*1 ELI LILLY v. MEDTRONIC, & CO. INC. February 26, 1990 Argued
No. 89-243. Decided June *2 J., Rehnquist, Scalia, Court, opinion delivered which JJ., J., Blackmun, Brennan, Marshall, Stevens, joined. and C. and J., J., joined, post, Kennedy, White, opinion, filed a dissenting which J., O’Connor, 679. p. part in the or decision of took no consideration case.
Timothy argued petitioner. Malloy J. the cause for With Vogler, Gregory Lawrence M. him on the briefs were J. Jar Gray. P. vis, and Edward argued respondent.
Arthur R. the cause With Miller Lynch, E. Lund, him on the Ronald F. brief were John Bryan Farney.* W. opinion delivered Court.
Justice Scalia presents question This case whether 271(e)(1) (1982 II) Supp ed., that would renders activities infringement noninfringing if otherwise constitute they purpose developing are and sub undertaken (FDA) mitting Drug to the Food Administration informa marketing necessary approval obtain for a medical tion *3 *Briefs of amici curiae urging reversal were filed for the Industrial Lawton; E. Stephan by Prop Biotechnology Association for Intellectual Wamsley; Donald W. Banner Herbert C. for Owners, erty Inc., by and Feather; R. John Inc., by Technologies, for Procter & Gam Neuromedical Witte; Zimmer, Hemingway L. ble Co. Ronald and Richard C. by and for Beers, Wendt, Delaney, Timothy by and Paul Inc., Donald O.Barbara J. David Schoenle. amici curiae urging
Briefs of affirmance were filed for the Common Attorneys respective al. for their Pennsylvania by wealth of et the General Preate, Jr., Terry Pennsylvania, Mary D. Ernest Sue of States as follows: Alabama, Arkansas, Siegelman of John Clark of Don Steven Virginia, of F. Hawaii, Oberly M. III Warren Price III of Neil Delaware, Charles of Guste, Jr., Kelley Louisiana, Hartigan of J. Frank Illinois, William J. of McKay Lacy Thornburg of Nevada, H. Brian Michigan, of of North Caro E. T. Medlock of lina, Island, James Travis Caro O’Neil of Rhode South Dakota, Utah, lina, Roger Tellinghuisen A. R. Paul Van Dam of of South Jeffrey Eikenberry Washington, Vermont, Amestoy L. Kenneth O. of of III Roger Humphrey II of and Hubert H. Tompkins W. Virginia, of West S. Minnesota; Jamie by for American of Persons the Association Retired Sallet; B. M. by Michael Inc. Gorelick Jonathan Implants and for Carbon Reeves; Inc., R. Intermedies, Phillips; Charles Group Inc. for by for Cook Inc., Merkling; R. Michael I. Rackman and Teletronics, John by by for Nealon; P. et al. William University by William C. for the Minnesota Donahue; Ventritex, Inc., Gerstman; GeorgeH. and for H. by for Dr. Gust L. David Garrison. Bardy by by Briefs of amici curiae Paralyzed were of America filed for Veterans Gholz, Nelson; Jeffrey Kaufman, H. L. L. and Robert Pfizer Charles for Hutz; E. Group, Inc., for
Hospital and Dr. Denton Products Rudolf E. Margaret Anderson. Cooley by Drug, and Cosmetic Food, the Federal under 515 of device § 360e. (FDCA), C. 90 Stat. U. S. Act 1338(a), predecessor- pursuant the In 1983, I to 28 U. S. C. against Lilly petitioner Eli filed an action & Co. in-interest respondent District Medtronic, Inc., in United States the Pennsylvania enjoin re District for Eastern Court implantable testing marketing spondent’s cardiac and of an of heart device used the treatment defibrillator, a medical respondent’s in patients. actions claimed that Petitioner rights fringed Patent its under United States exclusive 3,942,536. No. Re 27,757 Re and United States Patent No. sought against ground spondent defend the suit on the development “reasonably activities were related its FDCA, and thus submission of information under” exempt finding infringement from a under 35 (1982 II). Supp. rejected District ed., Court apply argument, concluding exemption that the does not this development relating to and submission of information Following jury jury returned a trial, medical devices. petitioner patent, infringement on of the first verdict petitioner on court directed a verdict *4 patent. judgment peti The court entered the second permanent injunction infringe against and tioner issued patents. both ment of appeal, Appeals Federal Circuit
On the Court 271(e)(1) respondent’s holding reversed, virtue of infringement they constitute had been activities could not develop reasonably to the information related undertaken necessary development submission of information to ob- and regulatory approval under the FDCA. It remanded for tain that condition the District Court to determine whether fact (1989). granted 2d 402 been met. 872 F. We certiorari. had (1989). S. 889 U. I I Congress Drug Competition In enacted the Price (1984 Act), Patent Term Restoration Act of 1984 98 Stat. 1585, which amended the FDCA and the laws in sev- important respects. eral The issue in this case concerns the proper interpretation portion of a of 202 of the 1984 Act, 271(e)(1). paragraph, origi- codifiedat 35 U. S. C. That nally provided: enacted,
“It shall not anbe act of to make, use, or (other patented sell invention than a new animal (as veterinary biologicalproduct or those terms are used Drug, Food, the Federal and Cosmetic Act and the Act 1913))solely reasonably March for uses related to development and submission of information under a regulates Federal law which the manufacture, use, sale § 271(e)(1)(1982 II).1 drugs.” Supp. 35 U. S. C. ed., parties dispute provision exempts The fringement whether this in- from patented develop
the use of inventions to marketing approval submit information for of medical devices under the FDCA.
