Biosimilars Council White Paper Condemns Patent Abuses, Defends Patent Settlements

The Biosimilars Council, a part of the Association for Accessible Medicines, has issued a new white paper in which it condemns abuses of the patent system that delay biosimilar competition.

The white paper says that the low number of available biosimilars in the United States is a “direct result of the patent schemes used by some brand-name pharmaceutical companies to maintain their lucrative product pricing monopolies” and estimates that the financial impact of these delays has cost the US healthcare system $7.5 billion in lost savings since 2015 and $7.6 billion since 2012.

To arrive at those figures, the council estimated the foregone savings for the approved biosimilars that are not on the market as a result of ongoing patent challenges, assuming that they had been marketed upon FDA approval. The council assumed a 30% price discount for each product relative to the reference, and biosimilar uptake of 40% for each molecule, or 50% in the case of 3 biosimilar options available for a given reference.

A substantial share of the lost US savings, says the council, is borne by taxpayers; the white paper estimates that Medicare has lost out on $1.2 billion in savings since 2015 as a result of the patent-related delayed biosimilar launches of Erelzi, Amjevita, Cyltezo, Mvasi, Ogivri, Hyrimoz, Herzuma, and Truxima.

The white paper takes aim at AbbVie’s patent thickets surrounding adalimumab (Humira) in particular, pointing to data from an Initiative for Medicines, Access, and Knowledge (I-MAK) case study that found that, as of 2018, Humira was covered by a total of 247 patents in the US context, 89% of which were filed after the drug was already marketed, and 49% of which were filed after the first patent on Humira expired.

To date, all biosimilar developers expected to launch biosimilars of adalimumab have signed agreements with AbbVie that will not allow for US market entry prior to 2023, though biosimilars have already entered the European market (where I-MAK found that Humira is covered by only 76 patents) as of October 2018.

While these US patent settlements have come under fire from many stakeholders—including lawmakers who have raised the possibility that such settlements could be anticompetitive “pay-for-delay” deals—the council characterizes these settlements as “pro-competitive” and says that they “provide for competition 11 years earlier than might otherwise be possible…if the manufacturers of biosimilars to Humira were not able to settle, competition could have been delayed until 2034.”

The white paper culminates by stating that some legislative proposals to regulate agreements that end patent litigation could create “a de facto prohibition on patent settlements,” which would “merely benefit companies investing in the creation of patent thickets” by “forcing competitors to slog through lengthy and expensive litigation with uncertain prospects of success.”