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Authors: Rekha Krishnan (Tilburg University)
Published in: 2003
Length: 21 pages
Data source: Field research

Abstract

The case describes the regulatory framework and patent laws for biopharmaceuticals in India, which is representative of many developing countries. The case covers specific quality and approval issues of life-saving biotechnology drugs, and the rising prices of these drugs. What are the consequences of bringing copied versions of patented biotech drugs to such a market? The case shows such a process where Nicholas Piramal India Limited (NPIL), in an attempt to protect Neupogen, an anti-cancer drug licensed to it by Hoffmann La Roche, charged Dr Reddy's (DRL) with making misleading claims and wrongfully cited references about its recently launched biotechnology drug against cancer, Grastim. Both NPIL and DRL are well-known Indian pharmaceutical companies. Though Dr Reddy's claimed that Grastim had the same properties as Neupogen, the Drug Controller General of India ordered Dr Reddy's to recall its drug, Grastim, from the Indian Market making it an unprecedented incident in India. The case provides enough information for the student to understand the ethical dilemma. The student is expected to analyse the case by placing the ethics of protecting high-priced patented biopharmaceuticals vis-a-vis the ethics of bringing to the market copied versions of these drugs at affordable prices, against the background of patent laws in a developing country like India and the specific nature of biotechnology drugs.
Location:
Industry:
Size:
Large
Other setting(s):
2001

About

Abstract

The case describes the regulatory framework and patent laws for biopharmaceuticals in India, which is representative of many developing countries. The case covers specific quality and approval issues of life-saving biotechnology drugs, and the rising prices of these drugs. What are the consequences of bringing copied versions of patented biotech drugs to such a market? The case shows such a process where Nicholas Piramal India Limited (NPIL), in an attempt to protect Neupogen, an anti-cancer drug licensed to it by Hoffmann La Roche, charged Dr Reddy's (DRL) with making misleading claims and wrongfully cited references about its recently launched biotechnology drug against cancer, Grastim. Both NPIL and DRL are well-known Indian pharmaceutical companies. Though Dr Reddy's claimed that Grastim had the same properties as Neupogen, the Drug Controller General of India ordered Dr Reddy's to recall its drug, Grastim, from the Indian Market making it an unprecedented incident in India. The case provides enough information for the student to understand the ethical dilemma. The student is expected to analyse the case by placing the ethics of protecting high-priced patented biopharmaceuticals vis-a-vis the ethics of bringing to the market copied versions of these drugs at affordable prices, against the background of patent laws in a developing country like India and the specific nature of biotechnology drugs.

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Location:
Industry:
Size:
Large
Other setting(s):
2001

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