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Subject: 89-243, OPINION, ELI LILLY & CO. v. MEDTRONIC, INC.




NOTICE: This opinion is subject to formal revision before publication in
the preliminary print of the United States Reports.  Readers are requested
to notify the Reporter of Decisions, Supreme Court of the United States,
Washington, D. C. 20543, of any typographical or other formal errors, in
order that corrections may be made before the preliminary print goes to
press.

SUPREME COURT OF THE UNITED STATES


No. 89-243



ELI LILLY AND COMPANY, PETITIONER v.
MEDTRONIC, INC.


on writ of certiorari to the united states court of appeals for the federal
circuit

[June 18, 1990]



    Justice Scalia delivered the opinion of the Court.

    This case presents the question whether 35 U. S. C. 271(e)(1) renders
activities that would otherwise constitute patent infringement
noninfringing if they are undertaken for the purpose of developing and
submitting to the Food and Drug Administration information necessary to
obtain marketing approval for a medical device under 515 of the Federal
Food, Drug, and Cosmetic Act, 90 Stat. 552, 21 U. S. C. 360e (FDCA).

I
    In 1983, pursuant to 28 U. S. C. 1338(a), the predecessor- in-interest
of petitioner Eli Lilly filed an action against respondent Medtronic in the
United States District Court for the Eastern District of Pennsylvania to
enjoin respondent's testing and marketing of an implantable cardiac
defibrillator, a medical device used in the treatment of heart patients.
Petitioner claimed that respondent's actions infringed its exclusive rights
under United States Patent No. Re 27,757 and United States Patent No.
3,942,536.  Respondent sought to defend against the suit on the ground that
its activities were "reasonably related to the development and submission
of information under" the FDCA, and thus exempt from a finding of
infringement under 35 U. S. C. 271(e)(1).  The District Court rejected this
argument, concluding that the exemption does not apply to the development
and submission of information relating to medical devices.  Following a
jury trial, the jury returned a verdict for petitioner on infringement of
the first patent and the court directed a verdict for petitioner on
infringement of the second patent.  The court entered judgment for
petitioner and issued a permanent injunction against infringement of both
patents.
    On appeal, the Court of Appeals for the Federal Circuit reversed,
holding that by virtue of 35 U. S. C. 271(e)(1) respondent's activities
could not constitute infringement if they had been undertaken to develop
information reasonably related to the development and submission of
information necessary to obtain regulatory approval under the FDCA.  It
remanded for the District Court to determine whether in fact that condition
had been met.  872 F. 2d 402 (1989).  We granted certiorari.  493 U. S.
(1989).

II
    In 1984, Congress enacted the Drug Price Competition and Patent Term
Restoration Act of 1984, 98 Stat. 1585 (1984 Act), which amended the FDCA
and the patent laws in several important respects.  The issue in this case
concerns the proper interpretation of a portion of section 202 of the 1984
Act, codified at 35 U. S. C. 271(e)(1).  That paragraph, as originally
enacted, provided:

    "It shall not be an act of infringement to make, use, or sell a
patented invention (other than a new animal drug or veterinary biological
product (as those terms are used in the Federal Food, Drug, and Cosmetic
Act and the Act of March 4, 1913)) 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."  35 U. S. C. 271(e)(1)
(1982 ed., Supp. II). {1}


The parties dispute whether this provision exempts from infringement the
use of patented inventions to develop and submit information for marketing
approval of medical devices under the FDCA.

