LS&HC Horizons 2022 - Flipbook - Page 49
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
Patents, Litigation, and Beyond
Trends in life sciences patent litigation in Spain
The patent litigation landscape in life sciences in Spain promises to be
exciting in 2022, with developments expected in both the court rooms
and the legislative arena. The interplay between national infringement
and validity litigation and opposition proceedings pending before the
European Patent Office (EPO) has been hotly debated in the last few
years, and will continue.
The Barcelona Court of Appeals, one of the most highly-regarded
IP courts in Spain, has recently issued some landmark rulings
allowing patentees to enforce their European patents as amended
further to opposition proceedings in national litigation pending at
second instance, and to give a second try to preliminary injunctions
proceedings in view of the change of circumstances consisting of the
amendment of the patent in opposition.
The triggering events allowing the patentee to take judicial action in
case of imminent infringement of its patent rights by generics’ and
biosimilars’ companies are currently under discussion in view of a
controversial ruling recently issued by the Barcelona Court of Appeals,
which included a dissenting opinion from one of the magistrates.
Following a restrictive approach, the court considered that, absent
an effective marketing declaration of the defendant’s generic to the
Spanish health authorities, there was no risk of infringement even if
reimbursement price had been obtained. Relevant decisions dealing
with supplementary protection certificates are also expected this year.
Reform of the Patents Act is also currently underway, which, amongst
other amendments, would allow the protection of pharmaceutical
substances and compositions by utility models and the possibility that
the court may stay the national litigation while opposition proceedings
are pending.
Immaculada Lorenzo
Partner, Madrid
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