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AMERICAN BIOSCIENCE, INC. v. SHALALA

October 3, 2000

AMERICAN BIOSCIENCE, INC. PLAINTIFF,
V.
DONNA E. SHALALA, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Kollar-kotelly, District Judge.

MEMORANDUM OPINION

Plaintiff American Bioscience, Inc. ("ABI"), which holds a patent related to the anti-cancer drug paclitaxel, claims that Defendant Food and Drug Administration ("FDA") improperly approved the application of Intervenor Baker Norton Pharmaceuticals ("BNP")*fn1 to market the drug generically. Intervenor Bristoll-Myers Squibb Company ("BMY") currently sells the drug under the brand name Taxol. In its Complaint, ABI asks the Court to direct FDA to rescind its approval of BNP's generic version.

Before the Court is ABI's Motion for a Temporary Restraining Order or, in the Alternative, for a Preliminary Injunction. As the parties have agreed, the Court addresses the proposed temporary restraining order and preliminary injunction simultaneously. Upon consideration of the motion, Defendants' opposition, ABI's reply, and the Intervenors' submissions, as well as supplemental pleadings ordered by the Court, the Court concludes that neither a temporary restraining order nor a preliminary injunction is warranted.

I. BACKGROUND

A. Statutory Framework

This case revolves around the interpretation of the statutory framework that governs the marketing of generic drugs. A generic drug contains the same active ingredients, but not necessarily the same inactive ingredients, as a brand-name prescription drug. United States v. Generix Drug Corp., 460 U.S. 453, 455, 103 S.Ct. 1298, 75 L.Ed.2d 198 (1983). Ready availability of generic drugs is believed to benefit consumers by increasing competition and reducing prices. All drugs, including generic drugs, must receive FDA approval before they can be marketed. Typically, a drug manufacturer wishing to market a new drug (so-called "pioneer manufacturers") must complete a New Drug Application ("NDA") in order to obtain FDA approval. The applicant must submit "data from studies showing the drug's safety and effectiveness," which renders the NDA process both time-consuming and expensive. Mova Pharm. Corp. v. Shalala, 140 F.3d 1060, 1063 (D.C.Cir. 1998).

Under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301, et seq. ("FFDCA"), the holder of an approved NDA (the entity with the right to sell a brand-name drug) must inform the FDA of any patents that could reasonably be asserted to cover the drug in question. This is known as "listing" the patents with the FDA. See 21 U.S.C. § 355 (b)(1); 21 C.F.R. § 314.53. If a relevant patent is issued after the NDA is approved, the NDA holder has thirty days from the date the patent was issued to "list" the patent. See 21 U.S.C. § 355 (c)(2); 21 C.F.R. § 314.53 (d)(3).

The procedure for obtaining approval of generic drugs is less onerous than that faced by pioneer manufacturers. In 1984, in an effort to facilitate the entry of generic drugs into the market, Congress passed the Hatch-Waxman Amendments to the FFDCA, which significantly revised the generic drug approval process. Instead of preparing an NDA, the generic drug proponent can submit an Abbreviated New Drug Application ("ANDA"). See 21 U.S.C. § 355 (j). Section 355 sets forth various requirements for the information that must be included in the ANDA. Unlike the pioneer manufacturer, who bears the burden of proving to the FDA that the active ingredient is safe and effective, the generic manufacturer bears the lesser burden of providing enough information to show that its product has the same active ingredient, labeling requirements, dosage form, and other essentials as a drug that has already been approved. See id. § 355(j)(2)(i)-(v). In other words, the generic manufacturer is allowed to rely on the safety and effectiveness data submitted in the pioneer's NDA.

To avoid the obvious patent infringement problems inherent in such a statutory scheme, § 355 also contains some protection for the holders of patents related to the approved brand-name drug. In addition to showing that the active ingredient in its drug is the same as the active ingredient in the brand-name drug, the ANDA applicant must also certify to the FDA that the generic version will not interfere with any patents that the NDA holder was required to "list." This can be accomplished by certifying

(I) that such patent information has not been filed,

(II) that such patent has expired,

(III) . . . the date on which such patent will expire, or
(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.

