AbbVie grew Humira into the world’s bestselling medicine in part through price hikes and an aggressive patenting strategy to defend against competition. The company is now deploying similar tactics to bolster Imbruvica, a cancer drug with numerous uses and big sales, experts concluded in a new report.
AbbVie has filed for 165 patents on Imbruvica, and officials have granted 88 of them, the Initiative for Medicines, Access & Knowledge reports. The company’s add-on patents have earned AbbVie another nine years of patent protections for a total of 29 years of commercial exclusivity, according to the group. AbbVie filed 55% of Imbruvica's patent applications after FDA approval, the report said.
Because Imbruvica generates more than $4.5 billion per year for AbbVie, I-MAK estimates the added patent life will cost payers $41 billion or more.
While the strategy is legal, as recently concluded by a federal judge, it’s “problematic,” Bernstein analyst Ronny Gal wrote in a note to clients. He pointed out that all companies try to extend their patent protections past the original patents.
But the strategy uses “weakness in the procedures of the PTO and courts to extend exclusivity," Gal wrote, and such moves will “gradually lead to efforts to reform.” Gal believes the moves also undercut the pharma industry’s argument that it’s merely seeking a “fair return” on investments.
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Before Imbruvica, AbbVie’s patenting strategy on its bestselling Humira faced scrutiny, including in a lawsuit from the City of Baltimore and other plaintiffs. The group alleged AbbVie illegally blocked competition for Humira by obtaining a “patent thicket" to shield it against would-be competitors while raising prices.
While the strategy might result in high prices, it isn’t illegal, a judge wrote in siding with AbbVie.
“AbbVie has exploited advantages conferred on it through lawful practices and to the extent this has kept prices high for Humira, existing antitrust doctrine does not prohibit it,” U.S. District Judge Manish Shah wrote in an order dismissing the plaintiffs' lawsuit.
I-MAK in 2018 found AbbVie filed 247 patent applications for Humira and won patents that could have protected the medicine for up to 39 years. The drug's price jumped 144% since 2012.
Over the years, biosimilar companies sued AbbVie in an effort to launch their copycats, but AbbVie’s patents successfully held them off. The branded drugmaker has inked numerous deals with biosimilar players allowing U.S. competition in 2023.
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At a Congressional hearing on drug prices last year, AbbVie CEO Richard Gonzalez said he felt the company struck a “reasonable balance” with the deals, although he knew they might not be “popular.” The company’s first patent expiration comes in 2022, and biosims will launch less than a year later, he said. Biosimilars have already launched in Europe, where Humira sales are sinking.