Oshlack et al.v.Devane et al. V. Oshlack et al.

Patent Trial and Appeal Board

Apr 29, 2016

14094968 (P.T.A.B. Apr. 29, 2016)

BoxInterferences@uspto.gov Filed: ________, 2015
Tel: 571-272-9797

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________

RECRO TECHNOLOGY, LLC
Application 11/372,857,
Junior Party

v.

PURDUE PHARMA L.P.,
Applications 13/833,263 and 14/094,968,
Senior Party
_______________
Patent Interference No. 106,022 (DK)
_______________

JUDGMENT
37 C.F.R. § 41.127

Before RICHARD E. SCHAFER, SALLY GARDNER LANE, and DEBORAH
KATZ, Administrative Patent Judges.

KATZ, Administrative Patent Judge. 1
Interference 106,022
2

As explained in the Decision on Motions (Paper 243), both parties claims 1
have been found to lack written description support under 35 U.S.C. § 112, first 2
paragraph. 3
It is ORDERED that claims 1 and 88-94 of Recro involved 4
application 11/372,857 be FINALLY REFUSED. 5
It is also ORDERD that claims 63-67 and 70-71 of Purdue’s involved 6
application 13/833,263 and claims 1, 6, 9, 10, 12-15, 23-26, 32, 39, 41-46, and 53-7
55 of Purdue’s involved application 14/094,968, be FINALLY REFUSED. 8
It is further ORDERED that a party seeking judicial review timely serve 9
notice on the Director of the United States Patent and Trademark Office. 10
37 C.F.R. §§ 90.1 and 104.2. See also 37 C.F.R. 41.8(b). Attention is directed to 11
Biogen Idec MA, Inc., v. Japanese Foundation for Cancer Research, 785 F.3d 648, 12
654–57 (Fed. Cir. 2015) (cert. denied 2016 WL 1078942, Mar 21, 2016) 13
(determining that pre-AIA § 146 review was eliminated for interference 14
proceedings declared after September 15, 2012). 15
It is further ORDERED that a copy of this judgment be entered into the 16
administrative records of Recro application 11/372,857 and Purdue applications 17
13/833,263 and 14/094,968. 18
.

Interference 106,022
3

cc (via e-mail): 1
2
Attorneys for junior party Recro Technology, LLC 3
4
FOX ROTHSCHILD, LLP 5
Shahnam Sharareh 6
Jeff E. Schwarz 7
ssharareh@foxrothschild.com 8
jeschwartz@foxrothschild.com 9
10
Paul K. Legaard 11
Daniel M. Scolnick 12
legaardp@pepperlaw.com 13
scolnickd@pepperlaw.com 14
15
Richard Kelly 16
Marina Miller 17
rkelly@oblon.com 18
mmiller@oblon.com 19
20
Attorneys for senior party Purdue Pharma, LP 21
22
DAVIDSON, DAVIDSON & KAPPEL, LLC 23
Clifford M. Davidson 24
Cary S. Kappel 25
Leslye B. Davidson 26
Oleg Ioselevich 27
cdavidson@ddkpatent.com 28
ckappel@ddkpatent.com 29
ldavidson@ddkpatent.com 30
oioselevich@ddkpatent.com 31
ddk@ddkpatent.com 32
33
Brian P. O’Shaughnessy 34
boshaughnessy@ratnerprestia.com 35
36

BoxInterferences@uspto.gov Filed: April 29, 2016
Tel: 571-272-9797

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________

RECRO TECHNOLOGY, LLC
Application 11/372,857,
Junior Party

v.

PURDUE PHARMA L.P.,
Applications 13/833,263 and 14/094,968,
Senior Party
_______________
Patent Interference No. 106,022 (DK)
_______________

DECISION ON MOTIONS
37 C.F.R. § 41.125(a)

Before RICHARD E. SCHAFER, SALLY GARDNER LANE, and
DEBORAH KATZ, Administrative Patent Judges.

KATZ, Administrative Patent Judge.

Interference 106,022
2

I. Introduction 1
The interference is before a panel for consideration of the parties’ pending 2
non-priority motions. 3
Parties 4
Junior Party Recro Technology LLC1 (“Recro”) is involved based on its 5
application 11/372,857 (“the ’857 application”), which was filed 10 March 2006. 6
(Declaration Paper 1, at 3.) 7
Senior Party Purdue Pharma L.P.2 (“Purdue”) is involved based on two 8
applications: 13/833,263 (“the ’263 application”), filed 15 March 2013, and 9
14/094,968 (“the ’968 application”), filed 3 December 2013. (Declaration Paper 1, 10
at 4.) The ’968 application is a continuation of the ’263 application. 11
Claims 12
Both parties claim “dosage forms” of hydrocodone, a known drug used for 13
the treatment of pain. (Purdue ’968 appl., Exh. 1026, ¶ 2; Recro ’857 appl., 14
Exh. 1014, ¶ 59.) Both parties’ claimed dosage forms comprise two components: 15
(1) a formulation for immediate release including, among other ingredients, 16
hydrocodone and hydroxypropylmethylcellulose and 17
(2) a formulation for extended or modified release including, among other 18
ingredients, hydrocodone and ammonio methacrylate. 19
(John G. Devane (“Recro”) Clean Copy of Claims, Paper 11; Oshlack (“Purdue”) 20
Clean Copy of Claims, Paper 7.) In contrast to “immediate release,” wherein the 21
drug is released immediately after administration (see Declaration of David Taft3 22

1 Junior Party represents that Recro Technology LLC is the real party-in-interest to
the involved application. (Paper 10.)
2 Senior Party represents that Purdue Pharma LP is the real party-in-interest to the
involved applications. (Paper 5.)
3 Purdue relies on the testimony of David Taft, Ph.D. Dr. Taft testifies that he has
been a Professor in the Division of Pharmaceutical Sciences in the Arnold & Marie
Interference 106,022
3

(“Taft Decl.”), Exh. 1012, at ¶ 28), the parties define “extended release,” 1
“modified release,” “controlled release,” and other similar terms to mean that the 2
release of the drug is not immediate, but slower to some degree. (See Recro 3
’857 appl., Exh. 1014, at ¶ 27; Purdue ’968 appl., Exh. 1026, at ¶ 37; Taft Decl., 4
Exh. 1012, at ¶ 30.) Unless specifically indicated, we use the terms “controlled 5
release” and “modified release” to refer to all of these types of non-immediate 6
release formulations. 7
Each parties’ claims also recite two different functional elements defining 8
the release of hydrocodone, including: 9
(1) in vitro release or dissolution of the drug as determined by an 10
experimental system (the “USP Basket Method” in Purdue’s claims or 11
the “USP Type 1 apparatus” in Recro’s claims); and 12
(2) in vivo release characterized by the concentration of the drug in the blood 13
plasma (expressed as “Tmax” or “C12/Cmax” measurements of blood plasma 14
concentration). 15
(See Recro Clean Copy of Claims, Paper 11; Purdue Clean Copy of Claims, 16
Paper 7.) 17
Motions 18
Purdue filed Motion 2 (Paper 144), arguing that there is no interference-in-19
fact between the parties’ claims. We deny this motion. 20

Schwartz college of Pharmacy and Health Sciences of the Long Island University
since 2013 and previously served as Dean of that college. (Taft Decl., Exh. 1012,
at ¶¶ 3 and 4.) Dr. Taft testifies further that he has received numerous honors and
awards, serves on the editorial board of four scientific journals, has been awarded
19 grants and contracts, and has published 34 articles in the field of
pharmacokinetics of drugs and drug formulations. (Id., at ¶¶ 9-11.) Dr. Taft is
qualified to provide opinion testimony as an expert witness based on his scientific,
and technical knowledge about the subject matter of the interference.

Interference 106,022
4

Purdue also filed Motion 1 (Paper 143), arguing that Recro’s involved 1
claims are unpatentable under 35 U.S.C. § 112, first paragraph. We grant this 2
motion. 3
Recro filed a motion to add a new claim to its involved application, 4
contingent on the grant of Purdue Motion 2, arguing that there is no interference-5
in-fact, and Purdue Motion 2, arguing that Recro’s currently involved claims are 6
unpatentable under 35 U.S.C. § 112, first paragraph. We deny this motion. 7
Recro file Motion 5, arguing that Purdue’s involved claims are unpatentable 8
under 35 U.S.C. § 112, first paragraph. We grant this motion. 9
Because we hold that both Recro’s and Purdue’s involved claims are 10
unpatentable, there is no reason to make a determination of patentability of either 11
party’s claims under 35 U.S.C. § 102(g). Accordingly, we terminate the 12
interference without deciding the parties’ remaining motions, which would impact 13
only a priority decision. Specifically, we decline to consider Recro Motion 1 14
(Paper 123) to substitute the count, Recro Motion 3 (Paper 148), to argue that 15
Purdue should not have been accorded the benefit of earlier applications as to the 16
count, and Purdue Motions 4 and 5 (Papers 145 and 154), to argue that Purdue 17
should be accorded the benefit of earlier applications as to the count. 18
19
II. Purdue Motion 2 –For Judgment of No Interference-in-Fact 20
Purdue argues that the interference was improperly declared because none of 21
its involved claims interfere with any of Recro’s involved claims. (Purdue 22
Motion 2, Paper 144.) Recro opposed this argument (Paper 188) and Purdue 23
replied (Paper 223). 24
“Whenever an application is made for a patent which, in the opinion of the 25
Director, would interfere with any pending application, or with any unexpired 26
Interference 106,022
5

