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A thorough review of the scientific and patent literature is an important first step during litigation. In addition, a search of scientific databases is often important to see if information on a certain polymorph exists. This helps us identify testing needs.
Testifying at deposition or trial in ANDA and PTAB cases requires skill and proper preparation. We work closely with our clients to prepare the expert for testimony. If needed, exhibits and teaching aids can be prepared to help the Court understand the complex topics being presented.
Experimental testing is often required for reference materials and alleged infringing polymorphs. Such tests include analysis of the active ingredient (API) or the excipients. When warranted, additional tests can also be run to determine the limit of detection (LOD) that is achievable.
The Expert Report is a make-or-break document that requires the utmost care in preparation. Typically, the report includes key information from the literature and patent reviews, design of and results from the experimental work, and the basis for the expert's opinion regarding the observed polymorphs.