Mathad et al.v.Sawant et al.

Patent Trials and Appeals Board

Sep 18, 2014

12294986 - (J) (P.T.A.B. Sep. 18, 2014)

1

BoxInterferences@uspto.gov Paper 159
Telephone: 571-272-4683 Entered: 18 September 2014

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Patent Interference 105,927 McK
Technology Center 1600
____________________

DR. REDDY’S LABORATORIES LTD. (INDIA)
and DR. REDDY’S LABORATORIES, INC. (US),

Patent 8,217,039 B2,
Junior Party,

v.

GLENMARK GENERICS LTD.,

Application 12/223,514
Senior Party.
____________________

Before: FRED E. McKELVEY, RICHARD E. SCHAFER, and
SALLY GARDNER LANE, Administrative Patent Judges.

McKELVEY, Administrative Patent Judge.

JUDGMENT
In view of the Decision on Motions (Paper 86) and the Decision on Priority 1
(Paper 158), it is 2
2

ORDERED that judgment be entered against junior party DR. REDDY’S 1
LABORATORIES LTD. (INDIA) and DR. REDDY’S LABORATORIES, INC. 2
(US) for Counts 3 and 4 (Paper 80.001, pages 3 and 5); 3
FURTHER ORDERED that claims 1-25 of DR. REDDY’S 4
LABORATORIES LTD. (INDIA) and DR. REDDY’S LABORATORIES, INC. 5
(US)'s involved U.S. Patent 8,217,039 B2 be CANCELED, 35 U.S.C. 135(a); 6
FURTHER ORDERED that a copy of this judgment be entered in the 7
administrative records of the involved patent 8,217,039 B2 and the involved 8
application 12/223,514; and 9
FURTHER ORDERED that a party seeking judicial review timely serve 10
notice on the Director of the United States Patent and Trademark Office. 11
37 C.F.R. §§ 90.1 and 104.2. 12
NOTICE: "Any agreement or understanding between parties to an 13
interference, including any collateral agreements referred to therein, made in 14
connection with or in contemplation of the termination of the interference, 15
shall be in writing and a true copy thereof filed in the Patent and Trademark 16
Office before the termination of the interference as between the said parties 17
to the agreement or understanding." 35 U.S.C. 135(c); see also Bd.R. 205 18
(settlement agreements). 19
3

cc (via electronic transmission): 1
2
Attorneys for Reddy: 3
Arnold H. Krumholz 4
Michael H. Teschner 5
Lerner, David, Littenberg, 6
Krumholz & Mentlik, LLP 7
akrumholz@ldlkm.com 8
mteschner@ldllm.com 9
10
Attorneys for Glenmark: 11
12
Jay P. Lessler 13
Joel Dion 14
Blank Rome, LLP 15
jlessler@blankrome.com 16
dion-j@blankrome.com 17

1

BoxInterferences@uspto.gov Paper 158
Telephone: 571-272-4683 Entered: 18 September 2014

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Patent Interference 105,927 McK
Technology Center 1600
____________________

DR. REDDY’S LABORATORIES LTD. (INDIA)
and DR. REDDY’S LABORATORIES, INC. (US),

Patent 8,217,039 B2,
Junior Party,

v.

GLENMARK GENERICS LTD.,

Application 12/223,514
Senior Party.
____________________

Before: FRED E. McKELVEY, RICHARD E. SCHAFER, and
SALLY GARDNER LANE, Administrative Patent Judges.

McKELVEY, Administrative Patent Judge.

DECISION
Priority
37 C.F.R. § 41.125

2

I. Introduction 1
The interference is before a merits panel for decision on priority. 2
Oral argument was requested by Glenmark. Paper 114. 3
We have determined that oral argument is not necessary. 4
II. Junior Party 5
The junior party is Dr. Reddy’s Laboratories Ltd. (India) and Dr. Reddy’s 6
Laboratories, Inc. (US) (hereinafter “Reddy”). Paper 5. 7
The junior party is involved on the basis of U.S. Patent 8,217,039 B2 8
(Ex. 2001), issued 10 July 2012, based on U.S. application 12/294,986, filed in the 9
PTO on 29 Sept. 2008 (application published as U.S. Patent Application 10
Publication 2010/0298327 A1 on 25 Nov. 2010). 11
The junior party has been accorded a constructive reduction to practice as of 12
29 Mar. 2006 based on U.S. Provisional Application 60,787,107. Paper 87, page 4. 13
III. Senior Party 14
The senior party is Glenmark Generics, Ltd. Paper 14. 15
The senior party is involved on the basis of U.S. application 12/223,514, 16
filed in the PTO on 22 Sept. 2008 (application published as U.S. Patent 17
Application Publication 2009/0192161 A1 on 30 July 2009). 18
The senior party has been accorded a constructive reduction to practice as of 19
07 Feb. 2006 based on Indian patent application 184/MUM/2006. 20
IV. Counts—Subject Matter of the Interference 21
There are two counts in the interference—Count 3 (substituted for original 22
Count 1) and Count 4 (substituted for original Count 2). First Redeclaration, 23
Paper 80.001, pages 3 and 5. 24
3

A. Count 3 1
A crystallized intimate mixture of aprepitant crystalline Form I 2
and crystalline Form II1 3
or 4
a crystalline polymorphic mixture, comprising at least about 5 weight 5
%, based on the total weight of the mixture, of polymorph Form I or 6
Form II of aprepitant, with the remaining amount of the mixture being 7
the other polymorph form of aprepitant, wherein the crystallization 8
polymorphic mixture has a D90 particle size of less than about 50 9
microns.2 10
B. Count 4 11
A process for preparing a crystallized intimate mixture of 12
aprepitant crystalline Form I and crystalline Form II, comprising: 13
(1) providing a solution comprising aprepitant and a suitable 14
solvent; 15
(2) removing solvent from the solution to form a solid; and 16
(3) drying the formed solid3 17
or 18
a process for the preparation of a crystallization polymorphic mixture, 19
comprising at least about 5 weight % based on the total weight of the 20

1 Based on Reddy Claim 1.

2 Based essentially on Glenmark Claim 46.

3 Based essentially on Reddy Claim 14. Language “optionally,” has been
eliminated from Reddy Claim 14.

4

mixture, with the remaining amount of the mixture being the other 1
polymorph form of aprepitant, wherein the crystallization 2
polymorphic mixture has a D90 particle size of less than about 50 3
microns, the process comprising: 4
(1) providing a solution of aprepitant in one or more solvents 5
capable of dissolving the aprepitant; 6
(2) adding an anti-solvent to the solution; and 7
(3) isolating the polymorphic mixture.4 8
V. Reddy Priority Motion 9
Reddy Motion 3 seeks entry of judgment based on priority. Paper 93. 10
Glenmark opposed. Paper 100. 11
Reddy replied. Paper 110. 12
Glenmark did not seek to establish a date of invention prior to any date 13
which Reddy might establish via Reddy Motion 3. 14
VI. Issue and Non-issues 15
A. Issue 16
The issue before us is whether Reddy has sustained its burden of 17
establishing an actual reduction to practice prior to Glenmark’s constructive 18
reduction to practice of 26 March 2006. 19
B. Non-issues 20
1. Corroboration 21
In resolving priority in an interference, we consider the issues presented to 22
us for consideration. See Brand v. Miller, 487 F.3d 862, 869 (Fed. Cir. 2007 (in an 23

