FTC Comment to the Food and Drug Administration Concerning Response to Citizen Petition by IVAX Pharmaceuticals Relating to Generic Drug Application

1 The Drug Price Competition and Patent Term Restoration Act of 1984, P.L. No. 98-417
(codified at 15 U.S.C. § 68b, 21 U.S.C. §§ 301, 355, 360cc, and 35 U.S.C. §§156, 271,
282).
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UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
WASHINGTON, D.C. 20580
Office of the Secretary
April 5, 2005
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane
Room 1061 (HFA-305)
Rockville, Maryland 20852
Re: 	Response to Citizen Petition by IVAX Pharmaceuticals, Inc.
Docket No. 2005P-0008/CP-1
The United States Federal Trade Commission (“FTC” or “Commission”) submits this
response to the above-referenced Citizen Petition, dated January 5, 2005. In that Citizen
Petition, IVAX Pharmaceuticals, Inc. (“IVAX”) objects to the Food and Drug Administration’s
(“FDA’s”) delisting of two patents from the Orange Book for which IVAX had previously filed
Paragraph IV certifications in its Abbreviated New Drug Application (“ANDA”) to market
generic simvastatin tablets. IVAX argues that subsequent ANDAs for simvastatin must submit
certifications for the two patents and that FDA may not approve those ANDAs until at least 180
days after its first commercial marketing.
We submit this response to discuss the implications for consumers and competition in the
pharmaceutical industry raised by IVAX’s Citizen Petition and its flawed view of the 180-day
marketing exclusivity as a right awarded to a first ANDA filer, rather than an incentive to
challenge weak patents and design products that avoid infringing narrow ones.
Interest of the Federal Trade Commission
The Federal Trade Commission is an independent administrative agency charged with
promoting the efficient functioning of the marketplace and protecting consumer interests. The
Commission has developed significant expertise regarding the pharmaceutical industry and the
operation of the Hatch-Waxman Act.1 It has brought a number of antitrust enforcement actions
affecting both branded and generic drug companies, alleging they had used certain provisions of

2 For a recent listing and discussion of all FTC pharmaceutical enforcement actions, see
FTC Antitrust Actions In Pharmaceutical Services and Products (Oct. 2004), available at
<http://www.ftc.gov/bc/0410rxupdate.pdf>.
3 See Generic Drug Entry Prior to Patent Expiration: An FTC Study (July 2002),
available at <http://www.ftc.gov/os/2002/07/genericdrugstudy.pdf>.
4 Comments of the Federal Trade Commission, In the Matter of Applications for FDA
Approval to Market a New Drug; Patent Listing Requirements and Application of 30-Month
Stays on Approval of Abbreviated New Drug Applications (Dec. 3, 2002), available at
<http://www.ftc.gov/be/v030002.pdf>.
5 Prepared Statement of the Federal Trade Commission Before the Committee on Judiciary,
United States Senate (Aug. 1, 2003), available at
<http://www.ftc.gov/os/2003/08/030801pharmtest.htm.>; Prepared Statement of the Federal
Trade Commission Before the Committee on Judiciary, United States Senate (June 17, 2003),
available at <http://www.ftc.gov/os/2003/06/030617pharmtestimony.htm>.
6 Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Title XI,
Access to Affordable Pharmaceuticals, PL 108-173, 117 Stat. 2066 (Dec. 8, 2003)
(hereinafter, “MMA”).
7 Bureau of Economics Staff Report, Federal Trade Commission, The Pharmaceutical
Industry: A Discussion of Competitive and Antitrust Issues in an Environment of Change
(Mar. 1999), available at <http://www.ftc.gov/reports/pharmaceutical/drugrep.pdf>; David
Reiffen and Michael R. Ward, Generic Drug Industry Dynamics, Bureau of Economics
Working Paper No. 248 (Feb. 2002), available at <http://www.ftc.gov/be/econwork.htm>.
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Hatch-Waxman to impede competition.2 In addition, the Commission released a study entitled
“Generic Drug Entry Prior to Patent Expiration” (“FTC Generic Drug Study”) in July 2002.
