MEMORANDUM OPINION
This is an action brought by Plaintiff Hospira, Inc. ("Hospira") along with Plaintiff-Intervenor Sandoz, Inc. ("Sandoz") pursuant to the Administrative Procedure Act ("APA"), 5 U.S.C. § 701, et seq., challenging various actions taken by Defendant Food and Drug Administration ("FDA").1 Specifically, Hospira and Sandoz contend that the FDA's August 18, 2014 decision authorizing the approval of generic versions of the drug dexmedetomidine hydrochloride violated § 355(j)(2)(A)(viii) of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the "Hatch-Waxman Amendments." Additionally, Hospira and Sandoz contend that through its August 18, 2014 decision, FDA effected a change to settled law thereby adopting a new "rule" as defined by the APA, which was not promulgated in accordance with the formal rulemaking procedures required by the APA. Accordingly, Hospira and Sandoz sought a temporary restraining order and/or preliminaryinjunction that, among other things, stayed the effect of the FDA's August 18, 2014 decision. Mylan Institutional, LLC ("Mylan") intervened.
On August 19, 2014, after an emergency hearing, the Court granted Hospira's and Sandoz's motions and issued a temporary restraining order that day. After staying a portion of the Court's temporary restraining order, and then granting, in part, and denying, in part, Mylan's motion for reconsideration of the temporary restraining order, the Court consolidated the preliminary injunction motion with a final decision on the merits under Rule 65(a)(2) of the Federal Rules of Civil Procedure. Accordingly, on August 29, 2014, all of the parties (except Sandoz) filed cross-motions for summary judgment.2
For the reasons stated below, the Court finds that the FDA's August 18, 2014 decision authorizing the approval of generic versions of Precedex® was not arbitrary, capricious, or otherwise not in accordance with law, but was instead based on a reasonable and sound interpretation of the relevant statute. Additionally, the Court finds that the FDA's August 18, 2014 decision was entirely consistent with the FDA's established practice of approving generic drugs and therefore did not effect a change to settled law. As such, no new "rule" was created by the FDA's decision and the FDA was therefore not required to follow the APA's formal rulemaking procedures. Hospira's motion for summary judgment is therefore DENIED, and summary judgment is GRANTED in favor of the FDA, Mylan, and Defendant-Intervenor Par Sterile Products, LLC ("Par Sterile").
A. Statutory and Regulatory Framework This case involves issues relating to the interpretation of the Hatch-Waxman Amendments, which substantially amended the Federal Food, Drug, and Cosmetic Act ("FDCA"). See Pub.L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C. § 355. These complex amendments have been thoroughly explained by the District Court for the District of Columbia on numerous occasions. See e.g., Purepac Pharm. Co. v. Thompson, 238 F. Supp. 2d 191, 193-96 (D.D.C. 2002) aff'd, 354 F.3d 877 (D.C. Cir. 2004); Mylan Pharm., Inc. v. Sebelius, 856 F. Supp. 2d 196, 199-201 (D.D.C. 2012); Apotex Inc. v. Food & Drug Admin., 414 F. Supp. 2d 61, 63-64 (D.D.C. 2006) aff'd, 226 F. App'x 4 (D.C. Cir. 2007). Given the parties' desire to have a swift resolution of this matter, and in the interests of judicial economy, the Court will forgo its opportunity to dissect the statutory and regulatory framework of the Hatch-Waxman Amendments and instead will rely on the thoughtful discussion from Purepac Pharm. Co., 238 F. Supp. 2d at 193-96 that fully describes the statutory and regulatory regime implicated in this case. The court in Purepac Pharm. Co. stated that:
[The Hatch-Waxman] amendments were designed to simplify and expedite the process by which generic drugs are brought to market. Generally, a company seeking FDA approval to market a particular drug must file a lengthy document called a New Drug Application ("NDA"), which, among other things, must include detailed data establishing the drug's safety and effectiveness. The NDA must also contain information on each patent that claims the drug or a method of using the drug that is the subject of the application and with respect to which a patent infringement claim could reasonably be asserted against a[n] unauthorized party. 21 U.S.C. § 355(b)(1); (c)(2). The FDA publishes the patent information that it receives in a publication entitled "Approved Drug Products With Therapeutic Equivalence Evaluations," known in agency parlance as the "Orange Book." See Am. Bioscience, Inc. v. Thompson, 269 F.3d 1077, 1079 (D.C. Cir. 2001); Terry G. Mahn, Patenting Drug Products: AnticipatingHatch-Waxman Issues During the Claims Drafting Process, 54 FOOD & DRUG L.J. 245, 249-50 (1999).
