British drugmaker GSK says it has no current plans to pull a group of patents that have been challenged by the US Federal Trade Commission as “junk.”
In April, the FTC expanded an ongoing campaign against patents it has described as superfluous and anticompetitive. It has challenged more than 300 listings covering treatments for asthma, diabetes, weight loss and more, that are found in the FDA’s database of approved products and patent information, also known as the Orange Book.
This weekend, the deadline passed for drugmakers to pull, amend or reaffirm the patent listings. GSK told Endpoints News on Monday that “we have affirmed that all of those Orange Book listings are appropriate and in compliance with applicable law, regulations and guidance.” The FTC had called into question several of GSK’s patents on Ellipta, an asthma and COPD treatment.
Alongside GSK, the FTC has sent challenges to AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Teva, Amphastar Pharmaceuticals, Covis Pharma and Novartis.
A Novo spokesperson on Monday said the FTC’s “allegation that we use this listing to keep prices artificially high is simply false.” The company declined to comment on whether it plans to withdraw challenged patents around Ozempic, Saxenda and Victoza.
“Novo takes its regulatory obligations very seriously for all its products and patenting activities,” the spokesperson said.
AstraZeneca, Boehringer Ingelheim, Teva, Amphastar, Covis and Novartis didn’t respond to requests for comment as of press time.
While not all patents are listed in the Orange Book, listing there gives drugmakers certain advantages. In some instances, suing a generic competitor for infringement of a listed patent “generally results in an automatic 30-month stay” of FDA approval, according to the FTC.
The FDA’s Center for Drug Evaluation and Research told Endpoints on Monday that it “has a ministerial role” with regard to the listing of patent information in the Orange Book, and “only lists in the Orange Book patents that new drug application (NDA) sponsors have attested comply with listing requirements.”
A spokesperson for CDER said the agency is working with other parts of government “to help identify and address efforts to block or unjustifiably delay generic drug and biosimilar competition,” including the patent office and the FTC.
The most recent round of challenges follow the FTC’s move to target more than 100 patent listings at the end of last year, leading GSK, Kaleo Inc. and Impax Labs to delist some of their patents.
While a few of those patents were pulled, the drugmaker has not walked away from them entirely. GSK said Monday that the patents it removed from the Orange Book remain “valid and enforceable.”