Business Ethics & Legal Issues

Topics: Generic drug, Pharmaceutical industry, Food and Drug Administration Pages: 4 (1241 words) Published: December 11, 2011
Business Ethics & Legal Issues
Marilyn Buck AIU Online Unit 4 IP December 4, 2011

A pharmaceutical company has rights to a drug paten but it takes a lot to get that patent. Until that can happen, anyone can make a similar drug and get it approved to sell on the market. Making sure the company acts in a proper way is important. When companies merge it may not always be in the best interest of the consumers, there is usually a lot of money involved in this deal and many times it’s the customer that will pay in the end.

Example 1
1. A drug maker would want to hinder the generic competition of its drug by being able to keep the patent on a drug by using the Hatch-Waxman Act enacted in 1984 which means that a patent is placed on a drug to prevent anyone else from making, using or selling the patented invention. It is granted by a government or regional authority. A patent term typically lasts for 20 years, which means that during that period of time, the patent holder has a monopoly on the invention (e.g. a medicine) and can charge the highest price the market will bear. Even though generic drug makers have continually challenged drug patents before they are scheduled for expiration. This is a billion dollar business and no one wants to share in the profits until they have to give up the rights to make the drugs. Keeping all others away from your drug and keeping the patents as long as possible will make more money for the company (European Generic Medicines Association, 2011). This has been proven to be the case for the HIV medicines in developing countries. When the HIV medicine first came out the patent prevented many people from using it because it was so costly, after the generic versions of...
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