EU SUPPLEMENTARY PROTECTION CERTIFICATES - MARCH 2019 AN EXCEPTION TO SPC PROTECTION FOR MEDICINES Support to generic pharmaceutical producers provided by the EU The European Union is adopting new rules that introduce an exception to Supplementary Protection Certificate (SPC) protection for medicines, allowing EU-based manufacturers of generic and biosimilar pharmaceuticals to manufacture for export to non-EU countries during the term of the Supplementary Protection Certificate. Under existing EU rules, a medicine protected by an SPC has intellectual property rights that effectively extend patent protection beyond the normal 20-year term of the patent, up to an additional five years. The proposed exceptions will allow under certain circumstances, the export to non-EU countries of generics or biosimilars during the last six months of an SPC, but only when those generics or biosimilars are produced exclusively for export to countries where there is no protection of the originator’s drug. The new exceptions will also include an exception for stockpiling purposes during the last six months of the SPC validity before the SPC expires. This important development follows a long debate between the innovative pharmaceutical industry and generic/biosimilar manufacturers on the impact of intellectual property on access, medicines prices and jobs in the EU. These new EU Rules have to be submitted for formal adoption to the European Parliament and the Council. The EU is considering that the regulation will affect only SPCs that are applied for on or after the date of entry into force of the regulation, or applied for but only come into force after a set future date. You may find more information by clicking here ►►► If you have questions or concerns relating to SPC’s or the new EU exemptions, please contact Marina Mauro, SPC Team Member of Murgitroyd: T: +39 02 8739 8550 E: [email protected] 1 EU SUPPLEMENTARY PROTECTION CERTIFICATES - MARCH 2019 UNITED KINGDOM IRELAND ABERDEEN SOUTHAMPTON DUBLIN Unit G10, The Enterprise Centre Kings Park House, 22 Kings Park Unit 1, Block 8, Blanchardstown Exploration Drive, Aberdeen, AB23 Road, Southampton, SO15 2AT Corporate Park, Cruiserath Road, 8GX Tel: +44 (0)23 8000 2022 Blanchardstown, Dublin 15, Ireland Tel: +44 (0)1224 706 616 Tel: +353 (0)1 882 9400 YORK BELFAST Unit F3, IT Centre, Innovation Way, 5th Floor, The Potthouse, 1 Hill Heslington, York, YO10 5NP ITALY Street, Belfast, BT1 2LB Tel: +44 (0)1904 898 881 Tel: +44 (0)2890 320 441 MILAN Piazza Borromeo 12, Milan 20123, CARDIFF FINLAND Italy Cardiff Business Technology Centre, Tel: +39 (0)2 87 39 85 50 Senghennydd Road, Cardiff, CF24 HELSINKI 4AY Mannerheimintie 12B 5th Floor, Tel: +44 (0)29 2009 9999 00100 Helsinki, Finland NICARAGUA Tel: +358 (0)92516 6388 GLASGOW MANAGUA Scotland House, 165-169 Scotland Embajada de Mexico, Una Cuadra Street, Glasgow, G5 8PL FRANCE Arriba, A la Esquina, Casa #100, Tel: +44 (0)141 307 8400 Managua, Nicaragua NICE Tel: + 1 (919) 474 8300 LONDON Immeuble Atlantis, 55 Allée Pierre Corinthian House, 17 Lansdowne Ziller, 06560 Valbonne, Sophia Road, Croydon, London, CR0 2BX Antipolis, France UNITED STATES OF AMERICA Tel: +44 (0)20 8688 3490 Tel: +33 (0)4 97 21 52 00 DURHAM LONDON CITY 4721 Emperor Blvd, Suite 430 CityPoint, 1 Ropemaker Street, GERMANY NC 27703, USA London, EC2Y 9HT Tel: +1 (919) 474 8300 Tel: +44 (0)20 7153 1255 MUNICH Bernhard-Wicki-Straβe 7, D-80636 SILICON VALLEY NEWCASTLE Munich, Germany 5201 Great America Parkway, Suite Collingwood House, 3 Collingwood Tel: +49 (0)89 3090 71100 320, Santa Clara, CA 95054, USA Street, Newcastle Upon Tyne, NE1 Tel: +1 (408) 542 2970 1JW Tel: +44 (0)191 211 3550 General Email: General Phone: General Fax: [email protected] +44 (0)141 307 8400 +44 (0)141 307 8401 2 .