Studies have shown that drugmakers profit greatly from secondary patents for inhalation devices

January 3, 2023 A research article published in the Journal of the American Medical Association (JAMA) [1] suggests that drugmakers are "substantially" benefiting
from avoiding generic competition through secondary patents, even if the primary patent has expired.

Lead author William Feldman of Brigham and Women's Hospital in Boston The MD says he noticed that some patients couldn't afford brand-name inhalers
during his internship in the pulmonary and intensive care units.
"The U.
S.
patent and regulatory system should reward meaningful clinical innovation — Major therapeutic breakthroughs
.
And his own article shows how profitable
it is for manufacturers of inhalers and other products to continue to earn high revenues from molecules developed decades ago.
”

Drugmakers have previously been accused of "device jumping.
" hopping)" (placing the same active ingredient in a new generation of inhalers protected by a new patent when a branded inhaler is withdrawn from the market), or incremental adjustments to older inhaler products to fend off generic competition
.
Feldman It was previously found that only one of the 62 inhalers approved by the FDA between 1986 and 2020 had a novel mechanism
of action.
According to a paper published in Health Affairs), about 85% of which are branded products
with a median patent protection of 16 years.

This article from JAMA indicates that from 2000 to 2021 years, drugmakers listed "much more" secondary patents than primary patents and earned "much more revenue"
after the active ingredient expired.
During the study period, drugmakers earned covenants on inhalers protected only by secondary patents, the study said $110.
3 billion, 98% of which was generated
during periods when there was no generic competition.

For example, the research article states that GlaxoSmithKline (GSK) accounted for about 62% of the $68.
2 billion in Advair revenue between 2000 and 2021 It was obtained
after the expiration of the main patent for the drug.
Nearly 75% of Flovent's revenue comes from the expiration of major patents on products
.
In May 2022, a patient filed a class action lawsuit against GSK, alleging GSK used its branded inhalers by device jumping to bypass generic competitors, with alleged products including the Ventolin, Flovent and Arnuity Ellipta series
.
But the plaintiff was in 8 The charges
were voluntarily dropped last month.

The study authors note that "current patent and regulatory regimes reward minor changes to existing molecular delivery systems, diversifying incentives to invest in new therapeutic breakthroughs
.
" The authors conclude by suggesting that this status quo can be reformed in a number of ways, including ensuring that only high-quality patents are issued in the first place, and increasing incentives for generic manufacturers to challenge brand-name patents
.

[1] Feldman WB, Tu SS, Alhiary R, Kesselheim AS, Wouters OJ.
Manufacturer Revenue on Inhalers After Expiration of Primary Patents, 2000-2021.
JAMA.
2023; 329(1):87–89.
doi:10.
1001/jama.
2022.
19691