| Abstract: | Legal context: The income streams of originating pharmaceutical manufacturersare under pressure as never before, from increasing R&Dcosts, regulatory pressures, and competition from generic manufacturers.This article examines the various strategies which originatingpharmaceutical manufacturers have adopted in response to thesethreats. Key points: The authors consider various strategies, including SupplementaryProtection Certificates, life-cycle management (‘evergreening’),second pharmaceutical use claims, trade marks, and the use ofdata exclusivity and interim injunctions, in order to prolongthe protection given to existing products, and to manage competitionfrom generic manufacturers. Practical significance: The authors also include two real-life case studies in orderto illustrate the practical applications of the strategies discussedin the article. |
