A fundamental premise in the Pharmaceutical and Biotech business is that you can legally exclude competitors from copying your drug product for a certain period of time. Obtaining patent coverage in the US and other countries can be an expensive and daunting process. There are essential procedures that should be followed to minimize the possibility that a patent will be declared invalid, thereby allowing competitors to enter your market. Patent law experts play a key role in patent authoring and defense, but need cooperation and support from their organizations.