Patent-Related Barriers to Market Entry for Generic Medicines in the European Union: A Review of Weaknesses in the Current European Patent System and their Impact on Market Access of Generic Medicines

Abstract

Patents are effective tools for promoting innovation in the pharmaceutical sector. Originator companies should be able to recoup their R&D investments during the term of the basic patent/SPC on an active pharmaceutical substance. Generic competition should be available immediately after expiry of that term. The chances of market entry for generic medicines companies in all markets the day following expiry of the main basic patent in all European Union markets is, however, not possible or, at best, is extremely difficult. Due to a diminishing number of newly registered products and contracting product pipelines, originator companies may be tempted to unjustly prolong the patent monopoly of existing products. The result is known as the ‘evergreening’ of a basic patent with the help of follow-on patents to keep generic competitors off the market. These follow-on patents are often weak or trivial and, upon careful examination, it is clear that they should never have been granted. Patent quality is therefore of the utmost importance. The European patent system should only reward true inventions and should discourage patent applications for ordinary innovation. An important way of reducing the incidence of poor quality follow-on patents is to remedy certain structural deficiencies and weaknesses in the current examination procedure. Priority must be given to ensuring that the European Patent Office (EPO) has the resources it needs to continue to improve the quality of patent examiners, along with their training and remuneration, and to increase the number of more experienced senior examiners in order to give every patent application the deliberate, expert review it deserves. This would lead to a more stringent application of the patentability requirements and fewer trivial patents. Applicants should be more rigorously required to provide patent applications of the highest quality accompanied by all relevant information at the start of the examination process. Similarly, they should be under obligation to disclose all information known to them that is material to the patentability of their invention. Furthermore, better third-party participation would also help to avoid inappropriate follow-on patents from being granted. When such patents are granted, an immediate review should be possible to avoid the assertion of ultimately invalid patents to hinder generic competition. This would require an acceleration of the current opposition proceedings that today can take many years. The structure established under the European Patent Convention only provides for a common and single European patent application and granting system by the EPO. A European patent is not a unitary patent, but essentially a bundle of national patents. As a result, questions of patent infringement and validity are governed by various national laws and are handled by the national courts operating under different procedural rules. This purely national litigation system results in a complex arena of multiple patent litigation involving high costs, forum shopping and diverging, even contradictory, court decisions. The lack of a central judiciary composed of experienced patent judges is regarded as one of the major defects in the current patent system. An effective solution would be the creation of a central European patent court that would deal with questions of invalidity and infringement at a pan-European level. Until this has been achieved, specialised national patent courts should be created with technically skilled judges with powers to reach a decision within an acceptable timeframe. Furthermore, the standard for obtaining an interim injunction should be returned to its roots as an equitable remedy since injunctions today are often used simply as a litigious tactic. This change would require a litigant to establish the existence of irreparable harm that cannot be compensated by monetary damages before a court would take the far-reaching step of enjoining a product. Finally, measures should be taken to ensure that originator companies do not use other means to unjustly prolong their monopoly by, for example, introducing a system of patent linkage, obtaining improperly granted SPCs, deploying inaccurate marketing campaigns for promoting ‘new’ products with no substantial added therapeutic value as innovative products, etc.