A new European Union policy could increase the supply of legitimate pharmaceuticals in developing countries and thereby minimize the problem of counterfeit medicines, but many challenges remain.
This is a preview of subscription content
Subscribe to Journal
Get full journal access for 1 year
only $8.25 per issue
All prices are NET prices.
VAT will be added later in the checkout.
Tax calculation will be finalised during checkout.
Rent or Buy article
Get time limited or full article access on ReadCube.
All prices are NET prices.
Max Planck Institute for Innovation and Competition. Study and annexes on the legal aspects of Supplementary Protection Certificates in the EU. https://ec.europa.eu/docsroom/documents/29524 (2018).
Copenhagen Economics. Study of the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe. https://ec.europa.eu/docsroom/documents/29521 (May 2018).
European Commission. Proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products. COM/20182018/317 final – 2018/0161(COD). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2018:317:FIN (2018).
European Commission. Impact assessment accompanying the document “Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products.” https://ec.europa.eu/docsroom/documents/29463 (2018).
EFPIA. EFPIA statement on the Commission's proposal to introduce an SPC manufacturing waiver, weakening Europe's knowledge based economy. https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/28052018-efpia-statement-on-the-commission-s-proposal-to-introduce-an-spc-manufacturing-waiver-weakening-europe-s-knowledge-based-economy/ (2018).
Medicines for Europe. Risk that European Council will “neuter” SPC manufacturing waiver and give foreign (non-EU) manufacturers strong advantage over EU-based manufacturers. https://www.medicinesforeurope.com/news/risk-that-european-council-will-neuter-spc-manufacturing-waiver-and-give-foreign-non-eu-manufacturers-strong-advantage-over-eu-based-manufacturers/ (2018).
Agreement on trade-related aspects of intellectual property rights (15 April 1994). Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (1994).
Patent Law Amendments Act of 1984, Pub. L. No. 98–622 (1984) (codified at 35 U.S.C. § 271(f)).
WesternGeco LLC v. ION Geophysical Corp., No. 16–1011, 138 S. Ct. 2129 (2018).
The authors gratefully acknowledge B. Bergsson for research support. This research was supported by a Novo Nordisk Foundation grant for a scientifically independent Collaborative Research Programme (grant number NNF17SA027784). J.J.D. and A.S.K. receive research support from the Laura and John Arnold Foundation, the Harvard Program in Therapeutic Science, and the Engelberg Foundation. The funders had no role in the conception, preparation, or approval of the manuscript, or in the decision to submit the manuscript for publication.
T.M. is a member of the Expert Board for Copenhagen Economics' “Study on the economic impact of SPCs, pharmaceutical incentives and rewards in Europe” (European Commission (DG GROW), Tender reference number 590/PP/GRO/SME/16/F/121).
About this article
Cite this article
Minssen, T., Kesselheim, A. & Darrow, J. An export-only exception to pharmaceutical patents in Europe: should the United States follow suit?. Nat Biotechnol 37, 21–22 (2019). https://doi.org/10.1038/nbt.4324
IIC - International Review of Intellectual Property and Competition Law (2019)