The Chicken Sandwich Conundrum: Parts is Parts . . . or Not
Orange Book Insights No. 43 (revised Feb. 24, 2024): The Chicken Sandwich Conundrum: Parts is Parts . . . or Not Parts may be parts (thinking back to that old Wendy’s commercial where they compared their chicken sandwich made solely from chicken breast meat to their competitor’s chicken sandwich that was allegedly made from various unknown parts of a chicken). However, all of the claims of Pat. No. 7500444 (‘444 patent) that Glaxo had listed in the Orange Book for their ADVAIR HFA (fluticasone propionate; salmeterol xinafoate) product, are directed to something called an “actuation indicator” which is nothing more than a mechanical part of the ADVAIR HFA device rather than a drug! Steve Auten had previously shared news about a November 7 FTC announcement that the FTC had submitted patent disputes to the FDA under 21 CFR 314.53(f) for patents that the FTC believes do not qualify for listing in the Orange Book. The FTC also sent the responsible drug manufacturers letters informing th