4 Based essentially on Glenmark Claim 53 re-written in independent form.

5

interference the Board's role is one of an impartial adjudicator of an adversarial 1
dispute between two parties). 2
The sole witness for Reddy is a named inventor—Dr. Raviram C. Elati. 3
Much of the documentary evidence relied upon by Dr. Elati consists of 4
laboratory notebooks and reports of testing done and recorded by others. 5
Glenmark has not challenged Reddy’s proof based on lack of corroboration. 6
Hence, “corroboration” based on a lack of testimony of a non-inventor is not 7
an issue raised by Glenmark for our consideration. 8
2. Admissibility of evidence 9
Much of the evidence presented by Reddy has not been authenticated in the 10
usual manner and in any event is hearsay. 11
Glenmark has not filed a motion to exclude (37 C.F.R. § 41.155(c)) based on 12
hearsay (Fed. R. Evid. 802) or lack of authentication (Fed. R. Evid. 901(a)).5 13
Admissibility of evidence is not an issue Glenmark has raised before us. 14
All evidence offered by Reddy is admitted into evidence. 15
However, we assign to the admitted evidence, including hearsay evidence, 16
the weight to which we believe it is entitled. 17

5 An objection to admissibility of evidence is made within five business days of
service of the evidence. 37 C.F.R. § 41.155(b)(1). If an objection is made, the
party relying on the evidence may file supplemental evidence to attempt to
overcome the objection. 37 C.F.R. § 41.155(b)(2). If an objection is made, a
motion to exclude must be filed to preserve the objection. 37 C.F.R. § 41.155(c).
A decision on the part of Glenmark not to object to the admissibility of evidence
may have formed part of Glenmark’s litigation strategy. For example, an objection
may not have been made because Glenmark may have felt that the evidence was
not sufficient on the merits to prove Reddy’s case. Also, by not objecting
Glenmark eliminated a possibility of Reddy filing supplemental evidence,
including testimony of individuals who conducted experiments and testing.

6

3. Indefiniteness of Reddy Claims 1
Glenmark maintains that the involved Reddy claims are unpatentable under 2
35 U.S.C. § 112 as indefinite. Paper 100, page 4:12 to page 18:4. 3
Glenmark was authorized to discuss indefiniteness as to language in the 4
courts as part of its opposition to Reddy Motion 3. Paper 91, page 2:22-23 and 5
page 3:18 to page 4:2. 6
In resolving priority we will adopt the meaning of “crystalline intimate 7
mixture” urged by Reddy. 8
Because under that meaning Reddy does not prevail on priority, there is no 9
occasion to further determine whether the involved Reddy claims are unpatentable 10
under § 112 for indefiniteness. 11
Accordingly, patentability based on indefiniteness is not an issue before us. 12
VII. Burden and standard of proof 13
Reddy has a burden of establishing priority. 37 C.F.R. §§ 41.207(a) and 14
41.208(b) (2013). 15
The standard of proof is preponderance of the evidence. 37 C.F.R. 16
§ 41.207(b) (2013). 17
Priority is established by filing a motion for judgment based on priority. 18
37 C.F.R. §§ 41.121 and 41.208 (2013). 19
In this case, that motion is Reddy Motion 3. Paper 93. 20
VIII. Background 21
A. Invention 22
The subject matter of the counts relates to a “mixture” of (1) crystalline 23
Form I of aprepitant and (2) crystalline Form II of aprepitant and a method for 24
making the “mixture”. 25
7

Reddy characterizes the “mixture” as an “intimate mixture”. Ex. 2001, 1
col. 2:35-37. 2
The Reddy patent defines “intimate mixture” as a “mixture of aprepitant 3
polymorphs Form I and Form II in any desired ratio [that] has an evenly dispersed, 4
uniform and stable mixture of the polymorphs and has the same composition of 5
polymorphs throughout the mixture.” Ex. 2001, col. 4:5-9. 6
The Reddy patent defines “stable” as follows: 7
The term "stable" is used to describe an intimate mixture of 8
aprepitant Form I and Form II that maintains an initial weight 9
ratio of forms during formulation into a pharmaceutical dosage 10
form and thereafter during a commercially useful period of 11
normal storage and use, such as about one year, about 18 12
months, about two years, or any other desired period. Stability 13
is typically indicated by maintenance of the weight ratio of 14
forms during stability testing, involving storage under standard 15
conditions, such as those described in Test 1150 16
"Pharmaceutical Stability," United States Pharmacopeia 29, 17
United States Pharmacopeial Convention, Inc., Rockville, Md., 18
2005, at pages 2994-2995 [Ex. 20536]. Stability testing 19
procedures are well known in the pharmaceutical industry. 20

6 In our Decision on Motions, we said:

Reddy should present as an exhibit Test 1150 "Pharmaceutical
Stability," United States Pharmacopeia 29, United States
Pharmacopeia Convention, Inc., Rockville, Md., 2005, at pages 2994-
2995, mentioned in Ex. 2001, col. 4:26-28.

Paper 86, page 19:20-22. Reddy has offered in evidence [Ex. 2053] what may be a
different version of United States Pharmacopeia, i.e., United States Pharmacopeia
28 (2005), containing pages 2699-2701, as well as pages numbered 2994-2995 (the
relevancy of which is not apparent). Reddy indicates that relevant material appears
on page 2700 (“Stability Protocols”) of the 28 version (Paper 93, page 15:13-29;
Glenmark also refers to page 2700 (“Controlled Room Temperature”) of the 28
8

Ex. 2001, col. 4:18-29. 1
B. Form I and Form II of aprepitant 2
Both parties identify aprepitant as a chemical having the name 5-[[(2R,3S)-3
2-[(1R)-1-[3,5-bis(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)-4-4
morpholinyl]methyl]-1,2-dihydro-3H-1,2,4-triazol-3-one, and having the structure 5
represented by Formula I, reproduced below. Ex. 1001 ¶ 0005 and Ex. 2001, 6
col. 1:14-16. 7

Formula I
Depicted is a chemical structure for aprepitant
Aprepitant can also be named 2-(R)-(1-(R)-3,5-bis(trifluoromethyl)-8
phenyl)ethoxy-3-(S)-(4-fluoro)phenyl-4-(3-(5-oxo-1H,4H-1,2,4-9
triazolo)methylmorpholine. Ex. 1004, col 3:1-20. 10

version (Paper 100, page 22:1-6). The parties appear to be content with citing and
relying on the 28 version. We will do likewise and assume that the 28 version is
sufficiently close to the 29 version cited in the patent to be relied upon in resolving
priority in this interference.

9

Fig. 1 of U.S. Patent 6,096,742 (Ex. 1004), reproduced below, is an X-ray 1
diffraction pattern of Form I of aprepitant. 2

Depicted is Fig. 1 of U.S. Patent 6,096,742—X-ray
diffraction pattern of Form I of aprepitant
Form I of aprepitant can be characterized by key reflections at 3
approximately: 12.0, 15.3, 16.6, 17.0, 17.6, 19.4, 20.0, 21.9, 23.6, 23.8, and 24.8º 4
(2 θ) of the diffraction pattern. Ex. 1004, col. 4, ll. 59-64. 5
Fig. 2 of U.S. Patent 6,096,742 (Ex. 1004), reproduced below, is an X-ray 6
diffraction pattern of Form II of aprepitant. 7
10

1
Depicted is Fig. 2 of U.S. Patent 6,096,742—X-ray 2
diffraction pattern of Form II of aprepitant 3
Form II can be characterized by with key reflections at approximately: 4
12.6, 16.7, 17.1, 17.2, 18.0, 20.1, 20.6, 21.1, 22.8, 23.9, and 24.8º (2 θ) of the 5
diffraction pattern. Ex. 1004, col. 4, l. 65 to col. 5, l. 3. 6
Figs. 1 and 2 are said to represent X-ray diffraction patterns generated with a 7
Philips model APD 3720 powder diffractometer equipped with a 3 kw X-ray 8
generator (CuKα1 radiation) and a NaI (Ti) scintillation detector. Measurements 9
are said to have been made from 3º to 45º (2 θ). Ex. 1004, col. 4, ll. 52-56. 10
C. Methods for making Form I and Form II 11
The Reddy patent describes alternate distillation and anti-solvent processes 12
for making its product as follows (Ex. 2001, col. 2, ll. 46-60): 13
11

