Life Sciences Horizons Brochure 2025 - Flipbook - Page 102
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2025 Horizons Life Sciences and Health Care
New EU antitrust standard for patent strategies and communication campaigns
The European Commission (EC) is intensifying its
enforcement of abuse of dominance cases under
Article 102 of the Treaty on the Functioning of the
European Union and one focus is the pharma sector.
Two recent cases have established stricter standards
for patent strategies and communication campaigns
that potentially affect rival products. One case (Teva
Copaxone) ended with a substantial fine of €462.6
million, and the other case with a commitment by the
company to alter its conduct. National competition
authorities in the EU are already following in the
EC’s footsteps: in January 2025, the Romanian
competition authority imposed fines of €26 million for
a misleading communication campaign against rival
generics. Below, we summarize the key aspects and
provide practical takeaways, taking into account the
Teva summary decision published in January.
The Teva case deals with potentially anti-competitive patent
strategies. Teva had filed multiple divisional patents, enforced
them, and withdrew selective patents when negative precedents
were anticipated. As this obstructed an effective legal review, the
EC found it to be an abuse of the patent system. The related press
release and summary decision do not yet contain the full legal
framework underlying the EC’s considerations. We see three key
elements of an “abuse” found in this case, noting that an abuse in
this sense is not limited to divisional patents but also concerns
other strategies such as filing SPCs or acquiring blocking patents:
The patent strategy cannot be deemed “competition on the
merits”; for example, because it does not pursue legitimate
objectives such as protecting innovation or ensuring further
R&D versus plain anti-competitive objectives.
It is capable of producing exclusionary effects; for example,
it artificially creates legal uncertainty and thus effectively
hinders market entry such as in the Teva case; and,
It is not justified, as filing patents in line with
European Patent Office rules does not constitute an
objective justification.
In both cases, the EC also incriminated aggressive and misleading
communication about rival products. If one attempts to derive the
legal standard behind both cases, communication on rival
products could be “abusive” if the following cumulative
requirements are met:
Communication cannot be deemed competition on the
merits; for example, if it is objectively misleading due to
inaccurate or incomplete information about the safety,
efficacy, or therapeutic equivalence of rival products and
spreads unfounded health risks. An EC official recently even
suggested that only randomized head-to-head clinical trials
would be accepted when making claims about a competing
product; this was, however, only an informal statement.
Communication is capable of producing exclusionary
effects; for example, targeted messaging to demand drivers
such as HCPs or systematic dissemination through various
channels.
It is not justified; for example, there are no evidence-based
public health objectives.
Therefore, we observe the following key compliance takeaways:
Keep potential antitrust implications of patent strategies and
communication campaigns in mind.
Document patent filings to demonstrate legitimate interests.
Ensure communications are accurate, evidence-based, and
not misleading.
Use neutral, objective language in internal documents.
Dr. Lukas Rengier
Counsel
Berlin, Munich
Benedikt Weiß, LL.M.
(Aberdeen)
Senior Associate
Berlin, Munich
