Patent linkage – the process whereby generic drugs are denied market authorisation, price or reimbursement status until all patents on the originator product have expired or are declared uninfringed, invalid or unenforceable – presents the single biggest barrier to generic competition, according to generic industry leaders.

The practice forces experts at drugs agencies and pricing and reimbursement authorities to make ill-informed judgements on complex patent issues that can only normally be determined in specialised courts, said Greg Perry, director general of the European Generic medicines Association (EGA). “Patent linkage is inconsistent with European law and must not be allowed to become ensconced in practice,” he added.

Mr Perry was speaking last week at the launch of a new report by the EGA which examines current barriers to market entry for generic drugs in the European Union (EU). These barriers - which result from weaknesses in the EU patent system and the surrounding legal and regulatory framework - include, as well as patent linkage, practices such as the use of marketing campaigns to shift consumer demand and the granting of Summaries of Product Characteristics (SPCs) based on incorrect information, says the report. In three areas in particular - failings in the system for granting quality patents, patent “thickets” and follow-on patents and patent litigation procedures - these weaknesses are failing to ensure an appropriate balance between incentives and competition, according to the EGA.

Market entry for generic versions of an innovator product the day after the main basic patent expires in all EU markets is currently not possible, or at best extremely difficult, says the report. This is because, with fewer new drugs coming to market and contracting R&D pipelines, originator companies “may be tempted to unjustly prolong” the patent monopoly of their existing products through “evergreening” the basic patent with the help of follow-on patents to keep generic competition 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,” says the report, adding that, when misused in this manner, patents can present an almost insurmountable barrier to market entry for generic drugs.

It calls on the EU patent system to reward true inventions only and discourage patent applications for “ordinary” inventions. Moreover, it adds that, to reduce the incidence of poor-quality follow-on patents, “certain deficiencies and weaknesses” in the current examination procedure have to be remedied. In particular, the European Patent Office (EPO) needs sufficient resources to continue improving the quality of its patent examiners, and to be able to increase its numbers of more experienced senior examiners.
There also need to be more rigorous requirements on applicants to provide patent applications of the highest quality, accompanied by all relevant information at the start of the examination process, and to disclose all the information known to them which is material to the patentability of their invention, the report adds.

Central EU patent court is necessary
Finally, the EGA calls for the creation of a central EU court to deal with questions of patent invalidity and infringement, instead of the current system under which these issues are dealt with by the EU member states’ own national courts. This present system results a complex arena of multiple patent litigation involving high costs, forum shopping and court decisions which are diverging and even contradictory, says the report, and it recommends that, until a central EU patent court can be established, specialised nation courts should be created, with technically-skilled judges who have powers to reach a decision within an acceptable timeframe.