The Weakening of Pharmaceutical Method Patents: The Federal Circuit Addresses the ‘FDA Conundrum’

Abstract

The US Food and Drug Administration (FDA) has strict requirements for generic drugs. These requirements may prevent a generic manufacturer from altering a drug product to unequivocally avoid patent infringement, and may also require a generic manufacturer to use a patented method for quality control purposes. These situations are called the ‘FDA conundrum.’ While Congress and the FDA desire to have generic drugs enter the market as soon as possible, the requirements FDA imposes raise issues of patent infringement that often take years to resolve. The Federal Circuit addressed these issues in the year 2012, in three separate cases: <i style="mso-bidi-font-style:normal">Momenta </i>v<i style="mso-bidi-font-style:normal"> Amphastar</i>, <i style="mso-bidi-font-style: normal">AstraZeneca </i>v<i style="mso-bidi-font-style:normal"> Apotex</i>, and <i style="mso-bidi-font-style:normal">Bayer Schering Pharma AG </i>v <i style="mso-bidi-font-style:normal">Lupin</i>.