Art. 3(a) SPC Legislation: An Analysis of the CJEU’s Ruling in Teva (C-121/2017) and a Proposal for Its Implementation

Posted: 25 Oct 2018 Last revised: 9 Jan 2019

See all articles by Roberto Romandini

Roberto Romandini

Max Planck Institute for Innovation and Competition

Date Written: October 12, 2018

Abstract

On 25 July 2018 the Grand Chamber of the CJEU delivered the eagerly awaited decision on Art. 3(a) Reg. 469/2009 following the referral by Justice Arnold in Teva (C-121/2017). In answering the question what it means to be protected by the basic patent under Art. 3(a) Reg. 469/2009, the CJEU formulated a two-pronged requirement. In order to be eligible for a supplementary protection certificate (SPC) the product (i) must necessarily fall under the invention covered by the basic patent and (ii) be specifically identifiable in that patent. This further formula in the case law following Medeva (C-322/10) is open to a number of interpretations, the most restrictive of which is that the CJEU has adopted a core-inventive-advance test with the first prong and required an individual disclosure of the product with the second prong. This article proposes a purposive implementation of the decision which takes into account the policy goals underlying the CJEU case law. These goals are to prevent multiple SPCs for the same product in conjunction with a number of other active ingredients (“evergreening”), unless such combinations represent a “totally separate innovation” (C-443/12), and to prevent the grant of a certificate for monotherapy products that were developed by a third unrelated entity after the priority date of the basic patent. In order to achieve the first goal, an inventive-advance test is necessary, but also sufficient. In order to ensure the second goal, requiring a disclosure of the product in an individualized form is in some cases sufficient, but not necessary where the patentee has, after the priority date of the basic patent, developed the product and obtained the MA submitted in support of the application for a certificate. In view of the persistent lack of clarity of the case law, the article concludes with some thoughts on the role of the CJEU, the task of the lawmakers and the implication of the Unified Patent Court Agreement (UPCA) for the operation of the SPC system.

Keywords: Supplementary protection certificates (SPCs); European patent law; Teva; Medeva; Eli Lilly; role of the CJEU; Unified Patent Court, evergreening

Suggested Citation

Romandini, Roberto, Art. 3(a) SPC Legislation: An Analysis of the CJEU’s Ruling in Teva (C-121/2017) and a Proposal for Its Implementation (October 12, 2018). In: GRUR Int, Vol. 68, Issue 1, 2019, pp. 9-24; Max Planck Institute for Innovation & Competition Research Paper No. 18-22. Available at SSRN: https://ssrn.com/abstract=3270898 or http://dx.doi.org/10.2139/ssrn.3270898

Roberto Romandini (Contact Author)

Max Planck Institute for Innovation and Competition ( email )

Marstallplatz 1
Munich, Bayern 80539
Germany

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