SPCs are an intellectual property right that serve as an extension to a patent right. An SPC can prolong a patent right for a maximum of five years. They aim to offset the loss of patent protection for pharmaceutical and plant protection products that occurs due to the compulsory lengthy testing and clinical trials these products require prior to obtaining regulatory marketing approval.
The Federal Patent Court found that the 6-phytase preparation at issue had not been approved as an active ingredient of a medicinal product and was therefore not amenable to SPC protection.
Alexa von Uexküll and Oswin Ridderbusch, partners at law firm, Vossius & Partner, when commenting on the case earlier this year, said it was noteworthy that the German court also rejected the argument that an equivalent application of the SPC regulation to feed additives should be mandated by the TRIPS Agreement, which stipulates that patents shall be available for any inventions in all fields of technology.
Parallel SPC applications filed for this same animal feed additive in other EU member states have likewise been rejected, said those legal experts.
However, they noted that while the question of whether SPCs should be made available for products other than medicinal products and plant protection products is currently not subject of any legislative initiatives, “it may well resurface if and when a fundamental reform of the European SPC system will eventually be tackled, possibly in the context of the future creation of a unitary SPC title based on the, still elusive, unitary European patent.”
Life of a patent
The effective patent life is the period of time between a product's introduction to the market and the patent's expiration date, and during this period the manufacturer of a product enjoys market exclusivity that may allow them to recover research and development (R&D) costs, explained Malwina Mejeri, in her 2017 study, 25 years of SPC protection for medicinal products in Europe: Insights and challenges.
“In industries that require regulatory approval to put the product on the market, the effective patent life can be suboptimal to recover R&D costs. This is true for pharmaceutical and agrochemical industries where providing the evidence on the efficacy and safety of the product to protect human and animal health is both time consuming and costly,” she noted.
