Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd., 601 F.3d 1359 (Fed. Cir. 2010) (RADER; CLEVENGER,, concurring; DYK, dissenting) NovoNordisk04142010
MAJOR ISSUES: listing method-of-use claims with Food and Drug Administration; FDA approved uses; labeling of generic drugs; Hatch-Waxman Act; 2003 counterclaim amendment
COMMENT. The legal relationship between patent coverage of pharmaceutical drugs and methods and the process of FDA approval of applications for approval of generic equivalents is fraught with complexities, most of which trace to the 1984 Hatch-Waxman Act, known in some quarters as the “Pharmaceutical Patent Attorney Full Employment Act of 1984.”
This case, in which a three judge Federal Circuit decisions produced three opinions, addressed the 2003 Medicare Prescription Drug Improvement and Modernization Act, which authorizes counterclaims requiring a NDA holder “to correct or delete patent information submitted by the holder” to the FDA. Over a vehement dissent by Judge Dyk, the majority holds that the Act’s counterclaim provision is limited to situations in which a FDA-listed patent does not claim either an FDA-approved drug or any FDA-approved method of using the drug. The provision does not apply to a FDA listing for a patent when the patent covers only one of several FDA-approved uses of a drug but the listing covers all the FDA approved methods, unpatented as well as patented.
1. A patent owner had listed with the FDA two patents relating to its FDA approved diabetes drug (Prandin). One patent (‘035) claimed the drug’s chemical composition (repaglinide) but expired on March 14, 2009. U.S. Patent No. RE 37,035. USPatRE37035 Another patent (‘358) claimed a method for treating diabetes that combined repaglinide with another composition (metformin). U.S. Pat. No. 6,677,358. USPatNo6677358 That patent did not expire until 2018. That method was only one of three FDA-approved uses.
2. In response to an accused infringer’s counterclaim, a district court directed a patent owner to request that the FDA replace a newer, broader “use code” (U-968) for the patent owner’s FDA-approved diabetes drug (Prandin) with a former, narrower use code (U-546). The newer use code, unlike the older one, prevented a generic maker from obtaining FDA approval of a “carve-out” label for a drug.
a. The old use code (U-546) specified use of the drug in combination with metformin. With that use code, the generic drug maker could gain FDA approval of its drug with a “carve-out” label that, unlike the patent owner’s label, did not refer to the patented use in combination with metformin.
b. The new use code specified more broadly use for improving control of diabetes. The new use would cover all the FDA-approved uses, patented and unpatented. The new use code would require the generic drug maker to use a label that would encompass the patented use as well as the unpatented ones, thereby likely causing the generic drug maker to commit indirect infringement of the unexpired method-of-use patent, the label being active inducment of patients to use the drug in an infringing manner (with metformin).
3. The Federal Circuit majority held that the district court’s order was erroneous as beyond the scope of the 2003 amendent’s authorization of counterclaims.4. UNAMBIGUOUS STATUTORY LANGUAGE: “AN” MEANS “ANY,” NOT “ALL.” The Act was unambiguous in its limitation to situations in which a patent did not claim the drug or “an” approved method.
a. TEXT. The text of the counterclaim amendment is as follows:
`(ii) Counterclaim to infringement action.–
(I) In general.–If an owner of the patent or the holder of the approved application under subsection (b) of this section 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 subsection (b) or (c) of this section 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.‘
21 U.S.C. § 355(j)(5)(C)(ii) (emphases added).”
b. GRAMMAR. Under “standard grammar,” the “an” word in the phrase meant “any,” not all, as the generic drug maker argued. Here, the patent did cover one of three FDA-approved methods. Therefore, no correction of patent information was authorized by the Act.
5.LEGISLATIVE HISTORY; RESPONSE TO MYLAN (2002). The 2003 Act’s legislative history provided no “clear intent to the contrary.” The Act’s counterclaim provision responded to Mylan Pharms., Inc. v. Thompson, 268 F.3d 1323 (Fed. Cir. 2002). In Mylan, a patent owner listed a patent that was “not related at all” to the FDA-drug or an FDA-approved method of using the drug. In Mylan, the court held that an accused generic maker had not remedy against the listing patent owner.
6. The proper, narrower construction of the counterclaim provision was consistent with the purposes of the Hatch-Waxman Act. With a broad use code, a generic maker must prove that its use does not overlap a patented use. This proof is through a Paragraph IV certification and suit, which will fully test “for infringement and its implications, including potential health and safety risks.” The generic maker cannot simply use a “carve-out” certification under “section viii” (21 U.S.C. § 355(j)(2)(A)(viii)).
7. “PATENT INFORMATION.” The counterclaim provision only provides for correction or deletion of “patent information.”
a. PATENT NUMBER AND EXPIRATION DATE. “Patent information” under the Act refers only to a patent’s number and expiration date. Thus, the provision does not include a “use code narrative.”
b. PRE-2003 ACT FDA INTERPRETATION OF “PATENT INFORMATION.” Six months prior to the 2003 Act, the FDA adopted a regulation with a broader interpretation of “patent information,” which included use code narratives. However, that interpretation cannot override the plain language of the subsequent statute.
8. CLEVENGER, CONCURRING. Concurring, Judge Clevenger took issue with the dissent. Contrary to the dissent’s suggestion, the patent owner here did nothing illegal. The FDA “gummed up the works” by “requiring a single broad indication” for the drug.
9. DYK, DISSENTING. In dissent, Judge Dyk argued at length that the majority’s interpretation was erroneous and contrary Congress’ purpose in enacting the counterclaim provision, which was “to permit the courts to order correction of information published in the [FDA’s] Orange Book.”
CROSS REFERENCES. On the Hatch-Waxman Act, see Chisum Patent Law Digest 5674; Chisum on Patents 16.03[d].