A
    The phrase "patented invention" in 271(e)(1) is defined to include all
inventions, not drug-related inventions alone.  See 35 U. S. C. 100(a)
("When used in this title unless the context otherwise indicates . . .
[t]he term `invention' means invention or discovery").  The core of the
present controversy is that petitioner interprets the statutory phrase, "a
Federal law which regulates the manufacture, use, or sale of drugs," to
refer only to those individual provisions of federal law that regulate
drugs, whereas respondent interprets it to refer to the entirety of any Act
(including, of course, the FDCA) at least some of whose provisions regulate
drugs.  If petitioner is correct, only such provisions of the FDCA as 505,
52 Stat. 1052, as amended, 21 U. S. C. 355, governing premarket approval of
new drugs, are covered by 271 (e)(1), and respondent's submission of
information under 21 U. S. C. 360e, governing premarket approval of medical
devices, would not be a noninfringing use.
    On the basis of the words alone, respondent's interpretation seems
preferable.  The phrase "a Federal law" can be used to refer to an isolated
statutory section, one might say, for example, that the judicial review
provision of the Administrative Procedure Act, 5 U. S. C. 706, is "a
Federal law."  The phrase is also used, however, to refer to an entire Act.
The Constitution, for example, provides that "Every Bill which shall have
passed the House of Representatives and the Senate, shall, before it become
a Law, be presented to the President of the United States."  U. S. Const.,
Art. I, 7, cl. 2 (emphasis added).  And the United States Code provides
that "[w]henever a bill . . . becomes a law or takes effect, it shall
forthwith be received by the Archivist of the United States from the
President."  1 U. S. C. 106a (emphasis added).  This latter usage, which is
probably the more common one, seems also the more natural in the pres ent
context.  If 271(e)(1) referred to "a Federal law which pertains to the
manufacture, use, or sale of drugs" it might be more reasonable to think
that an individual provision was referred to.  But the phrase "a Federal
law which regulates the manufacture, use, or sale of drugs" more naturally
summons up the image of an entire statutory scheme of regulation.  The
portion of 271(e)(1) that immediately precedes the words "a Federal law"
likewise seems more compatible with reference to an entire Act.  It refers
to "the development and submission of information under a Federal law"
(emphasis added).  It would be more common, if a single section rather than
an entire scheme were referred to, to speak of "the development and
submission of information pursuant to a Federal law," or perhaps "in
compliance with a Federal law."  Taking the action "under a Federal law"
suggests taking it in furtherance of or compliance with a comprehensive
scheme of regulation.  Finally, and perhaps most persuasively, the fact
that 202 of the 1984 Act (which established 271(e)(1)) used the word "law"
in its broader sense is strongly suggested by the fact that the immediately
preceding, and, as we shall see, closely related, section of the 1984 Act,
when it meant to refer to a particular provision of law rather than an
entire Act, referred to "the first permitted commercial marketing or use of
the product under the provision of law."  201, 98 Stat. 1598, 35 U. S. C.
156(a)(5)(A) (emphasis added).
    The centrally important distinction in this legislation (from the
standpoint of the commercial interests affected) is not between
applications for drug approval and applications for device approval, but
between patents relating to drugs and patents relating to devices.  If only
the former patents were meant to be included, there were available such
infinitely more clear and simple ways of expressing that intent that it is
hard to believe the convoluted manner petitioner suggests was employed
would have been selected.  The provision might have read, for example, "It
shall not be an act of infringement to make, use, or sell a patented drug
invention . . . solely for uses reasonably related to the development and
submission of information required, as a condition of manufacture, use, or
sale, by Federal law."  Petitioner contends that the terms "patented drug,"
or "drug invention" (or, presumably, "patented drug invention") would have
been "potentially unclear" as to whether they covered only patents for drug
products, or patents for drug composition and drug use as well.  Brief for
Petitioner 22.  If that had been the concern, however, surely it would have
been clearer and more natural to expand the phrase constituting the object
of the sentence to "patented invention for drug product, drug composition,
or drug use" than to bring in such a limitation indirectly by merely
limiting the laws under which the information is submitted to drug
regulation laws.
    On the other side of the ledger, however, one must admit that while the
provision more naturally means what respondent suggests, it is somewhat
difficult to understand why anyone would want it to mean that.  Why should
the touchstone of noninfringement be whether the use is related to the
development and submission of information under a provision that happens to
be included within an Act that, in any of its provisions, not necessarily
the one at issue, regulates drugs?  The first response is that this was a
shorthand reference to the pertinent provisions Congress was aware of, all
of which happened to be included in Acts that regulated drugs.  But since
it is conceded that all those pertinent provisions were contained within
only two Acts (the FDCA and the Public Health Service Act (PHS Act), 58
Stat. 682, as amended, 42 U. S. C. 201 et seq. (1982 ed. and Supp. II)),
that is not much of a time-saving shorthand.  The only rejoinder can be
that Congress anticipated future regulatory-submission requirements that it
would want to be covered, which might not be included in the FDCA or the
PHS Act but would surely (or probably) be included in another law that
regulates drugs.  That is not terribly convincing.  On the other hand, this
same awkwardness, in miniature, also inheres in petitioner's
interpretation, unless one gives "under a Federal law" a meaning it simply
will not bear.  That is to say, if one interprets the phrase to refer to
only a single section or even subsection of federal law, it is hard to
understand why the fact that that section or subsection happens to regulate
drugs should bring within 271(e)(1) other products that it also regulates;
and it does not seem within the range of permissible meaning to interpret
"a Federal law" to mean only isolated portions of a single section or
subsection.  The answer to this, presumably, is that Congress would not
expect two products to be dealt with in the same section or subsection, but
that also is not terribly convincing.
    As far as the text is concerned, therefore, we conclude that we have
before us a provision that somewhat more naturally reads as the Court of
Appeals determined, but that is not plainly comprehensible on anyone's
view.  Both parties seek to enlist legislative history in support of their
interpretation, but that sheds no clear light. {2}  We think the Court of
Appeals' interpretation is confirmed, however, by the structure of the 1984
Act taken as a whole.

