[Congressional Record Volume 141, Number 193 (Wednesday, December 6, 1995)]
[Senate]
[Pages S18104-S18105]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                    PATENT PROTECTION UNDER THE GATT

 Mr. FAIRCLOTH. Mr. President, I ask unanimous consent to have 
printed in the Congressional Record a letter from former Surgeon 
General Dr. C. Everett Koop.
  The letter follows:

                                                November 30, 1995.
     Mr. Morton Kondracke,
     Executive Editor, Roll Call, Washington, DC.
       In your special supplement on the FDA (October 9, 1995), an 
     article appeared concerning patent protection under the 
     General Agreement on Tariffs and Trade (GATT). I am of the 
     firm belief that any action on the part of the U.S. Senate to 
     weaken the hard-fought patent protections of the GATT would 
     imperil the future of intellectual property rights and 
     undermine the research activities of pioneering 
     pharmaceutical companies.
       A little-known revolution has taken place in my lifetime. 
     When I started practicing medicine, only a fraction of the 
     drugs that we now take for granted existed. Over the years, I 
     have witnessed great suffering endured by patients and their 
     families that, just a few years later, could have been eased 
     because of the advent of the latest ``miracle drug.'' These 
     breakthrough treatments have brought hope and, in many cases, 
     renewed health to thousands of patients. They are the product 
     of an increasingly important concept: the sanctity of 
     intellectual property.
       The right to claim ideas as property allows innovators to 
     invest their time and money bringing those ideas to fruition. 
     It is the basis if our patent system that allowed American 
     ingenuity to prosper throughout the Industrial Age. Today, we 
     are at the dawn of an Information Age and now, more than 
     ever, the rights of intellectual property holders must be 
     protected.
       Consider the enormous investment in time, money, and brain 
     power required to bring a single new medicine to patients: 12 
     years and more than $350 million is the average investment. 
     Only 20% of new compounds tested in a laboratory ever find 
     their way onto pharmacy shelves. Only a third of those ever 
     earns a return on the colossal investment made to discover 
     it.
       Though risky and expensive, this process works. The U.S. is 
     the world leader in the development of innovative new 
     medicines. Proceeds from the sales of these medicines support 
     the work and research invested in new successful drugs, as 
     well as the thousands of drugs that never make it out of the 
     lab.
       Patent protection makes that investment in research 
     worthwhile--and possible. Recently, patent protection around 
     the world was strengthened and harmonized by the GATT, which 
     required changes that equalized intellectual property 
     protection in all participating countries. These changes are 
     important to encourage the risky, expensive research 
     necessary to provide new medicines to fulfill unmet medical 
     needs.
       Now, some generic drug companies are challenging the GATT's 
     advance in intellectual property protection. They are urging 
     Congress to amend the 1948 Hatch-Waxman Act to give them an 
     advantage under the GATT that no other industry enjoys.
       A key provision of the Hatch-Waxman Act gives generic drug 
     companies a jump start on marketing by allowing them to use a 
     patented product for development and testing before the 
     patent expires. This special exemption from patent law is not 
     allowed for any other industry. For example, a television 
     manufacturer who wants to market or use its own version of a 
     patented component must wait until the patent expires; 
     otherwise, it risks liability for patent infringement.
       In return for these special benefits, the Hatch-Waxman Act 
     requires generic drug companies to wait until the expiration 
     of the research companies' patents before they can begin 
     marketing their drugs. Now, the generic drug industry is 
     asking Congress to give it a special exemption from that 
     restriction as well.
       In my opinion, that would be unwise. Treatment discovery 
     has already slowed; we should reverse that process, not 
     ensure it.
       While the generic drug industry continues to prosper as a 
     result of the benefits received in the 1984 Act, medical 
     research has continued to become more complex, more costly, 
     and more time consuming, further limiting the effective 
     market life for patented products.
       Generic drugs play an important role in helping lower the 
     cost of medicines. But it is the pharmaceutical research 
     industry that discovers and develops those medicines in 

[[Page S 18105]]
     the first place, investing billions of dollars in research and 
     development that can span decades without any guarantee of 
     success--an investment made possible by our system of patent 
     protection. Preserve protection and you preserve the 
     opportunity for the discovery of future cures and treatments 
     for disease. Undercut that protection, and you undercut 
     America's hope for new and better answers to our health care 
     needs.
           Sincerely yours,
     C. Everett Koop, M.D.

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