Our scientists are inventors on numerous solid form patents and patent applications for our clients. As such, we have provided technical and legal support for hundreds of patent challenges worldwide. Applying multiple techniques, including X-ray diffractometry, spectroscopy, microscopy and thermal analysis, we describe the important attributes of solid forms and provide scientifically valid interpretation.
When our screening services discover new crystalline forms, we provide reports containing experimental details, high-quality data and meaningful interpretation. From these reports, we assemble technical packages designed for ease of use in preparing patent applications. This includes publication quality (redacted) figures and classified peak lists when X-ray powder diffractometry (XRPD) patterns and spectral data are available. Solid form patents tend to be data heavy compared to other pharmaceutical patent applications, so this format provides ready access to the data. As a result, patent attorneys save time and you lower your legal costs while preparing the applications for submission.
For interpretation of XRPD data, we have devised nomenclature for further classification of peak lists, as simply observed, prominent, representative, or characteristic, to aid in the selection of peaks representative of the associated solid form. Peak position variabilities are based upon recommendations outlined in the current United States Pharmacopeia, USP 36/NF 31, <941>. For samples with only one XRPD pattern, and no other means to evaluate whether the sample provides a good approximation of a powder average, tables containing non-overlapping, low-angle prominent peaks, with strong intensity can be provided. If multiple diffraction patterns are available, then assessments of particle statistics (PS) and/or preferred orientation (PO) are possible. If the effects of both PS and PO are determined to be negligible, then the XRPD pattern is representative of the powder average intensity for the sample and prominent peaks may be further identified as representative peaks or characteristic peaks, to the extent they exist. Characteristic peaks are a subset of representative peaks and are used to differentiate one crystalline polymorph from another crystalline polymorph (polymorphs being crystalline forms having the same chemical composition).
We routinely assist attorneys and agents with the science and technical muscle supporting the patent applications of our mutual clients. Our experts can help patent professionals draft effective and comprehensive claims based on the invention and the characterization data. In addition to data, we provide clear scientific support throughout the entire application and prosecution process.