Four ways keep generics from consumers:
- Patent-holder pays the generic company not to launch the generic.
- Patent-holder extends the patent 150 days through a “citizen petition”, which is filed to delay action on the pending generic application (92% of such applications are submitted by the branded drug manufacturer; most are filed days before the patent is to expire)
- Patent-holder sells an “authorized generic” (Fox* explains in her article: “authorized generics” are another tactic to limit competition. These aren’t really generic products at all; they are the same product sold under a generic name by the company that sells the branded drug. Why? By law, the first generic company to market a drug gets an exclusivity period of 180 days. During this time, no other companies can market a generic product. But the company with the expiring patent is not barred from launching an ‘authorized generic.’ By selling a drug they’re already making under a different name, pharmaceutical firms are effectively extending their monopoly for another six months.”
- Patent-holders for personalized medicines “decline to sell drug samples to generics manufacturers by citing ‘FDA requirements,’ by which they mean the agency’s Risk Evaluation and Mitigation Strategies program.”*
Patents are enshrined in the Constitution.**
Congress is supposed to define how patents work for inventors and for society.
In a show of great bi-partisanship, neither party is addressing the problem.
*Read Erin Fox’s clear, brief and informative article at:
https://hbr.org/2017/04/how-pharma-companies-game-the-system-to-keep-drugs-expensive
**The Constitution on patents:
Article I, section 8: “Congress shall have power… to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.”