What would happen if the succession law were to be applied retroactively?

Law: Novartis lost its patent for Imatinib (Gleevec) in India but would a similar thing happen in the US?

• What has happened in similar cases in the US while companies re-applied for patents?

• Answer:

  No. Novartis developed a slightly modified form of imatinib and applied to patent it in India as a "new improved" drug. Indian law requires an improved drug be more effective than the old. The Indian High Court rejected the application because tests showed effectiveness was the same. In the US, this situation is covered by the Hatch-Waxman Act (1984) aka http://en.wikipedia.org/wiki/Drug_Price_Competition_and_Patent_Term_Restoration_Act. It allows the original patent to be extended by showing the "new improved" drug has equal bioavailability. It is not necessary to show it works better. The US patent on imatinib expires in 2016. It has already been extended to 2019. Imatinib turns leukemia into a chronic condition. You must take the drug for the rest of your life, or die. It originally sold for $30K per year. When it became an unexpected blockbuster, Novartis raised the price to $92K per year. Since 2001, they have sold $4.7 billion, putting it within range of the top 20 http://www.forbes.com/sites/simonking/2013/01/28/the-best-selling-drugs-of-all-time-humira-joins-the-elite/. Development costs were recovered long ago. Profit is at least 90% of sales. Generic imatinib sells for $9K per year in countries where the patent expired. It is a small molecule, not a biologic. We are entering an era that will be dominated by ultra-expensive drugs. No more mass market blockbusters like Lipitor and Crestor. Instead, the mass market will be served by custom formulated drugs, designed for your unique needs by computer. There will be no need for patents or generics when there are a billion different drugs. Needless to say, prices will be <cough cough> slightly higher.. I used to work for Novartis, but not on imatinib. It was developed by a group of independent researchers who sold or licensed it to Novartis. They signed a petition asking Novartis to stop price-gouging. It didn't stop. Update: When I wrote this answer in 11/2013, there was not the slightest hint I might have leukemia.I was diagnosed with leukemia in 2/2015. I receive free drugs under the government's Extra Help program. I am not taking imatinib.