Court Opinion

ID: 4177000
Source: CourtListenerOpinion
Date Created: 2017-06-13 15:05:08.260045+00
Date Added: 2024-06-11T14:38:57.652437
License: Public Domain

NOTE: This disposition is nonprecedential.

  United States Court of Appeals
      for the Federal Circuit
                 ______________________

               PURDUE PHARMA L.P.,
                    Appellant

                            v.

            RECRO TECHNOLOGY, LLC,
                      Appellee
               ______________________

                       2016-2260
                 ______________________

    Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. 106,022.
                  ______________________

                 Decided: June 13, 2017
                 ______________________

    CLIFFORD DAVIDSON, Davidson, Davidson & Kappel,
LLC, New York, NY, for appellant. Also represented by
OLEG IOSELEVICH, CARY KAPPEL; CHRISTOPHER H.
BLASZKOWSKI, RatnerPrestia, King of Prussia, PA; BRIAN
P. O'SHAUGHNESSY, Washington, DC.

    RICHARD KELLY, Oblon, McClelland, Maier & Neu-
stadt, LLP, Alexandria, VA, for appellee. Also represented
by KATHERINE DOROTHY CAPPAERT, MARINA IVANOVNA
MILLER; PAUL K. LEGAARD, DANIEL SCOLNICK, Pepper
Hamilton LLP, Berwyn, PA.
2             PURDUE PHARMA, L.P.   v. RECRO TECHNOLOGY LLC

                 ______________________

        Before DYK, BRYSON, and CHEN, Circuit Judges.
DYK, Circuit Judge.
    Purdue Pharma L.P. (“Purdue”), the senior party in
an interference proceeding, appeals from a judgment of
the Patent Trial and Appeal Board (“Board”) refusing
claims in Purdue’s Applications 13/833,263 (“’263 Applica-
tion) and 14/094,968 (’968 Application) (collectively, the
“Applications”). The Board granted junior party Recro
Technology, LLC’s (“Recro”) motion for judgment that
Purdue’s claims lack written description, concluding that
claims 1, 6, 9, 10, 12–15, 23–26, 32, 39, 41–46, and 53–55
of the ’968 Application and claims 63–67 and 70–71 of the
’263 Application (collectively, the “involved claims”) are
unpatentable for lack of written description support under
35 U.S.C. § 112. We affirm.
                       BACKGROUND
    Purdue’s Applications are directed to controlled-
release oral formulations of hydrocodone, a drug used to
treat pain. The specifications explain that, generally,
“controlled (slow) release formulations . . . provide a
longer period of pharmacological action after administra-
tion than is ordinarily obtained after administration of
immediate-release dosage forms.” 1 J.A. 1139, ¶ 3. The
specifications further explain that an object of the inven-
tion is “to provide bioavailable controlled-release hydroco-
done formulations which provide a substantially
increased duration of effect as compared to immediate
release hydrocodone formulations, but which provide an
early onset of analgesia.” J.A. 1140, ¶ 15.

    1   The specifications of the ’968 and ’263 Applica-
tions are identical. For convenience, we cite only to the
specification of the ’968 Application.
PURDUE PHARMA, L.P.   v. RECRO TECHNOLOGY LLC             3

    Importantly for purposes of this appeal, each of the
claimed dosage forms (capsules, for example) includes two
types of multiparticulates: controlled release (“CR”)
multiparticulates and immediate release (“IR”) multipar-
ticulates. The CR and IR multiparticulates are each
comprised of inert beads coated with hydrocodone. The
claims also recite various in vitro dissolution rates and in
vivo pharmacokinetic properties of the claimed dosage
forms. For example, claim 1 of the ’968 Application
recites,
       1. A twice-a-day solid oral controlled-release
   dosage form of a bitartrate salt of hydrocodone
   consisting of
       a pharmaceutically acceptable capsule,
       immediate release multiparticulates consist-
   ing of a first portion of pharmaceutically accepta-
   ble inert beads, a first portion of the bitartrate
   salt of hydrocodone, hydroxypropylmethylcellu-
   lose, glidant(s), and optional plasticizer(s), and
       controlled release multiparticulates consisting
   of the remaining portion of the pharmaceutically
   acceptable inert beads, the remaining portion of
   the bitartrate salt of hydrocodone, an ammonio
   methacrylate copolymer, glidant(s), and optional
   plasticizers(s),
       wherein the total amount of the bitartrate salt
   of hydrocodone in the dosage form is from about 5
   mg to 60 mg,
        said dosage form providing an in-vitro release
   of from 18% to about 42.5% by weight of the hy-
   drocodone from the dosage form at one hour, when
   measured by the USP Basket Method at 100 rpm
   in 700 ml of Simulated Gastric Fluid (SGF) for 55
   minutes at 37° C and thereafter switching to 900
4             PURDUE PHARMA, L.P.   v. RECRO TECHNOLOGY LLC

