Zentiva, a Portuguese generics company, sought and was granted marketing authorisation for a generic form of Boehringer Ingelheim's idiopathic pulmonary fibrosis drug Ofev (nintedanib) in August 2024. The drug in question is still in patent until December 2025, and is covered by a Supplementary Protection Certificate (SPC) that will expire in April 2026. Boehringer Ingelheim requested that the Lisbon Local Division grant a preliminary injunction against Zentiva, claiming an imminent risk of infringement of the patent, because marketing authorisation had been granted.
In Novartis and Genentech v Celltrion (order of 6 September 2024), the Düsseldorf Local Division stated that having a marketing authorisation is not relevant to the direct assessment of the risk of infringement. Having market authorisation alone is not indicative of an intention to take the product to market before patent protection expires. Instead, the risk of imminent infringement must be established based on the behaviour of the party and the facts of the case.
On 8 May 2025 the Lisbon Local Division confirmed this position and refused to grant the injunction against Zentiva. Achieving marketing authorisation before the patent for a drug expires is a crucial part of the preparation process pharmaceutical companies go through to bring a generic drug to market as soon as they are able. The UPC once again shows its business minded nature by ensuring third parties can achieve timely marketing authorisation without running the risk of an injunction being issued solely based on the authorisation.
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