Pharma sector inquiry – main issues investigated

  • Author: European Commission (Directorate General Competition)


This excerpt provides a detailed account of uncompetitive practices in the pharmaceutical sector in the European Union and is produced by the official EU body. It gives understanding how unfair utilization of intellectual property is prevalent and about the importance of using uncompetitiveness arguments in analysis of the sector. A part of the conclusions of the document: "The findings of the inquiry suggest that in recent years originator companies have changed their patent strategies. In particular, strategy documents of originator companies confirm that some of them aimed at developing strategies to extend the breadth and duration of their patent protection. Filing numerous patent applications for the same medicine (forming so called "patent clusters" or "patent thickets") is a common practice. Documents gathered in the course of the inquiry confirm that an important objective of this approach is to delay or block the market entry of generic medicines. In this respect the inquiry finds that individual medicines are protected by up to nearly 100 product-specific patent families, which can lead to up to 1,300 patents and/or pending patent applications across the Member States." While the document is lengthy you might easily navigate by interest or just look into the summary/conclusion pages in grey (in total 3 pages and they follow each descriptive part): 2.1. Patent Filing Practices: 2.1.1. Scenarios of Generic Market Entry Addressed by Patent Strategies 2.1.2. Patent Clusters 2.1.3. Divisional Patent Applications 2.1.4. Intended Effects of Patent Clusters and Divisionals Limitations of Generic Entry as an Immediate Consequence of Patenting Procedural Enforcement of Patent Rights 2.2. Patent-Related Exchanges and Litigation 2.2.1. Patent-Related Exchanges between Originator and Generic Companies out of Court Number of Contacts and Disputes between Originator and Generic Companies in the EU and INNs Most Often Concerned by Contacts and Disputes Number of Disputes Initiated in the EU by Originator and Generic Companies Disputes Resulting in Settlement Histogram with Patent Expiry Dates of Patents in Dispute 2.2.2. Litigation Number of Patent Litigations Initiated in the EU and per EU Member State Number of Patent Litigations Initiated in the EU by Type of Action and Initiating Party INNs Concerned by Patent Litigation Categories and Types of Patents Concerned by Patent Litigation Patent Expiry Dates and the Start of Patent Litigation Outcome of the Main Action on the Merits Interim Injunctions Cost of Fees for Legal Advice Incurred in Patent Litigation Contradicting Decisions 2.3. Oppositions and Appeals 2.3.1. General Information Number of Opposition Procedures and Opponents INNs most Concerned Comparison between EPO Oppositions in Pharmaceuticals and in all Sectors Duration of Procedures (Oppositions and Appeals) National Opposition Procedures 2.3.2. Opposition and Appeal Procedures with Generic Companies as Opponents

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