    ml of Simulated Intestinal Fluid (SIF) at 37° C,
    and
        after a first administration to a human pa-
    tient, providing a C12/Cmax hydrocodone ratio of
    0.55 to 0.85, a Tmax of hydrocodone at from about 2
    to 8 hours and a therapeutic effect for about 12
    hours.
J.A. 68.
     Recro also filed an application including claims di-
rected to oral formulations of hydrocodone. An interfer-
ence was declared, and the parties each filed several
motions including a motion asserting that the opposing
party’s claims were unpatentable under 35 U.S.C. § 112,
first paragraph.
    The Board granted both parties’ § 112 motions, con-
cluding that both parties’ claims lacked written descrip-
tion support. With respect to Purdue’s claims, the Board
found that the specifications do not describe “separate
particles of inert beads coated with the each different
formulation together in one dosage form.” J.A. 38. Ac-
cordingly, the Board “finally refused” the claims as un-
patentable. J.A. 2.
    Having concluded that the involved claims are un-
patentable, the Board issued a judgment terminating the
interference. Purdue appeals the Board’s written descrip-
tion decision with respect to Purdue’s involved claims.
We have jurisdiction pursuant to 28 U.S.C.
§ 1295(a)(4)(A) and 35 U.S.C. § 141.
                       DISCUSSION
    Whether patent claims satisfy the written description
requirement of 35 U.S.C. § 112 is a question of fact. Ariad
Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed.
Cir. 2010) (en banc). We review the Board’s factual
PURDUE PHARMA, L.P.   v. RECRO TECHNOLOGY LLC              5

findings for substantial evidence. Inphi Corp. v. Netlist,
Inc., 805 F.3d 1350, 1354 (Fed. Cir. 2015).
     The test for written description “is whether the disclo-
sure of the application relied upon reasonably conveys to
those skilled in the art that the inventor had possession of
the claimed subject matter as of the filing date.” Ariad,
598 F.3d at 1351. “Based on that inquiry, the specifica-
tion must describe an invention understandable to that
skilled artisan and show that the inventor actually in-
vented the invention claimed.” Id. “[W]hile the descrip-
tion requirement does not demand any particular form of
disclosure, or that the specification recite the claimed
invention in haec verba, a description that merely renders
the invention obvious does not satisfy the requirement.”
Id. (citations omitted).
    The issue here is whether the specifications adequate-
ly disclose the claimed separate populations of IR and CR
multiparticulates, which each comprise inert beads coated
with hydrocodone, combined in a single dosage form.
Both parties submitted expert testimony to the Board on
this issue. The Board found that the claimed formulation
is not disclosed. We conclude that substantial evidence
supports the Board’s finding.
    Although the written description generally discloses
that a single dosage form may include both IR and CR
hydrocodone components, it does not disclose a formula-
tion wherein the IR and CR components exist as separate
multiparticulates each containing an inert bead core. The
specifications explain, “[i]n certain embodiments of the
present invention, an effective amount of opioid in imme-
diate release form is included in the formulation.” J.A.
1142, ¶ 60. The specifications provide several possible
formulations combining CR and IR components:
    [A]n effective amount of the hydrocodone in im-
    mediate release form may be coated onto the sub-
    strates of the present invention. For example,
6             PURDUE PHARMA, L.P.   v. RECRO TECHNOLOGY LLC

    where the extended release hydrocodone from the
    formulation is due to a controlled release coating,
    the immediate release layer would be overcoated
    on top of the controlled release coating. . . . Where
    a plurality of the sustained release substrates
    comprising an effective unit dose of the hydroco-
    done (e.g., multiparticulate systems including pel-
    lets, spheres, beads and the like) are incorporated
    into a hard gelatin capsule, the immediate release
    portion of the opioid dose may be incorporated in-
    to the gelatin capsule via inclusion of the suffi-
    cient amount of immediate release hydrocodone as
    a powder or granulate within the capsule. Alter-
    natively, the gelatin capsule itself may be coated
    with an immediate release layer of the hydroco-
    done. One skilled in the art would recognize still
    other alternative manners of incorporating the
    immediate release hydromorphone portion into
    the unit dose.
J.A. 1143, ¶ 67 (emphases added); see also J.A. 1142, ¶ 60
(similar language).
     This disclosure describes inert beads coated with a CR
formulation of hydrocodone. See J.A. 1143, ¶ 67 (“sus-
tained release substrates comprising . . . hydrocodone
(e.g., . . . beads and the like)”). But it does not disclose
inert beads coated with only an IR formulation. Instead,
as the Board correctly found, the specification describes
IR “formulation[s] formulated as a ‘powder or granulate,’
or as a coating on a gelatin capsule that contains the
controlled release formulations.” J.A. 38.
    Purdue argues that the specifications do disclose inert
bead substrates coated with an IR formulation. Purdue
relies on the disclosure which states, “an effective amount
of the hydrocodone in immediate release form may be
coated onto the substrates of the present invention.” J.A.
1143, ¶ 67. Another passage defines “substrate” to “en-
PURDUE PHARMA, L.P.   v. RECRO TECHNOLOGY LLC             7

