Even if you have not been paying all that much attention, you could not really escape the recent EpiPen controversy. But just in case you have been completely checked out of every single news outlet in America, EpiPen owner Mylan just dramatically increased the price of the life-saving allergic reaction intervention. Critics and patients alike have barraged the company with inquiries as to not only why they would do something like this but more importantly, how something like this could possibly happen.
After all, isn’t there supposed to be some kind of measure in place to protect consumers from actions like this?
Short answer: Yes. Yes, there are supposed to be regulations in place to protect consumers from this kind of price gauging. And if that is the case—which it is—then how could Mylan be getting away with this?
Well, it is actually a matter of patenting. The EpiPen has four patents that protect it from all competition until 2025. Strangely enough—or maybe not—three of those four patents were only awarded in the last six years.
But this is where the story gets a little complicated. Not all of the patents for product improvement were filed while under Mylan ownership. In fact, Mylan inherited one key patent responsible for preventing a generic alternative by another drugmaker from hitting the market. That patent is associated with a company that produces the EpiPen as well the coming generic version, which will be owned by Mylan.
That company in question is the Pfizer subsidiary Meridian Medical Technologies. They are the only company that makes the EpiPen device. And it was this company that filed for the key patent that would come to be very important many years later.
What was this key EpiPen patent?
Well, it wasn’t for the medicine. No, it was actually for the automatic injector that delivers the drug via needle into the skin.
At the time the patent was filed, Meridian was owned by King Pharamceuticals and were producing the EpiPen for Dey, which is a subsidiary of Merck KgaA, a German company who had the physical rights to sell the drug. In 2009, King and Meridian both sued drugmaker Teva Pharmaceuticals who was seeking FDA approval for its own version of the EpiPen.
The parties settled, but Meridian soon after acquired Dey—and thus the rights to EpiPen; and then they continued to file new patents over the next three years, patents which some lawyers question actually represented any meaningful improvements to the actual medication.
“That’s a concern with the patent system that you get a 20-year right to exclude, and a lot of companies have layered patents so they extend protection far into the future,” explains Michael Carrier, who is a Rutgers University law professor that specializes in intellectual property within the pharmaceutical industry.
Accordingly, Washington University law professor Rachel Sachs comments, “This is a really important issue [about] a very common tactic: to apply for a patent on a slightly modified version of the drug or device in order to extend your monopoly.”