patent, an interference may be declared . . . .” 35 U.S.C. § 135(a)4. Because the 1
interference was declared by an APJ acting on behalf of the Director, 37 CFR 2
§ 41.203(b), there is presumption that at least one claim of each party interferes. 3
Claims interfere when they claim the same subject matter. Therefore, it is 4
Purdue’s burden to persuade us that the parties do not claim the same subject 5
matter. 37 C.F.R. §§ 41.121(b) and 41.208(b). 6
Findings of Fact 7
We make the following findings of fact regarding whether the parties’ 8
claims interfere. These facts, as well as those presented elsewhere in this opinion, 9
are supported by a preponderance of the evidence. 10
1. Recro claim 1 recites: 11
A multiparticulate modified release solid oral dosage form of 12
hydrocodone or a pharmaceutically acceptable salt thereof comprising 13
two populations of hydrocodone containing particles, granules, 14
beads or pellets, the dosage form comprising from about 1 to about 15
100 mg of hydrocodone or a pharmaceutically acceptable salt thereof, 16
said two populations consisting of 17
[1] a first population of particles, granules, beads or pellets, 18
consisting of non-pareil seeds, hydrocodone or a pharmaceutically 19
acceptable salt thereof, a hydrophilic polymer selected from the group 20
consisting of polyvinyl pyrrolidone, hydroxypropylmethylcellulose 21
and a mixture thereof, and at least one suitable excipient; and 22
providing an immediate release of hydrocodone, and 23
[2] a second population of particles, granules, beads or pellets, 24
comprising non-pareil seeds, hydrocodone or a pharmaceutically 25
acceptable salt thereof, an ammonio methacrylate copolymer and at 26
least one suitable excipient and providing a modified release of 27
hydrocodone such that release of hydrocodone is delayed for a period 28
of at least about 2 hours after administration, 29
[3] said dosage form providing an in-vitro dissolution profile of 30
the hydrocodone in an aqueous medium when measured in a USP 31

4 Patent interferences continue under the relevant statutes in effect on
15 March 2013. See Pub. L. 112-29, § 3(n), 125 Stat. 284, 293 (2011).
Interference 106,022
6

Type 1 apparatus (100 rpm) such that at least 25-50% by weight of the 1
hydrocodone is released within four hours, and at least 40-100% by 2
weight of the hydrocodone is released within four to eight hours, 3
[4] wherein said dosage form after a first administration to a 4
patient, provides a plasma profile substantially similar to the plasma 5
profile produced by administration of two or more IR [immediate 6
release] dosage forms of hydrocodone given sequentially, and 7
further wherein said dosage form provides a Tmax 1 of 8
hydrocodone from about 2 to about 8 hours. 9
10
(Paper 11, (bracketed numbers and emphasis added).) 11
2. Purdue Claim 63, of the ’263 application recites: 12
A twice-a-day solid oral controlled-release dosage form 13
comprising: 14
[1] (a) immediate release multiparticulates consisting of 15
pharmaceutically acceptable inert beads coated with hydrocodone 16
bitartrate, hydroxypropylmethylcellulose, glidant(s) and optional 17
plasticizer(s), 18
[2] (b) extended release multiparticulates comprising a plurality 19
of pharmaceutically acceptable inert beads coated with hydrocodone 20
bitartrate, an ammonio methacrylate copolymer, and glidant(s), 21
wherein the immediate release multiparticulates and the 22
extended release multiparticulates are contained in a pharmaceutically 23
acceptable hard capsule and the total amount of hydrocodone 24
bitartrate in the capsule is equivalent to from about 5 mg to about 25
60 mg hydrocodone; and 26
[3] wherein the dosage form provides an in-vitro release of 27
from 18% to about 42.5% by weight of hydrocodone from the dosage 28
form at one hour when measured by the USP Basket Method at 100 29
rpm in 700 ml of Simulated Gastric Fluid (SGF) for 55 minutes at 30
37° C and thereafter switching to 900 ml of Simulated Intestinal Fluid 31
(SIF) at 37° C, and 32
[4] after a first administration to a human patient population, 33
provides a mean C12/Cmax hydrocodone ratio of 0.55 to 0.85 and a 34
therapeutic effect for about 12 hours. 35
36
(Paper 7 (emphasis added).) 37
38
Interference 106,022
7

3. Both Recro and Purdue claim hydrocodone dosage forms that 1
comprise two types of particles (or “multiparticulates”): [1] particles providing for 2
immediate release that include a hydrocodone salt and a hydrophilic polymer such 3
as hydroxypropylmethylcellulose (Recro’s claims recite other hydrophilic 4
polymers in addition) and [2] particles providing for extended or delayed release 5
that include a hydrocodone salt and an ammonio methacrylate copolymer. (See 6
Recro Clean Copy of Claims, Paper 11; Purdue Clean Copy of Claims, Paper 7.) 7
4. Both Recro and Purdue recite elements (labeled [3] in the claims 8
above) that relate to the dissolution or release rate as measured by in vitro methods. 9
(See Recro Clean Copy of Claims, Paper 11; Purdue Clean Copy of Claims, 10
Paper 7.) 11
5. Both Recro and Purdue recite elements (labeled [4] in the claims 12
above) that relate to the concentration of hydrocodone in the blood plasma. (See 13
Recro Clean Copy of Claims, Paper 11; Purdue Clean Copy of Claims, Paper 7.) 14
6. Recro claim 1 includes an element that limits the concentration of 15
hydrocodone in the plasma: 16
wherein said dosage form after a first administration to a patient, 17
provides a plasma profile substantially similar to the plasma profile 18
produced by administration of two or more IR [immediate release] 19
dosage forms of hydrocodone given sequentially 20
(See Recro Clean Copy of Claims, Paper 11.) 21
7. Purdue claim 68 includes an element that limits the concentration of 22
hydrocodone in the plasma: 23
after a first administration to a human patient population, provides a 24
mean C12/Cmax hydrocodone ratio of 0.55 to 0.85 and a therapeutic 25
effect for about 12 hours 26
27
(Purdue Clean Copy of Claims, Paper 7.) 28
Interference 106,022
8

8. The term “C12” is not defined in the specification of the Purdue 1
applications or by either party’s witness, but is presumed to mean the plasma 2
concentration at 12 hours after administration. (See Purdue Motion 2, Paper 144, 3
at 9:6-9.) 4
9. The Purdue ’968 application states that “[t]he term ‘Cmax’ denotes the 5
maximum plasma concentration obtained during the dosing interval.” (’968 appl., 6
Exh. 1026, ¶ 38.) 7
10. Purdue’s witness, Dr. Taft, testifies: 8
A person having ordinary skill in the art understands the term "C12/Cmax 9
ratio" to mean the ratio of the plasma concentration at the 12 hour time 10
point after oral administration to the maximum plasma concentration 11
during the (12 hour) dosing interval. The C12/Cmax ratio provides 12
information concerning the shape of the plasma concentration curve. It is 13
calculated by dividing the plasma level determined to be the Cmax by the 14
plasma level measured at 12 hours after oral administration of the dosage 15
form.[5] Therefore, for example, a C12/Cmax ratio of 0.55 means that the 16
plasma concentration 12 hours after oral administration is 55% of the 17
maximum plasma concentration from the time of oral administration until 18
the 12 hour time point after oral administration. A C12/Cmax ratio of 0.85 19
means that the plasma concentration 12 hours after oral administration is 20
85% of the maximum plasma concentration from the time of oral 21
administration until the 12 hour time point after oral administration. 22
23
(Taft Decl., Exh. 1012, at ¶ 50.) 24
25
11. The Purdue ’968 application states: 26
It is a further object of the invention to provide orally 27
administrable controlled release opioid formulations suitable for 28
twice-a-day administration which provide an early onset of 29
therapeutic effect and which, after rising to a maximum concentration 30

5 Because the ratio is expressed as “C12/Cmax”, it appears to be calculated by
dividing the plasma level measured at 12 hours after oral administration by the
plasma level determined to be the Cmax, not the reverse, as explained by Dr. Taft.
We mention this difference for clarity – it has no impact on our decision.
Interference 106,022
9

during the dosage interval, provide a relatively flat serum plasma 1
profile, meaning that the plasma level of the opioid provides a 2
C12/Cmax ratio of 0.55 to 0.85, and which provides effective pain relief 3
to the patient. 4
5
(Purdue ’968 application, Exh. 1026, ¶ 16 (emphasis added).) 6
12. Paragraph 70 of the Recro ’857 application states: 7
In embodiments which include drug compounds used for pain 8
management, such as for example hydrocodone, the compositions and 9
dosage forms of the present invention may provide continuous 10
analgesia for up to 24 hours by providing minimum peak to trough 11
fluctuations in plasma levels and reduce or eliminate side effects 12
associated with such drug compounds. 13
14
(Recro ’857 appl. Exh. 1014, ¶ 70 (emphasis added).) 15
13. Paragraph 7 of the Recro ’857 application explains: 16
Many controlled release drug formulations are aimed at producing a 17
zero-order release of the drug compound. Indeed, it is often a specific 18
object of these formulations to minimize the peak-to-trough variation 19
in plasma concentration levels associated with conventional frequent 20
dosage regimes. 21
22
(Recro ’857 appl., Exh. 1014, at ¶ 7.) 23
24
14. Paragraph 68 of the Recro ’857 application explains that 25
[d]epending on the release profile of each component, the plasma 26
profile resulting therefrom may be bimodal or multimodal, and may 27
define well separated and clearly defined peaks associated with each 28
with each component (e.g. when the lag time between immediate 29
release and delayed release components is long) or superimposed 30
peaks associated with each component (e.g. in when the lag time is 31
short). . . . Alternatively, administration of a multiparticulate modified 32
release composition having an immediate release component and one 33
or more modified release components can result in a bimodal or 34
multimodal release profile but a plasma profile having a single peak 35
or peaks fewer in number than the number of components contained 36
in the composition. 37
Interference 106,022
10

