Case Study Bayer Corporation

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This case demonstrates an imbalance in innovative drug encouragement by not fulfilling ethical requirements and failing to ensure access to medicines for needy patients in India. Bayer Corporation (BC) failed to adhere to Indian patent laws by not making available Sorafenib Tosylate (ST) to patients in India, despite regulatory approval for marketing authorization and import rights in 2008 as a result failed to ensure access and affordability by blocking generic competition to provide ST at an affordable cost. 1.1 Situation Analysis According to the World Health Organization (WHO) chronic diseases account for almost two-thirds of all deaths and 80% of those deaths occur in low and middle-income countries, hence an increasing need to develop…show more content…
The cost of drug development and failure rates associated with developing and marketing a new drug does not apply here, since ST is classed as an orphan drug. According to the orphan drug act (ODA) USA 1983 (21 CFR Part 316) BC must make available the development costs to obtain orphan drug status and cost argument is not acceptable. The ODA highlights the benefit for the pharmaceutical industry namely tax credits, low tax liability, relief from regulatory feeds and marketing exclusivity for periods of 5-10 years. BC’s pricing strategy should be questioned for developing drugs to be marketed both in developed and developing countries and why this was not considered when filing the patent in India? Despite ST at its current cost not being affordable to 99% of patients in India how did BC justify MA and licensing? According to the Indian patent act (section 84) a CL can be granted if a ‘patented invention is not available to the public at a reasonably affordable price’ or ‘that the patented invention is not worked in the territory of…show more content…
8). BC could have adopted this approach to ensure patent is protected without the need for CL and collaborate with a generic company to manufacture ST. This would have address the cost barrier and ensure distribution, affordability, patient access and adherence to Indian patent laws. The benefits would be the decrease in manufacturing costs within the country and savings of importing, understanding and adherence to the local country regulations. The main disadvantages being cost of the merger and the logistics involved in finding local companies to agree with manufacturing a patent which belonged primarily to BC. This would be particularly challenging since India focuses mainly on the manufacturing of generics and could pose a threat to the generics market if many innovator drug companies follow this
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