INTRODUCTION OF LEGISLATION -- HON. ED BRYANT (Extensions of Remarks -
April 28, 1999)
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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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