Mylan Laboratories, Inc. v. Thompson

• Decision Date: 17 August 2004
• Docket Number: No. CIV.A.04-1049(RBW).,CIV.A.04-1049(RBW).
• Citation: 332 F.Supp.2d 106
• Parties: MYLAN LABORATORIES, INC., et al., Plaintiffs, v. Tommy G. THOMPSON, et al., Defendants, and Alza Corporation, et al., Intervenor-Defendants.
• Court: U.S. District Court — District of Columbia

332 F.Supp.2d 106

MYLAN LABORATORIES, INC., et al., Plaintiffs, v. Tommy G. THOMPSON, et al., Defendants, and Alza Corporation, et al., Intervenor-Defendants.

No. CIV.A.04-1049(RBW).

United States District Court, District of Columbia.

August 17, 2004.

COPYRIGHT MATERIAL OMITTED

Joseph Anthony Hynds, Rothwell, Figg, Ernst & Manbeck, PC, Washington, DC, for Plaintiffs.

Paul F. Brinkman, Alston & Bird LLP, Washington, DC, Thomas Parker, Alston & Bird LLP, New York City, for Intervenor-Plaintiffs.

Andrew E. Clark, US Dept. of Justice; Office of Consumer Litigation, Washington, DC, for Defendants.

Anthony Herman, Covington & Burling, Washington, DC, for Intervenor-Defendants.

MEMORANDUM OPINION

WALTON, District Judge.

Plaintiffs, Mylan Laboratories, Inc., Mylan Technologies, Inc., and Mylan Pharmaceuticals, Inc. (collectively "Mylan" or "plaintiffs"), commenced this action against Tommy G. Thompson, Secretary of Health and Human Services ("HHS"); Lester M. Crawford, Acting Commissioner of the United States Food and Drug Administration ("FDA"); and the FDA (collectively "FDA", "federal defendants", or "defendants"), seeking to enjoin the FDA from: (1) revoking the FDA's final approval of Mylan's abbreviated new drug application ("ANDA") for a generic version of a fentanyl transdermal system¹ and (2) applying Alza Corporation's ("Alza") pediatric exclusivity to Mylan's ANDA. Complaint ("Compl.") ¶ 1. Currently before this Court are (1) Mylan's Motion for Preliminary Injunction and Declaratory Relief, to Consolidate the Preliminary Relief Hearing with the Summary Judgment Hearing or the Trial on the Merits, and For Summary Judgment Granting Final Injunction Relief ("Pls' Mot.") and (2) the Federal Defendants' Memorandum in Opposition to Plaintiffs' Motion for Preliminary Injunction and Summary Judgment and In Support of Cross-Motion for Summary Judgment ("Defs.' Opp.").² At the request of the parties, the Court has consolidated the plaintiffs' request for a preliminary injunction with their request for summary judgment on the merits in accordance with Fed.R.Civ.P. 65(a)(2). Upon consideration of the parties' submissions, and for the reasons set forth below, the Court concludes that the plaintiffs' motion for summary judgment should be denied and that the defendants' cross-motion for summary judgment must be granted.

I. Statutory Scheme

This matter concerns the application of three different, but interrelated, statutory provisions pertaining to the FDA's approval of generic drugs. First, the 1984 amendments to the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et. seq., commonly referred to as the "Hatch-Waxman Amendments," see 21 U.S.C. § 355(j), which address the process by which the FDA approves generic drugs. Second, the 1997 amendments to the FDCA, which provides an additional six-month exclusivity period for patents held by brand-name drug manufactures that participate in pediatric studies of those patented drugs. See 21 U.S.C. § 355a. Finally, 35 U.S.C. § 271, a patent statute that was part of the Hatch-Waxman Amendments, which provides a district court with remedies if it finds that a patent for a new drug has been infringed by an ANDA. These statutory provisions have been explained in great detail in Allergan, Inc. v. Alcon Lab., Inc., 324 F.3d 1322, 1325-27 (Fed.Cir.2003); Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1063-65 (D.C.Cir.1998); and Barr Lab., Inc. v. Thompson, 238 F.Supp.2d 236, 239-41 (D.D.C.2002), therefore, they will only be discussed to the extent necessary for the disposition of this case.

(A) Hatch-Waxman Amendments — Approval of an ANDA

The Federal Circuit has "recently stated that, in the Hatch-Waxman [Amendments], `Congress struck a balance between two competing policy interests: (1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to the market.'" Allergan, 324 F.3d at 1325 (citing Andrx Pharms., Inc. v. Biovail Corp., 276 F.3d 1368, 1371 (Fed.Cir.2002)). Prior to the passage of the Hatch-Waxman Amendments, all drug manufacturers — brand-name and generic — were required to conduct controlled human clinical studies to demonstrate that the drug was safe and effective. This requirement delayed the entry into the market of both new drugs and generic versions of such drugs. Id. The Hatch-Waxman Amendments sought to address this situation.

