ABSTRACT
The 21st century was termed as the century of knowledge. However, merely having the
knowledge is not enough. It is the protection of that knowledge and conversion of that
knowledge into profit which are important for the survival of any high-tech business and
economy. The one who controls the knowledge and knows how to protect it is the winner
in modern-day industry. The pharmaceutical industry, like any other high-tech industry,
is no different. The company that has the upper hand will be the winner of the war. The
stakes are high, and success or failure can make or break a company. The life blood of the
pharmaceutical industry is innovative ideas and new products. It is clear that research
productivity has gradually declined over the last few decades, and the cost to bring a new
drug candidate to market has skyrocketed to an estimated whopping US$800 million or
more (1). How one can create new ideas and products at the proper time and protect the
life of current drug products has coined the term “Life Cycle Management (LCM)” in
pharmaceutical industry (2). The whole objective of pharmaceutical drug product LCM is
to maximize the profit of any drug product from start to market withdrawal and take full
advantage of the intellectual rights and food and drug laws and regulations. This is
extremely important for the survival of all pharmaceutical companies; no matter if it is a
huge multinational company, a medium-size company, a one drug wonder company, a
start-up company, or even a generic company. LCM is used as offensive or defensive
tools to act and counteract against real or potential future competitors. The one who
controls the knowledge and the know-how to develop and protect them is the sole
qualified player in modern-day industry.