B
    Under federal law, a patent "grant[s] to the patentee, his heirs or
assigns, for the term of seventeen years, . . . the right to exclude others
from making, using, or selling the invention throughout the United States."
35 U. S. C. 154.  Except as otherwise provided, "whoever without authority
makes, uses or sells any patented invention, within the United States
during the term of the patent therefor, infringes the patent."  35 U. S. C.
271(a).  The parties agree that the 1984 Act was designed to respond to two
unintended distortions of the 17-year patent term produced by the
requirement that certain products must receive premarket regulatory
approval.  First, the holder of a patent relating to such products would as
a practical matter not be able reap any financial rewards during the early
years of the term.  When an inventor makes a potentially useful discovery,
he ordinarily protects it by applying for a patent at once.  Thus, if the
discovery relates to a product that cannot be marketed without substantial
testing and regulatory approval, the "clock" on his patent term will be
running even though he is not yet able to derive any profit from the
invention.
    The second distortion occurred at the other end of the patent term.  In
1984, the Court of Appeals for the Federal Circuit decided that the
manufacture, use, or sale of a patented invention during the term of the
patent constituted an act of infringement, see 35 U. S. C. 271(a), even if
it was for the sole purpose of conducting tests and developing information
necessary to apply for regulatory approval.  See Roche Products, Inc. v.
Bolar Pharmaceutical Co., 733 F. 2d 858 (CA Fed.), cert. denied, 469 U. S.
856 (1984). {3}  Since that activity could not be commenced by those who
planned to compete with the patentee until expiration of the entire patent
term, the patentee's de facto monopoly would continue for an often
substantial period until regulatory approval was obtained.  In other words,
the combined effect of the patent law and the premarket regulatory approval
requirement was to create an effective extension of the patent term.
    The 1984 Act sought to eliminate this distortion from both ends of the
patent period.  Section 201 of the Act established a patent-term extension
for patents relating to certain products that were subject to lengthy
regulatory delays and could not be marketed prior to regulatory approval.
The eligible products were described as follows:


    "(1) The term `product' means:
    "(A) A human drug product.
    "(B) Any medical device, food additive, or color additive subject to
regulation under the Federal Food, Drug, and Cosmetic Act.
    "(2) The term `human drug product' means the active ingredient of a new
drug, antibiotic drug, or human biological product (as those terms are used
in the Federal Food, Drug, and Cosmetic Act and the Public Health Services
Act) including any salt or ester of the active ingredient, as a single
entity or in combination with another active ingredient."  35 U. S. C.
156(f).


