Merck & Co., Inc. v. Hi-Tech Pharmacal Co., Inc.

• Decision Date: 29 March 2007
• Docket Number: No. 2006-1401.,2006-1401.
• Citation: 482 F.3d 1317
• Parties: MERCK & CO., INC., Plaintiff-Appellee, v. HI-TECH PHARMACAL CO., INC., Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

482 F.3d 1317

MERCK & CO., INC., Plaintiff-Appellee, v. HI-TECH PHARMACAL CO., INC., Defendant-Appellant.

No. 2006-1401.

United States Court of Appeals, Federal Circuit.

March 29, 2007.

Robert L. Baechtold, Fitzpatrick, Cella, Harper & Scinto, of New York, New York, argued for plaintiff-appellee. With him on the brief was Bruce M. Wexler.

William L. Mentlik, Lerner, David, Littenberg, Krumholz & Mentlik, LLP, of Westfield, New Jersey, argued for defendant-appellant. With him on the brief was Roy H. Wepner. Of counsel on the brief was Alfred B. Engelberg, of Palm Beach, Florida.

Before LINN, Circuit Judge, FRIEDMAN and PLAGER, Senior Circuit Judges.

LINN, Circuit Judge.

This case presents the question of whether a patent term extension under the Hatch-Waxman Act, 35 U.S.C. § 156, may be applied to a patent subject to a terminal disclaimer under 35 U.S.C. § 253, filed to overcome an obviousness-type double-patenting rejection. Because the language of § 156 is unambiguous and fulfills a purpose unrelated to and not in conflict with that of § 253, we hold that a Hatch-Waxman term extension may be so applied.

I. BACKGROUND

Merck & Co, Inc. ("Merck") is the inventor of TRUSOPT®, a drug used to treat glaucoma. On June 26, 1987, Merck filed a patent application covering certain carbonic anhydrase inhibitors, including dorzolamide, which is the active ingredient in TRUSOPT®. That patent application eventually issued as United States Patent No. 4,797,413 (the "'413 patent"). During prosecution of the '413 patent, the examiner rejected all claims on the ground of obviousness-type double patenting over the claims of an earlier patent also owned by Merck. That patent, U.S. Patent No. 4,677,115 (the "'115 patent"), issued on June 30, 1987. To overcome this rejection, Merck filed a terminal disclaimer under 35 U.S.C. § 253. The terminal disclaimer disavowed any term of the '413 patent that would extend beyond June 30, 2004, the original term of the '115 patent (17 years from its date of issue). The filing of the terminal disclaimer was accepted by the Examiner as overcoming the double-patenting rejection and, on January 10, 1989, the '413 patent was granted.

In 1994, the Uruguay Round Agreements Act (URAA) was enacted. That act "harmonize[d] the term provision of United States patent law with that of our leading trading partners which grant a patent term of 20 years from the date of filing of the patent application." Merck & Co. v. Kessler, 80 F.3d 1543, 1547 (Fed.Cir.1996). Under the URAA, the term of a patent then in force was amended to the greater of 20 years from its earliest effective filing date or 17 years from its date of issue. See 35 U.S.C. § 154(a)(2), (c)(1). The '115 patent was subject to the URAA, and consequently, its expiration date was reset by operation of law to December 12, 2004 (twenty years from the filing date of the '115 patent). Because the terminal disclaimer linked the expiration date of the '413 patent to the term of the '115 patent, the expiration date of the '413 patent likewise was reset to December 12, 2004.

Merck sought and received approval from the United States Food & Drug Administration ("FDA") to market TRUSOPT®. As part of the approval process, Merck was required to submit information to the FDA on any patent that claims the approved drug or method of using the drug, and for which a claim of patent infringement could reasonably be asserted against an unauthorized party. See 21 U.S.C. § 355(b)(1). The FDA publishes patent information on approved drug products in the "Orange Book," a register that provides notice of patents covering name brand drugs. The Orange Book shows that the '413 patent covers TRUSOPT®. See Approved Drug Products with Therapeutic Equivalence Evaluation (the "Orange Book").

On March 20, 1997, at the request of Merck and pursuant to 35 U.S.C. § 156, the Patent and Trademark Office (the "PTO") extended the term of the '413 patent based on the period of regulatory review undertaken by the FDA of Merck's TRUSOPT® drug. The PTO granted the patent term extension for a period of 1233 days and calculated the extension to run from the effective date of the terminal disclaimer, i.e., December 12, 2004. Based on the patent term extension, the expiration date of the '413 patent thus became April 28, 2008.

