Novo Nordisk recently became the fourth company to ask FDA for guidance concerning whether patents on pre-filled drug delivery devices should be listed in the Orange Book. Novo markets several drug products as pre-filled pen-injector systems, including insulin and growth hormone products.
In a Request for Advisory Opinion dated November 26, 2012, Novo raised two specific questions:
- What constitutes an approved pre-filled drug delivery system for purposes of determining whether information on patents relating to that system should be submitted to FDA for Orange Book listing; and
- Whether information on patents relating to approved pre-filled drug delivery systems should be submitted to FDA for Orange Book listing if such patents neither disclose nor claim the active ingredient or formulation of the approved drug product.
Novo Nordisk's request follows similar requests submitted by GlaxoSmith Kline in 2005; AstraZeneca in 2006 and 2007; and Forest Laboratories in 2011. According to Novo, "To date, FDA has not substantively answered the advisory opinion requests or otherwise publicly addressed the patent listing issues they raise."
The Federal Food, Drug, and Cosmetic Act requires the sponsor of a New Drug Application to submit for listing in the Orange Book "any patent which claims the drug for which the applicant submitted the application 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."
Novo's request states that in June 2003, "FDA sought to clarify the types of patents that must and must not be submitted for listing in the Orange Book," and clarified "that if the patent claims the drug product as defined in 21 CFR 314.3, the patent must be submitted for listing." The term "drug product" is defined by FDA as "a finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance." According to Novo:
FDA stated that a key factor in determining whether to list a patent, therefore, is whether the patent claims the finished dosage form of the approved drug product. FDA noted that these finished dosage forms include "metered aerosols, capsules, metered sprays, gels, and pre-filled drug delivery systems" but do not include "bottles or containers and other packaging."
FDA's distinction between pre-filled drug delivery systems and product packaging remains unclear, however, because the term "pre-filled drug delivery system" is not defined. The Orange Book does not list "pre-filled drug delivery systems" as a dosage form in Appendix C (Uniform Terms); nor does FDA's Data Standards Manual Dosage Form Monograph (C-DRG-00201) provide any useful guidance.
Novo's request notes that in at least one instance a defendant in a Hatch-Waxman case filed a "delisting counterclaim" seeking the removal of a device-related patent. That case, King Pharms. v. Intelliject (D. Del.), was dismissed before the court ruled on the counterclaim. Novo argues that an advisory opinion from FDA addressing Novo's questions "could reduce the likelihood of patent delisting litigation and is in the interest of judicial economy." Novo also argues that the "patent notice" and "early patent challenge" functions of the Hatch-Waxman Act would be advanced if FDA were to issue such an advisory opinion.
Novo concludes its request by informing FDA--just as GSK, AstraZeneca, and Forest previously informed FDA--that in the absence of guidance from FDA that the listing of patents on pre-filled drug delivery devices is improper, Novo will submit such patents for listing in the Orange Book.