New report digs into top blockbusters and their reliance on patents to block competition
Although “pay-for-delay” agreements and other egregious generic-blocking tactics may be in the rearview mirror, a new report from the nonprofit I-Mak explains how companies are still looking to protect the next generation of blockbusters with piles of new patents.
While some industry insiders point to a broken system that incentivizes these dozens and dozens of new patents — on average there are 74 granted patents on each of America’s 10 top-selling drugs — drugmakers have filed more than 140 patent applications on average per drug, and about two-thirds of those filings came after the approval.
“Patent abuse is not limited to a few bad actors,” the I-Mak report says. “A growing body of evidence demonstrates that an essential part of the pharmaceutical industry’s business model for top-selling drugs is now built on maintaining market control by exploiting an outdated patent system.”
The most obvious and egregious examples of this patent thicket strategy are with AbbVie’s rheumatoid arthritis drug Humira, which will see its first US biosimilar competitor in January 2023, but has seen over two-thirds of its US sales after the expiration of its primary patents in 2016. Amgen’s RA drug Enbrel, which has FDA-approved biosimilars that have never been launched, will enjoy more than 30 years of exclusivity, and pull in another $20 billion over the next seven years, despite there already being biosimilar competition for both Humira and Enbrel already in Europe.
In comparison to Europe, the report notes that four times as many patents are granted on the top 10 drugs in the US.
“Primary patents on 7 out of 10 of America’s top selling drugs are set to expire this decade,” the report adds, particularly highlighting Merck’s strategy around Keytruda, as data “already suggests that the patent thicket will have an impact on when competition will enter after the primary patents expire in 2028.”