Bristol-Myers Co. v. Erbamont Inc., Civ. A. No. 89-103-CMW.

• Decision Date: 30 October 1989
• Docket Number: Civ. A. No. 89-103-CMW.
• Citation: 723 F. Supp. 1038
• Parties: BRISTOL-MYERS COMPANY, Plaintiff, v. ERBAMONT INC., Farmitalia Carlo Erba, S.r.l., and Erbamont, N.V., Defendants.
• Court: U.S. District Court — District of Delaware

723 F. Supp. 1038

BRISTOL-MYERS COMPANY, Plaintiff, v. ERBAMONT INC., Farmitalia Carlo Erba, S.r.l., and Erbamont, N.V., Defendants.

Civ. A. No. 89-103-CMW.

United States District Court, D. Delaware.

October 30, 1989.

David A. Anderson, of Potter, Anderson & Corroon, Wilmington, Del. (S. Leslie Misrock, John J. Lauter, Jr., Brian M. Poissant, Laura A. Coruzzi, and John J. Normile, of Pennie & Edmonds, New York City, of counsel), for plaintiff.

Robert H. Richards, III, of Richards, Layton & Finger, Wilmington, Del. (Garland P. Andrews, David L. Hitchcock, Eugenia S. Hansen, and Stuart L. Watt, of Richards, Harris, Medlock & Andrews, Dallas, Tex., of counsel), for defendant Erbamont Inc.

OPINION

CALEB M. WRIGHT, Senior District Judge.

The plaintiff, Bristol-Myers Company ("Bristol-Myers") brought a declaratory judgment action pursuant to 28 U.S.C. §§ 1338(a), 2201, and 2202 on March 3, 1989, against Defendants Erbamont, Inc. ("Erbamont"), Farmitalia Carlo Erba, S.r.l. ("Farmitalia"), and Erbamont, N.V. Bristol-Myers sought a declaration of invalidity, noninfringement, and unenforceability with respect to United States Patent 3,803,124 (the "'124 patent").

On April 12, 1989, Erbamont counterclaimed against Bristol-Myers for infringement of the '124 patent. This counterclaim was grounded upon the recently enacted patent process statute, 35 U.S.C. § 271(g).¹ In response to this counterclaim, Bristol-Myers moved for summary judgment of noninfringement on May 5, 1989. Accordingly, before the Court is plaintiff Bristol-Myers' motion for summary judgment of noninfringement.²

This Court has jurisdiction pursuant to 28 U.S.C. §§ 1338(a), 2201, and 2202.

For the reasons which will be stated herein, the Court grants Bristol-Myers' motion for summary judgment. As a result, Erbamont's counterclaim for infringement will be dismissed with prejudice.³

I. FACTS

The '124 patent issued on April 9, 1974 to Societa Farmaceutici Italia, the predecessor of Farmitalia.⁴ This patent discloses and claims, inter alia, a process for the preparation of doxorubicin, a well-known drug which is used in the chemotherapeutic treatment of cancer. Erbamont sells doxorubicin hydrochloride as a chemotherapeutic agent in the United States through its Adria Laboratories Division.

In December 1987, Bristol-Myers filed an Abbreviated New Drug Application ("ANDA") with the United States Food and Drug Administration ("FDA") seeking approval to import and sell doxorubicin hydrochloride for use in the chemotherapeutic treatment of cancer. Bristol-Myers' ANDA indicated that bulk doxorubicin hydrochloride would be manufactured in Japan by Meiji Seika Pharma International, Ltd. ("Meiji Seika") in accordance with a process approved by the FDA as part of Bristol-Myers' ANDA. The FDA approved Bristol-Myers' ANDA for doxorubicin hydrochloride on April 13, 1989.

During the FDA's review of its doxorubicin hydrochloride ANDA, Bristol-Myers received shipments of bulk doxorubicin hydrochloride from Meiji Seika totalling 13 kilograms.⁵ Bristol-Myers received the 13 kilograms by two separate shipments from Meiji Seika. The first shipment consisted of 2 kilograms that arrived in September of 1988; the second shipment consisted of 11 kilograms that arrived in mid-February of 1989. Meiji Seika delivered both of these shipments of bulk doxorubicin hydrochloride to Bristol-Myers' finishing facilities located in Mayaguez, Puerto Rico, Foreign Trade Zone No. 7. Although the 13 kilograms of doxorubicin hydrochloride was physically present in Puerto Rico before February 23, 1989,⁶ it apparently was warehoused in the custody of the United States Customs Service at that time. Bristol-Myers did not withdraw any of the 13 kilograms of doxorubicin hydrochloride from the warehouse and did not pay customs duties until after February 23, 1989.⁷

Bristol-Myers issued a purchase order for the 2 kilogram shipment on September 14, 1988 and Meiji Seika shipped this amount on September 16, 1988. The 2 kilogram shipment, which was identified by Lot Nos. CDXB-20009 and CDXB-20010, was received at the Mayaguez facility on September 29, 1988. Bristol-Myers issued a purchase order for the 11 kilogram shipment on February 2, 1989, and Meiji Seika shipped this amount on about February 11, 1989. The 11 kilogram shipment, which was identified by Lot Nos. CDXB-20011, CDXB-20012, CDXB-20013, CDXB-20016, CDXB-20017, and CDXB-20018, was received at the Mayaguez facilities on February 16, 1989. The 13 kilograms of doxorubicin hydrochloride remained warehoused in the custody of the Customs Service, until May 1, 1989, at which time Bristol-Myers withdrew 1.257 kilograms of the doxorubicin hydrochloride for entry into United States commerce. This amount of the doxorubicin hydrochloride was taxed with custom duties by the United States Customs Service on this same day.⁸ Bristol-Myers first received processed doses of the doxorubicin hydrochloride in the continental United States at Evansville, Indiana on May 2, 1989.

