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

Part VI: IPR & Anemia – An Effective, Low-Cost Tool for Resolving Patent Disputes

Since the inter partes review (IPR) process was established under the America Invents Act in 2011, IPR has become a popular and cost-effective tool compared to traditional patent litigation.  Even the U.S. Supreme Court has described the IPR process as a way to efficiently “weed out” bad patent claims. 

Over time, these proceedings have been successfully used to thwart anticompetitive tactics used by some major pharmaceutical companies to extend their monopolies on critical treatments and medications.  Consistent abuses of the U.S. patent system have largely contributed to rising drug costs and healthcare premiums, even as millions of American patients struggled financially throughout the coronavirus pandemic. 

While it is clear that IPR is a proven tool for balancing innovation with competition by reducing the cost of determining patent validity, this process has long been underutilized even though it generally results in quality decisions that typically do not get reversed by the Federal Circuit when it finds patents are indeed invalid. 

Moving forward, it is crucial that Congress and the Administration work together to strengthen IPR and ensure it remains apolitical so that outcomes are decided on the basis of science and law, putting patients and the U.S. healthcare system first.

Last time, we looked into how the IPR process struck down a patent relating to the drug Apriso (mesalamine) which treats certain gastrointestinal diseases, such as ulcerative colitis.  Today, we’ll wrap up this deep dive 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 VI: IPR & Anemia – An Effective, Low-Cost Tool for Resolving Patent Disputes

Here, we will look at how the IPR process amicably resolved a patent challenge by Hospira for the Janssen Pharmaceuticals’ patent on the dosing regimen for erythropoietin, a biologic compound used in the treatment of anemia.

Janssen Pharmaceuticals held a patent claiming the wait time between doses of erythropoietin, which was 5-30 days.  Hospira petitioned for IPR on the grounds that this dosing regimen was already revealed in an earlier patent filing from two years earlier.  Janssen agreed and statutorily disclaimed claims of the patent.

Had Hospira not pointed this out through IPR, Janssen would have benefited from an extra two years of exclusivity.  Because IPR resulted in the cancellation of claims of the patent, a erythropoietin biosimilar was able to enter the marketplace, saving patients money at the pharmacy counter.

It is clear that the inter partes review process is a faster, more effective, and less costly tool 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.  

For a primer on the IPR process, visit CAPA’s website here and check out the entire six-part blog series here.