Opposition Brief — Apotex, Inc. v. Sebelius
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Nos_J0-453
IN THE
Supreme Court of the United States
APOTEX, INC.,
Petitioner,
we
KATHLEEN SEBELIUS, IN HER OFFICIAL CAPACITY AS
SECRETARY OF HEALTH AND HUMAN SERVICES, E7'AL.,
Respondents.
On Petition for Writ of Certiorari to the
U.S. Court of Appeals for the D.C. Circuit
BRIEF IN OPPOSITION OF RESPONDENT
TEVA PHARMACEUTICALS USA, INC.
JAY P. LEFKOWITZ, P.C. MICHAEL D. SHUMSKY
KIRKLAND & ELLIS LLP Counsel of Record
153 Kast 53rd Street AARON L. NIELSON
New York, NY 10022 KIRKLAND & ELLIS LLP
(212) 446-4800 655 Fifteenth St., N.W.
jay.lefkowitz@kirkland.com Washington, DC 20005
(202) 879-5000
mshumsky@kirkland.com
anielson@kirkland.com
December 10, 2010
WILSON-EPES PRINTING Co., INC. — (202) 789-0096 — WASHINGTON, D.C. 20002
QUESTION PRESENTED
Whether the D.C. Circuit erred in holding that
the district court did not abuse its discretion by
denying Petitioner’s motion for — preliminary
injunctive relief.
11]
PARTIES TO THE PROCEEDING
Petitioner Apotex, Inc. was the plaintiff-appellant
below.
Respondents Kathleen Sebelius, in her official
capacity as Secretary of Health and Human Services;
Margaret Hamburg, M.D., in her official capacity as
Commissioner of Food and Drugs; the U.S. Food and
Drug Administration; and the U.S. Department of
Health and Human Services were the defendants-
appellees below.
Respondent Teva Pharmaceuticals USA, Inc. was
an intervenor-defendant/appellee below.
Non-party Roxane Laboratories, Inc. was a
plaintiff-appellant below and thus is a respondent
under this Court’s Rule 12.6.
CORPORATE DISCLOSURE STATEMENT
Respondent Teva Pharmaceuticals USA, Inc.
(“Teva”) is an indirect wholly owned subsidiary of
Teva Pharmaceutical Industries Ltd. through the
following parent companies: (i) Orvet UK Unlimited
(Majority Shareholder), which in turn is directly
owned by Teva Pharmaceuticals Europe B.V., which
in turn is directly owned by Teva Pharmaceutical
Industries Ltd.; and (1) Teva Pharmaceutical
Holdings Cooperatieve U.A. (Minority Shareholder),
which in turn is directly owned by IVAX LLC, a
direct subsidiary of Teva Teva Pharmaceutical!
Industries Ltd. is the only publicly traded direct or
indirect parent company of Teva, and no other
publicly-traded company owns more than 10% of its
stock.
Vv
TABLE OF CONTENTS
Page
TABLE OF AUTHORITIES. ee ee 1x
INTRODUCTION ........ cpaeumeneeate canitea catia oiauenae
OPINIONS BELOW...... :
PUG) fh kl by ye) ete {
STATUTORY PROVISIONS ...................00eeee: Pr
STATEMENT OF THE CASE ............. acccaasonsas ae
A. The Hatch-Waxman Framework...................5
i EE TNO i ovcccccnccscécecaieccntetscsaccosncains 8
C. Losartan Potassium Products ............ ce
D. The Teva Litigation....................... eer
K. Post-Judgment Proceedings ........................ 12
KF. Post-Remand Proceedings ......................0000 13
REASONS FOR DENYING THE WRIT............... .16
I. i ft 8 eee. |
A. ‘This Case Was Moot Even Before
Apotex Filed Its Petition...................... 16
B. This Issue Will Not Evade Review...... 17
Vi
] The Petition Arises In The Interlocutory
Context Of A Preliminary Injunction
Proceeding. ..... 19
A. ‘There Has Been No Final Judgment. .19
B. ‘The Legal Issue Apotex Seeks To
Raise Is Not Squarely Presented. 20
Ill. There Is No Circuit Spht, And Apotex
Kixaggerates the Likelihood That The
K;mbedded Merits Issue Will Recur..... ae
A. There Is No Circuit Split. ......... 22
B. Apotex Exaggerates The Likelihood
That The Issue It Purports To Raise
Will Recur........... 24
IV. The D.C. Circuit’s Preliminary Analysis Of
The Merits Was Correct............c.cccccceeees sees BO
A The MMA Did Not Abrogate
I PO ERIE LEO roe ee
B. The D.C. Circuit Properly Resolved
The Patent Expiry Issue...................... 29
C The D.C. Circuit’s Decision Is
Consistent With The Statute’s
Purposes. ....... vr are 33
CONCLUSION ... .. 36
APPENDIX CONTENTS
21 U.S.C. § 355G)(5)(C) :
35 U.S.C. § 41(c)(5)
Response Of Apotex Inc. ‘To Show Cause Orde)
(D.D.C. Oct. 18. 2010)
David Belian, FDA Expects More Litigation Over
Generic Exclusivity, GENERIC LINI
Oct. 27, 2010
,
1X
TABLE OF AUTHORITIES
Page(s)
Cases
aaiPharma Inc. v. Thompson,
296 F.3d 227 (4th Cir. 2002) ... error ee
Alvarez v. Smith,
Beer Oe, CD vin vccccaccvceuducecbinvsnsulelecedasecs 16
American Constr. Co. v. Jacksonville, T. & K.W.R.
C..
ic) ge RR ye aos. | eee DN ARS ARATE Rhy ee |
Apotex, Inc. v. Thompson,
347 F.3d 1335 (Fed. Cir. 2003).......................23
Bunting v. Mellen,
ST 67.5. LORD COO) inn cccceccccvcocsse: wees y
Cooper Indus., Inc. v. Aviall Servs., Inc.,
ve Bee. eee Ci” | re inc aceuses 18
Dolan Vv. USPS,
546 U.S. 481 (2ZO0G)........ccccscoscsssss ieeatvceuimee aa
Dr. Reddy's Labs., Inc. v. Thompson,
302 F. Supp. 2d 340 (D.N.J. 2003).......8, 23, 32
Eli Lilly & Co. v. Medtronic, Inc.,
496 U.S. 661 (1990)................ AESOP Oe
Erlenbaugh v. United States,
MEF UF es Be CRE vcinc i cctecccsscsncwsseseces Tecesnaee
Granutec, Inc. v. Shalala,
Nos. 97-1873, 97-1874,
1998 WL 153410 (4th Cir. Apr. 3, 1998)........2%
Gutierrez v. Ada,
528 U.S. 250 (2000) pce ae ice
X
Lewis v. Cont'l Bank Corp.,
494 U.S. 472 (1990).....cccccccceccecceccesceseceeeeseeseees 17
Locomotive Firemen v. Bangor & Aroostook R. Co.,
GRO U.S. B27 (2OGF).......ccccccccccosceoccceecssesecesessee. 20
MCI Telecomms. Corp. v. AT&T Co.,
US US, DES CUD. cao secs accsccnsses 9, 26
Mova Pharm. Corp. v. Shalala,
140 F.3d 1060 (D.C. Cir. 1998)......c.ccccccecccvervess 6
Munaf v. Geren,
553 U.S. 674 (2008).....ccccccccccecscecceseesscsseeeeceees 21
Mylan Pharms., Inc. v. FDA,
464 F.3d 270 (4th Cir. ZOOB) .........cccccccesscsnssess 23
Mylan Pharms., Inc. v. Thompson,
266 F390. 1323 (red. Cit. 2001 ).......cccscceservessaces aa
Pakootas v. Teck Cominco Metals, Ltd., 452 F.3d
TE Fe Cs as os schists 18
Powell v. McCormack,
eer ty Ue © Ris incciscicadianinn descr oe 16
Purepac Pharm. Co. v. Thompson,
e04 F.3G G77 (O).0, Cir, BIS)... 5.02. .ccccscscvccoseses 6
Ranbaxy Labs. Ltd. v. Leavitt,
469 F.3d 120 (D.C. Cir. 2006)............ 4, 8, 9, 13,
22, 25, 26, 34
Schering Corp. v. FDA,
51 F.3d 390 (3d Cir. 1995)......................s0.000. 23
Serono Labs., Inc. v. Shalala,
1668 F.3d 1313 (2.0. Cir. 1OBB) oicccscccciscccsscccesccD
Sociedad Anonima Vina Santa Rita v. Dep't of
Treasury,
193 F. Supp. 2d 6 (D.D.C. 2001)..................... 21
x1
Spencer v. Kemna,
G23 U.S. ECL) oo cccvisecs cased 17
Tandy v. City of Wichita,
380 F.3a 1277 (10th Cir. SOP see 18
Teva Pharmaceuticals USA, Inc. v. Sebelius,
595 F.3d 1303 (D.C. Cir. 2010)........ L. Be ae. 2h
12, 13, 14, 15, 18,
22, 24, 26, 26, 27.
28, 29, 30, 33, 35
Teva Pharmaceuticals USA, Inc. v. Sebelius, 638 IF.
