[Congressional Record (Bound Edition), Volume 145 (1999), Part 6]
[Extensions of Remarks]
[Page 7823]
[From the U.S. Government Publishing Office, www.gpo.gov]




                INTRODUCTION OF THE PATENT FAIRNESS ACT

                                 ______
                                 

                           HON. JIM McDERMOTT

                             of washington

                    in the house of representatives

                       Wednesday, April 28, 1999

  Mr. McDERMOTT. Mr. Speaker, today I have introduced a proposal that 
encompasses three principles--fair play, equity and de-politicization.
  The United States must do whatever possible to assure patent 
integrity, so we can continue to receive the desired public benefits 
from pharmaceutical research. Creating a fair and impartial process 
where an independent body can determine whether or not to restore lost 
patent life is a matter of fairness. It also is a matter of ensuring 
adequate incentives for research and development in the future.
  In this case, several drugs were caught in a review process that took 
significantly longer than Congress anticipated. Thus, the patent life 
of certain of these ``pipeline'' drugs was reduced by an unintended 
consequence that had nothing to do with their medical safety.
  There are two important questions: What type of process can we put in 
place to guarantee a fair and reasonable evaluation of the issues? And, 
what types of assurances should be embedded in this process to make 
sure it is equitable and removed from politics?
  Our bill answers these questions. Our bill establishes a process that 
is fair, equitable, independent, separated from politics, and fully 
open to the public, and subject to judicial review. Let me expand on 
these features.
  The bill establishes an independent and public review process within 
the U.S. Patent and Trademark Office. This would be a new 
administrative procedure--one that is fair and impartial. The experts 
at the Patent and Trademark Office are the right experts to hold a 
hearing about these issues, because these issues involve questions not 
of medical research, but legal issues involving patent life.
  Within the office, a procedure would be established to review claims 
for patent term restoration to compensate for unanticipated lengthy 
regulatory review of ten years or more in the FDA's New Drug Approval 
proceeding.
  The process established by this legislation would be akin to a court 
hearing. Any company that believed its product was unintentionally 
deprived of patent protection would have the opportunity to present its 
case. Any other interested party would also be free to make its case. 
Both sides would be treated equally. Everything would occur in the 
open. The review board would be bound by objective criteria.
  By turning over the issues to an independent panel of experts, the 
process would be driven by public policy objectives--not politics. This 
is an important point. Our bill is driven by the principle that it is 
best to take politics out of the equation, to de-politicize the 
process, to take Congress out of the job of deciding individual patent 
issues.
  Finally, fairness and equity are assured by another provision. The 
decision would be subject to judicial review.
  Another way to describe the legislation is to outline what it does 
not involve. There is no preferential treatment for any affected 
pipeline drug. There are no arbitrary decisions. There are no 
guarantees. Our bill is about process, not about answering a 
predetermined outcome.
  We are convinced this is the right solution. As a medical doctor and 
psychiatrist, I have seen the benefits of breakthrough drugs and 
innovations. They truly can make people's lives better, and there is 
more to do.

                          ____________________