Abstract

The case focuses on Ranbaxy Laboratories Limited’s patent litigations in the US. It elaborates on the factors that led to the company’s global expansion, focusing specifically on the US market. The case discuses in detail Ranbaxy’s approach to the US market and also discusses its initial successes. It also looks at the US pharma-ceutical industry and the patent system in the US in detail. The Hatch-Waxman Act of 1984 and its significant impact on the generics pharma industry in the US are also explained. The case discusses the problems faced by the generics players in the US in the extremely competitive generics market and the effect of increasing patent litigation costs involved in challenging patent holders. It ends with a note on Ranbaxy’s challenges in meeting its target of $ 2 billion for the year 2007.

Learning Objectives

The case is structured to achieve the following Learning Objectives:

• Growth strategy of a pharmaceutical company in the international market
• Benefits and downside of adopting of an inorganic growth strategy in an international market
• How patent litigations can be the strategy of choice of generics players for revenue growth
• and Impact of patent litigations on generics players as well as on patent holding companies.

Keywords

Ranbaxy Laboratories Limited, Pfizer, Lipitor, Teva Pharmaceuticals USA Inc., Glaxo Wellcome, Patent Litigations, Drug Price Control Order, Indian Patent Act of 1970, Ranbaxy Pharmaceuticals Inc., Food and Drug Administration, FDA, Generics, Patent and Trademark Office, Pharmaceutical Industry, Hatch-Waxman Act, Abbreviated New Drug Application, Paragraph IV, Para IV certification, Eli Lilly, Cefaclor, Patent, Dr. Reddy's Laboratories