Alaa El Kazak
Saudi Arabian Japanese Pharmaceutical Company Limited, Saudi Arabia
Title: Evergreening; good, bad or ugly?
Biography
Biography: Alaa El Kazak
Abstract
The cost of prescription drugs has been overwhelming different healthcare systems all over the world, especially with the emergence of specialty drugs. The introduction of lower price generic products is encouraged by national jurisdictions as a cost-containment measure against the highly priced off-patent branded products. The dramatic sales losses of brand products due to patent expiry have driven Big Pharma companies to embrace “evergreening” strategies to oppose the effect of genericization. Evergreening aims at maximizing the profits of existing near-to-expire patents, especially with the increased R&D costs and the diminished ability of developing new blockbuster medicines. Tactics used by originators to extend patents may include obtaining secondary patents for new molecular structures, methods of manufacturing, crystalline forms, formulas, dosage forms, combinations and/or indications. Such tactics have been proved to be efficient in stabilizing the originator market share and mitigating both generics introduction effect and jurisdictions cost-containment policies. Accordingly, authorities should set rational measures to detect and prevent patent abuse; to guarantee patients accessibility to affordable drugs and to reduce the global health care burden without compromising the innovation continuity.