How long does a drug patent last? With the variety of over-the-counter and prescription drugs available, many consumers would like to know because of the marked difference in cost between patented name-brand drugs and generic brands. Whether it is a patent for an invention, a process or a product, the government allows certain protections to the patent holders, and that includes drug companies.
The Process For Patenting A Drug
A pharmaceutical company will generally patent an invention of a unique drug combination while it is in development. After many tests are done and research is conducted, the company delivers it for review by the US Food and Drug Administration (FDA). Once a drug has been tested and approved for distribution by the FDA, the patent protects the company's product from competition for a set time. A patent on a drug prevents other companies from manufacturing and selling drugs with the same active ingredients until the patent expires.
Clinical Trials Impact Length Of Drug Patent
In the United States the patent filed on a drug lasts for 20 years; however, because companies file even before clinical trials, by the time the drug hits the marketplace, the patent may only have between 8 to 10 years left. Once the patent expires, other companies can produce the drug using the same ingredients and bring their version to the market, introducing competition and generally lowering the prices for the drug.
How Pharmaceutical Companies Extend Patents
Pharmaceutical companies employ several methods to extend the life of a drug. For example, a company can attempt to file a patent on improved forms of the drug or specific forms of the drug to start a new patent with the longer timeframe. Companies also rely on exclusivity, a concept that enables a pharmaceutical company to have exclusive rights to marketing the drug. The right of exclusivity does not necessarily have to coincide with the patent restriction-it can extend beyond the patent's timeline.
When both the patent and the exclusivity rights expire, the original pharmaceutical company no longer has a monopoly on the drug. Generic versions of the original can be produced, and the low cost will drive down the cost of the original, in order for it to compete. The early monopoly allows pharmaceutical companies to recoup some of the enormous cost of developing, researching and testing drugs and encourages them to continue to find more helpful drug combinations to benefit others.
Who was the first woman to receive a patent? The first woman to earn this honor created a method of combining straw and silk to create better hats.
Learning how to patent an idea isn't as easy as you might think. You need to determine what kind of patent you need, and then you need to fill out plenty of paperwork to prove the originality of your invention.