Patent Expiry and Pharmaceutical Market Opportunities at the Nexus of Pricing and Innovation Policy

This paper explores the academic literature and empirical evidence associated with the strategic and tactical opportunities available to pharmaceutical firms confronted with the loss of patent protection on their branded drug. The marketing dimensions of product innovation, pricing, and brand equity options are considered together with exclusivity options available through government regulators such as the US Food and Drug Administration. These options are then considered in the context of the legal monopolies available to innovators through the policy lenses of intellectual property. This paper further explores the maxim that sustainable competitive advantage for pharmaceutical innovators is realized at the nexus of marketing choices, intellectual property, and regulatory regimes. Separate examples in gastrointestinal and neurological medications will be used to explore how the various options might be integrated together and used in a time sequenced, longitudinal manner to extend the market advantages and earnings levels of the original pharmaceutical compound innovation. Areas of potentially fruitful future academic research are described.