On October 12, the European Commission called for feedback on a plan to change European Union patent rules. The plan, which was put forward in November 2015, would introduce the SPC waiver as well as other measures designed to bolster European industry competitiveness.
In Europe, SPCs extend the patent life of a drug by up to five years. The idea is to compensate the patent holder with sales exclusivity for the time due to the compulsory and lengthy testing and clinical trials that products require prior to obtaining regulatory marketing approval.
SPCs only apply in Europe. This has unintended consequences for European active pharmaceutical ingredient (API) manufacturers according to Sergio Napolitano, director of legal, trade and public affairs at industry group Medicines for Europe.
He told delegates at CPhI in Frankfurt, Germany that under the current regulations, “EU API developers cannot start making [the API] during this extra five years of protection and companies are forced to outsource in order to market in unprotected regions.”
“Big companies just go and produce outside of Europe as they have their own resources; small companies either don’t invest in manufacturing [at all] or outside to a CMO outside the EU.”
The SPC waiver is designed to address this and “level the playing field” according to Napolitano.
He said the idea is to let European manufacturers to export ingredients to markets not covered by the SPC, as well as stockpile them for use in Europe ahead of a commercial launch without infringing on current patent protection.
“This is a strongly competitive market,” he said. “If you don’t take a slice of the market immediately you’re out of the market.”
June 2019
The waiver would benefit Europe in other ways Napolitano said, citing an EC study suggesting that API and drug firms in the region could create up to 25,000 manufacturing jobs.
He also suggested it could increase the amount of revenue generated by Europe’s API industry by €9.5bn.
Napolitano told in-Pharmatechnologist that, in theory, SPC waivers could become law soon after the consultation period and subsequent impact assessment.
“Being a relatively small amendment it shouldn’t take too long,” Napolitano said, suggesting it could come into law by June 2019. “However,” he continued, “it may be later as we all know how the EU works.”