Amgen, Inc. v. United States International Trade Commission, Chugai Pharmaceutical Co., Ltd. And Chugai Pharma U.S.A., Inc., IntervenorsAmgen, Inc. v. United States International Trade Commission, Chugai Pharmaceutical Co., Ltd. And Chugai Pharma U.S.A., Inc., Intervenors
Amgеn, 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 erythropoiеtin, 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 hаs 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,
(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 аddition to any other provision of law, as provided in this section:
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(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—
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(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” Chugаi’s process for producing
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
OPINION
A. Jurisdiction
This court’s authority to review a decision of the Commission is limited by
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 Appеals 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
In response, Amgen contends that the Commission’s April 10 Order is intrinsically a final determination not tо exclude articles from entry, and thus is appealable under
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 judiсial 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
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
Further, we are of the opinion that the Commission should have treated Am-gen’s complaint on the merits and not on jurisdictional grounds. As is very common in situations where a tribunal’s subject matter jurisdiction is based on the same statute which gives rise to the federal right,
6
the jurisdictional requirements of
In Bell v. Hood, plaintiffs brought suit against the Federal Bureau of Investigation, seeking money damages based on alleged violations of their rights under the Fourth and Fifth Amendments to the Constitution. The District Court dismissed for lack of jurisdiction on the ground that the action did not “arise under the Constitution or laws of the United States.” The Supreme Court reversed, holding that since the complaint on its face clearly sought relief based on the Constitution, the District Court must assume jurisdiction to decide whether the allegations state a claim upon which relief can be granted.
Jurisdiction, therefore, is not defeated as respondents seem to contend, by the possibility that the averments might fail to state a cause of action on which petitioners could actually recover. For it is well settled that the failure to state a propеr cause of action calls for a judgment on the merits and not for a dismissal for want of jurisdiction. Whether the complaint states a cause of action on which relief could be granted is a question of law and just as issues of fact it must be decided after and not before the court has assumed jurisdiction over the controversy. If the court does later exercise its jurisdiction to determine that the allegations in the complaint do not state a ground for relief, then dismissal of the case would be on the merits, not for want of jurisdiction.
Bell v. Hood,
We deem this analysis to be applicable to the present case. Amgen’s complaint alleged that Chugai was importing rEPO and that the rEPO was made by a process covered by the ’008 patent; thus, on its face the complaint came within the jurisdiction of the Commission. The fact that Am-gen was later unable to sustain these allegations is not material to the issue of
jurisdiction.
We hold that the Commission should have assumed jurisdiction, and, if the facts indicate that Amgen cannot obtain relief under
Since the Commission’s dismissal for lack of subject matter jurisdiction was intrinsically a final decision on the merits, and should have been phrased as a dismissal on the merits, we hold that this court has jurisdiction to review the Commission’s Order. Therefore, the Commission’s and Chu-gai’s motions to dismiss are denied.
B.
The Scope of
1. Are Amgen’s Host Cell Claims Unique?
In its brief, Amgen repeatedly asks us to phrase the issue in this appeal as
being “whether
We think there is not. On their face, the host cell claims of the ’008 patent are limited to just that: host cells.
8
In
Diamond v. Chakrabarty,
Consequently, Amgen’s argument for relief under
2. Statutory Interpretation
The resolution of this issue turns on the interpretation of the phrase “a process covered by the claims of a ... patent” in
The parties expend much effort trying to convince us of what exactly the plain meaning of the word “covered” is. While the meaning of this word can vary slightly depending on the context, we are of the opinion that in normal parlance among patent lawyers, to whom patent statutes are directed, a patent “covering” a рrocess is a patent containing at least one claim defining a process.
3. The Legislative History
The key language in
Former
In response, several bills were introduced into Congress, the one that became former
This bill is designed to correct the present problem which was created when the Court of Customs and Patent Appeals in the case In re Amtorg Trading Corporation reversed its former decisions and held that the importation of products made abroad in accordance with a United States process patent without consent of patentee was not regarded as an unfair method of сompetition. [Emphasis ours.]
H.R.Rep. No. 1781, 76th Cong., 3d Sess. 1 (1940); see also S.Rep. No. 1903, 76th Cong., 3d Sess. 1 (1940). There is no indication in either the House or Senate reports, or the House committee hearings report, 12 that former section 1377a was intended to prohibit the importation of goods made by a process which merely used abroad a product, apparatus, or material patented in this country.