(’857 appl., Exh. 1014, ¶ 68 (emphasis added).) 1
15. Paragraph 69 of the Recro ’857 application explains 2
in the case of some disorders it is particularly useful to have such a 3
bimodal plasma profile. For example, a typical methylphenidate 4
treatment regime consists of administration of two doses of an 5
immediate release dosage formulation given four hours apart. . . . It is 6
believed that the trough in the plasma profile between the two peak 7
plasma concentrations is advantageous in reducing the development of 8
patient tolerance by providing a period of wash out of the active 9
ingredient. 10
11
(Recro ’857 appl., Exh. 1014, at ¶ 69 (emphasis added).) 12
16. Methylphenidate is characterized as a psychostimulant and cerebral 13
stimulant for the treatment of attention deficit hyperactivity disorder in Recro’s 14
’857 application. (Recro ’857 appl., Exh. 1014, ¶ 8.) 15
17. Dr. Taft testifies: 16
In my opinion, a person having ordinary skill in the art would 17
understand that the immediate release component of the twice-a-day 18
solid oral controlled-release dosage form claimed in the Purdue 19
Claims would act to provide an earlier time to maximum plasma 20
concentration of hydrocodone during the dosage interval (Tmax), but 21
would not consider it obvious that there would be two peak 22
concentrations separated by a lower blood plasma concentration (or 23
"trough"), as would be obtained from a formulation that provides a 24
plasma profile substantially similar to the plasma profile produced by 25
administration of two or more IR dosage forms of said active 26
ingredient given sequentially. 27
28
(Taft Decl., Exh. 1012, ¶ 99.) 29
18. Paragraph 10 of the Purdue specifications states the following: 30
31
Various techniques have been used to prepare controlled release 32
dosage forms. Specially coated pellets, tablets and capsules wherein 33
the slow release of the active medicament is brought about through 34
selective breakdown of the coating of the preparation or through 35
Interference 106,022
11

compounding with a special matrix to affect the release of a drug are 1
known in the art. Certain controlled release formulations provide for 2
related sequential release of a single dose of an active compound at 3
predetermined periods after administration. 4
5
(Purdue ’968 appl., Exh. 1026, paragraph [0010]). 6
19. Figure 2 of the Recro ’857 application is reproduced below. 7
8
Figure 2 depicts a graph of single dose simulations of 10 mg hydrocodone 9
formulations of the invention of the Recro ’857 application in which 20% of the 10
hydrocodone is contained in the immediate release (“IR”) component.6 11
(’857 appl., Exh. 1014, ¶ 36.) A line labeled “20%IR:80%SRka=0.3(10mgBID-2 12
pulses)” is indicated with a solid line and triangles and a line labeled 13
“SQ(5mgqid)” is indicated with a dashed line. 14

6 The x-axis in Figure 2 is “Concentration (ng/ml)” and the y-axis is not labeled.
Because all of other figures of the Recro ’857 application, which present similar
plots, have the x-axis labeled as time and the y-axis labeled as concentration, we
consider the labeling of the axes in Figure 2 to be reversed.
Interference 106,022
12

20. In regard to Figure 2 of the Recro ’857 application, Dr. Taft testifies 1
that most of the lines depicting plasma profiles do not depict a C12/Cmax 2
hydrocodone ratio of 0.55-0.85, as recited in Purdue’s claims, but that 3
the line defined as 20%IR80%SRka=0.3(10mgBID-2pulses) provides 4
two peaks within the dosage interval of 12 hours. That formulation 5
appears to depict a C12 of approximately 9.33 and a Cmax of 6
approximately 11.6 ng/ml at about 9 hours for a C12Cmax of about 0.80, 7
which appears to be within the upper limit of the C12/Cmax 8
hydrocodone ratio of 0.55 to 0.85 as required by the Purdue claims. 9
10
(Taft Decl., Exh. 1012, ¶ 119 (emphasis added).) 11
21. Dr. Taft testifies: 12
Based on my analysis above, it is my opinion that, although it is 13
possible for a formulation falling within the Recro Claims to provide a 14
C12/Cmax hydrocodone ratio of 0.55 to 0.85 as required by the Purdue 15
Claims, this is certainly not an obvious conclusion to draw. It appears 16
that of the formulations depicted in the Recro '857 application, the 17
vast majority would either not fall within the Recro Claims or not fall 18
within the Purdue claims. 19
20
(Taft Decl., Exh. 1012, ¶ 128.) 21
22
Analysis 23
Referring to the “two-way test,”7 Purdue argues that the parties’ claims do 24
not interfere because none of Recro’s claims is anticipated or rendered obvious by 25
any of Purdue’s claims. (Purdue Motion 2, Paper 144, at 6:21-13:6.) Purdue also 26
argues that none of its own claims are anticipated or rendered obvious by any of 27
Recro’s claims. (Id. at 13:7-16:8.) 28

7 See Eli Lilly & Co. v. Bd. of Regents of Univ. of Wash., 334 F.3d 1264, 1270
(Fed. Cir. 2003) (holding that the determination of whether two parties are
claiming the “same patentable invention” is properly made using a two-way test);
see also 37 C.F.R. § 41.203(a)
Interference 106,022
13

Both parties claim dosage forms of hydrocodone with hydrocodone particles 1
for immediate release (with compounds including hydroxypropylmethylcellulose) 2
and hydrocodone particles for modified release (with ammonio methacrylate 3
copolymer). (FFs 1-3.) Both parties also recite elements (labeled [3]) that refer to 4
the in vitro release or dissolution profile of hydrocodone. (FF 4.) Purdue does not 5
contest that these elements indicate an interference-in-fact. 6
Purdue focuses, instead, on the elements in the parties’ claims (labeled [4]) 7
that refer to the concentration of hydrocodone in the blood plasma after 8
administration. (See FF 5.) Recro’s claims require a plasma profile that is 9
“substantially similar to the plasma profile produced by administration of two or 10
more IR dosage forms of hydrocodone given sequentially.” (FF 6.) Purdue’s 11
claims require a hydrocodone C12/Cmax ratio, which compares the concentration of 12
drug in the blood plasma at 12 hours (“C12”) and at the maximum concentration 13
(“Cmax”), of 0.55 to 0.85. (FFs 7-9.) 14
Because there is a presumption that the parties’ claims interfere, there is a 15
presumption that the recited hydrocodone plasma concentration elements in each 16
parties’ claims is not a patentable difference. That is, there is a presumption that 17
the parties’ claims interfere, despite their different expressions of hydrocodone 18
concentration in the blood plasma. Purdue must present persuasive argument and 19
evidence to overcome this presumption. 20
We first take up Purdue’s argument that none of Recro’s claims would 21
anticipate or render obvious any of Purdue’s claims. Purdue argues that its claims 22
are not rendered obvious by Recro’s claims because there is no suggestion to 23
choose the recited C12/Cmax range given Recro’s claims. Purdue argues further that, 24
even if the Recro claims suggest this functional element, there is not a reasonable 25
expectation of success in doing so. (Purdue Motion 2, Paper 144, at 14:3-8.) The 26
C12/Cmax ratio is a ratio of the plasma concentration measured at 12 hours to the 27
Interference 106,022
14

maximum concentration measured. (FFs 8-10; Taft Decl., Exh. 1012, at ¶ 50.) 1
According to Dr. Taft, Purdue’s witness, the C12/Cmax ratio provides information 2
concerning the “shape of the plasma concentration curve.” (Id.) We note that the 3
“shape” referred to by Dr. Taft would be determined by only two points: the C12 4
and the Cmax. Thus, the C12/Cmax ratio cannot provide a very detailed description of 5
a “shape.” Purdue’s specifications describe the C12/Cmax ratio recited in Purdue’s 6
claims (0.55-0.85) to provide a “relatively flat profile.” (FF11, Purdue ’968 appl., 7
Exh. 1026, ¶ 16; Purdue Motion 2, Paper 144, at 9:12-14.) 8
According to Purdue, its claimed C12/Cmax range “is substantially higher than 9
that of sequential IR doses.” (Purdue Motion 2, Paper 144, at 14:17-15:2, citing 10
Taft Decl., Exh. 1012, at ¶ 127.) Purdue argues that the claimed range “would be 11
antithetical to the Recro Claims, which seek to mimic the plasma profile of 12
sequential IR doses . . . and would impermissibly change the theory of operation of 13
the Recro Claims.” (Id.) 14
This argument is unpersuasive because the evidence does not support it. 15
Paragraph 70 of Recro’s specification explains that a goal of embodiments 16
involving pain management with a dosage of hydrocodone is to “provid[e] 17
minimum peak to trough fluctuations in plasma levels and reduce or eliminate side 18
effects associated with such drug compounds” when formulating dosages. (FF 12; 19
Recro ’857 appl. Exh. 1014, ¶ 70; see Recro Opp. 2, Paper 188, at 2:16-3:78.) 20
Similarly, paragraphs seven and 68 of the Recro specification discuss the 21
usefulness of plasma profiles that minimize peak to trough fluctuations. (FFs 13 22

