In re Buspirone Antitrust Litigation

208 F.R.D. 516, 2002 U.S. Dist. LEXIS 11519, 2002 WL 1379985
CourtDistrict Court, S.D. New York
DecidedJune 26, 2002
DocketMDL No. 1413
StatusPublished
Cited by8 cases

This text of 208 F.R.D. 516 (In re Buspirone Antitrust Litigation) is published on Counsel Stack Legal Research, covering District Court, S.D. New York primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
In re Buspirone Antitrust Litigation, 208 F.R.D. 516, 2002 U.S. Dist. LEXIS 11519, 2002 WL 1379985 (S.D.N.Y. 2002).

Opinion

OPINION AND ORDER

GORENSTEIN, United States Magistrate Judge.

The plaintiffs in these consolidated antitrust eases have made two motions: (1) for a ruling that defendant Bristol-Myers Squibb Company (“Bristol-Myers”) has already waived its attorney-client privilege with respect to certain matters because it placed those matters “at issue” in this litigation and (2) to compel Bristol-Myers to elect whether it intends to assert “good faith” or “reliance on counsel” defenses to the claims asserted in the complaints.1 For the reasons stated [518]*518below, the first motion is denied and the second motion is granted.

I. BACKGROUND

Plaintiffs have filed antitrust claims against Bristol-Myers alleging that it engaged in anti-competitive conduct by improperly extending its monopoly over buspirone hydrochloride (“buspirone”), an anti-anxiety drug sold under the brand name BuSpar. Bristol-Myers is alleged to have done so by fraudulently exploiting federal patent and drug laws and by colluding with a potential competitor through the settlement of a lawsuit. On August 15, 2001, the Judicial Panel on Multidistrict Litigation consolidated in this district three patent infringement suits brought by Bristol-Myers, another patent infringement suit brought by generic drug companies against Bristol-Myers, and twenty-two antitrust actions brought by various plaintiffs. On February 14, 2002, District Judge John G. Koeltl granted summary judgment against Bristol-Myers with respect to the patent infringement claims, In re Buspi-rone Patent Litigation, 185 F.Supp.2d 340 (S.D.N.Y.2002), and granted in part and denied in part Bristol-Myers’s motion to dismiss the plaintiffs’ antitrust and related state law claims, In re Buspirone Patent Litigation, 185 F.Supp.2d 363 (S.D.N.Y.2002). The facts that underlie the instant motion are fully set forth in those two decisions, familiarity with which is assumed.

A. The Patent Infringement Claims

In brief, Bristol-Myers obtained a patent in 1980 (the “'763 patent”) that covered, among other things, a method of treating anxiety in humans through a dose of the drug buspirone. In re Buspirone Patent Litigation, 185 F.Supp.2d 340, 342 (S.D.N.Y. 2002). In order to sell this new drug, Bristol-Myers, as a pioneer drug company, obtained approval of a New Drug Application (“NDA”) from the Food and Drug Administration (the “FDA”). See 21 U.S.C. § 355. In 1986, Bristol-Myers began selling buspi-rone under the brand name BuSpar.

The '763 patent was due to expire on November 21, 2001. In anticipation of this date, manufacturers of generic drugs began preparations to sell a generic version of bus-pirone as soon as the patent expired. By virtue of the Hatch-Waxman Amendments, enacted in 1984, Pub.L. No. 98-417, 98 Stat. 1585, manufacturers may obtain expedited approval of generic versions of FDA-approved drugs by filing an Abbreviated New Drug Application (“ANDA”). 21 U.S.C. § 355(j). Two manufacturers filed such AN-DAs seeking FDA approval of generic buspi-rone.

The Hatch-Waxman Amendments also provide that a pioneer drug company filing an NDA must include information on any patent that claims a drug or a method of using the drug and “with respect to which a claim of patent infringement could be reasonably 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). If a pioneer drug company obtains such a patent after the NDA has been filed or approved (as Bristol-Myers claimed to be true in this case when it obtained a new patent in 2000), the pioneer company is required to file supplemental information on the new patent within thirty days of the date the patent is issued. See 21 U.S.C. §§ 355(b)(1) & (c)(2). Upon receipt of the supplemental information, the FDA publishes the submitted patent information in the Approved Drug Products with Therapeutic Equivalence Evaluations book, commonly known as the “Orange Book.” If an ANDA is pending at the time a new patent is listed in the Orange Book, the generic drug company must supplement its FDA submission to indicate that it may permissibly sell the generic version of the drug despite the patent claim. As occurred here, an applicant may certify that “the patent is invalid or will not be infringed by the manufacture, use or sale of the new drug for which the [ANDA has been] submitted.” 21 U.S.C. § 355(j)(2)(A)(vii)(IV).

By November 21, 2000, the FDA had granted tentative approval to two generic companies for their ANDAs, contingent only on the expiration of the '763 patent. One company had manufactured and was ready to ship buspirone the minute the '763 patent expired. 185 F.Supp.2d at 346. Hours before the '763 patent expired, however, Bris[519]*519tol-Myers was awarded a new patent, “the '365 patent,” that covered a metabolite referred to as the “6-hydroxy-metabolite” or “BMY 28674.” 6-hydroxy-metabolite is a substance that the human body naturally produces when it metabolizes buspirone. 185 F.Supp.2d at 344. While the '365 patent did not cover a use of buspirone, see id. at 352, 355, 359, Bristol-Myers nonetheless applied to have the '365 patent listed in the Orange Book. The application was accompanied with a declaration from Bristol-Myers’s patent counsel that the '365 patent was “a method of use patent covering, among other things, a method of using BuSpar for all of its approved indications ...” See Declaration of Richard P. Ryan, reproduced in Exhibit H to Plaintiffs’ Motion to Compel Production of Documents and Testimony Pursuant to the Crime-Fraud Exception and Memorandum In Support Thereof, dated March 8, 2002 (“PI. Crime-Fraud Mot.”). In other words, Bristol-Myers asserted to the FDA that the '365 patent covered a method of using the drug buspirone when in fact it only covered the metabolite. See 185 F.Supp.2d at 376.

The effect of making this assertion (that is, of listing the patent in the Orange Book) was to suspend the generic companies’ ANDAs for generic buspirone. The generic companies immediately submitted letters to the FDA pointing out (among other things) that the '365 patent covers only use of the metabolite and not the use of buspirone itself. The FDA thereupon wrote to Bristol-Myers emphasizing that:

The accuracy and completeness of [the] description of the patent is important to the issue of whether the patent meets the statutory requirements for listing. If the '365 patent contains only the claim for the use of [the metabolite], and no separate claim for an approved use of the parent drug buspirone ..., FDA may not be able to list it in the Orange Book as a protection for BuSpar.

November 30, 2000 FDA letter, reproduced as PI. Crime-Fraud Mot., Ex. G, at 1-2.

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Bluebook (online)
208 F.R.D. 516, 2002 U.S. Dist. LEXIS 11519, 2002 WL 1379985, Counsel Stack Legal Research, https://law.counselstack.com/opinion/in-re-buspirone-antitrust-litigation-nysd-2002.