The Center for Innovation and Free Enterprise encourages Congress to continue to support the U.S. patent system. This means opposing unnecessary legislation as part of an end-of-year package. The Senate Committee on Health, Education, Labor and Pensions (HELP) is planning to hold a markup that will include two pieces of legislation that fall under unnecessary and harmful as they relate to the U.S. patent system:
USPTO-FDA Coordination: S.2780 Medication Affordability and Patent Integrity Act
- Adds unnecessary new certification and disclosure requirements
- There is no evidence to show that the USPTO is issuing patents for “inherent” aspects of drugs
- Adds more work to an already overburdened USPTO, slowing down the patent process even further
- Requiring sensitive and personal information be shared with the USPTO risks publicly exposing companies’ trade secrets and other confidential information and data to foreign countries
S.2305 – Biosimilar Red Tape Elimination Act
- The FDA already has authority to require additional data or studies based on its scientific judgment to ensure patient safety
- Eliminating the need for an interchangeability determination will tie FDA’s hands, therefore limiting competition from more complex biologics as science continues to evolve
- Does not address anticompetitive PBM behaviors and may enhance PBMs at the expense of patients
These pieces of legislation aim to address problems that simply do not exist in the U.S. patent system and would have consequences for both patient safety and drug competition. Congress should be working to make the U.S. patent system stronger, not proposing legislation that does the opposite.