That study found that certain provisions of Hatch-Waxman were susceptible to strategies to
delay consumer access to generic alternatives to brand-name drug products.3 Based on its
findings in that study, the Commission provided comments to FDA regarding proposed
amendments to its regulations governing Orange Book listings and administration of the 30-
month stay provision. 4 Following Commission testimony on the operation of the Hatch-
Waxman Act,5 Congress adopted the study’s two major recommendations in its recent
amendments to Hatch-Waxman.6 The Commission has gained expertise regarding competition
in the pharmaceutical industry through other means as well. For instance, the Commission staff
has conducted empirical analyses of competition in the pharmaceutical industry, including in-
depth studies by the staff of the Bureau of Economics. 7
The Role of the Orange Book
An explanation of the Orange Book’s role in the approval of generic drugs under the
1984 Hatch-Waxman Act sets the stage for a discussion of IVAX’s Citizen Petition and its

8 21 U.S.C. § 355(b)(1).
9 Id. § 355(j)(2)(A)(vii); 21 C.F.R. § 314.94(a)(12)(i)-(iii).
10 21 C.F.R. § 314.95(a).
11 21 U.S.C. § 355(j)(5)(B)(iii) (2002).
12 Id. § 355(j)(5)(B)(iv) (2002).
13 Title XI, Access to Affordable Pharmaceuticals, PL 108-173, 117 Stat. 2066 (Dec. 8, 2003).
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implications for competition in the pharmaceutical industry. A brand-name drug manufacturer
seeking to market a new drug product must first obtain FDA approval by filing a New Drug
Application (“NDA”). At the time the NDA is filed, the brand-name company must provide
FDA with information regarding patents that cover the drug that is the subject of its NDA. 8 FDA
lists these patents in a publication entitled “Approved Drug Products with Therapeutic
Equivalence,” commonly known as the “Orange Book.” To obtain approval of a generic version
of a brand-name drug, a generic applicant files an Abbreviated New Drug Application
(“ANDA”). The ANDA must contain, among other things, a certification regarding each patent
listed in the Orange Book for the relevant NDA.9 One way to satisfy this requirement is to
provide a “Paragraph IV certification,” asserting that a listed patent is invalid or not infringed.
An ANDA applicant filing a Paragraph IV certification must serve notice on the patent owner
and the NDA holder. 10
By listing a patent in the Orange Book, a brand-name drug company begins the process
that may potentially trigger two provisions of the Hatch-Waxman Act – the 30-month stay
provision and the 180-day exclusivity provision. Under the 30-month stay provision, if a patent
holder brings an infringement suit within 45 days of receiving notice of an ANDA filer’s
Paragraph IV certification, that suit triggers an automatic 30-month stay of FDA approval of the
ANDA. 11 Under the 180-day exclusivity provision, subsequent generic applicants filing ANDAs
for the same drug containing a Paragraph IV certification may not receive final FDA approval
until 180 days after either (1) the first ANDA applicant that submitted a Paragraph IV
certification begins commercial marketing, or (2) a court decision holding that the relevant
patent is invalid or not infringed. 12
The 30-month stay provision and the 180-day exclusivity provision of the 1984 Hatch-
Waxman Act were amended by the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA).13 Under sections 1101(1) and 1102(b) of the MMA, the
1984 version of these provisions applies to IVAX’s ANDA, which was filed with the relevant
Paragraph IV certifications before the effective date of the revised statue. Although we focus on
the 1984 version of the statute for that reason, the principles we discuss are equally valid for the
MMA’s revised provisions, as explained below.

14 IVAX Citizen Petition at 12-13.
15 68 Fed. Reg. 36676, 36697 (June 18, 2003) (revising 21 C.F.R. § 314.53(b)).
16 21 C.F.R. § 314.94(a)(12)(viii)(B) (“If a patent is removed from the list, any applicant
with a pending application . . . who has made a certification with respect to such patent
shall amend its certification.”).
