ABSTRACT
Effective management of intellectual property is essential for success in the development and marketing of pharmaceuticals. Developing a new drug or a new method of treating or preventing disease is an extraordinarily expensive undertaking; many years of labor and many millions of dollars are needed to bring a new therapy to market. Pharmaceutical research organizations study and discard hundreds of new molecular entities and treatment regimens for each one that can be demonstrated to be safe and effective enough to be approved by regulatory agencies. These costs are borne by the originator of the new drug before the first prescription is written in the expectation that sales of the new drug will repay the development costs and
provide a profit. The term of marketing exclusivity granted by drug regulatory agencies and the exclusive rights provided by patents protect the originating company for a period of time before generic copies of the drug are introduced by competitors who have not shouldered the costs of development. Intellectual property, also known as industrial property, covers intangible assets: inventions covered by patent rights, trade secrets and know how, copyright, registered designs, and trademarks. Intangible assets differ from moveable, material property and real estate in that ideas are protected apart from their physical manifestations; they confer the right to exclude others from making a product, practicing a process, or copying a name, symbol, or text. Patents, trademarks, and design registrations are obtained by filing an applicationwith a national or international patent and trademark office. The application includes a description of the invention, mark, or design for which protection is desired along with the appropriate filing fees. Applications are reviewedbyexaminersandgrantedonly if theyare found tomeet the legal requirements for novelty and inventiveness. Practicing an invention covered by a patent-making, using, or selling anything described by the claims-or copying a trademark, design, or copyrighted text without the express permission of the owner is called infringement. Intellectual property rights are defended by filing a lawsuit in the civil courts asking for monetary damages and an injunction against further infringement.