Section 201 provides that patents relating to these products can be
extended up to five years if, inter alia, the product was "subject to a
regulatory review period before its commercial marketing or use," and "the
permission for the commercial marketing or use of the product after such
regulatory review period [was] the first permitted commercial marketing or
use of the product under the provision of law under which such regulatory
review period occurred."  35 U. S. C. 156(a).
    The distortion at the other end of the patent period was addressed by
202 of the Act.  That added to the provision prohibiting patent
infringement, 35 U. S. C. 271, the paragraph at issue here, establishing
that "[i]t shall not be an act of infringement to make, use, or sell 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."  35 U. S. C. 271(e)(1).
This allows competitors, prior to the expiration of a patent, to engage in
otherwise infringing activities necessary to obtain regulatory approval.
    Under respondent's interpretation, there may be some relatively rare
situations in which a patentee will obtain the advantage of the 201
extension but not suffer the disadvantage of the 202 noninfringement
provision, and others in which he will suffer the disadvantage without the
benefit. {4}  Under petitioner's interpretation, however, that sort of
disequilibrium becomes the general rule for patents relating to all
products (other than drugs) named in 201 and subject to premarket approval
under the FDCA.  Not only medical devices, but also food additives and
color additives, since they are specifically named in 201, see 35 U. S. C.
156(f), receive the patent-term extension; but since the specific
provisions requiring regulatory approval for them, though included in the
FDCA, are not provisions requiring regulatory approval for drugs, they are
(on petitioner's view) not subject to the noninfringement provision of
271(e)(1).  It seems most implausible to us that Congress, being
demonstrably aware of the dual distorting effects of regulatory approval
requirements in this entire area, dual distorting effects that were roughly
offsetting, the disadvantage at the beginning of the term producing a more
or less corresponding advantage at the end of the term, should choose to
address both those distortions only for drug products; and for other
products named in 201 should enact provisions which not only leave in place
an anticompetitive restriction at the end of the monopoly term but
simultaneously expand the monopoly term itself, thereby not only failing to
eliminate but positively aggravating distortion of the 17-year patent
protection.  It would take strong evidence to persuade us that this is what
Congress wrought, and there is no such evidence here. {5}
    Apart from the reason of the matter, there are textual indications that
sections 201 and 202 are meant generally to be complementary.  That
explains, for example, 202's exception for "a new animal drug or veterinary
biological product (as those terms are used in the Federal Food, Drug, and
Cosmetic Act and the Act of March 4, 1913)."  35 U. S. C. 271(e)(1).
Although new animal drugs and veterinary biological products are subject to
premarket regulatory licensing and approval under the FDCA, see 21 U. S. C.
360b (new animal drugs), and the Act of March 4, 1913, see 21 U. S. C. 151,
154 (veterinary biological products), each "a Federal law which regulates
the manufacture, use, or sale of drugs", neither product was included in
the patent-term extension provision of section 201.  They therefore were
excepted from 202 as well.  Interpreting 271(e)(1) as the Court of Appeals
did here appears to create a perfect "product" fit between the two
sections.  All of the products eligible for a patent term extension under
201 are subject to 202, since all of them, medical devices, food additives,
color additives, new drugs, antibiotic drugs, and human biological
products, are subject to premarket approval under various provisions of the
FDCA, see 21 U. S. C. 360e (medical devices); 348 (food additives); 376
(color additives); 355 (new drugs); 357 (antibiotic drugs), or under the
PHS Act, see 42 U. S. C. 262 (human biological products).  And the products
subject to premarket approval under the FDCA and the Act of March 4, 1913
that are not made eligible for a patent term extension under 201, new
animal drugs and veterinary biological products, are excluded from 202 as
well. {6}

III
    According to petitioner, "[t]he argument for a broad construction of
Section 271(e)(1) is refuted by the companion Sections (e)(2) and (e)(4)."
Brief for Petitioner 17.  The latter provide:

    "(2) It shall be an act of infringement to submit an application under
section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in
section 505(b)(2) of such Act for a drug claimed in a patent or the use of
which is claimed in a patent, if the purpose of such submission is to
obtain approval under such Act to engage in the commercial manufacture,
use, or sale of a drug claimed in a patent or the use of which is claimed
in a patent before the expiration of such patent.

