Patent Protection and Shelf Life Extension
The polymorph patent is the most important physical patent besides the composition of matter patent. CSP can provide complete coverage of crystal structures in the low energy region, helping pharmaceutical companies to evaluate whether there are additional potential high-quality crystal forms. As proven in many cases, XtalPi’s CSP service can provide information critical for decision-making within the scope of crystal patent protection and helps to reduce patent risk and protect the patent validity, safeguarding the drug throughout its exclusive sales period.
---XUS001, case study with a top multinational pharmaceutical company
Background: The drug candidate XUS001 was in the clinical development stage when a multinational pharmaceutical company bought the innovator company that developed the drug. During the acquisition, the acquiring company found through experimental research that the original company did not conduct a complete crystal form research on the compound that is up to its own filing standard. Therefore, there was a potential polymorph patent risk. The negotiation deadline was near, and the acquiring company did not have enough time to carry out sufficient crystal form screening with experiments. So it chose our CSP service to determine the polymorph risk and aid in negotiations during the acquisition process.
In the absence of any experimental information, XtalPi was able to help the acquiring company solve this problem by completing CSP within 17 days. From the CSP, we accurately predicted all three experimental crystal forms and their relative stability was determined. The CSP and stability ranking with temperature correction demonstrated that Form I, which was the form selected innitially for clinical trials, was the most stable crystal form. Based on these results, the acquiring company decided to complete the acquisition of the original company and started to market the drug XUS001 according to the original plan.