compass[] beads, pellets, spheroids, tablets, tablet cores,
etc.” Id. ¶ 68. But the Board correctly determined that
these disclosures “describe overcoating the different
release formulations on top of each other [and] not com-
bining two populations of beads.” J.A. 38. In other words,
the disclosed embodiments include inert beads that are
first coated with a CR layer and then additionally coated
with an IR layer. See J.A. 1143, ¶ 67 (“[T]he immediate
release layer would be overcoated on top of the controlled
release coating.”). The embodiments do not include inert
beads coated directly with an IR layer.
    Purdue argues that a different portion of the specifi-
cation discloses coating an IR layer directly onto an inert
bead. This portion describes a multi-step method for
preparing CR hydrocodone beads that contain inert cores.
The specifications explain that inert substrates, for ex-
ample, nu pariel 18/20 beads, are first sprayed with a
liquid coating solution that contains the drug, i.e., creat-
ing an immediate release layer. In a second step, an
additional coating is applied: “[t]he substrates may then
be overcoated with an aqueous dispersion of the hydro-
phobic controlled release material.” J.A. 1149, ¶ 141.
Purdue argues that the intermediate product of this
method (which exists after step one) is an IR bead, and
the final product (after the step two overcoating) is a CR
bead. Because the specification states that the interme-
diate product “may” be overcoated with the CR material,
in Purdue’s view, the second step is optional, and there-
fore the method teaches preparation of both IR and CR
beads.
    The Board considered this disclosure and was “not
persuaded that portions of these specifications are suffi-
cient to fulfill the requirements of 35 U.S.C. § 112, first
paragraph.” J.A. 38. Substantial evidence supports the
Board’s conclusion. Even if the method is read to disclose
both IR and CR beads, the disclosure does not suggest
8             PURDUE PHARMA, L.P.   v. RECRO TECHNOLOGY LLC

that the IR and CR beads would both be combined in a
single dosage form.
      Purdue finally urges that the claimed formulations
are supported by U.S. Patent No. 5,472,712, (“the ’712
Patent”), which was incorporated by reference into the
Purdue applications. The Board was “not persuaded that
the ’712 [P]atent sufficiently describes the specific dosage
forms Purdue claims. The descriptions do not recite the
actual elements of Purdue’s claims, most notably inert
beads coated with hydrocodone. Instead, the examples of
. . . [the] ’712 [P]atent describe formulations of [a] differ-
ent drug[]: . . . hydromorphone . . . .” J.A. 39 (emphasis
added). Recro’s expert, Dr. Palmieri, stated at deposition
that “the examples . . . in the [’712 Patent] are to a differ-
ent active pharmaceutical ingredient than the applica-
tions.” J.A. 1329.
      To the extent that Purdue contends that a person of
skill in the art would isolate and combine aspects from
various embodiments in the specifications (including
patents incorporated by reference involving a different
drug) to obtain the claimed invention, Purdue relies upon
the wrong test. “[A] description that merely renders the
invention obvious does not satisfy the [written descrip-
tion] requirement.” Ariad, 598 F.3d at 1352; see also
Novozymes A/S v. DuPont Nutrition Biosciences APS, 723
F.3d 1336, 1349 (Fed. Cir. 2013) (explaining that the
written description analysis requires “[t]aking each claim
. . . as an integrated whole rather than as a collection of
independent limitations”). Substantial evidence supports
the Board’s findings in this regard.
   We have considered Purdue’s remaining arguments
and conclude that they are without merit.
                        CONCLUSION
    We affirm the Board’s determination that claims 1, 6,
9, 10, 12–15, 23–26, 32, 39, 41–46, and 53–55 of the ’968
PURDUE PHARMA, L.P.   v. RECRO TECHNOLOGY LLC          9

Application and claims 63–67 and 70–71 of the ’263
Application are unpatentable for lack of written descrip-
tion support under 35 U.S.C. § 112.
                        AFFIRMED
                           COSTS
   Costs to appellee.