SECOND OPINION: LATEST PHRMA AD CAMPAIGN DEFENDS PATENT ABUSE “STATUS QUO”

Big Pharma Advertising Blitz Seeks to Protect Anti-Competitive Tactics That Cost Patients and Taxpayers Billions of Dollars Each Year

On Wednesday, Axios reported the pharmaceutical industry’s principal trade group is launching a new ad campaign seeking to deflect scrutiny from Big Pharma’s egregious abuse of the patent system that blocks competition from more affordable alternatives to high-priced brand name prescription drugs.

According to the report, The Pharmaceutical Research and Manufacturers of America (PhRMA) is planning “a new seven-figure ad campaign defending the drug patent system” from “growing threats the big industry group sees in patent reform legislation that could be part of a year-end health deal.” The article cites “bipartisan concern in Congress that drug companies are gaming the patent system,” as a reason behind the push.

In describing the campaign, PhRMA claimed, “the status quo lets companies innovate while allowing for eventual competition from cheaper generics and biosimilars.”

In other words, PhRMA’s campaign is designed to protect the status quo that allows Big Pharma giants to file dozens, even hundreds, of patents on existing brand name products disconnected from true innovation — extending monopolies and delaying competition for months and years, allowing them to repeatedly hike prices, keep prices high, and bank blockbuster profits — all at the expense of patients, taxpayers and the U.S. health care system.

In the article, PhRMA didn’t even attempt to disagree when “[a]sked if there are instances of companies gaming the system to fend off competition.”

“‘I certainly am not able to speak to every patent practice of all of our companies, so I wouldn’t dare to do that,’” PhRMA’s spokesperson told Axios.

Get the facts on Big Pharma’s patent abuse that costs patients and taxpayers billions of dollars each year — and a Dose of Reality on some of the most egregious examples from Big Pharma’s anti-competitive playbook:

BIG PHARMA’S PATENT ABUSE COSTS CONSUMERS AND THE U.S. HEALTH CARE SYSTEM BILLIONS OF DOLLARS EACH YEAR

Big Pharma’s Patent Thickets On Just Five Drugs Cost Over $16 Billion In a Single Year

A January 2023 report from Matrix Global Advisors, “Patent Thickets and Lost Drug Savings,” quantified the one-year cost of lost savings on five brand name drugs around which Big Pharma has built especially egregious patent thickets. The five drugs were 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 estimated one-year cost of patent thickets on each of these brand name drugs was:

• $7.6 billion for Humira
• $3.1 billion for Imbruvica
• $2.5 billion for Eylea
• $1.9 billion for Enbrel
• $1.8 billion for Opdivo

This amounts to a total of more than $16 billion.

The report calls for “tangible legislative reforms… to stop this long-standing anticompetitive practice.” In particular, the report points to “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.

EGREGIOUS EXAMPLES

Patent Thicket Surrounding Humira Drove More Revenue for Big Pharma Giant AbbVie Than All 32 NFL Teams Combined

While AbbVie’s blockbuster autoimmune drug Humira finally faced its first competition in the U.S. in 2023, over the course of its more than two decades on the market, AbbVie applied for more than 300 patents on the brand name medication, securing more than half of them. Ninety-four percent of the patents filed on Humira came after the drug was initially approved by the U.S. Food and Drug Administration (FDA). The strategy helped block competition for years and generated almost $200 billion for AbbVie. In 2022, the drug brought in more money for the company, $21 billion, than all 32 teams in the NFL combined, $19 billion.

Keytruda: 129 Patent Applications, and More on the Way, Already Costing Americans More than $137 Billion and Counting

In December 2022, 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 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.

Patent Abuse on Brand Name Inhalers Produced $111 Billion for Big Pharma After Active Ingredient Patents Expired 

In 2023, William B. Feldman and Aaron S. Kesselheim, physicians at Brigham and Women’s Hospital and faculty members at Harvard Medical School, highlighted Big Pharma’s extensive patent abuse on brand name inhalers used to treat asthma and chronic obstructive pulmonary disease in an op-ed published in The Washington Post.

The authors explained brand name manufacturers “have used the patent and regulatory system to keep generics off the market,” including through tactics like patent thicketing.

“Of the $178 billion that manufacturers earned on inhalers in the United States from 2000 to 2021, about $111 billion of that total came after patents on their active ingredients had expired,” according to the experts, who added, “the patent system was designed to promote innovation, not grant monopolies for small tweaks to devices containing decades-old drugs.”

Bringing the Patent Abuse Playbook to a New Category of Blockbuster Products: GLP-1 Weight Loss Drugs

A February 2024 analysis published in JAMA Network found brand name drug makers marketing a new category of weight loss drugs, glucagon-like peptide 1 (GLP-1) receptor agonists, are increasingly utilizing device patents to build patent thickets around these products to create and elongate periods of monopoly pricing power — despite the drugs effectively being older diabetes medications repackaged for a different indication. In other words, Big Pharma isn’t protecting actual innovation, but gaming the patent system to block competition, keep prices high, and boost profits.

The authors state in their conclusion, the “removal of these patents may substantially reduce barriers to generic entry by decreasing the number of patents that generic firms must contest ahead of [U.S. Food and Drug Administration] approval.” Without this competition, “prices for GLP-1 receptor agonists will remain high for many years, reducing access for patients and raising health care costs.”

A report released earlier this month from the IQVIA Institute for Human Data Science underscores the staggering potential cost of Big Pharma’s unsustainable prices on weight loss drugs if Congress does not act to foster competition. According to the report, spending on obesity drugs could reach between $35 billion and $73 billion by 2028, depending on the level of expansion in eligible patients for the drugs. Currently, spending on obesity medications was $5.4 billion in 2023, “up from just $0.7Bn in 2018 and largely driven by the uptake of novel GLP-1 treatments.”

BIPARTISAN, MARKET-BASED SOLUTIONS TO HOLD BIG PHARMA ACCOUNTABLE AND PROMOTE COMPETITION TO LOWER DRUG PRICES

Lawmakers must act to hold Big Pharma accountable for egregious abuse of the patent system.

The Senate Judiciary Committee has unanimously advanced several market-based solutions that would help crack down on Big Pharma’s egregious abuse of the patent system to lower prices for patients including:

• Affordable Prescriptions for Patients Act (S. 150), led by Senator John Cornyn and Senator Richard Blumenthal
• Legislation to Address Patent Thickets (S. 3583), led by Senator Peter Welch, Senator Mike Braun and Senator Amy Klobuchar
• Interagency Patent Coordination and Improvement Act (S. 79), led by Senator Richard Durbin, Senator Thom Tillis, Senator Chuck Grassley and Senator Chris Coons
• Stop STALLING Act (S. 148), led by Senator Amy Klobuchar and Senator Chuck Grassley
• Preserve Access to Affordable Generics and Biosimilars Act (S. 142), led by Senator Amy Klobuchar and Senator Chuck Grassley

Earlier this month, the Congressional Budget Office (CBO) released an updated score which found that just one of these bills, The Affordable Prescription Drugs for Patients Act, otherwise known as Cornyn-Blumenthal, would produce savings of more than $3 billion.

Read more on how Big Pharma’s patent abuse is the root cause of high prescription drug prices HERE.

Learn more about market-based solutions to hold Big Pharma accountable and lower drug prices HERE.