New EU Rules Will Help Generics and Biosimilars

February 28, 2019
Marshall Gerstein Alert

The European Union is implementing new rules that will benefit generic pharmaceutical and biosimilar manufacturers,  by providing exceptions to Supplementary Protection Certificate (SPC) intellectual property rights.

Under existing rules, a medicine protected by an SPC has intellectual property rights that extend patent protection beyond the normal 20-year term of the patent, up to an additional five years. The exceptions to be made by the new rules will allow, under certain circumstances, stockpiling of generics or biosimilars during the last six months of an SPC, when those generics or biosimilars are produced exclusively for export to countries where there is no protection of the innovator's medicine. 

The new EU Rules, already agreed upon by EU member states' ambassadors, will next be submitted for formal adoption to the European Parliament and the Council of the EU. Initially, the new rules are expected to affect only SPCs that are applied for on or after the date that the rules come into effect.  More details are provided in the following press release from the EU Council: https://www.consilium.europa.eu/en/press/press-releases/2019/02/20/eu-measures-in-support-of-generic-pharmaceuticals-producers/

If you have questions or concerns relating to the new EU Rules, please contact Michael Muczynski or another attorney in the Chemical Sciences or Biotechnology & Life Sciences practice groups at Marshall Gerstein.

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