(AKA How to Extend a Patent Without Having to Work For It!)
Ista Pharma released Bromfenac by the brand name of Xibrom as a non-steroidal anti-inflammatory eye drop. It was supposed to get to the vitreous cavity on its way to the macula and fight Cystoid Macular edema. We were to give it to our patients for about 2 weeks after cataract surgery. The cost of the eye drop was about $58 per milliliter, so a 5 cc bottle would cost about $300! All good.
It seems that the patent for Xibrom expired in January 2009. Ista was making about $100 million in revenue with this drop. Oy, but the patent was to expire. What to do?
Enter Bromday. It is a better medicine in that patients will now use it once a day instead of twice. No doubt the formulary was changed, right? Perhaps the medication was attached to a vehicle to stay in the ocular tissue longer? Maybe the makers found a clever new more effective additive?
Nope!
It turns out that Ista simply doubled the dose (from 0.09% to 0.18%). They did a study that showed that once a day dose was just as good as twice a day!
That’s it! Wholla! Now, the FDA approved this doubling of a dose as a NEW formulation, and the patent was extended for another 3 years! The upshot is that Ista can now enjoy another 3 years of patent protected Bromfenac.
How is that for innovation? Well done!