Under the Hatch-Waxman Amendments, only companies seeking to market a drug that has never been approved in the United States are required to submit a New Drug Application ("NDA"). An NDA is required to contain scientific data demonstrating the safety and effectiveness of the new drug. 21 U.S.C. § 355(a), (b), (c). However, companies seeking to market a generic drug of a previously approved drug no longer need to conduct human clinical tests. Instead, the generic drug manufacturer can submit an ANDA demonstrating, among other requirements, that the generic version of the drug is the bioequivalent³ to the NDA-approved version of the drug. 21 U.S.C. §§ 355, 360cc; 35 U.S.C. §§ 156, 271, 282. In addition, to further expedite the process of introducing generic drugs to the market, under the Hatch-Waxman Amendments, a generic drug manufacturer may, without liability for infringement, use a drug claimed in a patent or a method of using a drug claimed in a patent in order to prepare an ANDA application. 35 U.S.C. § 271(e)(1).

The approval of an ANDA depends, in part, upon the applicant submitting "a certification ... with respect to each patent which claims [a] listed drug [previously approved by the Secretary of HHS ("Secretary") for safety and effectiveness or whose approval has been withdrawn or suspended] or which claims a use for such a listed drug for which the applicant is seeking approval." 21 U.S.C. §§ 355(j)(2)(A)(vii), 355(7). In addition, the certification, which must be amended if, "at any time before the effective date of the approval of the application, the applicant learns the submitted certification is no longer accurate," 21 C.F.R. § 314.94(a)(12)(vii)(c)(1), 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;

(IV) that such patent is invalid or will not be infringed upon by the drug for which approval is sought.

35 U.S.C. § 355(j)(2)(A)(vii). "If a certification is made under paragraph I or II, the patent indicating that patent information pertaining to the drug or its use has not been filed with the FDA or that the patent has expired, approval of the ANDA may be made effective immediately." Barr, 238 F.Supp.2d at 240 (citing 21 U.S.C. § 355(j)(5)(B)(i)). A paragraph III certification indicates that the applicant seeks approval to market the drug only after the applicable patent has expired. 21 U.S.C. § 355(j)(5)(B)(ii).

When the ANDA contains a paragraph IV certification, the applicant must also provide notice of the paragraph IV certification to the NDA holder and the patent owner, and describe the factual and legal basis for the applicant's opinion that an active patent is invalid or not infringed. 21 U.S.C. § 355(j)(2)(B); 21 C.F.R. § 314.95. Under the Hatch-Waxman amendments, filing an ANDA with a paragraph IV certification is deemed to be a "highly artificial" act of infringement. 35 U.S.C. § 271(e)(2)(A); Eli Lilly & Co. v. Medtronic Inc., 496 U.S. 661, 676, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990). This act of infringement permits the NDA holder and the patent owner to sue the ANDA applicant before the drug comes to market, which helps expedite the generic drug reaching the marketplace. Alcon Labs., Inc., 324 F.3d at 1326. If the patent holder brings an infringement suit in district court within 45 days of receiving notice of the paragraph IV certification, the suit triggers an automatic stay of the FDA approval of the ANDA for 30 months. 21 U.S.C. § 355(j)(5)(B)(iii). If the patent holder or NDA holder does not bring suit within 45 days after it has received notice, the unexpired patent itself will not bar FDA's approval of the ANDA; rather, it is eligible for immediate approval. 21 U.S.C. § 355(j)(5)(B)(iii); 21 C.F.R. § 314.107(f)(2). "The patent holder is, of course, free to sue the applicant for infringement ... after the 45-day window expires. The 30-month stay of FDA approval, however, will not be triggered." Valley Drug Co. v. Geneva Pharm., Inc., 344 F.3d 1294, 1297 n. 5 (11th Cir.2003). It is important to note, however, that if the FDA gives final effective approval to an ANDA and the ANDA applicant begins to market the generic drug prior to a decision from the district court,⁴ the generic drug manufacturer may be liable for damages if it is determined that the patent is valid and infringed. See, e.g., Biovail Labs. Inc. v. Torpharm, Inc., 2002 WL 1732372 at ^*1-2 (N.D.Ill.2002) (noting that damages may be recoverable if a generic drug manufacturer brings the generic drug to market prior to a decision from the patent court). Thus, to protect the ANDA holder's interests, if the NDA holder or patent owner does not bring suit within the 45-day window, the ANDA applicant may seek a declaratory judgment that the patent is invalid and not infringed. 21 U.S.C. § 355(j)(5)(C)(II); see Minnesota Mining & Mfg. Co. v. Barr Lab. Inc., 289 F.3d 775, 791 (Fed.Cir.2002) (Gajarsa, J. concurring). Although the FDA is not a party to the patent infringement litigation, once the patent court rules on the validity of the patent and if ruled valid whether it has been infringed, the ANDA applicant is required to submit a copy of the entry of the order of judgment to the FDA. 21 C.F.R. § 314.107(e).

The FDA's approval of an ANDA becomes effective on the date the agency issues a letter approving the drug, "unless the approval letter provides for a delayed effective date." 21...