- Many of the patent applications for the blood cancer medicine Imbruvica were filed after the drug's initial approval in 2013, part of a strategy by its developer AbbVie to extend by years the market exclusivity for what's become one of its top-selling medicines.
- The legal shield, detailed in a new report by the non-profit group I-MAK, reflects an aggressive approach to drug patenting that's become common in the pharmaceutical industry. In Imbruvica's case, more than seven dozen patents have been granted in the U.S. over a period of 13 years, potentially restricting generic competition until early 2036.
- Each patent brings 20 years of market protection from the date it's filed. I-MAK argues the systematic patenting of Imbruvica's active ingredients, formulations and medical uses is designed as a "drip-feed" of legal protection, slowly pushing out the date when market exclusivity would lapse.
While legal, AbbVie's strategy raises larger questions that lawmakers should address, according to I-MAK, which advocates for patent reform and has previously targeted other drugmakers.
"The current one-size-fits-all patent system enables the 'drip-feed' patenting strategy seen in Imbruvica," I-MAK concluded. The group challenged policymakers to consider whether standards for what's "inventive" are too low and whether the incentives in the system are out of whack.
In the case of Imbruvica, 55% of all patent applications were filed after the medicine won U.S. approval in 2013, the report found. And the majority of all patents cover new uses and formulations, rather than the active substance in the medicine.
As an example of the "drip-feed" patent strategy, I-MAK pointed to one early patent on the main compound that described more than 100 possible uses for the medicine and potential new formulations. Three later patents "further specified aspects of the main patent," the group said.
AbbVie didn't immediately respond to BioPharma Dive's request for comment.
Consumers can end up paying the price for loopholes that allow companies to continually extend exclusivity and block cheaper generic alternatives from the market, I-MAK said.
Imbruvica sales jumped 30% to $4.7 billion last year, and it's on track to be the fourth-highest grossing drug in the U.S. by 2024, I-MAK said. The group estimated that payers will end up spending at least $41 billion during the extra nine years of exclusivity.
Imbruvica was originally developed by Pharmacyclics, which AbbVie bought in 2015 for $21 billion. Pharmacyclics had previously granted rights to the drug to Johnson & Johnson, which now splits commercialization of Imbruvica in the U.S. with AbbVie. J&J has exclusive rights to sell the drug outside of the U.S.
At list price, the drug costs roughly $13,500 for a 28-day supply.
AbbVie is far from alone in aggressively pursuing patents to protect top-selling drugs. An earlier I-MAK report studied the top 12 grossing U.S. drugs in 2017 and found an average of 125 patent applications for each, translating into attempts at an average of 38 years of patent protection.
Companies often go to court to protect their patents. This month, for example, Amgen won a legal victory to fend off biosimilar competition for its blockbuster inflammatory disease treatment Enbrel. The company now may not face a cheaper copycat rival for Enbrel until 2029, 31 years after the drug's approval.
Seventeen generic companies have filed for U.S. approval of generic copies of Imbruvica, according to I-MAK. AbbVie and J&J have settled with three of those firms — Teva, Hetero Labs and Shilpa — but the terms of the deals are not public.