THE REFILL Latest Dosage of Rx Patent Abuse
WHAT YOU NEED TO KNOW
- CAPA Releases Statement after AbbVie CEO Testifies Before the House Oversight and Reform Committee on Use of Anti-Competitive Tactics that Keep Drug Prices High:
- “CAPA applauds the Committee for its continued oversight on specific anti-competitive tactics that some big drug companies have engaged in over recent years. This patent gamesmanship has contributed directly to the high prices that millions of Americans grapple with every day… Companies like AbbVie abuse and manipulate the U.S. patent system to keep competition out and drug prices high… It is imperative that we balance innovation with competition while putting patients first which is why Congress needs to pass long overdue reforms to the U.S. patent system.”
- Earlier this week, I-MAK released a report on the cancer drug Keytruda, highlighting the tactics used by some pharmaceutical companies to effectively extend their drug monopolies indefinitely, keeping competition out and prices high. These tactics can range from evergreening, in which manufacturers make small, incremental changes to their products and attempt to extend their patent, as well as thicketing, where companies build a veritable “patent walls” around their products.“A significant driver of these high drug costs today is Big Pharma’s continued abuse of the patent system. Patents are supposed to be a reward for new innovations by granting temporary monopolies that are supposed to expire after a limited period of time, after which competition is free to flourish…” stated CAPA Executive Director Matthew Lane.Key Excerpt From I-MAK:
- “Keytruda has 129 patent applications; to date, 53 patents have been granted.”
- “50% of the patent applications on Keytruda were filed after its first FDA approval.”
- “74% of patent applications cover the different indications and formulations of the drug and not the key antibody.”
- “The estimated purchasing cost of branded Keytruda during the eight years of extended exclusivity without competition is at least $137 billion.”
- ICYMI: CAPA Joins in Conversation Around the Next U.S. Patent and Trademark Office DirectorIn a recent Bloomberg Law article, CAPA Executive Director Matthew Lane weighed in on the rumors that President Biden’s pick for USPTO Director could expand efforts to limit the number of patents granted.
- “Generic versions of medications can be kept off the shelves for longer periods through “patent thicketing,” in which overlapping intellectual property rights on a product and its uses can be applied to block competitors from entering the market. “Patent thickets are largely comprised of low-quality patents and ‘really hard to cut through’ for generic producers, said Matthew Lane, executive director at the Coalition Against Patent Abuse. The Obama administration, however, initiated PTAB trial reforms that made it easier for generic companies to get blocking patents invalidated, though Iancu ‘did a lot to undermine’ those efforts. “‘There are patent quality policy initiatives the USPTO director could take—those things would be extremely beneficial to drug prices,’ Lane said. “Also part of quality control is making it easier for generic producers to secure PTAB trials to challenge name brand drug patents, agency watchers say, a move they find likely under a Biden patent office…”
WHAT YOU SHOULD BE READING:
The Wall Street Journal: House Committee Takes On Pricing, Patents for Top-Selling Drug Humira
- AbbVie Inc.’s pricing practices for some of its top-selling medicines faced fresh scrutiny from federal lawmakers Tuesday, the latest effort by members of Congress probing the cost of prescription drugs. Democratic members of the U.S. House Committee on Oversight and Reform have been investigating how AbbVie sets the prices of some of its products, including its top-selling immunology drug, Humira.
- People in the United States end up paying more for prescription drugs over time due to rising list prices, according to new research… a team of researchers led by Dr. Benjamin Rome, an instructor of medicine at Harvard Medical School and a researcher at Brigham and Women’s Hospital in Boston, reported that the list price of 79 brand-name drugs rose by more than 16 percent while average out-of-pocket costs went up by more than 3 percent from 2015 to 2017.
Shira Stein & Alex Ruoff
- President Joe Biden’s pick to be the second in command at the Health and Human Services Department, Andrea Palm, was confirmed Tuesday by the full Senate….Palm previously headed the Wisconsin Department of Health Services—overseeing its $12 billion budget and over 6,000 employees—and served as the HHS’s chief of staff and as senior counselor to the secretary during the Obama administration.