Orange Book Patent Delisting Counterclaim Raised in 505(b)(2) Application Patent Infringement Litigation; Decision Could Provide Guidance on Drug Delivery System Patent Listability

By Kurt R. Karst –      

In what is, to our knowledge, the first instance in which a company has asserted the patent delisting counterclaim provisions added by the Medicare Modernization Act (“MMA”) in the context of a 505(b)(2) application – and even in the context of an ANDA outside of a patent use code challenge – Intelliject, Inc. (“Intelliject”) alleges in a recent court filing that U.S. Patent No. 7,794,432 (“the ‘432 patent”), which is listed in the Orange Book for Meridian Medical Technologies, Inc.’s (“Meridian’s”) EpiPen and EpiPen Jr Auto-Injectors (epinephrine injection) solution, 0.3mg/ml and 0.415/0.3 ml, approved under NDA No. 19-430, must be delisted from the Orange Book.  Intelliject’s request for a court order requiring Meridian to remove – or “delist” – the ‘432 patent from the Orange Book is among several counterclaims Intelliject asserts in responding to Meridian’s patent infringement lawsuit filed in the U.S. District Court for the District of Delaware after Intelliject notified Meridian of Paragraph IV certifications to the ‘432 patent and U.S. Patent No. 7,449,012 (“the ‘012 patent”) included in Intelliject’s 505(b)(2) application No. 201739 for its “epi-Card” epinephrine product.  Among other things, a court decision could provide an answer to a question posed to FDA several years ago about drug delivery device patent Orange Book listings. 

The patent delisting counterclaim provisions at FDC Act §505(c)(3)(D)(ii)(I) applicable to 505(b)(2) applications, as added by the MMA, state that:

If an owner of the patent or the holder of the approved application under FDC Act § 505(b)] for the drug that is claimed by the patent or a use of which is claimed by the patent brings a patent infringement action against the applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by the holder under FDC Act § 505(b) or (c)] on the ground that the patent does not claim either – (aa) the drug for which the application was approved; or (bb) an approved method of using the drug.

The MMA also added almost identical counterclaim provisions at FDC Act §505(j)(5)(C)(ii)(I) applicable to ANDA sponsors.  Both counterclaim provisions refer to  FDC Act §§ 505(b) and (c), under which an NDA holder must submit with its application and after NDA approval “the patent number and the expiration date of 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.”

The ‘432 patent, which is titled “Automatic injector with kickback attenuation,” is listed in the Orange Book as a drug product patent.  Intelliject alleges in the company’s patent delisting counterclaim that “[t]he ‘432 patent does not claim either a composition or a formulation of epinephrine” and “does not disclose a composition or a formulation of epinephrine.”  Because “the ‘432 patent does not claim either the drug for which Meridian’s NDA was approved or an approved method of using the drug,” according to Intelliject, “the ‘432 patent must be delisted from the Orange Book” pursuant to FDC Act §505(c)(3)(D)(ii)(I).

The ‘432 patent, which was issued on September 14, 2010, appears to be in a general class of drug delivery system patents that some NDA sponsors have decided to submit to FDA for Orange Book listing.  As we previously reported, since 2005, FDA has received, but has not substantively responded to, several advisory opinion requests on the Agency’s policy for the submission of patents for Orange Book listing that cover drug delivery systems.  For example, one 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 [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 requests were 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.” 

A court decision with respect to Intelliject’s ‘432 patent delisting counterclaim, although limited to that patent, could provide some helpful guidance on the listability of similar patents – as well as fodder for other companies challenging or defending similar patents.  (And for those of you wondering, if there is a court order requiring the delisting of the ‘432 patent, it would not result in a “failure-to-market” event triggering a forfeiture of 180-day exclusivity under FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC), because, according to FDA’s Paragraph IV Certification List, the first ANDA submitted to FDA containing a Paragraph IV certification occurred a few years ago when the only Orange Book-listed patent was the ‘012 patent.)