The intersection of regulatory and patent exclusivities for the life sciences industry: a comparative overview of American and European schemes

An Expert View from Jonathan Roses (pictured, left), counsel, Wolf, Greenfield & Sacks, and Toby Simpson, partner, Hoffmann Eitle, exploring legal differences between the two major jurisdictions of the USA and Europe that life sciences companies should be aware of.

Life sciences companies seeking to bring new products and treatments to market must clear regulatory hurdles that, while meeting the critical goals of efficacy and safety, also impose significant financial burdens.

These burdens are not simply the expenditure of assets for laboratory and clinical testing, but also the delay in the ability to commence recouping development costs until approval is received.