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

Part II: IPR & Zytiga – Competition Matters

The rising costs of prescription drugs is one of the most important issues to Americans, especially as millions continue to grapple with financial hardships brought on by the coronavirus pandemic. 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. 

One of the largest drivers of high drug costs is anticompetitive patent abuse by some major pharmaceutical companies that locks up important older drugs and prevents generic competition. Due to these companies’ gaming of the U.S. patent system, American patients have less access to cheaper generic options. Thankfully, there is an efficient, low-cost way to remove invalid patents and open up the marketplace for generic competition.

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. 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 invalidated insulin glargine patents and opened up the marketplace for biosimilars to lower prices. Today, we’ll continue 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 II: IPR & Zytiga – Competition Matters

Here, we will look at how the IPR proceeding for the prostate cancer medicine Zytiga (abiraterone acetate) accelerated patient access to generic medicine.

Janssen Biotech holds the patents to Zytiga, which claim the use of abiraterone in combination with at least one therapeutic. In this case, that combination is with the well-known steroid prednisone. During IPR, evidence showed that combining steroids with other anti-cancer treatments was common practice at the time that Janssen applied for the patent. The Board concluded that this combination is not a unique innovation and the Federal Circuit agreed that combining these drugs is a well-known method to make a treatment more effective. Ultimately, the patent claims were invalidated.

Thanks in part to the IPR process, generics were able to enter the marketplace in 2019. The generic competitors were able to offer $2-$9 per dose, compared to $88 for the brand name. At the end of the day, IPR enabled almost 98% savings on a drug that the World Health Organization lists as essential. Savings enabled by this competition means that more cancer patients will have access to treatment.

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.