Generic Plavix under Attack

In an interesting development, generic Plavix has gone on sale in the USA. Plavix, as we all know, is the block-buster drug from Sanofi-Aventis, marketed in USA by BMS but by Sanofi-A in Malaysia. It is a powerful anti-platelet agents well proven to lessen CVS events in patients with acute coronary syndrome, in secondary prevention of CAD and is invaluable in patients post-Drug Eluting Stents to reduce late stent thrombosis.

I must confess that I do not understand the whole situation, but it appeared that the Plvix molecule is rather complex. Apotex, a Canadian company making generics thought it had a good case for making generic Plavix due to holes in the patent. BMS chose to pay-off Apotex to stay out of the market until the patent expires in 2011. Now BMS looks to be in trouble due to anti trust issues.

Apotex included a clause in the agreement that if the setlement fails, Apotex can, within 5 days, go ahead to sell, and that is exactly what Apotex is doing. There appears little that Sanofi-A or BMS can do about it. However they seem to have bigger problems to worry about. Stock has fallen hard over the last two weeks and ratings agencies are mumbling about downgrades. Who knows how many heads will roll over this one.

How did all these happen? Generic drugs may find a shortcut to get into the market earlier if they can find the right legal team, and their opposition, the wrong legal team. Generic drugs are cheaper (in the case of Apotex Plavix, a little cheaper). What is more worrying is that, if patents can be easily broken, big companies may not be keen to spend so much in research to develop new drugs to help combat disease, and also may not be able to spend so much on continual medical education.

Almost all our CMEs are dependent on patent holding companies to support. So the Plavix fiasco may teach us a thing or two about what not to do when you are being challenged by generics. As for Plavix, we are all waiting for the Sanofi-A and BMS fightback.