17 IVAX Citizen Petition at 2.
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IVAX’s Citizen Petition
Merck & Co., Inc. holds the NDA for the drug Zocor, which contains the active
ingredient simvastatin and is used to treat high cholesterol. FDA approved the NDA in 1991 and
listed U.S. Patent No. 4,444,784 (the ‘784 patent), claiming simvastatin and the use of
simvastatin to treat high cholesterol, in the Orange Book. In 2000, Merck listed two additional
patents under Zocor, RE 36,481 (the ‘481 patent) and RE 36,520 (the ‘520 patent). Both patents
claim compounds related to simvastatin and the use of those compounds to treat high cholesterol,
but neither patent claims simvastatin itself or its use.
IVAX submitted its ANDA for generic Zocor in December 2000. The ANDA contained
a Paragraph III certification for the ‘784 patent and Paragraph IV certifications for the ‘481 and
‘520 patents. IVAX believes it filed the first ANDA containing a Paragraph IV certification for
at least some dosage strengths of Zocor. Merck has not sued IVAX for patent infringement.
IVAX expects to begin marketing generic Zocor on June 23, 2006, when the pediatric
exclusivity associated with the ‘784 patent expires. 14
In August 2003, FDA revised its regulations to clarify that a listed drug substance patent
must claim the active ingredient of an approved drug product and not a metabolite or
intermediate of that active ingredient. 15 Following that revision, in about September 2004 and
presumably at Merck’s request, FDA removed the ‘481 and ‘520 patents from the Orange Book.
In spite of this, IVAX has not amended its ANDA to omit its Paragraph IV certification for both
patents, as required by FDA’s regulations. 16 Instead, IVAX submitted the above-referenced
Citizen Petition to FDA, arguing that the applicable statute and regulations require that the
patents remain listed in order to support IVAX’s continuing eligibility for the 180-day
exclusivity. Specifically, IVAX petitioned FDA to:
1. 	Not approve subsequent ANDAs for simvastatin tablets for
180 days from the date of first commercial marketing of
simvastatin tablets under IVAX’s ANDA No. 76-052.
2. 	Reinstate the ‘481 and ‘520 patents in the Orange Book and
require subsequent ANDAs for simvastatin tablets to
contain certifications to the ‘481 and ‘520 patents. 17

18 21 C.F.R. § 314.94(a)(12)(viii)(B).
19 See 59 Fed. Reg. 50,338, 50,367 (Oct. 3, 1994).
20 955 F. Supp. 128 (D.D.C. 1997), aff’d, 140 F.3d 1060 (D.C. Cir. 1998).
21 63 Fed. Reg. 59,710 (Nov. 5, 1998).
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Were IVAX’s petition to be granted, it would prevent additional generic simvastatin products
from reaching consumers until 180 days after expiration of the ‘784 patent’s pediatric exclusivity
period.
In support of its petition, IVAX points to FDA’s regulation at 21 C.F.R. §
314.94(a)(12)(viii)(B) prohibiting the delisting of certain patents that had been the subject of a
lawsuit. That regulation states:
A patent that is the subject of a lawsuit under § 314.107(c) shall
not be removed from the list until FDA determines either that no
delay in effective dates of approval is required under that section
as a result of the lawsuit, that the patent has expired, or that any
such period of delay in effective dates of approval is ended. 18
This regulation prohibiting delisting does not apply here because the ‘481 and ‘520
patents were never “the subject of a lawsuit.” In spite of this, IVAX argues that the requirement
of a lawsuit should be read out of the regulation because it refers to a “lawsuit under
§ 314.107(c)” and 21 C.F.R. § 314.107(c) no longer pertains to a lawsuit.
