The battle over global drug markets: enforcement of pharmaceutical patents in the United States, Europe and Japan

The pharmaceutical industry is one of the most productive and competitive industries in the world. Many of the large pharmaceutical companies (often termed ‘Big Pharma’) base their primary operations in the USA and maintain extensive facilities in countries around the world. Pharmaceutical research is, therefore, an activity of global importance. The intensely competitive and global nature of Big Pharma, and the pharmaceutical industry in general, make pharmaceutical product innovation and development a crucial determinant of any company’s success. Innovator pharmaceutical companies are constantly challenged by the time and cost required to bring new, branded drug products, ie the so-called ‘pioneer’ drugs, successfully to market. Companies must continually seek new and improved ways to expedite the research, development, and regulatory approval phases of drug development and to manage competition from generic drug manufacturers. These companies seek to maintain an advantage in the marketplace both by introducing new drug products whenever possible and by finding new ways of protecting existing drug products, widening the breadth of patent protection for innovative products. Successful companies have maintained a competitive advantage in the global pharmaceutical industry by evaluating and strengthening the way existing drug products are protected, frequently changing the nature of protection under the patent laws by improving upon the product itself. In the pharmaceutical industry, there are several types of patents an innovator can obtain. The main type of patent is directed to brand-name pioneer drugs and their uses, eg for specific indications. Pioneer drug patents include (i) product patents that cover the active ingredient or compound in a drug; (ii) process patents that cover a process for manufacturing a drug; (iii) method-of-use patents that relate to a particular method of using a drug; and (iv) formulation patents that cover both the active and inactive ingredients in a drug (eg a final dosage form, tablet, or capsule). These types of patents are infringed by the sale and use