Photocure Asa v. Dudas

• Decision Date: 31 March 2009
• Docket Number: Civil Action No. 1:08-cv-718.
• Parties: PHOTOCURE ASA, Plaintiff, v. Jon W. DUDAS, et al., Defendants.
• Court: U.S. District Court — Eastern District of Virginia

622 F.Supp.2d 338

PHOTOCURE ASA, Plaintiff, v. Jon W. DUDAS, et al., Defendants.

Civil Action No. 1:08-cv-718.

United States District Court, E.D. Virginia, Alexandria Division.

March 31, 2009.

Erik Craig Kane, John Worthington Bateman, Kenyon & Kenyon LLP, Washington, DC, for Plaintiff.

Dennis Carl Barghaan, Jr., United States Attorney's Office, Alexandria, VA, for Defendants.

MEMORANDUM OPINION

LIAM O'GRADY, District Judge.

In this action, Plaintiff PhotoCure seeks to extend the term of its drug patent, which was effectively shortened by the lengthy Food and Drug Administration ("FDA") approval process. 35 U.S.C. § 156 (2006) permits patent term extensions in such circumstances, provided that the applicant meets specific statutory elements. One such element requires that the drug be the first permitted commercial marketing or use of "the product." 35 U.S.C. § 156(a)(5)(A) (2006). On May 13, 2008, the Defendants, employees of the United States Patent and Trademark Office ("USPTO"), denied PhotoCure's application for a patent term extension under "the product" provision. PhotoCure now appeals this decision. The question presented herein is whether the patented drug supporting the term extension application at issue meets the requirement of § 156(a)(5)(A) that the use of "the product" following FDA approval constitutes the first commercial marketing or use. The Court holds that the patented drug in this case meets the above statutory requirement.

I. BACKGROUND

On March 7, 2000 the USPTO issued U.S. Patent No. 6,034,267 (the "'267 patent") entitled "Esters of 5-Aminolevulinic Acid as Photosensitizing Agents in Photochemotherapy." The patent lists Plaintiff PhotoCure as the assignee. The '267 patent claims both a pharmaceutical compound called methyl aminoevulinate hydrochloride ("MAL hydrochloride"), and a method of using that compound to treat actinic keratoses through a technique called photochemotherapy.¹ Claims 8 and 9 of the '267 patent cover the MAL hydrochloride compound itself, while claims 1 and 3-7 cover the method of using that compound in conjunction with performing photochemotherapy.

MAL hydrochloride is an "ester" of the organic acid called aminolevulinic acid ("ALA"). An organic acid is a compound consisting of either a hydrogen or organic chemical group covalently bonded to an acid group. The specific acid group found in ALA is called the carboxyl group, which is represented by the chemical formula COOH. The chemical formula for ALA as a whole is C₅H₉NO₃. The chemical structure is diagrammed below:

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

When hydrochloric acid ("HCl") is added to an organic acid, a salt of that organic acid is formed. Thus, when HC1 is added to ALA, the resultant compound is a salt of ALA, called aminolevulinic acid hydrochloride (ALA hydrochloride). The chemical formula for ALA hydrochloride is C₅H₉ NO₃HCl. A diagram showing the chemical structure for ALA hydrochloride, which reflects the addition of HC1, is shown below:

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When the hydrogen atom (H) is removed from the COOH group of an organic compound and replaced with an organic chemical group, an ester of that organic compound is formed. Therefore, in the case of ALA hydrochloride, if the H from the COOH group is replaced with the organic chemical group CH₃, the resultant compound is an ester of ALA hydrochloride called MAL hydrochloride.² The chemical formula for MAL hydrochloride is C₆H₁₁NO₃HCl. The chemical structure is:

NOTE: OPINION CONTAINING TABLE OR OTHER DATA THAT IS NOT VIEWABLE

Worth noting is that ALA hydrochloride and MAL hydrochloride both have ALA as their base organic acid, or underlying molecule. In other words, ALA hydrochloride and MAL hydrochloride share the same parent acid, ALA. ALA hydrochloride and MAL hydrochloride are just two members of a large family of salts and esters that derive from the parent acid ALA.³

The commercial embodiment of the '267 patent is the drug Metvixia^TM ("Metvixia"), which contains MAL hydrochloride as its key ingredient.⁴ Metvixia was the first commercial drug to contain MAL hydrochloride as its key ingredient. However, a commercial drug predating Metvixia called Levulan^TM ("Levulan") implemented ALA hydrochloride as its key ingredient. As a result, the key ingredients in both Metvixia and Levulan share the same active moiety, ALA.⁵

Because Metvixia qualified as a "new drug" under § 201(p) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321 (p) (2006), it required approval by the FDA before it could be commercially marketed and sold. In an attempt to obtain this FDA approval, PhotoCure submitted a New Drug Application on September 26, 2001. On July 27, 2004, the Metvixia drug was approved for commercial and marketing use.