Supp. 2a 42 (D.2).C. DOOR). 2.2.0.1 ences ]
United States v. Brandau,
578 F.3d 1064 (9th Cir. 2009) ........-..00.- ie
VM1 v. United States,
508 U5. O46 (10Ge). .dessicladicnennteeeeee 19
Winter v. NRDC, Inc.,
129 S.Ct. 366 ClOOG? onockciccsc ee eee
Wisconsin Gas Co. v. FERC,
4188 F.260 669 2.0). (a8: 2 ki oiscecese ee 21
Constitutional Provisions, Statutes, and
Regulations
21 C.F.R. § 314.500) .......:cscnun
21 CFR. € 914.GOD) «cicada ers.
Bi UGC, © BUG icc cccsecsncecsalacca ee
Zi UF... & SEI) occ cocuaiveudacsneseversusiensscueeneeeeee
21 U.S.C. § 355(b)(2) «...ccceeceeeeee svelte ee
21 U.S.C. § BSG eric cceisssccdicuacac eee 6
21 U.S.C. § S66G)IMA) kc 6
21 U.S.C. § 355G)(2)(A)(vi1)..... ened Sai geee hae eien 6
Beers, © SOOUNZA)(Vii)(IILT) .................0eecsscceeeces. a1
eee SOOO) E)(IV) (ZOOZ)..............cessececcceesene 8
21 U.S.C. § 355G)(5)(B)CGiv)(ID (bb) o.....eecccceeceeeeeeeseesees 8
OE STONE 00] 0 re (Pe x
21 U.S.C. § 355(5)(5)(D) (a) (I)................... Naess traci 7, 29
21 U.S.C. § 355(j)(5)(D)(i)(D(bb)(CC) «cece. 9, 27, 28
en. © OI D)(DI)(1)(V1I) ..........000ccsceceseees 8, 30, 32
21 U.S.C. § 355(j)(7)(a) .......-. ee le eae eee 6
NEE) © SEGA ..............00ce0c..00c00000000- AE 10
METE FB5A(1)...............0...00000-0-c0cceeesceeccerceerceeees.
SE 7
I MEO DD... csncncccscccscocccsccccsscvcscccssccessesese
EEE ios. scsccvscscsccvcsesscecsscsssscsccccccesoses \eees
Other Authorities
David Belian, FDA Expects More Litigation Quer
Generic Exclusivity,
Seem, sme. Oct, 27, 2010 ..................006 4, 23
R. Stern, E. Gressman, & S. Shapiro,
SUPREME COURT PRACTICE § 4.18 (6th ed.
INTRODUCTION
Respondent Teva Pharmaceuticals USA, Inc.
(“Teva”) began selling generic losartan potassium
products on the evening of April 6, and its 180-day
period of marketing exclusivity for those products
thus ended at the stroke of midnight on October 3—
the day before Apotex, Inc. (“Apotex”) filed its
Petition challenging Teva’s then-expired exclusivity
period. Accordingly, this case was moot on arrival,
and the Petition should be denied. Nothing this
Court can say or do would revive Apotex’s lone claim,
which sought only declaratory and injunctive relhef
that would have allowed the company to launch its
losartan potassium products before the scheduled
expiration of Teva’s now-concluded exclusivity
period. Needless to say, this Court is not in the
business of exercising its discretionary jurisdiction to
render advisory opinions on purely academic
matters, and it should not do so here.
This case would in any cvent be a spectacularly
poor vehicle for doing so, because it bears the
dubious distinction of attempting to raise a moot
question in an interlocutory posture. After all, no
final judgment has been entered below. The district
court merely denied Apotex’s motion to preliminarily
enjoin Teva from marketing its products, and the
D.C. Circuit’s opinion simply affirmed — that
discretionary decision before remanding the case.
Pet. App. 3a.
While Apotex nonetheless pretends that the
merits of its claim are before the Court, see Pet. at 1,
that simply isn’t so. The preliminary injunction
calculus turns not only on whether the movant has
shown a likelihood of success, but also requires proof
that the movant is “likely” to suffer irreparable harm
in the absence of interim relief. Winter v. NRDC,
Inc., 129 S.Ct. 365, 375-76 (2008). Apotex, however,
does not challenge the district court’s factual finding
that it would not have suffered an irreparable harm
from the denial of injunctive relief—and, given that
Teva’s exclusivity period has come and gone, Apotex
cannot possibly make that showing now. ‘There is
thus no basis for reaching the merits. The D.C.
Circuit’s decision to affirm the district court’s denial
of Apotex’s preliminary injunction motion could be
summarily affirmed based solely on the equities,
leaving any discussion of the merits for an appeal in
which the legal issues are presented squarely (and
actually matter).
And while the fact that Apotex’s requests for
preliminary and permanent injunctive rehef both are
moot seemingly would leave the district court with
little left to do on remand, Apotex apparently doesn’t
think so. When the district court recently issued an
order to show cause why judgment should not be
entered in favor of FDA (and Teva), Apotex opposed
the entry of final judgment; indeed, it would not even
commit to dismissing its lawsuit in the event this
Court denies certiorari. Resp. App. 8a.
Kven if there were no jurisdictional or procedural
impediment to this Court’s review, and even if the
merits were squarely presented, there still would be
no need for the Court to intervene. In short, there is
no division of authority on the single question
presented by the Petition. Two different panels of
the D.C. Circuit now have rejected Apotex’s
arguments, in decisions that are fully consistent with
that of a third D.C. Circuit panel that rejected
3
Apotex’s arguments under the prior version of the
statute, see Ranbaxy Labs. Ltd. v. Leavitt, 469 F.3d
120 (D.C. Cir. 2006). Suffice it to say, no other court
has weighed in on the other side (whether under this
version of the statute or its predecessor).
Apotex tries to downplay the courts’ consistent
rejection of its arguments by speculating that a
circuit split is unlikely to develop because most
Hatch-Waxman cases are filed in the District of
Columbia. But there is no reason why that must be
so: Unlike many federal agencies whose decisions are
subject to exclusive review in the D.C. Circuit, FDA
can be—and often is—sued in other jurisdictions.
That likely explains why the Agency’s senior Hatch-
Waxman counsel reportedly told a recent conference
that the issues implicated by this litigation are
“likely to arise again soon tin other courts.” David
Behan, FDA Expects More Litigation Over Generic
Exclusivity, GENERIC LINE, Oct. 27, 2010 (Resp. App.
lla) (emphasis adde@).
Finally, and perhaps most important, the D.C.
Circuit’s analysis was correct. Contrary to Apotex’s
assertion that the appellate court “gave no
meaningful consideration to thle statute’s] text,” Pet.
29, that’s precisely what the D.C. Circuit did. In
fact, Apotex’s real complaint is not that the D.C.
Circuit failed to consider the statutory text; it is that
the appellate court considered the whole text of the
statute and not just the snippets Apotex focuses on.
Indeed, as Judge Williams carefully explained in the
precursor to the decision at issue here, Apotex’s
proposed interpretation of the statute’s forfeiture
triggers 1s both inconsistent with the remainder of
the statute’s text and structure and unsupported by
even “a single cogent reason.” Pet. App. 62:
(emphasis in original).
In sum, certiorari is unwarranted by = any
measure. This case is both moot and interlocutory;
there is no circuit split; and the decision below is
plainly correct. The Petition should be denied.
OPINIONS BELOW
The D.C. Circuit’s unreported per curiam
disposition is reprinted at Pet. App. la-3a. The
district court’s opinion is reported at 700 F. Supp. 2d
138 (D.D.C. 2010) and reprinted at Pet. App. 4a-1la.
The Food and Drug Administration’s unreported
Letter Decision is reprinted at Pet. App. 12a-30a.
Neither FDA nor Apotex timely petitioned this
Court for review of the D.C. Circuit’s related decision
in Teva Pharmaceuticals USA, Inc. v. Sebelius, which
is reported at 595 F.3d 1303 (2010). Nonetheless,
much of Apotex’s Petition addresses the merits of
that decision, which is reprinted at Pet. App. 3la-
Jia. The underlying district court decision in that
case 1s reported at 638 F. Supp. 2d 42 (D.D.C. 2009)
and reprinted at Pet. App. 72a-106a.
JURISDICTION
The D.C. Circuit’s judgment was entered on July
6, 2010, and Petitioner has invoked this Court's
jurisdiction under 28 U.S.C. § 1354(1). As set forth
below, however, the Petition does not present a live
‘ase or controversy, and this Court accordingly lacks
Article III jurisdiction to reach the merits. See U.S.
CONST. art. III.
5
PERTINENT STATUTORY AND
CONSTITUTIONAL PROVISIONS
Petitioner’s Appendix includes some—but not
all—of the pertinent statutory provisions. The
remainder are set forth at Resp. App. la-6a.
STATEMENT OF THE CASE
A. The Hatch-Waxman Framework
As modified by the Medicare Modernization Act
(“MMA”), the Hatch-Waxman Act establishes the
procedure for obtaining new drug approvals in the
United States. 21 U.S.C. § 355 et seq. It requires the
manufacturer of a proposed brand-name drug to
complete a New Drug Application (“NDA”) that
contains clinical data showing the proposed drug’s
safety and efficacy, id. § 355(b)(1), as well as
information regarding each patent the applicant
asserts as claiming the proposed drug (including its
scheduled expiration date), id. § 355(b)(2); 21 C.F-.R.
§ 314.50(h); id. § 314.53(b).
Generic drugs contain the same_ active
ingredients and provide the same benefits as their
brand-name counterparts, but typically are less
expensive. Before Hatch-Waxman, generic companies
had to complete a full NDA to obtain FDA approval;
that requirement almost invariably made generic
market entry cost-prohibitive. In 1984, Congress
enacted Hatch-Waxman to remove that barrier,
increase the availability of generics, and reduce drug
costs. Serono Labs., Inc. v. Shalala, 158 F.3d 1313,
1326 (D.C. Cir. 1998).
