The European pharmaceutical patent system has a number of challenges that are delaying market entry of inexpensive generic drugs, according to a report from the European Generic Medicines Association (EGA). The problems within the system are inhibiting innovation and competition in the pharmaceutical sector.

Greg Perry, director general of the EGA, stated that patent linkage is the "single biggest barrier" to generic competition. Patent linkage connects market approval of generic medicines to the patent status of the original reference product. Market authorization is prohibited until original drug patents have expired and a determination has been made that the patents in question are not infringed upon, invalid or unenforceable.

The EGA report says that the national medicines agencies which decide on market authorization have been pressured by the pharmaceutical industry to continue applying the complex practice of patent linkage, without a clear standard on how to apply it. Such ambiguity results, according to the EGA, in "ill-informed judgments on complex patent issues that normally can only be determined in specialized courts." The EGA's position is that the practice of patent linkage is not consistent with current European law, and should not be a common practice due to the inhibition of market entry for generic medicines.
In addition, the EGA argues that the patent process is being used to prevent innovation and competition in such ways as the submission of quantities of "follow-on" patents--patents of poor quality that are for the purpose of keeping the original patent continuing past expiration, which in turn delays the introduction of generic drugs. The EGA feels that the lowering of patentability requirements, in particular regarding to their innovativeness, have contributed to this influx of follow-on patents.

Patent holders also come into criticism from the EGA as abusing the judicial system in delaying resolving litigation with the generic companies, in order to maintain an advantageous position. The EGA concludes that these problems in the EU patent system are preventing an "appropriate balance between incentives and competition."

More information available at: http://www.egagenerics.com/ega-barriers_rpt.htm

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