Patent Office is asking the right questions to lower drug costs, writes Dr. Rachel Goode.
Brand pharmaceutical companies are gaming the patent system, and it’s costing us all. Fortunately, the Director of the U.S. Patent and Trademark Office, Kathi Vidal, seems poised to tackle what others before her have overlooked or ignored.Brand pharmaceutical companies are inappropriately extending their monopolies on the most expensive drugs in the market by protecting them behind a mountain of duplicative patents.
To be clear, incremental innovations to improve therapies for patients are critical and not at issue here. Rather, the scheme to block competition relies on a little-known maneuver called obviousness-type double patenting . Obviousness-type double patenting is what it sounds like — it is patenting one invention multiple times.
Why does it matter if a duplicative patent is approved if it expires at the same time as the original? Biosimilar makers work to identify weak, non-innovative, follow-on patents to challenge as a means to come to market sooner and compete. Challenging a patent, whether weak or strong, duplicative or innovative, costs about $1 million dollars from start to finish. A potential competitor must invalidate every single patent to enter the market.
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