To that end, Hatch-Waxman authorizes FDA to
approve a generic drug if the generic applicant can
6
demonstrate its product’s bioequivalence to a “listed”
(or previously approved) brand-name drug. Generic
applicants do so by submitting an Abbreviated NDA
(““ANDA”) that includes’ studies demonstrating
bioequivalence. 21 U.S.C. § 355Q). If FDA accepts
those studies, the generic applicant need not
replicate the brand manufacturer’s clinical studies.
Id. § 355G9)(2)(A); see also Mova Pharm. Corp. v.
Shalala, 140 F.3d 1060, 1063 (D.C. Cir. 1998).
The statute also requires each ANDA to include a
“certification” to each patent the brand manufacturer
identified as claiming the brand-name drug. /d.
§ 355G)(2)(A)(v11). To make this system work, FDA
must “publish” the patent information it receives
from brand companies. Id. § 355G)(7)(A). FDA's
official patent list is known as “the Orange Book.”
Purepac Pharm. Co. v. Thompson, 354 F.3d 877, 880
(D.C. Cir. 2004).
Generic applicants consult that list and then
make one of four certifications: (1) that no patent
information was filed for the brand-name drug
(“Paragraph I certification”); (2) that a listed patent
“has expired” (“Paragraph II certification”); (3) that
the generic drug will not be marketed until “the date
on which [a listed] patent will expire” (“Paragraph
lll certification”); or (4) that a listed patent is
invalid, unenforceable, and/or will not be infringed
by the proposed generic drug (“Paragraph IV
certification”). 21 U.S.C. § 355G)(2)(A)(vii).
Paragraph IV _ certifications are critically
important. They typically signal the generic’s intent
to sell its products before the scheduled expiration of
a listed patent and thereby provide consumers with
expedited price relief. Teva Pharms. USA, Inc. v.
7
Leavitt (“Teva v. Leavitt’), 548 F.3d 103, 106 (D.C.
Cir. 2008) (“The legislative purpose underlying
paragraph IV is to enhance competition by
encouraging generic drug manufacturers to challenge
the patent information provided by NDA holders in
order to bring generic drugs to market earlier.”).
But filing such certifications is risky. The first
Paragraph IV challenger bears significant research-
and-development and legal costs to design around
and/or contest the validity of a listed patent. And if
those efforts succeed, merely filing such a
certification is an act of infringement that could
result in years of costly patent litigation. See 35
U.S.C. § 271(e); see also Eli Lilly & Co. v. Medtronic,
Inc., 496 U.S. 661, 678 (1990).
To encourage generics to accept those risks, the
statute rewards the first patent challenger with a
180-day period of marketing exclusivity during
which no other generic version of the drug may be
sold. See, e.g., Teva v. Leavitt, 548 F.3d at 104
(“Marketing exclusivity is valuable, designed to
compensate manufacturers for research = and
development costs as well as the risk of litigation.”).
Pursuant to the MMA, the first patent challenger
can “forfeit” its exclusivity in certain circumstances.
21 U.S.C. § 355G)(5)(D)(i).. Two such circumstances
are relevant here. First, the first generic applicant
can forfeit exclusivity if it fails promptly to market
its products after certain events—including (in
general terms) a_ successful outcome in patent
litigation, or after the brand manufacturer
withdraws (or “delists”) a patent from the Orange
Book. Jd. § 3559)(5)(D)G)(ID. These provisions are
known as the “failure-to-market” forfeiture trigger.
8
Second, the first applicant may forfeit exclusivity
if “[ajll of the patents as tc which the applicant
submitted a [Paragraph IV certification] have
expired.” Jd. § 355()(5)(D)G)(VI). ‘This provision
codified FDA’s longstanding practice of rejecting
exclusivity where the first applicant failed to begin
selling its products before the challenged patent
expired naturally—i.e., at the end of its scheduled
term. See Dr. Reddy’s Labs., Inc. v. Thompson, 302
F. Supp. 2d 340, 354-55 (D.N.J. 2003).
B. The Delisting Rule
Shortly after Congress passed Hatch-Waxman,
brand companies realized that delisting a challenged
patent could eliminate exclusivity and thereby
undercut the incentive for generic applicants to
challenge patents over the long-run. That was so
because generic applicants can certify only to patents
listed in the Orange Book, and can _ receive
exclusivity only if they maintain a Paragraph IV
certification. 21 U.S.C. § 355())(5)(B)(iv) (2002); id.
§ 355(G)(5)(B)(iv) TD(bb) (2003). FDA acquiesced in
this practice, and given the ease with which brand
manufacturers thus could eviscerate the incentive for
challenging their patents, FDA’s approach to
delisting substantially reduced the motivation for
generic applicants to develop and file early patent
challenges.
Teva eventually sued FDA, and the D.C. Circuit
rejected the Agency’s acquiescence in_ this
manipulative practice at Chevron’ step. one.
Ranbaxy, 469 F.3d at 126. As Ranbaxy explained,
FDA’s delisting policy gutted the exclusivity reward
by allowing brand companies to “reduce[] the
certainty of receiving a_ period of marketing
9
exclusivity,” and thereby “diminish[ed] the incentive
for [generics] ... to challenge a [listed] patent.” /d.
at 126. In sum, the Court held, “FDA may not
change the incentive structure adopted by the
Congress, for the agency is bound ‘not only by the
ultimate purposes Congress has selected, but by the
means it has deemed appropriate, and prescribed, for
the pursuit of those purposes.” /d. (quoting MC/
Telecomms. Corp. v. AT&T Co., 512 U.S. 218, 231 n.4
(1994)).
Ranbaxy, however, was decided before the MMA.
And seizing upon the MMA’s new “failure-to-market”
forfeiture clause—which in certain circumstances
provides for forfeiture after a delisting, 21 U.S.C.
§ 355(G)(5)(D) (Gi) (D(bb)(CC)—-FDA held that Ranbaxy
did not survive the MMA. Pet. App. 36a. Instead,
according to FDA, “[b]rand manufacturers are ... free
to delist challenged patents whenever they please—
and any such delisting [causes a forfeiture].” /d. at
58a (emphasis added). This approach was known as
the “Delisting Rule.”
C. Losartan Potassium Products
Losartan potassium is an antihypertensive agent.
Merck holds two NDAs for the losartan potassium
products Cozaar® and Hyzaar®. When those drugs
were approved, Merck listed the same three patents!
in the Orange Book for both: U.S. Patent No.
5,138,069 (“the ‘069 patent”), which was scheduled to
block competition through February 11, 2010; U.S.
! Merck also listed a fourth patent for Cozaar®, but that patent
relates to a treatment for which Teva did not seek approval and
thus posed no barrier to the approval of Teva's ANDA
LO
Patent No. 5,153,197 (“the ‘197 patent”), which was
scheduled to block competition through April 6, 2010;
and U.S. Patent No. 5,608,075 (“the ‘075 patent”),
which was scheduled to block competition through
September 4, 2014.
On December 18, 2003, Teva submitted its
generic Cozaar® ANDA. ‘Teva’s ANDA contained
Paragraph III certifications to the ‘069 and ‘197
patents, meaning that it would not market its
products until the ‘197 patent’s scheduled expiration
in April 2010. However, Teva also submitted a
Paragraph IV certification to the ‘O75 patent,
claiming that that patent is invalid, unenforceable,
and/or would not be infringed by Teva’s products
and thus that Teva intended to begin marketing its
products years before that patent’s scheduled
expiration in 2014. ‘Teva was the first generic
applicant to challenge the ‘075 patent. Pet. App. 40a.
On May 24, 2004, Teva submitted its generic
Hyzaar® ANDA. That ANDA contained the same
patent certifications as Teva’s Cozaar® ANDA
including a Paragraph IV certification to the ‘075
patent. Once again, Teva was the first generic
Hyzaar® applicant to challenge the ‘075 patent. /d.
As the first Paragraph IV filer, Teva became
eligible for 180-day exclusivity for both drugs. /d.
Teva then notified Merck of its certifications,
explaining that most of the ‘O75 patent’s claims were
* Each patent actually was scheduled to expire before these
dates. However, Merck received a period of “pediatric
exclusivity” which prevented FDA from approving ANDAs until
six months after each patent expired. 21 U.S.C. § 355a
11
invalid based on prior art and that Teva’s products
would not infringe the patent’s remaining claims
under the doctrine of equivalents. Merck, however,
did not sue Teva. Jd. Instead, in March 2005—after
Teva submitted its exclusivity-qualifying Paragraph
IV certifications to the ‘075 patent—“Merck asked
the FDA to delist the ‘075 patent, which the agency
did.” Jd. Then, after asking FDA to delist the ‘075
patent, Merck apparently stopped paying
“maintenance fees” on the now-worthless patent.
Id. at 6a.
By doing so, Merck effectively conceded that
Teva’s Paragraph IV challenge was so strong that
Merck could not reasonably assert that patent
against any generic applicant. Teva thus achieved
precisely what Congress sought to reward with
exclusivity: It identified a competition-blocking
patent, invested the resources needed to challenge it,
and successfully removed it as a barrier to
competition—thereby opening the market to generic
entry more than four years earlier than would have
been possible without Teva’s challenge. Under
FDA’s Delisting Rule, however, “Teva had by the fall
of 2008 already forfeited” its exclusivity because of
Merck’s unilateral decision to delist the ‘075 patent.
Id. at 41a (emphasis original).
D. The Teva Litigation
In June 2009, Teva sued FDA to protect its 180-
day exclusivity period, arguing that the Dehsting
Rule was arbitrary, capricious, and inconsistent with
the statute. The district court (Collyer, J.)
ultimately consolidated Teva’s initial request for
preliminary injunctive relief with a trial on the
merits, and entered judgment for FDA. Jd. at 33a.