8 We note that while Recro provided line numbers on the pages of its briefs, the
line numbers do not necessarily correspond to the actual number of the line. For
example, the line closest to the line labeled “16 on page 2 of Recro’s Opposition 2
is actually the 14th line of the page. We refer to the line number provided by Recro
that is closest to the line cited.
Interference 106,022
15

and 14.) Thus, Recro’s specification indicates that providing a flat profile, such as 1
Purdue argues would result from a C12/Cmax ratio of 0.55-0.85, would be beneficial 2
in some circumstances, such as with hydrocodone. 3
Purdue argues that paragraph 70 of Recro’s specification was not part of 4
Recro’s provisional application and should not be considered because Recro relied 5
on the date of its provisional application when it provoked this interference. (See 6
Purdue Reply 2, Paper 223, at 5:3-11.) The determination of interference-in-fact is 7
a determination of what the parties’ involved claims encompass, when those claims 8
are construed in light of their currently involved specifications. It is not a 9
determination of whether benefit of an earlier application should be accorded to a 10
party. Once declared with the presumption that the parties’ claims interfere, the 11
burden lies with Purdue to show they do not interfere; the burden does not lie with 12
Recro. 13
Purdue also argues that paragraph 69 of Recro’s specification shows that 14
Recro’s dosage forms require distinct peaks in plasma concentration rather than 15
minimal fluctuations. (See Purdue Reply 2, Paper 223, at 5:12-20, citing Recro 16
’857 appl., Exh. 1014, ¶ 69, FF 15; see also Purdue Motion 2, Paper 144, at 8:15-17
9:4.) Paragraph 69 of Recro’s specification discusses examples of dosage forms 18
with two distinct peaks are beneficial, such as for the drug methylphenidate. 19
Methylphenidate is not hydrocodone nor an opioid, but is used to treat attention 20
deficit disorder by acting as a stimulant. (FF 16; Recro ’857 spec., Exh. 1014, at 21
¶ 18.) Because paragraph 70 specifically refers to hydrocodone and the desirability 22
of minimizing fluctuations in plasma levels, we are not persuaded by Purdue’s 23
argument that paragraph 69 is more relevant. 24
Purdue asserts that other references that reportedly teach avoiding minimum 25
fluctuations for opioids in order to avoid the development of tolerance. (See 26
Purdue Reply 2, Paper 223, at 5:18-20, citing Exh. 1054 at p. 81, left col., ¶ 2.) 27
Interference 106,022
16

This evidence was presented for the first time in Purdue’s Reply Brief, without 1
supporting testimony. Purdue has not persuaded us that oxycodone treatment 2
regimens discussed in these references are more relevant to hydrocodone than 3
those of paragraph 70 of Recro’s specification, which expressly refers to 4
hydrocodone. 5
Purdue also fails to present sufficient evidence that those of skill in the art 6
would not have a reasonable expectation of success in modifying Recro’s claimed 7
subject matter to render Purdue’s claimed subject matter obvious. (See Purdue 8
Motion 2, Paper 144, at 14:6-8.) Though Purdue cites to his testimony, Dr. Taft 9
merely provides the conclusory statement that “a person having ordinary skill in 10
the art would not have had a reasonable expectation of success in obtaining a 11
dosage form capable of providing a C12/Cmax hydrocodone ratio range of 0.55 to 12
0.85 using the teachings of the Recro Claims in view of the prior art.” (See Taft 13
Decl., Exh. 1012, ¶ 129.) Dr. Taft fails to explain why there would be any 14
uncertainty in modifying the components of Recro’s claimed formulations, which 15
are the same as those of Purdue’s claimed formulations, to achieve the plasma 16
concentrations recited by Purdue. 17
Purdue’s other arguments regarding other prior art are also not persuasive. 18
(See Purdue Motion 2, Paper 144, at 15:3-16:3.) The appropriate inquiry to 19
determine interference-in-fact is to compare the parties’ claims by posing each as 20
hypothetical prior art against the other. See 37 C.F.R. § 41.203(a) (“An 21
interference exists if the subject matter of a claim of one party would, if prior art, 22
have anticipated or rendered obvious the subject matter of a claim of the opposing 23
party and vice versa.” (emphasis added).) That some prior art references would not 24
provide a motivation to modify is not persuasive of whether the subject matter of 25
its claims would not have been obvious over the subject matter of Recro’s claims. 26
Interference 106,022
17

In regard to the second prong of the “two-way test” for interference-in-fact 1
between the parties’ claims, Purdue argues that none of its claims anticipate or 2
render obvious any of Recro’s claims. (Purdue Motion 2, Paper 144, at 6:21-13:6.) 3
Again, we are not persuaded. Purdue relies on Dr. Taft’s testimony to argue that a 4
person of ordinary skill would not consider it obvious to modify the dosage form 5
claimed by Purdue to have two peak concentrations separated by a lower blood 6
plasma concentration, as reportedly claimed by Recro. (See FF 17Taft Decl., 7
Exh. 1012, at ¶ 99; Purdue Motion 2, Paper 144, at 11:3-5.) In contrast, the Purdue 8
specification explains that “[c]ertain controlled release formulations provide for 9
related sequential release of a single dose of active compound at predetermined 10
periods of time after administration.” (FF 18, Purdue ’968 appl., Exh. 1026, at 11
¶ 10.) Thus, reading the Purdue claims in view of the specification, we understand 12
them to include formulations having plasma profiles that resemble the profile 13
resulting from sequential release claimed by Recro. 14
In addition to not being persuaded that either prong of the “two-way test” 15
fails when the parties’ claims are compared, we also note that according to 16
Purdue’s witness, Dr. Taft, an embodiment disclosed in Recro’s specification falls 17
within the scope of Purdue’s claimed plasma profile. Specifically, Dr. Taft 18
testifies that the line labeled 20%IR80%SRka=0.3(10mgBID-2pulses) in Figure 2 19
in Recro’s specification (see FF 19) provides two peaks within the dosage interval 20
and that the calculated C12/Cmax of that line appears to be within the scope of 21
Purdue’s claims. (FF 20; Taft Decl., Exh. 1012, ¶ 119.) Thus, according to 22
Dr. Taft, the line labeled 20%IR80%SRka=0.3(10mgBID-2pulses) falls within the 23
scope of Purdue’s claims. 24
Dr. Taft testifies that this line does not provide the plasma profile claimed by 25
Recro, because the line is not “substantially similar” to another line (labeled 26
“SD(5mgqid)” on the graph). (See Taft Decl., Exh. 1012, at ¶ 88; see Purdue 27
Interference 106,022
18

Reply 2, Paper 223, at 9:16-10:2.) We are not persuaded that one line on a graft 1
represents the entire scope of Recro’s claimed plasma profile. Relying on 2
paragraph 69 of Recro’s specification, Purdue argues that Recro’s claimed plasma 3
profile is a “bimodal plasma profile” with a trough between two peak 4
concentrations. (Purdue Motion 2, Paper 144, at 7:14-8:2.) As we explained 5
above, though, paragraph 69 is not necessarily relevant to hydrocodone. Instead, 6
we noted that Recro’s specification contemplates minimizing the fluctuation 7
between peaks and troughs for dosage forms of hydrocodone in paragraph 70. (See 8
FF 12, Recro ’857 appl., Exh. 1014, at ¶ 70; see Recro Opp. 2, Paper 188, at 2:16-9
3:9.) Because Purdue agrees that the line labeled 20%IR80%SRka=0.3(10mgBID-10
2pulses) line of Figure 2 in Recro’s specification results from two doses of 11
immediate release hydrocodone, providing two peaks in the plasma concentration 12
(see FF 20; Taft Decl., Exh. 1012, at ¶ 119), we are not persuaded that it fails to 13
meets the requirements of Recro’s claims. 14
Purdue does not direct us to evidence that this line is an anomaly or is the 15
only line that meets both parties’ claimed limitations. Instead Dr. Taft testifies that 16
“it is possible for a formulation falling within the Recro Claims to provide a 17
C12/Cmax hydrocodone ratio of 0.55 to 0.85 as required by the Purdue Claims . . . .” 18
(FF21, Taft Decl., Exh. 1012, ¶ 128.) Therefore, we consider the line 19
20%IR80%SRka=0.3(10mgBID-2pulses) and others like it to fall within the scope 20
of both parties’ claims. 21
When two parties claim the same formulation, along with limitations that 22
have not been shown to be distinct, an interference-in-fact can exist. See Aelony v. 23
Arni, 547 F.2d 566, 570-71 (C.C.P.A. 1977) (where both parties claim the same 24
process but recite different common Diels-alder dienes holding interference-in-fact 25
because only one patent should issue for one inventive concept). Purdue has not 26
persuaded us that the parties’ claims encompass patentably different inventions. 27
Interference 106,022
19

