‚As part of the ANDA process, a generic manufacturer must make a certification addressing each patent identified in the Orange Book pertaining to its drug. 21 U.S.C. § 355(j)(2)(A)(vii). Specifically, the generic manufacturer must select one of four alternatives permitting use of the patented product or process: … (III) the patent is set to expire on a certain date [referred to as a Paragraph III certification]; or (IV) the patent is invalid or will not be infringed by the manufacture, use or sale of the generic drug. 21 U.S.C. § 355(j)(2)(A)(vii) [referred to as a Paragraph IV certification]. … If a generic manufacturer wishes to seek FDA approval for a use not covered by a method-of-use patent for a listed drug, it must make a “section viii statement”. 21 U.S.C. § 355(j)(2)(A)(viii). Along with the Section viii statement, the generic manufacturer must submit a proposed label to the FDA that does not contain the patented method of using the listed drug. When considering approval of these requests for a use not covered by a patent, the FDA relies on the applicable patent's use code narrative to determine the scope of the patented method [as discussed below]’. Novo, 601 F.3d at 1361.
2.
21 U.S.C. § 355(j)(5)(C)(ii) reads: (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. (II) No independent cause of action. — Subclause (I) does not authorize the assertion of a claim described in subclause (I) in any civil action or proceeding other than a counterclaim described in subclause (I).
3.
The '358 patent issued with the following five claims:.
4.
A pharmaceutical composition comprising repaglinide and metformin together with a suitable carrier.
5.
A pharmaceutical composition of claim 1 provided in the form of a tablet.
6.
A pharmaceutical composition of claim 1 provided in the form of a capsule.
7.
A method for treating non-insulin dependent diabetes mellitus (NIDDM) comprising administering to a patient in need of such treatment repaglinide in combination with metformin. 5. A kit for use in the treatment of a patient having non-insulin dependent diabetes mellitus (NIDDM), said kit comprising an amount of repaglinide formulated for administration to said patient and an amount of metformin formulated for administration to said patient.
21 U.S.C. § 355(b)(1)(G) states: The applicant shall file with the application 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 (emphasis added).
10.
The Supreme Court's ruling in Chevron USA, Inc. v. Natural Resources Defense Council, Inc., 467 US 837 (1984), set forth the legal test for determining whether to grant deference to a government agency's interpretation of its own statutory mandate. In a subsequent decision the Supreme Court summarized Chevron deference by stating ‘[w]hen a statute speaks clearly to the issue at hand we” must give effect to the unambiguously expressed intent of Congress”, but when the statute “is silent or ambiguous” we must defer to a reasonable construction by the agency charged with its implementation’. Barnhart v. Thomas, 540 US 20, 26 (2003).
11.
Novo's suit was dismissed for lack of jurisdiction but ‘Novo Nordisk has vowed to sue again and Mylan may need to file a counterclaim under the statute at issue here’. Id.