In an embodiment, a process for the preparation of an 1
intimate mixture of aprepitant polymorphic Form I to Form II, 2
in a ratio of either form to the other as desired, comprises: 3

a) providing a solution comprising aprepitant and a 4
suitable solvent; 5

b) removing solvent from the solution; and 6

c) optionally, drying a formed solid. 7

Another embodiment . . . provides a process for the 8
preparation of an intimate mixture of aprepitant polymorphic 9
Form I to Form II in a desired ratio of either form to the other, 10
comprising: 11

a) providing a solution comprising aprepitant and a 12
suitable solvent; 13

b) combining an anti-solvent with the solution of a); and 14

c) optionally, drying a solid formed in b). 15
IX. Analysis 16
A. Meaning of “crystalline intimate mixture” 17
Counts 3 and 4 define the subject matter of the interference in 18
alternative fashion. 19
The first alternative of each count is based on Reddy’s patent. 20
Reddy attempts to establish an actual reduction to practice based on 21
the first alternative of the counts. 22
Each alternative uses the language “crystalline intimate mixture.” 23
The parties have a difference of opinion on the meaning of 24
“crystalline intimate mixture.” 25
12

For the purpose of deciding Reddy Motion 3, as noted earlier we elect 1
to adopt the meaning of “crystalline intimate mixture” urged by Reddy. 2
An intimate mixture is an evenly dispersed, uniform and stable 3
mixture of aprepitant polymorph Form 1 and aprepitant polymorph Form II 4
in any desired ratio having an evenly dispersed, uniform and stable mixture 5
of the polymorphs and has the same composition of polymorphs throughout 6
the mixture. Paper 93, page 5:11-14. 7
A “stable” mixture is one that maintains an initial weight ratio of 8
Form I and Form II (1) during formulation into a pharmaceutical dosage 9
form and (2) thereafter during a commercially useful period of normal 10
storage and use, such as about one year. Paper 93, page 5:19-21. 11
According to the Reddy patent, stability is typically indicated by 12
maintenance of the weight ratio of From I and Form II during stability 13
testing, involving storage under standard conditions, such as those described 14
In United States Pharmacopia 29, pages 2994-2995 (Ex. 2053). Paper 93, 15
page 5:22-26. 16
B. “Actual Reductions to Practice” 17
1. Introduction 18
Reddy relies on a series of experiments, each of which is said to be an 19
actual reduction to practice. 20
Those experiments include the following. 21
13

Experiments
Experiment
Number
Experiment
Date
Motion 3 page
where discussed
APT/D568/IXD/02 29 July 2005 11:4-12:21
APT/D791/I/09 2 August 2005 12:22-13:17
APT/D843/VIII/33 27 September 2005 14:1-16:21
APT/D843/VIII/34 27 September 2005 16:22-17:17
APT/D843/VIII/35 27 September 2005 17:18-18:16
APT/D843/VIII/36 27 September 2005 18:17-19:13
APT/D843/VIII/37 27 September 2005 19:14-20:11
APT/D843/VIII/38 27 September 2005 20:12-21:8
APT/EO23/IX/21 28 January 2006 21:9-22:2

2. Experiment APT/D568/IXD/02 1
Reddy relies on the testimony of a named inventor: Dr. Raviram C. 2
Elati (Dr. Elati) (Ex. 2012). 3
Dr. Elati was cross-examined. Ex. 1014. 4
In 2005-2007, Elati was a “process chemist” at Dr. Reddy’s 5
Laboratories Ltd. Ex. 2012, ¶ 1. 6
In his capacity as a process chemist, Dr. Elati had “direct supervision 7
and control of . . . activities carried out by . . . [Reddy] chemists involved 8
with aprepitant, including . . . [1] [S.] Rao, as well as [2] N. Anitha, 9
[3] N. Venu and [4] A. Muthulingam . . . [as well as] appropriate guidance 10
related to their experimental work.” Ex. 2012, ¶ 5:1-3. 11
14

S. Rao, N. Anitha, N. Venu, and A. Muthulingam were not called as 1
witnesses on behalf of Reddy. 2
On or about 29 July 2005, S. Rao is said to have carried out an 3
experiment under Dr. Elati’s “direct supervision and control.” 4
Ex. 2012, ¶¶ 5-6, Ex. 2013, Ex. 2014, and Ex. 2015 contain 5
discussion and entries which are reasonably consistent with Dr. Elati’s 6
description of the following events. 7
Beginning at about 8:50 a.m., a “mixture” was prepared by mixing 8
(1) 3.0 grams of APT-VIID and (2) 9.0 ml of dimethylformamide (DMF) 9
into a clean and dry round-bottomed flask. Ex. 2012, ¶ 6:22-24; Ex. 2013 10
(S.No. 1 and 2; Instructions, line 1)). 11
APT-VIID is said to be a precursor intermediate of aprepitant, 12
prepared on or about 24 July 2005 and whose structure is said to have been 13
confirmed on 6 August 2005. Ex. 2012, ¶ 5:10-13 and 15-19. 14
Dr. Elati’s testimony is based on a laboratory notebook of S. Rao. 15
The mixture was then stirred for 5-10 minutes to prepare a “reaction 16
mass”. 17
Thereafter, 1.034 grams of K2CO3 (potassium carbonate) were added 18
to the “reaction mass.” 19
The next step involved dissolving 1.1 grams of a “triazole derivative” 20
(a/k/a “triazoline derivative”) in 3.0 ml DMF to prepare a dissolved mixture 21
and then adding the “dissolved mixture” to the reaction mass while stirring. 22
The triazole derivative is said to have the formula: 23
15

We note that the structural formula is not complete. The valance of 3 1
of the nitrogen (N) attached to a double bond (══) is not satisfied. 2
Likewise, the valance of 3 of the NH moiety attached to a single bond 3
(──) is not satisfied. 4
Accordingly, it is not clear how the structure set out in Dr. Elati’s 5
testimony accurately depicts a specific triazole derivative (Ex. 2012, 6
page 3:1) or a specific “tirazoline derivative” (Ex. 2012, page 3:10). 7
As a next step, 30 ml of de-mineralized (DM) water were added to 8
form a “reaction solution”. 9
The reaction solution was then cooled to 0-5 ºC with stirring. 10
Cooling and stirring continued for about 3-4 hours. 11
According to Dr. Elati, “[t]he reaction solution was checked by thin 12
layer chromatography (TLC)” which is said to have “confirmed [the reaction 13
solution] to be a solution of aprepitant.” Ex. 2012, page 3:4-6. 14
Following analysis of the reaction solution, 15
and based on [a] review of . . . XRD [X-ray diffraction] results 16
by . . . [Dr. Elati] along with the chemists working on . . . [the] 17
project, and as I observed on page 240 of Laboratory Notebook 18
No. D568 (Exhibit 2013 . . .) . . ., [the] analytical results 19
16

confirmed the fact that a crystallized intimate mixture of 1
crystalline Form 1 and Form II of aprepitant was produced . . . . 2

Ex. 2012, page 4:1-5. 3
The Laboratory Notebook states: 4
Remarks: Yield to be improved further. XRD of the product 5
obtained is matching with mixture of Form I: Form II (1:1). 6
7
Conclusion: product confirmed on the basis of mass, 1HNMR 8
[hydrogen-1 nuclear magnetic resonance]. Addition of 9
acetonitrile to the crude syrup of aprepitant results in 10
precipitation of 1:1 mixture of aprepitant. 11

We pause from our discussion of Experiment APT/D568/IXD/02 to 12
analyze the need for testing to determine whether a mixture is a crystalline 13
intimate mixture having the necessary uniformity and stability. 14
We have more to say about Experiment APT/D568/IXD/02 later in 15
this opinion. 16
3. Need for Testing for Intimate Mixture and Stability 17
Establishment of an actual reduction to practice requires that a party show 18
that every limitation of the interference count must exist in an embodiment and the 19
embodiment must have performed as intended. Eaton v. Evans, 204 F.3d 1094, 20
1097 (Fed. Cir. 2000) (to establish an actual reduction to practice, it must be shown 21
that (a) the party constructed an embodiment that met every element of the count 22
and (b) the embodiment operated for its intended purpose; "there can be no actual 23
reduction to practice if the constructed embodiment . . . lacks an element recited in 24
the count . . . .”; Estee Lauder, Inc. v. L'Oreal, S.A., 129 F.3d 588, 593 (Fed. Cir. 25
1997); Newkirk v. Lulejian, 825 F.2d 1581, 1582 (Fed. Cir. 1987). 26
17

