Court Opinion

ID: 2761310
Source: CourtListenerOpinion
Date Created: 2014-12-16 20:00:50.645525+00
Date Added: 2024-06-11T11:26:14.293080
License: Public Domain

UNPUBLISHED

                  UNITED STATES COURT OF APPEALS
                      FOR THE FOURTH CIRCUIT

                             No. 14-1522

MYLAN PHARMACEUTICALS, INCORPORATED,

                Plaintiff – Appellant,

          and

WATSON LABORATORIES, INCORPORATED; LUPIN PHARMACEUTICALS,
INCORPORATED,

                Intervenors/Plaintiffs,

          v.

UNITED STATES FOOD AND DRUG ADMINISTRATION,

                Defendant – Appellee,

TEVA PHARMACEUTICALS USA, INCORPORATED,

                Intervenor/Defendant – Appellee.

                             No. 14-1529

MYLAN PHARMACEUTICALS, INCORPORATED,

                Plaintiff,

WATSON LABORATORIES, INCORPORATED,

                Intervenor/Plaintiff,

          and
LUPIN PHARMACEUTICALS, INCORPORATED,

                Intervenor/Plaintiff – Appellant,

          v.

UNITED STATES FOOD AND DRUG ADMINISTRATION,

                Defendant – Appellee,

TEVA PHARMACEUTICALS USA, INCORPORATED,

                Intervenor/Defendant – Appellee.

                             No. 14-1593

MYLAN PHARMACEUTICALS, INCORPORATED,

                Plaintiff,

LUPIN PHARMACEUTICALS, INCORPORATED,

                Intervenor/Plaintiff,

          and

WATSON LABORATORIES, INCORPORATED,

                Intervenor/Plaintiff – Appellant,

          v.

UNITED STATES FOOD AND DRUG ADMINISTRATION,

                Defendant – Appellee,

TEVA PHARMACEUTICALS USA, INCORPORATED,

                Intervenor/Defendant – Appellee.

                                  2
Appeals from the United States District Court for the Northern
District of West Virginia, at Clarksburg.     Irene M. Keeley,
District Judge. (1:14-cv-00075-IMK)

Argued:   September 17, 2014         Decided:   December 16, 2014

Before WILKINSON, SHEDD, and WYNN, Circuit Judges.

Reversed and remanded by unpublished opinion. Judge Wynn wrote
the opinion, in which Judge Wilkinson and Judge Shedd joined.

ARGUED: Douglas Brooke Farquhar, HYMAN, PHELPS & MACNAMARA,
P.C., Washington, D.C.; Chad Allen Landmon, AXINN, VELTROP &
HARKRIDER LLP, Hartford, Connecticut; Arthur Y. Tsien, OLSSON
FRANK WEEDA TERMAN MATZ, PC, Washington, D.C., for Appellants.
Daniel Tenny, UNITED STATES DEPARTMENT OF JUSTICE, Washington,
D.C.; Michael David Shumsky, KIRKLAND & ELLIS LLP, Washington,
D.C., for Appellees. ON BRIEF: John H. Tinney, Jr., THE TINNEY
LAW FIRM, PLLC, Charleston, West Virginia, for Appellant Lupin
Pharmaceuticals, Incorporated.      Jennifer M. Thomas, HYMAN,
PHELPS & MCNAMARA, P.C., Washington, D.C.; Ralph S. Tyler,
VENABLE    LLP,   Washington,    D.C.,    for   Appellant   Mylan
Pharmaceuticals, Incorporated.       Mark D. Alexander, AXINN,
VELTROP & HARKRIDER LLP, Hartford, Connecticut, for Appellant
Watson Laboratories, Incorporated.    Stuart F. Delery, Assistant
Attorney General, William B. Schultz, General Counsel, Scott R.
McIntosh, Civil Division, UNITED STATES DEPARTMENT OF JUSTICE,
Washington, D.C.; William J. Ihlenfeld, II, United States
Attorney, OFFICE OF THE UNITED STATES ATTORNEY, Wheeling, West
Virginia; Elizabeth H. Dickinson, Associate General Counsel,
Annamarie Kempic, Deputy Chief Counsel, UNITED STATES FOOD AND
DRUG ADMINISTRATION, Rockville, Maryland; Shoshana Hutchinson,
Associate Chief Counsel, UNITED STATES DEPARTMENT OF HEALTH AND
HUMAN SERVICES, Washington, D.C., for Appellee United States
Food and Drug Administration. John C. O'Quinn, John K. Crisham,
Stephen S. Schwartz, KIRKLAND & ELLIS LLP, Washington, D.C., for
Appellee TEVA Pharmaceuticals USA, Incorporated.

