DOSE OF REALITY: AARP ANALYSIS EXAMINES PATENT ABUSE ON BRAND NAME INHALER THAT KEPT PRICES HIGH FOR PATIENTS

Report Details How Tactics Like Patent Thicketing and Product Hopping Delayed Competition and Enabled Repeated Price Hikes on Blockbuster Inhaler Symbicort

A new analysis from AARP’s Public Policy Institute examines the array of tactics Big Pharma deploys to extend monopoly pricing on blockbuster products and keep more affordable alternatives from reaching patients. The report analyzes AstraZeneca’s blockbuster asthma and chronic obstructive pulmonary disease (COPD) inhaler Symbicort as a case study.

Symbicort became a multibillion-dollar franchise for AstraZeneca, bringing in more than $55 billion globally since first entering the market. Yet for years after the brand name drug should have started to face competition, the company extended exclusivity in the U.S. market, leaving patients, including roughly one million Medicare beneficiaries each year, stuck paying high prices.

As the report states: while “[t]he key US patents for Symbicort expired in 2023, effectively ending its 16-year market monopoly period […] rather than simply accept generic competition and its impact on revenue, AstraZeneca engaged in multiple activities that appear designed to help protect and extend its US market monopoly for as long as possible.”

The report outlines several tactics AstraZeneca utilized to extend their monopoly on Symbicort, including constructing a “patent thicket” around the drug and executing a “product hopping” or “evergreening” strategy to switch patients onto a newer version of the drug right around the time the drug was expected to face generic competition. AstraZeneca also repeatedly increased the price of the drug while it faced no competition.

Patent Thickets

Over the course of its time on the market, AstraZeneca was able to construct a patent thicket of more than 90 patents around Symbicort. AstraZeneca’s patents on the drug were connected to both the active ingredients in the drug, as well as its delivery device, which forced potential generic competitors to “wait for both patent types to expire” before being able to bring generic competition to market. As the report notes, AstraZeneca “spent years successfully defending its patents in court to ensure its market monopoly continued.”

Product Hopping

Near the end of Symbicort’s original period of exclusivity, AstraZeneca introduced two new inhaler products to the market – in a classic example of “product hopping.” As the report notes:

“AstraZeneca developed two major line extensions of Symbicort. In 2023, the FDA approved Symbicort Aerosphere for the treatment of COPD, which used a new ‘aerosphere’ inhaler device to deliver a different strength of Symbicort. However, AstraZeneca quickly deprioritized the product and instead focused its marketing efforts on another line extension called Breztri Aerosphere.”

Historically, when drug makers employ this tactic, their aim is to switch a significant portion of their patients from their older product, which now faces competition, to a newer product, which does not. The approval of Breztri Aerosphere granted AstraZeneca an entirely new period of exclusivity around their inhaler product category and enabled them to obtain monopoly pricing on this new product.

As the report notes, “Breztri Aerosphere entered the market in 2020 at a significantly higher price point than Symbicort, and its price has continued to grow over time.” Breztri Aerosphere is already “a top source of Medicare spending, with an average annual spending growth rate of 1,300 percent from 2020 to 2023.”

Repeated Price Hikes

AstraZeneca also raised Symbicort’s price repeatedly while the drug was protected from meaningful competition. As noted in the report, “[t]he list price of Symbicort increased by 158 percent between 2007 and 2023, more than three times faster than inflation over the same period.” At the same time, “the retail price for Symbicort rose from $1,965 to $4,583 between 2007 and 2023.”

The report concludes by urging lawmakers to pass two legislative solutions currently being considered in Congress: The Eliminating Thickets to Improve Competition (ETHIC) Act and the Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act.

The ETHIC Act, according to the report, “would address patent thickets by preventing brand name drug companies from asserting more than one patent from a group of related patents in litigation against potential competitors.”

The REMEDY Act, “would address evergreening by removing incentives for brand name drug companies to file additional patents.”

Lawmakers should pass these, and additional, bipartisan, market-based solutions to foster greater competition from generics and biosimilars and hold brand name drug companies accountable for anti-competitive practices that keep drug prices high.

Read the full analysis from AARP’s Public Policy Institute HERE.  

Read more on how Big Pharma games the system to block competition and keep drug prices high HERE.

Read more about how generic and biosimilar competition lower out-of-pocket costs for patients HERE.

Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.