by Dennis Crouch
Prof. Erika Lietzan (Missouri) and Prof. Kristina Lybecker have released an important new article that they title Distorted Drug Patents. (Forthcoming in Washington Law Review).
The basics: New drug treatments require pre-approval based upon evidence of safety and effectiveness. That research takes time — with the treatment’s 20-year patent clock typically ticking away throughout the approval period. This is an old issue that was addressed in the 1984 Drug Price Competition and Patent Restoration Act. However, as Lietzan and Lybecker point out – the Patent Term Extension (PTE) “doesn’t restore all of the lost time.” In particular, PTE restors 1/2 of clinical testing time (after the patent issues) and caps recovery at five years of added time. In addition, PTE cannot extend the patent more than 14 years beyond regulatory approval and can only be applied to one patent for each drug treatment listing. Note – PTE is added to any PTA term.
The new data-driven article focuses on the question of whether the partial-restoration steers research “away from drugs that take a long time to develop.”
The article looks at every PTE grant (1984-2018) and ties that grant to product to the clinical research period and launch dates of the brand and generic (if launched). Some conclusions:
- Longer clinical period => shorter patent life post-approval;
- Being a “child” in a family of patents => shorter patent life post-approval;
This second point seems obvious to patent-law youngsters who have always seen patent term calculated from the parent-filing-date. However, the article argues that the shorter child-life is “the opposite of what lawmakers intended in 1984.”