Wednesday, 8 July 2009

Interim relief "more nuanced than expected", says Pharma Report

Today's Pharma Sector Report from the European Commission's DG Competition contains a large amount of statistical data concerning the litigation and/or settlement of disputes involving pharmaceutical patents in more than half the member states of the European Union. There's far too much data for PatLit to be able to make a convenient summary of it and, despite its extensive use of tabular formats to illustrate and contrast numbers and trends, there is in any event only a limited amount that one can learn from them. For example, they cannot take into account the merits of the cases before the courts in terms of such core issues as the (non)obvious nature of disputed patents and the scope of the claims in both infringement and validity proceedings.

While DG Competition comes out in support of both a Community patent and a unitary court system for the litigation of patent disputes, its investigation was principally into matters concerning competitiveness within the pharma sector and the report does little more than endorse the position which the Commission is already known to hold.

One matter which may be of particular interest to readers of this blog is that of interim relief against alleged infringement. On this the report says
"(656) ... the subsample of cases with interim injunctions shows two particular features, namely: a high ratio of settled cases (73%, i.e. 44 out of 60 cases, which are final) and a low ratio of judged final cases (27%, i.e. 16 out of 60 cases). Furthermore, it is interesting to note that in the subgroup of settled cases, there is a tendency to end litigation with the conditions that are favourable to generic companies (i.e. either allowing generic entry or a value transfer from the originator to the generic company). Even if this cannot be regarded to be a conclusive indication as to likely outcome of the respective court cases, this element needs to be borne in mind when interpreting a higher proportion of the cases with interim injunction won by originator companies (11 out of 16 cases).

(657) The overall picture is thus more nuanced than one would have expected from the cases in which interim injunctions, the most restrictive legal tool, were granted, taking into account that, when requesting interim injunctions, the applicant is usually required to show that he is likely to succeed in the main proceedings and to demonstrate urgency. Adding up the actual generic successes (8%) and the settled cases appearing to be particularly favourable to the generic companies (38%), it would seem that in almost a half of the closed cases the grant of interim injunctions might not have been justified, whilst in another 25% of the cases that were settled the situation is unclear".

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