Amgen contends that Congress’ intent to prohibit such activity can be seen from the legislative history of the 1988 Trаde Act which repealed former
A continuing goal of Congress is to encourage innovation by providing meaningful protection for the inventions and discoveries of American inventors and for the manufacture of innovative products made by American workers. The emerging biotechnology industry has pioneered a revolutionary genetic engineering technology that produces recombi-nantly derived materials used to make previously unavailable products.
With respect to section 1342 of the Trade Act (title 19), this bill reenacts prior section 337a of the Tariff Act of 1940 (as 337(a)(1)) which addresses protection of U.S. business from importation of products made outside of the United States by a process covered by a claim of a U.S. patent.
Section 337(а)(1) (a reenactment of section 337a) will provide the assistance necessary for emerging U.S. industries, such as the biotechnology industry, to compete in a marketplace without interference due to unfair acts of foreign competitors. The continued broad jurisdiction of the International Trade Commission will help U.S. industry address the unfair activity of foreign competitors who, for example, import products manufactured using patented genetic enginеering technology. Merely moving manufacture offshore does not absolve the wrongdoer from the requirement to compete fairly. This Trade Act protection prohibits the foreign enterprise from taking jobs from American workers by doing offshore that which they could not lawfully do in the United States.
This statement supports the Commission’s position just as much as, if not more than, Amgen’s position. As noted above, former
In fact, the only portion of Senator Lau-tenberg’s statement (and of the entire legislative history of the 1988 Trade Act, for that matter) which supports Amgen’s position is the last sentence: “Trade Act protection prohibits ... doing offshore that which they could not lawfully do in the United States.” However, we do not consider that what Amgen attempts to make of this single sentence, in light of the remaining legislative history of both the 1940 enactment of former
It is our impression from study of this case that the possibility of doing what Chu-gai is doing in Japan — using Amgen’s patented host cells in the larger process by which it produces rEPO through utilization of the life processes of the host cells — is something which was not considered by the Congress in connection with the 1988 revision of
C. Conclusion
Since none of the claims of the ’008 patent cover the process performed overseas by Chugai, Amgen’s complaint under
COSTS
Amgen to bear the costs.
VACATED AND REMANDED.
Notes
. The application which matured into the '008 patent originally contained claims to the process of producing rEPO. The Patent and Trademark Office (PTO) Examiner rejected these claims, at least in part, because he considered the claims to be to the application of an old process to new starting materials and thus not patentable on the authority of
In re Durden,
. As discussed later in this opinion,
Former
Former
Importation of products produced under process covered by claims of unexpired patent
The importation for use, sale, or exchange of a product made, produced, processed, or mined under or by means of a process covered by the claims of any unexpired valid United States letters patent, shall have the same status for the purposes ofsection 1337 of this title as the importation of any product or article covered by the claims of any unexpired valid United States letters patent.
. While
Block
was decided with reference to former
.
See
. Dismissals for lack of jurisdiction may be given res judicata effect as to the jurisdictional issue.
See Underwriters Nat'l Assurance Co. v. North Carolina Life & Accident & Health Ins. Guar. Ass’n,
. In a concurring opinion issued with the Commission’s April 10, 1989 Order, two Commissioners indicated that they would dismiss Am-gen's complaint on the merits because they considered the Commission's jurisdiction to be based not on
The Commission shall investigate any alleged violation of this section on complaint under oath or upon its initiative_ The Commission shall conclude any such investigation, and make its determination under this section, at the earliest practicable time....
Because we conclude that the dismissál of Am-gen’s cоmplaint should have been on the merits even assuming that jurisdiction is based on
.The Commission argues that the case of
Federal Trade Comm’n v. Raladam Co.,
In
Albert,
the jurisdictional finding which the district court failed to make (the existence of interfering patents) did not mesh with the finding on the merits which it did make (that Ke-vex’s patent was invalid).
Albert,
. Claim 4 of the '008 patent is representative of the host cell claims involved on this appeal. It reads:
4. A procaryotic or eucaryotic host cell transformed or transfected with a DNA sequence according to claim 1, 2 or 3 in a manner allowing the host cell to express er-ythropoietin [rEPO].
.
Whoever invents or discovers any new and useful process, machine, manufacture, оr composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
. I.e., inside the machine.
. As that word is used in
. Importation of Goods Covered by United States Patents: Hearings on H.R. 7851 Before the House Committee on Patents Subcommittee on Phosphate Rock Process Patents, 75th Cong., 3d Sess. (1938). H.R. 7851 was a predecessor version of H.R. 8285 which died in committeе.
. Amgen also points out that
. We are aware that the ITC decision in this case has, in fact, led to the introduction of H.R. 3957 in the present Congress, to amend, inter alia,