A phrase “patented invention” in is defined to drug-related include all inventions, not inventions alone. 100(a) (“When See 35 U. C.S. used in this title unless [t]he context otherwise indicates . . . term ‘invention’means discovery”). present invention or The core of the contro- versy petitioner interprets statutory phrase, is that “a regulates Federal law which the manufacture, use, or sale of drugs,” provisions to refer to those individual of federal regulate drugs, respondent interprets law that whereas it to entirety (including, refer to the Act course, specified, Unless otherwise references to sections of the United States Code they upon are to those sections as existed the effective date of the 1984 Act.
666 FDCA) provisions regulate drugs. at least some of whose If provisions petitioner is such the FDCA correct, as 21 § 505, amended, § 355, Stat. U. S. C. governing premarket approval drugs, by of new are covered (e)(1), respondent’s submission of information under governing premarket approval 360e, U. C. of medical de S. noninfringing vices, would not be use. respondent’s interpreta alone, the basis of the words
On preferable. phrase tion seems The “a Federal law” can be statutory might say, used to refer to an isolated section—one example, judicial provision that the review of the Admin 5Act, istrative Procedure U. S. C. is “a Federal law.” phrase used, however, The is also to refer to an entire Act. example, provides “Every Constitution, The Bill passed Representatives which shall have the House of presented Senate, shall, law, the before it become a be President of the United Art. Const., I, § 7, States.” U. S. added). (emphasis pro 2cl. And the United States Code “[w]henever a vides that bill. . . becomes a law or takes ef fect, it shall be received the Archivist of the forthwith (em United States from the President.” 106a added). phasis usage, probably This latter which is pres one, more common seems also the more natural in the 271(e)(1) ent context. If referred to “a Federal law which pertains drugs” might to manufacture, use, or sale of it be provision more to think that an reasonable individual was re phrase regulates ferred to. But the “a Federal law which naturally drugs” or sale manufacture, use, more sum up image statutory regula mons of an entire scheme of portion immediately precedes tion. compatible “a words Federal law” likewise seems more develop with reference an entire Act. It refers to “the ment and submission of under a Federal information law” added). (emphasis single It would be more sec common, speak to, tion rather than an entire scheme were referred *6 development pursuant of “the and submission of information perhaps compliance to a law,” Federal or “in with a Federal Taking suggests law.” the action “under a Federal law” tak ing compliance comprehensive it in furtherance of or awith regulation. Finally, perhaps persua scheme of and most (which sively, the fact that 202 of the 1984Act established 271(e)(1)) used the word “law” in its broader sense is strongly by suggested immediately preced the fact that the ing—and, closely see, we shall related—section of the 1984 particular provision Act, when it meant to refer to a of law permitted than an Act, entire rather referred to “the first marketing product provi commercial or use of the under the 156(a)(5)(A) sion law.” § 201, Stat. 35 U. S. C. added). (emphasis (from centrally important legislation distinction in this affected) standpoint of the commercial interests is not be applications drug approval applications tween for and for de approval, patents relating drugs pat vice but between relating patents ents If devices. the former were infinitely meant to included, be there were available such simple ways expressing more clear and that intent that it is petitioner suggests hard to believe the convoluted manner employed provision was would have been selected. The might example, read, have for “It shall not be an in act of fringement patented drug to make, use, or sell a invention solely reasonably development . . . for uses related to the required, and submission of information as a condition of or manufacture, use, sale, Federal law.” Petitioner con “patented drug,” “drug tends that the terms or invention” invention”) (or, presumably, “patented drug would have been “potentially they only patents unclear” as to whether covered drug products, patents drug composition drug for or use as well. Brief for Petitioner 22. If that had been the surely concern, however, it would have been clearer and expand phrase