The written description rejection as a barrier to biotech patent prosecution.

Biotech firms always pursue broad claims to secure new discoveries, new technologies and even as yet undiscovered results of future research. However, expansive claims without sufficient description violate the principal of granting the patentee the right to exclude others from using the technical development for a certain amount of time in return for disclosing the innovation. Based on this investigation, a written description can be a barrier to biotech patents with broad claims. To avoid a written description rejection during patent prosecution or invalidation in litigation, the patent applicant or assignee should demonstrate possession of the claimed invention by describing the claimed invention with all of its limitations using descriptive means such as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Although the court cases analyzed in this study were not directly related to vaccines, the guideline indeed is applicable to patents of vaccine. Furthermore, a vaccine patent application is also demonstrated.