Unpublished opinions are not binding precedent in this circuit.

                                3
WYNN, Circuit Judge:

       In    April     2014,     the   U.S.       Food   and   Drug   Administration

(“FDA”) issued a letter decision regarding the rights of patent

holders and the ease with which generic drugs could enter the

market place under the Hatch-Waxman Act.                        Though disclaiming

that it was adjudicating the rights of any specific parties,

this         letter       effectively             prevents     Appellants        Mylan

Pharmaceuticals,         Inc.,     Watson     Laboratories,       Inc.,    and   Lupin

Pharmaceuticals, Inc. from bringing their generic versions of

celecoxib, an arthritis treatment drug currently sold under the

brand name Celebrex, to the market until June 2015.                          The FDA

based its decision on its interpretation of a Hatch-Waxman Act

provision it deemed ambiguous.                    However, as explained below, we

find        the   pertinent        provision          unambiguous     in    context.

Accordingly, we reverse the district court’s opinion upholding

the FDA’s letter decision.

                                            I.

       In 1984, Congress amended the Food, Drug, and Cosmetic Act

to “make available more low cost generic drugs by establishing a

generic drug approval procedure for pioneer drugs first approved

after 1962.”          H.R. Rep. No. 98-857, part 1, at 14.             See The Drug

Price Competition and Patent Term Restoration Act of 1984 (the

“Hatch-Waxman Act” or “Hatch-Waxman”), Pub. L. No. 98-417, 98

                                              4
Stat. 1585 (1984), formerly codified at 21 U.S.C. § 355 and 35

U.S.C. §§ 156, 271, 282.                  In furtherance of this goal, the

Hatch-Waxman       Act     created    a    truncated         approval       process     for

generic drugs and, crucially for this case, the potential for a

180-day period of market exclusivity for the first company to

bring     its     generic     drugs       to       market.         The     statute,    and

specifically the language at issue in this case, has since been

amended      by    the     Medicare   Prescription           Drug     Improvement      and

Modernization Act, Pub L. No. 108-173, 117 Stat. 2066 (2003).

Because the initial Abbreviated New Drug Applications at issue

in this case were filed prior to the enactment of this revision,

the pre-amendment version of the statute applies.

        Before marketing a new drug, a drug company must submit a

New   Drug    Application,      an    elaborate        document      detailing,       among

other things, the drug’s safety and efficacy.                            See 21 U.S.C. §

355(b)(1).        A New Drug Application also must contain “the patent

number and the expiration date of any patent which claims the

drug . . . or which claims a method of using such drug[.]”                              Id.

The FDA publishes information about those patents and methods of

use “in a fat, brightly hued volume called the Orange Book[.]”

Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670,

1676 (2012).

        Generic    drug     companies,     by       contrast,      need    not   submit   a

complete New        Drug    Application        to    seek    FDA   approval      of   their

                                               5
drugs.      Under Hatch-Waxman, they may instead file an Abbreviated

New Drug Application, in which they may “rely on the clinical

studies performed by the pioneer drug manufacturer” instead of

having “to prove the safety and effectiveness of [their] generic

drug from scratch.”              aaiPharma, Inc. v. Thompson, 296 F.3d 227,

231 (4th Cir. 2002).               “[T]he generic manufacturer must prove

only that its drug is bioequivalent to the brand name drug it

wants to copy.”          Id.

      In its Abbreviated New Drug Application, a generic drug

company must make one of four certifications regarding the non-

infringement of “listed” patents referenced in the Orange Book.

See   21      U.S.C.        §     355(j)(2)(A)(vii).                   With        the     fourth

certification        option       (a    “Paragraph         IV    certification”),               the

relevant one for this case, generic drug makers confirm that any

patent for the pioneer drug is invalid or will not be infringed.

