A recent opinion piece in The Economist discusses a very polarizing topic whether patents granted to pharmaceutical companies help or discourage innovation in biomedical research.
Unlike reflexive reactions of many other groups and commentators, who somehow think that it is fair to take intellectual property away from one particular industry, the Economist article recognizes that this is impossible, that is, if we ever want to see a new drug again.
The article also takes note of certain intricacies that are rarely discussed. The most important is the enormous difference in time that it takes drugs for different conditions to get through clinical trials.
Since the U.S. now grants patent protection for 20 years from the date of filing, the playing field is anything but even. Quite the opposite.
This rears its head in a number of ways.
Drugs for chronic diseases, such as diabetes, must have a much better safety profile than drugs for cancer. This requires more clinical studies and more time, all of which eat away at the patent protection.
Then there is the matter of endpoint. There are any number of ways to set up a trial. For antibiotics, you can tell rather quickly if a drug is clearing the infection. But if your endpoint is survival, this is a different story.
For Alzheimer s, this is even tougher. No one is going to start giving an experimental drug to individuals 60 years of age and wait 15 years to see if they develop the disease. So, trials typically measure a marker, for instance memory function after a certain number of years. This still takes a long time.
Cancer is one big bag of unknowns, which is the main thrust of the piece. Very expensive, often marginally effective cancer drugs are making it to the market. The endpoint is usually survival, but it can also be time during which the cancer does not progress.
ACSH s Dr. Josh Bloom explains how patents and their timing present difficult choices for drug companies: Let s say that you want to maximize the patent life of your new drug. One way to do this is to file your patent as late in the process typically 14 years from benchtop to pharmacy as possible. But the downside is huge. During this time, another company may file a patent that includes your drug in their own patent. Then you are in all kinds of trouble.
This is a very complex issue that involves many factors. The Economist piece does recognize the need for a better system, but there is not one in place right now. Not surprising, since this is an extremely difficult problem to tackle.
You can read Dr. Bloom s Wall Street Journal in-print debate about pharmaceutical patents here.