12
Teva appealed, and the D.C. Circuit (per
Williams, J.) reversed on March 2, 2010. Jd. at 66a.
Paying close attention to the statute’s text and
structure, Judge Williams’s opinion for the court held
there was “no reason to conclude that the 2003
addition of forfeiture provisions meant to give the
brand manufacturer a right to unilaterally vitiate a
generic’s exclusivity.” Jd. at 63a; see also id. at 62a
(“The agency ... offers not a single cogent reason why
Congress might have ... provided for a scenario in
which the brand maker can unilaterally deprive the
generic of its exclusivity.”) (emphasis original).
The D.C. Circuit then remanded the case for the
entry of appropriate relief, id. at 66a, but
simultaneously entered a routine order withholding
its mandate until seven days after FDA’s deadline
for seeking rehearing.
E. Post-Judgment Proceedings
That routine order would have prevented the
district court from entering relief on remand before
FDA could have approved other applicants on April
6. So on March 9, Teva moved the D.C. Circuit to
issue its mandate forthwith. Emer. Mot. To Issue
Mandate (Mar. 9, 2010).
That same day, however, Apoiex apparently
informed FDA that Merck’s ‘075 patent may have
prematurely expired in March 2009 due to Merck’s
unilateral failure to pay maintenance fees. FDA
then opposed Teva’s motion for immediate issuance
of the mandate, asserting (like Apotex here) that
Merck’s decision to halt maintenance fee payments
meant that “a forfeiture event other than the
delisting of the ‘075 patent—namely, expiration of a
patent that is the subject of a paragraph IV
13
certification[—]has, in fact, occurred.” FDA Opp. to
Emer. Mot. To Issue Mandate at 7 (Mar. 11, 2010).
Teva promptly replied, explaining that FDA’s
effort to divorce Merck’s unlawful delisting request
from its failure to pay maintenance fees
boils down to the absurd proposition that
brand manufacturers somehow are allowed to
achieve through the back door (by not paying
maintenance fees on a challenged patent)
precisely what th[e D.C. Circuit]’s decisions in
both this case and Ranbaxy forbid them from
doing through the front door (by delisting the
challenged patent in the first place). As |7Jeva]
recognized, however, there is ‘not a_ single
cogent reason why Congress might have
permitted ... a scenario in which the brand
maker can unilaterally deprive the generic of
its exclusivity, and that judgment is
controlling here.
Reply in Supp. of Emer. Mot. at 11 (Mar. 12, 2010)
(quoting Pet. App. 62a). After considering the
parties’ submissions, the D.C. Circuit granted Teva’s
motion and issued its mandate on March 12.3
F. Post-Remand Proceedings
On remand, the district court directed FDA to
promptly file an administrative decision addressing
the potential impact of Merck’s conduct on Teva’s
eligibility for exclusivity, and suggested that any
challenge to that decision could be raised “in a new
3 FDA later petitioned for rehearing en banc, but the D.C.
Circuit unanimously denied the petition on May 17.
14
lawsuit.” Order Amending Judgment at 3 n.4
(D.D.C. Mar. 26, 2010).
On March 26, FDA then issued the Letter
Decision giving rise to this litigation. Pet. App. 12a-
30a. Although the Agency took issue with the D.C.
Circuit’s delisting opinion, it nonetheless held that
the appellate court’s reasoning “preclude[s] a
forfeiture of exclusivity on the basis of a patent
expiration where the expiration is in the control of
the NDA holder.” /d. at 28a (discussing td. at 62a).
It therefore declared that FDA “will not approve any
other [losartan] ANDA until [Teva] has received
approval of its ANDA, begun commercial marketing,
and the 180-day exclusivity period has expired.”
Id. at 29a.
Apotex then filed a new lawsuit, seeking a TRO
and preliminary injunction that together would bar
FDA from awarding Teva exclusivity and compel the
Agency to approve Apotex’s ANDA immediately. On
April 2, the district court denied the motion. Jd. at
lla. With respect to Apotex’s likelihood of success,
the district court held that FDA properly “applied
the reasoning of the Circuit to a different but, on
these facts, closely related question.” Jd. at 9a. And
on the equities, the court held that Apotex’s purely
economic injuries did not constitute irreparable
harm, id. at 10a; that the requested relief “would
certainly injure Teva,” id.; and that the public
interest weighed against relief given the exclusivity
reward’s “pro-consumer” goals. Id. at 10a-lla
(quoting id. at 64a).
On April 5, Apotex asked the D.C. Circuit to stay
all generic losartan approvals and summarily reverse
the district court’s decision. The D.C. Circuit
_"
wn
promptly denied those motions, and FDA approved
Teva’s ANDAs on April 6. Teva began selling its
products that evening, thereby triggering its 180-day
exclusivity period.
On July 6, another D.C. Circuit panel (Tatel,
Griffith, Kavanaugh, JJ.) affirmed the district court’s
denial of Apotex’s preliminary injunction request in
an unpublished per curiam order. Pet. App. la-3a.
That summary disposition explained that once “the
Hatch-Waxman Act’s forfeiture provisions are viewed
in the context of the statute’s incentive structure, it
becomes clear that Congress could not have intended
a brand manufacturer’s unilateral decision to cause
the premature expiration of a patent ... to strip the
first generic applicant of the 180-day period of
marketing exclusivity granted by the statute.” Jd. at
2a-3a.
Teva’s 180-day period of exclusivity ended on
October 3. The next day, Apotex filed its Petition.
Apotex received approval to market its generic
losartan potassium products on October 6, and
apparently has been selling its products ever since.‘
4 See FDA, Drugs @ FDA: FDA Approved Drug Products, at
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
?fuseaction=Search.Set_Current_ Drug&App|INo=090790&Drug
Name=LOSARTAN%20POTASSIUM&ActiveIngred=LOSARTA
N%20POTASSIUM&SponsorApplicant=A POTEX%20CORP&P
roductMktStatus=1 (last visited Dec. 9, 2010).
16
REASONS FOR DENYING THE WRIT
I. This Case Is Moot.
Apotex’s complaint—and the preliminary
injunction motion addressed by the sole D.C. Circuit
decision at issue here, Pet. App. 2a-3a—sought only
prospective relief challenging Teva’s entitlement to
180-day marketing exclusivity. But Teva’s 180 days
of exclusivity have come and gone, and while this
Court can do many things, it can’t turn back time.
There is thus no case or controversy left for the
Court to resolve; any opinion regarding the merits
would be purely advisory.
Nor does this case present one of those
“exceptional situations” involving an issue that is
“capable of repetition while evading review.” Alvarez
v. Smith, 130 S. Ct. 576, 581 (2009) (internal
citations and quotations omitted). Though Apotex
has identified a handful exclusivity-grounding
patents that the brand manufacturer deliberately let
lapse, there is no reason why the question it seeks to
raise here will evade review if, as Apotex speculates,
it ever arises again. After all, challenges to the legal
rules FDA apples in making exclusivity decisions
can be brought well before an exclusivity period is
scheduled to begin—and with ample time for this
Court to review the issue Apotex seeks to raise in a
case where it actually matters.
A. This Case Was Moot Even Before
Apotex Filed Its Petition.
It is black-letter law that “a case is moot when
the issues presented are no longer ‘live’ or the parties
lack a legally cognizable interest in the outcome.”
Powell v. McCormack, 395 U.S. 486, 496 (1969).
17
Accordingly, a given case or controversy not only
must be “live” at the outset of litigation; it must
remain so “through all stages of federal judicial
proceedings, trial and appellate.” Spencer v. Kemna,
523 U.S. 1, 7 (1998) (quoting Lewis v. Contl Bank
Corp., 494 U.S. 472, 477-478 (1990)).
Apotex’s lawsuit, however, was moot even before
the Petition was filed. This case involved a single
180-day period of marketing exclusivity that began
on April 6 and ended at midnight on October 3.
Apotex is now selling its products, unhindered by the
exclusivity period it sought to challenge. Any
interest Apotex had when it filed suit long ago ceased
to exist; nothing this Court can do would give Apotex
relief. Accordingly, the Petition should be denied.
See Lewis, 494 U.S. at 480 (“Where on the face of the
record it appears that the only concrete interest in
the controversy has terminated, reasonable caution
is needed to be sure that mooted litigation is not
pressed forward, and unnecessary ‘judicial
pronouncements ... obtained.”); see also Bunting v.
Mellen, 541 U.S. 1019, 1021 (2004) (Stevens, Breyer,
and Ginsburg, JJ., respecting the denial of certiorari)
(explaining that certiorari is properly denied where
“there no longer is a live controversy’).
B. This Issue Will Not Evade Review.
Nonetheless, Apotex half-heartedly suggests that
this case falls within the “capable of repetition, yet
evading review’ exception to mootness. See Pet. 17
n.8. But that bald assertion is incorrect: There is no
reason to assume that future cases raising this issue
cannot be filed with “ample time to obtain judicial
review.” Lewis, 494 U.S. at 482.
18
That is so, as the D.C. Circuit’s original delisting
decision made clear, because there is no bar to pre-
enforcement review of exclusivity issues. Given that
the issues presented in such cases are “purely legal”
and implicate a cognizable “hardship,” Pet. App. 43a,
46a, courts “routinely reach the merits of generic
manufacturers’ claims to exclusivity before the FDA
has granted final approval to any ANDA concerning
the drug at issue.” Jd. at 48a (citations omitted).
That, of course, explains why Apotex does not
even try to argue that subsequent cases cannot be
filed with sufficient lead-time to permit full judicial
review. All a subsequent applicant would have to do
is file a declaratory judgment action next time it
faces an allegedly unlawful exclusivity period—and if
Apotex is to be believed, there are 27 possible cases
in which one might do so, see Pet. 25 (though that
considerably overstates the number of cases in which
the actual merits issue embedded in this preliminary
injunction appeal might arise, see infra at ITI.B.).