Id.        Additionally,          the     Abbreviated           New     Drug       Application

applicant must also certify to “later-listed patents” when they

are published in the Orange Book.                   Id. § 355(j)(2)(B).

      If,    as     in    this    case,    a       generic      drug       company       makes   a

Paragraph     IV     certification,         it      must     provide        notice        of    its

Abbreviated       New     Drug    Application        to    the   owner        of    any   patent

covered by the Paragraph IV certification and to the brand-name

company      that        filed    the     New       Drug     Application.                 Id.     §

355(j)(2)(B)(i).                 Hatch-Waxman          treats          a      Paragraph          IV

                                               6
certification as an artificial act of patent infringement by the

generic drug company.                 Id. §§ 355(j)(2)(B)(i)-(ii); Eli Lilly &

Co. v. Medtronic, Inc., 496 U.S. 661, 678 (1990).                                    If the brand-

name   company        wants      to     defend      its      patent,       it       must    bring   an

infringement          action     within          forty-five        days        of   receiving       the

generic company’s notice.                   21 U.S.C. § 355(j)(5)(B)(iii).

       In   general,         the      FDA    “shall       approve         or    disapprove”         the

generic     drug       application           within      180       days    of       receiving       the

Abbreviated New Drug Application.                        Id. § 355(j)(5)(A).                However,

the effective date of the FDA’s approval is dependent on several

factors, including which of the four certifications the generic

company used.          In the case of a Paragraph IV certification, the

timing      of   the      FDA’s       approval          of    an     Abbreviated           New   Drug

Application depends on whether the brand-name company brings an

action to defend its patent.                      If it does, the FDA’s approval of

the Abbreviated New Drug Application is stayed for 30 months.

Id.    If, during that 30-month stay, “a court decides that such

patent is invalid or not infringed, the approval shall be made

effective        on    the       date       of    the        court    decision.”              Id.    §

(j)(5)(B)(iii)(I).

       If more than one applicant submits an Abbreviated New Drug

Application        with      a     Paragraph        IV       certification,           the    statute

provides that a later-filed “application shall be made effective

not earlier than one hundred and eighty days after” either (1)

                                                   7
the date that the FDA received notice that the first-filer began

marketing the drug; or (2) “the date of a decision of a court in

an action [brought by the brand-name company against the company

filing the Abbreviated New Drug Application] holding the patent

which is the subject of the certification to be invalid or not

infringed”—also known as the “court-decision trigger.”                       Id. §

(j)(5)(B)(iv).      This   180-day   exclusivity           period,    potentially

worth   millions   of   dollars,    is   meant        to   incentivize      generic

pharmaceutical     companies   to    bear       the    costs    of    the   patent

infringement lawsuit.      Teva Pharm., USA, Inc. v. Leavitt, 548

F.3d 103, 104 (D.C. Cir. 2008).

     Finally, when multiple patents protect a brand-name drug

from competition, the FDA, under the pre-amendment version of

Hatch-Waxman at issue in this case, took a “patent-by-patent

approach”   in   determining   whether      a    generic       drug   company   is

entitled to the 180-day exclusivity period.                 As it explained in

its letter decision:

     eligibility for 180-day exclusivity would be based on
     which   company   submitted  the  first   paragraph  IV
     certification    challenging   each    listed   patent.
     Therefore, in cases where multiple patents are listed,
     different applicants may have the first paragraph IV
     certification as to different patents and multiple
     ANDA applicants may simultaneously be eligible for
     180-day exclusivity as to the particular patents on
     which they were first.

                                     8
J.A. 43.        None of the parties challenge the FDA’s patent-by-

patent   approach          (while    recognizing         that    the     law   has,    in    the

interim,    changed          and    that    the    FDA     now    uses     a   drug-by-drug

approach).

                                             II.

       Pfizer        produces      the   brand-name        arthritis       drug    Celebrex.

