“Spot-On Savings” How The IPR Process Generates Savings

Today, some major pharmaceutical companies continue to game the U.S. patent system by limiting generic competition while keeping drug prices high for millions of patients. 

Big Pharma’s manipulation of patent laws prevent or delay generic medications from going to market which ultimately denies patients access to more affordable, life-saving, and quality of life enhancing drugs.  The reality is that patients who rely on prescription drugs are not the only ones that suffer from high prices because of Big Pharma’s patent abuse.  Soaring drug prices raise insurance premiums for everyone, all while some major pharmaceutical companies line their pockets with profits.

Thankfully, proceedings conducted by the U.S. Patent and Trade Office (USPTO) Patent Trial and Appeal Board (PTAB), known as the inter partes review (IPR) process, are instrumental in cancelling erroneously-issued patents. IPR is one of the best tools we have for this task. It is important that IPR proceedings conducted by the Board remain apolitical and ensure outcomes are decided on the basis of science and law, rather than politics.

Last time, we looked into how the IPR proceeding for an opioid addiction treatment known as Suboxone opened the door for generic competition. Today, we’ll continue diving into how the IPR process conducted by PTAB has repeatedly and successfully thwarted anticompetitive behavior by some major pharmaceutical companies to increase competition and dramatically lower drug prices.

Part IV: IPR & Heart Disease – Knocking Down Erroneously Extended Patents

Here, we will look at how the IPR process knocked down erroneously extended patents of an anti-blood clot drug used to treat cardiovascular disease.

In 2017, the patent for an anti-clotting drug prasugrel, under the brand named Effient, expired. However, the patent holder Daiichi Sankyo also held a later obtained patent for the use of Effient with aspirin, which extended patent protections and exclusivity by six years.

During an IPR analysis of the patent, the Board concluded that the combination of Effient with aspirin is not a unique or novel innovation since aspirin is a blood thinner that also limits blood clots. Once again, the IPR process successfully prevented the exploitation of the U.S. patent system. Ultimately, competition in the marketplace reduced prices by 97% below the brand cost.

It is clear that the inter partes review process is a faster, more effective, and less costly alternative to correct errors in issued patents. That means patients see sharp price reductions in the drugs they rely on years faster. IPR should be strengthened, but repeated legal challenges have weakened its ability to correct erroneously issued patents. 

Congress should ensure that this does not happen, and look for opportunities to allow IPR to do more to maintain a strong patent system which balances innovation, free-market competition, and affordability.