Ip Pharmaceutical Industry

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Selected Industry: Pharmaceutical

Intellectual property is defined as “Property that can be protected under federal law, including copyrightable works, ideas, discoveries, and inventions. (http://www.lectlaw.com/def/i051.htm)

In the Pharmaceutical industry, intellectual property is classified as the following: patents, orphan drug designation, trademarks, drug formulations, and copyright.

In addition, items of tangible intellectual property consist of printed material or notes that are proprietary in nature, drawings, documents, or electronic media such as CDs or data discs containing proprietary information, data obtained from drug research studies in animals and humans, and biological materials such as animal study models or patient specimens collected for research and/or as part of the drug development stage.

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Patents

In the pharmaceutical industry the patents normally equals the product. Patent protection in very important in the pharmaceutical industry because research and testing cost are very high. According to the Center for Drug Evaluation and Research, “patents issued by the Patent Trademark Office (PTO) grant patent holders the right to exclude others from making, using, or selling an invention.” (http://www.fda.gov/CDER/about/smallbiz/patent_term.htm) The owners of the patent have the right to exclude others from making and selling the product (drug) for twenty years, from the date of first filing the patent application. It is important to note that many patents generally have a shorter term, “because patents are often obtained before products are actually marketed.” (http://www.fda.gov/CDER/about/smallbiz/patent_term.htm)

A patent can also be extended. According to the CDER, “A maximum of 5 years can be restored to the patent. In all cases, the total patent life for the product with the patent extension cannot exceed 14 years from the product’s approval date, or in other words, 14 years of potential marketing time.”...