THE REFILL: Latest Dosage of Rx Patent Abuse
WHAT YOU NEED TO KNOW:
- CAPA Dives Into What’s Driving Up Drug Prices: No-Innovation Patenting
Brand name drug companies often attempt to bury competition from generic and biosimilar drugs indefinitely by finding ways to re-package existing inventions in later patents. These later patents are often not innovative, meaning they are likely invalid.
A practice known as patent thicketing is increasingly used as a strategy to preserve monopoly pricing of brand name drugs by using non-innovative patents, with the makers of the twelve best selling drugs in the U.S. filing hundreds of patent applications to extend their monopolies.
According to a study by Nature Biotechnology titled, “The Characteristics of Patents Impacting Availability of Biosimilars,” many pharmaceutical companies engage in patent thicketing to limit competition from lower-cost alternatives in the marketplace. Out of the 21 patent lawsuits examined, only 6 percent of patents covered active ingredients. The overwhelming majority of patents asserted were for manufacturing processes (42%) and methods of use (24%).
As often pointed out, drug manufacturer AbbVie has filed over 240 patent applications for a single drug, Humira, and received over 130 granted patents. This patent thicket has allowed Humira to control the marketplace in the U.S., leading to Humira claiming the number 1 spot as the world’s bestseller since 2012.
- The Evidence Exists: Discover the Truth Behind Out-of-Control Drug Prices
The choir calling on Congress to lower prescription drug prices is as loud as it has ever been. Though, the particular method by which lawmakers will tackle the crisis of unaffordability of prescription drugs remains to be seen. The evidence exists that the patent abuse is chief among the underlying causes of sky-high prices.
- Bloomberg Law reported that globally top-selling drug Humira has secured over 100 patents and has held off competition for 15 years.
- In fact, Mike Fuller, chair of the biotechnology practice group at law firm Knobbe Martens, told Bloomberg that if you have a $16 billion-a-year drug, “every month is a good month that you’re on market alone. So you’re going to spend whatever it takes to be as aggressive as possible and get as many patents as possible.”
Humira is far from alone in this practice and it is precisely these practices that need to be addressed in order to lower prescription drug prices for Americans.
Patent abuse by many major pharmaceutical companies is the true underlying cause of unaffordable prescription drugs, and necessary reforms like strengthening tools within the U.S. Patent and Trademark Office to weed out bad patents would deliver swift relief for patients and taxpayers nationwide.
WHAT YOU SHOULD BE READING:
Medical, Marketing, and Media: Patients For Affordable Drugs Gets Back On The Air
- As the healthcare world reels from COVID-19 and the leak of a draft of a Supreme Court decision that would overturn Roe v. Wade, drug pricing reform advocacy groups are reigniting the push for Congress to lower drug costs. Advocacy organization Patients for Affordable Drugs has debuted “Push for Lower Rx Prices,” a series of short videos that will air in D.C. during the next several weeks. The goal, the group noted, is to encourage lawmakers to do something about drug pricing by Memorial Day. The effort arrives after proposed drug pricing reform has stalled in Congress once anew. Late last year, congressional Democrats reached a deal to put drug pricing legislation into Biden’s $1.75 trillion social spending package.
STAT News: Congress Moves Toward Reforming FDA Accelerated Approvals, But With Pharma-Friendly Concessions
- House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s accelerated approval pathway, but their latest legislation is friendlier to industry than previous drafts. The House Energy and Commerce Committee announced Wednesday that its sweeping user fee authorization bill will include a revised policy from Rep. Frank Pallone (D-N.J.) that would make it easier for the Food and Drug Administration to rescind its approval for drugs cleared through the pathway when drug makers don’t complete required follow-up studies.
- Each year, the Association for Accessible Medicines releases a savings report that highlights where and how generic and biosimilar drugs save the US health care system hundreds of billions of dollars – over $338 billion in 2021. Since the report’s inception, generics and biosimilars have overwhelmingly been the lion share of prescriptions dispensed but the smallest portion of drug spend.
WHAT WE’RE SHARING