Critical Legislation Targets Anti-Competitive Practices like Patent Thickets and Product-Hopping That Cost Patients and the U.S. Health System Billions of Dollars
Today, the U.S. Senate Committee on the Judiciary is scheduled to consider legislation that would crack down on Big Pharma’s egregious anti-competitive tactics that block competition from more affordable alternatives. Introduced by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT), “The Affordable Prescriptions for Patients Act of 2023,” has previously won strong bipartisan support and would help end practices like patent-thicketing and product-hopping that brand name drug companies’ use to extend monopolies and keep prices high.
Ahead of the markup of this important legislation, get a Dose of Reality on Big Pharma’s egregious practices designed to game the system to extend exclusivity, block more affordable alternatives and boost profits by keeping drug prices high.
PATENT ABUSE: ‘BUSINESS AS USUAL’ FOR BIG PHARMA
Big Pharma has a long history of price gouging American patients through tactics used to game the system, such as patent thicketing and product hopping, to hinder generic competition and maintain monopolies over their biggest money makers.
Voters Support Market-Based Solutions to Crack Down on Big Pharma’s Patent Abuse
A recent survey conducted by Morning Consult found overwhelming majorities of American voters support market-based solutions to stop Big Pharma from continually exploiting loopholes and abusing the U.S. patent system.
I-MAK Call for Patent Reform to Be Top Priority in 118th Congress
In January, Tahir Amin and Priti Krishtel, co-executive directors of the Initiative for Medicines, Access & Knowledge (I-MAK), published an op-ed in The Hill calling on Congress to lower prescription drug prices by holding Big Pharma accountable for the industry’s egregious abuse of the patent system.
Report Highlights the Staggering Cost of Big Pharma’s Patent Thickets
A new report released last week from Matrix Global Advisors and commissioned by the Coalition for Affordable Prescription Drugs, “Patent Thickets and Lost Drug Savings,” examines the cost of Big Pharma’s use of ‘patent thickets’ on patients and the U.S. healthcare system.
The report quantifies the one-year cost of lost savings on five brand name drugs around which Big Pharma has built especially egregious patent thickets: AbbVie’s autoimmune drug Humira and oncology drug Imbruvica, Regeneron’s ophthalmology drug Eylea, Amgen’s autoimmune drug Enbrel, and Bristol Myers Squibb’s oncology drug Opdivo.
The report assesses what the savings would be for these five drugs if “a steady state of competition [existed] where generics and biosimilars have achieved price discounts and uptake currently observed in the market.” Based on these calculations, the one-year cost of delayed competition from patent thickets on these five drugs would range from $1.8 billion to $7.6 billion. The one-year cost of each of these brand name drugs on the U.S. health care system due to their patent thickets is:
While the report points to recent progress on the issue of Big Pharma’s patent abuse, including efforts from lawmakers and President Biden to increase coordination between the U.S. Patent and Trademark Office (PTO) and U.S. Food and Drug Administration (FDA), the report calls for “tangible legislative reforms… to stop this long-standing anticompetitive practice.”
In particular, the report points to the legislation being marked up by the Judiciary Committee today, “the Affordable Prescriptions for Patients Act,” which would “limit the number of patents a brand drug manufacturer can contest,” as one important solution for lawmakers to consider.
A Recent Case Study in Big Pharma’s Patent Greed: Keytruda
In December, Big Pharma giant Merck announced that it will seek new patents on its blockbuster cancer drug Keytruda, which last year brought in over $17 billion for the company. According to reporting from Reuters, Merck is seeking “to patent a new formulation of its $20 billion cancer immunotherapy Keytruda that can be injected under the skin, allowing it to protect its best-selling drug from competition expected as soon as 2028.”
This is just the latest example of a strategy Big Pharma companies have used repeatedly to extend their monopolies on blockbuster products – filing for patents for changes such as intake method or dosage that don’t represent truly new innovations or improve clinical benefits for patients. This enables Big Pharma to add to patent thickets designed to block competition from more affordable alternatives, keep drug prices high and boost profits.
Dr. Shailender Bhatia, an oncologist at the Fred Hutchinson Cancer Center in Seattle said, “I don’t think it’s going to improve the safety or the effectiveness of the drug.”
“It’s the way the pharmaceutical companies now use that system — it’s all about taking up as much space as possible, making it difficult for anybody to enter,” Tahir Amin, co-founder of Initiative for Medicines, Access & Knowledge (I-MAK), said in Reuters coverage of the move. “Keytruda is going to be the next Humira by all accounts.”
According to research from I-MAK, Merck has filed for 129 patent applications on Keytruda – more than half of which were filed after the drug’s initial approval by the U.S. Food and Drug Administration (FDA). The Big Pharma company has been granted 53 patents on this one drug. I-MAK estimates that Americans will spend at least $137 billion on Keytruda while the drug faces no competition due to its extended exclusivity that already totals more than eight years — without reflecting the added impact of the Big Pharma giant’s new patent strategy.
Targeting Blockbuster Products for Patent Abuse
And a May 2022 study published in JAMA Health Forum revealed how brand name drug companies target their most profitable products for reformulation to extend monopolies and prohibit generic competition from entering the market.
Read more about how Big Pharma’s patent abuse blocks competition, harms consumers and contributes to ballooning taxpayer spending HERE.
Read more on why Big Pharma’s tired argument that innovation justifies their out-of-control prices doesn’t hold up to scrutiny HERE.
Read more on market-based solutions to hold Big Pharma accountable and lower prescription drug prices HERE.