In any event, this Court need “not decide in the
first instance” whether an exception to the mootness
doctrine applies. Cooper Indus., Inc. v. Aviall Servs.,
Inc., 543 U.S. 157, 168-169 (2004) (internal citation
and quotations omitted). As explained below, this
case remains pending before the district court—
which can and should resolve the mootness issue (by
making any necessary findings that bear on that
inquiry) in the first instance. See, e.g., United States
v. Brandau, 578 F.3d 1064, 1065 (9th Cir. 2009);
Pakootas v. Teck Cominco Metals, Ltd., 452 F.3d
1066, 1071 n.10 (9th Cir. 2006); Tandy v. City of
Wichita, 380 F.3d 1277, 1291 (10th Cir. 2004).
19
II. The Petition Arises In The Interlocutory
Context Of A Preliminary Injunction
Proceeding.
Even if this case were not moot, it would be a poor
vehicle to address the question it purports to present,
because it arises in the interlocutory context of a
preliminary injunction proceeding. Again, the D.C.
Circuit merely affirmed the district court’s denial of
Apotex’s motion for interim relief, and the case
remains pending below.
This Court typically does not exercise its
discretionary jurisdiction over interlocutory appeals,
and petitions arising from preliminary injunction
proceedings are particularly ill-suited for review.
After all, the legal issues embedded in such petitions
are not squarely presented: The question on appeal
from the denial of a preliminary injunction is not
whether the lower courts properly resolved the
merits, but whether the court abused its discretion
by denying interim relief. While that inquiry turns
in part on a tentative assessment of the merits, it
also requires the movant to demonstrate a likelihood
of irreparable injury absent immediate relief. Here,
of course, Apotex cannot possibly demonstrate such
an injury because Teva’s exclusivity period is over—
and the D.C. Circuit’s decision thus would have to be
affirmed without respect to the merits.
A. There Has Been No Final Judgment.
As set forth above, no final judgment has been
entered in this case. That fact alone is fatal to the
Petition, because this Court’s settled practice is to
“await final judgment in the lower courts before
exercising ... certiorari jurisdiction.” VMI v. United
States, 508 U.S. 946, 946 (1993) (Scalia, J.,
20
respecting the denial of certiorari) (citing American
Constr. Co. v. Jacksonville, T. & K.W.R. Co., 148 U.S.
372, 384 (1893); Locomotive Firemen v. Bangor &
Aroostook R. Co., 389 U.S. 327, 328 (1967) (per
curiam); R. Stern, E. Gressman, & S. Shapiro,
SUPREME COURT PRACTICE § 4.18, pp. 224-226 (6th
ed. 1986)).
That approach controls here, where the only
decision before this Court is the D.C. Cuircuit’s
unpublished order affirming the district court’s
denial of Apotex’s preliminary injunction motion.
Pet. App. 2a-3a. The legal merits remain pending
before the district court on remand. And while one
might think there is little left for the district court to
resolve given that Teva’s exclusivity period now has
ended, Apotex continues to resist the entry of a final
judgment; indeed, Apotex won’t even commit to
dismissing its lawsuit in the event this Court denies
certiorari. See Resp. App. 8a (“Should the petition
not be granted, Apotex will then consider whether to
dismiss the case ....”) (emphasis added).
The Petition thus should be denied. While Teva
has no idea what Apotex intends to do at the district
court, this Court’s review can surely await the entry
of judgment after Apotex decides it has finished
litigating the merits of its case.
B. The Legal Issue Apotex Seeks To Raise
Is Not Squarely Presented.
The fact that this Petition arises from the denial
of a preliminary injunction provides an additional
basis for denying review. While Apotex purports to
raise the purely legal question of whether the D.C.
Circuit properly interpreted the Hatch-Waxman Act,
see Pet. i, that question isn’t actually presented.
21
Instead, the only question before this Court is
whether the district court abused its discretion when
it applied the four-factor preliminary injunction test
to deny Apotex’s motion. See Winter, 129 S. Ct. at
374; Munaf v. Geren, 553 U.S. 674, 690-91 (2008).
Yet for all the ink it spills on the underlying
merits, Apotex doesn’t say a word about the
preliminary injunction standard—and for good
reason. As the district court recognized, Pet. App.
8a-9a, that standard requires Apotex to demonstrate,
among other things, both a likelihood of success on
the merits and a likelihood of irreparable injury in
the absence of immediate equitable relief. Winter,
129 S. Ct. at 374-75.
Apotex cannot satisfy either requirement. On one
hand, the fact that Apotex’s sole legal claim is moot
forecloses any _ possibility that Apotex could
demonstrate a likelihood of success. On the other
hand, Apotex does not contest the district court’s
factual finding that the company would not suffer
irreparable injury absent injunctive relief. Pet. App.
10a (citing Wisconsin Gas Co. v. FERC, 758 F.2d 669,
674 (D.C. Cir. 1985) (per curiam); Sociedad Anonima
Vina Santa Rita v. Dep’t of Treasury, 193 F. Supp. 2d
6, 14 (D.D.C. 2001)). And Apotex certainly cannot
demonstrate such an injury now: Teva's exclusivity
period is over, and Apotex is on the market. There is
thus nothing left to enjoin, and no need for this
Court to reach the merits. The case would have to be
affirmed based solely on the equities. See, e.g.,
Winter, 129 S. Ct. at 374-76 (conditioning injunctive
relief on proof that irreparable injury is “likely,” and
denying such relief without addressing the merits
22
based on “[a] proper consideration of the[ equitable]
factors alone”) (emphasis added).
Ill. There Is No Circuit Split, And Apotex
Exaggerates the Likelihood That The
Embedded Merits Issue Will Recur.
Separate and apart from those grounds for
denying the Petition, there is no circuit split on the
issue Apotex purports to raise, and Apotex in any
event exaggerates the likelihood that it will recur.
A. There Is No Circuit Split.
Apotex concedes that the D.C. Circuit is the only
appellate court that has addressed whether the
Hatch-Waxman Act allows brand manufacturers to
deprive generic applicants of 180-day exclusivity by
ceasing to pay maintenance fees on Orange Book-
listed patents. Pet. 26. And the appellate court’s
decision on this point is both fully consistent with
two prior D.C. Circuit cases, see Pet. App. 3la-71la;
Ranbaxy, 469 F.3d at 126, and uncontested by any
other circuit court.
Despite this uniformity, Apotex claims that
certiorari is appropriate because it believes a circuit
split is unlikely to develop. See Pet. 26-27. That is
so, Apotex asserts, because “the D.C. Circuit is the
usual forum for these disputes.” /d. at 26 (internal
quotation omitted).
Unlike many federal agencies, however, FDA is
not subject to exclusive suit in the D.C. Circuit. And
despite Apotex’s best efforts to obscure the record,
lawsuits regarding FDA’s interpretation of the
Hatch-Waxman Act (including its 180-day exclusivity
provisions) commonly are filed outside Washington
D.C. Indeed, these out-of-circuit cases include some
23
of the most significant Hatch-Waxman cases that
have ever been litigated. See, e.g., Mylan Pharms.,
Inc. v. FDA, 454 F.3d 270 (4th Cir. 2006) (180-day
exclusivity); Apotex, Inc. v. Thompson, 347 F.3d 1335
(Fed. Cir. 2003) (Orange Book patent listings);
aaiPharma Inc. v. Thompson, 296 F.3d 227, 230 (4th
Cir. 2002) (same); Mylan Pharms., Inc. v. Thompson,
268 F.3d 1323 (Fed. Cir. 2001) (Orange Book patent
listings); Granutec, Inc. v. Shalala, Nos. 97-1873, 97-
1874, 1998 WL 153410 (4th Cir. Apr. 3, 1998) (180-
day exclusivity); Schering Corp. v. FDA, 51 F.3d 390
(3d Cir. 1995) (generic approval requirements); Dr.
Reddy’s Labs., 302 F. Supp. 2d at 340 (180-day
exclusivity); Mylan Pharms., Inc. v. Thompson, 207
F. Supp. 2d 476 (N.D. W.Va. 2001) (180-day
exclusivity).
That perhaps explains why FDA itself is
preparing to litigate these issues in_ other
jurisdictions. Indeed, as the Agency’s senior Hatch-
Waxman counsel recently explained, FDA expects
that the issues addressed in the losartan cases are
“likely to arise again soon in other courts.” Resp.
App. lla (emphasis added). There is thus no basis
for Apotex’s attempt to rule out the possibility of a
future circuit split.
Faced with these facts, Apotex ultimately resorts
to speculation. It hypothesizes that future first
applicants might be able to channel all 180-day
exclusivity cases to the D.C. courts before
subsequent applicants are “able to bring suit
elsewhere.” Pet. 27. But without belaboring the
point, such admittedly creative conjecture—which
even Apotex concedes rests on an “unclear” premise,
id.—hardly provides a basis for granting certiorari.
24
B. Apotex Exaggerates The Likelihood
That The Embedded Merits Issue Will
Recur.
Of course, the absence of a circuit split does not
automatically preclude review; this Court sometimes
takes cases that present particularly important
issues which are likely to recur. Apotex thus tries to
shoehorn its Petition into this narrow class of cases,
asserting that “billions of dollars” are at stake
because “[m]Jany more [cases] are coming down the
pike.” Pet. 24-25. Indeed, Apotex argues, it has
identified “27 patents for brand-name drugs ... for
which ... the challenged patent has been delisted or
allowed to expire.” Jd. at 25 (emphasis added).
