The Bipartisan Policy Center (BPC) https://bipartisanpolicy.org presented up-to-date policy discussions during Health Week at BPC December 9-11, 2019 in Washington D.C.
An important conversation was held regarding how the U.S Patent and Trademark Office (USPTO) https://www.uspto.gov currently deals with patent practices and operates and also comments on how the Federal Trade Commission (FTC) https://www.gov meets their regulatory obligations.
To begin the discussion, a fireside chat was held with Drew Hirshfeld Commissioner for Patents USPTO, and with Markus Meier, J.D, Assistant Director for Healthcare at the Federal Trade Commission (FTC). Dr. Anand Parekh, Chief Medical Advisor for BPC moderated the chat.
Drew Hirshfeld opened the conversation, by saying, “It is important to improve innovations in medicine and devices. The U.S patent system provides innovators with exclusive rights for a limited period of time for their inventions and awards patents in order to bring new drugs to the marketplace.”
He said, “Today, developers of biological drugs and producers of generic drugs are often involved in disputes involving mergers, and acquisitions, which can require more complex discussions on practices. As a result, the Patent Office actively works with legislators on Capitol Hill to produce reform in areas related to patents.”
Drew Hirshfeld presenting testimony before the “Senate Subcommittee on Intellectual Property Committee on the Judiciary” on October 30, 2019 said, “The U.S patent system provides innovators with exclusive rights for a limited period of time for their inventions, which enables them to raise capital, build their businesses, and bring new innovative products and services to the marketplace. Timely issuance of high quality patents is critical for helping businesses and entrepreneurs invest, develop, and roll out innovative new products and services.”
He reports that the Patent Office employs more than 8,300 patent examiners that need to understand cutting-edge technologies but also need to understand the legal issues and complexities pertaining to these technologies.
According to the testimony, “Examiners have 22.5 hours on average to examine each patent application which includes time to review and understand the invention and time to determine whether the invention is new, determine if the invention is eligible for patent protection, determine if the invention is useful, adequately disclosed, and if the information is clearly identified.
Markus Meier at the FTC, emphasized that the FTC is primarily an investigative and enforcement agency. The goal is to determine whether the patent activity is being used to slow down or prevent competition. The agency protects consumers by investigating and stopping unfair deceptive or fraudulent practices in the marketplace and works to develop rules to guide the marketplace.
The FTC works with Capitol Hill staff on independent studies, conducts research, and holds hearings and workshops on anticompetitive behaviors within industry, and seeks answers to the issues currently facing the American public and the FTC.
Go to https://bipartisanpolicy.org/event/health-week-at-bpc/ to view videos on the three discussions held during Health Week at BPC. The videos include:
- Advancing Comprehensive Primary Care in Medicaid (December 9, 2019)
- Examining Pharmaceutical Patent Practices and their Impact on Drug Prices (December 10, 2019)
- Modernizing the Stark Law and Anti-Kickback Statute to Promote Value-Based Care (December 11, 2019)