The patent infringement dispute at issue here began in August 2005, when Hi-Tech Pharmacal Co., Inc. ("High-Tech") filed with the FDA Abbreviated New Drug Application Nos. 77-846 and 77-847 ("ANDA Nos. 77-846 and 77-847") for a generic version of a drug containing the active ingredient dorzolamide and used in drops for the treatment of ocular hypertension. The Federal Food, Drug, and Cosmetic Act requires that an ANDA application contain a certification for each patent listed in the Orange Book for the brand-name drug. This certification must state one of the following: (i) that the required patent information relating to such patent has not been filed; (ii) that such patent has expired; (iii) that the patent will expire on a particular date; or (iv) that such patent is invalid or will not be infringed by the drug for which approval is being sought. 21 U.S.C. § 355(b)(2)(A). The ANDA applicant who certifies, under paragraph iv, that a listed patent is invalid or not infringed, must, among other things, notify the patent owner that it has filed an ANDA containing a patent challenge. 21 U.S.C. § 355(b)(3). Pursuant to these rules, Hi-Tech sent a paragraph iv patent certification notice to Merck, stating that Hi-Tech's generic eye-drops do not infringe the '413 patent. In response, on January 18, 2006, Merck sued Hi-Tech for infringement pursuant to 35 U.S.C. § 271(c)(2)(A), alleging that the filing of ANDA Nos. 77-846 and 77-847 was an act of infringement. Hi-Tech answered that the patent had expired on December 12, 2004 and was not enforceable after that date.

On March 1, 2006, Hi-Tech filed a motion to dismiss pursuant to Fed.R.Civ.P. 12(b)(6) on the ground that while its products were covered by the claims of the '413 patent, the terminal disclaimer foreclosed the patent term extension and the '413 patent therefore expired on December 12, 2004. On April 3, 2006, Merck filed a cross-motion for judgment on the pleadings on the ground that the terminal disclaimer did not foreclose the Hatch-Waxman term extension, arguing that the reasoning of King Pharmaceuticals, Inc. v. Teva Pharmaceuticals, Inc., 409 F.Supp.2d 609 (D.N.J.2006), should apply.

On April 25, 2006, the district court entered a final judgment, denying Hi-Tech's motion to dismiss and granting Merck's motion for judgment on the pleadings. See Merck & Co. v. Hi-Tech Pharmacal Co., Nos. 06-266 and 06-268 (D.N.J. April 25, 2006). The District Court adopted the reasoning of King Pharmaceuticals and enjoined Hi-Tech from commercializing the drug claimed in the '413 patent until the end of the patent term extension, i.e., until April 28, 2008. See Merck, Nos. 06-266 and 06-268, slip op. at 2. Hi-Tech timely appealed to this court. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).

II. DISCUSSION

A. Standard of Review

As with Rule 12(b)(6) motions, the question of whether a motion for judgment on the pleadings was properly granted is a purely procedural question not pertaining to patent law, to which this court applies the rule of the regional circuit. See C & F Packing Co. v. IBP, Inc., 224 F.3d 1296, 1306 (Fed.Cir.2000). The Third Circuit exercises plenary review of such Rule 12(c) motions using the same standard as the district court. E.g., CoreStates Bank, N.A. v. Huls Am., Inc., 176 F.3d 187, 193 (3d Cir.1999). The only debated question in this case—the scope of 35 U.S.C. § 156—is a question of statutory construction, over which we also exercise plenary review. NTP, Inc. v. Research In Motion, Ltd., 418 F.3d 1282, 1314 (Fed. Cir.2005).

B. Analysis

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act"), 98 Stat. 1585, which amended the Federal Food, Drug, and Cosmetic Act and the patent laws. The issue in this case concerns the proper interpretation of a portion of § 201 of the Hatch-Waxman Act, codified at 35 U.S.C. § 156.

This provision established a patent term extension for patents relating to certain products subject to regulatory delays that could not be marketed prior to regulatory approval. Section 156 provides an extension of up to five years if certain conditions are met. The conditions are set forth in the five numbered sub-paragraphs of § 156(a).

35 U.S.C. § 156 provides, in relevant part:

(a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section from the original expiration date of the patent, which shall include any patent term adjustment granted under section 154(b), if

(1) the term of the patent has not expired before an application is submitted under subsection (d)(1) for its extension;

(2) the term of the patent has never been extended under subsection (e)(1) of this section;

(3) an application for extension is submitted by the owner of record of the patent or its agent and in accordance with the requirements of paragraphs (1) through (4) of subsection (d);

(3) the product has been subject to a regulatory review period before its commercial marketing or use;

(5)(A) except as provided in subparagraph (B) or (C) [not relevant in this case], the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial marketing or use of the product under the provision of law under which such regulatory review period occurred.

35 U.S.C. § 156(a) (emphasis added).

Hi-Tech does not challenge that the '413 patent meets each of the enumerated conditions of § 156 but rather contends that as a condition for the lifting of the double-patenting...