Mylan Pharm., Inc. v. U.S. Food & Drug Admin.

Citation23 F.Supp.3d 631
Decision Date29 May 2014
Docket NumberCivil Action No. 1:14CV75.
CourtU.S. District Court — Northern District of West Virginia
PartiesMYLAN PHARMACEUTICALS, INC., Plaintiff, Watson Laboratories, Inc., Intervenor–Plaintiff, and Lupin Pharmaceuticals, Inc., Intervenor–Plaintiff, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, Defendant, and Teva Pharmaceuticals, USA, Inc., Intervenor–Defendant.

Douglas B. Farquhar, James P. Ellison, Jennifer M. Thomas, Jessica A. Ritsick, John R. Fleder, Kurt R. Karst, Hyman, Phelps & McNamara, P.C., Washington, DC, Gordon H. Copland, William J. O'Brien, Steptoe & Johnson PLLC, Bridgeport, WV, Ralph S. Tyler, Venable LLP, Baltimore, MD, for Plaintiff.

Chad A. Landmon, Mark D. Alexander, Axinn, Veltrop & Harkrider LLP, Hartford, CT, Suchira Ghosh, Axinn, Veltrop & Harkrider LLP, New York, NY, William R. Slicer, Shuman, McCuskey & Slicer, PLLC, John H. Tinney, Jr., The Tinney Law Firm, Charleston, WV, Arthur Y. Tsien, Jonathan M. Weinrieb, Olsson Frank Weeda Terman Matz PC, Washington, DC, for Intervenor Plaintiff.

Gerald C. Kell, U.S. Dept. of Justice, Washington, DC, Helen Campbell Altmeyer, U.S. Attorney's Office, Wheeling, WV, for Defendant.

David A. Barnette, Vivian H. Basdekis, Jackson Kelly PLLC, Charleston, WV, John K. Crisham, John C. O'Quinn, Michael D. Shumsky, Stephen S. Schwartz, Kirkland and Ellis LLP, Washington, DC, for Intervenor Defendant.

MEMORANDUM OPINION AND ORDER DENYING MYLAN PHARMACEUTICALS, INC.'S MOTION FOR PRELIMINARY INJUNCTION [DKT. NO. 9]

IRENE M. KEELEY, District Judge.

Pending before the Court is the motion of the plaintiff, Mylan Pharmaceuticals, Inc. (Mylan), seeking a preliminary injunction pursuant to Federal Rule of Civil Procedure 65. (Dkt. No. 9). Mylan's motion requires the Court to consider the permissibility of the United States Food and Drug Administration's (“the FDA”) interpretation of exclusivity rights under the Hatch–Waxman Act for reissued patents. For the reasons that follow, the Court DENIES the motion.

I. PROCEDURAL HISTORY

Mylan filed a complaint in this case on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application (“ANDA”) applicants. (Dkt. No. 1). Mylan then filed a motion for preliminary injunction on April 28, 2014, seeking an injunction to enjoin the FDA from withholding final approval on May, 30, 2014 to any first-to-file celecoxib ANDA applicant, pending either the Court's decision on the merits of this case or expiration of the 180–day celecoxib marketing exclusivity period. (Dkt. No. 9). Watson Laboratories, Inc. (Watson) and Lupin Pharmaceuticals, Inc. (Lupin) subsequently intervened as plaintiffs in this case, and Teva Pharmaceuticals USA, Inc. (Teva) intervened as a defendant.

In its motion for preliminary injunction, Mylan challenges a letter decision of the FDA that it contends erroneously concluded a reissued patent does not give rise to eligibility for a period of marketing exclusivity that is separate and distinct from the period of exclusivity arising from the original patent. According to Mylan, original and reissued patents should be treated as two distinct patents, thereby triggering separate periods of exclusivity.

During a hearing on May 15, 2014, the Court heard arguments from the parties and intervenors. It then requested supplemental briefing on whether it had subject matter jurisdiction to review the FDA's letter decision. The motion is now fully briefed and ripe for review.

II. STATUTORY AND REGULATORY BACKGROUND
A. Pharmaceutical Drug Applications:

Pharmaceutical drugs fall into two categories: drugs sold under brand names

and generics. United States v. Generix Drug Corp., 460 U.S. 453, 454–55, 103 S.Ct. 1298, 75 L.Ed.2d 198 (1983). Pioneer and generic drugs in the United States are regulated under the Food, Drug and Cosmetic Act (“FDCA”), which Congress amended extensively in 1984. This version is commonly referred to as the Hatch–Waxman Act. 21 U.S.C. § 355.

