Patents and regulatory data protection, while complementary, serve two distinct purposes. Patents protect inventions ranging from the foundational inventions that underpin new drugs and biotechnological products to the incremental advances necessary to bring those products to market and manufacture them at scale. Data protection, on the other hand, is intended to incentivize innovators to invest the enormous amount of resources and time necessary to conduct the complex development work required to prove a new drug or biotechnological product is safe and effective, and to secure regulatory approval of that new product. Data protection does so by requiring third parties seeking to gain the approval of the same or similar product to independently generate the full range of evidence for their own product or to wait a defined period of time before seeking a regulatory shortcut to approval based on the innovator’s prior approval. Data protection thus prevents parties from unfairly ‘free-riding’ on the investments and efforts made by the innovator to secure original approval of its product.
- BIO White Paper, A Follow-On Biologics Regime Without Strong Data Exclusivity Will Stifle the Development of New Medicines
- BIO’s Response to FTC’s questions regarding competition provided by developing a regulatory approval pathway for follow-on biologic
- BIO White Paper, The Difference with Biologics: The Scientific, Legal, and Regulatory Challenges of Any Follow-On Biologics