NOTE: This disposition is nonprecedential.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 & Neustadt, 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 Application) 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 controlledrelease 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 administration 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 invention is “to provide bioavailable controlled-release hydrocodone 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 Applications 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”) multiparticulates. 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 consisting of a first portion of pharmaceutically acceptable inert beads, a first portion of the bitartrate 

salt of hydrocodone, hydroxypropylmethylcellulose, 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 hydrocodone 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 patient, 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 directed to oral formulations of hydrocodone. An interference 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, concluding that both parties’ claims lacked written description 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. Accordingly, the Board “finally refused” the claims as unpatentable. J.A. 2.

Having concluded that the involved claims are unpatentable, the Board issued a judgment terminating the 

interference. Purdue appeals the Board’s written description 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 disclosure 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 specification must describe an invention understandable to that 

skilled artisan and show that the inventor actually invented the invention claimed.” Id. “[W]hile the description 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 adequately 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 formulation 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 immediate 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 immediate release form may be coated onto the substrates 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 hydrocodone (e.g., multiparticulate systems including pellets, spheres, beads and the like) are incorporated 

into a hard gelatin capsule, the immediate release 

portion of the opioid dose may be incorporated into the gelatin capsule via inclusion of the sufficient amount of immediate release hydrocodone as 

a powder or granulate within the capsule. Alternatively, the gelatin capsule itself may be coated 

with an immediate release layer of the hydrocodone. 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 (“sustained 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 combining 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 specification 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 example, nu pariel 18/20 beads, are first sprayed with a

liquid coating solution that contains the drug, i.e., creating 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 hydrophobic 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 intermediate product “may” be overcoated with the CR material, 

in Purdue’s view, the second step is optional, and therefore 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 sufficient 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] different 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 different active pharmaceutical ingredient than the applications.” 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 description] 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 description support under 35 U.S.C. § 112.

AFFIRMED

COSTS

Costs to appellee.