The Hatch–Waxman scheme distinguishes between New Drug Applications (NDAs) and ANDAs. To seek approval from the FDA for a brand name drug such as Celebrex

®, the manufacturer must file a complete NDA. Such a filing must provide the FDA with a listing of all patents that claim the approved drug or a method of using the drug, 21 U.S.C. § 355(j)(2)(A)(vii), and set forth data establishing that the drug is safe and effective. 21 U.S.C. § 355(b). The NDA's sponsor also must “file with the application the patent number and the expiration date of any patent which claims the drug ... 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.” 21 U.S.C. § 355(b)(1).1

The Hatch–Waxman Act grants brand name NDA holders a five year exclusivity period before generics may enter the market. 21 U.S.C. § 355(j). Once the NDA holder's five year exclusivity period is over, a company manufacturing a generic drug that is biologically equivalent to the pioneer drug may seek FDA approval for the drug by filing an ANDA. Id. ANDA applicants need not submit their own safety and effectiveness studies, but may instead rely on the NDA applicant's studies. Id.

ANDA applicants also must provide a certification as to whether their proposed generic drug would infringe the pioneer drug's patent. Id. Pertinent here is the fourth of the Hatch–Waxman Act's four certification options (paragraph IV certification”), allowing ANDA applicants to certify that the NDA patent “is invalid or will not be infringed by the manufacture, use, or sale of the proposed generic drug.” 21 U.S.C. § 355(j)(2)(A)(vii). Thus, “an ANDA applicant making a paragraph IV certification intends to market its product before the relevant patents have expired.” aaiPharma Inc. v. Thompson, 296 F.3d 227, 232 (4th Cir.2002). The NDA holder must receive notice that a paragraph IV certification on behalf of an ANDA applicant has been filed. If, upon receiving such notice, the patent holder sues the applicant for patent infringement within 45 days, the FDA must stay a decision on whether to approve the ANDA for 30 months, unless the patent expires or a court holds that it is invalid or not infringed during that time. 21 U.S.C. § 355(j)(5)(B)(iii).

Paragraph IV ANDA recipients receive a key 180–day marketing exclusivity advantage. 21 U.S.C. § 355(j)(5)(B)(iv). During this time, the FDA may not approve any later-filed ANDAs, thus allowing the first applicant to sell its generic drug without competition from other generic manufacturers.2 Id. The marketing exclusivity period is triggered on the earlier of two dates: either (1) the date the FDA receives notice “of the first commercial marketing of the drug under the previous application” (the “commercial marketing trigger clause”), or (2) the date a court decides that the patent is either invalid or not infringed (the court decision trigger clause”).See 21 U.S.C. § 355(j)(5)(B)(iv).

The 180–day marketing exclusivity period provides an opportunity for significant economic gain for the recipient, as it allows the first-filing ANDA applicant to be the only entity gaining profit from the sale of a generic version of the brand drug during that time. As the Federal Trade Commission has stated, this period “increases the economic incentives for a generic company to be the first to file, because the generic applicant has the potential to reap the reward of marketing the only generic product (and, thus, to charge a higher price until more generic products enter [the market] ).” Federal Trade Commission, To Promote Innovation: The Proper Balance of Competition and Patent Law and Policy, Ch. 3, at 12(Oct.2003), available at http:www.ftc.gov/os/2003/10/innovationrpt.pdf.

B. Reissued Patents

A patent may be reissued to correct certain errors in the scope of claims or defects that would have otherwise invalidated the patent. 35 U.S.C. § 251(a). The relevant statute, 35 U.S.C. § 252, establishes the effect of reissued patents:

The surrender of the original patent shall take effect upon the issue of the reissued patent, and every reissued patent shall have the same effect and operation in law, on the trial of actions for causes thereafter arising, as if the same had been originally granted in such amended form, but in so far as the claims of the original and reissued patents are substantially identical, such surrender shall not affect any action then pending nor abate any cause of action then existing, and the reissued patent, to the extent that its claims are substantially identical with the original patent, shall constitute a continuation thereof and have effect continuously from the date of the original patent.

A reissued patent is identified by the U.S. Patent and Trademark Office (“PTO”) with the letters “RE” preceding the patent number. A reissued patent must reference the original patent on its face. It also has the same expiration date as the original patent. 35 U.S.C. § 251(a).

In order to provide timely notice of reissuance to pending and potential ANDA applicants, an NDA holder must submit information regarding reissued patents to the FDA within 30 days of the date of reissuance. 21 U.S.C. § 355(c)(2). An ANDA applicant must amend any prior patent certification(s) to address the patent as reissued. 21 C.F.R. § 314.94(a)(12)(viii)(C)(1).

A reissued patent remains listed in the Orange Book until the FDA has determined either that no ANDA applicant is eligible for 180–day exclusivity as to that patent or that their exclusivity period has expired. 21 U.S.C. § 355(c)(2).

III. Factual Background:

A. Celebrex

® and Generic Celecoxib Products

Celebrex

® is a nonsteroidal anti-inflammatory drug marketed by Pfizer Inc. (“Pfizer”) under NDA No. 020998. The Orange Book currently lists four patents for Celebrex ® capsules in 100 mg, 200 mg, and 400 mg strengths: U.S. Patent No....

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