In its current formulation, § 314.107(c) follows the 180-day exclusivity provision of the
1984 Hatch-Waxman Act by stating that a subsequent ANDA containing a Paragraph IV
certification will not be approved until at least 180 days after either the first ANDA filer begins
commercial marketing or a court decision on the relevant patent. However, as IVAX notes,
FDA’s original version of § 314.107(c) required that a first ANDA applicant “successfully
defend” a Paragraph IV patent infringement lawsuit to be eligible for the 180-day exclusivity.19
After the court struck down the “successful defense requirement” in Mova v. Shalala, 20 FDA
removed the reference to a lawsuit in §314.107(c) to eliminate the “successful defense
requirement.” 21 FDA did not, however, revise the delisting regulation, which continues to
prohibit the delisting of patents that are the “subject of a lawsuit under §314.107(c).”
Because of this incongruity in the delisting regulation, IVAX argues that the regulation
must be interpreted to prohibit the delisting of a patent whenever a generic company has
established its “right” to the 180-day exclusivity by being the first ANDA applicant to submit a
Paragraph IV certification, regardless of whether the patent was the subject of successful
litigation or the reasons for the delisting:

22 IVAX Citizen Petition at 2-3.
23 Consumers saved roughly $8-10 billion by purchasing generic equivalents of brand-
name drugs in 1994 alone. Congressional Budget Office, How Increased Competition
from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry, ix
(July 1998), available at <ftp://ftp.cbo.gov/6xx/doc655/pharm.pdf>.
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When the right to a 180-day exclusivity period has accrued to an
ANDA applicant, however, FDA’s regulations prohibit the
removal of a patent from the Orange Book for as long as the
ANDA applicant remains eligible for the 180-day exclusivity, the
patent expires, or the 180-day exclusivity period has elapsed. §
314.94(a)(12)(viii)(B). The prohibition against delisting a patent
in this circumstance is for the sole purpose of enforcing an ANDA
applicant’s right to180-day exclusivity, and is not based on the
accuracy or relevance of the patent information. Therefore, the
NDA applicant has no say in the listing of a patent to enforce 180-
day exclusivity after an ANDA applicant becomes eligible for it.22
The Negative Implications of IVAX’s Citizen Petition
Were FDA to adopt IVAX’s interpretation of the pertinent regulations, an NDA holder
could no longer correct an improper Orange Book patent listing following the submission of a
Paragraph IV certification for that patent, regardless of whether the delisting was motivated by a
clarification or better understanding of the listing requirements, an FDA inquiry, an FTC
investigation, or even an FTC or district court order requiring the delisting. Such a rule would
have significant, negative implications for competition in the pharmaceutical industry, to the
detriment of consumers.
Because Orange Book listing serves as the predicate for the 30-month stay and the 180-
day exclusivity provisions of Hatch-Waxman, it is critical that only those patents meeting the
statutory and regulatory criteria for inclusion in the Orange Book be listed. Improper listings
create the potential for those patents to unduly delay generic entry through an unwarranted 30-
month stay or 180-day exclusivity period, a result that harms consumers by preventing access to
lower-cost generic drugs.
Consumers have benefitted greatly from sales of lower cost generic versions of
prescription drugs. 23 Moreover, competition among generic manufacturers typically increases
the price savings. One study found that, as the number of approved generic versions of a drug
increased from one to 10, the average price for the generic version fell from 60% to just 34% of

24 R. Caves, et al., Patent Expiration, Entry and Competition in the U.S. Pharm. Indus.,
Brooking Papers on Economic Activity: Microeconomics, 36, table 9 (1991).
25 In the Matter of Biovail Corp., No. 011-0094, available at
<http://www.ftc.gov/os/2002/04/biovaildecision.htm> (complaint);
<http://www.ftc.gov/os/2002/04/biovaildecision.htm> (decision).
26 In the Matter of Bristol-Myers Squibb Co., Nos. 001 0221, 011 0046, and 021 0181,
available at http://www.ftc.gov/os/2003/03/bristolmyerscmp.pdf (complaint);
<http://www.ftc.gov/os/2003/03/bristolmyersdo.pdf> (decision).
27 Statement by Federal Trade Commission Chairman Timothy J. Muris on Generic Paxil
Launch (Sept. 11, 2003), available at <http://www.ftc.gov/opa/2003/09/paxillaunch.htm>.
