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

Part V: IPR & Ulcerative Colitis – Balancing Innovation and Competition

Over the last year, the coronavirus pandemic has caused financial hardships for millions of Americans and our federal government continues to face unprecedented debt.  As recovery efforts are underway, the issue of skyrocketing prescription drug costs remains more prevalent than ever.  A major contributing factor to high drug costs is the continued manipulation of patent laws in a manner that limits access and affordability. 

Brand-name pharmaceutical companies’ manipulation of patent laws prevents or delay generic medications from going to market which ultimately denies patients access to more affordable, life-saving, and quality of life enhancing drugs. 

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 process invalidated erroneously extended patents of an anti-blood clot drug used to treat cardiovascular disease.  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 balance innovation with competition and ultimately lower drug prices.

Part V: IPR & Ulcerative Colitis – Balancing Innovation and Competition

Here, we will look at how the IPR process struck down a patent relating to the drug Apriso (mesalamine) which treats certain gastrointestinal diseases, such as ulcerative colitis.  Specifically, the patent in question claimed the practice of having patients take the drug without food or antacids. 

Thanks to IPR, the Board struck down claims of the patent held by Dr. Falk Pharma.  The Board reasoned that taking this type of drug without food or antacids was common practice and knowledge throughout the medical community.  Ultimately, there was not enough proof to show that this practice was innovative enough to require a patent.

Since October of 2019, generic entry has brought prices down 42%, increasing access and affordability for millions affected by this disease.

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 faster and sharper price reductions.  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.