Nor has Purdue directed us to sufficient evidence to prove that the plasma 1
concentrations recited by both parties are not obvious over each other. We are not 2
persuaded that because the parties express plasma concentrations in different ways 3
an interference-in-fact does not exist. 4
Accordingly, we DENY Purdue Motion 2. 5
6
III. Purdue Motion 1 – For Judgment that Recro’s Claims Lack 7
Written Description Support 8
Purdue argues that all of Recro’s claims are unpatentable under 35 U.S.C. 9
§ 112, first paragraph, because they lack a sufficient written description of the in 10
vitro dissolution profiles and rates recited. (Paper 143.) Recro opposed this 11
argument (Paper 187) and Purdue replied (Paper 222). 12
The test for written description under 35 U.S.C. § 112, first paragraph, “is 13
whether the disclosure of the application relied upon reasonably conveys to those 14
skilled in the art that the inventor had possession of the claimed subject matter as 15
of the filing date.” Ariad Pharm., Inc., v. Eli Lilly & Co., 598 F3d 1336, 1351 16
(Fed. Cir. 2010). It is not enough that a disclosure render a claim obvious. “[T]he 17
subject matter must be disclosed to establish possession.” PowerOasis, Inc. v. T-18
Mobile USA, Inc., 522 F.3d 1299, 1310 (Fed. Cir. 2008). Though the claimed 19
subject matter need not be presented in haec verba in the specification, see Purdue 20
Pharma L.P. v. Fauling Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000), “the missing 21
descriptive matter must necessarily be present in the [original] application's 22
specification such that one skilled in the art would recognize such a disclosure.” 23
Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed.Cir.1998). Thus, the written 24
description must actually or inherently disclose the claim element. Id. 25
Interference 106,022
20

Compliance with the written description requirement of the first paragraph 1
of 35 U.S.C. § 112 is a question of fact. Centocor Ortho Biotech, Inc. v. Abbott 2
Labs., 636 F.3d 1341, 1347 (Fed. Cir. 2011). 3
We cite to the specification of the Recro ’857 application as published on 4
26 October 2006 (Exh. 1014) in the findings of fact and analysis below. 5
6
Findings of Fact 7
22. Recro claim 1 recites a dosage form of hydrocodone, or a salt thereof, 8
that provides an in vitro dissolution profile of the active ingredient in an aqueous 9
medium when measured in a USP Type 1 apparatus (100rpm) such that: 10
at least 25-50% by weight of the hydrocodone is released 11
within four hours, and 12
at least 40-100% by weight of the hydrocodone is released 13
within four to eight hours . . . . 14
15
(Recro Clean Copy of Claims, Paper 11, at 2 (indentations added).) 16
17
23. Recro claim 88 recites a dosage form of hydrocodone that provides an 18
in vitro dissolution profile of the active ingredient in an aqueous medium when 19
measured in a USP Type 1 apparatus (100rpm) such that: 20
at least about 50% by weight of the active ingredient is released 21
after 2 hours, 22
at least about 54% by weight of the active ingredient is released 23
after 4 hours, and 24
greater than about 70% by weight of the active ingredient is 25
released after 8 hours. . . . 26
27
(Recro Clean Copy of Claims, Paper 11, at 3 (indentations added).) 28
29
24. Recro claim 89 recites a dosage form of hydrocodone that provides an 30
in vitro dissolution profile of the active ingredient in an aqueous medium when 31
measured in a USP Type 1 apparatus (100rpm) such that: 32
Interference 106,022
21

at least about 30% to about 50% by weight of the active 1
ingredient is released after 2 hours, 2
at least about 54% to about 56% by weight of the active 3
ingredient is released after 4 hours, and 4
greater than about 64% by weight of the active ingredient is 5
released after 8 hours . . . . 6
7
(Recro Clean Copy of Claims, Paper 11, at 4 (indentations added).) 8
9
25. Recro claim 90 recites a dosage form of hydrocodone that provides a 10
dissolution profile of the active ingredient in an aqueous medium when measured 11
in a USP Type 1 apparatus (100rpm) such that: 12
from 22% to about 51% by weight of hydrocodone [is released] 13
at one hour . . . , 14
at least about 54% to about 56% by weight of the hydrocodone 15
is released after 4 hours, and 16
greater than about 64% by weight of the hydrocodone is 17
released after 8 hours . . . . 18
19
(Recro Clean Copy of Claims, Paper 11, at 5 (indentations added).) 20
21
26. Table 8 provides a dissolution profile for two multiparticulate 22
modified release formulations prepared as provided in Example 3. (Recro 23
’857 appl., Exh. 1014, ¶ 102.) 24
27. Table 8 of the involved Recro ’857 application is reproduced below: 25
Interference 106,022
22

1
2
28. Example 3 of the Recro ’857 application explains the results in 3
Table 8 as “indicat[ing] that about 20 % of the hydrocodone was released in the 4
first hour and about 80% of the hydrocodone was released over a period of about 5
11 hours.” (Recro ’857 appl., Exh. 1014, ¶ 102.) 6
29. Examples 1 and 2 of the Recro ’857 application describe formulations 7
of methylphenidate. (Recro ’857 appl. Exh. 1014, at ¶¶ 79-98.) 8
9
Interference 106,022
23

Analysis 1
Purdue argues that the Recro ’857 application does not describe the range of 2
in vitro dissolution release times recited in Recro’s claims. (Purdue Motion 1, 3
Paper 143, at 7:18-8:2.) According to Purdue, in vitro dissolution is found only in 4
the examples of Recro’s specification and Table 8 provides the only data relevant 5
to hydrocodone and Recro’s claims. (Purdue Motion 1, Paper 143, at 6:17-7:7 and 6
8:3-9:17.) 7
Recro’s claims recite ranges of in vitro dissolution. (FFs 22-25.) As Purdue 8
notes, Table 8 provides dissolution data for only two hydrocodone formulations 9
(with and without fumaric acid) as single percentage points for the times given. 10
(See FFs 26-27; Purdue Motion 1, Paper 143, at 9:13-17.) Purdue argues that, for 11
example, Recro claim 1 recites “at least 25-50% by weight of hydrocodone is 12
released within four hours,” but Table 8 discloses only 54% released at four hours 13
for either hydrocodone formulation. (Purdue Motion 1, Paper 143, 9:20-10:4.) 14
According to Purdue, one data point would not support a range of 25-50%, even if 15
54% fell within that range. (Purdue Motion 1, Paper 143, at 9:24-104.) 16
Similarly, Purdue argues that Recro’s specification does not support the 17
range of 40-100% by weight of hydrocodone released within four to eight hours 18
recited in Recro’s claim 1 because Table 8 provides a highest dissolution rate of 19
77% at eight hours. (Purdue Motion 1, Paper 143, at 10:5-15.) Purdue argues that 20
Recro claims encompass release of at least 40-100% hydrocodone within 4 to 21
8 hours, but that the highest release of any drug described by Recro in the 22
’857 application is 94.8%. (Purdue Motion 1, Paper 143, at 7:21-8:2, citing Recro 23
’857 appl., Exh. 1014, ¶¶ 86-88, 90, and 102, including Tables 3(a)-(c), which 24
provide information regarding dosage forms of methylphenidate.) Purdue also 25
argues that the lower limit of Recro’s claimed range, 40%, is not described at four 26
hours. (Purdue Motion 1, Paper 143, at 10:5-15.) 27
Interference 106,022
24

Purdue presents similar arguments against the dissolution profile ranges 1
recited in Recro’s other independent claims 88, 89, and 90. (Purdue Motion 1, 2
Paper 143, at 11:5-15:3.) 3
Recro opposes Purdue’s argument by asserting that Purdue has improperly 4
construed Recro’s claims. (Recro Opp. 1, Paper 187, at 2:11-21.) According to 5
Recro, description of the release of hydrocodone that is “at least” 25% by the four 6
hour time point, such as release of 31% or 33% at two hours, as reported in 7
Table 8, supports the term “at least 25-50% by weight hydrocodone is released 8
within four hours.” Recro argues further that the report of 54% hydrocodone at 9
four hours in its specification also supports the limitation to “at least 25-50% . . . 10
within four hours.” (Recro Opp. 1, Paper 187, at 2:11-21.) In a similar argument, 11
Recro asserts that the data points of 64% and 68% release at six hours and of 77%, 12
and 73% released at eight hours describes “at least 40-100% by weight of the 13
hydrocodone is released within four to eight hours.” (Recro Opp. 1, Paper 187, at 14
2:22-27.) 15
We are persuaded by Purdue’s argument that the Recro specification does 16
not provide sufficient support for Recro’s claims because it does not describe the 17
full ranges of in vitro release claimed. Disclosure of isolated points within a 18
claimed range is not sufficient description of the entire range under 35 U.S.C. 19
§ 112. See In re Lukach, 442 F.2d 967, 969 (C.C.P.A. 1971) (holding that a single 20
copolymer having a Mw/Mn ratio of 2.6 does not describe the claimed range of 21
from 2.0 to 3.0); see also Atofina v. Great Lakes Chemical Corp., 441 F.3d 991, 22
1000 (Fed. Cir. 2006) (holding that the disclosure of a range is no more a 23
disclosure of the end points of the range than it is of each of the intermediate 24
points). 25
Even if we accepted Recro’s interpretation of its claims and a single point 26
could demonstrate release of “at least” the lower limit of the claimed range within 27
Interference 106,022
25