constituting object more natural to “patented drug product, drug the sentence to invention bring in such a limitation composition, than to use” merely limiting in- indirectly by under which the the laws drug regulation laws. is submitted formation ledger, however, one must admit side of the the other On naturally respond- provision means what more that while why any- suggests, to understand it is somewhat difficult ent Why the touchstone that. should want it to mean one would *7 noninfringement related to the the use is be whether provision development under a of information and submission happens in its that, an Act to be included within that regulates drugs? necessarily provisions, issue, at the one not response reference to that this was a shorthand is The first Congress provisions pertinent of, was aware all of which drugs. regulated But happened in Acts that to be included pertinent provisions were conceded that all those it is since (the only FDCA and the Public two Acts within contained (PHS Act), amended, as Act 58 Stat. Health Service time-saving seq.), of a that is not much et Congress only rejoinder antici that The can be shorthand. requirements regulatory-submission it pated that future might be included in the not covered, be which would want to (or probably) surely in be Act would the PHS but FDCA or drugs. regulates ter That is not in law that cluded another ribly convincing. hand, same awkward other this On the interpretation, petitioner’s in inheres ness, miniature, also meaning simply gives a it “under a Federal law” unless one interprets phrase say, to That is to one not bear. will only single subsection of federal section or even to refer why or the fact that that section to understand law, it is hard bring regulate drugs happens should within subsection regulates; products it does that it also other permissible meaning range inter- within the not seem portions single pret of a mean isolated “a Federal law” to presumably, this, is The answer to subsection. section or products expect Congress with two to be dealt would not also is terri- or not in the same section subsection—but bly convincing. concerned, therefore, we conclude that
As far the text is naturally provision that more we have us a somewhat before Appeals determined, but that is not reads as the Court parties anyone’s plainly comprehensible on view. Both seek interpretation, history support legislative of their to enlist Ap- light.2 We think the Court but that no clear sheds peals’ interpretation confirmed, the structure however, of the 1984Act taken as a whole.
B patentee, patent “grant[s] his law, Under federal years, assigns, or for the term of seventeen . . . the heirs making, using, selling right in others from exclude throughout 35 U. S. 154. vention the United States.” C. provided, authority Except as “whoever without otherwise any patented invention, makes, or sells within uses during in therefor, States the term United § 271(a). agree fringes parties patent.” that the *8 designed respond to two distor Act to unintended 1984 was patent produced by requirement 17-year term tions of the premarket regulatory ap products must receive that certain patent relating prod proval. to a such First, the holder of reap any practical be finan matter not able to ucts would as a early years during term. an When cial rewards ordinarily discovery, potentially he useful inventor makes a patent by applying protects Thus, at dis once. it covery product that cannot be marketed without to a relates approval, testing regulatory on “clock” substantial 2 history argument legislative is that principal Petitioner’s course, different, saying from quite its only drugs—which mentions not) (as the law a stat only drugs are included. “It is not that it does in its explicitly legislative which are not mentioned ute can have no effects (1988). 106, Sebben, history Group . . . v. 488 U. S. .” Pittston Coal notes, § 201—whose ex history of text respondent legislative even the As to devices. scant references plicitly includes devices—contains patent running though yet his term will be even he is not able any profit to derive from the invention. pat
The second distortion occurred at the other end of the
Appeals
ent term.
In 1984,the Court of
for the Federal Cir
patented
cuit decided that the manufacture, use, or sale of a
during
patent
invention
the term of the
constituted an act of
271(a),
infringement,
purpose
see
even if it was for the sole
conducting
developing
necessary
tests
information
apply
regulatory approval.
See Roche Products, Inc. v.