An evaluation of whether testing is sufficient to establish an actual reduction 1
to practice is made on a case-by-case basis. Scott v. Finney, 34 F.3d 1058, 1061 2
(Fed. Cir. 1994); Gordon v. Hubbard, 347 F.2d 1001, 1006 (CCPA 1965); Blicke 3
v. Treves, 241 F.2d 718, 720 (CCPA 1957). 4
An inquiry into the sufficiency of testing is not what kind of test was 5
conducted, but whether the test conducted shows that the invention would work as 6
intended in its contemplated use. Scott v. Finney, 34 F.3d 1058, 1061 (Fed. Cir. 7
1994); Eastern Rotocraft Corp. v. United States, 384 F.2d 429, 431 (Ct.Cl. 1967). 8
Any evaluation should be guided by a common sense approach, applying a 9
"reasonableness standard," in weighing the sufficiency of any testing. Scott v. 10
Finney, 34 F.3d 1058-61, 1062 (Fed. Cir. 1994). 11
Although testing under actual operating conditions of use is not necessarily a 12
requirement for an actual reduction to practice, the tests must prove that the 13
invention will perform satisfactorily in the intended functional setting. Koval v. 14
Bodenschatz, 463 F.2d 442, 447 (CCPA 1972) (tests in the 7-13 volt range 15
hopelessly out of line with that which would be employed in any normal use of 16
circuit breaker of the count); Knowles v. Tibbetts, 347 F.2d 591, 594 (CCPA 1965). 17
In determining what tests are necessary to constitute an actual reduction to 18
practice, it is proper to take into consideration statements in the specifications of 19
the applications involved in the interference, as well as limitations appearing in the 20
counts. Tomecek v. Stimpson, 513 F.2d 614, 618-19 (CCPA 1975); Blicke v. 21
Treves, 241 F.2d 718, 721 (CCPA 1957). 22
To establish an actual reduction to practice, generally it is not necessary to 23
show that the invention has proceeded to the point where it is ready for 24
commercialization. DSL Dynamic Sciences, Limited v. Union Switch & Signal, 25
18

Inc., 928 F.2d 1122, 1126 (Fed. Cir. 1991); Koval v. Bodenschatz, 463 F.2d 442, 1
447 (CCPA 1972). 2
Reddy set out to prove that its experimental work resulted, in the 3
words of the relevant part of Count 3, in “[a] crystallized intimate mixture of 4
aprepitant crystalline Form I and crystalline Form II.” 5
In order to establish that “[a] crystallized intimate mixture” was 6
obtained, Reddy must establish (1) that any Form I and Form II in the 7
mixture “has . . . [a] . . . stable mixture of the polymorphs” and (2) “has 8
the same composition of polymorphs throughout the mixture.” Ex. 2001, 9
col. 4:5-9. 10
Stability and uniformity are elements of the counts. 11
The parties do not agree on how one skilled in the art goes about 12
determining whether a mixture is “stable” and “uniform.” 13
a. Stability 14
The involved Reddy patent contains a definition of “stable” set out 15
above but for convenience repeated here: 16
The term "stable" is used to describe an intimate mixture of 17
aprepitant Form I and Form II that maintains an initial weight 18
ratio of forms during formulation into a pharmaceutical dosage 19
form and thereafter during a commercially useful period of 20
normal storage and use, such as about one year, about 18 21
months, about two years, or any other desired period. Stability 22
is typically indicated by maintenance of the weight ratio of 23
forms during stability testing, involving storage under standard 24
conditions, such as those described in Test 1150 25
"Pharmaceutical Stability," United States Pharmacopeia 29 26
United States Pharmacopeial Convention, Inc., Rockville, Md., 27
2005, at pages 2994-2995. Stability testing procedures are well 28
known in the pharmaceutical industry. 29

19

Ex. 2001, col. 4:18-29. 1
Version 28 of United States Pharmacopeia under “Stability Protocols” 2
reveals: 3
Stability of manufactured dosage forms must be 4
demonstrated by the manufacturer, using methods adequate for 5
the purpose. Monograph assays may be used for stability 6
testing if they are stability-indicating (i.e., if they accurately 7
differentiate between the intact drug molecules and their 8
degradation products). Stability considerations should include 9
not only the specific compendial requirements, but also changes 10
in physical appearance of the product that would warn users 11
that the product’s continued integrity is questionable. 12

Stability studies on active substances and packaged 13
dosage forms are conducted by means of “real-time,” long-14
term tests at specific temperatures and relative humidities 15
representing storage conditions experienced in the distribution 16
chain of the climatic zone(s) of the country or region of the 17
world concerned. Labeling of the packaged active substance or 18
dosage form should reflect the effects of the temperature, 19
relative humidity, air and light on its stability. Label 20
temperature storage warnings will both reflect the results of the 21
real-time storage tests and allow for expected seasonal 22
excursions of temperature. 23

Ex. 2053, page 2700, col. 1. 24
Version 28 of United States Pharmacopeia under “Controlled Room 25
Temperature” further reveals: 26
Controlled room temperature . . . delineates the allowable 27
tolerance in storage circumstances at any locating in the chain 28
of distribution (e.g., pharmacies, hospitals, and warehouses). 29
This terminology also allows patients or consumers to be 30
counseled as to appropriate storage for the product. Products 31
may be labeled either to store at “Controlled room temperature” 32
or to store at temperatures “up to 25 [ºC]” where labeling is 33
20

supported by long-term stability studies at the designated 1
storage condition of 25º [C.]. Controlled room temperature 2
limits the permissible excursions to those consistent with 3
maintenance of a mean kinetic temperature calculated to be not 4
more than 25º [C.]. See Mean Kinetic Temperature. The 5
common international guideline for long-term stability studies 6
specifies 25 ± 2º [C.] at 60 ± 5% relative humidity. Accelerated 7
studies are specified at 40 ± 2º[C.] and at 75 ± 5% relative 8
humidity. Accelerated studies also allow the interpretation of 9
data and information on short-term spikes in storage conditions 10
in addition to the excursions allowed by controlled room 11
temperature. 12

The term “room temperature” is used in different ways in 13
different countries, and for products to be shipped outside the 14
continental U.S. it is usually preferable for product labeling to 15
refer to a maximum storage temperature or temperature range in 16
degrees Celsius. 17

The discussion in version 28 of United States Pharmacopeia is 18
believed to relate to commercial practices. 19
As noted earlier in our opinion, as a general proposition of law, testing 20
to establish an actual reduction to practice need not establish “commercial” 21
utility. 22
However, in this case the applicable Reddy definition of “stable” is: 23
an intimate mixture of aprepitant Form I and Form II that 24
maintains an initial weight ratio of forms during [1] formulation 25
into a pharmaceutical dosage form (i.e., when first made) and 26
[2] thereafter during a commercially useful period of normal 27
storage and use, such as about one year, about 18 months, about 28
two years, or any other desired period. 29