All 13 kilograms of the doxorubicin hydrochloride had entered the Mayaguez facility prior to the FDA's approval of the Bristol-Myers ANDA. This bulk doxorubicin hydrochloride is currently being processed at the Mayaguez facility into individual vials of lyophilized injectable preparations of powdered doxorubicin hydrochloride. Bristol-Myers has indicated that sales of these vials containing individual lyophilized doses of doxorubicin hydrochloride will begin in the near future as permitted by the terms of Bristol-Myers' recently approved ANDA.

Erbamont's counterclaim for infringement under 35 U.S.C. § 271(g) is based upon Bristol-Myers' receipt of the 13 kilograms of doxorubicin hydrochloride at the Mayaguez, Puerto Rico facility. Erbamont contends that this claim is inappropriate for resolution by summary judgment because the terms "imports" and "importation" in section 271(g) require an examination of Bristol-Myers' intent in causing the 13 kilograms to be shipped to its facility in Puerto Rico. Bristol-Myers, however, asserts noninfringement as an affirmative defense and specifically argues that the 13 kilograms of doxorubicin hydrochloride had been "imported" into the United States prior to the effective date of 35 U.S.C. § 271(g).

II. SUMMARY JUDGMENT STANDARD

Federal Rule of Civil Procedure 56(c) ("Rule 56") provides that summary judgment is appropriate if "there is no genuine issue as to any material fact and ... the moving party is entitled to judgment as a matter of law." A court confronted with a summary judgment motion "must view all facts, and any reasonable inference from those facts, in the light most favorable to the party opposing summary judgment." Wilmington Housing Authority v. Pan Builders, Inc., 665 F.Supp. 351, 353 (D.Del. 1987) (citing Adickes v. Kress Co., 398 U.S. 144, 157, 90 S.Ct. 1598, 1608, 26 L.Ed.2d 142 (1970)). Summary judgment is as proper in a patent case as any other case, if the conditions of Rule 56 have been satisfied. See Chemical Engineering Corp. v. Essef Industries, 795 F.2d 1565, 1571 (Fed.Cir. 1986); Barmag Barmer Maschinenfabrik AG v. Murata Machinery, Ltd., 731 F.2d 831, 835 (Fed.Cir.1984). See also Porter v. Farmers Supply Service, Inc., 617 F.Supp. 1175, 1179 (D.Del.1985), aff'd, 790 F.2d 882 (Fed.Cir.1986).

III. DISCUSSION

Erbamont contends that summary judgment is not suitable in this case because "to resolve the issue of importation in section 271(g), it is necessary to determine Bristol's intent and purpose in both (a) ordering bulk doxorubicin from Meiji after the date of enactment of the Act, and (b) obtaining delivery before February 23, 1989 of enough doxorubicin to supply 27% of the annual United States market." Answering Brief of Defendant at 13. Erbamont urges that Bristol-Myers' conduct represents a deliberate attempt to circumvent the purposes of the § 271(g) by "stockpiling" the doxorubicin hydrochloride so that it would be present in the United States before the effective date of the statute. Id. The Court, however, finds Erbamont's position in conflict with the plain meaning of the statute and unsupported by any clearly expressed legislative history to the contrary.

A. The Patent Process Legislation

On August 23, 1988, Congress passed the Omnibus Trade and Competitiveness Act of 1988 (the "Act"), Public Law No. 100-418. The Act added a new subsection to section 271 of the patent statute (title 35).⁹ This new subsection, 35 U.S.C. § 271(g), created a new infringement cause of action based upon the importation, sale, or use of a product manufactured abroad by a process protected by a United States patent.¹⁰ Section 271(g) provides in pertinent part:

(g) Whoever without authority imports into the United States or sells or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, sale, or use of the product occurs during the term of such process patent.

35 U.S.C. § 271(g).

Section 9006(a) of the Act, however, states that 35 U.S.C. § 271(g) would not be effective until six months after the date of enactment of the Act:

§ 9006 Effective Date

(a) IN GENERAL.—The amendments made by this subtitle take effect 6 months after the date of enactment of this Act and, subject to subsections (b) and (c), shall apply only with respect to products made or imported after the effective date of the amendments made by this subtitle.¹¹

Bristol-Myers received all 13 kilograms of the doxorubicin hydrochloride in the United States prior to the effective date of section 271(g), i.e. prior to February 23, 1989. Consequently, the Court must ascertain whether this receipt avoids the scope of § 271(g).¹²

B. Appropriateness of Summary Judgment

Erbamont's initial argument is that summary judgment is not proper here because the present case calls for the interpretation of a new statutory provision. Answering Brief of Defendant at 14-18. Erbamont...