In Support of Industry-Conscious Disclosure Standards for Pharmaceutical and Biotechnology Patents

Abstract

One of the fundamental requirements for a patent application is a disclosure of the invention via an accurate written description with sufficient detail to enable the recreation of the invention. The U.S. patent system has historically reviewed patent applications from various industries with a uniform set of requirements and standards. However, the biotechnology and pharmaceutical industries operate on notably extended product development timelines and face unique administrative pressures related to their products when compared with other industries. In response to these pressures, biotechnology and pharmaceutical companies have traditionally applied for patent protections through liberal use of genus claims and other strategies that allow for early and broad protection of groups of related products. However, three recent decisions by the Federal Circuit, and a subsequent appeal to the Supreme Court, have notably heightened patent disclosure requirements for technologies from these industries. This Comment discusses the Federal Circuit’s and Supreme Court’s decisions, compares these decisions to prior trends in the judiciary, and considers the potential impact of the decisions on the patent environment in the biotechnology and pharmaceutical industries. In light of the decisions’ potential impact on these industries, this Comment argues that the federal judiciary should align the disclosure standard more closely to the requirements of the Patent Act while protecting the usefulness of genus claims for the pharmaceutical and related industries.