Investor confidence is key---PTAB creates a chilling effect that deters innovation
Thomas Hemphill 22. David M French Professor and Professor of Management, School of Management, The University of Michigan-Flint. “Biopharmaceutical patent protection vs. generic drug competition: Traversing the public policy tightrope.” Science Direct. February 2022. https://www.sciencedirect.com/science/article/abs/pii/S0160791X21003249
If patent owners cannot have full faith and confidence in the patent granted by the Federal Government, and they similarly cannot have full faith and confidence in a final adjudication by the federal courts, how can they be expected to invest the millions, and sometimes billions, required to bring technology to the marketplace? [11].
If this question is to be answered to the satisfaction of those domestic and international inventors and companies expecting U.S. patent protection for their inventions, further analysis of more recent (2018–21) patent-related validity data should be undertaken. In addition, evaluating the impact of the recently enacted CREATES Act on the strength of patent protection for biopharmaceutical patent-holders should be factored into this future research program. The complexity of the interactive effects of public policy enacted and implemented among the judicial (federal courts), executive (USPTO), and legislative (U.S. Congress) branches has the potential for deleterious impacts not only on international biopharmaceutical firms entering the U.S. marketplace, but also on U.S. patients who potentially may not get access to drugs and biologics (both patent-protected and generic versions) that will treat maladies and improve the quality of their lives.
Author statement
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.