SECOND OPINION: CLOSING LOOPHOLES BIG PHARMA EXPLOITS TO BLOCK COMPETITION AND KEEP DRUG PRICES HIGH WILL NOT UNDERMINE INNOVATION

Big Pharma’s Arguments Against Bipartisan, Market-Based Solutions to Foster Greater Competition from More Affordable Alternatives to Brand Name Drugs Don’t Hold Up to Scrutiny

On Tuesday, an op-ed published in The Hill repeats pharmaceutical industry talking points opposing bipartisan, market-based solutions to lower prescription drug prices for the American people by fostering greater competition from more affordable alternatives, like generics and biosimilars, on the basis it would undermine innovation into new cures.

Brand name drug companies, and their defenders, commonly cite this refrain when solutions that would effectively boost competition to lower drug prices are being considered by policymakers. This latest op-ed reiterating that rhetoric focuses on the Medication Affordability and Patent Integrity Act (S. 2658), which the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) is scheduled to consider in a markup this week.

This legislation would help strengthen coordination between the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) by requiring more consistent information to be shared across agencies, helping to improve patent quality and reduce Big Pharma manipulation of loopholes to file more patents, delay competition and keep drug prices high.

According to the op-ed, and Big Pharma, the bill would add “new regulatory burdens…making it harder and taking longer to develop” new medicines. That’s a drastic, and false, claim for a bill that merely requires drug companies to share the same information they present to one government agency, with another government agency.

Why is this solution needed? Because the pharmaceutical industry has a demonstrated history of pursuing “follow-on” or secondary patents, disconnected from a prescription drug’s active pharmaceutical ingredients, or API, late in a drug’s exclusivity period, to extend that drug’s exclusivity with minor changes to its makeup or formulation, that oftentimes do not improve the drug’s clinical value for patients.

As the op-ed admits, “brand-name drug companies occasionally seek new or additional patents after a drug has been released in the marketplace.”

“Occasionally,” is a dramatic understatement. The pharmaceutical industry is, in fact, increasingly, and aggressively, pursuing secondary and tertiary patents disconnected from any actual innovation, to extend exclusivity periods, block competition and keep prescription drug prices high for American patients, taxpayers and the U.S. health care system.

Increasing Reliance on Secondary and Device Patents

Brand name drug companies are increasingly pursuing a strategy of seeking secondary patents late in a drug’s exclusivity period to lock in profits for longer by blocking competition.

Just 4.2 Percent of FDA Orange Book Patents on Active Pharmaceutical Ingredients: A January 2026 study published in JAMA Health Forum highlights how Big Pharma has been increasingly relying on secondary and tertiary patents that are unconnected to the API in top-selling drugs, in order to extend monopoly pricing.

As coverage of the study in Inside Health Policy notes, “[d]rugmakers are systematically extending monopolies across hundreds of medicines – from birth control and migraine treatments to cancer therapies and heart drugs – by patenting delivery devices and peripheral technologies that often have little to do with the drugs themselves.”

The JAMA study examined “every small-molecule drug the FDA has approved from 1986 to 2023 and found 331 products with at least one tertiary patent, defined as a patent on a delivery device or related technology rather than the drug itself.” Among the 331 analyzed drugs, drug makers “listed 3,241 patents in the FDA’s Orange Book…more than half – 54 percent – were tertiary patents covering devices or device-related features, while only 4.2 percent were primary patents on the active pharmaceutical ingredient.”

Half of FDA Patents Now “Continuation” Patents: According to a December 2025 Health Affairs study, the number of patents listed per drug has tripled since 1980, dramatically expanding the size of patent thickets surrounding brand name products. Nearly half of FDA patents are now derivative “continuation” patents, additional patents layered onto existing ones that can be used to prolong exclusivity and block competition from more affordable alternatives, like generics and biosimilars. Each round of Hatch–Waxman litigation costs generic manufacturers an average of $6.2 million, increasing financial risk and discouraging timely market entry.

A “Whopping” 200 Percent Increase In The Number Of “Secondary” Patent Filings: According to coverage from STAT News of an August 2023 analysis in JAMA, “there has been a whopping 200 percent increase in patents filed by companies that made few substantive changes to their drugs.” According to STAT News, the analysis published in JAMA found that from 2000 to 2015, “The ratio of continuation patents increased from 0.6 for drugs that were approved in 2000 to 1.8 for drugs approved in 2015,” or a 200 percent increase. Meanwhile, “the ratio of the number of original patents for each FDA approval increased by just 15 percent.” 

GLP-1 Medications as a Case Study

Most GLP-1 Listings Are Device Patents: As 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.

To conduct the analysis, the authors examined, “all patents listed on GLP-1 receptor agonists using annual editions of the FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (Orange Book) from 2006 to 2023.” Based on this analysis, the authors found that out of 188 listed patents on these GLP-1 products, “107 [were] device patents (57%) and 81 [were] non-device patents (43%).” Of the device patents the authors examined, none of them “contained claims mentioning their active ingredients, chemical structures, or therapeutic classes.” The authors found this significant, as “[s]uch reliance on disconnected device patents goes beyond what has been observed for other drug-device combinations,” such as inhalers and insulin pens.

Overall, according to the analysis, the number of device patents that are unconnected to active ingredients in these GLP-1 products are significantly higher than other drug categories that rely on drug-device combinations, such as certain kinds of insulin and inhalers.

320 Patent Applications for Products with the Same Active Ingredient: An April 2025 report from the Initiative for Medicine, Access and Knowledge (I-MAK) highlights how Big Pharma giants Novo Nordisk and Eli Lilly are gaming the U.S. patent system to extend monopolies and keep prices high on blockbuster GLP-1 drugs like Ozempic, Wegovy and Mounjaro. 

Novo Nordisk has filed 320 U.S. patent applications, with 154 being granted for semaglutide, the same active ingredient in Ozempic, Rybelsus and Wegovy. The report found that “the main compound patent for semaglutide as used in the three drugs was set to expire in March 2026, it said, but regulatory extensions have lengthened Novo’s exclusivity until December 2031.” I-MAK estimates that this five-year period will grant Novo Nordisk an additional $166 billion.  

The report also found, “Eli Lilly has filed 53 U.S. patent applications and been granted 16 patents,” on its two blockbuster GLP-1 products, Mounjaro and Zepbound, which also rely on the same active ingredient. 

Additional Case Studies in Patent Thicketing

AbbVie’s Humira: While AbbVie’s blockbuster rheumatoid arthritis drug Humira finally faced its first competition in the U.S. starting in 2023, over the course of its more than 20 years on the market, AbbVie applied for more than 300 patents on Humira, securing more than half of them. Critically, ninety-four percent of the patents AbbVie filed on Humira came after the drug was initially approved by the FDA. This strategy helped block competition for years, driving massive profits instead of true innovation, and generated almost $200 billion for AbbVie. In fact, in 2022, the drug brought in more money for the company, $21 billion, than all 32 teams in the NFL combined, $19 billion.

Merck’s Keytruda: Following in AbbVie’s footsteps, Merck recently surpassed a major milestone in the company’s scheme to delay competition and maintain monopoly pricing on blockbuster cancer drug Keytruda – by securing FDA approval for a new, subcutaneous version of the drug.

As patent exclusivity on the current version of Keytruda approaches the end of its life, which has already been significantly extended by patent abuse, Merck is following “a wellworn playbook…by develop[ing] a new version of the drug, given as a shot under the skin,” that will “keep Keytruda revenue flowing,” according to The New York Times. The company expects “up to 40 percent of Keytruda users” to shift to the new version of the drug, called Keytruda Qlex.

Lawmakers on the U.S. Senate Committee on HELP should see through Big Pharma’s false rhetoric, and instead advance the Medication Affordability and Patent Integrity Act (S. 2658), and other bipartisan, market-based solutions to hold brand name drug companies accountable for their egregious abuse of the patent system, which is a root cause of high prescription drug prices in the U.S.

Read CSRxP’s letter to the HELP Committee ahead of the markup HERE.

Read more on how Big Pharma games the system to block competition and keep drug prices high HERE.

Read more about how generic and biosimilar competition lower out-of-pocket costs for patients HERE.

Read more on how Big Pharma’s innovation rhetoric doesn’t hold up to scrutiny HERE.

Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.