Amgen, Inc. v. United States International Trade Commission, Chugai Pharmaceutical Co., Ltd. And Chugai Pharma U.S.A., Inc., Intervenors

902 F.2d 1532, 14 U.S.P.Q. 2d (BNA) 1734, 1990 U.S. App. LEXIS 6558
CourtCourt of Appeals for the Federal Circuit
DecidedApril 27, 1990
Docket19-2072
StatusPublished
Cited by39 cases

This text of 902 F.2d 1532 (Amgen, Inc. v. United States International Trade Commission, Chugai Pharmaceutical Co., Ltd. And Chugai Pharma U.S.A., Inc., Intervenors) 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
Amgen, Inc. v. United States International Trade Commission, Chugai Pharmaceutical Co., Ltd. And Chugai Pharma U.S.A., Inc., Intervenors, 902 F.2d 1532, 14 U.S.P.Q. 2d (BNA) 1734, 1990 U.S. App. LEXIS 6558 (Fed. Cir. 1990).

Opinion

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 erythro-poietin 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 er-ythropoietin. 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. Er-ythropoietin 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 *1534 rEPO itself, and no claim to any process of making rEPO, or any other process. 1

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. § 1337; See also 19 U.S.C. § 1337a by importing recombinant erythro-poietin (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 (AU). 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, Am-gen’s complaint became one under section 1337(a)(l)(B)(ii), which reads as follows:

(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 Chu-gai 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 AU: (1) Chu-gai’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 AU 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 AU determined that the claims of the ’008 patent do not “cover” Chugai’s process for producing *1535 rEPO, and thus that no violation of section 1337(a)(l)(B)(ii) occurred.

On April 10, 1989, after review of the AU’s Initial Determination, the Commission, disagreeing with the AU 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 AU’s extensive analysis of the scope of section 1337(a)(l)(B)(ii) but concluded that the existence of a process patent claim was a jurisdictional prerequisite for an investigation under section 1337(a)(l)(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.

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.

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902 F.2d 1532, 14 U.S.P.Q. 2d (BNA) 1734, 1990 U.S. App. LEXIS 6558, Counsel Stack Legal Research, https://law.counselstack.com/opinion/amgen-inc-v-united-states-international-trade-commission-chugai-cafc-1990.