                . . . . .



    "(4) For an act of infringement described in paragraph (2) ,
    "(A) the court shall order the effective date
    of any approval of the drug involved in the
    infringement to be a date which is not earlier
    than the date of the expiration of the patent
    which has been infringed,
    "(B) injunctive relief may be granted against
    an infringer to prevent the commercial
    manufacture, use, or sale of an approved drug, and
    "(C) damages or other monetary relief may be
    awarded against an infringer only if there has
    been commercial manufacture, use, or sale of an
    approved drug.
"The remedies prescribed by subparagraphs (A), (B), and (C) are the only
remedies which may be granted by a court for an act of infringement
described in paragraph (2), except that a court may award attorney fees
under section 285."  35 U. S. C. 271(e)(2), (4).


Petitioner points out that the protections afforded by these provisions are
conferred exclusively on the holders of drug patents.  They would, he
contends, have been conferred upon the holders of other patents if Congress
had intended the infringement exemption of 271(e)(1) to apply to them as
well.
    That is not so.  The function of the paragraphs in question is to
define a new (and somewhat artificial) act of infringement for a very
limited and technical purpose that relates only to certain drug
applications.  As an additional means of eliminating the de facto extension
at the end of the patent term in the case of drugs, and to enable new drugs
to be marketed more cheaply and quickly, 101 of the 1984 Act amended 505 of
the FDCA, 21 U. S. C. 355, to authorize abbreviated new drug applications
(ANDAs), which would substantially shorten the time and effort needed to
obtain marketing approval.  An ANDA may be filed for a generic drug that is
the same as a so-called "pioneer drug" previously approved, see 21 U. S. C.
355(j)(2)(A), or that differs from the pioneer drug in specified ways, see
21 U. S. C. 355(j)(2)(C).  The ANDA applicant can substitute bioequivalence
data for the extensive animal and human studies of safety and effectiveness
that must accompany a full new drug application.  Compare 21 U. S. C.
355(j)(2)(A)(iv), with 355(b)(1).  In addition, 103 of the 1984 Act amended
505(b) of the FDCA, 21 U. S. C. 355(b), to permit submission of a so-called
paper new drug application (paper NDA), an application that relies on
published literature to satisfy the requirement of animal and human studies
demonstrating safety and effectiveness.  See 21 U. S. C. 355(b)(2).  Like
ANDAs, paper NDAs permit an applicant seeking approval of a generic drug to
avoid the costly and time-consuming studies required for a pioneer drug.
    These abbreviated drug-application provisions incorporated an important
new mechanism designed to guard against infringement of patents relating to
pioneer drugs.  Pioneer drug applicants are required to file with the FDA
the number and expiration date of any patent which claims the drug that is
the subject of the application, or a method of using such drug.  See 21 U.
S. C. 355(b)(1).  ANDAs and paper NDAs are required to contain one of four
certifications with respect to each patent named in the pioneer drug
application: (1) "that such patent information has not been filed," (2)
"that such patent has expired," (3) "the date on which such patent will
expire," or (4) "that such patent is invalid or will not be infringed by
the manufacture, use, or sale of the new drug for which the application is
submitted."  21 U. S. C. 355(b) (2)(A), 355(j)(2)(A)(vii).
    This certification is significant, in that it determines the date on
which approval of an ANDA or paper NDA can be made effective, and hence the
date on which commercial marketing may commence.  If the applicant makes
either the first or second certification, approval can be made effective
immediately.  See 21 U. S. C. 355(c)(3)(A), 355(j)(4)(B)(i).  If the
applicant makes the third certification, approval of the application can be
made effective as of the date the patent expires.  See 21 U. S. C.
355(c)(3)(B), 355(j)(4)(B)(ii).  If the applicant makes the fourth
certification, however, the effective date must depend on the outcome of
further events triggered by the Act.  An applicant who makes the fourth
certification is required to give notice to the holder of the patent
alleged to be invalid or not infringed, stating that an application has
been filed seeking approval to engage in the commercial manufacture, use,
or sale of the drug before the expiration of the patent, and setting forth
a detailed statement of the factual and legal basis for the applicant's
opinion that the patent is not valid or will not be infringed.  See 21 U.
S. C. 355(b)(3)(B), 355(j)(2)(B)(ii).  Approval of an ANDA or paper NDA
containing the fourth certification may become effective immediately only
if the patent owner has not initiated a lawsuit for infringement within 45
days of receiving notice of the certification.  If the owner brings such a
suit, then approval may not be made effective until the court rules that
the patent is not infringed or until the expiration of (in general) 30
months, whichever first occurs.  See 21 U. S. C. 355(c)(3)(C),
355(j)(4)(B)(iii).
    This scheme will not work, of course, if the holder of the patent
pertaining to the pioneer drug is disabled from establishing in court that
there has been an act of infringement.  And that was precisely the
disability that the new 271(e)(1) imposed, with regard to use of his
patented invention only for the purpose of obtaining premarketing approval.
Thus, an act of infringement had to be created for these ANDA and paper NDA
proceedings.  That is what is achieved by 271 (e)(2), the creation of a
highly artificial act of infringement that consists of submitting an ANDA
or a paper NDA containing the fourth type of certification that is in error
as to whether commercial manufacture, use, or sale of the new drug (none of
which, of course, has actually occurred) violates the relevant patent.  Not
only is the defined act of infringement artificial, so are the specified
consequences, as set forth in paragraph (e)(4).  Monetary damages are
permitted only if there has been "commercial manufacture, use, or sale."
35 U. S. C. 271(e)(4)(C).  Quite obviously, the purpose of (e)(2) and
(e)(4) is to enable the judicial adjudication upon which the ANDA and paper
NDA schemes depend.  It is wholly to be expected, therefore, that these
provisions would apply only to applications under the sections establishing
those schemes, which (entirely incidentally, for present purposes) happen
to be sections that relate only to drugs and not to other products. {7}

