Patent Law & Its Application to the Pharmaceutical Industry

The development of drugs is costly for pharmaceutical companies and without intellectual property law protection the formula for the drugs can be easily duplicated and the drugs can be synthesized at a cheaper cost. Thus intellectual properties laws often allow companies to monopolize the synthesis and sales of drugs. Unfortunately this exclusive right to manufacture and sell drugs provides the necessary monetary incentive for drug discovery. The patent law is based upon the Patent Act of 1952 codified in Title 35 of the United States Code. This statute allows inventors to obtain patents on processes machines manufactures and compositions of matter that are useful new and nonobvious. Granted patents confer the right to exclude others from making using selling offering to sell or importing into the United States the patented invention. This book covers issues through the year 2002 Modifications of the Hatch-Waxman Act were implemented in P.L. 108-173 the Medicare Prescription Drug and Modernization Act of 2003.