SSCI scientists are inventors on numerous solid form patents and patent applications for our clients. It is well established that solid forms are valuable intellectual property for protecting pharmaceutical products. The ability to patent such forms derives in no small part from the fact that the discovery of different solid forms, and their properties, are not predictable. Multiple techniques, including x-ray diffractometry, spectroscopy, microscopy, and thermal analysis are often needed to describe the important attributes of solid forms. SSCI has provided technical and legal support for hundreds of patent challenges worldwide. Based on this experience and interactions with the United States and European patent offices, SSCI recognizes the value of high quality data with scientifically valid interpretation.
Output from all of our screening services where new crystalline forms are discovered includes reports containing experimental details, high-quality data, and meaningful interpretation. From these reports, “Technical Packages” are assembled with the goal of providing to our clients’ patent attorneys details of new crystalline forms discovered during screening. SSCI’s Technical Packages are 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 has been designed to provide ready access to the data. As a result, patent attorneys save time and our clients lower their legal costs, as the applications are prepared for submission.
For interpretation of XRPD data, SSCI has 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).
SSCI understands the value of Intellectual Property Support, with more than a quarter century of providing research support. Our unique research offerings are designed to enhance client value during the patent application/patent protection process. Although, as inventors on many of our client’s patents and patent applications, we do not write patent applications, we routinely assist attorneys and agents with the science and technical muscle supporting the patent applications of our mutual clients. We can help the patent professionals with all that is necessary to draft effective and comprehensive claims based on the invention and the characterization data. These data come with our ability to provide clear scientific support throughout the entire application and prosecution process.