                ***
    No interpretation we have been able to imagine can transform 271(e)(1)
into an elegant piece of statutory draftsmanship.  To construe it as the
Court of Appeals decided, one must posit a good deal of legislative
imprecision; but to construe it as petitioner would, one must posit that
and an implausible substantive intent as well.
    The judgment of the Court of Appeals is affirmed, and the case remanded
for further proceedings consistent with this opinion.
So ordered.


    Justice O'Connor took no part in the consideration or decision of this
case.







------------------------------------------------------------------------------
1
    Unless otherwise specified, references to sections of the United States
Code are to those sections as they existed upon the effective date of the
1984 Act.

2
    Petitioner's principal argument is that the legislative history of 202
mentions only drugs, which is quite different, of course, from its saying
(as it does not) that only drugs are included.  "It is not the law that a
statute can have no effects which are not explicitly mentioned in its
legislative history . . . ."  Pittston Coal Group v. Sebben, 488 U. S. 105,
115 (1988).  As respondent notes, even the legislative history of 201,
whose text explicitly includes devices, contains only scant references to
devices.

3
    Petitioner suggests that it was "the 1984 Roche decision which prompted
enactment of [202]," Brief for Petitioner 20, n. 13, which should therefore
be regarded as quite independent of the simultaneously enacted patent-term
extension of 201.  Undoubtedly the decision in Roche prompted the proposal
of 202; but whether that alone accounted for its enactment is quite a
different question.  It seems probable that Congress, for the reasons we
discuss in text, would have regarded 201 and 202 as related parts of a
single legislative package, as we do.

4
    We cannot readily imagine such situations (and petitioner has not
described any), except where there is good enough reason for the
difference.  Petitioner states that disequilibrium of this sort will often
occur because the 271(e)(1) noninfringement provision applies "whether the
patent term is extended or not," and even with respect to "patents which
cannot qualify for a term extension."  Reply Brief for Petitioner 11.  But
if the patent term is not extended only because the patentee does not
apply, he surely has no cause for complaint.  And the major reason relevant
patents will not qualify for the term extension is that they pertain to
"follow-on" drug products rather than "pioneer" drug products, see
156(a)(5)(A), 156 (f)(2); Fisons plc v. Quigg, 876 F. 2d 99 (CA Fed. 1989).
For these, however, the abbreviated regulatory approval procedures
established by Title I of the 1984 Act, 98 Stat. 1585, see 21 U. S. C.
355(b)(2), (j), eliminate substantial regulatory delay at the outset of the
patent term, and thus eliminate the justification for the 156 extension.