Bolar
Co.,
Pharmaceutical
The 1984Act to eliminate this distortion from both patent period. ends of the Section 201 of the Act established patent-term patents relating prod- extension for to certain subject lengthy regulatory delays ucts that were and could prior regulatory approval. eligible not be marketed products were described as follows:
“(1) ‘product’ The term means: “(A) drug product. A human suggests Petitioner it was “the 1984 Roche decision which prompted 202],” [§ enactment of Brief for Petitioner n. which should *9 regarded therefore be quite independent as simultaneously of the enacted patent-term § 201. Undoubtedly extension of the decision in Roche
prompted 202; proposal the but whether that alone accounted for its quite enactment question. a different probable It seems that Con gress—for the reasons we discuss in regarded § text—would have 201 and § 202 parts as single legislative related of a package, as we do.
“(B) Any addi- additive, or color device, food medical Drug, regulation subject Food, the Federal under tive Act. and Cosmetic
“(2) drug product’ the active means The term ‘human drug, drug, ingredient or human bio- antibiotic of a new (as logical product used in the Federal those terms are Drug, Act the Public Health and Cosmetic Food, Act) including active ester of the salt or Service single entity ingredient, in combination with or 156(f). ingredient.” 35 S. C. U. another active relating products patents provides to these Section 201 product years up alia, inter the if, to five can be extended regulatory period “subject com before its review was permission marketing the com and “the use,” mercial regulatory product marketing the after such or use of mercial permitted period [was] market the first commercial review provision product ing law under the under or use of period regulatory 35 U. S. C. occurred.” such review which 156(a). period ad was the other end of The distortion at provision § 202 Act. That added to of the dressed para infringement, prohibiting patent § 271, 35 U. S. C. establishing “[i]t graph act shall not be an here, at issue patented invention . . . make, use, or sell a development reasonably solely to the related for uses regu law which under a Federal submission of information § 271(e)(1). drugs.” use, or sale of manufacture, lates the patent, expiration competitors, prior of a to the This allows necessary infringing engage to ob activities otherwise regulatory approval. tain respondent’s interpretation, rel there be some
Under patentee atively in which a will obtain rare situations disadvantage advantage extension but not suffer provision, noninfringement and others the 202 *10 672 disadvantage the benefit.4 the without will suffer
which he
interpretation,
petitioner’s
that sort of dis
however,
Under
relating
general
patents
equilibrium
the
rule for
becomes
(other
§
drugs)
subject
products
in 201
named
than
all
premarket
only
approval
the
Not
medical de
under
FDCA.
they
additives, since
and color
also food additives
vices, but
156(f),
specifically
C.
re
§ 201,
named in
see 35 U. S.
are
specific provi
patent-term
the
extension; but since
ceive the
though
regulatory approval
requiring
in
them,
for
sions
regulatory
provisions requiring
FDCA,
are not
cluded
the
view)
(on
they
petitioner’s
subject
drugs,
approval
are
not
for
271(e)(1).
noninfringement provision of
It seems
to the
being demonstrably
Congress,
implausible to us that
most
regulatory approval
distorting
aware
the dual
effects
distorting
requirements
effects that
in this entire area—dual
beginning
roughly offsetting,
disadvantage
the
at the
were
corresponding advantage
producing a more or less
the term
to address both those
at the end of the term—should choose
only
drug products;
products
and for other
distortions
only
provisions
not
in 201 should enact
which
leave
named
place
anticompetitive
at the end of the mo
an
restriction
simultaneously expand
monopoly
nopoly
term
term but
positively ag
thereby
only failing
but
not
to eliminate
itself,
4
(and petitioner
readily imagine such situations
has not de
We cannot
any), except
good enough reason for the difference.
scribed
where there is
disequilibrium
will often occur because
Petitioner states that
of this sort
provision applies
patent
noninfringement
“whether
term
not,”
respect
“patents
qualify
which
is
and even with
cannot
extended
Reply
patent
11. But if
for a term extension.”
Brief for Petitioner
patentee
apply,
surely
term not extended
because the
does not
he
major
patents
complaint. And the
reason relevant
will
has no cause for
they
qualify
pertain
extension is that
to “follow-on”
not
for the term
156(a)(5)(A),
§§
products
“pioneer” drug products,
than
see
156
rather
1989).
