The new rules regarding[12] patents aim to introduce new compulsory licensing rules for patents in Europe and to simplify and harmonize the EU Supplementary Protection Certificate system by introducing a Unitary Supplementary Protection Certificate (SPC).
While J&J recognizes the role of Compulsory Licenses as the last resort tool in exceptional cases when voluntary agreements failed, we have seen no evidence that justifies an added value of an EU-wide Compulsory License on top of existing well-functioning national frameworks. Moreover, if such an EU-wide Compulsory License was to be introduced, it would need appropriate guardrails for it to be exercised within the right policy and judicial framework.
We welcome the goal of establishing a harmonized, centralized approach to Supplementary Protection Certificate application, examination, and issuance. It will lead to more clarity and efficiency in the EU IP framework. However, the aim of this legislation could be undermined if, due to missing procedural guardrails, it could open the door for misuse of pre-grant opposition proceedings by third parties to delay the SPC grant until the basic patent expires.