TAPP Urges Congress Support Patent System, Not Add Legislation

This month, the Senate Committee on Health, Education, Labor and Pensions (HELP) plans to deliberate over two pieces of legislation related to the U.S. Patent system. The bills in question are unnecessary and would cause numerous problems involving both patient safety and drug competition. In the midst of an election year, Congress should be working to make the U.S. patent system stronger, not passing misguided legislation at the 11th hour. 

Congress is considering the implementation of two different bills, the Medication Affordability and Patent Integrity Act, and the Biosimilar Red Tape Elimination Act. Here is why TAPP opposes each of these bills:

The Medication Affordability and Patent Integrity Act

  • The bill would significantly increase certification and disclosure requirements, forcing companies to submit additional information to the already-overburdened USPTO. This law would throw extra, unnecessary information at the agency, slowing the patent examination process.

  • Supporters of the bill claim it would help prevent the USPTO from issuing patents for "inherent" aspects of drugs, even though there is no evidence suggesting that companies are systematically deceiving the USPTO and FDA. The law already addresses companies meaning to deceive the USPTO or FDA.

  • The bill would require companies to share highly confidential information and trade secrets with the USPTO when they are already required to do that with the FDA. This would put companies' trade secrets and other confidential information at risk therefore threatening innovation and global competitiveness. Data from American life-science companies would be a gift to our global adversaries like China, Russia, and Iran.

The Biosimilar Red Tape Elimination Act

  • The bill proposes all biosimilars being interchangeable without the FDA needing to make any additional determination of the risks to patient safety. New data or studies are not currently required for interchangeability because they’re not needed. The FDA has the authority to require them or not based on its judgment to preserve patient safety. Adding additional steps would only slow the process even moreso.

  • Eliminating the need for an interchangeability determination would limit competition and stunt drug research and development as a result.

  • The bill would do nothing to address anticompetitive PBM behaviors which block access to low cost biosimilars.

Moving forward with these bills would restrict patient access, decrease R&D, and threaten America’s global competitiveness. For these reasons, TAPP is calling on Congress to reject these two unnecessary pieces of legislation and support the U.S. patent system.

Ainsley Shea