Showing posts from February, 2024

The Chicken Sandwich Conundrum: Parts is Parts . . . or Not

 Orange Book Insights No. 43: 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 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 rather than a drug! The independent claim of the ‘444 patent is as follows: 1. An actuation indicator comprising a drums sub-assembly comprising a rotatable actuation indicator wheel, a rocking, ratchet pawl for rotating the indicator wheel in a set direction and a rocking mechanism for the pawl driven by a slipping clutch arrangement, wherein the slipping clu