ARTICLE
11 March 2019

New EU Rules Will Help Generics And Biosimilars

MG
Marshall, Gerstein & Borun LLP

Contributor

Marshall, Gerstein & Borun is a full service intellectual property law firm that protects, enforces and transfers the intellectual property of clients in more than 150 countries worldwide.  Nearly half the Firm’s professionals have been in-house as general counsel, patent counsel, technology transfer managers, scientists or engineers, and offer seasoned experience in devising and executing IP strategy and comprehensive IP solutions. Learn more at www.marshallip.com.
The European Union is implementing new rules that will benefit generic pharmaceutical and biosimilar manufacturers,
European Union Food, Drugs, Healthcare, Life Sciences

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/

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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