The best-selling drug in the world, Humira, costs patients five times more in the US than in the UK – but no one else can make a competitor.
Humira, which treats a number of diseases including rheumatoid arthritis, made its maker, Abbvie, $18 billion in 2017.
And it can continue jacking its price up because the American patent system – and the company’s abuse of it – keeps any other company from making a competing drug.
Abbvie has filed 247 different patents for, effectively, the same drug, keeping a monopoly on it for 39 years.
Without laws against so-called ever-greening patents, or competition to drive the price down, Abbvie will just keep getting richer while Americans with now choice but to take the blockbuster drug keep paying up.
A prescription for two shots of Humira now costs an eye-watering average of $5,684 for a carton of two injections in the US. In the UK the same thing sells for $934.
Humira – in pill or injection forms – costs $5,684 in the US, where its maker, Abbvie, has made many tiny tweaks to the formula just to extend its monopoly on the drug
Humira was patented in 1996 and approved by the Food and Drug Administration (FDA) in 2002.
Abbvie’s patent on Humira gave it 20 years of exclusive rights to sell the arthritis, Crohn’s disease and psoriasis drug in the US.
The US patent system is, in theory, designed to protect ideas and encourage innovation.
By giving inventors a guarantee that no one could sell the exact same thing they have developed for a period of time, the hope is that inventors will be encouraged to disclose their discoveries so others could learn from them.
When Abbvie patented Humira, it had come up with a totally new compound and was given that 20-year protection.
That patent expired in 2016.
And yet, Humira still has no competition, and Abbvie still keeps hiking the price of its blockbuster medication.
Abbvie now has 247 patents for the same drug, which means it has accumulated 39 years worth of protection.
For each ‘new’ patent, the company leaves the key components of its golden formula unchanged, but makes tiny tweaks to clinically insignificant elements of the injection.
Abbvie’s scientists might adjust the way it absorbs in the body, something about the dosage, or even capsule that the pill form comes in.
None of these changes are substantive, but they were new and that was enough to get all new protections for the Humira’s important elements for which previous patents had expired.
Meanwhile, Abbvie has been methodically drawing up contracts with other companies that make biosimilars – generic forms of drugs in the same class as Humira – to license the drug to them once its newer rounds of patents expire in 2023.
That means that in 2023, Humira’s price will probably fall somewhat as the biosimilars enter the market, but the company will still glean profits royalties from ‘pay to delay’ settlements (as industry insiders call them) licensing agreements.
These settlements come at the expense of patients, costing American consumers an estimated $3.5 billion a year, according to the Lown Institute, a health care think tank.
Although Humira was originally developed in the UK, Abbvie has not filed nearly as many patents in Europe on the other hand, and allowed its Humira patent to expire last year.
Abbvie’s patent conduct in the US – where it has become big business – may be the most egregious and obvious example, but the company is hardly alone in these underhanded patent strategies.
A recent study found that the vast majority of drugs that were patented between 2005 and 2015 had previously been patented – their makers were just making small tweaks to extend their monopolies.
This suggests that the patent system is helping to drive up numerous drug costs for patients in the US – and consumers likely have no idea.