A brief guide to understanding patentability and the meaning of patents.

This author provides a brief overview to the U.S. patent system with respect to DNA-based or gene patents, examines the statutory requirements for the U.S. Patent and Trademark Office (USPTO) and its processes of review, and explains how this system is implemented in the issue or decline of a patent. The author describes the important role played by the courts in their continuing reinterpretation and application of the patent law. He notes that many issues raised in discussions about the perceived benefits to society or general concerns arising from the patenting of gene sequences actually pertain to matters of enforcement and licensing of patents. These aspects, the author notes, lie outside of the USPTO's purview. Social questions about access to patented subject matter-such as the practice of patented gene-based diagnostic tests-must be addressed in other forums.