Supreme Court Grants Certiorari: Caraco Pharmaceuticals v. Novo Nordisk

June 29, 2011 – Blog Post

This entry updates the original entry regarding this case posted on January 12, 2011. The Supreme Court granted certiorari with respect to the Federal Circuit’s decision in Caraco Pharmaceutical v. Novo Nordisk.

To refresh the reader’s memory, when an ANDA is filed, the ANDA holder must address each patent listed in the Orange Book as covering, among other things, methods of using the approved product. Specifically, the ANDA holder must either certify that each such patent is expired will expire prior to launch of the ANDA product, or that the patent is not infringed, invalid, and/or unenforceable.

Absent one of these certifications, an ANDA holder may only receive approval if it seeks approval of a method of use not claimed by any patent listed in the Orange Book. Since the FDA is not an expert on patent law, it relies upon the NDA holder/patentee to provide information regarding the scope of the patent(s) listed in the Orange Book. As part of this information, the ANDA applicant must provide “a description of the patented method of use. . .” 21 C.F.R. § 314.53(c)(2)(ii)(2)(P). This description is called a “use code.” The FDA relies upon the use code to determine whether an ANDA applicant is seeking approval for a method of use claimed by a patent listed in the Orange Book.

Caraco sought approval of a generic version of Prandin®, a diabetes drug with an active pharmaceutical ingredient of repaglinide. The patent to repaglinide is expired. Novo Nordisk also had an Orange Book listed patent claiming the combination of repaglinide and metformin to treat diabetes. Novo Nordisk sued Caraco on the combination patent. When Caraco initially filed its ANDA, Novo Nordisk’s use code stated “Use of repaglinide in combination with metformin to lower blood glucose.” Caraco amended its Paragraph IV statement to “carve-out” the combined use and only sought approval for the use of repaglinide, by itself, to lower blood glucose. The FDA indicated that such a carve out would be approved. Prior to approval, however, Novo Nordisk amended its use code to read “A method for improving glycemic control in adults with type 2 diabetes mellitus.” The change in use code did not permit a “carve out” as it was not limited to repaglinide in combination with metformin. Accordingly, the FDA decided not to approve Caraco’s ANDA with the carve out.

Caraco filed a counterclaim against Novo Nordisk in the district court, seeking summary judgment and an injunction against Novo Nordisk from amending the use code. The district court granted the injunction. Novo Nordisk appealed. The Federal Circuit reversed, finding that the counterclaim provision of the Hatch Waxman act was limited to situations where the listed patent did not claim any of the approved methods of using the drug. The Federal Circuit further held that the provisions of the Hatch Waxman permitting counterclaims were limited to improper listing of “patent information” as covering approved methods of using a drug and that use codes were not “patent information” as defined by the statute. A rehearing en banc was denied. Caraco sought writ of certiorari to the Supreme Court.

A number of amici curiae briefs were filed with the Supreme Court, including a brief from the Solicitor General pursuant to an invitation from the Supreme Court. The Solicitor General and the generic pharmaceutical industry took the position that the Federal Circuit’s decision should be reversed because the intent of the Hatch Waxman Act was to foster the availability of generic versions of brand name drugs. The Solicitor General asked the Supreme Court to reverse for three reasons: (1) the Federal Circuit read the Hatch Waxman counterclaim provision too broadly – a counterclaim can be asserted if the NDA holder’s use code is misleading as indicating that the patent(s) listed in the Orange Book covers an approved method, especially the particular method of use for which the ANDA applicant seeks approval, even if patent(s) also cover different methods of use; (2) the Federal Circuit’s definition of “patent information” to exclude use codes was unduly restrictive; and (3) the Federal Circuit’s interpretation is inconsistent with Congress’ clear intent to curb any exaggerated claims by an NDA holder regarding the scope of its patent protection.

The Supreme Court’s grant of writ of certiorari will have an important impact on the availability of counterclaims to ANDA holders when use codes are expansively worded by the NDA holder to avoid carve outs. An affirmance of the Federal Circuit’s decision would like cause more NDA holders to use this strategy to delay generic entry and expose ANDA holders to a greater likelihood of infringement suits based upon potentially improper use codes. Alternatively, a reversal of the Federal Circuit’s decision would make it more likely that ANDA holders would seek and obtain relief from potentially improper use codes, thereby, possibly increasing the speed at which generic pharmaceuticals will become available to the general public.