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.