Due to the inability of PhotoCure to obtain FDA approval until more than four years after the USPTO issued the '267 patent, a significant portion of time elapsed between when PhotoCure gained patent rights and when it could profit from those patent rights by commercially marketing and selling the drug. In order to aid patent holders in PhotoCure's position, Congress passed 35 U.S.C. § 156 (2006), commonly referred to as the Hatch-Waxman Act, which permits patent term extensions for patent holders who have their terms reduced by the FDA regulatory process.

Not every patent having its term shortened by the FDA regulatory process, however, qualifies for an extension. Extensions are only appropriate if the statutory requirements of § 156(a) are met. One such requirement provides that an extension may only be granted if the drug covered by the patent is the "first permitted commercial marketing or use of the product." 35 U.S.C. § 156(a)(5)(A) (2006).⁶ Section 156(f) further defines the term "product" to mean the "active ingredient" of the drug, as well as any salt or ester of the active ingredient. 35 U.S.C. § 156(f)(2) (2006).

On September 22, 2004, PhotoCure timely filed a patent term extension application with the USPTO for the '267 patent. This application was denied. On November 13, 2007, PhotoCure filed a "Request for Reconsideration of Final Determination of Ineligibility for Patent Term Extension." The USPTO issued its final agency decision on May 13, 2008.

In this decision, the USPTO interpreted § 156(a)(5)(A) to mean that the underlying molecule, or active moiety, and all of its salts and esters qualify as the same "product." United States Patent and Trademark Office, Final Decision Regarding Patent Term Extension Application under 35 U.S.C. § 156 for U.S. Patent No. 6,034,267, 3 (May 13, 2008) [hereinafter "USPTO Decision"]. Because Levulan's key ingredient (ALA hydrochloride) and Metvixia's key ingredient (MAL hydrochloride) share the same active moiety (ALA), Levulan and Metvixia contain the same "product" under this interpretation, which is ALA. And because Levulan earned FDA approval before Metvixia, the USPTO held that "the [FDA] approval of METVIXIA^TM (methyl aminolevulinate hydrochloride) [did] not constitute the first permitted commercial marketing or use of the `product'" under § 156(a)(5)(A). USPTO Decision at 1. As a result, PhotoCure's request for a patent term extension was denied.

PhotoCure now appeals the USPTO's decision. In its complaint, PhotoCure alleges that the USPTO's decision was contrary to law (Count I), as well as arbitrary and capricious and not in accordance with law (Count II).

II. JURISDICTION AND VENUE

Subject matter jurisdiction exists pursuant to 28 U.S.C. § 1331 (2006) because this action arises under federal law; 28 U.S.C. § 1338(a) (2006) because this action arises under an "Act of Congress relating to patents"; and 28 U.S.C. § 1361 (2006), which provides district court jurisdiction over a "mandamus to compel an officer or employee of the United States or any agency thereof to perform a duty owed to the plaintiff."

The relief requested is authorized by 28 U.S.C. §§ 2201-2202 (2006), which permit declaratory judgment when an actual controversy exists. The parties do not dispute that an actual controversy exists. The relief requested is also authorized by 5 U.S.C. §§ 701-705 (2006), which outline a framework for judicial review of agency decisions.

Finally, venue is proper under 28 U.S.C. § 1391(e) (2006).

III. STANDARD OF REVIEW

Because this case involves judicial review of a final agency decision, the Administrative Procedure Act ("APA") provides the applicable standard of review. Glaxo Operations UK Ltd. v. Quigg, 894 F.2d 392, 395 n. 4 (Fed.Cir.1990). Under the APA, agency action may be set aside if the court finds that the agency action was "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." 5 U.S.C. § 706(2)(A). In making this determination, "the focal point for judicial review should be the administrative record already in existence, not some new record made initially in the reviewing court." Camp v. Pitts, 411 U.S. 138, 142, 93 S.Ct. 1241, 36 L.Ed.2d 106 (1973).

Here, the parties agree that no factual disputes exist and that the undisputed facts of the case are contained in the administrative record. Accordingly, PhotoCure moved for summary judgment on October 14, 2008, and Defendants Jon Dudas and John Doll of the USPTO moved for summary judgment on November 4, 2008. Because this action presents no disputed issues of material fact, the Court will resolve it at the summary judgment stage under Fed.R.Civ.P. 56. The Court, using the facts found in the administrative record, will base its decision on whether the USPTO's action was "arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law." 5 U.S.C. § 706(2)(A).

IV. ANALYSIS

A. Statutory Framework

A patent can only qualify for a term extension under § 156 if the following five conditions are met:

(1) the term of the patent has not expired before an application is...