The makers of the world’s biggest-selling drug cheat competitors and consumers as they extend their exclusive right to sell Humira.
Humira is a rheumatoid-arthritis and gut-disorders drug that enjoys sales of around $18 billion a year. Last Tuesday, one of its patents was set to expire. When a drug’s patent expires, generic manufacturers are free to sell biosimilar drugs to U.S. consumers. But AbbVie, Humira’s manufacturer, was careful to line up additional patents (totalling 100) to prevent this from happening. Planning ahead to 2016, when the first of its patents was set to expire, AbbVie filed over 100 patents over 6 years, building what is known as a “patent thicket” to prevent generics from entering the market. As a result, AbbVie will legally hold on to Humira’s exclusivity in the U.S. until 2030.
One of the pharmaceutical companies now poised to market a “biosimilar” or generic version of Humira in Europe is German company Boehringer Ingelheim. When one of AbbVie’s key patents for Humira expired, the EU approved Boehringer to sell its generic drug in Europe. But AbbVie sued the company for infringement of 74 of the 100+ patents that comprise their patent estate. In response, the German company countered that “AbbVie has ‘engaged in a pattern of pursuing numerous overlapping and non-inventive patents for the purpose of developing a ‘patent thicket,’ using the patenting process itself as a means to seek to delay competition against its expensive and lucrative’ Humira.”
Other pharmaceutical companies that were also ready to sell a generic version of Humira have instead settled for payments, from AbbVie, to sit by and wait while AbbVie rakes in exclusive U.S. sales until 2023. These “pay for delay” payments, described in this blog post, http://keeleydeangelo.com/index.php/blog/waxing-lyrica-big-pharma-subverts-patent-process are the equivalent of hush money.
The US Patent and Trademark office gives a 20-year grant of exclusivity to a patent-holder. It does this to protect the inventor’s hard work of research and development. But at the end of 20 years that exclusivity expires to make way for the market to open up to other manufacturers. The idea is to protect an innovation for a reasonable amount of time, not perpetually. Even if they claim in their albeit granted patents to be protecting new methods of treatments, new drug formulations and manufacturing, these companies are abusing their market power to take advantage of the system and artificially dominate the market. The losers, of course, are patients who have come to rely on drugs like Humira. A year’s worth of Humira has gone from $19,000 at its introduction to $38,000 currently in the United States. (In the UK, it costs half that; in Switzerland, it costs one-third that.)