That not only overstates the case; it highlights
yet another problem with the Petition. Despite
Apotex’s best efforts to challenge the D.C. Circuit's
original delisting decision (Pet. App. 3la-7la), this
Petition does not arise from ‘Teva's’ lawsuit
challenging the FDA’s Delisting Rule, and the
decision in that case is not before the Court. Instead,
this case arises from Apotex’s subsequent—
separate—lawsuit challenging FDA’s application of
the patent-expiry forfeiture trigger, and that’s the
only merits issue addressed in the appellate court’s
preliminary injunction decision, Pet. App. 2a-3a.
That matters, because as Apotex noted in the
district court (but tellingly declines to mention here),
only four of the “27 patents” it claims to be at issue
involve alleged patent expiry—and one of those is the
losartan patent at issue in this case. See Apotex
Reply to Opp. to Mot. for Prelim. Inj. at 8 & n.3
(D.D.C. Apr. 1, 2010). Thus, contrary to Apotex’s
suggestion that another 27 cases are likely to raise
25
the issue addressed by the appellate court, just 3
other cases implicate this issue—and one of them
appears to arise under the pre-MMA statute (and so
would not be controlled by a decision in this case).
Neither of the remaining two cases involves a
“blockbuster” drug, cf. Pet. 25, and even if they did,
the prospect that two future cases may (or,
depending on their unique facts, may not) give rise to
similar litigation is far too thin a reed on which to
ground certiorari.
IV. The D.C. Circuit’s Preliminary Analysis
Of The Merits Was Correct.
Finally, there is no need for this Court’s review
because the appellate court’s preliminary analysis of
the merits was correct. As three different panels of
the D.C. Circuit now have recognized, it upends both
law and logic to think that Congress created an
elaborate incentive scheme designed to encourage
generic companies to challenge dubious brand-name
patents, but simultaneously empowered the brand
companies who assert those dubious patents to
eviscerate that incentive scheme. Ranbaxy, 469 F.3d
at 126; Pet. App. 64a-66a; Pet. App. 2a-3a. In short,
because Apotex’s interpretation of the statute would
allow brand companies to manipulate the exclusivity
incentive despite the absence of any suggestion in
the text, history, or structure of the statute that
Congress intended to give brand companies that
power, the D.C. Circuit properly held that Apotex
was unlikely to prevail on the merits. Pet. App. 2a.
A. The MMA Did Not Abrogate Ranbaxy’s
Holding On Delisting.
Long before this case arose, the D.C. Circuit held
that the plain text and structure of the Hatch-
26
Waxman Act precluded FDA’s policy of acquiescing
in a brand manufacturer’s unilateral request to
delist a patent from the Orange Book following the
submission of an exclusivity-qualifying Paragraph IV
certification. As then-Chief Judge Ginsburg’s
opinion in Ranbaxy explained, “FDA’s policy allows
an NDA holder [to] diminish[] the incentive for a
manufacturer of generic drugs to challenge a patent
listed in the Orange Book.... FDA may not, however,
change the incentive structure adopted by the
Congress, for the agency is bound ‘not only by the
ultimate purposes Congress has selected, but by the
means it has deemed appropriate, and prescribed, for
the pursuit of those purposes.” Ranbaxy, 469 F.3d
at 126 (quoting MCI, 512 U.S. at 231 n.4).
Apotex did not challenge that holding in either
the original delisting case or its follow-on case
regarding patent expiry. And apart from a stray
footnote that would not be sufficient to raise the
issue here even if it were not waived below, Pet. 26
n.11, Apotex does not seriously contest that holding
now. Accordingly, as the D.C. Circuit recognized in
its original delisting decision, “[t]he real issue” is
whether the MMA “altered the statute’s incentive
structure to the point that Ranbaxy’s reasoning no
longer controls ....” Pet. App. 60a.
Apotex contends that that’s precisely what the
MMA did, and points to the statute’s new “forfeiture
triggers” for support. Pet. 29-32. Indeed, Apotex
claims that “[t]he D.C. Circuit gave no meaningful
consideration to that text.” Jd. at 29: see also id. at
30 (“[T]he D.C. Circuit ... ignored those clear textual
commands ....”). The court did no such thing.
" 27
To the contrary, its original delisting decision
began by addressing the MMA’s failure-to-market
forfeiture trigger head-on—and carefully explained
that the text of each of its subsections requires some
action by the generic applicant before it kicks in:
Setting aside the subsection at issue in this
cuse—|the delisting forfeiture trigger] codified
as (bb)(CC)—the “failure to market” forfeiture
provision does not permit a_ brand
manufacturer to vitiate a generic’s exclusivity
without the generic manufacturer’s having
had some say in the matter. No forfeiture can
take place unless the brand manufacturer
brings an infringement suit against the
generic and either loses on the merits or
enters an unfavorable settlement agreement.
The latter necessarily entails some
participation by the generic; the former
invariably involves significant expense for the
brand manufacturer, and_ affords’ the
victorious generic the opportunity to ask the
court to delay entering final judgment until a
date that would not trigger forfeiture
prematurely.
Pet. App. 6la-62a (discussing 21 U.S.C.
§ 355G)(5)(D)G@))).
Apotex nonetheless claims that the delisting
forfeiture trigger is different than the provisions to
which it is connected: “lhe MMA specifically
identified patent delisting as a ‘forfeiture event’ and
gave no indication that it would not apply if that
delisting was the result of ‘unilateral’ action by the
brand-name manufacturer.” Pet. 29. But the
appellate court carefully considered—and quite
28
properly rejected—that argument as well. As Judge
Williams explained, that trigger does apply if “the
patent targeted in a= paragraph-IV filing ‘is
withdrawn by the’ brand manufacturer.” Pet. App.
62a (quoting 21 U.S.C. § 355G9)(5)(D)@)()(bb)(CC)).
But that language says nothing about when brand
manufacturers are permitted to withdraw challenged
patents. As the appellate court then explained,
another provision of the statute helps answer that
question, and it makes clear that the delisting
trigger—just like the forfeiture provisions to which it
is lhnked—also requires action by the generic
applicant before it can be activated. /d. (discussing
21 U.S.C. § 355G)(5)(C) Gi) (1).
That key statutory provision, which Apotex
inexplicably omits from its statutory appendix, is
known as the “delisting counterclaim,” and it was
enacted at the same time Congress added the
delisting forfeiture trigger. See id. at 57a & n.4. As
the appellate court explained, “[t]he [MMA]
introduced a new procedure, a counterclaim in the
brand manufacturer’s patent infringement suit,
through which generic companies can force brand
companies to delist an improperly asserted patent.
This counterclaim provision is the only portion of the
statute that explicitly provides for the delisting of a
patent after it has been challenged in an ANDA.”
Id. at 57a (emphases added; citing 21 U.S.C.
§ 355g)(5)(C)(@)(D).
And reading the delisting forfeiture trigger tn
part materia with the delisting counterclaim
provision, see Erlenbaugh v. United States, 409 U.S.
239, 243 (1972)); construing the language of the
delisting forfeiture trigger in the context of the other
29
failure-to-market forfeiture provisions, see Gutierrez
v. Ada, 528 U.S. 250, 255, (2000) (“[WJords ... are
known by their companions.”); and interpreting these
provisions in light of “the whole statutory text,
considering the purpose and context of the statute,”
Dolan v. USPS, 546 U.S. 481, 486 (2006), the
appellate court explained that there is “not a single
cogent reason why Congress might have permitted
brand manufacturers to trigger subsection (CC) by
withdrawing a challenged patent, outside the
counterclaim scenario identified by Teva.” Pet. App.
62a (second emphasis added).
Given the .).C. Circuit’s meticulous analysis of
the Act’s interwoven text and structure, it is unclear
how Apotex possibly can assert that the appellate
court “gave no meaningful consideration to” the
statute’s language. Pet. 29. And with all due respect
to Apotex, it is not Judge Williams’s analysis of the
statute that “wholly misses the point.” Pet. 30. It is
Petitioner’s.
B. The D.C. Circuit Properly Resolved
The Patent Expiry Issue.
Against this backdrop, it is easy to see why
Judges Tatel, Griffith, and Kavanaugh concluded
that Apotex’s patent-expiry arguments warranted no
more than a two-page per curiam disposition. Pet.
App. 2a-3a. As FDA itself had concluded, Pet. App.
28a, the D.C. Circuit’s prior decision in the delisting
case foreclosed Apotex’s claim: If brand companies
cannot “unilaterally’ deprive the generic applicant of
its exclusivity [by] delisting” a challenged patent,
they cannot “unilaterally’ deprive the generic
applicant of its exclusivity” through the simple
artifice of ceasing to pay maintenance fees on such a
30
patent. Jd.at 27a-28a (quoting id.at 35a, 63a;
discussing 21 U.S.C. § 355g)(5)(D)G)(VI)).
Any other outcome would be absurd. It would
allow brand manufacturers to do through the back
door (not paying maintenance fees) precisely what
the statute bars them from doing through the front
door (delisting a patent), despite the lack of “a single
cogent reason why Congress might have permitted
brand manufacturers [to] unilaterally deprive the
generic of its exclusivity.” /d. at 62a (emphasis
original). FDA thus did not remotely err by reading
the patent expiry forfeiture trigger in the context of
the broader statute and pertinent caselaw. As the
appellate court explained, when “viewed in the
context of the statute’s incentive structure, it
becomes clear that Congress could not have intended
a brand manufacturer’s unilateral decision to cause
the premature expiration of a [challenged] patent ...
to strip the first generic applicant of the 180-day
[exclusivity] period.” Pet. App. 2a-3a (citing td. at
62a-64a); see also Dolan, 546 U.S. at 486
(“Interpretation of a word or phrase depends upon
reading the whole statutory text, considering the
purpose and context of the statute, and consulting
any precedents or authorities that inform the
analysis.”) (emphasis added).
