Hatch-Waxman Amendments: A Case Study

The Drug Price Competition and Patent Term Restoration Act of 1984 also known as the Hatch-Waxman Amendments is significant because it establishes the way the public have access to affordable, safe generic drugs and the process by which those drugs get approved and marketed. To understand the importance of this act it is vital to know the process for how patent on drugs worked before this law was put into place. The time frame of a “patent or process for manufacturing a drug or therapeutic use for a drug” was that any one could bring the drug to the market immediately after the patent was issued or sooner. Yet for new drugs, it was a longer process. You would have to get approval from the FDA before going out on the market as well as have the necessary data from clinical trials

To be able to encourage society to use generic drugs, the act was believed to allow generic drug companies to expedite the FDA approval process so that their products were able to go to the market as soon as brand name products for patents expired. Generic designers “may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by original pioneer drug manufacture and adds only bioequivalence studies”. It is hard to say if the Hatch-Waxman has improved “pharmaceutical innovation” however, the approval and marketing process for generic drugs has helped people significantly. There was an increase in ANDA applications during 1998 and there has been a “high success rate for patent invalidation”. “Since Hatch-Waxman, virtually all top-selling drugs not covered by patent face generic competition; whereas pre–Hatch-Waxman, only 35% had generics available. Similarly, today more than 70% of prescriptions are for generics, whereas pre–Hatch-Waxman generic prescriptions numbered