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12 dicembre 2009

Abuse of Intellectual Property on pharmaceuticals: the European Commission Sector Inquiry

Mauro Turrini

On 1st December 2009 took place a seminar in Milan on “Abuse of Intellectual Property on pharmaceuticals”. The seminar, which was mainly focused on the findings of the European Commission DG Competition Sector inquiry into pharmaceuticals (the “Inquiry”), also analyses the subtle and uncertain line diving lawful use from abuse of IPRs under existing legislation. Participate as speakers at the seminar also well known Italian IP experts Giorgio Floridia and Paolo Auteri.

The Inquiry, which is the tool typically used by the Commission in order to improve its knowledge about a particular sector with a view to better identifying possible obstacles to competition, was essentially aimed at indentify the reasons why number of novel and innovative medicines reaching the market worryingly decreased over time and why generics medicines delay on entry on the EU market.

In particular, the Inquiry, which involved either originator either generic companies, for the purposes above analyses three main topics: patents; marketing authorization for medicinal products and pricing and reimbursement. As to patents, the Commission analyses in particular proportion between patent granted and patent eventually sentenced void, patents litigation and relating settlement agreement, intervention before competent regulatory authorities at the time of generics marketing authorization proceedings based on claim for alleged patent infringements.
At the seminar, it was debated by the panel of experts, whether some of the conducts above commonly put in place by originator companies in defense of their IPRs should be regard as lawful or not and therefore whether there was an use or abuse of IPRs.

The panel of experts seemed not unanimous as to the legitimacy of all the behaviors described above. In particular, those in favor of the lawfulness of above mentioned use of IPRs (“use of patents”) stressed the facts that most of the conducts assessed by the EC are expressly allowed by existing legislation (e.g. to file a patent, to act against alleged infringers, intervene with observation on administrative proceedings), while those skeptic about the actual lawfulness of above mentioned use of IPRs (“abuse of patents”) referred to the well known principle of law that the use of rights for purposes otherwise than those intended by the legislation is itself a such an abuse of such rights.

All members of the panel, however, concluded stating that further clarifications should be provided in the future either by the legislator or by the case law so to better identify the line between use an abuse of IPRs.

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