Indeed, wholly apart from its consistency with the
D.C. Circuit’s original decision on delisting, there are
independent reasons for construing the patent-expiry
trigger to prevent this sort of backdoor manipulation
by brand manufacturers.
First, Hatch-Waxman’s other references to patent
expiration demonstrate that Congress was concerned
only with natural patent expiration. In particular,
3]
the statute requires Paragraph III certifications to
state, at the time certification is filed, “the date on
which [the listed] patent will expire.” 21 U.S.C.
§ 355()(2)(A)(vi) TID (emphasis added). But if brand
manufacturers can cause listed patents to “expire”
for Hatch-Waxman purposes by simply declining to
pay maintenance fees, Paragraph III would be
reduced to a guessing game: Because the brand
manufacturer could quit paying those fees at any
time, generic applicants could only speculate about
what date to list. By contrast, the only date that can
be stated with certainty is the date when the patent
is scheduled to expire naturally, and as Paragraph
III thus makes clear, that is the one that counts for
purposes of the Hatch-Waxman Act.
Second, unlike patents that expire naturally,
patents which “expire” for non-payment of
maintenance fees don’t actually die. Instead, they
can be revived—in some cases “at any time”—and
thereafter “shall be considered as not having
expired” at all. 35 U.S.C. § 41(c)(1). There simply is
no reason to think that Congress intended Hatch-
Waxman exclusivity to turn on a technical form of
patent expiry that may only be transient and
fleeting. Indeed, that interpretation of the statute is
doubly absurd. It not only would allow brand
companies to deliberately strip the first generic’s
exclusivity, but would allow them to do so negligently
as well. In particular, if the brand manufacturer
inadvertently misses a fee payment and the first
applicant is deemed to have forfeited exclusivity,
FDA could approve all ANDAs immediately—leaving
the first applicant without recourse if the patent
later is revived and thus treated “as not having
expired.” Jd. Congress could not possibly have
32
intended the patent-expiry trigger to produce such
an absurdity.
Finally, the underlying rationale for divesting the
first applicant of exclusivity based on patent
expiration does not remotely apply where a brand
manufacturer artificially pretermits a challenged
patent’s natural term. Long before the MMA was
enacted, FDA interpreted the statute to preclude
exclusivity after a patent’s natural expiration. See
Dr. Reddy’s, 302 F. Supp. 2d at 354-55. The basis for
that approach was simple. Paragraph IV challenges
are designed to help expedite generic competition,
Teva v. Leavitt, 548 F.3d at 106, but where the first
applicant fails to launch before the challenged patent
expires on its own, “there is no longer a need to
provide an incentive to challenge it.” Dr. Reddy’s,
302 F. Supp. 2d at 354. In other words, where a
Paragraph IV challenge accomplishes nothing, there
is nothing to reward.
By contrast, where a patent lapses not by the
mere passage of time, but rather (as here) because
the first applicant’s Paragraph IV certification
caused the patentee to abandon its patent, the
applicant’s challenge has accomplished precisely
what the statute rewards: It has opened the market
to competition years earlier than would have been
possible absent that challenge, and there is no
reason to think that Congress intended to deprive
generic applicants of their reward for achieving
precisely what Paragraph IV challenges are designed
to achieve.
Against this backdrop, it is clear that the patent-
expiry trigger simply codified FDA’s prior practice of
stripping exclusivity following a patent’s natural
33
expiration; there is no support in the text, structure,
or history of the MMA for any otlrer interpretation,
as the D.C. Circuit’s decision in this case recognized.
Pet. App. 3a (“Congress could not have intended a
brand manufacturer’s unilateral decision to cause
the premature expiration of a patent (in the face of a
generic applicant’s challenge to the patent in a
paragraph IV certification) to strip the first generic
applicant of the 180-day period of marketing
exclusivity.”).
C. The D.C. Circuit’s Decision Is Consistent
With The Statute’s Purposes.
Finally, Apotex asserts that awarding exclusivity
under these circumstances harms consumers, and
indeed that it only serves the brand manufacturer’s
interests. Pet. 32-34. Nothing could be further from
the truth. As the D.C. Circuit repeatedly has
explained, the Hatch-Waxman Act’s’ 180-day
exclusivity incentive exists to encourage generic
companies to challenge bogus patents as quickly as
possible; without that incentive, fewer patent
challenges will be filed, and those that are filed will
not be filed as fast. E.g., Pet. App. 63a-64a.
Apotex does not deny that reality, but seeks to
downplay it by asserting that “any discouraging
effect such action might have on_- generic
manufacturers would be, at best, indirect and
delayed.” Pet. 33. That assertion is at odds with the
reality of this business. Like every other company,
Teva has a limited budget—and every day it must
make decisions about how to use its limited
resources. So when the company is comparing two
potential patent challenges head-to-head, a_ key
question 1s which of those two opportunities is most
34
likely to yield exclusivity. After all, that reward “is
valuable, designed to compensate manufacturers for
research and development costs as well as the risk of
litigation.” Teva v. Leavitt, 548 F.3d at 104. But if
the company’s analysis reveals that one of the
patents at issue is held by a serial patent delister (as
the record demonstrates to be the case here), the
economics would change dramatically under Apotex’s
interpretation of the statute; as the D.C. Circuit long
ago recognized, and with some understatement,
“reducing the certainty of receiving a period of
marketing exclusivity ... diminishes the incentive for
a manufacturer of generic drugs to challenge a
patent.” Ranbaxy, 469 F.3d at 126.
Far from being “indirect and delayed,” Pet. 33,
the impact of Apotex’s proposed interpretation would
be felt every day, in virtually every ANDA filing
decision—at least at any rational company. And
make no mistake: Those consequences would have a
significant adverse impact on the public’s health and
welfare over the long-run. As the D.C. Circuit once
again explained in its original delisting decision:
The statute’s grant of a 180-day delay in
multiple generic competition for the first
successful paragraph IV filer is a_ pro-
consumer device. And it happens to be
precisely the device Congress has chosen to
induce challenges to patents claimed to
support brand drugs. The statute thus
deliberately sacrifices the benefits of full
generic competition at the first chance allowed
by the brand manufacturer’s patents, in favor
of the benefits of earlier generic competition,
brought about by the promise of a reward for
35
generics that stick out their necks (at the
potential cost of a patent infringement suit) by
claiming that patent law does not extend the
brand maker’s monopoly as long as the brand
maker has asserted. As Congress deliberately
created the 180-day exclusivity bonus, the
FDA cannot justify its interpretation by
proudly proclaiming that it has eviscerated
that bonus.
Pet. App. 64a.
Teva thus earned its exclusivity here. It made
enormous investments to both design around and
mount a legal challenge to Merck’s patent, all in the
hopes of securing exclusivity and launching its
products early. That effort resulted in a Paragraph
IV certification so powerful that Merck simply gave
up—first by delisting that patent, and then by
ceasing to pay maintenance fees on a patent that
Teva’s Paragraph IV certification had rendered
worthless.
Teva's Paragraph IV certification thereby cleared
the path for generic competition to begin on these
$1.5-billion-per-year drugs four years earlier than it
would have if Teva had not challenged that patent—
and thus will save consumers literally billions of
dollars between April 6, 2010 (when Teva launched)
and September 4, 2014 (when generics could have
launched in the absence of a Paragraph IV
challenge). ‘There is no basis for thinking that
Congress intended to let Merck punish Teva for
delivering those savings to the public, and the D.C.
Circuit thus properly affirmed the district court’s
decision denying Apotex’s motion for preliminary
injunctive relief.
36
CONCLUSION
Kor the foregoing reasons, the Petition should be
denied.
JAY P. LEFKOWITZ, P.C MICHAEL D. SHUMSKY
KIRKLAND & ELLIS LLP Counsel of Record
153 East 53rd Street AARON L. NIELSON
New York, NY 10022 KIRKLAND & ELLIS LLP
(212) 446-4800 655 Fifteenth St., N.W
jay.lefkowitz@kirkland.com Washington, DC 20005
(202) 879-5000
mshumsky@kirkland.com
anielson@kirkland.com
APPENDIX
APPENDIX CONTENTS
35 USC S Li(c)(d)
Response O)] Apotex, Inc. ‘To Show Cause Orde
(D.D.C. Oct. 18, 2010)
David Belian, FDA Expects More Litigation O
Generic Exclusivity, GENERIC LINI
Oct. 27, 2010
21 U.S.C. § 355(j)(5)(C)
(C) Civil action to obtain patent certainty.
G) Declaratory judgment absent infringement
action.
(I) In general. No action may be brought
under section 2201 of title 28 by an applicant
under paragraph (2) for a declaratory judgment
with respect to a patent which is the subject of
the certification referred to in subparagraph
(B)(iii) unless—
(aa) the 45-day period referred to in such
subparagraph has expired;
(bb) neither the owner of such patent nor
the holder of the approved application under
subsection (b) of this section for the drug that
is claimed by the patent or a use of which is
claimed by the patent brought a civil action
against the applicant for infringement of the
patent before the expiration of such period;
and
(cc) in any case in which the _ notice
provided under paragraph (2)(B) relates to
noninfringement, the notice was accompanied
by a document described in subclause (III).
