Big firms will exploit patents, creating thickets and consolidating monopolies
Cooper, American Prospect managing editor and The Week national correspondent, 23
[Ryan Cooper, 6-6-23, Prospect managing editor and The Week national correspondent, The American Prospect, “How Big Pharma Rigged the Patent System,” , accessed: 07-07-24, ES]
One legal strategy Big Pharma uses is filing dozens or even hundreds of patents on the same drug. An Initiative for Medicines, Access, and Knowledge (I-MAK) report from September last year investigated these “patent thickets” on America’s ten best-selling drugs, and the revelations were staggering. The companies have obtained an average of 74 patents apiece on each of those drugs. More tellingly still, of the 140 patent applications on these drugs (on average), two-thirds of them happened after the drug was approved by the FDA.
The point is to create a huge legal deterrent to any generic or biosimilar competitors who might attempt to enter the market when the original patent expires. Even when a competitor might have a legal right to produce the original formulation of a drug, cutting through the patent thicket would require millions of dollars in litigation and take years.
For example, AbbVie managed to extend patent protection on its arthritis drug Humira for an additional seven years. It filed 312 patents on the drug, 94 percent of which after it had already received FDA approval, and secured 166 of those patents. Its original patent expired in 2016, but the rest of the patents extended its complete control of the medication through the first quarter of 2023. As a result, Humira was the top-selling drug in the U.S. market in 2021, with $17.3 billion in sales—almost twice as much as second-place Revlimid (a cancer drug). Of all the money AbbVie has made on Humira, about two-thirds (or nearly $100 billion) came after its primary patent expired.