Before the Hatch-Waxman Amendments were enacted, a firm that hoped to manufacture and sell a generic version of an already-approved drug was required to submit a new NDA complete with new safety and effectiveness data. See Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1063 (D.C. Cir. 1998). Obviously, this requirement imposed considerable burdens on would-be generic manufacturers, delaying and increasing the cost of bringing generic drugs to market. In order to benefit consumers, the amendments altered this requirement, creating a streamlined procedure for the approval of generic drugs whereby the generic applicant is permitted to piggyback on the original NDA filed by the manufacturer of the brand-name drug (the so-called "pioneer" or "innovator" drug). Under this new system, generic drugs may be approved through an Abbreviated New Drug Application ("ANDA"), which relies on the FDA's previous determination that the pioneer drug is safe and effective. See Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 675, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990) ("The ANDA applicant can substitute bioequivalence data for the extensive animal and human studies of safety and effectiveness that must accompany a full new drug application."). This allows applicants to avoid the costly and time-consuming process associated with NDAs, thus facilitating the approval and dissemination of low-costs generic drugs. See H.R.Rep. No. 98-857 (Part I) at 14 (June 21, 1984).
At the same time, Congress sought to protect patent holders whose rights could be threatened by the marketing of generic versions of their patented innovations. See Am. Bioscience, Inc. v. Thompson, 243 F.3d 579, 580 (D.C. Cir. 2001). To this end, the Hatch-Waxman Amendments require that ANDAs contain specified information about the patents protecting the pioneer drug, including "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." 21 U.S.C. § 355(b)(1). There are two means by which applicants may satisfy this requirement . . . .
First, in a situation in which the patent potentially implicated by the generic drug "claims the listed [i.e. FDA-approved] drug . . . or which claims a use for such listed drug for
which the applicant is seeking approval," the ANDA applicant is required to certify that the new drug will not infringe the patent and explain why it will not. 21 U.S.C. § 355(j)(2)(A)(vii). The statute provides four bases on which this certification may be made: (I) that the required patent information has not been filed; (II) that the patent has expired; (III) that the patent will expire on a date certain; or (IV) that the patent is invalid or will not be infringed by the drug for which approval is sought. Id. [The fourth option is commonly referred to as a "paragraph IV certification."]
When an ANDA includes a paragraph IV certification, the applicant must give notice of the filing both to the owner of the patent and to the holder of the NDA for the approved drug. The statute then provides a 45-day window during which the patent owner may bring suit against the generic applicant. If a suit is initiated, the FDA's approval of the ANDA is automatically stayed for 30 months, a period that can be lengthened or shortened by the court hearing the case if either party fails to "reasonably cooperate in expediting the action." 21 U.S.C. § 355(j)(5)(B)(iii). If, before the expiration of the 30-month stay, the court finds that the patent is invalid or would not be infringed by the new drug, the FDA's approval of the ANDA becomes effective on the date of that ruling. See Andrx Pharms., Inc. v. Biovail Corp. Int'l, 256 F.3d 799, 802 (D.C. Cir. 2001). As an incentive to generic manufacturers willing to run the risk of defending against patent infringement actions, the statute provides that the first party to gain approval of an ANDA containing a paragraph IV certification is entitled to a 180-day period of market exclusivity. 21 U.S.C. § 355(j)(5)(B)(iv). During this "[e]denic moment of freedom from the pressures of the market," Mova Pharm., 140 F.3d at 1064, the FDA may not allow any subsequent ANDAs for the drug in question to become effective, thus allowing the first mover to sell its drug without competition from other generic manufacturers. See Mylan Pharm., Inc. v. Shalala, 81 F.Supp.2d 30, 33 (D.D.C. 2000) ("In other words, no ANDA for the same generic drug product will be approved during those 180 days.").
As noted, however, the statute provides an alternative to a paragraph IV certification, known as a "section viii statement," which applies where the patent in question is a "method of use patent which does not claim a use for...
