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

Part I: IPR & Insulin – The True Value of PTAB Proceedings

Year after year, pharmaceutical companies engage in anticompetitive strategies to game the U.S. patent system and keep drug prices high at the expense of patients. Even as millions of Americans grapple with financial hardships brought on by the COVID-19 pandemic, these pharmaceutical companies have continued to manipulate the U.S. patent system which deprives patients of access to affordable medications.

Today, the U.S. pays some of the highest prices in the world for prescription drugs thanks in large part to the lack of competition permitted into the system. In fact, Americans individually pay up to 65% more for drugs than other countries due in large part because of patent abuse. 

The 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 that monopolize medical therapies, making them unaffordable or inaccessible to many Americans. IPR is one of the best tools we have for this task. It is important that IPR proceedings conducted by the Board must remain apolitical and ensure outcomes are decided on the basis of science and law rather than politics.

To show the real impact of IPR, we are diving into how the IPR process conducted by PTAB has repeatedly and successfully struck down bad patents to enable competition and dramatically lower prices for critical medications and treatments.

Part I: IPR & Insulin – The True Value of PTAB Proceedings

Here, we will look at how the IPR proceeding involving patents of insulin glargine, a formulation of insulin first approved in 2000 that releases itself slowly into the bloodstream, reducing the number of injections needed by patients.

Sanofi held many patents on its glargine product, Lantus. Most of these have expired, and the last remaining active patents was found invalid in 2019. However, biosimilar entry was still delayed. Why? In part, because Sanofi held an active patent on the SoloStar injector pen device which is used to dispense Lantus.

It was the IPR review process that revealed just how little innovation the injector pen accounted for. In fact, the supposedly novel injector pen was strikingly similar to the many other insulin injectors already in the marketplace, with only minor changes made to features such as screw threads that PTAB easily deemed lacking valuable innovation.

After successful IPR proceedings, Mylan announced plans to launch a biosimilar glargine injector pen that would deliver a 65% price cut, bringing affordability to patients in need of this critical drug. This legal battle is ongoing, but PTAB invalidated Sanofi’s Lantus device patent in an IPR proceeding and their formulation patents were previously confirmed to be invalid by the Federal Circuit. Today, Mylan has launched its biosimilar thanks in part because the of the trust in the accuracy of IPRs, the Federal Circuit generally upholds 80% of PTAB’s decisions.

It is clear that the inter partes review process is a faster, more effective, and less costly alternative to correct errors in issued patents. IPR should be strengthened, but repeated legal challenges 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.