Federal antitrust officials have redoubled efforts to challenge what they see as improper pharma patent listings that delay the market entry of generic drugs.

This week, the Federal Trade Commission (FTC) sent warning letters to 10 drugmakers, disputing the accuracy of some 300 patent listings in the Food and Drug Administration’s so-called “Orange Book.” 

The crackdown, which comes six months after FTC challenged 10 pharma majors in a similar fashion, targets so-called “junk” patents — listings the regulator disputes as improper or inaccurate. 

The most recent letters call into question patents across 20 different brand-name products, including diabetes and weight loss drugs like Novo Nordisk’s Ozempic and Victoza, as well as GSK’s asthma/COPD treatment Trelegy Ellipta.

“By filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,” FTC chair Lina Khan said in a statement. 

In its letters to the 10 drugmakers, the FTC took issue with the accuracy or relevance of the patent listings, warning the firms that patents for some 20 products were invalid. 

In addition to Ozempic and Victoza, products singled out included inhalers and more diabetes and obesity drugs from the likes of AstraZeneca, Boehringer Ingelheim, Covis, GSK, Novartis, Novo, Teva, Amphastar and some of their units.

GSK and Novo Nordisk said they had received the letters and were reviewing them. Several other companies didn’t respond to MM+M’s request for comment.

In their defense, companies have argued that listing patents is not a way to prevent legitimate and lawful competition but a regulatory obligation they take seriously. In fact, doing so creates transparency that may assist generics makers in timing their patent challenges.

The allegation that patents are used to keep prices artificially high “is simply false,” said a Novo spokesperson.

Patent strategy, explained

However, some of the patents apply to the devices employed to deliver the medications, like the Ozempic injection device’s spring-loaded, rotatable display, or Victoza’s injection button, according to a report in The Wall Street Journal

These kinds of patents are improper, the FTC charges, because drugmakers only need to list patents related to their drugs’ active ingredient or formulation, or its method of use. 

Furthermore, improper patents “may disincentivize investments in developing a competing product and increase the risk of delayed generic and follow-on product entry,” FTC wrote in September.

The disagreement underscores the value of Orange Book listings. Under a legal framework known as the Hatch-Waxman Act, a generic firm that successfully challenges a patent for a brand-name pharmaceutical listed in the Orange Book is granted a period of exclusivity before other generics are approved. 

However, such a challenge also results in a 30-month stay of FDA approval of the generic drug’s application, should the brand-name manufacturer elect to fight in court. FTC says there have been numerous cases where the 30-month stay was used to block competition. 

Over the years, the agency hasn’t been shy to speak out about what it sees as cases of inappropriate Orange Book listings. One of the most recent involved Jazz Pharma’s suit against Avadel Pharma, for which it filed an amicus brief.

Following the FTC’s November challenge, GSK said it asked the FDA to remove four patent listings from the Orange Book with respect to certain products, while affirming a fifth patent the company insisted was appropriate. 

Two other drugmakers chose to delist patents with the FDA, as well, and another five did not, per the WSJ, which said the FTC refused to rule out further legal action. 

FTC crusade continues 

Some see the attack on patents as part of a pattern of overreaching by the FTC chair. Indeed, Tuesday’s letters were but one plank in the agency’s assault on the healthcare industry for alleged anticompetitive behavior. 

Under Khan’s watch, the agency has also subjected pharma M&A to additional antitrust scrutiny, launched inquiries into pharmacy benefit managers (PBM) and brought suit against a PE company seeking to roll up a number of medical practices in Texas.

“But you’ve got to draw a line someplace. Where is that point where a manufacturer, whether a pharma manufacturer or any other, doesn’t have a right to protect their inventions?” asked Gary Stibel, founder and CEO of the New England Consulting Group. 

“If [Khan] has a complaint,” added Stibel, “it’s not with the pharmaceutical companies. It’s with the U.S. Patent and Trademark Office. Why doesn’t she say to them, ‘You’re issuing patents that you shouldn’t be?’”

That said, when it comes to pharma patents being used to extend the life of a blockbuster, the case of AbbVie’s Humira looms large. 

The drug, an injectable treatment for rheumatoid arthritis and other autoimmune diseases, tacked on extra years of exclusivity thanks to a “thicket” of 240 patents that spanned manufacturing methods to formulations. In this way, AbbVie kept would-be biosimilar competitors at bay for years.