Aetna U.S. Healthcare, Inc. v. Hoechst Aktiengesellschaft

54 F. Supp. 2d 1042, 1999 U.S. Dist. LEXIS 10125, 1999 WL 447117
CourtDistrict Court, D. Kansas
DecidedJune 9, 1999
DocketCivil Action 99-2034-KHV
StatusPublished
Cited by30 cases

This text of 54 F. Supp. 2d 1042 (Aetna U.S. Healthcare, Inc. v. Hoechst Aktiengesellschaft) is published on Counsel Stack Legal Research, covering District Court, D. Kansas primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Aetna U.S. Healthcare, Inc. v. Hoechst Aktiengesellschaft, 54 F. Supp. 2d 1042, 1999 U.S. Dist. LEXIS 10125, 1999 WL 447117 (D. Kan. 1999).

Opinion

MEMORANDUM AND ORDER

VRATIL, District Judge.

This matter comes before the Court on plaintiffs’ Motion To Remand For Lack Of Subject Matter Jurisdiction (Doc. # 16) filed March 8, 1999; Defendant, Andrx Pharmaceuticals, Inc.’s Motion To Stay Proceedings (Doc. # 8) filed February 19, 1999; and Hoechst Marion Roussel’s Motion To Join Andrx Pharmaceuticals Motion To Stay Proceedings (Doc. # 13) filed March 2, 1999. 1 For reasons stated below, *1046 the motions of plaintiffs and Hoechst Marion Roussel are sustained, and the motion by Andrx is denied.

Facts

Hoechst Marion Roussel, Inc. (“HMR”) manufactures Cardizem CD (“Cardizem”), a prescription drug which is used to treat high blood pressure and chronic chest pain. HMR is a combination of two former companies — Marion Merrell Dow, Inc. (“MMD”) and HoechsNRoussel Pharmaceuticals, Inc. (“HRP”). MMD created Cardizem. Before it merged with MMD, HRP developed a competing product (Tia-zac) in cooperation with Biovail Corporation International (“Biovail”). Andrx Pharmaceuticals, Inc. (“Andrx”) was the first manufacturer to develop and receive approval from the U.S. Food & Drug Administration (“FDA”) to produce a generic version of Cardizem.

In 1996, Hoechst Aktiengesellschaft (“Hoechst”), the parent company of HMR, entered into a consent order with the Federal Trade Commission (“FTC”) regarding its acquisition of MMD. As part of this process, HMR divested its interest in Tia-zac. The consent order required HMR to give Biovail a right to rely upon toxicology data which HMR had produced to the FDA — a so-called “right of reference.” The right of reference was intended to help get Tiazac on the market by allowing Biovail to get FDA approval for Tiazac. Around November 8, 1996, however, HMR renounced its right of reference by limiting Biovail’s access to information regarding drugs other than Tiazac. Because of HMR’s renunciation, Biovail could not obtain FDA approval for a product that would have competed with Cardizem.

Under the Hatch-Waxman Act, 21 U.S.C. § 355, which is part of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq., a manufacturer of a generic drug must certify that its product does not infringe any valid patent before the product can receive FDA approval. A patent holder can challenge the certification, however, and bring a patent infringement suit within 45 days of the notice of non-infringement. If the holder brings suit, the FDA stays the final approval of the generic product for 30 months after the date that notice was given, or until the date on which the patent litigation produces a final determination of non-infringement or patent invalidity, whichever date is earlier. See 21 U.S.C. § 355(j)(4)(B)(iii).

The Hatch-Waxman Act also provides 180 days of market exclusivity to the first generic manufacturer who applies to produce a generic product. The 180 day period begins to run on the date the applicant first sells its generic product or the date on which a final, non-appealable decision determines that the patent is invalid or not infringed-whichever is the earlier date. See 21 U.S.C. § 355(j)(5)(B)(iv).

In September of 1995, Andrx asked the FDA to approve a generic version of Car-dizem. Andrx served on HMR its certification that the generic drug did not infringe any outstanding HMR patents. In January of 1996, HMR responded by filing a patent infringement action against Andrx. By bringing suit, HMR delayed final FDA approval until the end of the 30 month waiting period, which would expire July 3, 1998, or the end of the patent litigation.

On September 15, 1997, the FDA gave preliminary approval to Andrx’s generic drug. On September 26, 1997, HMR entered into an agreement (the “stipulation agreement”) with Andrx. Under that agreement HMR makes quarterly payments to Andrx in the amount of $10,000,-000. In exchange, Andrx agreed to dismiss its counterclaims in the patent suit, refrain from marketing its generic drug until the end of the suit, continue to diligently prosecute its claim for FDA approval, and assert its rights as first in line against other potential producers of generic drugs.

Since reaching this agreement, HMR and Andrx have not actively pursued the patent infringement suit. Andrx has not *1047 begun selling its generic product, and its 180 day exclusivity period has yet to begin. Consequently, producers of competing generic products have been unable to compete against either HMR or Andrx.

On behalf of a class of Kansas plaintiffs who purchased Cardizem, Aetna U.S. Healthcare, Inc. (“Aetna”) filed suit in state district court in Johnson County, Kansas, against Hoechst, HMR and Andrx. The suit alleges that defendants have harmed class members by preventing production of a lower-cost generic version of Cardizem. Specifically, Aetna alleges unfair competition in violation of the so-called Unfair Trade and Consumer Protection Act, K.S.A. § 50-101 et seq., for which it seeks treble damages on account of defendants’ illegal trust and conspiracy in restraint of trade. Aetna also seeks disgorgement of all monies obtained as part of the conspiracy and restraint of competition and, under a theory of unjust enrichment, recovery of benefits which defendants have received from overpayments by Aetna and other members of the proposed class. Aetna also seeks a declaration that the stipulation agreement is void for violation of Kansas law regarding unfair competition. It alleges that individual class members suffered damages which amount to less than $75,000 apiece.

Standard For Remand

A civil action is removable only if plaintiffs could have originally brought the action in federal court. 28 U.S.C. § 1441(a). The Court is required to remand “[i]f at any time before final judgment it appears that the district court lacks subject matter jurisdiction.” 28 U.S.C. § 1447(c). Because federal courts are courts of limited jurisdiction, the law imposes a presumption against federal jurisdiction. Frederick & Warinner v. Lundgren, 962 F.Supp. 1580, 1582 (D.Kan.1997) (citing Basso v. Utah Power & Light Co., 495 F.2d 906, 909 (10th Cir.1974)). The rule is inflexible and without exception, and requires a court to deny its jurisdiction in all cases where such jurisdiction does not affirmatively appear in the record. Insurance Corp. of Ireland, Ltd. v. Compagnie des Bauxites de Guinee, 456 U.S. 694, 702, 102 S.Ct.

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Bluebook (online)
54 F. Supp. 2d 1042, 1999 U.S. Dist. LEXIS 10125, 1999 WL 447117, Counsel Stack Legal Research, https://law.counselstack.com/opinion/aetna-us-healthcare-inc-v-hoechst-aktiengesellschaft-ksd-1999.