Tahir Amin, DipLP, cofounder and director of intellectual property of Initiative for Medicines, Access, and Knowledge (I-MAK), explains the role of patents in delays to US adalimumab biosimilar launches.
The US market is going to have to wait for biosimilar versions of AbbVie’s drug Humira because the AbbVie has accumulated a number of patents on the drug. In fact, our study found they have filed over at least 247 applications for Humira. Many of these will expire in 2037 and as a result of the stockpiling of patents that AbbVie has compiled, it is going to delay biosimilars in the market at least until 2023, and I think what’s important about that is that the companies that have agreed licenses with AbbVie to enter the market in 2023 will still be paying royalties, according to reports, to AbbVie. So those are going to go back to the consumer as well, even when biosimilars come to the market, and AbbVie’s chief financial officer has actually gone on record and said that they’re quite pleased with their patent and legal strategy and this is why we’re not seeing earlier entry of biosimilars in the US market.
I think it’s also worth saying the regulatory procedure under the [Biologics Price Competition and Innovation Act] in the United States is different to that in Europe, so getting a biosimilar version on the market in Europe is less onerous…and that’s also why we see a quicker uptake in the market in the European market. It’s also worth mentioning that the number of patents that AbbVie filed were considerably fewer; in fact there were 3 times as many patents in the US than there were in Europe and almost 4 times in Japan.