Karthikeyan Ramadoss , Haema Ganapathi , Vijayan Venugopal , Sakthiganapathi Meenatchi Sundaram , Shanmuganathan Seetharaman , Velmurugan Vadivel

Abstract

The major topic of this review study involves the connection between particular scientific, legal, and regulatory elements of pharmaceutical crystal forms. By referring to current scientific advancements in this area, the article provides an examination of pharmaceutical co-crystals as patentable inventions. The following few potential business benefits of pharmaceutical co-crystals and the other recent court rulings concerning important problems are compiled. The regulatory status of co-crystals has become a major concern recently with the rise of pharmaceutical co-crystals. The situation has grown even more problematic as a result of the new regulations from the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA), as there are vastly divergent viewpoints. The essay offers a perspective on the potential effects of co-crystallization on the landscape of pharmaceutical intellectual property. Another point that has been considered is whether co-crystals qualify for patent protection in accordance with the literature and standards on pharmaceutically approved co-crystals.