Id. § 355(j)(2)(vii). The last of these, the so-called "Paragraph IV" certification, is the only certification at issue in this litigation.

In addition to the requisite certification to the FDA, the Paragraph IV ANDA applicant must also provide notice to the patent holder and to the NDA holder explaining why the generic version does not infringe the patent or why the patent is invalid. See id. § 355(j)(2)(B). If the patent holder does not bring a patent infringement action within forty-five days of receipt of that notice, the FDA may approve the ANDA effective immediately. See id. § 355(j)(5)(B)(iii). If the patent holder brings suit within forty-five days, the effective date of any FDA approval is delayed, either for thirty months or until the court concludes that the patent is invalid or has not been infringed, whichever is shorter. See id.

B. The Factual Scenario of this Case

In 1992, the FDA approved BMY's New Drug Application for the anti-cancer drug paclitaxel, which BMY has subsequently marketed under the brand name Taxol. See Compl. ¶ 17. On July 30, 1997, BNP submitted an ANDA for a generic version of the drug. See Mem. of P. & A. in Supp. of the Mot. of Pl. [ABI] for a T.R.O. or, in the Alternative, for a Prelim. Inj. [hereinafter "Pl.'s Mot."] Ex. 5 (Aug 28, 2000, FDA letter to BNP). Following that submission, BMY listed two patents with the FDA, and BNP certified as to them under Paragraph IV. BMY thereupon initiated a patent infringement suit which delayed any FDA approval for thirty months. That thirty month period ended in June 2000. See Fed. Defs.' Mem. in Opp'n to Pl.'s Mot. for a T.R.O. or Prelim. Inj. at 9 [hereinafter "FDA's Opp'n Mem."]; Mem. of Defs. Intervenors [BNP] in Opp'n to Pl.'s Mot. for a T.R.O. or, in the Alternative, for Prelim. Inj. at 2, 4-5 [hereinafter "BNP's Opp'n Mem."].

On August 1, 2000, ABI received a patent for a novel dosage form of Taxol ("'331 patent"). See Pl.'s Mot. Ex 3(A)(b) (printout from U.S. Patent and Trademark Office website). Ten days later, ABI sued BMY in U.S. District Court in California to compel BMY to list the '331 patent. That same day, the California court issued a Temporary Restraining Order ("TRO") directing BMY to list the '331 patent "subject to the proviso that, unless [ABI] carries its burden of proof [regarding a preliminary injunction], BMY shall then take all steps under its control to cause the de-listing" of the '331 patent. See Compl. Ex. 1(B) at 2 (TRO). BMY, which had requested the TRO's narrow language and proviso, complied with the requirements the same day, August 11, 2000. See BNP's Opp'n Mem. Ex. 4 at 16-17 (Tr. of 9/16/00 hearing before Judge Byrne) (describing BMY's desire for limitation on scope and requirements of the TRO); Compl. Ex. 3 (BNP's August 11, 2000, submission to the FDA). At that time, only ten of the thirty days allotted for listing had expired.

On August 14, 2000, BNP submitted a Paragraph IV certification in which it acknowledged the recently listed '331 patent, but stated that its ANDA would not result in infringement. See Pl.'s Mot. Ex. 5 (Aug. 28, 2000 FDA letter to BNP); FDA's Opp'n Mem. at 14. Two weeks later, the FDA informed BNP that it had completed its substantive review of BNP's ANDA, but that it could not issue final approval until the questions about the '331 patent had been resolved. See Pl.'s Mot. Ex. 5.

Simultaneously, in the California lawsuit between ABI and BMY, BNP moved to intervene and argued for dismissal on the ground, inter alia, that there is no private right of action under the FFDCA. See BNP's Opp'n Mem. Ex. 8 at 3 (BNP's August 18, 2000, Mem. in Opp'n to Pl.'s Mot. for Prelim. Inj. & in Supp. of BNP's Mot. to Dismiss and for Enforcement of the Contingent Provision of the T.R.O.). Over the course of three hearings on the record held in August and September, the California court reviewed the circuitous history of the litigation, probed the parties in an effort to understand their motivations and affiliations, and questioned its own authority to render judgment in the matter. See BNP's Opp'n Mem. Exs. 3 (Tr. of 8/21/2000 hearing), 4 (Tr. of 9/6/2000 hearing), 17 (Tr. of 9/7/2000 hearing).

