Verordnung (EU) 2019/933

Impact Assessment

Unitary SPC, SPC Verordnung (recast)

SPC Waiver Industry Report (June 2023)

Intro Video

Medicines for Europe policy vision on the SPC manufacturing waiver - YouTube

Management IP, Risk of SPC waiver counterattack makes generics extra cautious

Kluwer Patent Blog, Analysing the use of the SPC waiver provisions and its reach outside the EU

IIC 2019, 971 Analyse der SPC-Waiver-Verordnung durch Vidal-Quadras (EN Text)

Verordnung EU 2019 - 933 über das erg. Schutzzertifikat für Arzneimittel

JUVE Patent, Formycon and Janssen Biotech put EU SPC waiver to the test in Munich

Samsung Bioepis and Simmons repel Janssen infringement claims over SPC waiver

Bericht der Kommission zur Durchsetzung des Wettbewerbsrechts im Arzneimittelsektor (2009-2017)

Assessing the economic impacts of changing exemption-ET0417817ENN

Assessing the economic impacts of changing exemption-ET0417817ENN

Future-proofing-eu-competitiveness-by-limiting-the-negative-impact-of-the-spc-manufacturing-waiver