. The Proposed Regulation comes with several benefits for companies, such as the centralized examination procedure, which removes the hurdle to apply individually in each member state.
Article 3 of the Proposed Regulation, similarly to Article 3 of Regulation 469/2009, sets the conditions for obtaining a USPC. According to Article 3, paragraph 1 of the Proposed Regulation, a USPC shall be granted by a central examination authority on the basis of a basic patent if, in each of the Member States in which that basic patent has unitary effect, the following conditions are met: (a) the product is protected by a basic patent in force; (b) there is a valid authorization to place the product into the market; (c) the product has not been the subject of a certificate and; (d) the authorization is the first authorization to place the product into the market.
The new Article 3, however, does not limit itself in laying down the conditions for obtaining an USPC but instead adds a new paragraph. Article 3, paragraph 2 of the Proposed Regulation, which further specifies that the holder of multiple patents shall not be granted more than one certificate or unitary certificate for that same product for any given Member State. If two or more applications concerning the same product are submitted by two or more holders of different patents, one certificate might be granted to each of those holders, where they are not economically linked, by the competent authority.
Is The Rule “One Certificate Per Product, Per Patent, Per Patent Holder” Finally Becoming Clearer (and Stricter)?
While the proposed legislation explicitly states in its Explanatory Memorandum that it does not intend to modify, nor further clarify, the relevant case law of the Court of Justice, the new text does include some new wording, and more specifically it explicitly recognizes that companies economically linked amongst themselves cannot obtain more than one certificate per product. If the Proposed Regulation were to become law, it could indeed restrict the possibility to interpret Article 3 in a more liberal manner, creating a new limit for obtaining a second supplementary protection certificate through, for example, a subsidiary company. While this might not be good news for companies, the inclusion of this new specification might help to close the debate over whether two entities, economically linked, might hold two different certificates for the same product.
