60 F.4th 1373
Fed. Cir.2023Background
- Jazz owns NDA for Xyrem (sodium oxybate/GHB), approved with REMS due to abuse risk; REMS originally required a single-pharmacy distribution system.
- U.S. Patent No. 8,731,963 (’963 patent) claims a "computer-implemented system" (single database, pharmacy tracking, data processor queries) tied to REMS distribution; Jazz listed the patent in the Orange Book as a method-of-use patent in 2014.
- Avadel filed an NDA for a competing GHB product (FT218) in 2020; FDA required Avadel to certify with respect to the ’963 patent; Jazz sued Avadel for infringement.
- Avadel counterclaimed under 21 U.S.C. § 355(c)(3)(D)(ii)(I) seeking an order to correct/delete the Orange Book listing, arguing the ’963 patent does not claim a drug or approved method of using the drug.
- The district court construed the ’963 claims as system (not method) claims and ordered Jazz to ask the FDA to delist the patent; the Federal Circuit affirmed, lifting a stay and directing Jazz to request delisting.
Issues
| Issue | Jazz's Argument | Avadel's Argument | Held |
|---|---|---|---|
| Whether the ’963 patent claims an "approved method of using the drug" for Orange Book listing | The claims effectively recite REMS-based steps/conditions of use and thus constitute a listable method | The claims are apparatus/system claims (computer memories, data processor) not method claims | Court: claims are system claims; not listable as a method-of-use patent |
| Whether 21 C.F.R. § 314.53 (and related statutory language) broadens "method" to include REMS/system patents and warrants Chevron deference | §314.53 shows "conditions of use"/method language includes REMS elements; FDA interpretation should be deferred to | §314.53 does not convert system claims into method claims; the statutory listing term borrows patent-law meaning and FDA has no definitive rule here | Court: §314.53 does not broaden "method" to cover system/REMS patents; Chevron deference not applicable |
| Whether § 355(c)(3)(D)(ii)(I) provides a delisting remedy now even if listing may have been permissive earlier | Because listing the patent in 2014 was at least permissive, accused infringers cannot invoke the delisting remedy now | The statute permits an accused infringer to seek correction/deletion if the patent does not claim the drug or an approved method of use, regardless of earlier permissive listing | Court: § 355(c)(3)(D)(ii)(I) provides an available delisting remedy; ordered Jazz to request delisting |
Key Cases Cited
- Apotex, Inc. v. Thompson, 347 F.3d 1335 (Fed. Cir. 2003) (FDA Orange Book duties are ministerial; FDA does not adjudicate listing correctness)
- Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (2012) (statutory framework for Orange Book listings and counterclaim remedies)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claims define the invention; claim construction principles)
- Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996) (look to claim language and intrinsic evidence for claim scope)
- Finjan, Inc. v. Secure Computing Corp., 626 F.3d 1197 (Fed. Cir. 2010) (distinguishing apparatus/system claims from method claims)
- In re Kollar, 286 F.3d 1326 (Fed. Cir. 2002) (product/apparatus vs. process claim distinction)
- MasterMine Software, Inc. v. Microsoft Corp., 874 F.3d 1307 (Fed. Cir. 2017) (functional language in system claims does not convert them into method claims)
- Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (claim construction reviewed de novo)