Pharmaceutical Patents Issues and Considerations

Although brand-name pharmaceutical companies routinely procure patents on their innovative medications, such rights are not self-enforcing. Brand-name firms that wish to enforce their patents against generic competitors must therefore commence litigation in the federal courts. Such litigation ordinarily terminates in either a judgement of infringement, which typically blocks generic competition until such time as the patent expires, or a judgement that the patent is invalid or not infringed, which typically opens the market to generic entry. This book introduces and analyses innovation and competition policy issues associated with pharmaceutical patent litigation settlements. It begins with a review of pharmaceutical patent litigation procedures under the Hatch-Waxman Act, then introduces the concept of reverse payment settlements, and analyses the status of reverse payment settlements under antitrust laws, and discusses congressional issues and possible alternatives.