Connaught Laboratories, Inc. v. Smithkline Beecham P.L.C. And Smithkline Beecham Corporation v. U.S. Food & Drug Administration, Dr. Drusilla Burns, and Dr. Michael Brennan, Subpoenaed Parties-Appellants

165 F.3d 1368, 49 U.S.P.Q. 2d (BNA) 1540, 42 Fed. R. Serv. 3d 690, 1999 U.S. App. LEXIS 897
CourtCourt of Appeals for the Federal Circuit
DecidedJanuary 25, 1999
Docket98-1471
StatusPublished

This text of 165 F.3d 1368 (Connaught Laboratories, Inc. v. Smithkline Beecham P.L.C. And Smithkline Beecham Corporation v. U.S. Food & Drug Administration, Dr. Drusilla Burns, and Dr. Michael Brennan, Subpoenaed Parties-Appellants) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Connaught Laboratories, Inc. v. Smithkline Beecham P.L.C. And Smithkline Beecham Corporation v. U.S. Food & Drug Administration, Dr. Drusilla Burns, and Dr. Michael Brennan, Subpoenaed Parties-Appellants, 165 F.3d 1368, 49 U.S.P.Q. 2d (BNA) 1540, 42 Fed. R. Serv. 3d 690, 1999 U.S. App. LEXIS 897 (Fed. Cir. 1999).

Opinion

165 F.3d 1368

49 U.S.P.Q.2d 1540

CONNAUGHT LABORATORIES, INC., Plaintiff,
v.
SMITHKLINE BEECHAM P.L.C. and SmithKline Beecham
Corporation, Defendants-Appellees,
v.
U.S. Food & Drug Administration, Dr. Drusilla Burns, and Dr.
Michael Brennan, Subpoenaed Parties-Appellants.

No. 98-1471.

United States Court of Appeals,
Federal Circuit.

Jan. 25, 1999.

Richard L. Rainey, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Washington, DC, argued for defendants-appellees. With him on the brief were Donald R. Dunner, Susan H. Griffen, and Jeffrey B. Chasnow. Of counsel on the brief were Mark S. Brown, King & Spalding, of Washington, DC, and Zoltan Kerekes, SmithKline Beecham Corporation, of King of Prussia, Pennsylvania.

John S. Koppel, Attorney, Appellate Staff, Civil Division, Department of Justice, of Washington, DC, argued for subpoenaed parties-appellants. With him on the brief were Frank W. Hunger, Assistant Attorney General, and William Kanter, Deputy Director, Appellate Staff.

Before MAYER, Chief Judge, CLEVENGER and GAJARSA, Circuit Judges.

MAYER, Chief Judge.

The United States Food and Drug Administration ("FDA") appeals the judgment of the United States District Court for the District of Delaware, 98-MC-24, which granted the motion of SmithKline Beecham P.L.C. and SmithKline Beecham Corp. ("SmithKline") to compel the FDA to comply with subpoenas requiring testimony from its employees. See Connaught Lab., Inc. v. Smithkline Beecham P.L.C., 7 F.Supp.2d 477 (D.Del.1998). Because this court lacks jurisdiction to consider an appeal of the non-final district court order to compel, we dismiss.

Background

On September 16, 1997, Connaught Laboratories, Inc. sued SmithKline for infringement of its U.S. Patent No. 5,667,787 ("the '787 patent"). The '787 patent describes the purification of pertactin, an active ingredient in a type of pertussis vaccine. SmithKline argued that the '787 patent was unenforceable, invalid, and not infringed. In particular, SmithKline asserted that the FDA had performed scientific research on purified pertactin before April 4, 1990, the '787 patent's priority date.

In an attempt to prove this allegation, SmithKline filed a subpoena for documents describing the FDA's pertactin research, a request with which the FDA complied. Maintaining that the documents provided were not sufficient for its purposes, SmithKline also filed a request under 21 C.F.R. § 20.1 for testimony of FDA employees involved in the pertactin research, but the FDA refused to allow the testimony. In response to this denial, SmithKline served subpoenas on three FDA employees to elicit their testimony and filed a motion to compel compliance with the subpoenas in the United States District Court for the District of Delaware. The FDA moved to quash the subpoenas.

