Court Opinion

ID: 9440773
Source: CourtListenerOpinion
Date Created: 2023-08-03 17:06:22.325131+00
Date Added: 2024-06-11T17:27:55.042268
License: Public Domain

LINN, Circuit Judge,
concurring-in-part and dissenting-in-part.
I am pleased to join Parts I.B and II of the majority opinion insofar as they relate to the asserted product claims, but I respectfully dissent from Part I.A, which holds that the safe harbor from infringement liability provided by 35 U.S.C. § 271(e) extends to the exclusion by the Commission of pharmaceutical products produced abroad by means of a patented process. Like the majority, I do not find persuasive Amgen’s arguments that the term “patented invention” in § 271(e)(1) was intended to exclude process patents. See Majority Op. at 7-8. Nor do I disagree that § 271(e)(1) is to be construed broadly. See id. at 8. My conclusion, rather, follows from the fact that § 271(e)(1) declares that certain activities “shall not be an act of infringement,” while the plain language of the statute governing process claims before the Commission, 19 U.S.C. § 1337(a)(1)(B)(ii), does not require an act of infringement for the Commission to issue an exclusion order.
Specifically, § 1337(a)(1)(B)(ii) declares unlawful the importation, inter alia, of articles that “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.” Assuming, arguendo, that Amgen prevails as to its infringement and validity contentions on the merits, the EPO at issue in this case would be “produced ... by means of[ ] a process covered by the claims of a valid and enforceable United States patent” — regardless of whether the use to which the EPO is put is shielded from liability for infringement by § 271(e)(1). The thrust of the majority’s position is that Congress probably intended § 271(e)(1) to apply in section 337 proceedings the same way it applies in patent infringement litigation under Title 35. While I agree that it would make sense for section 337 to apply that way, the problem remains that if that is what Congress intended, it is not what Congress unambiguously said.
The language of § 1337(a)(1)(B)(ii) contrasts with the language of § 1337(a)(1)(B)(i), the corresponding provision governing proceedings regarding patented products. Section 1337(a)(1)(B)(i) declares unlawful the importation of articles that “infringe a valid and enforceable United States patent.” Thus, there is no dispute that the safe harbor of § 271(e) applies to product claims before the Commission; the unlawfulness under section 337 of the importation of a patented product hinges on whether the importation is itself an act of infringement.
It appears that this difference in language is not accidental. Although Title 35 and section 337 are ordinarily coextensive, their scope has differed with respect to imported goods made by patented processes for almost seventy years. In 1940, Congress enacted § 1337a — the predecessor to today’s § 1337(a)(1)(B)(ii) and the origin of its “covered by the claims” language — in response to a decision by our predecessor court that the importation of an article *856produced abroad by a process covered by a U.S. patent was not an unfair trade practice forbidden by section 337. See In re Amtorg, 22 C.C.P.A. 558, 75 F.2d 826 (1935) (observing that it was not the “purpose of the Congress in enacting section 337 of the Tariff Act of 1930 to broaden the field of substantive patent rights”). Such importations were not acts of infringement until Congress enacted 35 U.S.C. § 271(g) in 1988. Even under the present statutory scheme, as the majority acknowledges, we have held that the defenses enumerated in § 271(g) do not apply in actions under § 1337(a)(1)(B)(ii). See Kinik v. Int’l Trade Comm’n, 362 F.3d 1359, 1362-63 (Fed.Cir.2004). This is because the language of the two provisions differs and because the legislative history of § 271(g) indicates that Congress did not intend for it to narrow the scope of preexisting remedies before the Commission.
It is important to recognize that the former § 1337a was recodified into § 1337(a)(1)(B)(ii) as part of the same statute that created 35 U.S.C. § 271(g). Omnibus Trade and Competitiveness Act of 1988, Pub.L. 100-418. In enacting § 1337(a)(1)(B)(ii), Congress reaffirmed its choice of language that required only that a process be “covered by the claims of a valid and enforceable United States patent,” even though § 271(e) had by this time been enacted. Congress easily could have referred to the newly-created § 271(g), which for the first time extended “liability] as an infringer” to those who import products made abroad by processes patented in the United States, or it could have used the same language in § 1337(a)(1)(B)(ii) as in § 1337(a)(1)(B)(i) if it intended those sections to correspond exactly to § 271(g) and § 271(a), respectively. Instead, it chose to recodify language that had deliberately broadened the scope of section 337 proceedings beyond the scope of infringement liability under § 271. Thus, with respect, I do not find persuasive the majority’s conclusion that we should ignore the language of § 1337(a)(1)(B)(ii) based on “congressional policy as set forth in enactment of § 271(g).” Majority Op. at 851. Whether deliberately or through oversight, when Congress passed § 271(g), it enacted statutory text that is not consistent with the majority’s interpretation of congressional policy.
In short, I see no basis for concluding that Congress did not intend what it said. I do not disagree with the majority’s policy judgment that § 1337 and § 271 should be brought into synchrony. But that is not a decision for a court to make, particularly in light of the legislative history. “[I]t is not our function to eliminate clearly expressed inconsistency of policy and to treat alike subjects that different Congresses have chosen to treat differently.” W. Va. Univ. Hosps., Inc. v. Casey, 499 U.S. 83, 101, 111 S.Ct. 1138, 113 L.Ed.2d 68 (1991). Indeed, it is worth noting that there are also potential policy arguments in support of the textual reading of the statute. Congress may not have intended to extend the same benefits of § 271(e)(1) to foreign pharmaceutical companies as it extended to domestic ones, or it may have intended to discourage the importation of pharmaceuticals that have not yet been approved by the FDA. But “[i]t is not our job to speculate upon congressional motives.” Riegel v. Medtronic, Inc., — U.S. -, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008).
Accordingly, I would reverse and remand to the Commission for consideration of the merits of Amgen’s complaint with respect to the process claims, without regard to the use to which the imported EPO is put. I join the majority’s disposition as to the product claims.