An export-only exception to pharmaceutical patents in Europe: should the United States follow suit? image

Nature Biotechnology, January 3, 2019
Timo Minssen (Former Visiting Scholar), Aaron S. Kesselheim, and Jonathan Darrow (Student Fellow Alumnus)

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From the article:

"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.

In Europe, the United States, and other countries with strong patent laws, patents covering brand-name drugs generally prevent competing manufacturers from producing generic or biosimilar copies of those drugs even if they are intended exclusively for export to a country where corresponding patents were not obtained or have expired. This strict policy is intended to protect brand-name manufacturers' research investments and avoid difficult enforcement issues associated with product tracking. However, it also encourages manufacturers of generic and biosimilar medicines to systematically expand production capacity in those potential export markets, rather than in Europe or the United States, in anticipation of the end of the patent period.

But the European Union is now considering a change to this aspect of patent law. Simultaneous with the publication of two major studies on pharmaceutical incentives in May1,2, the European Commission announced plans to introduce a Supplemental Protection Certificate (SPC) manufacturing waiver.3 This proposed EU Regulation, which must still be approved by the European Parliament and Council of the European Union, is intended to change the rules that place EU-based generic and biosimilar manufacturers at a competitive disadvantage vis-à-vis their overseas counterparts." 

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health law policy pharmaceuticals regulation