Pharmaceutical manufacturer AbbVie faces another legal challenge related to anticompetitive tactics in the US. On 12 October 2020, the US Public Interest Research Group (US PIRG) filed an appeal accusing AbbVie of employing tactics that have delayed market entry of biosimilars.
It is argued that biosimilar delayed market entry caused by AbbVie’s reverse payment settlements and creation of ‘patent thickets’ have costed American citizens billions of dollars. It is hoped that the outcome of this case will prevent further illegal abuses of the American patent system and deliver affordable treatment options to patients. The case was previously dismissed by the district court.
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In a reverse payment – or pay-for-delay ‒ settlement, a patent holder pays a potential competitor not to sell their product for a period of time. This maintains originator monopoly and allows them to continue to charge high prices for drugs. A patent thicket is when a patent holder makes multiple, overlapping patents related to an originator product that work to extend its patent period.
It is alleged that AbbVie has used these anticompetitive practices to continually raise the price of Humira in the US. This is the world’s best-selling drug and is primarily used to treat rheumatoid arthritis. Its current price is US$72,000 per patient per year, which has more than tripled since 2006. However, biosimilars of Humira are available in Europe where AbbVie’s product can cost up to 80% less. The case’s brief states that in the US, Humira’s patent was due to expire in 2016, before it set up a patent ticket. When its competitors challenged this, they agreed to delay market entry until 2023 in exchange for earlier entry to the European market.