Kevin Outterson

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Penicillin and other antibiotics were the original wonder drugs and laid the foundation of the modern pharmaceutical industry. Human health significantly improved with the introduction of antibiotics. By 1967, the U.S. Surgeon General declared victory over infectious diseases in the United States. But pride goes before a fall. The evolutionary pressure of antibiotic use selects for resistant strains. Effective drugs should be used. But when they are used, no matter how carefully, evolutionary pressure for resistance is created. The problem is not limited to antibiotics. Variants of the human immunodeficiency virus (HIV) develop resistance to anti-retroviral drugs. Antifungal agents face similar challenges. Even cancer cells may develop resistance to pharmaceuticals. Tens of thousands of Americans are dying every year from drug-resistant infections. Some pharmaceutical knowledge is therefore exhaustible, and after patent expiration the public domain may receive a drug which is no longer useful. For these drugs, the public domain vanishes.

Source Citation

Outterson, Kevin. (2005). The Vanishing Public Domain: Antibiotic Resistance, Pharmaceutical Innovation And Intellectual Property Law. University of Pittsburgh Law Review, 67(1).