Tuesday, April 30, 2024

FTC Again Polices FDA's Laziness With Improper Orange Book Listings for Diabetes, Weight Loss, Asthma and COPD Drugs

Today (April 30, 2024), the U.S. Federal Trade Commission (FTC) announced that it had expanded its campaign against pharmaceutical manufacturers’ improper or inaccurate listing of patents in the Food and Drug Administration's (FDA) Orange Book (see the news release at https://www.ftc.gov/news-events/news/press-releases/2024/04/ftc-expands-patent-listing-challenges-targeting-more-300-junk-listings-diabetes-weight-loss-asthma for more information). FTC is targeting what it describes as more than 300 "junk" patent listings because the particular patents are legally ineligible to even be listed in the FDA Orange Book.

Listing patents in the Orange Book can, if listings are improper (as defined by law) adversely impact competition. Because the FDA Orange Book is populated by the pharmaceutical industry, and the FDA really has little supervision of the listings contained in the Orange Book unless there is a drug recall, it is essentially self-enforced. Which leaves the listings open to the type of abuse FTC is now challenging.

FDA entrusts branded drug manufacturers to be responsible for ensuring their patents are properly listed. Yet certain manufacturers have improperly submitted patents for listing in the Orange Book which claim neither the reference listed drug, nor a method of using it. Unfortunately, several companies focused on diabetes products were included among the 300 listings which appear to be improperly listed in the FDA Orange Book patents anyway.

For example, the letter the FTC sent to Novo Nordisk (see the FTC letter to Novo Nordisk at https://www.ftc.gov/system/files/ftc_gov/pdf/novo-nordisk-ozempic-saxenda-victoza-_4302024.pdf for more) said that certain patents (all told, the number was 36 of improper Orange Book listings) have been improperly or inaccurately listed with regard to Novo Nordisk Inc.'s GLP-1 inhibitor products branded as Ozempic, Saxenda, and Victoza products. Many of the patents were related to pen injector devices, and not the medicines themselves which is not allowed. FTC added "we have availed ourselves of the FDA's regulatory process and submitted patent listing dispute communications to the FDA regarding the listings identified' in a table outlined in its letter."

All told, a number of the improperly-listed patents relate to either manufacturing processes, or medical devices such as injection pen devices, neither of which is eligible to be listed in the FDA Orange Book; only the small molecule drug or protein molecules themselves are permitted in the Orange Book. Its letters say they are improperly listed as "DP" which is the acronym for "Drug Product" when they are for devices, not for drugs. For example, Novo Nordisk's Patent 7762994 is for a pen needle mounting system and methods for mounting a needle assembly on a needle mount, while Novo Nordisk Patent RE46363 is for a dial-down mechanism for an injection pen device. Again, only the drug or protein molecules themselves, and not the injector devices for those are even permitted in the FDA Orange Book. And yet, by knowingly and improperly listing the injector pen device patents, Novo Nordisk might automatically lead to a statutory stay that blocks the introduction of competing drug products for up to 30 months. By challenging these improper listings, FTC will enable some biosimilars to come to market sooner.

FTC argues this constitutes "unfair methods of competition in violation of Section 5 of the Federal Trade Commission Act" and therefore has the legal authority to challenge the improperly-listed patents.

Novo Nordisk was not alone.

Amphastar Pharmaceuticals, which on April 24, 2023 acquired from Eli Lilly & Company that company's "modern" glucagon product known as Baqsimi, which is a product which does not require cumbersome reconstitution and can be administered nasally. However, FTC challenges a Baqsimi Orange Book listing (see the FTC letter at https://www.ftc.gov/system/files/ftc_gov/pdf/amphastar-baqsimi-4302024.pdf for more). Baqsimi's patent 10894133 is not for the glucagon product, but for a dispenser device for dispensing a fluid or powder composition. Again, it is completely unlawful to list that in the FDA Orange Book, and yet the product was listed there anyway. 

Because Amphastar acquired Baqsimi from Lilly, its quite possible that the fault for the improper listing could be attributed to Lilly, but now that Amphastar is the owner, it must fix the improper listing.

Ironically, while the FTC slapped Amphastar with one hand, Amphastar is also poised to become one of the biggest beneficiaries due to the very same FTC action. Yes, Amphastar will lose illegal protections on patents for Baqsimi, but Amphastar is also poised to become one of the biggest suppliers of biosimilar versions for the GLP-1 inhibitor known generically as liraglutide (fka Novo Nordisk Victoza/Saxenda) in just months when FDA considers its Biologics License Application (BLA) for that medicine. 

FTC notes it has several tools at its disposal to address improper Orange Book listings. One of those tools is using the FDA's process to dispute "the accuracy or relevance of patent information submitted" to the FDA for publication in the Orange Book.

Given the preponderance of improperly-listed patents in the FDA Orange Book, we should ask whether the FDA needs to do more to crack down on this form of systemic abuse? After all, it was the Federal Trade Commission which raised the issue, not the Food and Drug Administration which is responsible for the Orange Book. FDA should be doing this. But FTC has a legal right to challenge the listings, hence it took steps to work with FDA on the patents in question.

The FTC letters all close by saying:

"We have opted to use the FDA's regulatory dispute process to address the improper listings, but we retain the right to take any further action the public interest may require, which may include investigating this conduct as an unfair method of competition under Section 5 of the FTC Act, 15 U.S.C. § 45, and as described in the Policy Statement."

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