(CA
Quigg,
gravating It distortion strong persuade would us that this is what take evidence Congress wrought, and there is no such evidence here.5
Apart matter, the reason of the there are textual indi from §§ 201 generally comple cations that and 202 are meant to be § 202's mentary. explains, example, exception That for for (as veterinary biologicalproduct “a new animal those Drug, in Food, terms are used the Federal and Cosmetic 1913).” 271(e)(1). § Act and Act March 35 4, veterinary Although drugs biological prod new animal and subject premarket regulatory licensing ap ucts are to and (new § proval 21 FDCA, see C. 360b animal under U. S. §§ drugs), 21 4, 1913, 151, and the Act of March see U. S. C. (veterinary biological products)—each 154 “a Federal law drugs”—nei regulates manufacture, use, which or sale of product patent-term pro in ther was included extension § § They excepted vision of 201. therefore were from 202 as 271(e)(1) § Appeals Interpreting well. as the Court of did argues good Congress that there was reason for to 5 Petitioner estab devices, exemption respect drugs lish an with to but not greater paten- latter much economic harm to the testing since of the does Devices, contends, expensive petitioner drugs tee. are much more than ($17,000 defibrillators); apiece respondent’s allegedly infringing customers, many only potential purchase will have a small number of who each, only depleting through testing may single a device so that the market concerns, do harm. Brief for Petitioner 30-31. These how substantial ever, apply respect drugs According to certain as well. to one with (used source, dosage Cyclosporine suppress rejection to of new year’s (used AIDS) $5,000 $7,000; $8,000; AZT organs) costs from to to treat (used hemophiliacs) $25,000; speed clotting to blood and of Monoclate (used dwarfism) Pollack, $8,000 $30,000. A. Growth Hormone to treat Times, 9, 1988, Hope, Troubling Drugs That N. Y. Feb. Cost Offer Activator, A1, p. drug, Plasminogen Another new Tissue used col. 3. $2,200 clots, per blood costs dose the treatment of heart attacks to dissolve Moreover, if the fac prescribed single and is dose. Ibid. even § petitioner explain the from of med tors mentions could omission devices, they explain could not the omission of food additives and color ical additives. fit between the to create a perfect “product”
here appears All for a term two sections. of the products eligible patent all 202, extension under 201 are since of them— subject devices, additives, additives, food color new drugs, medical human subject antibiotic drugs, biological products—are FDCA, under various approval provisions premarket (medical (food devices); 360e additives); see 21 U. S. C. (color (new (antibiotic additives); § 376 § 355 § 357 drugs); (human Act, § 262 or under the PHS see U. S. drugs), C. And the biological products). products subject premarket under the FDCA and the Act of March approval are not made for a term extension under 201 eligible animal and veterinary —new drugs biological products—are excluded from as well.6
6 202, interpreted apply products by § regulated It is true that to all statutes, drug-regulating product coverage the FDCA and other has a products, veterinary in drugs includes other addition to new animal and biological products, among specifically products not numbered named food, formulas, cosmetics, example, § 201—for in pesticides, infant and vi § exemption applicable, patent tamins. But for the 202 to be use must “reasonably development be related to the and submission information drugs veterinary law. New animal biological under” the relevant and products appear products by drug- to be the additional covered regulating requirement premarket approval—and which the statutes for “development the need for and hence submission of information”—existed. food, formulas, cosmetics, respect pesticides, infant With and for exam merely ple, generally applicable the FDCA established standards that had (infant See, (food); formula); § 341 g., § 350a met. e. 21 to be U. S. C. (vitamins). (cosmetics); § § § (pesticides); 346a cf. 350 acknowledged seemingly complete product It must be that the correla destroyed when, § 202 in adding tion between and was without products eligible patent-term “new infant formula” to the defined for the § Congress premarket approval require extension under established a product, automatically eligible ment and thus rendered it for the 271(e)(1) 99-570, exemption patent infringement. from See Pub. L. 350a(d). 4014(a)(7), 3207-116, 100 Stat. codified at That subsequent change enactment does not our view of what the statute means. That isolated indication of lack of correlation between 156 and 271(e)(1) by in event contradicted the 1988amendment that added I I I According petitioner, argument “[t]he for a broad con- struction companion of Section is refuted (e)(2) (e)(4).” Sections Brief for Petitioner 17. The lat- provide: ter
