Amgen, Inc. v. U.S. Intern. Trade Com'n

• Decision Date: 27 April 1990
• Docket Number: No. 89-1523,89-1523
• Citation: 14 USPQ2d 1734,902 F.2d 1532
• Parties: , 14 U.S.P.Q.2d 1734 AMGEN, INC., Appellant, v. UNITED STATES INTERNATIONAL TRADE COMMISSION, Appellee, Chugai Pharmaceutical Co., Ltd. and Chugai Pharma U.S.A., Inc., Intervenors.
• Court: U.S. Court of Appeals — Federal Circuit

Page 1532

902 F.2d 1532

12 ITRD 1209, 14 U.S.P.Q.2d 1734

AMGEN, INC., Appellant, v. UNITED STATES INTERNATIONAL TRADE COMMISSION, Appellee,

Chugai Pharmaceutical Co., Ltd. and Chugai Pharma U.S.A.,

Inc., Intervenors.

No. 89-1523.

United States Court of Appeals,

Federal Circuit.

April 27, 1990.

S. Leslie Misrock, Pennie & Edmonds, New York City, argued, for appellant. D. Dennis Allegretti, Jon O. Nelson, John J. McDonnell, and Paul H. Berghoff, Allegretti & Witcoff, Ltd., Chicago, Ill., were on the brief, for appellant. Also on the brief, were Paul Plaia, Jr., Cecilia H. Gonzalez, Howrey & Simon, Washington, D.C., and Robert D. Weist and Steven M. Odre, Amgen, Inc., Thousand Oaks, Cal., of counsel.

Jean H. Jackson, Office of the Gen. Counsel, U.S. Intern. Trade Com'n, Washington, D.C., argued for appellee. With her on the brief, were Lyn M. Schlitt, Gen. Counsel, James A. Toupin, Asst. Gen. Counsel and Abigail A. Shaine.

Kurt E. Richter, Morgan & Finnegan, New York City, argued for intervenors, Chugai Pharmaceutical Co., Ltd., Chugai Pharma U.S.A., Inc. With him on the brief, were Eugene Moroz, William S. Feiler, Michael P. Dougherty and Valerie Fedowich. Also on the brief, were Will E. Leonard, Jon F. Tuttle, Jonathan Hemenway Glazier, Edward R. Easton, Philippe M. Bruno and Kenneth J. Nunnenkamp, Dorsey & Whitney, Washington, D.C., of counsel.

Mary Helen Sears, Peter M. Kirby and William J. McNichol, Jr., Ginsburg, Feldman & Bress, Chartered, Washington, D.C., were on the brief, for amicus curiae, Mayflower Imports, Inc.

Before RICH and ARCHER, Circuit Judges, FRIEDMAN, Senior Circuit Judge.

RICH, Circuit Judge.

Amgen, Inc. (Amgen) appeals from the April 10, 1989 Order of the United States International Trade Commission (Commission), Inv. No. 337-TA-281 entitled Certain Recombinant Erythropoietin, 10 USPQ2d 1906 (USITC 1989), dismissing its complaint for lack of subject matter jurisdiction. We vacate and remand.

BACKGROUND

Erythropoietin is a hormone which controls the synthesis of red blood cells in bone marrow and which is useful for treating patients suffering from anemia. Because the amount of erythropoietin naturally present in humans and animals is very small, it is impractical to obtain erythropoietin from natural sources for the purpose of treating anemia. Therefore, scientists from the emerging field of biotechnology have used recombinant DNA technology to produce genetically-altered cells (host cells) which produce large amounts of erythropoietin. To simplify the recombinant DNA procedure, the particular DNA sequence, or gene, responsible for a desired trait, here the production of erythropoietin, is isolated and removed from human cells. The isolated DNA sequence is then "recombined" with the DNA present in the host cells. As a result, the host cell is genetically-altered so as to express the desired trait: in this case, to produce erythropoietin. Erythropoietin produced in this way is referred to as recombinant erythropoietin, or rEPO, in order to distinguish it from naturally-occurring erythropoietin.

Appellant Amgen is the owner by assignment of U.S.Pat. No. 4,703,008 (the '008 patent), which has claims directed toward recombinant DNA sequences, vectors and host cells used to produce rEPO. The '008 patent contains no claim to the product On January 4, 1988, Amgen filed a complaint with the Commission, alleging that Chugai Pharmaceutical Co. of Japan and its U.S. subsidiary, Chugai Pharma U.S.A., Inc., (collectively Chugai) had violated former section 337 of the Tariff Act of 1930, 19 U.S.C. Sec. 1337; See also 19 U.S.C. Sec. 1337a by importing recombinant erythropoietin (rEPO) made by a process covered by the '008 patent. ² On February 2, 1988, the Commission voted to institute an investigation, and referred the matter to an Administrative Law Judge (ALJ). During the course of the proceeding, Congress passed, on August 23, 1988, the 1988 Trade Act, which substantially amended former section 1337 and repealed former section 1337a. Because the Trade Act stated that amended section 1337 would apply to all pending Commission investigations, Amgen's complaint became one under section 1337(a)(1)(B)(ii), which reads as follows:

rEPO itself, and no claim to any process of making rEPO, or any other process. ¹

(a) Unlawful activities; covered industries; definitions

(1) Subject to paragraph (2), the following are unlawful, and when found by the Commission to exist shall be dealt with, in addition to any other provision of law, as provided in this section:

* * * * * *

(B) The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee, of articles that--

* * * * * *

(ii) are made, produced, processed, or mined under, or by means of, a process covered by the claims of a valid and enforceable United States patent.