The Commission closed its investigation of Organon USA, Inc.’s listing of a patent for the
drug Remeron only after the attorneys general of several states entered a settlement with
Organon reached through their combined efforts with the FTC. Statement of the Federal
Trade Commission Regarding the Decision to Close Its Investigation into the Conduct of
Akzo Nobel, NV and Its Organon Subsidiaryy (Oct. 20, 2004), available at
<http://www.ftc.gov/opa/2004/10/organon.htm>.
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the price for the brand-name version.24 Consequently, even a modest delay in the entry of a first
generic product or subsequent generic products may impose substantial costs on consumers.
The Commission has brought a number of enforcement actions involving the improper
listing of patents in the Orange Book by brand-name companies, which allegedly delayed
generic drug approval and resulted in consumer harm. The Commission charged Biovail
Corporation with unlawfully acquiring a license to a patent and improperly listing it in the
Orange Book to delay approval of generic Tiazac. Biovail entered a consent agreement with the
Commission in which it agreed to dismiss its patent infringement suit that supported the
unwarranted 30-month stay.25 The Commission also charged Bristol-Myers Squibb (“BMS”)
with improperly listing patents in the Orange Book that delayed approval of generic versions of
two cancer drugs, Taxol and Platinol, and its anti-anxiety drug, BuSpar, causing significant harm
to consumers. Like Biovail, BMS entered a consent agreement with the Commission in which it
agreed, among other things, to list only patents complying with applicable law. 26 In addition to
these matters, the Commission has publicly announced investigations of two other instances of
potentially improper Orange Book listings, but has explained that it closed those investigations
for practical reasons. In particular, the Commission closed its investigation involving Paxil only
after GlaxoSmithKline plc voluntarily delisted three patents from the Orange Book, removing
the 30-month stay on generic approval.27
The FTC Generic Drug Study examined the potential for abuse of the Hatch-Waxman
process for Orange Book listings and 30-month stays. The data received by the Commission
showed that brand-name companies were increasingly listing multiple patents in the Orange
Book, and suing on these patents. The FTC Study also found that later-issued patents frequently

28 FTC Generic Drug Study at 39-40, 48-50.
29 MMA § 1101(a).
30 See FTC Generic Drug Study at vii-viii, 34, 57, 63.
31 For an in-depth discussion of this issue, see Brief of Amicus Curiae, Federal Trade
Commission, Teva Pharms. USA, Inc. v. Pfizer, Inc., available at
<http://www.ftc.gov/os/2004/04/040331amicusbrieftevavpfizer.pdf>; see also Teva Pharms.
USA, Inc. v. Pfizer, Inc., 395 F.3d. 1324 (Fed. Cir. 2005) (subsequent ANDA filer who was
not sued for patent infringement may not bring a declaratory judgment act against NDA
holder).
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raised listability or validity concerns. 28
Although the source of consumer harm identified through investigations and the FTC
Generic Drug Study related to the problem of multiple 30-month stays on generic approval, and
Congress amended the Hatch-Waxman Act through the MMA to allow only one 30-month stay,29
these matters remain relevant to fully understanding the competitive implications of IVAX’s
Citizen Petition. They show that NDA holders may improperly list patents in the Orange Book
that generate a 30-month stay that delays generic entry. They also show that an antitrust action
by either the FTC or other litigants may seek to remedy the consumer harm by seeking delisting
of that patent and future compliance with the regulatory listing criteria. In addition, an NDA
holder may voluntarily delist a patent in the face of an FTC investigation. Were FDA’s
regulations to prohibit delisting as IVAX argues, there would be no means by which to stop the
on-going consumer harm caused by an unwarranted 30-month stay.
