Document: 496 U.S. 661 110 S.Ct. 2683 L.Ed.2d 605 ELI LILLY AND COMPANY, Petitionerv.MEDTRONIC, INC. No. 89-243. Argued Feb. 26, 1990. Decided June 18, Rehearing Denied Aug. 13, See 497 1047, 111 11. Syllabus Claiming infringement of two its patents, petitioner Eli Lilly's predecessor-in-interest filed suit to enjoin respondent Medtronic's testing and marketing a medical device. Medtronic defended on the ground that activities were undertaken develop submit Government information necessary obtain premarketing approval for device under § 515 Federal Food, Drug, Cosmetic Act (FDCA) therefore exempt from finding 35 U.S.C. 271(e)(1), which authorizes manufacture, use, or sale patented "solely uses reasonably related development submission law regulates drugs." The District Court concluded 271(e)(1) does not apply devices and, after jury trial, entered judgment verdicts Lilly. Appeals reversed that, could constitute if they obtaining regulatory FDCA, remanded determine whether condition had been met. Held: Section exempts use inventions needed FDCA. Pp. 665-679. (a) statutory phrase "a drugs," is ambiguous. It somewhat more naturally read (as asserts) refer entirety any Act, including at least some whose provisions regulate drugs, rather than Lilly contends) only those individual federal drugs. However, text, by itself, imprecise plainly comprehensible either view. 665-669. (b) Taken as whole, structure 1984 established supports interpretation. was designed remedy unintended distortions standard 17-year patent term produced requirement certain products receive premarket approval: (1) patentee would practical matter be able reap financial rewards during early years while he engaged in seeking approval; (2) end effectively extended until obtained competing inventions, since competitors initiate process term's expiration. 202 addressed latter distortion creating 201 sought eliminate former 156, sets forth patent-term extension subject lengthy process. interpretation allow other FDCA-regulated nondrug product advantage 201's without suffering disadvantage 202's noninfringement provision. implausible Congress, being demonstrably aware dual distorting effects requirements, should choose address both drug products, named enact leave place an anticompetitive restriction monopoly but simultaneously expand thereby failing positively aggravating protection. Moreover, fact expressly excepts exemption new animal veterinary biological product"—each licensing under, respectively, FDCA another "Federal neither included provision—indicates §§ are meant generally complementary. Interpreting did appears create perfect "product" fit between sections. 669-674. (c) Sections 271(e)(2) 271(e)(4), establish provide remedies type with respect do suggest applies well. sections have technical purpose relating abbreviated procedures happened products. 675-678. 872 F.2d 402 (Fed.Cir.1989), affirmed remanded. SCALIA, J., delivered opinion Court, REHNQUIST, C.J., BRENNAN, MARSHALL, BLACKMUN, STEVENS, JJ., joined. KENNEDY, dissenting opinion, WHITE, joined, post, p. ----. O'CONNOR, took no part consideration decision case. Timothy J. Malloy, petitioner. Arthur R. Miller, respondent. Charles L. Gholz, Jeffrey H. Kaufman, Oblon, Spivak, McClelland, Maier & Neustadt, Arlington, Va. (Robert Nelson, Va., counsel), amicus curiae Paralyzed Veterans America support David Garrison, Garrison Stratton P.S., Seattle, Wash., Dr. Gust Bardy Justice SCALIA Court. 1 This case presents question (1982 ed., Supp. V) renders otherwise noninfringing developing submitting Food Drug Administration (FDA) (FDCA), 90 Stat. 552, 21 360e. 2 * In 1983, pursuant 28 1338(a), action against United States Eastern Pennsylvania respondent's implantable cardiac defibrillator, used treatment heart patients. Petitioner claimed actions infringed exclusive rights Patent Re 27,757 3,942,536. Respondent defend "reasonably under" thus 271(e)(1). rejected this argument, concluding devices. Following returned verdict first patent, court directed second patent. issued permanent injunction patents. 3 On appeal, Circuit reversed, holding virtue (1989). We granted certiorari. 493 889, 232, 107 183 II 4 1984, Congress enacted Price Competition Term Restoration (1984 Act), 98 1585, amended laws several important respects. issue concerns proper portion codified That paragraph, originally enacted, provided: 5 "It shall act make, sell invention (other terms March 4, 1913)) solely II).1 6 parties dispute provision A. 7 "patented invention" defined include all drug-related alone. 100(a) ("When title unless context indicates . [t]he 'invention' means discovery"). core present controversy interprets phrase, whereas it (including, course, FDCA) If correct, such 505, 52 1052, amended, 355, governing covered 360e, devices, use. 8 basis words alone, seems preferable. law" can isolated section—one might say, example, judicial review Administrative Procedure 706, law." also used, however, entire Act. Constitution, provides "Every Bill passed House Representatives Senate, shall, before becomes law, presented President States." Const., Art. I, 7, cl. (emphasis added). And Code "[w]henever bill takes effect, forthwith received Archivist President." 