“(2) infringement It shall be an act of to submit an application 505(j) under section of the Federal Food, Drug, 505(b)(2) and Cosmetic Act or in described section drug patent of such Act for a in claimed or the use of patent, purpose which is in claimed if the of such sub- approval engage mission is to obtain under such Act to in drug commercial manufacture, use, or sale of a patent claimed in a or the use of which is claimed in a patent expiration patent. before the of such
“(4) infringement paragraph For an act of described (2)-
“(A) any ap- the court shall order the effective date of proval of the involved to be a expiration date which is not earlier than the date of the infringed, which has been “(B) injunctive may granted against relief be in an fringer prevent the commercial manufacture, use, approved drug, sale of an
“(C) damages monetary or other relief be awarded *13 against infringer only an if there has been commercial approved drug. manufacture, use, or sale of an prescribed by (A), subparagraphs (B), “The remedies (C) only may granted by and are the remedies which be infringement paragraph court for an act described in drugs veterinary most new animal biological products and §to 156 and 271(e)(1) simultaneously § deleted from exception for products. those Drug See Generic Animal and Patent Term Restoration Act, 102 Stat. 3984-3989. attorney
(2), may except award fees under that a court (4). 271(e)(2), §§ 285.” 35 section points protections afforded these out that the Petitioner exclusively drug provisions on the holders of are conferred They petitioner patents. been would, contends, have con- patents Congress upon in- had ferred holders of other § infringement exemption apply tended the as well. them paragraphs question in is not so. The function of the
That (and artificial) infringe a new act of is to define somewhat very purpose ment for a limited and technical that relates drug applications. As an means to certain additional eliminating de at the end of the extension facto drugs drugs, case of and to enable new to be mar term the § cheaply quickly, 101 of the 1984 Act keted more § § FDCA, 505 of the 21 U. S. C. to authorize amended (ANDA’s), drug applications abbreviated new which would substantially shorten the time and effort needed to obtain marketing approval. generic An ANDA be filed for a “pioneer drug” previously drug the same that is as a so-called § 355(j)(2)(A), pioneer approved, see or that differs from the ways, 355(j)(2)(C). specified appli The ANDA see bioequivalence cant can substitute data for the extensive ani safety and mal and human studies of effectiveness that must accompany (A)(iv) drug application. Compare 355(j)(2) a full new 355(b)(1). addition, with In of the 1984 Act 505(b) §355(b), permit FDCA, amended submis drug application (paper NDA), paper a so-called new sion of application published satisfy an that relies on literature to requirement demonstrating of animal and human studies 355(b)(2). safety ANDA’s, and effectiveness. Like See permit paper applicant seeking approval NDA’s an of a generic drug costly time-consuming to avoid the studies required pioneer drug. for a provisions incorpo- drug-application abbreviated
These important designed guard against rated an new mechanism *14 infringement patents relating pioneer drugs. Pioneer drug applicants required FDA are to file with the the number expiration any patent drug which claims the date subject application, using is the the or a method of such 355(b)(1). drug. paper See ANDA’s and NDA’s are re- quired respect to contain one of four certifications with (1) patent pioneer drug application: each named the “that (2) patent filed,” such information has not been “that such (3) patent expired,” patent “the date on which such will has (4) expire,” patent “that such is invalid or or will not be infringed by drug manufacture, use, the or sale of the new §§355(b)(2)(A), application for which the is submitted.” 355(j)(2)(A)(vii). significant, in that it
This certification is determines approval paper ANDA NDA date on which of an or can be effective, made and hence the date on which commercial mar- keting may applicant If the commence. makes either the approval certification, first or second can be made effective 355(c)(3)(A), §§ immediately. 355(j)(4)(B)(i). ap- If the See applica- plicant approval certification, third makes the patent expires. tion can be made effective as of the date the 355(c)(3)(B), §§ 355(j)(4)(B)(ii). applicant If See makes date must de- certification, however, the fourth effective triggered by pend of further events the Act. on the outcome required applicant An makes the fourth who certification patent alleged give of the invalid or notice to holder to be stating application infringed, not that an has been filed seek- ing approval engage manufacture, use, in the commercial expiration patent, or sale of the before the legal setting a detailed statement of the factual and forth applicant’s opinion patent basis for the that the is not valid §§ 355(b)(3)(B), infringed. 355(j)(2)(B)(ii). will not be See Approval paper containing of an ANDA or NDA the fourth immediately only become effective if the certification owner has not initiated a lawsuit for days receiving If within 45 notice of the certification. *15 approval brings not be made ef- suit, such a then owner infringed patent is not court rules that the fective until the (in general) expiration months, whichever first of until the 355(c)(3)(C), §§ 355(j)(4)(B)(iii). See occurs. if course, the holder of the work, will not of
