Forbes' Matthew Herper takes a look at how the ever-longer amount of time needed to study a new drug is colliding with limited patent protection timelines. And he starts with an anecdote about the Medicines Co., which just barely missed a deadline back in 2001 to file for a patent extension on Angiomax to account for regulatory delays in gaining an approval.
The huge amount of money and time it takes to provide the FDA with convincing data on a new blockbuster has to be balanced against the amount of time developers are allowed for patent protection. And increasingly the balancing act could force some companies to back away from big programs.
"Over time, it will become more difficult" to develop new drugs for heart disease and other chronic ailments, Roger Perlmutter, chief of research and development at Amgen, tells Forbes. "As the time required to get a drug on the market has been extended, we find ourselves running against the clock."
- read the article from Forbes