Ex. 2001, col. 4:18-23 (emphasis added). 30
21

Accordingly, satisfactory evidence of “stability” requires proof of 1
weight ratios of Form I to Form II during some form of “commercially 2
useful period.” 3
As will become apparent “accelerated” testing may provide 4
satisfactory proof of commercial stability to one skilled in the art. 5
If stability is tested by an accelerated process, an 18-month 6
experiment may not be necessary. 7
b. Uniformity 8
The parties disagree on how “uniformity” is to be measured. 9
We understand that Reddy maintains that uniformity can be measured 10
by taking samples of a “mixture” over a period of time and analyzing the 11
ratio of Form I to Form II. 12
Results of this nature are discussed later in this opinion. 13
On the other hand, we understand that Glenmark maintains that 14
different samples for different portions of a “mixture” have to be taken at the 15
same time and analyzed for a Form I to Form II ratio. 16
According to Glenmark, a single sample will not establish uniformity. 17
We agree-in-part with Reddy and we further agree-in-part with 18
Glenmark. 19
We agree with Glenmark that from an analytical standpoint a single 20
sample reasonably cannot be expected to show uniformity in a “mixture.” 21
Ex. 1016, ¶ 6 (direct declaration testimony of Dr. Leonard R. MacGillivray); 22
Ex. 1014, page 32:1-2 (cross-examination of Dr. Elati). 23
On the other hand, we agree with Reddy that samples taken at 24
different times may show uniformity. 25
22

Samples taken at different times seemingly would be from different 1
portions of the “mixture. 2
4. Experiment APT/D568/IXD/02 (continued) 3
Reddy has failed to prove to our satisfaction that it conducted 4
sufficient testing to factually establish uniformity “throughout the mixture” 5
(Ex. 2001, col. 4:5-9). 6
Assuming the reported Form I to Form II ratio was 1:1, it does not 7
follow that the 1:1 ratio was uniform throughout the mixture albeit an 8
overcall ratio of the mixture was 1:1. Ex. 1016, ¶ 8:8-11. 9
Reddy also has failed to prove to our satisfaction that it conducted any 10
stability testing to factually establish stability (1) when the product was 11
initially formed and (2) thereafter for some acceptable period as defined in 12
the patent. 13
Actual reduction to practice is an issue of law to be resolved on the 14
facts of the case. Estee Lauder, Inc. v. L'Oreal, S.A., 129 F.3d 588, 592 15
(Fed. Cir. 1997). 16
A failure to factually establish “uniformity” and “stability” is fatal to 17
Reddy’s case for an actual reduction to practice based on Experiment 18
APT/D568/IXD/02. 19
5. Experiment APT/D791/I/09 20
Dr. Elati testified that Experiment APT/D791/I/09 was carried under 21
his direct supervision and control by N. Venu. 22
N. Venu was not called as a witness by Reddy. 23
Ex. 2012, ¶ 16 and Ex. 2016 contain entries which are reasonably 24
consistent with Dr. Elati’s description of the following events. 25
23

Beginning at about 10:30 am on 2 August 2005, 0.5 grams of 1
aprepitant (identified as APT/05) and 12.0 ml of methanol were mixed in a 2
flask to form a “mixture.” 3
The mixture was stirred for 45 minutes at 60-70 ºC. 4
According to Dr. Elati, a clear solution of aprepitant in methanol was 5
observed. 6
The clear solution was cooled to 40 ºC. 7
Thereafter 0.5 mg of aprepitant obtained from a batch (identified as 8
batch number APT/06) of a physical mixture of Form I and Form II of 9
aprepitant “was added to the clear solution for purposes of seeding the 10
solution.” Ex. 2012, page 9:6-7. 11
Demineralized water (0.2 ml) was added (as an anti-solvent) at room 12
temperature and stirred for 45 minutes. 13
A precipitated solid was filtered, washed with methanol and dried at 14
50 ºC for about 3 hours to obtain a “sample.” 15
The sample was sent for XRD analysis. 16
According to Dr. Elati, the sample “was found to contain a crystalized 17
intimate mixture of crystalline Form I and Form II of aprepitant . . . .” 18
Ex. 2012, page 9:14-15. 19
Dr. Elati’s opinion is based on 4 August 2005 XRD results reported in 20
Ex. 2024. See Ex. 2012, page 9:15-16. 21
Page 40 of a Laboratory Notebook (Ex. 2016) states: “Form I & 22
Form II mixture obtained.” 23
The experiment fails as proof of an actual reduction to practice 24
because Reddy has not established as a matter of fact that (1) the “mixture” 25
24

was uniform or (2) it was stable as defined in the Reddy patent and required 1
by the counts. Ex. 1016, ¶ 9:18-21. 2
6. Experiment APT/D843/VIII/33 3
A series of experiments are said to have been carried out on 4
27 September 2005. 5
Dr. Elati testified that Experiment APT/D843/VIII/33 was carried 6
under his direct supervision and control by S. Rao. 7
S. Rao was not called as a witness by Reddy. 8
Ex. 2012, ¶ 19 discusses and Ex. 2025 contains entries which are 9
reasonably consistent with Dr. Elati’s description of the following events. 10
Beginning at about 8:00 am on 27 September 2005, 0.5 grams of 11
aprepitant (APT/15) was mixed with a solvent comprising 250 ml of DCM 12
(dichloromethane), 5 ml of MeOH (methanol) and 0.5 ml of aqueous NH3 13
(aqueous ammonia) in a flask to make a “solvent mixture.” 14
The solvent mixture was stirred for 10-15 minutes at room 15
temperature. 16
Distillation took place under a vacuum at 30-35 ºC. 17
A solid was observed after distillation (which removed the solvent). 18
According to Dr. Elati, the solid was “a crystallized intimate mixture 19
of crystalline Form I and Form II of aprepitant.” Ex. 2012, page 10:29-30. 20
A 1 gram portion of the solid was dried at room temperature for 21
5 hours to produce Sample No. APT/D843/VIII/33AD. 22
The remaining solid was dried in an oven at 40-45 ºC to produce a 23
dried solid. 24
25

After one, three, and five hours, 1.0 gram samples of the dried solid 1
were submitted for XRD analysis. 2
XRD analysis showed the following results. 3
Sample Form I (%) Form II (%)
APT/D843/VIII/33-AD <5 >95
APT/D843/VIII/33-AD—1 hour <5 >95
APT/D843/VIII/33-AD—3 hours <5 >95
APT/D843/VIII/33-AD—5 hours <5 >95

Ex. 2012, page 11:7-8; Ex. 2025, page132. 4
Dr. Elati testified: 5
The method of [accelerated] testing the stability of a 6
crystallized mixture of polymorphs [i.e., mixture of Form I and 7
Form II polymorphs] would be considered to be a standard and 8
reliable test by one of ordinary skill in the art, and was so 9
considered by me. I can confirm . . . that these XRD results 10
establish that a crystallized intimate mixture of crystalline Form 11
I and Form II of aprepitant was produced in this experiment, as 12
reflected by the observations that the product was stable after 13
various drying periods. 14
15
Ex. 2012, page 11:8-13 16
17
A first observation is that the results reported in terms of <5% Form I 18
and >95% Form II have not been shown to be particularly meaningful. 19
There are numerous values between <5 and >95 and it is not apparent 20
why we should find that the values would be the same or essentially the 21
same over a 5-hour period. 22
26

A second observation is that no literature-based support is cited by 1
Dr. Elati’s opinion that “the method of testing . . . would be considered to be 2
a standard and reliable test by one of ordinary skill in the art . . . .” 3
We decline to accept unsupported conclusory assertions. Cf. Rohm and 4
Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed. Cir. 1997). See also 5
Ashland Oil, Inc. v. Delta Resins and Refractories, Inc., 776 F.2d 281, 294 (Fed 6
Cir. 1985) (“[l]ack of factual support for expert opinion . . .may render the 7
testimony of little probative value . . . .”). 8
It is true that Phamarcopeia describes an accelerated study at 40 ± 2 ºC at 9
75 ± 5% relative humidity. Ex. 2053, page 2700, col. 1. 10
However, Pharmacopeia does not reveal how long a product should be 11
maintained at 40 ± 2 ºC or otherwise satisfactorily describe a precise protocol for 12
accelerated testing. 13
Nor is there any evidence of the state of the humidity when Reddy testing 14
occurred. 15
Dr. Elati’s answer is that humidity was “[n]ot taken into account because we 16
believe that this molecule [aprepitant] is not hygroscopic in nature.” Ex. 1014, 17
page 36:14-19 (Elati cross-examination). 18
Reddy and Dr. Elati have not called our attention to documents 19
explaining test data or other convincing evidence based on scientific testing 20
as to what effect, if any, moisture would have on aprepitant. 21
Dr. Elati conceded during cross-examination Reddy’s accelerated 22
testing is “[n]ot exactly the same” as that described in Pharmacopeia. 23
Ex. 1014, page 35:22-25. 24
27

