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JVT Autumn 2009—Pharmaceutical Solids
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Patent Potential
Author: John F. Bauer

“Pharmaceutical Solids” discusses scientific principles associated with pharmaceutical solids useful to practitioners in validation and compliance. We intend this column to be a useful resource for daily work applications. The key objective for this column: Usefulness.

Reader comments, questions, and suggestions are needed to help us fulfill our objective for this column. Case studies illustrating principles associated with pharmaceutical solids submitted by readers are most welcome. Please send your comments and suggestions to column coordinator John Bauer at Consultjbnow@gmail.com or to journal coordinating editor Susan Haigney at shaigney@advanstar.com.

KEY POINTS
The following key points are discussed in this article:
• Pharmaceutical compounds with specific physical properties may be patentable
• It is important to show a correlation between the specific physical property and a useful benefit in manufacturing, stability, or some other area
• Although polymorphism is a common phenomenon, the existence of stable polymorphs is not obvious
• It is important to identify an analytical method in the patent that can be used to demonstrate infringement.


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