Federal Circuit Gives Amgen a Mixed Decision on Its ITC Complaint against Roche's Mircera®
By Kevin E. Noonan --
The Federal Circuit in a decision handed down on Wednesday affirmed the International Trade Commission's grant of summary judgment against Amgen in its attempts to block importation of Roche's Mircera® peglylated erythropoietin product. In so doing, the Federal Circuit continued its parsing of the expansive scope of the "safe harbor" provisions of 35 U.S.C. § 271(e)(1) established by the Supreme Court in Merck KGaA v. Integra Lifesciences I, Ltd. and Eli Lilly and Co. v. Medtronic, Inc.
Amgen requested the ITC to ban importation of Mircera® under the provisions of 19 U.S.C. § 1337(a)(1)(B)(ii):
19 U.S.C. 1337(a)(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--
(i) infringe a valid and enforceable United States patent or a valid and enforceable United States copyright under title 17, United States Code; or
(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.
Amgen's complaint was based on alleged infringement of the following patents: U.S. Patent Nos. 5,411,868 (claims 1 and 2); 5,547,933 (claims 3, 4, 5, and 11); 5,618,698 (claims 4-9); 5,621,080 (claims 4 and 6); 5,756,349 (claim 7); and 5,955,422 (claim 1). (These patents also formed the basis for Amgen's successful patent infringement action against Roche in the District Court of Massachusetts.)
Roche countered that its Mircera® drug product was exempt from infringement under the "safe harbor" provisions of 35 U.S.C. § 271(e)(1):
35 U.S.C. §271(e)(1) It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.
The ITC agreed with Roche, that the imported Mircera® was exempt from infringement under the safe harbor provisions of § 271(e)(1). The ITC made this determination on summary judgment, despite allegations by Amgen that: (1) the importation at issue occurred after Roche had submitted its Biologic License Application to the U.S. Food and Drug Administration; (2) the imported Mircera® drug product was used for marketing surveys, infringement analysis, and activities related to Amgen's patent infringement litigation with Roche and not for activities "reasonably related to the development and submission of information" to the FDA; and (3) these activities were not protected under the safe harbor provisions of § 271(e)(1).
In addition to granting summary judgment on the safe harbor issues, the ITC also determined that it lacked jurisdiction to "investigate and resolve" Amgen's charges of infringement, since its jurisdiction was limited to acts of importation and sale of infringing articles (or articles made by using an infringing process) and there was no evidence that any of Roche's Mircera® drug product had been sold or the subject of a contract for sale in the U.S. (which was true, since Roche had not yet received FDA approval for Mircera®).
The Federal Circuit (in an opinion by Judge Newman, joined by Judge Lourie and in part by Judge Linn) affirmed the ITC's interpretation of the interactions of 19 U.S.C. § 1337, 35 U.S.C. § 271(e)(1) and § 271 (g), but reversed and remanded on the jurisdictional issue. The CAFC rejected Amgen's argument that the ITC, pursuant to § 1337, had the authority to bar importation of any product made by the infringing use of a patented process, regardless of any exemption from infringement that may apply to the product. Amgen's argument was that the exemption vel non of Roche's Mircera® drug product under § 271(e)(1) was irrelevant, since the act of importing a product made using an infringing method was sufficient. The Federal Circuit refused to adopt this rationale, since to do so would have permitted Amgen to use the ITC to prevent Roche from importing Mircera® solely for purposes falling within the safe harbor provisions of § 271(e)(1). This outcome would contravene the Supreme Court's determination that § 271(e)(1) should be read broadly to prevent a patentee from any action that would prevent or inhibit another from using a patented invention for activities (even otherwise infringing ones) that are "reasonably related" to producing information for submission in support of obtaining regulatory approval (e.g., for a generic version of a patented drug).
In making this decision, the Federal Circuit distinguished its decision from the rationale for the Court's decision in Kinik Co. v. International Trade Comm'n. In the Kinik case, the Federal Circuit held that the accused infringer could not avail itself of the exceptions set forth in 35 U.S.C. § 271(g)(1) or (2):
35 U.S.C. §271(g) Whoever without authority imports into the United States or offers to sell, 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, offer to sell, sale, or use of the product occurs during the term of such process patent. . . . A product which is made by a patented process will, for purposes of this title, not be considered to be so made after--
(1) it is materially changed by subsequent processes; or
(2) it becomes a trivial and nonessential component of another product.
But in that case, the Court recognized that the act constituting infringement (using a process abroad that is patented in the U.S., and then importing the product of that process) was being newly established as a basis for patent infringement in U.S. district courts. However, such activities for many years had been a basis for instituting an ITC action under 19 U.S.C. § 1337(a)(1)(B)(ii). Taking into consideration this statutory situation in view of statements from § 271(g) and the legislative history to the effect that the statute was not intended to affect already-existing causes of action under, inter alia, the ITC, the Court in Kinik held that § 271(g) did not confer the two exemptions onto acts forming the basis for ITC action under 19 U.S.C. § 1337(a)(1)(B)(ii).
In the instant case, the Federal Circuit found that Congressional purposes for § 271(e)(1), as interpreted by the Supreme Court in Merck and Eli Lilly, would be thwarted should the ITC be able to ban importation of articles falling within the safe harbor provisions of the statute that were made using an infringing method. Accordingly, the CAFC affirmed the ITC's judgment not to impose a ban on Roche's importation of its Mircera® drug product to the extent that the imported drug was used for activities "reasonably related" to obtaining FDA approval for the drug.
The Court reversed the ITC on the question of its jurisdiction to determine whether any portion of the imported Mircera® drug product had been used for activities other than those "reasonably related" to obtaining FDA approval for the drug, however. Citing Merck, the Federal Circuit held that the Supreme Court expressed the view that its textual reading of the statute should give an expansive scope to the activities falling within the safe harbor. However, the Federal Circuit asserted that the Supreme Court did not intend to give carte blanche to an accused infringer for all activities using an otherwise infringing product. Rather, the CAFC found Supreme Court guidance that the accused activities must be scrutinized to determine whether they properly could be said to be "reasonably related" to obtaining FDA approval for the drug. As for the ITC's contention that the absence of a sale or contract for sale thwarted its jurisdiction, the Federal Circuit held that the ITC had the power to use prophylactically its authority to ban importation, so as to prevent harm to American industry "in its incipiency." The CAFC reasoned that the purpose of ITC actions were to prevent infringing articles from getting into the stream of commerce, and to unify actions against an accused infringer before commercial activities required a profusion of individual suits to prevent infringement.
Judge Linn dissented from affirming summary judgment regarding the safe harbor to ITC actions. While acknowledging that the majority's interpretation was consistent with Supreme Court teachings on the scope of § 271(e)(1) and with the extant Congressional record, he opined that consistency was not enough: it was up to Congress not the Court to say unambiguously that its intention was to extend safe harbor protection to activities that would otherwise fall within the scope of the ITC's authority to ban under 19 U.S.C. § 1337(a)(1)(B)(ii).
Amgen Inc. v. International Trade Comm'n (Fed. Cir. 2008)
Panel: Circuit Judges Newman, Lourie, and Linn
Opinion by Circuit Judge Newman, opinion concurring-in-part and dissenting-in-part by Circuit Judge Linn