The district court granted SmithKline's motion to compel and denied the FDA's motion to quash. The FDA argued that the only avenue for challenging its refusal to permit its employees' testimony was pursuant to the Administrative Procedure Act, 5 U.S.C. §§ 702-706 (1994) ("APA"), but the district court held that SmithKline was proceeding under the Federal Rules of Civil Procedure, not the APA. The court also rejected the FDA's argument that it is protected by sovereign immunity, holding that such immunity applies only in state court, not to subpoenas of a federal court to a federal agency. The FDA appeals the district court's grant of SmithKline's motion to compel testimony of FDA employees in a lawsuit to which the FDA is not a party.

Discussion

Our jurisdiction is limited to review of "final decisions of district courts." See 28 U.S.C. §§ 1291, 1295(a)(1) (1994); Micro Motion, Inc. v. Exac Corp., 876 F.2d 1574, 1575-76 (Fed.Cir.1989). Consequently, "[t]he nonappealability of orders requiring the production of evidence from witnesses has long been established." Micro Motion, 876 F.2d at 1576 (citing Alexander v. United States, 201 U.S. 117, 121-22, 26 S.Ct. 356, 50 L.Ed. 686 (1906)). This finality rule is also applicable where discovery orders are made upon witnesses who are not parties to a suit. See id. Nonparties may secure review of a discovery order by refusing to comply with it and appealing a consequent contempt order, which is considered final. See id. at 1577-78. The FDA, however, argues that review is available without incurring a contempt charge through either the collateral order doctrine or a writ of mandamus.

In Cohen v. Beneficial Industrial Loan Corp., 337 U.S. 541, 69 S.Ct. 1221, 93 L.Ed. 1528 (1949), the Supreme Court held that a class of decisions-- "collateral orders"--are exempt from the finality rule. Under Cohen, collateral orders are those that "conclusively determine the disputed question, resolve an important issue completely separate from the merits of the action, and [are] effectively unreviewable on appeal from a final judgment." Coopers & Lybrand v. Livesay, 437 U.S. 463, 468, 98 S.Ct. 2454, 57 L.Ed.2d 351 (1978) (citing Cohen, 337 U.S. at 546, 69 S.Ct. 1221); see also Heat & Control, Inc., v. Hester Indus., Inc., 785 F.2d 1017, 1020 (Fed.Cir.1986).

A writ of mandamus provides another path around the finality rule. But it may be used to overturn a district court order "only when there has been a clear abuse of discretion or usurpation of judicial authority in the grant or denial of the order." In re Regents of Univ. of Cal., 101 F.3d 1386, 1387 (Fed.Cir.1996). Moreover, "[t]he petitioner has the burden of establishing that its right to the issuance of the writ is clear and indisputable, and that it lacks adequate alternative means to obtain the relief sought." Id. (internal citation omitted).

The FDA's avenue of refusing to comply with the order and appealing a subsequent contempt citation is an "adequate alternative" that provides an "effective review" of the order. Its ability to secure review of the discovery order precludes application of either exception to the finality rule.

The FDA responds that the government should not have to take contempt to secure review of a discovery order. For that reason it says that effective review of the order is unavailable absent the collateral order doctrine or writ of mandamus, because to comply with the order to avoid contempt would make an appeal of the order, after final judgment of the underlying patent case, moot.

