New EU intellectual property legislation to strengthen the position of European manufacturers of generics and biosimilars

In the future, EU-based manufacturers of generics and biosimilar will be allowed to manufacture their products in Europe during the term of a Supplementary Protection Certificate (SPC). Stockpiling will also now be permitted. This means that European manufacturers of generics and biosimilars will be able to produce a stockpile of their product that they can put on the EU market on the day after the SPC expires. The aim of the Commission’s new rules on intellectual property is to strengthen the competitiveness of EU-based manufacturers of generics and biosimilars. The European Parliament, the Council and the Commission reached agreement at the beginning of February 2019.

Supplementary Protection Certificates extend patent protection for pharmaceutical products that must undergo compulsory lengthy testing and clinical trials before obtaining regulatory approval. An SPC can extend a patent right for up to five years.

European health insurance providers have also called for this adjustment so that generics and biosimilars have faster access to the market in order to relieve the strain on national health budgets and provide access to affordable medicines. Pharmaceutical companies which carry out research have criticised this as undermining patent protection regulations.

A formal agreement has yet to be reached by the Council and Parliament. The proposal is based on Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products. The Regulation will then apply directly in all Member States and becomes binding 20 days after publication in the Official Journal.

More information is available here.