106a usage, probably common one, natural context. referred pertains drugs" reasonable think to. But summons up image scheme regulation. immediately precedes likewise compatible reference refers "the common, single section to, speak law," perhaps "in compliance Taking "under suggests taking furtherance comprehensive Finally, most persuasively, (which 271(e)(1)) word "law" broader sense strongly suggested preceding—and, we see, closely related—section when particular permitted commercial 201, 1598, 156(a)(5)(A) 9 centrally distinction legislation (from standpoint interests affected) applications approval, patents drugs included, there available infinitely clear simple ways expressing intent hard believe convoluted manner employed selected. read, required, sale, contends drug," "drug (or, presumably, invention") "potentially unclear" composition Brief 22. concern, surely clearer constituting object sentence product, composition, use" bring limitation indirectly merely limiting submitted regulation laws. 10 side ledger, one must admit what suggests, difficult understand why anyone want mean that. Why touchstone happens within provisions, necessarily issue, drugs? response shorthand pertinent of, Acts regulated conceded contained (the Public Health Service (PHS 58 682, 42 et seq.), much time-saving shorthand. rejoinder anticipated future regulatory-submission requirements covered, PHS (or probably) terribly convincing. hand, same awkwardness, miniature, inheres petitioner's interpretation, gives meaning simply will bear. even subsection regulates; seem range permissible interpret portions subsection. answer this, expect dealt subsection—but 11 As far text concerned, therefore, conclude us reads determined, anyone's Both seek enlist legislative history their sheds light.2 Appeals' confirmed, taken whole. B 12 Under "grant[s] patentee, his heirs assigns, seventeen years, right exclude others making, using, selling throughout 154. Except provided, "whoever authority makes, sells invention, therefor, infringes patent." 271(a). agree respond approval. First, holder term. When inventor makes potentially useful discovery, ordinarily protects applying once. Thus, discovery relates cannot marketed substantial "clock" running though yet derive profit invention. 13 occurred decided constituted infringement, see 271(a), sole conducting tests Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 858, cert. denied, 469 856, 105 183, 83 117 (1984).3 Since activity commenced who planned compete expiration term, patentee's de facto continue often period obtained. words, combined effect effective 14 ends period. delays prior eligible described follows: 15 "(1) 'product' means: 16 "(A) A human product. 17 "(B) Any device, food additive, color additive 18 "(2) 'human product' active ingredient drug, antibiotic Act) salt ester ingredient, entity combination ingredient." 156(f). 19 these five if, inter alia, "subject use," permission [was] occurred." 156(a). 20 added prohibiting 271, paragraph here, establishing "[i]t allows competitors, engage infringing may relatively rare situations suffer provision, benefit.4 sort disequilibrium general rule drugs) Not additives additives, specifically 156(f), extension; specific requiring them, (on view) area—dual roughly offsetting, beginning producing less corresponding term—should products; take strong evidence persuade wrought, here.5 22 Apart reason matter, textual indications explains, exception 1913)." Although 360b (new drugs), 1913, 151, 154 (veterinary products)—each drugs"—neither 201. They excepted here All 202, them products—are various 360e (medical devices); 348 (food additives); 376 (color 355 drugs); 357 (antibiotic 262 (human products). made 201—new excluded well.6 23 - III 24 According petitioner, "[t]he argument broad construction refuted companion (e)(2) (e)(4)." 17. provide: 25 application 505(j) 505(b)(2) 26 27 "(4) For (2)— order date involved earlier has infringed, 29 injunctive relief infringer prevent approved 30 31 "(C) damages monetary awarded drug. 32 "The prescribed subparagraphs (A), (B), (C) (2), except award attorney fees 285." 271(e)(2), (4). 33 points out protections afforded conferred exclusively holders would, contends, upon intended 34 so. function paragraphs define (and artificial) very limited applications. additional eliminating enable cheaply quickly, 101 505 authorize (ANDA's), substantially shorten time effort An ANDA generic so-called "pioneer drug" previously approved, 355(j)(2)(A), differs pioneer specified ways, 355(j)(2)(C). applicant substitute bioequivalence data extensive studies safety effectiveness accompany full application. Compare 355(j)(2)(A)(iv) 355(b)(1). addition, 103 505(b) 355(b), permit paper (paper NDA), relies published literature satisfy demonstrating effectiveness. 355(b)(2). Like ANDA's, NDA's avoid costly time-consuming required These drug-application incorporated mechanism guard Pioneer applicants file FDA number claims application, method using ANDA's contain four certifications each application: "that filed," expired," (3) expire," (4) invalid submitted." 355(b)(2)(A), 355(j)(2)(A)(vii). 36 certification significant, determines NDA effective, hence commence. certification, immediately. 355(c)(3)(A), 355(j)(4)(B)(i). third expires. 355(c)(3)(B), 355(j)(4)(B)(ii). fourth depend outcome further events triggered give notice alleged stating setting detailed statement factual legal applicant's valid infringed. 355(b)(3)(B), 355(j)(2)(B)(ii). Approval containing become owner initiated lawsuit 45 days receiving certification. brings suit, then rules (in general) months, whichever occurs. 