A new study by Professor Robin Feldman examines all drugs on the market between 2005 and 2015, identifying and analyzing every instance in which the company added new patents or exclusivities.
"Why do drug prices remain so high?" asks Feldman in May Your Drug Price Be Ever Green. "Even in sub-optimally competitive markets such as health care, one might expect to see some measure of competition, at least in certain circumstances. Although anecdotal evidence has identified instances of evergreening, which can be defined as artificially extending the protection cliff, just how pervasive is such behavior? Is it simply a matter of certain bad actors, to whom everyone points repeatedly, or is the problem endemic to the industry?"
The results, she finds, show a startling departure from the classic conceptualization of intellectual property protection for pharmaceuticals. "The results show definitively that misuse of the patent and regulatory systems is not limited to a few pharma bad apples," says Feldman. "It is business as usual throughout the industry." In addition, says Feldman, "blockbuster drugs have earned billions of dollars for pharma, and abusing the patent system has paved the way."
The study also reveals data pertinent to the discussion of opioid addiction. "As the nation awaits release of the final report from the White House Opioid Commission," notes Feldman, "the pharmaceutical industry continues to be under fire for opioids and more. Many are hoping the White House report will help ease access to medicines that treat opioids. Reckitt, which makes the brand name drug Suboxone, is a serial offender when it comes to manipulating the systems. Our data set shows that Suboxone extended its protection cliff 8 times, including obtaining an orphan drug designation, which is intended for drugs that serve only a small number of patients."
The paper offers strategies to help fix the problems:
Professor Feldman is the Director of the Institute for Innovation Law at the University of California Hastings College of the Law in San Francisco and author most recently of Drug Wars: How Big Pharma Raises Prices and Keeps Generics off the Market (Cambridge University Press 2017). See links below to other papers of Professor Feldman on the pharmaceutical industry: