Pharmaceutical companies don’t only get to set their prices on brand-name drugs, they can flood the FDA with patents to keep those brand-name drugs without generic competition for extensive periods of time. Thankfully, the Federal Trade Commission (FTC) is challenging what it is calling “junk” patents on 20 brand-name drugs, Bruce Gil reports for Quartz. The goal is to clean up the mess in the drug patent arena, allow generic drugs to enter the market sooner, and bring down drug prices.
Ozempic is one of the 20 drugs that the FTC claims has junk patents. If not undone, it will take longer for generic alternatives to compete with it. Novo Nordisk will be able to continue to charge insanely high prices for Ozempic. The FTC is also disputing the patents on Saxenda and Victoza.
As a rule, a drug patent extends for 20 years beginning when the drug manufacturer files the patent. Once the manufacturer files the patent, it can charge what it pleases for a drug.
Manufacturers tend to file patents as early as they can, usually even before requisite clinical trials are completed and their drugs are approved. They then file more patents as a way to extend their ability to control the price of their drugs.
The manufacturers claim they need to recoup their research and development investments. But, substantial evidence suggests that these investments do not justify the prices.
Junk patents generally support small changes to a drug, such as how they are manufactured or how they are taken, e.g., orally or by injection. With Ozempic, the FTC challenge is to a patent on its “injection device with torsion spring and rotatable display.” By having this device listed in the FDA’s Orange Book, Novo Nordisk gets 30 months of additional exclusivity on its drug.
But, even if the FTC wins its challenges on these 20 brand-name drugs and they are removed from the FDA’s Orange Book, the manufacturers can sue companies for violating their patents. Through these lawsuits, the pharmaceutical companies can continue to quash competition.
Some say that the FDA needs more time to review patent applications in order to nip them in the bud and deny them where appropriate. One study finds that if those determining whether patents should be issued were given 50 percent more time, more patents would be denied and Americans would spend about $5 billion less each year for drugs.
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