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

Legal context: Pharmaceutical patent litigation is on the rise. The focal pointof this increasingly contentious area of litigation is the surgein pharmaceutical patent challenges mounted by generic drugmanufacturers. Pharmaceutical companies need to identify viableenforcement strategies that can survive these challenges andeffectively manage the life cycle of their pharmaceutical productsaround the world. Key points: The degree to which pharmaceutical companies can capitalizeupon the value of their second generation patents to extendthe protection given to existing drug products depends in parton the patent landscape, country by country, and also on theregulatory landscape for generic drug products and their entryinto the marketplace.This paper will examine the patent laws,drug approval regulations, and court decisions on the validityand enforceability of later stage or second generation patentsdirected to combination compounds, selection inventions, andnew indications, in three major jurisdictions: The United States,Europe/UK, and Japan. Practical significance: Successful pharmaceutical companies can maintain a competitiveadvantage in the global pharmaceutical industry by evaluatingand strengthening the way existing drug products are protectedand, in many cases, changing the nature of protection underthe patent laws by improving upon the pharmaceutical productitself.