the time provided, we find nothing to support the recitation of the actual endpoints 1
claimed by Recro. Under Recro’s argument, by including the words “at least,” 2
Recro can claim any range that begins with a point greater than the few data points 3
actually described. This reasoning conflicts with the concept that the written 4
description must show the inventor possessed what is claimed. For example, 5
under Recro’s reasoning (see Recro Opp. 1, paper 187, at 8:1-9), a claimed range 6
of “at least 40-100%” is valid even though Recro’s specification fails to 7
demonstrate that 100% release is obtainable. 8
We are similarly unpersuaded by Recro’s arguments regarding the 9
interpretation of the term “after 2 hours,” “after 4 hours,” and “after 8 hours” in its 10
claims 88, 89, and 90. (See Recro Opp. 1, Paper 187, at 9:21-13:5.) Recro argues 11
that the term “after” is properly interpreted to mean that the dissolution recited is 12
achieved not “at” the time, but “after” it. Thus, according to Recro, data points in 13
Table 8 that provide for less dissolution at the time recited satisfy the written 14
description requirement because further dissolution will occur “after” that time. 15
Again, Recro’s argument is unpersuasive because it would allow for claims to 16
release rates that are merely hypothetical given the data actually presented in the 17
specification. 18
We are also unpersuaded by Recro’s argument that its specification provides 19
sufficient written description for its claim elements because “[t]he Specification 20
. . . not only conveys to one of ordinary skill in the art the structural variations of 21
the claimed formulations, but also the manner that release characteristics of 22
preferred formulations may be adjusted.” (Recro Opp. 1, Paper 187, at 6:15-19; 23
see also, id. 5:10-6:14.) According to Recro, the ’857 specification provides for 24
multiple formulations in Tables 6 and 7 and that additional guidance on levels of 25
coating to delay release of an active ingredient is provided in Tables 3(a) – (c). 26
(Recro Opp. 1, Paper 187, at 5:10-6:14.) 27
Interference 106,022
26

Recro fails to support this argument with sufficient evidence to persuade us 1
that the missing release data would necessarily be present in the specification or 2
that those of skill in the art would recognize this disclosure from the other tables, 3
some of which provide data from a different drug. See Tronzo v. Biomet, Inc., 156 4
F.3d 1154, 1159 (Fed.Cir.1998). Recro’s argument that a person of ordinary skill 5
in the art “would easily see the blazemarks directing him/her to sufficient structural 6
requirement of the claimed dosage form” (Recro Opp. 1, Paper 187, at 6:4-9) is 7
unsupported attorney argument9 and not persuasive. 8
We are persuaded by Purdue’s argument and citations to the Recro ’857 9
specification that Recro’s claims are not supported by a sufficient written 10
description under 35 U.S.C. § 112, first paragraph. 11
Accordingly, we GRANT Purdue Motion 1. 12
13
IV. Recro Motion 6 – To add a claim to Recro’s application 14
In response to Purdue’s challenges to the support in Recro’s specification for 15
its claims, Recro moved to add a new claim to its application and the interference. 16
(Paper 163.) Purdue opposed this addition (Paper 193) and Recro replied 17
(Paper 227.) 18
Recro states that it requests the addition of new claim 95 to its involved 19
’857 application, in response to Purdue’s Motion 1 for lack of written description 20
and Purdue’s Motion 2 for no interference-in-fact. (Recro Motion 6, Paper 163, at 21
1:2-8.) Recro was authorized to file a motion responsive to Purdue Motion 2 22

9 Recro relies on the testimony of Dr. Rekhi only for the generic characteristics of a
person of ordinary skill in the art, not what that person would have actually known
in regard to the structural requirements of the claimed dosage form. (See Recro
Material Fact 68, citing Rekhi Decl., Exh. 2075, at ¶ 27.) Thus, we do not consider
Dr. Rekhi’s testimony to be persuasive evidence of written description support.
Interference 106,022
27

(Order, Paper 152), but the record does not show that Recro requested 1
authorization or that authorization was granted regarding a motion responsive to 2
Purdue Motion 1. Because we deny Purdue Motion 2 for a judgment of no 3
interference-in-fact, we need not consider Recro Responsive Motion 6. 4
Even if we were to consider it, though, we would deny Recro Responsive 5
Motion 6. 6
Recro’s proposed claim 95 recites: 7
A multiparticulate modified release solid oral dosage form of 8
hydrocodone or a pharmaceutically acceptable salt thereof comprising 9
two populations of hydrocodone containing particles, granules, 10
beads or pellets, said two populations comprising 10 mg, 20 mg, 11
30 mg, or 40 mg of hydrocodone or a pharmaceutically acceptable salt 12
thereof, said two populations consisting of 13
a first population of particles, granules, beads or pellets 14
prepared by a method comprising coating sugar spheres of 30/35 mesh 15
as an inert core with a composition comprising about 6.0 % (w/w) of 16
hydrocodone or a pharmaceutically acceptable salt thereof, about 17
1.5 % (w/w) of hydroxypropylmethylcellulose, about 2.0 % (w/w) of 18
silicon dioxide, and about 90.5 % (w/w) of water, and drying the 19
coated sugar spheres, wherein the weight-by-weight percentages, 20
% (w/w), are based on the total of the composition for coating the 21
sugar spheres, wherein the first population of particles, granules, 22
beads or pellets provides an immediate release of hydrocodone, and 23
wherein a size of the first population of particles, granules, beads or 24
pellets is from 0.5 to 0.6 mm, and 25
a second population of particles, granules, beads or pellets 26
prepared by a method comprising coating a portion of the first 27
population of particles, granules, beads or pellets with a composition 28
comprising about 5.5 % (w/w) of an ammonio methacrylate 29
copolymer exhibiting pH independent release properties, about 1.0 % 30
(w/w) of silicon dioxide, about 1.0 % (w/w/) of talc, about 15.0 % 31
(w/w/) of acetone, about 72.5 % (w/w) of isopropyl alcohol, and about 32
5.0 % (w/w) of water, and drying the coated first population of 33
particles, granules, beads or pellets to remove residual solvents, 34
thereby obtaining the second population of particles, granules, beads 35
or pellets having a moisture content of about 3-6%, wherein the 36
Interference 106,022
28

second population of particles, granules, beads or pellets provides a 1
modified release of hydrocodone, 2
wherein said dosage form providing an in vitro dissolution 3
profile of said hydrocodone such that about 54% by weight of the 4
hydrocodone is released within four hours in vitro measured in a USP 5
Type 1 apparatus at 100 rpm, pH of 2.0 and 37º C, 6
wherein said solid oral dosage form comprising 10 mg, 20 mg, 7
30 mg, or 40 mg of said hydrocodone providing a Tmax of the 8
hydrocodone of 6.3, 6.0, 6.3, and 6.1 hours respectively, 9
a Cmax of the hydrocodone of 8.9, 17.9, 31.7, and 37.5 ng/ml, 10
respectively. 11
12
(Recro Motion 6, Paper 163, at 1:15-3:5.) 13
Recro argues, by presenting a claim chart, that proposed claim 95 14
corresponds to Count 1 and to Counts 2 and 3, which it proposes in its pending 15
Motion 1 (Paper 123). (Recro Motion 6, Paper 163, at 3:11-6:26.) Recro asserts 16
that proposed claim 95 is a species of Example 3 falling within the scope of 17
Count 1 and proposed Counts 2 and 3. (Recro Motion 6, Paper 163, at 6:25-26.) 18
“A claim corresponds to a count if the subject matter of the count, treated as 19
prior art to the claim, would have anticipated or rendered obvious the subject 20
matter of the claim.” 37 C.F.R. § 41.207(b)(2). 21
Even if Recro provided more explanation to show that proposed claim 95 is 22
a species of its Example 3 and therefore, must fall within the scope of Count 1 or 23
proposed Counts 2 or 3, which is lacking in Recro’s argument, Recro fails to 24
persuade us that proposed claim 95 would correspond to any of the counts. Recro 25
fails to provide an explanation or to direct us to evidence showing that the subject 26
matter of Count 1 or proposed Counts 2 or 3 would render obvious the subject 27
matter of proposed claim 95. Even if proposed claim 95 is a species of Count 1 or 28
of the proposed counts, which Recro does not state, it is not necessarily anticipated 29
by or rendered obvious by a genus that encompasses it. We note that proposed 30
Interference 106,022
29

claim 95 includes limitations not found in Count 1, for example, “a first population 1
of particles, granules, beads or pellets prepared by a method that includes coating 2
sugar spheres of 30/35 mesh with a composition comprising” hydrocodone, 3
hydroxypropylmethylcellulose, and silicon dioxide. Recro fails to explain why 4
Count 1 anticipates a dosage form with this limitation or renders it obvious. 5
Furthermore, Recro fails to present argument supported with citation to 6
evidence that proposed claim 95 interferes with any of Purdue’s claims. Though 7
Recro argues that the C12/Cmax limitation recited in proposed claim 95 is inherent to 8
the C12/Cmax range of 0.55-0.85 recited in Count 1 and also in Purdue’s claims 9
(Recro Motion 6, Paper 163, at 11:3-12:16), Recro does not present any other 10
comparison between the elements of Purdue’s claims and proposed claim 95. 11
Recro asserts that its proposed claim 95 is “the same patentable invention” as 12
recited in Purdue application ’968 claim 41 (Recro Motion 6, Paper 163, at 17:4-13
but Recro fails to explain why proposed claim 95 would anticipate or render 14
obvious Purdue’s claims and vice versa. See Standing Order ¶ 208.5.1. 15
We are also unpersuaded by Recro’s assertion that claim 95 is narrower in 16
scope than the allowed Recro application claims and therefore is patentable 17
because Recro’s claims were held to be patentable. For example, proposed 18
claim 95 includes the limitation: “in vitro dissolution profile of said hydrocodone 19
such that about 54% by weight of the hydrocodone is released within four hours in 20
vitro dissolution profile of said hydrocodone such that about 54% by weight of the 21
hydrocodone is released within four hours in vitro . . . .” (Recro Motion 6, 22
Paper 163, at 2:23-25.) Recro’s currently involved claims include related, but 23
different limitations on dissolution profiles of within four hours and within four to 24
eight hours (claim 1), after two, four, and eight hours (claims 88 and 89), or after 25
one, four, and eight hours (claim 90). (See Recro Clean Copy of Claims, 26
Paper 11.) Recro does not explain why a limitation to a dissolution profile at only 27
Interference 106,022
30

