N OTE : This disposition is nonprecedential.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

______________________
C LIFFORD D AVIDSON , Davidson, Davidson & Kappel, LLC, New York, NY, for appellant. Also represented by O LEG I OSELEVICH , C ARY K APPEL ; C HRISTOPHER H. B LASZKOWSKI , RatnerPrestia, King of Prussia, PA ; B RIAN P. O'S HAUGHNESSY , Washington, DC.

R ICHARD K ELLY , Oblon, McClelland, Maier & Ne ustadt, LLP, Alexandria, VA, for appellee. Also represented by K ATHERINE D OROTHY C APPAERT , M ARINA I VANOVNA M ILLER ; P AUL K. L EGAARD , D ANIEL S COLNICK , Pepper Hamilton LLP, Berwyn, PA.PURDUE PHARMA , L

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______________________
Before D YK , B RYSON , and C HEN , Circuit Judges.

D YK , 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 Applic ati on) 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

. B ACKGROUND
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 administr ation 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 inve ntion is “to provide bioavailable controlled

- release hydroc odone formulatio ns 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 Applic ations are identical. For convenience, we cite only to the specification of the ’968 Application.PURDUE PHARMA , L

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Importantly for purposes of this appeal, each of the claimed dosage f orms (capsules, for example) includes two types of multiparticulates : controlled release (“CR”) multiparticulates and immediate release (“IR”) multipa rticulates. T he CR and IR multiparticulates are each

com prised of inert beads coated with hydrocodone. T he 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 consis ting of a first portion of pharmaceutically accept able inert beads, a first portion of the bitartrate salt of hydrocodone, hydroxypropylmethy lcell ulose, 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 methac rylate 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 o f the h ydrocodone 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 900PURDUE PHARMA , L

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ml of Simulated Intestinal Fluid (SIF) at 37 ° C, and

af ter a first administration to a human p atient, providing a C 12 /C max hydrocodone ratio of 0.55 to 0.85, a T max 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 d irected to oral formulations of hydrocodone

. An interfe rence 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, co ncluding that both parties’ claims lacked written descri ption 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. A ccordingly, the Board “finally refused” the claims as u npatentable. J.A. 2.
Having concluded that th e involved claims are u npatentable, the Board issued a judgment terminat ing the interference. P urdue appeals the Board’s written descri ption 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

. D ISCUSSION 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 factua lPURDUE PHARMA , L

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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 discl osure of the application relied upon reasonably conveys to those skilled in the art that the inv entor had possession of the claimed subject matter as of the filing date. ” Ariad

, 598 F.3d at 1351

. “ Based on that inquiry, the specific ation must describe an invention understandable to that skilled artisan and show that the inventor actually i nvented t he invention claimed. ” Id. “[W] hile the descri ption 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 d oes not satisfy the requirement.” Id. (citations omitted).

The issue here is whether the specifications adequat ely disclose the claimed separate populations of IR and CR multiparticulates , which each compri se 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 . W e conclude that substantial evidence supports the Board’s finding.

A lthough t he written descript ion generally disclose s that a single dosage form may include both IR and CR hydrocodone components, it does not disclose a formul ation wherein the IR and CR components exist as separate multiparticulates each containing an inert bead core. The specificat ions explain, “[i] n certain embodiments of the present invention, an effective amount of opioid in imm ediate release form is included in the formulation. ” J.A. 1142, ¶ 60. The specifications provide several possible formulations combining CR and IR compo nents: [A] n effective amount of the hydrocodone in i mmediate release form may be coated onto the su bstrates of the present inve n tion . For example

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where the extended r e lease hydrocodone from the formulation is due to a controlled release coating, the immediate release layer would be overcoa t ed on top of the controlled release coating

. . . . Where a plurality of the sustained r e lease substrates comprising an effective unit dose of the hydroc odone (e.g., mult i particulate systems including pe llets, sphere s, beads and the like) are incorp o rated into a hard gelatin capsule, the i m mediate release portion of the opioid dose may be incorporated i nto the gelatin ca p sule via inclusion of the sufficient amount of immediate release hydrocodone as a powder or granulate within the capsule

. Alte rnatively

, the gelatin capsule itself may be coated with an immediate release layer of the hydroc odone. One skilled in the art would recognize still other altern a tive manners of incorporating the immed i ate release hydromorphone portion into the un it dose.
J.A. 1143, ¶ 67 (emphas e s 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 “e n-PURDUE PHARMA , L

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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 co mbining two populations of beads.” J.A. 38. In other words, the disclosed embodiments include inert b eads 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 coat ed 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 describe s a multi

- step method for preparing CR hydrocodone beads that contain inert cores

. T he specifications explain that inert substrates, for e xample, nu pariel 18/20 beads, are first sprayed with a liquid coating solution that contains the drug

, i.e.

, crea ting 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 hydr ophobic controlled release material.” J.A. 1149, ¶ 141. Purdue argues that the intermediate product of this method ( which exist s after step one) is an IR bead, and the final p roduct (after the step two overcoating ) is a CR bead. Because the specification states that the interm ediate product “may” be overcoated with the CR material, in Purdue’s view, the second step is optional

, and the refore 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 suggestPURDUE PHARMA , L

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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. Pat ent No . 5,472,712, (“the ’712 Pa tent”), 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 t he 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] diffe rent 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 diffe rent active pharmaceutical ingredient than the applic ations.” J.A. 1329.

To the extent that Purdue contends that a person of skill in the art w ould isola te 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 inv ention obvious does not satisfy the [written descri ption] re quirement.” 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 limita tions”). Substantial evidence supports the Board’s findings in this regard.
We have considered Purdue’s remaining arguments and conclude that they are without merit.

C ONCLUSION

W e affirm the Board’s determination that claims 1, 6, 9, 10, 12

– 15, 23

– 26, 32, 39, 41

– 46, and 53

– 55 of the ’968PURDUE PHARMA , L

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Application and claims 63

– 67 and 70

– 71 of the ’263 Application are unpatentable for lack of written descri ption support und er 35 U.S.C. § 112.

AFFIRMED

C OSTS Costs to appellee

.