FDA-USPTO collaboration initiatives should be evidence-based, prioritize innovation

The United States Patent and Trademark Office (USPTO) and the U.S. Food and Drug Administration (FDA) are in the process of considering new collaboration initiatives aimed at biopharmaceutical patents. As outlined in a recent public statement and written comments, PhRMA appreciates the agencies seeking public participation on important innovation policy issues and we strongly support the agencies stated commitment to “ensuring our innovation system strikes the appropriate balance—encouraging meaningful innovation in drug development while supporting a competitive marketplace that can promote greater access to medicines for American families.”   

However, we also have concerns that future changes to the U.S. patent system brought on by agency collaboration could unnecessarily put confidential information at risk and negatively impact the current system of incentives for innovation.

As the process of considering initiatives continues, we encourage the USPTO and FDA to keep in mind several key points:

• Any policy changes to the U.S. patent system, including increased collaboration between the USPTO and FDA, should be based on evidence of a need for change – not false narratives, flawed data or unsupported assertions. To date, we have not seen reliable evidence of systemic issues within the U.S. patent system or FDA approval process that would necessitate the proposed changes.
  
  
• Today, more than 90% of drug prescriptions are filled with generics thanks to the IP framework created by the Hatch-Waxman Act. The overall conceptual framework for generic and biosimilar market entry is the same: after an innovator undertakes the time-consuming and expensive development process and obtains FDA approval, they have an appropriate period of IP protections, following which a generic or biosimilar version may become available.
  
  
• Research and development does not stop and should not stop with initial FDA approval of a medicine. Post-approval research and development leads to improvements such as new uses, new dosage forms and routes of administration for patients. Further, once IP protections on an original product have ended, generic or biosimilar copies of that product may be approved.
  
  
• Increased information-sharing across agencies will almost certainly create confidentiality issues as each agency has different practices for handling confidential information. While the USPTO’s general position is that information material to patentability must be disclosed to the public, the FDA is subject to specific statutory restrictions on sharing proprietary information.

We appreciate the USPTO and FDA for soliciting comment from stakeholders on collaboration initiatives. We hope to have the opportunity for additional dialogue regarding the potential unintended consequences of certain initiatives and the various ways intellectual property protections are crucial to ensuring next generation cures and treatments reach the patients who need them most.

Read the full comments submitted by PhRMA here.