one time point (four hours) is not broader than a limitation to a dissolution profile 1
at two or three time points. We are not persuaded that Recro’s proposed claim 95 2
is necessarily narrower than Recro’s or Purdue’s allowed, involved claims. 3
Furthermore, Recro has failed to provide certification that it is not aware of any 4
reason why proposed claim 95 is not patentable. 5
Accordingly, we DENY Recro Motion 6. 6
7
V. Recro Motion 5 – For Judgment that Purdue’s Claims Lack 8
Written Description and Enabling Support 9
Recro argues that Purdue’s claims are not supported as required under 10
35 U.S.C. § 112, first paragraph, by Purdue’s specifications. (Paper 140.) Purdue 11
opposed Recro’s arguments (Paper 192) and Recro replied (Paper 218.) 12
Recro argues that the Purdue specifications do not contain a written 13
description of a single dosage form comprising two types of coated 14
pharmaceutically acceptable inert beads, which provides the functional limitations 15
recited. (Recro Motion 5, Paper 140, at 2:19-3:8.) 16
Recro also argues that the specification does not contain an enabling 17
description of these limitations or of the functional limitations regarding in vitro 18
release of hydrocodone or the C12/Cmax hydrocodone ratio recited. (Recro 19
Motion 5, Paper 140, at 3:9-11.) 20
The parties agree that the specifications of the involved ’263 and 21
’968 applications are identical. (Recro Motion 5, Paper 140, at 2:1; Purdue Opp. 5, 22
Paper 192, at 1, n. 1.) We cite to the specification of the ’968 application as 23
published on 24 April 2014 (Exh. 1026) in the findings of fact and analysis below. 24
25
Findings of Fact 26
30. Purdue’s claimed dosage forms require two types of multiparticulates: 27
Interference 106,022
31

[1] “pharmaceutically acceptable inert beads” coated with 1
hydrocodone (or hydrocodone bitartrate), 2
hydroxyproylmethylcellulose, and other ingredients, for immediate 3
release, and 4
5
[2] “pharmaceutically acceptable inert beads” coated with 6
hydrocodone (or hydrocodone bitartrate), ammonio methacrylate 7
copolymer, and other ingredients, for extended or controlled release. 8
9
(Purdue Clean Copy of Claims, Paper 7.) 10
31. Purdue’s claimed dosage forms require specific rates of in vitro 11
release and specific in vivo plasma profiles, for example: 12
wherein the dosage form provides an in-vitro release of from 18% to about 13
42.5% by weight of hydrocodone from the dosage form at one hour when 14
measured by the USP Basket Method at 100 rpm in 700 ml of Simulated 15
Gastric Fluid (SGF) for 55 minutes at 37° C and thereafter switching to 16
900 ml of Simulated Intestinal Fluid (SIF) at 37° C 17
18
and 19
after a first administration to a human patient population, provides a mean 20
C12/Cmax hydrocodone ratio of 0.55 to 0.85 and a therapeutic effect for about 21
12 hours 22
23
(See e.g. id. at 2 (Purdue ’263 appl., claim 1.) 24
25
32. The specifications of the involved Purdue applications provide for 26
formulations of hydrocodone for both immediate and modified release. (See 27
’968 appl., Exh. 1026, ¶¶ 60, 67, 99, and 139-41.) 28
33. The specifications of the involved Purdue applications describe 29
immediate and controlled release hydrocodone as coatings on the surface of 30
substrates of a matrix with hydrocodone incorporated into it. (’968 appl., 31
Exh. 1026, ¶¶ 60 and 67.) 32
34. The specifications of the involved Purdue applications provide for 33
immediate release hydrocodone incorporated into or sprayed onto a gelatin capsule 34
Interference 106,022
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that contains multiparticulate systems such as pellets, spheres, or beads of 1
sustained release hydrocodone. (’968 appl., Exh. 1026, ¶¶ 60, 67, and 99.) 2
35. The specifications of the involved Purdue applications provide for 3
dosage forms including immediate release of therapeutically active agent as 4
separate pellets within a gelatin capsule. (’968 appl., Exh. 1026, ¶ 99.) 5
36. The specifications of the involved Purdue applications describe 6
dosage forms that are a combination of controlled release beads and “matrix 7
multiparticulates.” (’968 appl., Exh. 1026, ¶ 99.) 8
37. The specifications of the involved Purdue applications provide inert 9
pharmaceutical beads, such as nu pariel10 18/20 beads, as substrates for coatings. 10
(’968 appl., Exh. 1026, ¶ 137.) 11
38. The specifications of the involved Purdue applications provide for 12
inert nu pariel 18/20 beads coated with therapeutically active agents and additional 13
ingredients, including hydroxyproylmethylcellulose. (’968 appl., Exh. 1026, 14
¶¶ 139-41.) 15
39. The specification of the involved Purdue applications provide for 16
“other alternative manners of incorporating the immediate release opioid portion 17
into the unit dose.” (’968 appl., Exh. 1026, ¶¶ 60 and 67.) 18
40. Purdue’s specifications provide: 19
Another method of producing controlled release bead 20
formulations suitable for about 24-hour administration is via powder 21
layering. U.S. Patent No. 5,411,745, assigned to the Assignee of the 22
present invention and hereby incorporated by reference in its entirety, 23
teaches preparation of 24-hour morphine formulations prepared via 24

10 The published ’968 Purdue specification provides for “nu pariel 18/20 beads” in
paragraph 137 and “no pariel 18/20 beads in paragraph 139. After comparison to
the ’263 application as filed, we find that the correct term is “nu pariel.” (See ’263
appl., Exh. 2015, at p. 28.)
Interference 106,022
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powder layering techniques utilizing a processing aid consisting 1
essentially of hydrous lactose impalpable. 2
3
(’968 appl., Exh. 1026, ¶ 150.) 4
41. Examples 1-3 of U.S. patent 5,411,745 (“the ’745 patent”) are 5
directed to immediate release beads of morphine sulfate and Examples 4-6, 9, and 6
10 are directed to controlled release beads of morphine sulfate. (’745 patent, 7
Exh. 1013, at 11:45-19:19.) 8
42. Purdue’s specifications provide: 9
Other examples of controlled-release formulations and coatings which 10
may be used in accordance with the present invention include 11
Assignee's U.S. Pat. Nos. 5,324,351; 5,356,467, and 5,472,712, 12
hereby incorporated by reference in their entirety. 13
14
(’968 appl., Exh. 1026, at ¶121.) 15
43. Examples 16 and 17 of U.S. Patent 5,472, (“the ’712 patent”) describe 16
dosage forms of hydromorphone, not hydrocodone. (’712 patent, Exh. 1047, at 17
32:20-34:35.) 18
19
Analysis 20
Recro argues that the Purdue specifications fail to support Purdue’s claims 21
under 35 U.S.C. § 112, first paragraph, because there is no description of a dosage 22
form with the two types of particles recited in Purdue’s claims and no description 23
of a dosage form having the functional limitations recited. (Recro Motion 5, 24
Paper 140, at 3:5-7.) 25
We agree with Recro that the examples of the Purdue specifications do not 26
describe hydrocodone dosages as Purdue claims. (See Recro Motion 5, Paper 140, 27
at 5:13-6:27.) Nevertheless, written description support may be found in portions 28
of the specification other than the working examples. See Centocor Ortho Biotech, 29
Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011) (“we have repeatedly 30
Interference 106,022
34

indicated that the written description requirement does not demand either examples 1
or an actual reduction to practice.”). 2
In general, Recro argues that a sufficient written description must provide 3
more than isolated elements; it must describe the combination of these elements as 4
claimed or provide “blazemarks” for obtaining it. (Recro Motion 5, Paper 140, at 5
7:3-15.) 6
Recro acknowledges that the Purdue specifications describe inert “nu pariel” 7
beads coated with modified release material (see FF 37, ’968 appl., Exh. 1026, 8
¶ 137), but argues that there is no description of inert beads coated with immediate 9
release formulations of hydrocodone, hydroxypropylmethylcellulose, and glidant, 10
as claimed by Purdue. (Recro Motion 5, Paper 140, at 9:1-9, citing Declaration of 11
Professor Anthony Palmieri,11 Exh. 2028, ¶ 18.) Purdue also argues that the 12
description of controlled release hydrocodone on inert beads does not specifically 13
include hydrocodone formulated with ammonio methylacrylate copolymer and 14
glidant, as Purdue claims. (Recro Motion 5, Paper 140, at 9:10-12.) 15
We agree with Recro that the Purdue specifications do not expressly 16
describe a formulation of hydrocodone having two types of inert pharmaceutically 17
acceptable beads coated with hydrocodone formulations. For example, although 18

11 Recro relies on the testimony of Anthony Palmieri. Dr. Palmieri testifies that he
has a Ph.D. in Pharmaceutics and is currently an Adjunct Professor in the College
of Pharmacy at the University of Florida, Department of Pharmaceutics. (Palmieri
Decl., Exh. 2028, at ¶¶ 1 and 2.) He testifies further that he has worked and taught
in the field of pharmacy for over 35 years and has authored over 80 publications in
that field. (Id. at ¶¶ 1 and 5.) He testifies that he is on the editorial board of
research journals in the pharmaceutical field and has received honors in the field.
(Id. at ¶ 3.) Dr. Palmieri is qualified to provide opinion testimony as an expert
witness based on his scientific, and technical knowledge about the subject matter
of the interference.

