Parts is Parts? A few thoughts about some of the comments that were submitted to the FDA about Orange Book listings
The deadline for submitting comments to the FDA about patent listings in the Orange Book has long passed. The result was the submission of seventeen comments by a variety of organizations. A big issue discussed in the comments is the eligibility for listing in the Orange Book of patents that claim a drug administration device or a part thereof. This issue can be broken down into: 1) for a patent claiming the device as a whole, does there have to be a claim that recites the presence of a drug (or “the” drug) in the device in order to make the patent eligible for listing in the Orange Book? 2) is a patent that claims only an individual part of the device eligible for listing in the Orange Book? Presence of “a” drug or “the” drug ? Presence of “a” drug ? Yes, patent attorneys have drafted claims for patent administration devices that, even when they know that the device was designed with a particular active ingredient in mind, do not include a drug as an element i