Abstract

PHARMACEUTICAL PATENTS: THE HATCH - WAXMAN AMENDMENTS, EVERGREENING, 180 DAYS EXCLUSIVITY, LISTING IN ORANGE BOOK AND FEW RECENT UNPRECEDENTED DECREES BY INDIAN COURTS

Amit Gangwal

Smriti college of pharmaceutical education, Indore, MP. India.

ABSTRACT

Patents provide an incentive to the pharmaceutical industry to invest in the development of new medicines to treat diseases that are currently untreatable or incurable, and provide options when patients develop resistance to older drugs. Around the world it has been a challenge for last one or two decades to innovate concepts and mechanisms to hasten the drug development schemes/process, while augmenting dereplication ways in a full proof manner to save time, man power and financial input. High failure rate at any stage in drug development process is bothering and evoking various tools to be discussed like never before. The pharmaceutical industries world over, are in a period of crisis due to the poor number of approved drug molecules relative to the high levels of R&D investment. The drug industry is facing major scientific and strategic challenges. Conversion of genomics knowledge into new molecules seems to be unimpressive and futile at least for now. Moreover competition from generic giants is giving tough challenge to established products. The concerns are further aggravated by couple of decisions announced by Indian courts (Nexavar® followed by long time pending battle of Gleevac®). These two decrees by Indian courts were not ruled in the favor of pharma giants; Bayer and Novartis respectively. In this review article various provisions of patents will be discussed. Certain recent ruling by courts, (which became historical, being unprecedented moves), Indian system of patent and one of the world’s most robust patent systems; USFDA (IV filing, Hatch-Waxman Amendments, para IV filing and patent evergreening will also be summarized.

Keywords: Patents, Compulsory license, The Hatch-Waxman act, Evergreening, Pharma, Nexavar, Gleevec, 180 days exclusivity