The FTC Generic Drug Study also explained that the 180-day exclusivity period has
proven susceptible to strategies to delay generic competition. First ANDA applicants have
entered into agreements with brand-name drug manufacturers that required the first ANDA
applicant to delay entering the market until a predetermined future date, thereby having the
effect of “parking” the 180-day period. This “parking” delays generic entry not only by the first
ANDA applicant, but also by any subsequent generic until 180 days after the first ANDA
applicant enters, the relevant listed patents expire, or a subsequent ANDA applicant can itself
trigger the running of the 180-day period.30 This problem can be particularly acute if subsequent
ANDA filers are unable to trigger the running or forfeiture of the 180-day exclusivity period by
obtaining a court decision on the patent because they have not been sued for patent
infringement.31 Thus, “parking” a 180-day exclusivity based on an improperly listed patent can
generate substantial consumer harm beyond the 180-day period. Were FDA’s regulations to
prohibit delisting as IVAX argues, there would be no means by which to stop the on-going
consumer harm caused by a “parked” 180-day exclusivity period.
Congress intended the Hatch-Waxman Act to increase the flow of pharmaceuticals into
the marketplace by balancing incentives for innovation with opportunities for market entry by

32 See H.R. Rep. No. 98-857(I), at 14-15 (1984), reprinted in 1984 U.S.C.C.A.N. at 2647-48.
33 The 1984 version of the 180-day marketing exclusivity provision provided:
If the [subsequent ANDA] contains a [paragraph IV
certification] and is for a drug for which a previous
[ANDA] has been submitted [containing a paragraph IV
certification], the [subsequent ANDA] shall be made
effective not earlier than one hundred and eighty days after
- (I) [the first filer’s commercial marketing] or (II) [a court
decision], whichever is earlier.
U.S.C. § 355(j)(5)(B)(iii) (2002). The MMA limited the trigger for the 180-day
exclusivity to commercial marketing, but also established several “forfeiture events,”
including a court decision, by which the first ANDA filer could lose its exclusivity.
MMA § 1102(a). Significantly, the MMA, like the 1984 version of the 180-day
provision, delays approval of only those subsequent ANDAs containing a Paragraph IV
certification.
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generic drugs.32 Delays in generic entry produced by the inability to delist patents from the
Orange Book are contrary to that policy. Therefore, it is important that a viable mechanism for
correcting erroneous Orange Book patent listings exist. An NDA holder that realizes it erred in
submitting patents for listing, as Merck presumably did, should be able to correct that error. To
avoid consumer harm, an NDA holder seeking to delist a patent in compliance with an FTC or
court order must also be allowed to do so.
IVAX is Mistaken in Its Characterization of the 180-Day Exclusivity
IVAX characterizes its eligibility for the 180-day exclusivity as a right, established upon
filing a first ANDA containing a Paragraph IV certification, which cannot be divested even when
that eligibility is based on an erroneously listed patent. In doing so, IVAX errs. The nature of
the 180-day exclusivity, as established by the 1984 Hatch-Waxman Act and confirmed in the
MMA, is that of an incentive to challenge weak patent claims and design products that avoid
infringing narrow ones. The 180-day exclusivity is better viewed as an incentive, rather than a
right, because neither the statute nor the regulations guarantee the first ANDA filer that it will
reap the benefit of the exclusivity period once FDA approves its generic product.
The Hatch-Waxman Act and its MMA amendments include numerous mechanisms by
which the first ANDA filer can lose its eligibility for the 180-day exclusivity. For instance, a
first ANDA filer may lose the exclusivity as the patent certifications of subsequent filers change.
Although the statute is commonly described as granting a 180-day exclusivity period to the first
ANDA filer, in fact, it actually prevents approval of subsequent ANDAs containing a paragraph
IV certification for 180 days. 33 The distinction is subtle but important. If subsequent ANDAs
do not include Paragraph IV certifications, the statute expressly contemplates that their approval
will not be delayed by the first filer’s status as such. Subsequent ANDAs may lack the

34 21 C.F.R. § 314.94(a)(12)(viii)(C) (when patent expires, applicants must amend
ANDAs to delete paragraph IV certifications and include Paragraph II certifications).
35 A court decision triggering the 180-days includes a decision obtained by a subsequent
ANDA applicant, through declaratory judgment or otherwise. Teva Pharms., USA, Inc.
v. FDA, 182 F.3d 1003, 1008-10 (D.C. Cir. 1999).
