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

Part III: IPR & Opioid Addiction – Ending Brand Pharma’s Monopoly on Patents

Some major pharmaceutical companies have enormous incentives to block market entry of lower-cost, generic drugs for as long as possible. 

By taking advantage of certain rules or exploiting legal loopholes that extend a drug’s monopoly far beyond what Congress intended, millions of patients are denied access to affordable, life-saving medications.  Today, skyrocketing prescription drug costs have left many families unable to afford medications they need to live.

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 the prostate cancer medicine Zytiga (abiraterone acetate) accelerated patient access to generic medicine. 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 III: IPR & Opioid Addiction – Ending Brand Pharma’s Monopoly on Patents

Here, we will look at how the IPR proceeding for an opioid addiction treatment known as Suboxone opened the door for generic competition:

  • In 2008, Reckitt Benckiser made over $540 million on Suboxone, but stood to lose that revenue stream when the company’s exclusive rights over the drug were set to expire. This expiration would subsequently open up the market to generic competition. 
  • In efforts to maintain its monopoly, the firm devised a scheme to switch Suboxone from a tablet-form to a film that would dissolve under a patient’s tongue, which the company could acquire a patent to delay generic entry.
  • There was no evidence proving that this dissolving film method for taking Suboxone improved the drug’s effectiveness.
  • Ultimately, Indivior pled guilty to fraud and paid a $600 million fine, following a $1.4 billion settlement by Reckitt Benckiser. However, the scheme to switch from a tablet pill form to a dissolving film was successful – most Suboxone users switched and Indivior even went as far as to discontinue the tablet form of the drug.  Undoing this fraudulent marketing scheme meant undoing the patents that monopolized the sublingual method of taking Suboxone. 
  • In an IPR proceeding, PTAB found an error in five claims of Indivior’s patent and the Federal Circuit affirmed the decision. Due to this IPR review as well as other litigation surrounding Indivior’s patents, the door was opened to generic competition for Suboxone. 
  • Today, several generics are approved for sale for the sublingual film, and prices have dropped about 50%. IPR created tremendous patient savings by enabling competition, despite a company’s brazen efforts to stifle it.

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 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.