LSHC Horizons Brochure 2024 - Flipbook - Page 53
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Litigation
Patent filing and enforcement strategies under competition law scrutiny
The European Commission (Commission)
and many European competition authorities
regularly pursue investigations in the life
sciences sector. In recent years, their focus
seems to have shifted and new practices have
come under scrutiny. We summarize these
developments and provide take-aways for the
compliance practice.
After the Commission’s 2009 inquiry in the
pharmaceutical sector, the Commission and
national competition authorities sanctioned
several companies for agreements to extend
the exclusivity of an otherwise ending
patent protection “pay for delay” under the
cartel prohibition (Article 101 Treaty on the
Functioning of the European Union (TFEU)).
Hefty fines were imposed and there is a risk
of potential civil damages claims.
More recent cases focus on different practices
and rely on the abuse of dominance prohibition
(Article 102 TFEU), which does not focus
on anti-competitive agreements but rather
prohibits unilateral conduct. Infringements can
equally trigger fines and civil damages claims.
The Commission’s recent Teva (Copaxone) case
illustrates this enforcement trend. After raiding
several Teva subsidiaries, the Commission
opened an investigation against Teva in March
2021. It accused Teva of delaying the market
entry of generic drugs competing with its
blockbuster drug Copaxone. The Commission
alleges a misuse of patent procedures by
applying for multiple divisional patents
and selectively withdrawing them in appeal
proceedings to avoid negative precedents.
Dr. Lukas Rengier
Counsel
Munich
In addition, the allegations concern Teva’s
communication on rival products towards health
care professionals. Teva rejected the allegations
and a decision by the Commission is pending.
The Commission and national competition
authorities in Europe pursue several further
practices of pharmaceutical companies related
to the filing and enforcement of patents or other
exclusive rights and communication campaigns.
We indicate some of these practices that the
authorities are investigating below (without
covering all individual circumstances).
For the practice, this enforcement trend means
that companies should ensure compliance with
competition law if considering practices such
as (taking all circumstances into account):
• patent, brand or product strategies to
maintain – de jure or de facto – exclusivity
after patent expiry;
• applications for (multiple) divisional patents
or supplementary protection certificates
(SPCs) in particular combined with specific
enforcement strategies;
• acquisition of patents that are not used
for own product innovation (but could
potentially be enforced against competitors);
• communication campaigns that are critical
towards rival products.
Finally, since competition authorities often
rely on internal documents to prove anticompetitive intent, companies should be
careful when drafting internal documents
“watch your language”.
Benedikt Weiß
Associate
Berlin, Munich
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