AstraZeneca filed a request for an advisory opinion from the FDA pursuant to 21 C.F.R, § 10.85, asking whether patents directed to drug delivery systems, such as inhalation devices, that do not recite the approved active ingredient or formulation should be listed in the “Approved Drug Products With Therapeutic Equivalence Evaluations” (“Orange Book“).

21 C.F.R. § 314.53 requires that New Drug Application (“NDA”) applicants submit for listing in the Orange Book the patent numbers and expiration dates of any patent that claims the drug or a method of using the drug that is the subject of the NDA “with respect to which a claim of patent infringement could reasonably be asserted… .”. The regulation states that patents that claim the “drug product” that is the subject of the NDA must be listed, but also states that patents claiming “packaging” must not be listed.

Earlier, the FDA published its final rules, Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug is Invalid or Will Not Be Infringed, 68 Fed. Reg. 36676 (June 18, 2003).

In the rules, the FDA stated that drug products include “metered aerosols,. . . metered sprays . . . and pre-filled drug delivery systems” and that patents claiming such drug products should be listed in the Orange Book and noted that “[t]he key factor is whether the patent being submitted claims the finished dosage form of the approved drug product.” The FDA didn’t directly address whether patents directed to drug delivery systems that do not recite the approved active ingredient or formulation should be listed in the Orange Book.

GlaxoSmithKline asked the same question in January 2005, asking:

“If the patent claims a drug delivery device or elements of a drug delivery device approved as part of a New Drug Approval (“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?”

The FDA has not responded to GSK’s request. In attempt to set out its intent, AstraZeneca summed up the request with the statement: “AstraZeneca will continue to list them unless it receives guidance from FDA that such listings are improper.”

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