(I) Filing of civil action. If the conditions
described in items (aa), (bb), and as applicable,
(cc) of subclause (I) have been met, the applicant
referred to in such subclause may, in accordance
with section 2201 of title 28, bring a civil action
under such section against the owner or holder
referred to in such subclause (but not against any
owner or holder that has brought such a civil
action against the applicant, unless that civil
2a
action was dismissed without prejudice) for a
declaratory judgment that the patent is invalid or
will not be infringed by the drug for which the
applicant seeks approval, except that such civil
action may be brought for a declaratory judgment
that the patent will not be infringed only in a case
in which the condition described in subclause
(I)(ec) is applicable. A civil action referred to in
this subclause shall be brought in the judicial
district where the defendant has its principal
place of business or a regular and established
place of business.
(III) Offer of confidential access to application.
For purposes of subclause (I)(cc), the document
described in this subclause is a document
providing an offer of confidential access to the
application that is in the custody of the applicant
under paragraph (2) for the purpose. of
determining whether an action referred to in
subparagraph (B)(ilil) should be brought. The
document providing the offer of confidential
access shall contain such restrictions as_ to
persons entitled to access, and on the use and
disposition of any information accessed, as would
apply had a protective order been entered for the
purpose of protecting trade secrets and other
confidential business information. A request for
access to an application under an offer of
confidential access shall be considered acceptance
of the offer of confidential access with the
restrictions as to persons entitled to access, and
on the use and disposition of any information
accessed, contained in the offer of confidential
access, and those restrictions and other terms of
the offer of confidential access shall be considered
3a
terms of an enforceable contract. Any person
provided an offer of confidential access shall
review the application for the sole and limited
purpose of evaluating possible infringement of the
patent that is the subject of the certification
under paragraph (2)(A)(vii)(IV) and for no other
purpose, and may not disclose information of no
relevance to any issue of patent infringement to
any person other than a person provided an offer
of confidential access. Further, the application
may be redacted by the applicant to remove any
information of no relevance to any issue of patent
infringement.
(i) Counterclaim to infringement action.
(1) In general. If an owner of the patent or the
holder of the approved application under
subsection (b) of this section for the drug that is
claimed by the patent or a use of which is claimed
by the patent brings a patent infringement action
against the applicant, the applicant may assert a
counterclaim seeking an order requiring the
holder to correct or delete the patent information
submitted by the holder under subsection (b) or
(c) of this section on the ground that the patent
does not claim either
(aa) the drug for which the application was
approved; or
(bb) an approved method of using the drug.
(II) No independent cause of action. Subclause
(I) does not authorize the assertion of a claim
described in subclause (I) in any civil action or
proceeding other than a counterclaim described in
subclause (I).
1a
Gn) No damages. An applicant shall not be
entitled to damages 1n a civil action under clause
(i) or a counterclaim under clause (11)
35 U.S.C. § 41(c)
(c)
(1) The Director may accept the payment of any
maintenance fee required by subsection (b) of
this section which is made within twenty-four
months after the six-month grace period if the
delay is shown to the satisfaction of the Director
to have been unintentional, or at any time after
the six-month grace period if the delay is shown
to the satisfaction of the Director to have been
unavoidable. The Director may require the
payment of a surcharge as a condition of
accepting payment of any maintenance fee after
the six-month grace period. If the Director
accepts payment of a maintenance fee after the
six-month grace period, the patent shall be
considered as not having expired at the end of
the grace period.
(2) A patent, the term of which has been
maintained as a result of the acceptance of a
payment of a maintenance fee under this
subsection, shall not abridge or affect the right
of any person or that person’s successors in
business who made, purchased, offered to sell,
or used anything protected by the patent within
the United States, or imported enything
protected by the patent into the United States
after the 6-month grace period but prior to the
acceptance of a maintenance fee under this
subsection, to continue the use of, to offer for
sale, or to sell to others to be used, offered for
sale, or sold, the specific thing so made,
purchased, offered for sale, used, or imported.
The court before which such matter is in
6a
question may provide for the continued
manufacture, use, offer for sale, or sale of the
thing made, purchased, offered for sale, or used
within the United States, or imported into the
United States, as specified, or tor’ the
manufacture, use, offer for sale, or sale in the
United States of which substantial preparation
was made after the 6-month grace period but
before the acceptance of a maintenance fee
under this subsection, and the court may also
provide for the continued practice of any process
that is practiced, or for the practice of which
substantial preparation was made, after the 6-
month grace period but before the acceptance of
a maintenance fee under this subsection, to the
extent and under such terms as the court deems
equitable for the protection of investments made
or business commenced after the 6-month grace
period but before the acceptance of a
maintenance fee under this subsection.
7a
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
APOTEX, INC.,
Plaintiff,
v.
KATHLEEN SEBELIUS et ai.,
Defendants.
Case No. 1:10-cv-00517-RMC
RESPONSE OF APOTEX, INC. TO SHOW
CAUSE ORDER
On September 27, 2010, this Court issued an
Order requiring Apotex, Inc. (“Apotex”) to show
cause why this case should not be dismissed for
failure to state a claim. Apotex respectfully requests
that the Court continue to stay the proceedings in
this case for an additional limited period of time in
order to allow the Supreme Court to consider the
petition for writ of certiorari filed by Apotex on
October 4, 2010.
As this Court is aware, in this case Apotex
challenged the Food and Drug Admuiunistration’s
(“FDA”) determination that the decision in Teva _v.
Sebelius, 595 F.3d 1303 (D.C. Cir. 2010), precluded
the forfeiture of exclusivity based on _ unilateral
action by the brand-name manufacturer resulting in
the expiration of a patent. This Court affirmed
FDA’s conclusion that Teva was entitled to
Sa
exclusivity for its ANDAs referencing Cozaar or
Hyzaar. Apotex appealed and filed an emergency
motion to stay the commencement of Teva’s
exclusivity period. The Court of Appeals for the
District of Columbia denied Apotex’s motion and, on
July 6, 2010, issued a per curiam judgment affirming
this Court’s decision. The mandate was filed in this
Court on September 2, 2010. On October 4, 2010,
Apotex filed a petition for writ of certiorari in the
Supreme Court from the decision of the Court of
Appeals, docketed as Apotex, Inc. v. Kathleen
Sebelius, et al., No. 10-453. A copy of the petition is
attached. A response to the petition currently is due
on November 4, 2010.
In the event the petition is granted, the Supreme
Court would be expected to address the merits of
FDA’s interpretation of the Hatch-Waxman
forfeiture provisions. Should the petition not be
granted, Apotex will then consider whether to
dismiss the case, thereby rendering further
proceedings unnecessary. Apotex’s counsel will
notify the Court promptly of any action taken by the
Supreme Court.
For these reasons, Apotex respectfully requests
that the Court stay further proceedings in this case
pending consideration of Apotex’s petition for
certiorari.
9a
Date: October 18, 2010 Respectfully submitted
Carmen M. Shepard
D.C. Bar No. 331314
Kate C. Beardsley
D.C. Bar No. 416806
Buc & Beardsley, LLP
919 18th Street, N.W.
Suite 600
Washington, D.C. 20006
(202) 736-3600
Counsel for Apotex, Inc.
10a
FDA NEWS
Generic Line
Oct. 27, 2010 | Vol. 27 No. 21
FDA Expects More Litigation Over Generic
Exclusivity
A senior FDA attorney has admitted that Teva’s
successful challenge of the agency’s policy for
withdrawing a_generic-drug maker’s’ exclusivity
period caught the FDA off-guard and predicted the
issue is almost certain to come up again.
The case in question took place earlier this year
when the U.S. Court of Appeals for the District of
Columbia Circuit overturned FDA precedent and
ruled that any unilateral action by a brand-drug
maker, such as delisting a patent or letting it expire,
cannot be used as a means for canceling a generic-
drug maker’s 180-day exclusivity period.
FDA Precedent
Teva had brought the case against the FDA in an
attempt to stop the agency from withdrawing its
exclusivity on generic versions of Merck’s
hypertension drugs Cozaar (losartan potassium) and
Hyzaar (hydrochlorothiazide/losartan potassium)
(Generic Line, March 17).
Prior to that ruling, the FDA had interpreted the
Medicare Modernization Act (MMA), which contains
the regulations for withdrawing an_ exclusivity
period, as stating that patent delisting or expiration
were valid reasons a generic-drug maker could lose
its exclusivity.
While the agency said it disagreed with the
appellate court’s ruling, it nonetheless approved
lla
Teva’s exclusivity, saying the court’s interpretation
of the MMA gave it no choice (Generic Line, March
31).
Since that time, numerous companies have
questioned the FDA about the decision and the
agency feels it is likely to arise again soon in other
courts, Elizabeth Dickinson, senior counsel in the
FDA’s Office of Chief Counsel, said this month at the
Generic Pharmaceutical Association/FDA Fall
Technical Conference in Bethesda, Md.
“The outcome of that case was something that
surprised FDA,” Dickinson said. “It severely
constrained our decisionmaking on any exclusivity
that appeared to be within the control of the
innovator company.”
The first place the issue may arise again could be
the Supreme Court. Despite Teva’s exclusivity on
the drugs having already expired, generic-drug
maker Apotex is appealing the case to the Supreme
Court, saying that how exclusivity is awarded in all
future cases is at stake (Generic Line, Oct. 13).
“If left undisturbed, the decision will benefit
brand-name manufacturers, who want nothing more
than to see a first applicant win exclusivity and
thereby delay full-scale competition with multiple
generic manufacturers,” Apotex says in its petition
for a writ of certiorari filed earlier this month. “It
will also richly reward the generic manufacturer who
wins a race to file a Paragraph IV certification but is
unable promptly to bring the generic drug to
market.” — David Belian
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.