During the August 21 hearing, BMY, ABI and BNP discussed the schedule for resolving the outstanding motion for a preliminary injunction. While none of the three informed the judge that the thirty-day listing window would close on August 31, BNP pushed the court to hold a hearing on the preliminary injunction (and the possible dissolution of the TRO) prior to that date. Oddly, both BMY and ABI, the parties with the greatest interest in ensuring proper and timely listing of the '331 patent, opposed holding the hearing so early and urged the court to extend the TRO as long as the Federal Rules would allow. See BNP's Opp'n Mem. Ex. 3 at 26-34.

At the September 6 hearing, BMY made clear that it was unwilling to list the '331 patent without a court order requiring it to do so. See BNP's Opp'n Mem. Ex. 4 at 41-43. At the same hearing, the court ruminated on its power to enforce compliance with the FFDCA and determined that it lacked jurisdiction to do so. See id. Ex. 4 at 107 ("I find that the court did not have jurisdiction over this matter at the time that Judge Rea was presented with the T.R.O. that he issued requiring listing of the ['331] patent.").

On September 7, 2000, the California court dismissed the case, which included the FFDCA claim and state law claims, under Rule 12(b)(6). In the order announcing the dismissal, the court noted that ABI did not have a private right of action under the FFDCA. Accordingly, the court dissolved the TRO and commanded that "[p]ursuant to the condition in the TRO and in order to restore the status quo, BMY shall use its best efforts to cause the de-listing of [ABI's] Patent. . . . ABI shall cooperate with BMY in its efforts to delist the '331 Patent pursuant to the TRO." Compl. Ex. 5 ¶¶ 1-4 (September 7, 2000, dismissal order). The effective date of the dissolution was stayed until September 13 in order to give the parties an opportunity to appeal. See id. ¶ 11.

The court also noted that, at the time the TRO was issued, BMY had twenty more days within which to file its listing of the '331 patent. Since those twenty days had expired by the time the TRO was dissolved, the court "recommend[ed] to the FDA that the time that the TRO was in effect should toll the period in which BMY may timely cause such listing." Id. ¶ 5.

Also on September 7, 2000, ABI brought a patent infringement suit against BNP in the Central District of California. See Pl.'s Mot. Ex. 3 (H). ABI informed the FDA of this litigation on September 8, 2000, and asserted that the lawsuit barred the FDA from approving BNP's ANDA for thirty months. See Pl.s' Mot. Ex. 7.

On September 11, 2000,*fn2 BMY sent another letter to the FDA listing the '331 patent. In that letter, BMY did not reference its August 11 listing pursuant to the TRO, and it did not indicate that it believed that the patent was already listed in some manner. See Pl.'s Mot. Ex. 9. According to the FDA, the September 11 letter amounted to a "late listing" of the '331 patent. See Tr. of 9/29/00 Hearing Before Judge Kollar-Kotelly at 47 [hereinafter "9/29/00 Tr."]. In the view of BNP, the September 11 letter is a nullity because BMY had already listed the '331 patent via its August 11 letter. See BNP's Opp'n Mem. at 18.

On September 14, 2000, after the California court's dismissal order took effect, BMY withdrew its August 11 listing of the '331 patent "to the extent that listing was compelled by the TRO." Pl.'s Mot. Ex. 10 (BMY letter to FDA, 9/14/2000). BMY also expressly stated that the withdrawal did "not affect the continued and continuous listing of the patent." Id. Ex. 10. The FDA and BNP agree that this letter completely removed the August 11 listing. The FDA maintains that BMY's voluntary, but tardy, listing on September 11 is still on the books. See 9/29/00 Tr. at 47. BNP argues that the ...


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