In Italy, a remarkable judgment was rendered at the interface
between competition law and patent law. According to the highest
Italian administrative court, how patent rights in the
pharmaceutical industry are invoked can under certain circumstances
be contrary to competition rules. This judgment could be important
for your company's divisional and SPC strategy.
The Consiglio di Stato (CdS), Italy's highest administrative
court, upheld the original decision of the Italian competition
authority (ICA) to impose a EUR 10.6 million fine on Pfizer for the
abuse of its dominant position by misuse of patent and
supplementary protection certificates SPC rights. The CdS thus
overturned the decision of the court in first instance. The only
known precedent in Europe somewhat related to this case was in AstraZeneca where AstraZeneca's
alleged misleading representation of information to a patent office
relating to SPCs for medicinal products was held to be abusive and
to support unlawful exclusionary behaviour. Here, however, the
situation was quite different.
Pfizer held a European patent for Xalatan – a product used
to treat glaucoma – containing the active ingredient
latanoprost. The patent expired in September 2009. In
Italy, this patent had not been extended by a supplementary
protection certificate (SPC), allegedly due to oversight. The ICA
established that Pfizer obtained a divisional patent for the same
product and then relied on this as a basic patent to obtain an SPC
for Xalatan in Italy. The acts carried out by Pfizer to achieve
this resulted, according to the ICA and upheld by the CdS, in a
complex and articulated conduct that amounted to abuse of right
and, in particular, anti-competitive behaviour meant to delay the
entry of generic products. This is, again according to the ICA and
the CdS, confirmed by the circumstance that the divisional patent
for latanoprost did not lead to the introduction of a new
drug in the market, which circumstance supports the exclusionary
intent found by the ICA in the overall assessment (also of internal
emails and of Pfizer's conduct vis-à-vis generic
companies). The ICA was also critical of Pfizer having applied for
and obtained a paediatric extension for this product which is used
to treat a disease that typically affects older people whereas the
authorities generally stimulate application for this extension.
The CdS considered that this case does not concern the
lawfulness of conduct under patent (and SPC) law, but the
anti-competitive effects of a series of acts that are per se
unlawful. How rights were used here is artificial, i.e. for a goal
which is inconsistent with that for which such rights were granted:
in this case the exclusion of competitors from the market.
There is, however, no explicit explanation about how the rights
were used contrary to the goal for which they were granted, given
that patent rights and SPCs give the holders a monopoly the effect
of which is precisely to exclude competitors from the market. In
AstraZeneca, there was a finding that information had been
misrepresented, which seemed to underlie the finding of abuse. In
this case, Pfizer seems to have acted in accordance with the law.
This decision seems to suggest that there is no need for such
additional reprehensible conduct and even the exercise of lawfully
obtained exclusive rights by a company that is in a dominant
position (which position the rights holder has) can lead to
violation of competition laws. This is a rather unsatisfactory
outcome as no clear guidance is provided on why the goal pursued by
Pfizer in this case differs from those goals for which the rights
Though the facts of this case are rather special and it might be
difficult to generalise the outcome, this judgment could be
important for your company's divisional and SPC strategy.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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