Arnold Partnership v. Dudas, 03-1339.

• Decision Date: 24 March 2004
• Docket Number: No. 03-1339.,03-1339.
• Citation: 362 F.3d 1338
• Parties: The ARNOLD PARTNERSHIP, Plaintiff-Appellant, v. Jon DUDAS, Acting Under Secretary of Commerce for Intellectual Property and Acting Director, Patent and Trademark Office, and Nicholas P. Godici, Commissioner for Patents, Defendants-Appellees.
• Court: U.S. Court of Appeals — Federal Circuit

362 F.3d 1338

The ARNOLD PARTNERSHIP, Plaintiff-Appellant, v. Jon DUDAS, Acting Under Secretary of Commerce for Intellectual Property and Acting Director, Patent and Trademark Office, and Nicholas P. Godici, Commissioner for Patents, Defendants-Appellees.

No. 03-1339.

United States Court of Appeals, Federal Circuit.

DECIDED: March 24, 2004.

Christopher N. Sipes, Covington & Burling, of Washington, DC, argued for plaintiff-appellant.

Linda Moncys Isacson, Associate Solicitor, Office of the Solicitor, United States Patent and Trademark Office, of Arlington, VA, argued for defendants-appellees. With her on the brief were John M. Whealan, Solicitor; and Raymond T. Chen, Associate Solicitor.

Donald O. Beers, Arnold & Porter, of Washington, DC, for amicus curiae GlaxoSmithKline. With him on the brief was David E. Korn. Of counsel on the brief was Scott A. Chambers, Patton Boggs, LLP, of McLean, VA.

Before RADER, BRYSON, and DYK, Circuit Judges.

RADER, Circuit Judge.

On summary judgment, the United States District Court for the Eastern District of Virginia ruled that the United States Patent and Trademark Office (PTO) properly denied an application for extending the term of U.S. Patent No. 4,587,252 under 35 U.S.C. § 156. Arnold P'ship v. Rogan, 246 F.Supp.2d 460 (E.D.Va.2003). Because the district court did not err in upholding the PTO's interpretation of § 156, this court affirms.

I.

The Arnold Partnership (Arnold) is the owner of record for the '252 patent, which claims compositions comprising hydrocodone (or a salt thereof) and ibuprofen (or a salt thereof) as well as methods of treating pain with those compositions.¹ The '252 patent was filed on December 18, 1984, was issued on May 6, 1986, and is due to expire on December 18, 2004. The commercial embodiment of the '252 patent is Vicoprofen® — a combination of hydrocodone bitartrate (a salt of hydrocodone) and ibuprofen. Because these components had only been available separately, the Food and Drug Administration (FDA) required a New Drug Application (NDA) before clearing Vicoprofen for the market.

The marketing applicant for Vicoprofen, Knoll Pharmaceuticals (Knoll), filed an Investigational New Drug Application (IND) with FDA on December 30, 1986. Knoll later filed an NDA on April 25, 1996, which FDA approved on September 23, 1997. Abbott Labs has since succeeded Knoll as both the exclusive licensee of the '252 patent and the holder of the Vicoprofen NDA.

On November 20, 1997, Arnold filed an application with the PTO for patent term restoration under 35 U.S.C. § 156. The PTO denied the application solely because Vicoprofen did not comply with the "first commercial marketing" requirement of § 156(a)(5)(A). The PTO reasoned that both hydrocodone and ibuprofen had been marketed previously either alone or in combination with other active ingredients. For this reason, the PTO determined the patent was not eligible for patent term extension to compensate for the period of regulatory review. In particular, hydrocodone bitartrate had been marketed in conjunction with various other active ingredients, including acetaminophen and aspirin. Ibuprofen had been marketed alone.

Arnold then filed suit in the United States District Court for the Eastern District of Virginia challenging the PTO's denial under the Administrative Procedure Act (APA). Arnold argued that the combination of hydrocodone and ibuprofen was an active ingredient within the meaning of § 156. According to Arnold, the statute permits extension of a combination drug product when the combination itself had not been previously on the market. Specifically, Arnold argued that the statute examines a drug product as a whole and not on a component-by-component basis. Because hydrocodone and ibuprofen were never marketed previously in combination with one another, Arnold argued that the patent claiming the two in combination deserves an extension. The district court, however, agreed with the PTO's interpretation of the statute and affirmed the agency's denial of an extension to the '252 patent.

II.

This court reviews a district court's grant of summary judgment without deference, reapplying the same standard as the district court. Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1353 (Fed.Cir.1998). Because Arnold brought this case under the APA, this court may reverse the PTO's final decision denying patent term extension if the decision is "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." 5 U.S.C. § 706(2)(A); see also Dickinson v. Zurko, 527 U.S. 150, 154, 119 S.Ct. 1816, 144 L.Ed.2d 143 (1999). An abuse of discretion occurs if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. In re Gartside, 203 F.3d 1305, 1315-16 (Fed.Cir.2000).

This court reviews statutory interpretation, the central issue in this case, without deference. Merck & Co. v. Kessler, 80 F.3d 1543, 1549-50 (Fed.Cir.1996). When construing a statute, the language of the statute controls its meaning. Ardestani v. Immigration & Naturalization Serv., 502 U.S. 129, 135, 112 S.Ct. 515, 116 L.Ed.2d 496 (1991). The statutory language on patent term extensions states:

(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);

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

(5)

(A) ... 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;

* * *

(f) For purposes of this section:

(1) The term "product" means:

(A) A drug product.

* * *

(2) The term "drug product" means the active ingredient of —

(A) a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act) ...

including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient.

35 U.S.C. § 156 (2004).

In rejecting the application for a patent term extension, the PTO asserted that Arnold did not satisfy the fifth condition under subsection (a) — the "first commercial marketing requirement." That subsection refers to "the product," a term defined in subsection (f). Subsection (f) defines "the product" as "a drug product." The subsection further defines "a drug product" as "the active ingredient of a new drug ... product ... including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient." Thus, in simple terms, the statute permits extension for a patent claiming an active ingredient of a new drug product.

This statutory language requires this court to examine a drug product patent's eligibility for extension on a component-by-component, or an ingredient-by-ingredient basis. The final phrase in subsection (f) — "including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient" — emphasizes this point. This final phrase of subsection (f) shows that the statute refers to a drug product on a component-by-component basis, not as a whole.

A closer examination of this statutory language confirms this meaning. The subsection uses the disjunctive to show that the drug product may consist of either a single active ingredient or an active ingredient in combination with another active ingredient. Thus, the statute places a drug product with two active ingredients, A and B, in the same category as a drug product with a single active ingredient. In both instances, those active ingredients individually qualify for examination under the first permitted marketing requirement. To extend the term of a patent claiming a composition comprising A and B, either A or B must not have been previously marketed. In other words, at least one of the claimed active ingredients must be new to the marketplace as a drug product. In this respect, the district court's opinion correctly summarizes: "Even though a drug may contain two or more active ingredients in combination with each other, for the purpose of patent extension that drug is defined through reference to only one of those active ingredients; the other active ingredient or ingredients are merely `in combination' with this first active ingredient." Arnold P'ship, 246 F.Supp.2d at 464-65. This court has not found any statutory history that contradicts this straightforward reading of the statute, particularly none that would qualify as a "most extraordinary showing" to "justify a limitation on the `plain meaning' of the statutory language." Garcia v. United States, 469 U.S. 70, 75, 105 S.Ct. 479, 83 L.Ed.2d 472 (1984).

Section 1 of title 1 of the United States Code does not change this meaning of the...