The Court of Appeal over-turned the Lisbon LD decision and granted Boehringer Ingelheim's preliminary injunction (PI) application against Zentiva's generic product. In doing so, the Court of Appeal lowered the threshold for "imminent infringement" to situations where although the infringement has not yet occurred, the infringer has already set the stage for it to occur; and the preparations are complete.
Background
In Portugal, Zentiva obtained marketing authorizations (MAs) and a prior evaluation procedure (PEP) approval for generic nintedanib medicines. The purpose of the PEP evaluation is to establish conditions for public entities to acquire medicines; such as reimbursement prices. As a result of Zentiva's MAs and PEP approval, Boehringer Ingelheim asserted there was a risk of imminent infringement of its patent covering nintedanib for use in the treatment of idiopathic pulmonary fibrosis.
The Lisbon LD held that Zentiva's products fell within the scope of Boehringer Ingelheim's patent. However, it described Zentiva's MAs and PEP as "mere administrative actions" that do not establish an imminent risk of infringement; and found that Zentiva had not taken "any other steps" indicating it will market the medicine. As a result, the PI application was dismissed with costs to Zentiva.
In overturning the first-instance decision and granting Boehringer Ingelheim a preliminary injunction, plus costs, the Court of Appeal made an important finding of law and several findings of mixed fact and law.
On the legal point, the Court held:
"...a situation of imminent infringement may be characterised by certain circumstances which suggest that the infringement has not yet occurred, but that the potential infringer has already set the stage for it to occur. The infringement is only a matter of starting the action. The preparations for it have been fully completed..."
On the findings of mixed fact and law, the Court held:
"In the context of marketing of generics, the mere application for a marketing authorisation by a generics company does not amount to an imminent infringement, nor does the grant of such an authorisation create one. Completion of the national procedures for health technology assessment, pricing and reimbursement for a generic medicine can amount to an imminent infringement. The assessment must be made with due regard to the national regulatory and legislative context and considering the circumstances of the case."
Turning to the facts of the case, the Court held Zentiva's PEP approval enables it to offer its medicines to public entities and the threatened infringement was imminent. In other words, Zentiva had set the stage for offering its products and the preparations were fully completed.
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