The primary issue throughout the proceedings in the Commission was whether the rEPO produced and imported by Chugai is "made ... by means of a process covered by" a claim of the '008 patent, even though the '008 patent does not contain, as Amgen calls them, "conventional process claims." Amgen presented two related arguments before the ALJ: (1) Chugai's process for producing rEPO necessarily requires the use of Amgen's patented DNA sequences, vectors and host cells, and thus is "covered" by the claims of the '008 patent; and (2) the claims to the host cells are "unique hybrid claims" which cover not only the cells themselves, but also the unique intracellular life processes inherently performed by the host cells.

After conducting a full investigation on the merits, the ALJ delivered an extensive, 188 page Initial Determination on January 10, 1989. While finding that the Commission does have subject matter jurisdiction over Amgen's complaint, the ALJ determined that the claims of the '008 patent do not "cover" Chugai's process for producing On April 10, 1989, after review of the ALJ's Initial Determination, the Commission, disagreeing with the ALJ on the jurisdiction issue, entered an order terminating the investigation for lack of subject matter jurisdiction. In an accompanying Opinion joined by a majority of four Commissioners, the Commission adopted the ALJ's extensive analysis of the scope of section 1337(a)(1)(B)(ii) but concluded that the existence of a process patent claim was a jurisdictional prerequisite for an investigation under section 1337(a)(1)(B)(ii). Since, concluded the Commission's April 10 Opinion, the '008 patent does not contain any process patent claims, the Commission must dismiss not on the merits, but for lack of subject matter jurisdiction. This appeal followed.

rEPO, and thus that no violation of section 1337(a)(1)(B)(ii) occurred.

OPINION

A. Jurisdiction

This court's authority to review a decision of the Commission is limited by section 1337(c), which states in part:

Any person adversely affected by a final determination of the Commission under subsection (d), (e), (f), or (g) of [section 1337] may appeal such determination ... to the United States Court of Appeals for the Federal Circuit....

This language has been interpreted as requiring a "final determination decision on the merits, excluding or refusing to exclude articles from 'entry' " under section 1337(d), (e), (f) or (g). Block v. U.S. Int'l Trade Comm'n, 777 F.2d 1568, 1571, 228 USPQ 37, 38 (Fed.Cir.1985) (emphasis in original). ³ Thus, both the Commission and Chugai have filed motions to dismiss on the ground that this court is without jurisdiction to review the Commission's April 10, 1989 Order, since that Order constituted a dismissal for lack of subject matter jurisdiction and not a final determination on the merits.

In response, Amgen contends that the Commission's April 10 Order is intrinsically a final determination not to exclude articles from entry, and thus is appealable under section 1337(c). We agree.

The fact that the Commission termed its dismissal as one for lack of subject matter jurisdiction rather than as one on the merits is not dispositive. If this fact were dispositive, then the Commission could effectively shield all negative determinations from judicial review simply by labelling the determination as a dismissal for lack of jurisdiction. Such a result would be clearly contrary to the statutory scheme, which provides for judicial review of both positive and negative determinations. ⁴ Instead, this court has recognized that when a decision is intrinsically a final determination, i.e., a determination on the merits, then that decision is appealable under section 1337(c). Block; Import Motors Ltd. v. U.S. Int'l Trade Comm'n, 530 F.2d 940, 944, 188 USPQ 491, 494 (CCPA 1976).

In Block, this court reviewed an Order of the Commission terminating an investigation, initiated on its own motion, after the patent forming the basis for the alleged section 1337 violation was substantially amended during reexamination proceedings in the PTO. In concluding that the Order was not an intrinsically final determination, this court found the lack of any findings by the Commission to be critical; nothing in the termination Order prejudiced the Commission or any private party in a future proceeding. Block, 777 F.2d at 1571-72, 228 USPQ at 38-39. To the contrary, the Commission in this case made one very important finding: that the claims of the '008 patent do not, in fact, cover a process. This finding clearly reaches the merits of Amgen's complaint and determinatively decides Amgen's right to proceed in a section 1337 action; even assuming that the Commission's dismissal is not given res judicata effect, ⁵ any future action brought by Amgen would necessarily raise the same issue, and would presumably be dismissed for the same reason.

Further, we are of the opinion that the Commission should have treated Amgen's complaint on the merits and not on jurisdictional grounds. As is very common...