AbbVie: Defendiendo Humira...

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A new front has opened in the war against Abbvie’s efforts to sustain and secure its Humira market monopoly. This time in The Netherlands where investigative journalist Lucien Hordijk has unearthed AbbVie’s tactics aimed at keeping lower-cost versions of Humira off the market. His article [in Dutch] appeared on 27 March 2019 in the Dutch weekly De Groene Amsterdammer.

Humira is the brand name of the biologic medicine adalimumab and was first approved for the treatment of rheumatoid arthritis in the US in 2002 and in the EU in 2003. With close to 20 billion US$ in sales in 2018 Humira is the world’s best-selling drug.

It accounts for 70% of AbbVie’s total turnover. It is therefore no surprise that the company fiercely protects its market monopoly. AbbVie built a web of patents and other exclusivities around the product to keep competitors at bay. I-Mak, a US-based legal research group documented that in the US alone Humira is subject to 247 patent applications of which 132 were granted. 89% of those patents were filed after the company had obtained marketing approval for the product. The company also obtained orphan drug designation for certain specific indications for Humira which adds a different kind of market exclusivity granted through the medicines regulatory system.

Statnews reported that in the US, a trade union and other drug companies are suing AbbVie for using patent dispute settlement agreements to obstruct competition in the market. The German pharmaceutical company, Boehringer Ingelheim, which obtained FDA marketing approval for its version of adalimumab in 2017, is fighting a legal challenge by AbbVie’s alleging infringement on dozens of Humira patents. AbbVie’s ring of patents in the US is expected to keep competitors off the market until 2023.

Apparently, AbbVie’s aggressive approach to protecting its monopoly is not confined to the US.(Más)



In a novel step, a New York union accused AbbVie and seven other drug makers of anticompetitive behavior for striking deals that resolved patent lawsuits, but also meant that lower-cost biosimilar versions of the Humira treatment would not be available in the U.S. for several years. In its lawsuit, Local 1500 of the United Food and Commercial Workers, which represents grocery store workers, alleged that AbbVie “abused the patent system” and “erected significant barriers to entry to block biosimilar competition” by filing dozens of patents for Humira, its franchise product.
(Más)