Competition Law in Italy The first 20 years of law and practice

The Competition Authority’s substantive analysis arguably departs from established EU
case law, whereby refusals to license intellectual property rights may be found abusive only
if a number of cumulative conditions are met, including that the refusal prevents the
emergence of a new product for which there is potential consumer demand. Clearly, this
condition was not met in Glaxo’s case. Indeed, FIS intended to produce exactly the same
active ingredient produced and marketed by Glaxo. Likewise, generics manufacturers would
have offered an identical product. In its decision, the Competition Authority argued that the
case at hand was different from those analyzed in the relevant EU case law, insofar as
Glaxo’s refusal prevented commercialization of both Sumatriptan and Sumatriptan-based
drugs in countries where it did not hold any intellectual property rights covering the active
ingredient. According to the Competition Authority, Glaxo’s conduct did not fall within the
subject matter of its SPCs because it prevented the development of competition in markets
falling outside the scope of protection guaranteed by the SPCs.
In a parallel case, Merck-Principi Attivi, 504
136
the Competition Authority followed a
similar approach. Dobfar, a manufacturer of active ingredients for generic producers,
requested Merck & Co. (Merck) to release a license for the production and export of the
active ingredients Imipemen-Cilastatin and Finasteride. Such request was based on the
above-mentioned Italian legislation for the holders of SPCs. The Competition Authority
found that Merck’s refusal to grant a license for the production and export of active
ingredients into countries where the relative patents have been already expired was capable
of having an anticompetitive impact in the downstream pharmaceutical markets and was not
justified by any legitimate reason. Accordingly, by way of an interim measure, the
Competition Authority ordered Merck to release the mentioned licenses. In the course of the
proceedings, Merck concluded a license agreement with Dobfar, granting it, in compliance
with the order issued by the Competition Authority, a license for the production in Italy of
Imipemen-Cilastatin, whose relevant SPC had in the meantime expired. Moreover, Merck
committed to grant non-exclusive free licenses to make possible the production and sale of
the Finasteride active ingredient and the relative generic medicines two years before the
expiration of the relevant SPC. The Competition Authority deemed these commitments
capable of removing all the anticompetitive aspects of the abusive conducts in question, and
hence it closed the proceedings without imposing a fine.
G. Agency Enforcement
1. National Enforcement
(a) Responsible Agencies & Structure
The enforcement of the Competition Law is entrusted to the Competition Authority. The
structure of the Competition Authority is discussed in Part I.C. of this Chapter, supra.
504 Merck-Principi Attivi, 21 Mar. 2007, n. A364, Bulletin 11/2007.