Intellectual Property Litigation Support
Our expert team applies sophisticated characterization techniques and a robust analytical approach to support your pharmaceutical intellectual property protection. We save time and lower your legal costs while preparing your applications for submission.
Our skilled scientists are inventors on numerous solid form patents and patent applications for our clients. 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 expertly describe the important attributes of solid forms and provide scientifically valid interpretation.
With nearly 30 years of experience, we routinely assist attorneys and agents with the science and technical expertise supporting your patent applications. Our experts 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.
When our sophisticated screening services discover new crystalline forms, we provide accurate 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.
For interpretation of XRPD data, our technical experts have devised nomenclature for further classification of peak lists to aid in the selection of peaks representative of the associated solid form:
- Simply observed,
- Prominent
- Representative
- Characteristic
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).