Pharmaceutical firms receive favorable news due to UPC's elucidation on impending patent violations
The Unified Patent Court (UPC) has overturned a previous decision regarding the requirements for direct patent infringement, in a case involving pharmaceutical companies Boehringer Ingelheim International GmbH (Boehringer) and Zentiva Portugal, LDA (Zentiva). The ruling concerns Boehringer's patent for Ofev, a drug used for treating various lung diseases, with nintedanib, as esylate, as its active ingredient.
Boehringer had claimed that administrative activities undertaken by Zentiva in Portugal had represented evidence of imminent infringement of its patent for Ofev. The patent is due to expire on 21 December 2025, but Boehringer has exclusive rights to sell products containing nintedanib through to 9 April 2026 by virtue of a supplementary protection certificate (SPC).
In Portugal, the originator has no way to determine when a generic product is to be launched, making it unable to police the market. However, the court found that Zentiva's actions were potentially threatening infringement. The company had obtained a PEP (Product Entry Plan) approval, which meant that the generic product could be offered to public hospitals in Portugal without any further administrative steps.
The court concluded that, in this case, it is more likely than not that Zentiva had "set the stage" for offering its product in Portugal. Zentiva failed to provide a credible explanation for obtaining the PEP more than a year prior to the patent expiry, leading the court to conclude that the only use of the PEP was for offering a generic product and infringing the patent.
The UPC Court of Appeal decision reverses an earlier decision by the UPC's Lisbon local division (LD) that certain pre-launch activities did not represent imminent infringement of a patent. The ruling provides essential clarity to both patentees and generics and biosimilar medicines manufacturers about what steps may lead to imminent infringement being found.
The court's ruling also has implications for the proposed recasting of the Bolar exemption as part of the EU's ongoing pharma law reform. It suggests a potentially broader scope of exclusion from patent infringement for steps necessary to bring a generic product to market.
The UPC's rules of procedure give practical effect to those provisions and provide criteria the UPC can consider when assessing applications for preliminary injunctions (PIs). Article 62 of the UPC Agreement (UPCA) provides powers to the divisions of the UPC to grant injunctions to prevent imminent infringement.
The decision may have significant implications for the pharmaceutical industry, as it emphasizes the level of detail into which the court will delve in investigating the factual matrix upon which to decide the question of whether an imminent threat of infringement exists. The ruling provides clarity on activities that may constitute imminent infringement of a patent, offering essential guidance for companies operating in the sector.
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