Pharmaceutically Speaking: Enbrel is Patented Forever

Danie Roy

Okay, it’s not patented forever, it just FEELS like Enbrel got patented forever.  The patent expires in 2028.

To put that in perspective, by the time this patent expires:

• We will have gone through 4 Presidential Elections
• I will have gone through 8 different phones (assuming 2-year contract deals, and that I don’t utterly destroy them somehow)
• Some kid born last year will have graduated high school
• Some kid that just started middle school this year will have a PhD
• Kids that aren’t even born yet will be driving
• We will have heard of no less than 15 new dates on which the world is predicted to end
• I will be middle-aged

Okay, I scared myself with that last one. You get the general point, though.

Some of you may recall that I said the Enbrel patent was supposed to expire in October 2012.  Well, turns out there’s more than one patent.  The infinity and beyond patent was filed back in 1996, which means that it falls under the “17 years from date of issue” rule.  So, instead of expiring in 2016 (which it would under the 20 years from filing rule), this patent expires sometime in the flying car future.

Okay, maybe the patent wouldn’t expire in 2016, either.  Once we instituted the 20 years from filing rule, we also added this thing called “patent term adjustment”… you could get time added for certain delays.  And, really, with a 15 year delay, it’s quite likely that, had the patent been filed after the 20 year rule was instituted, this gem would qualify for SOME patent term adjustment.

Now, if you’re familiar with the Pharmaceutically Speaking series (or pharma IP in general), you may have noticed a dull, aching sensation in your wallet.  That’s because this means any possibility of biosimilars for Enbrel is out FOREVER!  (Or at least 17 years).