NCPA - National Center for Policy Analysis

Poor Protection For Drug Innovation

April 13, 1999

Federal law guarantees copyright protection to the creators of Mickey Mouse and Fred Flintstone for 95 years. But it allows far less time to the innovators who create life-saving pharmaceuticals.

  • It costs an average of $500 million to discover and develop one new medicine -- and it takes an average of 12 to 15 years before a new drug successfully travels from the laboratory to the local drug store.
  • Congress recently extended copyright protection from 75 to 95 years.
  • The average effective life of nonpharmaceutical products is 18.5 years; but the typical effective life for drug patents is only 11.5 years -- because of the years spent winning regulatory approval.
  • Critics say the patent protection clock starts ticking long before a drug is approved by the Food and Drug Administration and the intervening years significantly deplete a drug's limited patent protection.

Without any research of their own, generic drug companies that merely imitate dramatic breakthrough innovations prepare to reap large profits by offering similar products for sale the day the patent expires.

Article I, Section 8 of the Constitution 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 European Union has launched a process to rewrite the patent protection system throughout its 15 member states. Patent experts are urging Congress to reform the U.S. system and grant more time for drug innovators to enjoy their rewards.

Source: Anthony F. Troy (former Virginia attorney general), "Protect Innovation, Not Imitation," Washington Times, April 12, 1999.


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