AbbVie slammed over ‘drip feed’ of Imbruvica patents
AbbVie has used a “drip feed” of patents to secure more than nine years of extra exclusivity on blood cancer drug Imbruvica (ibrutinib), a new report has revealed.
The report, published last week by non-profit I-MAK, says that Imbruvica’s “patent wall” will cost the US public $41 billion until generic competition becomes available.
Imbruvica is a small molecule drug which was first approved by the US Food and Drug Administration (FDA) in 2013. It is used to treat B cell cancers including types of lymphoma and leukemia.
Since its initial approval in 2013, the price of Imbruvica has increased by 57%, with the non-discounted annual price currently standing at $174,156 per person.
AbbVie owns 88 granted patents on Imbruvica, and has filed 165 patent applications covering the drug.
Most of these (55%) were filed after the FDA first approved it in 2013, the I-MAK report revealed, with the most recent patent having been granted in September 2019.
This means that the most recent patent on the drug is currently set to expire in 2036, with the first Imbruvica patent having been filed in 2006.
Just more than a third of the patents (38%) cover methods of treating specific diseases, while 28% cover the active substance in Imbruvica.
According to I-MAK, AbbVie has pursued a “drip feed” patenting strategy, designed to extend the company’s monopoly on the drug as far as possible.
“Knowledge that is broadly disclosed in early patent applications is defined ever more narrowly and specifically in a spread of subsequent patent applications,” the report said.
This strategy is enabled by a flawed “one-size-fits-all patent system”, which does not differentiate between patents covering the main compound in a drug, and those covering more specific uses, the report argued.
As each patent grants the same period of exclusivity (20 years), AbbVie could extend its monopoly on the drug, at least for certain uses, even further beyond 2036.
“As long as subsequent patents are written specifically enough to be considered outside the scope of disclosure of the first patent(s), the potential to keep stacking additional patents on a single, already patented active substance is limitless,” the report said.
According to the report, Imbruvica is projected to become the fourth highest grossing drug in the US by 2024, with annual revenues of nearly $9 billion.
LSIPR has contacted AbbVie for comment in response to the claims.
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