The US Court of Appeals for the First Circuit held that
pharmaceutical companies that wrongly list patents in FDA's
Orange Book must prove they acted in good faith to avoid antitrust
liability. In re Lantus Direct Purchaser Antitrust
Litigation, Case No. 18-2086 (1st Cir. Feb. 13, 2020)
(Kayatta, J).
In applying for FDA approval to market new drugs, drug
manufacturers must list all patents that "claim" the drug
or the method of using the drug in FDA's "Orange
Book." Listing a patent in the "Orange Book" allows
the drug manufacture to trigger an automatic 30-month stay of FDA
approval of any application for a competing drug product.
Sanofi-Aventis first obtained FDA approval to market insulin
glargine under the brand name "Lantus" in 2000, and filed
a patent for the drug set to expire in 2014. In 2006, Sanofi filed
a "supplemental" new drug application to sell insulin
glargine in a disposable injector pen device called the
"Lantus SoloSTAR," and in 2013 listed a