36 59 Fed. Reg. 50,338, 50,348 (“If a patent were removed from the list immediately
upon a court decision that the patent is invalid or unenforceable, an applicant with a
subsequently filed application might seek to certify that there is no relevant patent and
seek an immediately effective approval. To ensure that this does not occur, the agency
has required that a patent remain on the list after being declared invalid or unenforceable
until the end of any applicable 180-day exclusivity period.”)
37 See, e.g., 21 C.F.R. § 314.94(a)(12)(viii)(B) (requiring that patent certifications be
amended when a patent is removed from the Orange Book).
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Paragraph IV certification contained in the first ANDA for several reasons, including that the
patent has expired. In that case, the subsequent ANDAs would include Paragraph II
certifications (certifying that the patent has expired) and the statute would not require that FDA
delay approval because of the first ANDA filer’s status.34 Likewise, the subsequent ANDAs
may lack the Paragraph IV certification because the patent has been removed from the Orange
Book. Instead, they would include Paragraph I certifications (no patent information is listed)
and, again, the statute would not require that FDA delay approval. The first ANDA filer may
lose the benefit of the 180-day exclusivity through other mechanisms as well. For instance, a
court decision obtained by either the first or a subsequent ANDA filer35 may trigger the 180-day
exclusivity (under the 1984 version of the statute) or a forfeiture event (under the MMA) before
FDA has approved the ANDA, in which case the exclusivity may run or be forfeited before the
first ANDA applicant can take advantage of it.
FDA’s regulations also treat the 180-day exclusivity as an incentive rather than a right.
Its delisting regulation (§ 314.94(a)(12)(viii)(B)) prohibits the delisting of “[a] patent that is the
subject of a lawsuit under § 314.107(c).” FDA promulgated this regulation to prevent an NDA
holder, whose patent had been invalidated through a successful challenge by an ANDA filer,
from removing the patent from the Orange Book. Without that prohibition, the delisting would
provoke a perverse result by extinguishing the first ANDA filer’s 180-day exclusivity based on
its bringing a successful patent challenge. FDA was concerned that such a result would
undermine the incentive to challenge weak patent claims provided by the 180-day exclusivity.36
That concern is legitimate and unchanged by elimination of the successful defense requirement
from the original version of § 314.107(c). It is best addressed by continuing to read the delisting
regulation as it was written, to prohibit delisting of only those patents that had been the subject
of a successful patent challenge by the first ANDA filer. Any broader prohibition on delisting is
inconsistent with other FDA regulations recognizing that the exclusivity is not a right conferred
when the first ANDA is filed because patent certifications may change and the exclusivity may
be lost. 37

38 MMA §§ 1101(a)(2)(C), 1102(a)(2).
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Thus, the statute and regulations do not support IVAX’s premise that the 180-day
exclusivity be treated as a right that cannot be altered by changed circumstances such as delisting
of the patent. Certainly, nothing in the statute prevents removing improperly and erroneously
listed patents from the Orange Book. On the contrary, the structures of both the 1984 Hatch-
Waxman Act and the MMA recognize that circumstances change over time and exclusivity may
be lost. The MMA goes farther by allowing ANDA applicants to challenge patent listings in a
counterclaim and by listing withdrawal of a patent from the Orange Book as a forfeiture event
for the 180-day exclusivity.38 The pertinent regulation prevents delisting only of those patents
that have been successfully challenged by the first ANDA filer, in order to protect the incentive
to challenge weak patents provided by the 180-day exclusivity.
Conclusion
Because IVAX’s proposed rule preventing the delisting of patents from the Orange Book
is based on a flawed view of its entitlement to the 180-day exclusivity period, and because that
rule would have significant negative implications for competition in the pharmaceutical industry,
to the detriment of consumers, we urge FDA to reject it.
We appreciate your consideration of this matter.
By direction of the Commission.
Donald S. Clark
Secretary