5
    Petitioner argues that there was good reason for Congress to estab-
lish an infringement exemption with respect to drugs but not devices, since
testing of the latter does much greater economic harm to the patentee.
Devices, petitioner contends, are much more expensive than drugs ($17,000
apiece for respondent's allegedly infringing defibrillators); and many have
only a small number of potential customers, who will purchase only a single
device each, so that depleting the market through testing may do
substantial harm.  Brief for Petitioner 30-31.  These concerns, however,
apply with respect to certain drugs as well.  According to one source, a
year's dosage of Cyclosporine (used to suppress rejection of new organs)
costs from $5,000 to $7,000; of AZT (used to treat AIDS) $8,000; of
Monoclate (used to speed blood clotting in hemophiliacs) $25,000; and of
Growth Hormone (used to treat dwarfism) $8,000 to $30,000.  A. Pollack, The
Troubling Cost of Drugs That Offer Hope, N. Y. Times, Feb. 9, 1988, p. A1,
col. 3.  Another new drug, Tissue Plasminogen Activator, used in the
treatment of heart attacks to dissolve blood clots, costs $2,200 per dose,
and is prescribed for only a single dose.  Ibid.  Moreover, even if the
factors petitioner mentions could explain the omission from 271(e)(1) of
medical devices, they could not explain the omission of food additives and
color additives.

6
    It is true that 202, if interpreted to apply to all products regulated
by the FDCA and other drug-regulating statutes, has a product coverage that
includes other products, in addition to new animal drugs and veterinary
biological products, not numbered among the specifically named products in
201, for example, food, infant formulas, cosmetics, pesticides, and
vitamins.  But for the 202 exemption to be applicable, the patent use must
be "reasonably related to the development and submission of information
under" the relevant law.  New animal drugs and veterinary biological
products appear to be the only additional products covered by
drug-regulating statutes for which the requirement of premarket approval,
and hence the need for "development and submission of information",
existed.  With respect to food, infant formulas, cosmetics, and pesticides,
for example, the FDCA merely established generally applicable standards
that had to be met.  See, e. g., 21 U. S. C. 341 (food); 350a (infant
formula); 361 (cosmetics); 346a (pesticides); cf. 350 (vitamins).
    It must be acknowledged that the seemingly complete product-correlation
between 201 and 202 was destroyed in 1986, when, without adding "new infant
formula" to the defined products eligible for the patent-term extension
under 156, Congress established a premarket approval requirement for that
product, and thus automatically rendered it eligible for the 271(e)(1)
exemption from patent infringement.  See Pub. L. 99-570, 4014(a)(7), 100
Stat. 3207-116, codified at 21 U. S. C. 350a(d).  That subsequent enactment
does not change our view of what the statute means.  That isolated
indication of lack of correlation between 156 and 271(e)(1) is in any event
contradicted by the 1988 amendment that added most new animal drugs and
veterinary biological products to 156 and simultaneously deleted from
271(e)(1) the infringement exception for those products.  See Generic
Animal Drug and Patent Term Restoration Act, 102 Stat. 3971, 3984-3989.

7
    Although petitioner has not challenged 271(e)(1) on constitutional
grounds, it argues that we should adopt its construction because of the
"serious constitutional question under the takings clause of the Fifth
Amendment . . . [that would arise] if the statute is interpreted to
authorize the infringing use of medical devices."  Brief for Petitioner 31.
We do not see how this consideration makes any difference.  Even if the
competitive injury caused by the noninfringement provision is de minimis
with respect to most drugs, surely it is substantial with respect to some
of them, so the "serious constitutional question" (if it is that) is not
avoided by petitioner's construction either.