The Basis of Operating the Patent Linkage: Understanding the Nature of Pharmaceutical Patent and the Key Role of the IP Court
After the implementation of the patent linkage, over 400 marketing approvals have been listed with patents by the NDA holders. It demonstrates the successful effect in the first step of operating the patent linkage. In the second step with respect to dispute resolution, however, the court faces challenges from the new legal issues such as eligibility of patent listing and Paragraph IV litigation. This article suggest that the court should lower down the validity threshold and strengthen infringement assessment aimed at meeting the nature of pharma patents and providing adequate patent protection.