Patents and The Pharmaceutical Industry, Products of Liability and The Role of Whistleblowers

  1. When the patent on a drug expires, other drug companies are free to copy the drug and sell what is known as a generic version.  This increases competition and the price of the drug usually drops once generics enter the marketplace.  Pharmaceutical companies have developed a couple of strategies to deal with the emergence of generics.  First, there is the practice of “pay to delay” meaning the company holding the patent will pay the generic producer to delay entering the market.  This extends the period of time that the patent holder can continue to collect very high margins on their drug.  In other words, the price remains high even though the patent has expired.  Second, companies sometimes give their drug a minor tweak that extends patent protection and continues to keep prices high for that drug.  Sometimes the tweak is an extended release version or may involve combining the drug with another compound that can be as simple as calcium carbonate (the ingredient in Tums) or aspirin.  For more explanation of these practices, read



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There have been legal, regulatory and legislative initiatives against some of these practices.  However, I am interested in purely the ethical issues.  Assume that these practices are legal.

  • What do you see as the ethical issues in “pay to delay” and product tweaking?
  • What ethical theory would you apply to determine whether these practices are ethical? (Use the reading material in our class)
  • Apply the theory and explain your conclusions with the class reading to support it.


Theme 1:  Pharmaceutical Industry

Theme 2: Products of Liability

  • The Danger Of Loosely Regulated Supplements
  • Unregulated supplements send thousands to hospital each year
  • The ethics of global clinical trials In developing countries, participation in clinical trials is sometimes the only way to access medical treatment. What should be done to avoid exploitation of disad
  • Supreme Court lets pay-to-delay ruling against pharma stand
  • Appendix K Antibiotics In Animal Feeds
  • Ethical dimensions of the prescription opioid abuse crisis
  • The War on Opioids: An Ethical Perspective

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