Celebrex was protected by the following patents listed in the

Orange Book as of 2003: 5,466,823 (“the ‘823 patent”); 5,563,165

(“the    ‘165    patent”);          5,760,068      (“the    ‘068       patent”);      and    one

other patent not at issue in this case.                            In 2003, Teva filed

Abbreviated          New     Drug     Application         76-898,        which     contained

Paragraph       IV    certifications        as     to    the     ‘823,    ‘165,    and      ‘068

patents.        Pfizer       sued    Teva   for     patent       infringement,        and    the

District Court of New Jersey held that all three patents were

valid and infringed by Teva.                 Pfizer, Inc. v. Teva Pharms. USA,

Inc., 482 F. Supp. 2d 390 (D.N.J. 2007).                          The Federal Circuit,

however, reversed in part, deeming eleven of the claims in the

‘068 patent invalid.                Pfizer, Inc. v. Teva Pharms. USA, Inc.,

518 F.3d 1253 (Fed. Cir. 2008).

       Teva then resubmitted its certifications as to the ‘823 and

‘165    patents       as   “Paragraph       III    certifications”—that            is,      they

sought approval of their Abbreviated New Drug Application only

subsequent      to     the    expiration      of    those       two    patents.        See    21

                                              9
U.S.C. § 355(j)(2)(A)(vii).            Meanwhile, several other generic

drug    manufacturers,   including      Mylan,     Watson      and   Lupin,      filed

Abbreviated      New   Drug    Applications        for    Celebrex         based     on

Paragraph IV certifications.

       On March 5, 2013, the United States Patent and Trademark

Office (“PTO”) reissued the invalidated ‘068 patent as RE44048

(“the    ‘048   patent”),     Pfizer   notified     the    FDA,      and   two     days

later, the FDA listed the ‘048 patent in the Orange Book.                            On

March 7, 2013, Teva, Mylan, and Watson amended their Abbreviated

New Drug Applications so that their Paragraph IV certifications

included the reissued patent.          And Lupin amended its Abbreviated

New Drug Application on March 28, 2013.               Again, Pfizer sued for

patent infringement.

       One year later, in March 2014, the District Court for the

Eastern District of Virginia deemed the ‘048 patent invalid for

substantially the same reasons that the ‘068 patent had been

invalidated.     G.D. Searle LLC v. Lupin Pharms., Inc., No. 2:13-

cv-00121 (E.D. Va. Mar. 12, 2014).           Teva and Pfizer entered into

a   settlement    agreement    allowing     Teva    to    market     celecoxib       in

December 2014.     Mylan and Watson also settled with Pfizer.                      Only

Lupin remains in the appeal of that decision, which is pending

in the Federal Circuit.

       During the litigation of the ‘048 patent, the various drug

manufacturers     engaged     in   letter   writing      and   private      meetings

                                       10
with    the   FDA     inquiring      into     how       the    agency     would      approach

approval of their celecoxib Abbreviated New Drug Applications.

On April 24, 2014, the FDA issued a letter decision addressed to

“Celecoxib ANDA Applicant.”                 The question the FDA purported to

answer    was    “whether      a    prior     court      decision        on   the    original

patent   triggered       (and      exhausted)       any       exclusivity       to   which   a

first applicant on the original patent was entitled.”                                J.A. 41.

Underlying      the    FDA’s       question    was       the       assumption    “that     the

reissued patent cannot be the basis for a new period of 180-day

exclusivity[.]”        J.A. 49.       The FDA concluded that:

       for purposes of 180-day exclusivity, upon the listing
       of a reissued patent, a prior court decision on the
       original patent is not regarded as having triggered
       180-day exclusivity for the single bundle of patent
       rights represented by the original and reissued
       patent.    In such a case, eligibility for 180-day
       exclusivity is only available to the applicant that
       first filed a paragraph IV certification to the
       original patent, and that applicant must make a timely
       submission of a paragraph IV certification to the
       reissued   patent  to  remain  eligible   for  180-day
       exclusivity.

J.A. 51.        The letter decision stated that the FDA was merely

clarifying      “the     regulatory      framework            to    be   applied      to   the

relevant ANDAs when such exclusivity determination is made[,]”

and    “not     making     a    determination           with        respect     to    180-day

exclusivity in a particular case[.]”                    J.A. 46.

       The following day, April 25, 2014, Mylan sought injunctive

and    declaratory       relief     against       the    FDA       regarding    its    letter

                                             11
decision.        Mylan sought to prevent the FDA from granting any

other company a 180-day exclusivity period.                             Watson and Lupin

intervened as plaintiffs, and Teva intervened as a defendant.

