Court Opinion

ID: 9495954
Source: CourtListenerOpinion
Date Created: 2023-08-05 16:14:06.374375+00
Date Added: 2024-06-11T17:57:17.043009
License: Public Domain

*1345LINN, Circuit Judge,
concurring in the judgment.
I concur in the conclusion of the panel that this case is controlled by Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed.Cir.2003). I also agree that it is reasonable, as a matter of patent policy, to conclude, as the Warner-Lambert panel did, that it should not be “an act of infringement to submit an ANDA for approval to market a drug for a use when neither the drug nor that use is covered by an existing patent, and the patent at issue is for a use not approved under the NDA.” Id. at 1354-55. I write separately to express my disagreement not with the logical conclusions reached by the court in Warner-Lambert but with the court’s looking beyond the congressional intent expressed in the plain meaning of the statute to reach those conclusions. In my opinion, the court in Warner-Lambert has ventured beyond our interpretive role and, in interpreting the complex statutory scheme before it, has allowed its policy choices and its evaluation of the legislative history— reasonable as they may be — to override the terms of the statute chosen by Congress.
While the statutory scheme forming the basis for an ANDA filing is hardly a model of clarity, see Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 679, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990), 35 U.S.C. § 271(e)(2) is itself not grammatically complex. It simply states that “[i]t shall be an act of infringement to submit — (A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act ... for a drug claimed in a patent or the use of which is claimed in a patent.” The normal reading of “the use” in this context is simply “any use.” This is also consistent with the surrounding provisions of the Hatch-Waxman Act, as carefully described in Judge Schall’s concurring opinion. There is no indication that Congress deliberately selected the definite article in order to restrict the scope of the term to a use already approved by the FDA. Rather, the language employed is simply the natural way to express the concept that the filing of an ANDA to produce a drug having a patented use is an act of infringement. In such cases, our judicial role is to follow the plain meaning of the particular provision at issue, even if there are policy concerns that could be addressed by declining to adhere to the strict literal terms of the statutory language Congress has employed. See Fed. Bureau of Investigation v. Abramson, 456 U.S. 615, 633, 102 S.Ct. 2054, 72 L.Ed.2d 376 (1982) (O’Connor, J., dissenting) (“A judge must not rewrite a statute, neither to enlarge nor to contract it. Whatever temptations the statesmanship of policy-making might wisely suggest, construction must eschew interpolation and evisceration.”) (quoting Felix Frankfurter, Some Reflections on the Reading of Statutes, 47 Colum. L.Rev. 527, 533 (1947)).
In effect, the court in Warner-Lambert reads the words “the use for which the FDA has granted an NDA” into the statute, concluding that “it is clear that the phrase ‘the use’ in § 271(e)(2)(A) refers to the use for which the FDA has granted an NDA.” Warner-Lambert, 316 F.3d at 1356. Moreover, the opinion discusses the purposes of the Hatch-Waxman Act and concludes that a broader interpretation of section 271(e)(2) would lead to undesirable consequences:
Warner-Lambert’s proposed interpretation [that “the use” means “any use”] is inconsistent with both of the stated purposes of the Hatch-Waxman Act, and would confer substantial additional rights on pioneer drug patent owners that Congress quite clearly did not intend to confer. If Warner-Lambert’s interpretation were correct, for example, an NDA holder would be able to main*1346tain its exclusivity merely by regularly filing a new patent application claiming a narrow method of use not covered by its NDA. It would then be able to use § 271(e)(2)(A) as a sword against any competitor’s ANDA seeking approval to market an off-patent drug for an approved use not covered by the patent. Generic manufacturers would effectively be barred altogether from entering the market.
Warner-Lambert, 316 F.3d at 1359. However compelling such arguments may be, it is the function of Congress, not the courts, to shape legislation in accordance with policy goals. “Under our constitutional framework, federal courts do not sit as councils of revision, empowered to rewrite legislation in accord with their own conceptions of prudent public policy.” United States v. Rutherford, 442 U.S. 544, 555, 99 S.Ct. 2470, 61 L.Ed.2d 68 (1979). See also Artuz v. Bennett, 531 U.S. 4, 10, 121 S.Ct. 361, 148 L.Ed.2d 213 (2000) (“Whatever merits these and other policy arguments may have, it is not the province of this Court to rewrite the statute to accommodate them.”); Badaracco v. Comm’r of Internal Revenue, 464 U.S. 386, 398, 104 S.Ct. 756, 78 L.Ed.2d 549 (1984) (“Courts are not authorized to rewrite a statute because they might deem its effects susceptible of improvement.”); Bankamerica Corp. v. United States, 462 U.S. 122, 140, 103 S.Ct. 2266, 76 L.Ed.2d 456 (1983) (“[W]e are not to rewrite the statute based on our notions of appropriate policy.”).
It is for Congress, not this court, to explain why the intent expressed in the plain meaning of the language used in section 271(e)(2) does not reflect its intent as to the policy governing applications by generic drug manufacturers to produce drugs that may have patented “off-label” uses. See Blount v. Rizzi 400 U.S. 410, 419, 91 S.Ct. 423, 27 L.Ed.2d 498 (1971) (“[I]t is for Congress, not this Court, to rewrite the statute.”). The importance of this issue suggests that Congress consider revisiting the terms of the Hatch-Waxman Act to clarify or confirm its intent. In the absence of any congressional action to that end, I would interpret the statute as set forth in Judge Schall’s concurring opinion if I were not bound to follow the precedent of our Warner-Lambert decision.