Apparently Tired of Waiting for an FDA Opinion, GSK Submits Drug Delivery Patents to FDA for Orange Book Listing

By Kurt R. Karst –      

The recent addition of numerous patents to the Orange Book covering various GlaxoSmithKline (“GSK”) drug products, such as VENTOLIN (albuterol sulfate), FLOVENT (fluticasone propionate), ADVAIR (fluticasone propionate; salmeterol xinafoate), and SEREVENT (salmeterol xinafoate), begs the question why?  Many of the new patent listings concern patents issued years ago and are therefore late-listed patents.  (Generic applicants with pending applications need not certify to late-listed patents; however, subsequent applicants must certify to them.)  Nevertheless, the FDC Act and FDA’s regulations require each NDA sponsor to submit to FDA for Orange Book listing  “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the [NDA] or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.”  The answer as to why GSK decided to submit the patents to FDA for Orange Book listing might be related to a January 2005 advisory opinion request the company submitted to FDA – and that the Agency has not yet responded to – raising important questions about Orange Book patent listing. 

We previously reported on the GSK request, as well as two similar requests submitted by AstraZeneca in 2006 and 2007.  GSK’s request asks FDA the following question:

If a patent claims a drug delivery device or elements of a drug delivery device approved as part of a New Drug Applicatin (“NDA”), but the patent does not specifically claim the active ingredient or mention the active ingredient or ingredients contained in the approved drug product, or if a patent claims the protective overwrapping of a drug delivery device, should information concerning that patent be submitted to the FDA for listing in the Orange Book? [(italics in original)]

The advisory opinion request was apparently prompted by FDA’s response to comments stated in the preamble to the Agency’s June 2003 regulations implementing the FDC Act’s patent listing provisions.  Those comments sought clarification as to whether patents claiming delivery devices or containers “integral” to a drug product should be submitted to FDA for Orange Book listing.  FDA did not directly address the issue, but rather stated that the key factor in determining whether a drug product patent must be submitted for Orange Book listing is “whether the patent being submitted claims the finished dosage form of the approved drug product.” 

Many of the patents now listed in the Orange Book for the above-referenced GSK drug products appear to cover drug delivery devices and components of such devices.  For example, one patent claims:

An inhalation device for use with a medicament pack having a plurality of containers for containing medicament in powder form wherein the containers are spaced along the length of and defined between two peelable sheets secured to each other . . . .

GSK’s decision to submit such patents to FDA for Orange Book listing could be a creative way of pushing the Agency to more promptly address the three outstanding advisory opinion requests.  It is also possible that FDA will address the issue of the Orange Book listing of drug delivery device and device component patents in upcoming regulations implementing the Medicare Modernization Act (“MMA”).  We understand that such regulations are in the works and will (eventually) be issued in two sets – one set addressing the 180-day exclusivity forfeiture provisions added to the FDC Act by the MMA, and the other addressing other amendments made to the FDC Act by the MMA.