Interference 106,022
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Purdue cites to paragraphs 60 and 66-68 of the ’968 application as explaining that 1
a dosage form may comprise both immediate release and controlled release 2
multiparticulates in a capsule, these paragraphs describe overcoating the different 3
release formulations on top of each other not combining two populations of beads. 4
These paragraphs describe layers of different hydrocodone formulations, such as 5
an immediate release formulation formulated as a “powder or granulate,” or as a 6
coating on a gelatin capsule that contains the controlled release formulations. (See 7
FFs 32-37, ’968 appl., Exh. 1026, at ¶¶ 60, 66-68, 99, and 137; see Purdue Opp. 5, 8
Paper 192, at 4:10-23.) The paragraphs do not, though, describe separate particles 9
of inert beads coated with the each different formulation together in one dosage 10
form. 11
Purdue argues that its specifications explain that “other alternative manners 12
of incorporating the immediate release opioid portion into the unit dose” are 13
contemplated in the invention (See FF 39, ’968 appl., Exh. 1026, at ¶¶ 60 and 67; 14
see Purdue Opp. 5, Paper 192, at 4:20-23 and 6:20-23.) Purdue also argues that the 15
description of overcoating controlled release material on an immediate release 16
bead is described as only an optional embodiment, thus allowing for a separate 17
immediate release formulation on a coated bead instead. (Purdue Opp. 5, 18
Paper 192, at 5:8-6:2, citing ’969 appl., Exh. 1026, at ¶¶ 139-41; FF 38.) We are 19
not persuaded that portions of these Purdue specifications are sufficient to fulfill 20
the requirements of 35 U.S.C. § 112, first paragraph. Neither portion demonstrates 21
possession of the specific invention claimed. 22
Purdue argues further that the patents incorporated by reference into the 23
specifications of its involved applications provide written description support for 24
the claimed dosage forms. Purdue cites to the incorporation by reference of 25
U.S. Patent 5,411,745 (“the ’745 patent”). According to Purdue, the ’745 patent 26
expressly describes inert beads coated with agents such as 27
Interference 106,022
36

hydroxypropylmethylcellulose and that the examples are directed to immediate 1
release beads and controlled release beads. (Purdue Opp. 5, Paper 192, at 8:17-9:4; 2
’968 appl., Exh. 1026, at ¶ 121 and ’745 patent, Exh. 1013; see FFs 40-41.) The 3
examples of the ’745 patent describe dosage forms of inert beads coated with either 4
an immediate formulation of hydrocodone and or a modified release formulation, 5
but not both. Furthermore, the examples of the ’745 patent describe dosage forms 6
of morphine sulphate, not hydrocodone. (See ’745 patent, Exh. 1013, at 11:44-7
20:22; FF 41.) 8
Purdue argues further for written description support in its specifications by 9
relying on the incorporation by reference of U.S. Patent 5,472,712 (“the 10
’712 patent”). (Purdue Opp. 5, Paper 192, at 7:16-8:13, citing ’968 appl., 11
Exh. 1026, at ¶ 121; FF 42.) According to Purdue, the ’712 patent expressly 12
describes a combination of immediate release and controlled release beads in one 13
dosage form in Examples 16-17. As Recro notes, though, the dosage forms of 14
these examples include hydromorphone, not hydrocodone. (Recro Reply 5, 15
Paper 218, at 4:2-3; FF 43.) 16
Like the descriptions of the ’745 patent, we are not persuaded that the 17
’712 patent sufficiently describes the specific dosage forms Purdue claims. The 18
descriptions do not recite the actual elements of Purdue’s claims, most notably 19
inert beads coated with hydrocodone. Instead, the examples of both the ’745 and 20
’712 patent describe formulations of different drugs: morphine sulfate in the 21
’745 patent and hydromorphone in the ’712 patent. 22
Purdue argues: 23
One of skill in the art would understand that although the in vivo 24
parameters achieved by a formulation in the body would vary greatly 25
from, for example hydromorphone or morphine to hydrocodone, 26
formulation techniques control the time of release of the drug from the 27
dosage form and such technology is readily transferable between 28
Interference 106,022
37

different drugs, particularly drugs within the same class such as 1
opioids. 2
3
(Purdue Opp. 5, Paper 192, at 10:9-13.) Similarly, in regard to formulations of 4
hydrocodone not expressly described in Purdue’s specifications, Purdue argues that 5
those of skill in the art would have known how to provide different embodiments 6
of the invention by a “wide variety” of known controlled release formulations. 7
(Purdue Opp. 5, paper 192, at 11:7-9, citing ’968 appl, Exh. 1026, at ¶ 59.) Purdue 8
also argues that its involved specifications recite the claimed in vitro and in vivo 9
dissolutions rates. (Purdue Opp. 5, Paper 192, at 11:3-7 and 11:19-12:14, citing 10
Purdue ’968 appl., Exh. 1026, at ¶¶ 17-19.) According to Purdue, the 11
specifications demonstrate that those of skill in the art would have known how to 12
vary elements of the disclosed dosage forms, including the thickness of a coating, 13
the amount of overcoating, and the manner in which a coating is made, to arrive at 14
dosage formulations with the claimed in vitro and in vivo functional limitations. 15
(See Purdue Opp. 5, Paper 192, at 11:9-18, citing ’968 appl., Exh. 1026 ¶ 138.) 16
We are not persuaded because Purdue’s argument is that the specific dosage 17
forms claimed would have been obvious in view of what was described in the 18
Purdue specifications. That is, Purdue argues that one of skill in the art would 19
have known how to formulate the claimed hydrocodone dosage forms, even if the 20
specifications of the involved applications, the ’745 patent, and the ’712 patent do 21
not provide a specific description. 22
The written description requirement of 35 U.S.C. § 112 is not fulfilled by a 23
demonstration that the claimed subject matter would have been obvious over the 24
disclosure, but is fulfilled only when the disclosure demonstrates the specific 25
subject matter was in the possession of the inventors. See Lockwood v. Am. 26
Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (“The question is not whether 27
a claimed invention is an obvious variant of that which is disclosed in the 28
Interference 106,022
38

specification. Rather, a prior application itself must describe an invention, and do 1
so in sufficient detail that one skilled in the art can clearly conclude that the 2
inventor invented the claimed invention as of the filing date sought.”) Arguments 3
that skilled artisans could have invented the claimed subject matter themselves 4
does not show that the named inventors did so. 5
Because we agree that the Purdue specifications do not describe the specific 6
hydrocodone dosage forms claimed by Purdue, we agree with Recro that Purdue’s 7
claims are unpatentable under 35 U.S.C. § 112, first paragraph. 8
Accordingly, we GRANT Recro Motion 5. 9
10
VI. Conclusion 11
We deny Purdue filed Motion 2 (Paper 144) that there is no interference-in-12
fact between the parties’ claims. 13
We grant Purdue Motion 1, arguing that Recro’s involved claims are 14
unpatentable under 35 U.S.C. § 112, first paragraph. 15
We deny Recro Motion 6, arguing that, contingent on the grant of Purdue 16
Motion 2 and Purdue Motion 2, Recro be allowed to add a new claim to its 17
application and to the interference. 18
We grant Recro Motion 5, arguing that Purdue’s involved claims are 19
unpatentable under 35 U.S.C. § 112, first paragraph. 20
Because we hold that both Recro’s and Purdue’s involved claims are 21
unpatentable, there is no reason to make a determination of patentability of either 22
party’s claims under 35 U.S.C. § 102(g). Accordingly, we terminate the 23
interference. Judgment will be entered separately. 24

Interference 106,022
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cc (via e-mail): 1
2
Attorneys for junior party Recro Technology, LLC 3
4
FOX ROTHSCHILD, LLP 5
Shahnam Sharareh 6
Jeff E. Schwarz 7
ssharareh@foxrothschild.com 8
jeschwartz@foxrothschild.com 9
10
Paul K. Legaard 11
Daniel M. Scolnick 12
legaardp@pepperlaw.com 13
scolnickd@pepperlaw.com 14
15
Richard Kelly 16
Marina Miller 17
rkelly@oblon.com 18
mmiller@oblon.com 19
20
Attorneys for senior party Purdue Pharma, LP 21
22
DAVIDSON, DAVIDSON & KAPPEL, LLC 23
Clifford M. Davidson 24
Cary S. Kappel 25
Leslye B. Davidson 26
Oleg Ioselevich 27
cdavidson@ddkpatent.com 28
ckappel@ddkpatent.com 29
ldavidson@ddkpatent.com 30
oioselevich@ddkpatent.com 31
ddk@ddkpatent.com 32
33
Brian P. O’Shaughnessy 34
boshaughnessy@ratnerprestia.com 35
36