[Congressional Record (Bound Edition), Volume 145 (1999), Part 6]
[Extensions of Remarks]
[Page 7816]
[From the U.S. Government Publishing Office, www.gpo.gov]



[[Page 7816]]


             CONGRESSIONAL RECORD 

                United States
                 of America



April 28, 1999





                          EXTENSIONS OF REMARKS

                      INTRODUCTION OF LEGISLATION

                                 ______
                                 

                             HON. ED BRYANT

                              of tennessee

                    in the house of representatives

                       Wednesday, April 28, 1999

  Mr. BRYANT. Mr. Speaker, I rise today to extend my remarks with an 
introduction of an important piece of legislation.
  Today, we are introducing legislation that links two important 
issues--the need for pioneering research and development, and the need 
for patents with integrity to encourage that research. This 
relationship of R&D and patent integrity is one of mutual dependence * 
* * a relationship in which each fosters the other for the benefit of 
us all.
  We all know that pharmaceutical research is one of the best patient 
protection policies we can buy as Americans. Just ask any physician--or 
any patient who has benefited from the healing powers of a new 
pharmaceutical.
  In fact, pharmaceutical research and development is one of America's 
success stories.
  But R&D is not a matter of simply walking into a laboratory one day, 
discovering a product, and putting it on the pharmacist's bench the 
next week. Drug research is a marathon, not a sprint. It is expensive. 
And it is time-consuming. It costs more than $500 million to discover 
and develop one new medicine. Research-oriented pharmaceutical 
companies spend an average of 15 years between the time they discover a 
drug and the time they are allowed to bring it to market.
  That explains our legislation and the necessity for patent integrity. 
Patent integrity is the cornerstone, the wellspring, of research and 
development. The protection of intellectual property is even spelled 
out in the Constitution, which states: ``Congress shall have the power 
* * * to promote the progress of science and useful arts, by securing 
for limited times to authors and inventors the exclusive right to their 
respective writings and discoveries.''
  The message of the Founding Fathers was simple, straightforward and 
unmistakably clear--and for those reasons, it has stood the test of 
time. It was--and is--a directive that innovators should be able to 
benefit from their labors through the protection of intellectual 
property, which in turn will create the incentive to create pioneering 
products that benefit us all.
  Pharmaceuticals assume a special importance in our nation's research 
and development efforts. I know this for a fact because my district is 
home to a major facility of Schering-Plough. This plant contributes in 
a major way to the economy of the region and employs 800 highly skilled 
people. But the issues here are much larger and more significant than 
one plant or one company.
  The issues, instead, involve fairness and predictability in America's 
intellectual property laws--in other words, patent integrity.
  In 1984, Congress passed the Hatch-Waxman Act, which was designed to 
accomplish two goals. One was to enable generic drugs to get to market 
faster. The other goal was to restore some of the patent life that 
branded drugs were losing to lengthy regulatory reviews.
  As time passed, however, it has become clear that the goals of Hatch-
Waxman were significantly undermined by unintended consequences.
  When it passed the legislation in 1984, Congress rightly assumed and 
anticipated that there would be relatively quick FDA approval for drugs 
that were in the approval ``pipeline'' at the time. In fact, that did 
not occur. For some drugs, the regulatory review took significantly 
longer than anticipated. This regulatory delay unintentionally deprived 
them of critical portions of their patent life.
  Regulatory delay is an unfortunate occurrence in Washington. In many 
cases, it has direct consequences. This legislation is intended to 
address one of those consequences.
  This legislation addresses this issue in the right way. It seeks to 
establish an independent and public review process within the Patent 
Office. This process would consider claims for patent restoration to 
offset regulatory delay.
  Ultimately, this legislation enables Congress to assure patent 
integrity. And, by assuring patent integrity, Congress will be assuring 
a continuation of the types of research and development that helps 
patients every day.

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