The     district        court     consolidated            the    hearing        on     Mylan’s

preliminary       injunction       motion       with       a    trial    on     the    merits,

granted Mylan’s motion for judgment, but in favor of the FDA,

and dismissed the case.                 Mylan Pharmaceuticals, Inc., v. FDA,

No. 1:14-cv-00075-IMK Doc. 125 (N.D. W.Va. June 16, 2014).                                  This

appeal followed.

                                              III.

      Summary judgment is appropriate “if the movant shows that

there is no genuine dispute as to any material fact and the

movant is entitled to judgment as a matter of law.”                                   Fed. R.

Civ. P. 56(a).          We review a grant of summary judgment de novo,

Nat’l Audubon Soc’y v. Dep’t of the Navy, 422 F.3d 174, 185 (4th

Cir. 2005), taking the facts in the light most favorable to the

non-moving party.             Anderson v. Liberty Lobby, Inc., 477 U.S.

242, 255 (1986).

      Under the Administrative Procedure Act, 5 U.S.C. § 551 et

seq.,    we     must    set     aside   an     agency       action      that    is    “not    in

accordance with law.”              Id. § 706(2)(A).               To determine whether

the     FDA’s    interpretation          of    the        Hatch-Waxman         Act    was    “in

accordance       with    law,”    we    engage       in    the   analysis       set    out    by

                                               12
Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc., 467 U.S.

837, 842 (1984).               The first inquiry under Chevron is whether

“Congress has directly spoken to the precise question at issue.”

Id. at 842.            “If the statute is clear and unambiguous ‘that is

the end of the matter, for the court, as well as the agency,

must       give    effect      to   the     unambiguously        expressed     intent    of

Congress.’”             Bd.    of   Governors      of   the    Fed.   Reserve    Sys.    v.

Dimension Fin. Corp., 474 U.S. 361, 368 (1986) (quoting Chevron,

467    U.S.       at    842-43).       In    determining       whether    Congress      has

“directly spoken,” we “begin by examining the plain language and

give the relevant terms their common and ordinary meaning.”                              Yi

Ni    v.    Holder,      613    F.3d   415,     424     (4th   Cir.    2010)    (internal

quotation marks and citation omitted).                     “This is because we must

‘assum[e] that the ordinary meaning of that language accurately

expresses the legislative purpose.’”                    Id. (quoting      Gross v. FBL

Fin. Servs., Inc., 557 U.S. 167, 175 (2009)).                         When ascertaining

the ordinary meaning of words we may refer to standard reference

works      such    as    legal      dictionaries.         See,    e.g.,   Id.    at     425;

Dickenson-Russell Coal Co., LLC v. Sec'y of Labor, 747 F.3d 251,

258 (4th Cir. 2014).                Further, we are not to limit our inquiry

solely to a precise statutory provision in isolation, as “[t]he

meaning—or ambiguity—of certain words or phrases may only become

evident when placed in context.”                   Food & Drug Admin. v. Brown &

Williamson Tobacco Corp., 529 U.S. 120, 132 (2000).

                                              13
       If   step     one   leads       to   the      conclusion        that    Congress      has

spoken clearly, that is the end of the Chevron inquiry.                                We move

to Chevron step two only if “devices of judicial construction

have    been     tried       and      found     to     yield      no    clear        sense    of

congressional intent.”                Gen. Dynamics Land Sys., Inc. v. Cline,

540 U.S. 581, 600 (2004).                See also Chamber of Commerce of U.S.

v. N.L.R.B., 721 F.3d 152, 160 (4th Cir. 2013) (“Only if the

statute     is   silent      or    ambiguous       with    respect       to    the    specific

issue are we to proceed to Chevron’s second step, asking whether

the agency’s answer is based on a permissible construction of

the statute.” (internal quotation marks omitted)).

       Here,     Congress       has    spoken      directly       regarding      the    court-

decision     trigger.           The   statute      makes    plain       that    the    180-day

exclusivity runs from “the date of a decision of a court in an

action . . . holding the patent which is the subject of the

certification        to    be     invalid     or     not   infringed.”            21    U.S.C.

