DC order for Jazz to delist “computer-implemented system” claims from Orange Book affirmed

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC

Docket No. 2023-1186 (https://cafc.uscourts.gov/opinions-orders/23-1186.OPINION.2-24-2023_2085825.pdf)


February 24, 2023

Brief Summary:   DC order for Jazz to delist “computer-implemented system” claims from OB affirmed.

Summary:  Jazz appealed DC grant of an injunction motion brought by Avadel regarding the Orange Book (OB) U.S. Pat. No. 8,731,963 directed to “[a] computer-implemented system for treatment of a narcoleptic patient with a prescription drug that has a potential for misuse, abuse or diversion, comprising: one or more computer memories” and “a data processor”, including dependent claim 6 directed in which “the prescription drug comprises gamma hydroxyl butyrate (GHB)” (“Jazz’s single-pharmacy distribution system, which controls access to abuse-prone prescription drugs prescribed to narcolepsy patients through a central pharmacy and computer database by tracking prescriptions, patients, and prescribers.”)   Jazz listed the ‘963 patent in the OB “as covering a method of using Xyrem”.  Twenty-eight of the claims were found unpatentable following an IPR brought by Amneal (IPR2015-01903) and the remaining claims expired in December 2022.  However, pediatric exclusivity extended the date the FDA could approve follow-on products to June 2023.  Avadel filed an “505(b)(2)” (now 355(b)(2)) NDA for its GHB-based drug FT2018 in December 2020 and was required to file a certification regarding the ‘963 patent.  Jazz then sued Avadel, and “Avadel contemporaneously sued the FDA, alleging that it violated the Administrative Procedure Act (‘APA’) by requiring certification over the ’963 patent.” The FC panel opinion noted that “the FDA does not verify that submitted patents actually meet statutory listing criteria, nor does [it] proactively remove improperly listed patents” (Apotex, FC 2003).  It also explained that “[a]nother remedy for an improper listing is for an accused infringer to counterclaim when it is sued, seeking an order requiring the patent owner to correct or delete a listing”.  The DC therefore dismissed Avadel’s suit against the FDA, and Avadel responded to Jazz with “a counterclaim seeking delisting of the ’963 patent for failure to claim a drug or method of use.”  The DC then “ordered Jazz to ask the FDA to delist the ’963 patent” as it did not claim a drug or method of use and was therefore inappropriate for listing on the OB, Jazz filed a notice of appeal, and the FC issued a temporary stay.  In this appeal, Jazz argued the DC “abused its discretion in finding that the ’963 patent is not a method-of-use patent for listing and delisting purposes under the FDCA” and “in determining that § 355(c)(3)(D)(ii)(I) provides a delisting remedy.”  Jazz argued that the ‘963 patent claims “elements of a REMS-based procedure to ensure that Xyrem® can be safely prescribed by doctors and safely used by patients” and that “the word ‘system’ as it appears in the ’963 patent claims is, essentially, a synonym for “method’”.  The FC panel explained that “method claims require the performance of steps; claims that describe physical components of a whole are system, or apparatus, claims” (Finjan, FC 2010; In re Kollar, FC 2002), the ‘963 claims “recite ‘an assemblage of components,’ defining a system”, and not a method (MasterMine, FC 2017; HTC, 2012), and that section 314.53 “narrows [the] category of listable patents to those that (1) claim methods of use, wherein (2) those methods of use are directly relevant to the NDA in question”.  It also noted that the FDA has not “definitively answered” whether REMS patents belong in the OB.  The FC panel also found the DC’s order requiring delisting was proper under section 355(c)(3)(D)(ii)(I).  The DC decision was therefore affirmed.

This entry was posted in Claim Construction, Generics / ANDA, Injunction, Method claims. Bookmark the permalink.

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