In a recent decision, the Athens First Instance Single Member Court examined arguments routinely raised in preliminary injunction proceedings involving disputes between originator and generic pharmaceutical companies.
In the case at issue, the claimant, a well-known originator pharmaceutical company, filed a preliminary injunction application against a generic company. The defendant had informed the claimant of its intention to launch a generic copy of one of the claimant’s best-selling products, falling under the scope of the claimant’s supplementary protection certificate (SPC), a few months before the SPC’s expiry.
In response, the defendant challenged the validity of the SPC paediatric extension and argued that granting the requested injunction would effectively provide the claimant with the full benefit of the relief that could be sought in the main proceedings, thereby creating an irreversible situation until the SPC expired in November 2026. The defendant further contended that it would suffer disproportionate and irreparable harm if an injunction were granted, as it had already incurred substantial costs in preparing for the product launch and would be unable to establish a reliable basis for any future claim for lost profits should it ultimately succeed in invalidating the SPC.
The court’s findings
Having found that the completion of the regulatory approval process established a credible and imminent risk of patent infringement, the court proceeded to assess the balance of interests between the parties, a factor of particular importance in Greek preliminary injunction proceedings.
The court emphasised the absolute nature of patent rights, which entitle the patent holder to exclusively exploit the invention and prevent third parties from doing so. It further stressed that strong protection of pharmaceutical intellectual property is essential to encourage innovation, creativity, and investment in pharmaceutical research. The development of originator medicines requires extensive, costly research and clinical trials, and the legal framework provides supplementary patent protection, including additional extensions for paediatric studies, to help innovators recover their investments.
By contrast, the court noted that generic medicines can generally be brought to market through a shorter and less costly regulatory process and achieve the same therapeutic effect without requiring comparable inventive effort.
After balancing the parties’ interests, the court concluded that the claimant would suffer greater economic harm if the generic product were allowed to enter the market prematurely than the harm the defendant would suffer from delaying its launch. The court also considered that early entry of the generic product would give the defendant an unfair commercial advantage by enabling it to benefit from the reputation and market acceptance of the originator product while offering its generic product at a lower price.
Wider significance of the ruling
Beyond its case-specific findings, this decision contributes to the growing body of Greek pharmaceutical patent case law by reaffirming the central role of the balance-of-interests analysis in preliminary injunction proceedings. The judgment illustrates that, even where arguments concerning disproportionate harm to generic manufacturers are raised, Greek courts will closely scrutinise the commercial realities of the case and the purpose of patent exclusivity before determining whether provisional protection is warranted.
