This Comment examines the newly revised PTO utility examination guidelines for biotechnology patents. The race for patenting human genes is well underway. When complete sequences of human genes are found, researchers have been quick to seek patents. This “patent grab” has been driven less by the expectation that a particular gene sequence will result in production of a useful protein and more by the idea that enough patenting will create a protectable “haystack” in which one will find a few “genetic needles of value.” The new utility guidelines may not completely aid the underlying and fundamental policies on patenting. While the guidelines may possibly provide some surety that DNA patents will hold up under challenges in the courts, the solution to gene patenting problems will require something more. Help is needed in the areas of public misconception, legislation for licensing agreements, and possible limits on claims involving drugs of extreme medical importance.
Anna E. Morrison, The USPTO's New Utility Guidelines: Will They Be Enough to Secure Patent Protection in Biotech?, 1 J. Marshall Rev. Intell. Prop. L. 142 (2001)