Dr. Elati goes on to justify why “[n]ot exactly the same” is 1
nevertheless representative. 2
Dr. Elati testified on cross-examination that: 3
we . . . exposed the same to distillation of the sample product a 4
various temperatures, and also subject to drying [the sample] at 5
various temperatures. That’s what we did. 6

Based on that, we extrapolated[7] the data, and one is 7
skilled in the art could [would be?] able to interpret that. 8

Ex. 1014, page 36:2-9. 9
On further cross-examination, Dr. Elati testified: 10
Q. “[G]oing back to the patent, it refers [Ex. 1004, 11
col. 4:18-19] to a commercially-useful period of normal storage 12
and use. 13

A. Uh-huh [which we take to mean “yes”]. 14

Q. Such as about one year, about 18 months, about two 15
years or any other desired period. What use do you think they 16
are alluding to? 17

A. What? 18

Q. What do you believe is being alluded to? 19

A. I think this allows the storage of the product. This allows 20
storage of the product without altering the quality. 21

Q. The storage commercially; is that correct? 22

7 We have not been directed to testimony explaining what was involved in
extrapolating any data. 37 C.F.R. § 41.158(b).

28

A. Storage of the act—either the—yeah, storage of the 1
formulated product commercially without altering the product 2
quality. 3

Q. Did you do—were any of the experiments described in 4
your declaration [Ex. 2012] conducted with a storage period of 5
at least one week? 6

A. No, one week—no, but we . . . did it under extreme 7
conditions, extreme reaction conditions. That’s a representation 8
of the conditions that’s been cited in the USP [Ex. 2053]. So 9
the intent of the experiments that we cited is to give an 10
understanding of how this product behaves under extreme 11
conditions based on which one who is skilled in the art could 12
extrapolate or understand that his product behaves well under 13
the . . . [USP] conditions. That’s the intent. 14

Ex. 1014, page 38:18 to page 29:23. 15
Dr. Elati has not explained (1) how one skilled in the art goes 16
about interpreting/extrapolating data obtained from an accelerated test or 17
(2) how personnel, including Dr. Elati, extrapolated the data said to have 18
been obtained as a result of the various Reddy experiments. 37 C.F.R. 19
§ 41.158(b). 20
What we have on the record is essentially an unsupported assertion 21
that (1) appropriate data was obtained, (2) somehow was 22
interpreted/extrapolated, and (3) a conclusion was reached that Reddy 23
obtained a desired result consistent with its definition of “stable” in the 24
involved Reddy patent—a conclusion rendered after-the-fact that appears to 25
be conveniently consistent with its priority position. 26
29

7. Experiment APT/D843/VIII/34 1
Dr. Elati testified that Experiment APT/D843/VIII/34 was carried 2
under his direct supervision and control by S. Rao. 3
S. Rao was not called as a witness by Reddy. 4
Ex. 2012, ¶ 21 discusses and Ex. 2029 contains entries which are 5
reasonably consistent with Dr. Elati’s description of the following events. 6
Beginning at about 8:30 am on 27 September 2005, 5.0 grams of 7
aprepitant (APT/15) was mixed with a solvent comprising 250 ml of DCM 8
(dichloromethane), 5 ml of MeOH (methanol) and 0.5 ml of aqueous NH3 9
(aqueous ammonia) in a flask to make a “solvent mixture.” 10
The solvent mixture was stirred and a clear solution was obtained. 11
Distillation took place under a vacuum at 40-50 ºC to produce a solid. 12
A solid was observed after distillation (which removed the solvent). 13
According to Dr. Elati, the solid was “a crystallized intimate mixture 14
of crystalline Form I and Form II of aprepitant. Ex. 2012, page 12:4-5. 15
A 1.0 gm portion of the solid was dried at room temperature for 16
5 hours to produce Sample No. APT/D843/VIII/34AD. 17
The remaining solid was dried in an oven at 40-45 ºC to produce a 18
dried solid. 19
After one, three, and five hours, 1.0 gram samples of the dried solid 20
were submitted for XRD analysis. 21
XRD analysis showed the following results. 22
30

Sample Form I (%) Form II (%)
APT/D843/VIII/34-AD 19.2 80.8
APT/D843/VIII/34-AD—1 hour 19.85 80.15
APT/D843/VIII/34-AD—3 hours 21.35 78.65
APT/D843/VIII/34-AD—5 hours 19.30 80.70

Ex. 2012, page 12:12-13; Ex. 2029, page136; Ex 2030. 1
A “Conclusion” portion of the Laboratory Notebook states “[t]he 2
resultant aprepitant obtained after dissolving aprepitant in 50:1:0.1 3
DCM:MeOH:AqNH3 solution followed by distillation on [rotovapor ?] 4
under vacuum at 45-50 ºC contains ~20% Form-I and ~80% Form II.” 5
Ex. 2029, page 136. 6
There is no contemporaneous notation concerning “uniformity” or 7
“stability.” 8
Glenmark argues that “Reddy has not provided any data to show that 9
[sample APT/D843/VIII/34] is uniform or that Forms I and II are evenly 10
dispersed.” Paper 100, page 21:2-4. 11
However, Reddy has provided some data; the real question is the 12
weight to which the data is entitled. 13
Glenmark further argues that “measurements taken over 5 hours” to 14
“show that [sample APT/D843/VIII/34] . . . are evenly dispersed” is not 15
appropriate. Paper 100, page 22:8-9.8 16

8 Glenmark states that Reddy argued for the first time during Dr. Elati’s cross-
examination deposition (Ex. 1014, page 24:20 to page 26:22) that a 5-hour test was
appropriate. Paper 100, page 22:7. However, Dr. Elati’s cross-examination
testimony is based on questions asked by Glenmark. Dr. Elati certainly cannot be
31

Resolution of the opposing points of the parties requires some 1
understanding of the term “uniform” as it relates to “stable”. 2
The involved Reddy patent uses the term “uniform” one time: 3
By the term "intimate mixture," it is meant that the mixture of 4
aprepitant polymorphs Form I and Form II in any desired ratio 5
has an evenly dispersed, uniform and stable mixture of the 6
polymorphs and has the same composition of the polymorphs 7
throughout the mixture. 8

Ex. 2001, col. 4:5-9. 9
Stability as a function of weight ratio of Form I to Form II was 10
discussed during Dr. Elati’s cross-examination. 11
Q. [W]ould we need at least two samples of the material to 12
determine whether or not the mixture has the same composition 13
of the polymorphs throughout the mixture? 14

A. Yes, from “an” analytical standpoint that may be required 15
but . . . both of these are produced from a single environment, 16
that itself shows the uniformity. 17

Q. The definition at Column 4, Line 5 [Ex. 2001] also 18
indicates that the mixture is to be stable. And if you go down to 19
Line 18 in that same column, the term “stable” is described. 20
21
A. Uh-huh [which we take to mean “yes”]. 22

Q. Can you read it, please? 23

A. This one? 24

faulted for answering questions asked by Glenmark. A possible moral to the story
is: “do not ask a question on cross-examination and after getting an answer then
say the witness raised a new argument!”

32

Q. Column 4, Line 18. 1

A. Yeah, I can read it. 2
Can you repeat the question? I’m sorry. Yes, please. 3

Q. How much can the weight ratio of Form I and Form II in 4
the mixture vary and still be considered stable? 5

A. As I told you, it can be less that 5 percent. That, again, 6
depends on the sensitivity of the analytical method.[9] 7

Q. Is the error of 5 percent that you’re referring to 8
experimental error of the analytical instrument? 9

A. I’m not sure whether it is an analytical error or it is a 10
uniformity issue. 11
How do we determine that? 12

Q. Where do you get the number percent? 13

A. By XRD. 14

Q. The error range of 5 percent, where do you get that? Is it 15
in the [involved Reddy] patent? 16

A. It’s there in the patent, I think.[10] Somewhere, roughly 17
around 5 percent. I’m not sure about the exact number. 18

Ex. 1014, page 31:21 to page 33:10. 19

9 Reddy has not directed our attention to any evidence related to the sensitivity of
the analytical measurements or any apparatus used to make those measurements.
37 C.F.R. § 41.158(b).

