XRD and thermal analysis data are commonly used in patents to define the scope of a patented drug and to distinguish the various polymorphs. We are able to generate such data under strict cGMP controls.
Prior to any patent application or litigation, we can work with a customer to see if a new polymorph under development is similar to or different from patented forms described in existing patents.
We can provide support for cases before the Patent Trial and Appeal Board (PTAB). Support may include technical review of patents, generation of test data, and preparation of reports for submission to the PTAB.
In preparation for an ANDA or NDA application to the FDA, we provide analytical services to demonstrate structural similarity or differences between a generic drug polymorph and an approved reference drug.