Article originally published in Global Competition Policy, February 2009
The release of DG Competition’s Preliminary Report on its Pharmaceutical Sector Inquiry on November 28, 2008 was a Brussels media event, with press briefings, press releases, and an all-day public hearing that was covered by the Commission’s live television channel.1 Much of the discussion at the time of the Report’s release and since has revolved around the European regime governing the recognition and enforcement of patents. Intellectual property experts are troubled by inaccuracies in the Report as well as by suggestions that practices that are common not just in the pharmaceutical sector, but all high-tech sectors, such as taking out numerous patents around an invention, are incompatible with the competition rules. Innovative pharmaceutical companies are concerned that practices that are critical to the protection of their patents and that are permissible under the intellectual property regime are being called into question. These concerns will undoubtedly be discussed in-depth in many of the submissions that were made to DG Competition at the end of January and that will be posted on its website.
Somewhat ironically, given that the Preliminary Report was issued by the competition directorate, it says virtually nothing about the assessment under EC competition law of the various practices described as comprising the nefarious “tool-box” of instruments used by innovative pharmaceutical companies to delay the entry of generics. Instead, DG Competition presents the Preliminary Report as a set of neutral findings that will form the “factual basis” for a decision on whether further action is needed. It goes out of its way to disavow any intent to opine on the legality of the practices described in the Report, stating that “[i]t is not the purpose of this report to identify wrongdoing of individual companies or provide guidance on the compatibility of certain behavior with EC competition law.”
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