10 We have reviewed the written description portion of the involved Reddy patent
and have not been able to find any discussion of a variation of 5% as being a
suitable standard.

33

Dr. Elati’s attempt during cross-examination testimony to justify an 1
about 5% variation gives us pause. 2
First, the involved Reddy patent does not appear to discuss a 3
5 percent variation as a basis for determining uniformity or stability. 4
Second, Reddy points to no evidence that a 5 percent variation is a 5
variation which one skilled in the art generally would accept or reply upon. 6
Third, the 5 percent variation is ambiguous when considered in light 7
of the actual data offered as evidence. For example, if the variation is 8
measured as a function of the amount of Form I, then the variation is 9
10.1 percent (((21.35 - 19.2)/21.35) x 100 = ~10.1 %). On the other hand, if 10
the variation is measured as a function of the amount of Form II, then the 11
variation is 2.7 percent (((80.8 – 78.65)/80.8) x 100 = ~ 2.7%). Thus, apart 12
from the fact that the involved Reddy patent does not discuss a 5% variation, 13
it appears that whether that variation is achieved is a function of which 14
polymorph one skilled in the art is to consider. 15
Because of the concerns raised above, we decline to give much weight 16
to the data presented and consequently are unable to find that the data 17
convincingly establishes either uniformity or stability. 18
8. Experiment APT/D843/VIII/35 19
Dr. Elati testified that Experiment APT/D843/VIII/35 was carried 20
under his direct supervision and control by S. Rao. Ex. 2012, ¶ 23:26-27. 21
S. Rao was not called as a witness by Reddy. 22
Ex. 2012, ¶ 23 discusses and Ex. 2031 contains entries which are 23
reasonably consistent with Dr. Elati’s description of the events surrounding 24
Experiment APT/D843/VIII/35. 25
34

Beginning at about 9:00 am on 27 September 2005, 5.0 grams of 1
aprepitant (APT/15) was mixed with a solvent comprising 250 ml of DCM 2
(dichloromethane), 5 ml of MeOH (methanol) and 0.5 ml of aqueous NH3 3
(aqueous ammonia) in a flask to make a “solvent mixture.” 4
The solvent mixture was stirred and a clear solution was obtained. 5
Distillation took place under a vacuum at 60-65 ºC, which differs 6
from the 45-50 ºC temperature used in Experiment APT/D843/VIII/34. 7
A solid was observed after distillation (which removed the solvent). 8
According to Dr. Elati, the solid was “a crystallized intimate mixture 9
of crystalline Form I and Form II of aprepitant.” Ex. 2012, page 12:4-5. 10
A 1.0 gm portion of the solid was dried at room temperature for 11
5 hours to produce Sample No. PT/D843/VIII/35AD. 12
The sample was dried in an oven at 40-45 ºC. 13
After one, three, and five hours, 1.0 gram samples were submitted for 14
XRD analysis. 15
XRD analysis showed the following results. 16
Sample Form I (%) Form II (%)
APT/D843/VIII/35-AD 76.6 25.4
APT/D843/VIII/35-AD—1 hour 73.9 26.1
APT/D843/VIII/35-AD—3 hours 75.5 24.5
APT/D843/VIII/35-AD—5 hours 74.5 25.5

A “Conclusion” portion of the Laboratory Notebook states “[t]he 17
resultant aprepitant obtained after dissolving aprepitant in 50:1:0.1 18
35

DCM:MeOH:AqNH3 solution followed by distillation on [rotovapor ?] 1
without vacuum at 60-60 ºC contains ~75% Form-I and ~25% Form II. 2
There is no contemporaneous notation concerning “uniformity” or 3
“stability.” 4
A review of the data reveals the same ambiguity observed earlier with 5
respect to data obtained in Experiment PT/D843/VIII/34AD. 6
If the variation is measured as a function of the amount of Form I, 7
then the variation is 3.5 percent (((76.6 – 73.9)/76.6) x 100 = ~3.5 %). 8
On the other hand, if the variation is measured as a function of the amount of 9
Form II, then the variation is 6.1 percent (((26.1 – 24.5)/26.1) x 100 10
= ~ 6.1%)—exceeding the 5% mentioned by Dr. Elati. 11
We decline to credit the testimony and data for Experiment 12
PT/D843/VIII/35AD for essentially the same reasons that we declined to 13
credit the testimony and data for Experiment PT/D843/VIII/34AD. 14
9. Experiment APT/D843/VIII/36 15
Dr. Elati testified that he “supervised further activities carried out 16
by Mr. Rao” in conducting Experiment APT/D843/VIII/36. Ex. 2012, 17
¶ 25:24-25. 18
S. Rao was not called as a witness by Reddy. 19
Ex. 2012, ¶ 23 discusses and Ex. 2033 contains entries related to 20
Experiment APT/D843/VIII/36. 21
At the conclusion of the experiment, a product was obtained and after 22
one, three, and five hours, 1.0 gram samples of the product were submitted 23
for XRD analysis. 24
XRD analysis showed the following results. 25
36

Sample Form I (%) Form II (%)
APT/D843/VIII/36-AD >95 <5
APT/D843/VIII/36-AD—1 hour >95 <5
APT/D843/VIII/36-AD—3 hours >95 <5
APT/D843/VIII/36-AD—5 hours >95 <5

A “Conclusion” portion of the Laboratory Notebook states “[t]he 1
resultant aprepitant obtained after dissolving aprepitant in 50:1:0.1 2
DCM:MeOH:AqNH3 solution followed by classical distillation with stirring 3
under vacuum at 30-35 ºC contains >95% Form-I and <5% Form II.” 4
There is no contemporaneous notation concerning “uniformity” or 5
“stability.” 6
A review of the data reveals the same ambiguity observed earlier with 7
respect to data obtained in Experiment PT/D843/VIII/33AD. 8
We decline to credit the testimony and data for Experiment 9
PT/D843/VIII/36AD for essentially the same reasons that we declined to 10
credit the testimony and data for Experiment PT/D843/VIII/33AD. 11
10. Experiment APT/D843/VIII/37 12
Dr. Elati testified that he “supervised further activities carried out 13
by Dr. Rao” in conducting Experiment APT/D843/VIII/37. Ex. 2012, 14
¶ 27:1-2. 15
S. Rao was not called as a witness by Reddy. 16
Ex. 2012, ¶ 28 discusses and Ex. 2035 contains entries related to 17
Experiment APT/D843/VIII/37. 18
37

At the conclusion of the experiment, a product was obtained and after 1
one, three, and five hours, 1.0 gram samples were submitted for XRD 2
analysis. 3
XRD analysis showed the following results. 4
Sample Form I (%) Form II (%)
APT/D843/VIII/37-AD 72.3 26.7
APT/D843/VIII/37-AD—1 hour 71.4 28.6
APT/D843/VIII/37-AD—3 hours 73.8 26.2
APT/D843/VIII/37-AD—5 hours 70.0 30.0