This scheme pioneer drug pertaining from estab is disabled infringement. lishing there has an act of in court that been disability precisely the new 35 that And that was 271(e)(1) pat imposed regard to use of his with obtaining premarket only purpose for the ented invention infringement ing approval. had to be Thus, an act of created paper proceedings. That ANDA and NDA is what for these (e)(2)—the by highly creation of a artificial is achieved submitting infringement that an ANDA or a act of consists containing type paper the fourth of certification is NDA manufacture, use, commercial or sale in error as to whether (none actually has which, course, oc- of the new curred) patent. only the relevant Not is the defined violates specified are the conse- artificial, act of so (e)(4). Monetary damages quences, as set forth subsection only permitted manufac- there has been “commercial are 271(e)(4)(C). obviously, pur- or sale.” ture, use, Quite (e)(2) (e)(4) judicial pose is to enable the of subsections paper adjudication upon which the ANDA and NDA schemes wholly expected, depend. therefore, that It is to be these apply only applications provisions would under the sec- (entirely establishing those schemes—which inciden- tions tally, present purposes) happen to be sections that relate products.7 drugs and not to other § 271(e)(1) petitioner challenged has not on constitutional 7 Although adopt we because of the “se grounds, argues it should its construction takings Fifth question under the clause of the Amend rious constitutional interpreted arise] if the statute is to authorize the [that ment . . . would devices.” 31. We do not see infringing use of medical Brief Petitioner competitive if the in this consideration makes difference. Even how noninfringement provision respect minimis with jury is de caused respect drugs, surely it is substantial with to some of them—so the most
[*] [*] [*] imagine interpretation can trans- we have been able to No statutory elegant piece draftsman- into an form Appeals ship. decided, one it as the Court of To construe posit good legislative imprecision; but to con- must deal of posit petitioner im- must that and an would, strue it one plausible well. substantive intent as Appeals judgment affirmed, and the of the Court of proceedings with this for further consistent
case is remanded *16 opinion. ordered.
So in the consideration or took no part Justice O’Connor decision of this case. joins, with whom Justice White Kennedy,
Justice dissenting. infringed patents respondent its contends that
Petitioner marketing by testing known as a cardiac a medical device 271(e)(1) § 35 U. S. C. The Court holds that defibrillator. (1982 II), patent give provision Supp. law, the a of ed., charge. particular, respondent rules, It a defense to this 271(e)(1) respondent the sole if it acted for will excuse that necessary purpose developing information market to obtain of ing approval Food, of the Federal for the device under (FDCA), Drug, 552, 21 U. S. C. Act 90 Stat. and Cosmetic contrary I decision find the Court’s I dissent because 360e. statutory language. reading plausible of the: the most 271(e)(1) states: version of applicable infringement make, use, or an act of “It shall not be drug (other a new animal patented than invention sell a (as biologicalproduct veterinary are used those terms or Drug, the Act and and Cosmetic Food, Federal in the 1913)) reasonably solely related for uses March Act of (if that) by petitioner’s not avoided question” it is constitutional “serious construction either. a development under ofinformation and submission the regulates use, or sale manufacture, the which law
Federal II). (1982 § 271(e)(1) Supp. ed., drugs.” 35 S. C. U. of phrase Congress says “a Federal law the used The Court drugs” to regulates use, or sale of manufacture, which portion entirety of at least some Act, to the refer description. drugs. As regulates fits this The FDCA which marketing approval sought though respondent result, a even drug, the instead of a a device for medical the FDCA under 271(e)(1) may as a defense to serve concludes Court disagree. infringement. I testing privilege 271(e)(1), my not view, does Section When defibrillator. as the cardiac such medical devices regulates drugs, speaks I think that of a law which implicate particular enactments refer to it does not drugs. anything regulation It addresses other than products. opposed drugs legal regulation to other permit manufacturer to use the section would while Thus, obtaining marketing approval purpose under use or sell a manufacturer to not authorize FDCA, it does *17 happens by products also coincidence, the FDCA that, other consequence, Respondent, defense regulate. in has no 271(e)(1). § under specified Congress have this that could asserts