355(c)(3)(C), 355(j)(4)(B)(iii). 37 work, pertaining disabled infringement. precisely disability imposed regard created proceedings. achieved 271(e)(2)—the creation highly artificial consists error (none which, actually occurred) violates relevant artificial, so consequences, set (e)(4). Monetary "commercial sale." 271(e)(4)(C). Quite obviously, subsections (e)(4) adjudication schemes depend. wholly expected, schemes—which (entirely incidentally, purposes) happen relate products.7 38 No imagine transform into elegant piece draftsmanship. To construe decided, posit good deal imprecision; substantive 39 affirmed, proceedings consistent opinion. 40 So ordered. 41 O'CONNOR whom WHITE joins, dissenting. 43 known defibrillator. holds defense charge. rules, particular, excuse acted I dissent because find Court's contrary plausible reading language. 44 applicable version states: II). 46 says fits description. result, instead concludes serve disagree. 47 my view, privilege speaks enactments implicate anything addresses opposed manufacturer coincidence, regulate. Respondent, consequence, 48 asserts result manner. ante, 667-668. too true. tell how express intent. Instead, discern assuming employs phrases accordance ordinary usage. case, clarified ascribes unusual existing Numerous decisions, variety jurisdictions, almost identical never here. 49 instance, delineating scope pre-emption Employee Retirement Income Security 1974 (ERISA), stated "nothing construed relieve person State insurance, banking, securities." 88 897, 1144(b)(2)(A) language imply free hand conflicts ERISA long state enactment securities. contend result. Texas Legislature, like manner, said pay $1 cost conviction criminal offense arising pedestrians parking motor vehicles included." Tex.Govt.Code Ann. 56.001(b) (Supp.1990) convictions arise traffic code, speeding addition parking. And, Missouri Legislature "[n]o governmental subdivision agency enforce conduct area [of gambling] offense," Mo.Rev.Stat. 572.100 (1986) added), doubt invalidate local whenever gambling. Countless examples confound operative See, e.g., N.C.Gen.Stat. 42-37.1 (1984) (prohibiting retaliatory eviction landlords complaints about violations "[s]tate premises dwelling purposes ") added); Cochran Peeler, 209 Miss. 394, 408, So.2d 806, 809 (1950) ("the violation operation roads becomes, fiat, negligence") Local 456 Int'l Brotherhood Teamsters Cort- landt, 68 Misc.2d 645, 653, 327 N.Y.S.2d 143, 153 (1971) ("[U]nder home power laws, town powers, duties, qualifications, [etc. ] officers employees Amdt. 14, ("No make abridge privileges immunities citizens Unless assume reflect doing, hold conclude, actual 50 irrational drew True, high cost. 673, n. 5. Testing greater holder's comparable asserted, manufacturers test versions procedures. 355(j). procedures, general, affect market small subjects, healthy persons buy 355(j)(7)(B) (stating showing "bioequivalence" drugs). By contrast, clinical trials patients purchased holder. App. 39-42; CFR 812.7(b) (1989) (permitting recover costs trials). dosages, demonstrate detracts sales. determined differences difference justified excluding ambit 879 849, 850, (CA Fed.1989) (Newman, denial rehearing en banc). reasons, dissent. specified, references existed Petitioner's principal mentions drugs—which quite different, saying not) included. statute explicitly mentioned history. ." Pittston Coal Group Sebben, 488 105, 115, 109 414, 420-421, 102 408 (1988). notes, 201—whose includes devices—contains scant prompted [§ 202]," 20, regarded independent Undoubtedly proposal 202; alone accounted different question. probable Congress—for reasons discuss text—would parts package, do. readily any), where enough difference. states occur "whether not," "patents qualify extension." Reply apply, cause complaint. major pertain "follow-on" "pioneer" 156(a)(5)(A), 156(f)(2); Fisons plc Quigg, 876 99 Fed.1989). these, Title 355(b)(2), (j), delay outset justification 156 extension. argues economic harm patentee. Devices, expensive ($17,000 allegedly defibrillators); many potential customers, purchase each, depleting through harm. 30-31. concerns, source, year's dosage Cyclosporine (used suppress rejection organs) $5,000 $7,000; AZT treat AIDS) $8,000; Monoclate speed blood clotting hemophiliacs) $25,000; Growth Hormone dwarfism) $8,000 $30,000. Pollack, Troubling Cost Drugs Offer Hope, N.Y. Times, 9, 1988, Al, col. 3. Another Tissue Plasminogen Activator, attacks dissolve clots, $2,200 per dose dose. Ibid. factors explain omission additives. true interpreted drug-regulating statutes, coverage numbered among 201—for food, infant formulas, cosmetics, pesticides, vitamins. applicable, law. New appear statutes approval—and need "development information"—existed. With standards 341 (food); 350a (infant formula); 361 (cosmetics); 346a (pesticides); cf. 350 (vitamins). acknowledged seemingly complete correlation destroyed 1986, when, adding "new formula" automatically rendered Pub.L. 99-570, 4014(a)(7), 100 3207-116, 350a(d). subsequent change our view means. indication lack event contradicted 1988 amendment deleted Generic Animal 3971, 3984-3989. challenged constitutional grounds, adopt "serious takings clause Fifth Amendment [that arise] devices." 31. Even competitive injury caused minimis them—so question" (if that) avoided either.

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