Patentability of vaccines: A practical perspective

Abstract

This chapter provides a non-exhaustive survey of current structures governing patent granting and defense mechanisms, patentability approaches, and notable legal trends relating to vaccine-based innovations. Developing a strategically meaningful global patent portfolio entails a balanced approach between a thoughtful strategy that safeguards an actual or contemplated market position such that a reliable revenue stream can be maintained, with a careful selection of inventions for patenting given the constantly evolving worldwide patent systems and landscapes. A robust patent strategy typically begins by building upon a core technology, with an eye to capturing secondary subject-matter springing from such first inventions. For vaccine developments, initial patent filings might include a variety of components affording a new structural or therapeutic function, including antigens (any of nucleic acid sequences, proteins, with accompanying expression technologies), adjuvants, and excipients, delivery platforms, administration regimes, and target patient groups, either alone or in combination. Secondary follow-on patents may extend exclusivity for these foundational technologies by claiming improvements and/or further advances of existing technical teachings. It is our hope that this chapter will enable the reader to identify and understand the impact of developing new patent rights as an important business tool, in addition to identifying potential opportunities and uncovering niche markets for developing and/or exploiting vaccine technologies, as well as recognizing existing patent rights that might present a barrier to planned or ongoing research initiatives. This chapter addresses patentability schemes, trends, and landmark judicial holdings that potentially impact vaccine-based innovations. Our analysis will primarily focus on the European and US systems in terms of what constitutes patentable subject matter and claiming strategies commonly employed to protect vaccine-oriented inventions. It is our hope that this analysis will be useful not only when carrying out activities leading up to the acquisition of intellectual property rights but also for enabling the reader to identify and understand the impact of already existing patent rights that might present a barrier to planned or ongoing research initiatives, to recognize when licensing of exiting rights might be desirable, and to identify potential areas where new opportunities or niche markets for vaccine technologies might be pursued.