For better, for worse? How shifting IP laws change the global life sciences regulatory chessboard


Richard Gough and Jane Woodhouse

With IP laws around the world subject to frequent and sometimes unpredictable changes, it can be difficult to keep abreast of everything you need to know. Richard Gough and Jane Woodhouse take a look.

Is your life sciences invention—whether pharmaceutical, biologic, medical device or diagnostic—patentable? Can the term of your patent be extended? If so, what conditions apply and how long can you extend it for? Can proprietary data be used by third parties for product registration, marketing approval and market access? Can your data be used for an upcoming and competing biosimilar?

Intellectual property rights axiomatically confer monopolies, and the IP laws that provide answers to such questions frequently also delineate the cutting edge of pharmaceutical regulation around the globe. Not only do the answers differ in different countries, they are in constant flux as governments adjust their IP laws, changing the rules of the game. This can be for better or for worse, depending on whether you are an innovator and first to market, or a generic following the trail of the pioneers.

This article looks at some recent changes to IP rights in selected countries that have a particular impact on the life sciences industry. It is indicative rather than comprehensive, and the picture that emerges is quite mixed. Both innovators and generics can find cause for concern, but there are also incremental gains to be found on each side.

IP laws, pharmaceuticals, biosimilars,