Anyone who follows the pharma industry can tell you the intellectual property landscape for drugs is ever-changing, with add-on patents and invalidations periodically extending and upending protections for top sellers. Now, new research takes a wide look at the strategy of "evergreening," or adding new patents to extend a drug's exclusivity, and found that the majority are for just that.
The research, published in a paper called "May Your Drug Price Be Ever Green," found that 74% of new drug patents in FDA records between 2005 and 2015 were awarded to existing drugs, not new medications. Of the top 100 pharma products by sales, nearly 80% won an add-on patent or other type of exclusivity extension, while nearly half did so more than once. The authors concluded that since branded drugs are winning lengthy and lucrative IP extensions, generics are taking longer to reach the market and prices around the industry continue to rise.
Authors Robin Feldman and Connie Wang said the data "demonstrate that throughout the industry, companies create serial barriers to hold off the type of competitive entry that is fundamental to our innovative system."
For instance, AbbVie's Humira has a particularly thick patent shield. According to a recent lawsuit, the drug has more than 100 patents, the company says. Executives have said it will climb to $21 billion in sales by 2021, after its initial approval in 2002. It's already the bestselling drug in the world, reeling in $16 billion last year.
Amgen and Boehringer Ingelheim have FDA-approved biosims to Humira but can't launch them due to the company's patent shield. Biogen and Samsung previously sued AbbVie in the U.K. for its Humira defenses.
For the new study, the researchers manually entered more than 160,000 individual data points from monthly and annual FDA publications. So far, evidence about "evergreening" has been mostly anecdotal, they wrote, so they sought to paint an industrywide picture.
Other findings were that use of the strategy has increased over time, and that companies that use the strategy often repeat the moves.
Responding to the study, a PhRMA spokesperson said the "authors overlook a number of key points on the biopharmaceutical pipeline, ignoring the important role of strong intellectual property protections in fostering innovation." Further, she added, new patents are often the result of "substantial R&D investments" even after approval.
"New formulations can create more effective and convenient ways of delivering a medicine, contributing to increased competition and improving patient outcomes," PhRMA's representative said via email. "New indications can also expand a previously approved drug to new patient populations and diseases."
It's far from the first time market watchers have trained their sights on pharma's patent maneuvering. A study last August found that drugmakers are using lawsuits, add-on patents, patient switching and "pay-for-delay" deals to delay competition. That group concluded that prices aren't based on R&D costs but rather on what the market will bear.
The new work hasn't yet been published in a peer-reviewed journal and was funded in part by the Laura and John Arnold Foundation. With a focus on drug prices, the foundation has been funding organizations such as the Institute for Clinical and Economic Review (ICER), a cost watchdog that has been critical of the industry's pricing and has received criticism from pharma in return.
Most recently, the foundation gave ICER a $13.9 million grant to expand its operations. With the new funding, ICER plans to publish an annual report on drug price hikes, update its reviews more frequently with available data, and more. ICER's drug value assessments have garnered plenty of backlash from pharma, with companies saying its reviews are flawed and could restrict patient access.
Editor's note: This story was updated with a statement from PhRMA.