A “Conclusion” portion of the Laboratory Notebook states “[t]he 5
resultant aprepitant obtained after dissolving aprepitant in 50:1:0.1 6
DCM:MeOH:AqNH3 solution followed by classical distillation with stirring 7
under vacuum at 45-50 ºC contains ~70% Form-I and ~30% Form II.” 8
Ex. 2035, page 148. 9
There is no contemporaneous notation concerning “uniformity” or 10
“stability.” 11
A review of the data reveals the same ambiguity observed earlier with 12
respect to data obtained in Experiments PT/D843/VIII/35 and 13
PT/D843/VIII/36. 14
If the variation is measured as a function of the amount of Form I, 15
then the variation is 5.1 percent (((73.8 – 70.0)/73.8) x 100 = ~5.1 %)—16
slightly exceeding the 5% mentioned by Dr. Elati. If the variation is 17
measured as a function of the amount of Form II, then the variation is 12.7 18
38

percent (((30.0 – 26.2)/30) x 100 = ~ 6.1%)—exceeding the 5% mentioned 1
by Dr. Elati. 2
We decline to credit the testimony and data for Experiment 3
PT/D843/VIII/37AD for essentially the same reasons that we declined to 4
credit the testimony and data for Experiment PT/D843/VIII/35AD. 5
11. Experiment APT/D843/VIII/38 6
Dr. Elati testified that Experiment APT/D843/VIII/38 was “carried 7
out by Mr. Rao under my direct supervision and control . . .” Ex. 2012, 8
¶ 30:12-13. 9
S. Rao was not called as a witness by Reddy. 10
Ex. 2012, ¶ 30 discusses and Ex. 2037 contains entries related to 11
Experiment APT/D843/VIII/38. 12
At the conclusion of the experiment, a product was obtained and after 13
one, three, and five hours, 1.0 gram samples were submitted for XRD 14
analysis. 15
XRD analysis showed the following results. 16
Sample Form I (%) Form II (%)
APT/D843/VIII/38-AD 58.0 42.0
APT/D843/VIII/38-AD—1 hour 66.0 34.0
APT/D843/VIII/38-AD—3 hours 60.0 40.0
APT/D843/VIII/38-AD—5 hours 59.7 40.3

A “Conclusion” portion of the Laboratory Notebook states “[t]he 17
resultant aprepitant obtained after dissolving aprepitant in 50:1:0.1 18
DCM:MeOH:AqNH3 solution followed by classical distillation without 19
39

vacuum at 60-65 ºC contains ~60% Form-I and ~40% Form II.” Ex. 2037, 1
page 152. 2
There is no contemporaneous notation concerning “uniformity” or 3
“stability.” 4
A review of the data reveals the same ambiguity observed earlier with 5
respect to data obtained in Experiments PT/D843/VIII/35 and 6
PT/D843/VIII/36. 7
If the variation is measured as a function of the amount of Form I, 8
then the variation is 12.1 percent (((66.0 – 58.0)/58.0) x 100 = ~ 12.1%)—9
exceeding the 5% mentioned by Dr. Elati. On the other hand, if the variation 10
is measured as a function of the amount of Form II, then the variation is 11
28.6 percent (((42.0 – 34)/42) x 100 = ~28.6%)—exceeding the 5% 12
mentioned by Dr. Elati. 13
We decline to credit the testimony and data for Experiment 14
PT/D843/VIII/37AD for essentially the same reasons that we declined to 15
credit the testimony and data for Experiment PT/D843/VIII/35AD. 16
12. Experiment APT/E023/IX/12 17
Dr. Elati testified that Experiment APT/E023/IX/12 was “carried out 18
by Miss Anitha under my direct supervision and control . . .” Ex. 2012, 19
¶ 32:19-20. 20
Miss Anitha was not called as a witness by Reddy. 21
Ex. 2012, ¶ 31 discusses and Ex. 2043 contains entries related to 22
Experiment APT/E023/IX/12. 23
Beginning at about 9:15 am on 28 January 2006, 4.0 grams of 24
aprepitant (identified as APT/12) and a solvent consisting of 200 ml DCM, 25
40

40 ml of MeOH, and 0.4 ml of aq.NH3 were mixed in a flask to form a 1
“mixture.” 2
Thereafter a distillation was arranged and the mixture was distilled 3
under vacuum at below 45 ºC. 4
After distillation, a solid was observed and the solid was sent for XRD 5
quantification. 6
The XRD results (obtained on 8 February 2006) are said to have 7
shown a crystalline intimate mixture of crystalline Form I and Form II 8
aprepitant having 16% Form II and 84% Form 1. 9
The XRD results are said to be shown in Ex. 2042. 10
The experiment fails as proof of an actual reduction to practice 11
because Reddy has not established as a matter of fact that (1) the “mixture” 12
was uniform or (2) it was stable as defined in the Reddy patent and required 13
by the counts. 14
C. Credibility of witnesses 15
Two witnesses testified in this proceeding and both were cross-16
examined: (1) Dr. Elati for Reddy and (2) Dr. MacGillivray for Glenmark. 17
We have discussed testimony of both witnesses. 18
However, in general we find that neither witness is particularly 19
credible. 20
Dr. Elati is a named inventor and therefore has an interest in the 21
outcome of the case. 22
While an interest in the outcome is not fatal to the credibility of 23
a witness, Dr. Elati’s opinions are in large measure based on a lack of 24
contemporaneous recognition of uniformity and stability. 25
41

Dr. Elati’s testimony regarding uniformity and stability is 1
opinion-based without sufficient support in the form of prior art 2
contemporaneous scientific literature to establish to our satisfaction that 3
what Reddy did would have been recognized by one skilled in the art as a 4
proper scientific basis for measuring uniformity and stability. 5
Dr. Elati, while testifying about a 5% variation and asserting that the 6
involved Reddy patent contained a discussion of the 5% figure, Dr. Elati did 7
not point out where the patent describes the use of a 5% standard for 8
assessing uniformity or stability. 9
The laboratory documentation relied upon by Dr. Elati is hearsay. 10
We have not excluded the documentation, because as explained above 11
no objection to the admissibility of the hearsay evidence was made by 12
Glenmark. 13
However, missing from that hearsay evidence is a contemporaneous 14
recognition of “uniformity” and “stability” consistent with the definition of 15
“intimate mixture” and “stable” as set out in the involved Reddy patent. 16
The absence of contemporaneous recognition gives us considerable pause 17
concerning the sufficiency of the hearsay evidence in support of inventor 18
Dr. Elati’s testimony and therefore we decline to give controlling weight to the 19
hearsay evidence. Cf. Langer v. Kaufman, 465 F.2d 915, 919 (CCPA 1972) 20
(conception and actual reduction to practice cannot be established nunc pro tunc). 21
See also Heard v. Burton, 333 F.2d 239, 241 (CCPA 1964). 22
Dr. MacGillivray had not been involved with research, development 23
or commercialization of a polymorphic form of a drug product. Ex. 2055, 24
page 13:10-14. 25
42

While Dr. MacGillivray had an opinion that the properties of an 1
aprepitant product may vary over time, he could not “recall the details of . . . 2
accelerated testing.” Ex. 2055, page 46:6-7. 3
Accordingly, we decline to give Dr. MacGillivray’s “5-hours is too 4
short a time period to show stability for a commercially useful period” 5
testimony much weight. 6
The 5-hour testing by Reddy fails for reasons we have set out above 7
apart from Dr. MacGillivray’s opinion, which we do not credit. 8
X. Other Arguments 9
Various arguments not addressed above have been made by the 10
parties. 11
We have considered those arguments, but conclude that the arguments 12
do not provide a basis for us to reach a different result. 13
XI. Order 14
Upon consideration of Reddy Motion 3, and for the reasons given, it is 15
ORDERED that Reddy Motion 3 is denied. 16
FURTHER ORDERED that a JUDGMENT will be entered 17
against Reddy in a separate paper entered concurrently with this DECISION 18
ON MOTIONS. 19

43

cc (via electronic transmission): 1
2
Attorneys for Reddy: 3
Arnold H. Krumholz 4
Michael H. Teschner 5
Lerner, David, Littenberg, 6
Krumholz & Mentlik, LLP 7
akrumholz@ldlkm.com 8
mteschner@ldllm.com 9
10
Attorneys for Glenmark: 11
12
Jay P. Lessler 13
Joel Dion 14
Blank Rome, LLP 15
jlessler@blankrome.com 16
dion-j@blankrome.com 17