We do not share the FDA's concern over the controversy becoming moot.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Alexander v. United States
201 U.S. 117 (Supreme Court, 1906)
Cohen v. Beneficial Industrial Loan Corp.
337 U.S. 541 (Supreme Court, 1949)
United States v. Nixon
418 U.S. 683 (Supreme Court, 1974)
Coopers & Lybrand v. Livesay
437 U.S. 463 (Supreme Court, 1978)
Franklin v. Massachusetts
505 U.S. 788 (Supreme Court, 1992)
Heat & Control, Inc. v. Hester Industries, Inc.
785 F.2d 1017 (Federal Circuit, 1986)
In Re United States of America
985 F.2d 510 (Eleventh Circuit, 1993)
Rhone-Poulenc Rorer Inc. And Armour Pharmaceutical Company v. The Home Indemnity Company, a New Hampshire Corporation v. Aetna Casualty & Surety Insurance Aiu Insurance Company American Centennial Insurance Company Birmingham Fire Insurance Company First State Insurance Company Granite State Insurance Company Hartford Insurance Company Insco, Limited Insurance Company of Pennsylvania Lexington Insurance Company Manhattan Fire & Marine Insurance Company Motor Vehicle Casualty Company Old Republic Insurance Company Pantry Pride Inc. Promethean Insurance, Ltd. Prudential Reinsurance Company Puritan Insurance Company Revlon Inc. Twin City Insurance Company London Market Co. John Barrington Hume, as Representative of Underwriters at Lloyds Insurance Company of North America National Union Fire Insurance Company of Pittsburgh, Pennsylvania All City Insurance Company Employer's Mutual Casualty Gibralter Casualty Company Landmark Insurance Company New England Insurance Company Royal Insurance Company Republic Insurance Company International Insurance Company Pacific Insurance Company, Ltd. Atlanta International Insurance Company Century Indemnity Company Liberty Mutual Insurance Company Transport Insurance Company Midland Insurance Company Integrity Insurance Company Union Indemnity Insurance Transit Casualty Company City Insurance Company Drake Insurance Company Excess Insurance Company Home Insurance Company Pacific Employer's Insurance Company Royal Indemnity Company Zurich International Insurance Company Henrijean Illinois National Insurance Company North Star Reinsurance Company and National Casualty Insurance Company, and the Honorable James McGirr Kelly, United States District Judge for the Eastern District of Pennsylvania, Nominal Morgan, Lewis & Bockius Reed Smith Shaw & McClay Shanley & Fisher, P.C. Hughes Hubbard & Reed Montgomery McCracken Walker & Rhoads Skadden Arps Slate Meagher & Flom and Coopers & Lybrand, Intervenors in Support of Rhone-Poulenc Rorer Inc. And Armour Pharmaceutical Company v. The Home Indemnity Company, a New Hampshire Corporation v. Aetna Casualty & Surety Insurance Aiu Insurance Company American Centennial Insurance Company Birmingham Fire Insurance Company Transportation Insurance Company First State Insurance Company Granite State Insurance Company Hartford Insurance Company Illinois National Insurance Co. Insco, Ltd. Insurance Company of the State of Pennsylvania Lexington Insurance Company Manhattan Fire & Marine Insurance Company Motor Vehicle Casualty Company National Union Fire Insurance Company of Pittsburgh, Pa New England Reinsurance Company New Hampshire Insurance Company Old Republic Insurance Company Pacific Employers Insurance Company Pantry Pride, Inc. Promethean Insurance, Ltd. Prudential Reinsurance Company Puritan Insurance Company Revlon, Inc. Twin City Insurance Company the London Market Companies and John Barrington Hume, a Representative of Underwriters at Lloyds of London and Revlon, Inc. v. City Insurance Company Drake Insurance Company Excess Insurance Company Henrijean the Home Insurance Company Pacific Employer's Insurance Company Royal Indemnity Company Zurich International Insurance Company Insurance Company of North America National Union Fire Insurance of Pittsburgh, Pa All City Insurance Company Employers Mutual Casualty Company Gibralter Casualty Company Landmark Insurance Company New England Insurance Company Royal Insurance Company Republic Insurance Company International Insurance Company Pacific Insurance Company, Ltd. Atlanta International Insurance Co. Century Indemnity Company Liberty Mutual Insurance Company Transportation Insurance Company Midland Insurance Company Pacific Insurance Company, Ltd. Atlanta Insurance Company Ltd. Century Indemnity Company Liberty Mutual Insurance Midland Insurance Company Integrity Insurance Company Union Indemnity Insurance Company Transit Casualty Company Royal Insurance Company Royal Indemnity Company New England Insurance Company Insurance Company of North America North Star Reinsurance Company and National Casualty Insurance Company, Morgan, Lewis & Bockius Reed Smith Shaw & McClay Shanley & Fisher, P.C. Hughes Hubbard & Reed Montgomery McCracken Walker & Rhoads Skadden Arps Slate Meagher & Flom and Coopers & Lybrand, Intervenors-Appellants
32 F.3d 851 (First Circuit, 1994)
In Re: David A. Kessler, M.D.
100 F.3d 1015 (D.C. Circuit, 1996)
In Re the Regents of the University of California
101 F.3d 1386 (Federal Circuit, 1996)
In Re Ford Motor Company
110 F.3d 954 (Third Circuit, 1997)

Cite This Page — Counsel Stack

Bluebook (online)
165 F.3d 1368, 49 U.S.P.Q. 2d (BNA) 1540, 42 Fed. R. Serv. 3d 690, 1999 U.S. App. LEXIS 897, Counsel Stack Legal Research, https://law.counselstack.com/opinion/connaught-laboratories-inc-v-smithkline-beecham-plc-and-smithkline-cafc-1999.