The Court ante, 667-668. That is at in manner. See result a clearer all express Congress its how to tell But we do not too true. by assuming its intent Instead, discern intent. we that employs Congress phrases words and in with their accordance ordinary Congress usage, have could case, In this even 271(e)(1), unusual mean- ascribes a most the Court clarified statutory provi- existing language. ing Numerous to the variety jurisdictions, use decisions, from sions and court 271(e)(1), they never to those of identical words almost they says mean here. what Court mean pre-emption by delineating scope of instance, For Security Employee Act of 1974 Income Retirement (ERISA), “nothing Congress that in this title shall be stated any any person exempt from law relieve or construed banking, any regulates insurance, or securities.” State which 1144(b)(2)(A) added). (emphasis 29 U. S. C. Stat. interprets language Interpreting as the Court this give Congress imply a free intended to the States that would long any so conflicts with ERISA law that hand to enact regulates portion insurance, enactment of the state some banking, for this result. would contend No one or securities. per Legislature, has said that “a manner, in a like Texas any pay criminal conviction of a court cost on son shall as$1 any arising except under law . that conviction offense . . parking pedestrians vehicles is regulates motor or the that 56.001(b) (Supp. Ann. Tex. Code included.” Govt. not 1990) added). (emphasis Texas intended I not think that do might by language that arise all convictions to exclude this regulates speeding that code, as a traffic Act, under an such parking. pedestrians Mis And, when the addition governmental “[n]o specified Legislature subdi that souri regulates agency or a law enact or enforce or vision gambling] an offense,” area [of conduct in the makes (1986) added), (emphasis § 572.100 I doubt Mo. Rev. Stat. entirety in their invalidate local enactments that it meant to gambling. regulates portion Count them whenever some reading examples method of the Court’s confound less other g., language N. operative See, e. C. Gen. in this case. (1984) retaliatory (prohibiting § 42-37.1 eviction Stat. any “[s]tate complaints violations of about landlords for dwelling pur regulates premises used law federal added); (emphasis 209 Miss. poses”) Peeler, v. Cochran (“[T]he (1950) a law which violation of 806, 809 408, 47 2d So. operation on the regulates *18 vehicles in the human conduct of (emphasis negligence”) by legislative fiat, becomes, roads added); v. Cort- Teamsters Brotherhood Local Int’l 456 of 682 (1971) 143, N. Y. S. 2d 153 645, 653, Misc. 2d
landt, 68 (“[U]nder power laws, enact local a town the home rule regulates powers, quali may duties, which the enact a law employees’’) (emphasis [etc.] its fications, of officers (“No added); shall Const., S. Arndt. State see also U. abridge privileges any law which shall or enforce make States”) (emphasis immunities added). citizens United of of examples we assume that these do not re Unless doing, ordinary usage, I no we can which see basis flect entirety refers to the of the FDCA or not hold that regulates drugs. I Instead, which would con other Act regulation drugs refers to the actual of clude, the section pat exempt testing a medical device from not does infringement. ent
Congress act in an manner when it drew a did not irrational drugs True, distinction between and medical devices. like drugs very high some have a cost. See devices, medical Testing patented device, n. 5. medical how- ante, at patent greater will have effects on holder’s ever, often comparable testing patented drug. peti- rights of a As than may generic test versions asserted, tioner has manufacturers drugs, proce- patented devices, but not under abbreviated §355(j). procedures, gen- C. These dures. See U. S. the market in a manner eral, do not affect substantial because may drugs manufacturers test the on a small number of sub- jects, healthy persons include who who otherwise would buy drug. 355(j)(7)(B) (stating require- not See showing drugs). By “bioequivalence” ments of a case, in this manufacturers test and contrast, market med- patients pur- ical devices in clinical trials on would who have patent App. from the chased the device holder. See 39-42; 812.7(b) (1989) (permitting see also 21 CFR manufacturers trials). Although to recover their costs clinical the Court gives examples high drug dosages, it cost does not demon- testing drugs that the detracts from a strate these Congress holder’s sales. could have determined that the dif- *19 testing drugs ferences in or some other difference between justified excluding and devices the latter from the ambit of 271(e)(1). (CA 1989) F. 849, 850, See 879 2d n. Fed. (Newman, dissenting rehearing J., from the denial en banc). I reasons, For these dissent.