Patent Perspective on Orodispersible Films

Abstract

The traditional oral dosage forms (tablets, capsules, syrups, and elixirs) suffer from various disadvantages. They are pretty challenging to administer to patients with dysphagia, mucositis, and vomiting tendency. Therefore, gaining patient compliance using conventional dosage forms is highly cumbersome. One of the most transformative and innovative approaches to overcome such challenges is Orodispersible Films, a Novel Drug Delivery System. They are easy to consume, no need to chew or swallow and they do not even require water for consumption. Therefore, several drugs have been converted into orodispersible films to gain patient compliance. With the advent of these film formulations, new innovations are erupting and accordingly, companies in India are actively protecting them by filing ordinary patent applications in India and internationally under the Patent Cooperation Treaty. Patenting in India poses unique patentability challenges when compared with rest of the world. Nonetheless, meeting all the challenges and obtaining a valid patent not only help in recouping the cost involved in developing new drugs and its novel drug delivery systems but also helps in taking legal action against alleged infringers. This review article identifies key active Indian players in the domain of ODF based on their patent filings in India (and abroad) and also identifies the challenges they face to obtain a grant.

Keywords: Orodispersible film; formulation; oral thin film; patent; patient compliance; patient compliance orodispersible film.