§355(j)(5)(B)(iv).           As to generic celecoxib, such a decision was

reached by the Federal Circuit in 2008.                            Pfizer Inc. v. Teva

Pharms.     USA,     Inc.,      518    F.3d     1253      (Fed.    Cir.       2008).         That

decision struck eleven of the claims in Pfizer’s ‘068 patent as

invalid.       Id.    The ‘068 patent was the subject of the Paragraph

IV certification that Teva submitted to FDA.                                  Teva’s 180-day

exclusivity period as to the ‘068 patent began to run from the

date the Federal Circuit issued its mandate in May 2008.                                      And

                                              14
the exclusivity period expired on November 9, 2008, i.e., 180

days later.

       Hatch-Waxman          does        not        define      “patent”        nor        does    it

specifically speak to reissued patents.                           This does not, however,

render       the    statute       ambiguous.             The    “court-decision            trigger”

speaks       of      “the        patent       which        is     the     subject          of     the

certification.”             21 U.S.C. §355(j)(5)(B)(iv) (emphasis added).

FDA’s interpretation of this language treats the original patent

and the reissued patent as a single “bundle of rights” which can

only    be    the     subject       of       one    Paragraph      IV    certification            and

therefore      provides          only    a    single       180-day      exclusivity         period.

However, this interpretation is contrary to the plain statutory

language.

       Black’s        Law        Dictionary           defines      “patent”           as     “[t]he

governmental         grant        of     a    right,       privilege,          or     authority.”

Black’s Law Dictionary 1300 (10th ed. 2014).                               It also defines

“reissue       patent”       as    “[a]       patent      that    is    issued        to    correct

unintentional or unavoidable errors in an original patent, such

as to revise the specification or to fix an invalid claim.”                                       Id.

at 1301.           In other words, a reissue patent exists because of

some mistake in the original patent.                           It does not grant the same

“right[s],         privilege[s],             or     authorit[ies]”        as        the    original

patent because the original cannot protect the rights it claims—

it     was    issued        in    error        or    was       otherwise       mistake-ridden.

                                                    15
Instead, it is a separate grant of rights, even if elements of

the reissued patent overlap with those of the original patent.

See    35    U.S.C.     §   251     (describing        the   reissue   of       defective

patents).

       The    original      2008     court        decision   triggered      a     180-day

exclusivity period regarding the ‘068 patent.                      That patent was

thus “the patent which” was “the subject of the certification”

Teva sent to FDA in 2003.                 Because the ‘068 patent could not

protect the rights it claimed, Teva’s marketing of celecoxib

would not infringe the original patent, at least to the eleven

invalidated claims.            Teva’s successful challenge of the ‘068

patent, however, could not address its rights as to the ‘048

patent, which did not come into existence until years later.

The reissued ‘048 patent represented a new set of rights granted

by the PTO, due to the court-recognized mistake in the original

‘068     patent.         The      reissue    necessitated       new    Paragraph       IV

certifications and a subsequent legal challenge to determine the

patent’s validity.          Because the statute requires recertification

as to a reissued patent, the ‘048 reissued patent thus was also

“the patent which” was “the subject of the certification[s]”

that Mylan, Teva, and Watson issued in 2013 and that led to

litigation.

       The   plain      language     of     the    statute    indicates     that     each

patent      that   is   the    subject       of    a   certification     may      trigger

                                             16
exclusivity.         The Hatch-Waxman Act required Abbreviated New Drug

Application applicants to certify as to both the original and

reissued patents; each could be “the patent which is the subject

of the certification.”           21 U.S.C. §355(j)(5)(B)(iv).              Because we

find    that    FDA’s   interpretation         to    the   contrary   violated      the

plain    statutory      language,   we    must       set   it   aside.      Household

Credit Servs., Inc. v. Pfennig, 541 U.S. 232, 239 (2004) (“If

[Congress has spoken to the question at issue], courts, as well

as the agency, must give effect to the unambiguously expressed

intent of Congress.”).           See also Mylan Pharms., Inc. v. FDA, 454

F.3d 270, 274-75, 276-77 (4th Cir. 2006) (holding that 21 U.S.C.

§   355(j)(5)(B)(iv)       was   plain    and       therefore   the   court   had   no

choice but to enforce the language as written).

                                         IV.

        For    the    reasons    above,    we        reverse    and      remand   with

instructions for the district court to proceed with adjudicating

the rights of the Abbreviated New Drug Application applicants

consistent with this opinion.

                                                            REVERSED AND REMANDED

                                          17