Patent Issues

Patents are the final demarcation of market launch timings in regulated markets as well as they provide key insights to the active of NCEs from a generic perspective. The demarcation dictates the basic timelines in the markets with respect to generic entries, both by excluding generic commercialization in the protected markets, but also as a key trigger point for first generic developments (another key trigger is first approval in the US and partly in the EU) in less regulated markets – most importantly India and China.

Different uses of patents are seen with the significant increases in patents applied for by generic companies at the end of the basic protection period. Several objectives other than market demarcation are important here. Firstly, they have a very important signal value of non-infringement to in-licensees of the API. Moreover, these patents will provide the first understanding of the ability of the API manufacturer to by-pass any protection in the different markets. Understanding these issues is essential to understand the real market timing of the individual markets globally.