American Cyanamid v. Fermenta

CourtCourt of Appeals for the Third Circuit
DecidedMarch 14, 1995
Docket94-5413
StatusUnknown

This text of American Cyanamid v. Fermenta (American Cyanamid v. Fermenta) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
American Cyanamid v. Fermenta, (3d Cir. 1995).

Opinion

Opinions of the United 1995 Decisions States Court of Appeals for the Third Circuit

3-14-1995

American Cyanamid v Fermenta Precedential or Non-Precedential:

Docket 94-5413

Follow this and additional works at: http://digitalcommons.law.villanova.edu/thirdcircuit_1995

Recommended Citation "American Cyanamid v Fermenta" (1995). 1995 Decisions. Paper 73. http://digitalcommons.law.villanova.edu/thirdcircuit_1995/73

This decision is brought to you for free and open access by the Opinions of the United States Court of Appeals for the Third Circuit at Villanova University School of Law Digital Repository. It has been accepted for inclusion in 1995 Decisions by an authorized administrator of Villanova University School of Law Digital Repository. For more information, please contact Benjamin.Carlson@law.villanova.edu. UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT

N0. 94-5413

AMERICAN CYANAMID COMPANY, Appellant

v.

FERMENTA ANIMAL HEALTH COMPANY, a Delaware corporation

On Appeal From the United States District Court For the District of New Jersey (D.C. Civil Action No. 93-cv-04936)

Argued October 28, 1994

BEFORE: STAPLETON, HUTCHINSON and ROSENN, Circuit Judges

(Opinion Filed March 14, 1995)

John Vanderstar (Argued) Christopher N. Sipes Covington & Burling 1201 Pennsylvania Ave., N.W. P. O. Box 7566 Washington, D.C. 20044 and Donald A. Robinson Robinson, St. John & Wayne Two Penn Plaza East Newark, N.J. 07105-2249

Of Counsel: Ronald J. Cracas Jane Y.C. Mathews American Cyanamid Company One Cyanamid Plaza Wayne, N.J. 07470-8426 Attorneys for Appellant Clinton R. Batterton (Argued) Edward John Allera Naomi Joy Levan Akin, Gump, Strauss, Hauer & Feld 1333 New Hampshire Ave., N.W. Suite 400 Washington, D.C. 20036-1511

Of Counsel: James B. Daniels Friedman Siegelbaum 7 Becker Farm Road Roseland, N.J. 07068 and Lars H. Liebeler The Robinson Law Firm 717 D Street, N.W., #400 Washington, D.C. 20004

Attorneys for Appellee

OPINION OF THE COURT

STAPLETON, Circuit Judge:

The issue in this case is whether a 1980 contract

between the parties and a 1983 amendment thereto conveyed to

American Cyanamid Company ("Cyanamid") perpetual rights to use

the federal regulatory authority of Fermenta Animal Health

Company ("Fermenta") to market an animal feed supplement.

Cyanamid marketed the drug under the trademark Aureozol. Before

the district court, both sides maintained that these documents

are unambiguous, although each side differed on what was

unambiguously stated therein. The district court held that "the plain language of the 1980 agreement and the 1983 amendment,"

when read against the background of the parties' pre-contract

negotiations and post-contract conduct, did not convey that

right. We will affirm.

I.

This dispute arises from a contract that was signed

between Cyanamid, a chemical and pharmaceutical conglomerate, and

Diamond Shamrock Corporation ("Diamond Shamrock") in 1980.

Fermenta, the defendant in this case, became the successor in

interest to Diamond Shamrock through an acquisition in 1985. The

purpose of the contract was to enable Cyanamid to produce and

sell an animal feed drug that Diamond Shamrock had developed and

was marketing. The drug was an antibiotic animal feed supplement

consisting of chlortetracycline, sulfathiazole, and penicillin,

known as CSP 250. As consideration, Diamond Shamrock would

receive an advance royalty and future royalties from Cyanamid's

sales.

In order for Cyanamid to manufacture and sell Diamond's

product, the contract granted it two distinct rights. First,

Cyanamid was given access to Diamond Shamrock's proprietary

information about its animal feed drug for the purpose of

manufacturing and selling it. Equally important, the agreement

gave Cyanamid the right to reference Diamond Shamrock's

regulatory authority to sell the drug.

The FDA licenses the sale in interstate commerce of

animal drugs by approving a manufacturer's New Animal Drug Application (NADA), which remains on file with the FDA. Through

the NADA, the FDA approves both the properties of the drug and

its place and method of manufacture. See 21 U.S.C. § 360b(a).

In 1971, Diamond Shamrock had obtained FDA approval for a NADA

for its animal feed drug.1

Obtaining a NADA can be an expensive and lengthy

process because of the amount of resources that must be expended

on researching and demonstrating the safety and efficacy of the

proposed animal drug. However, a company may be able to avoid

the costs associated with obtaining its own NADA if it wishes to

market a drug identical to that marketed by another company by

requesting that company to allow it to reference the safety and

efficacy data in its NADA. The current NADA holder must apply to

the FDA for a "supplemental NADA" to enable the other company to

reference its original NADA. See 21 C.F.R. § 514.8(a)(4)(v).2

Cyanamid entered into this contract with Diamond

Shamrock because its own animal drug, which competed in the

1 . When Fermenta became the successor in interest to Diamond Shamrock's animal drug business, it acquired Diamond Shamrock's NADA authority, as noted in 21 C.F.R. § 558.15(g)(1). 2 . 21 C.F.R. § 514.8(a)(4)(v) provides in part:

A communication proposing a change in a new animal drug application should provide for any one of the following kinds of changes: . . .

(v) Provision for outside firm to participate in the preparation, distribution, or packaging of a new animal drug (new distributor, packer, supplier, manufacturer, etc.). market with Diamond Shamrock's CSP 250, was under scrutiny by the

FDA for the possible carcinogenic effects of one of its

components, sulfamethazine. Cyanamid sought to "insure" itself

in the event the FDA took adverse action against its existing

animal product by expanding its own product line to include

Diamond Shamrock's animal feed supplement. Thus, in 1979, it

entered negotiations with Diamond Shamrock, hoping to obtain the

right to develop and sell Diamond Shamrock's product. Since

Cyanamid could not sell Diamond Shamrock's drug without federal

regulatory authority, the agreement required Diamond Shamrock to

prepare and file a supplemental NADA establishing Cyanamid's

facility as an alternate manufacturing site and designating

Cyanamid as a distributor of the drug. In addition to pursuing

an agreement with Diamond Shamrock, Cyanamid was formulating

plans to obtain its own NADA for an animal product consisting of

aureomycin, sulfathiazole and penicillin, a combination similar

to CSP 250. This was reflected in a letter sent from Cyanamid to

Diamond Shamrock during the course of negotiations in December of

1979.

Cyanamid and Diamond Shamrock executed their contract

on July 23, 1980. Diamond Shamrock obtained the supplemental

NADA in June of 1982 and the original five year contract period

commenced on that date. Cyanamid thus enjoyed both commercial

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