Preliminary Response

Paper No.
__
Filed: July 28, 2015
UNITED STATES PATENT AND TRADEMARK OFFICE
________________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________
COALITION FOR AFFORDABLE DRUGS VI LLC
Petitioner,
v.
CELGENE CORPORATION
Patent Owner
________________
Case IPR2015-01092
Patent 6,045,501
________________
PATENT OWNER PRELIMINARY RESPONSE

PURSUANT TO 35 U.S.C. 313 AND 37 C.F.R. 42.107
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Patent Owner Preliminary Response
IPR2015-01092
Patent 6,045,501
TABLE OF CONTENTS
Page
I.
INTRODUCTION ........................................................................................... 1
II.
BACKGROUND ............................................................................................. 4
III.
A.
The Challenge of Protecting A Fetus From A Teratogenic

Drug While Allowing A Patient Access to Its Efficacy........................ 6
B.
Previous Attempts To Control Access

To Other Drugs Were Unsuccessful ..................................................... 8
C.
The 501 Patent ................................................................................... 11
ARGUMENT ................................................................................................. 12
A.
B.
Ground 2 Should Be Denied Because

The NIH Reference Is Not Prior Art ................................................... 13
1.
CFAD Has Not Proven That The NIH

Reference Was Publicly Available ........................................... 15
2.
CFAD Has Not Offered Any Evidence of Dissemination ........ 19
The Petition Should Be Denied

Because CFAD Has Failed To Show A Reasonable
Likelihood That The Claims Would Have Been Obvious .................. 20
1.
2.
CFADs Expert Declaration

Is Entitled To little or no weight ........................................... 20
(a)
Dr. Fudin Is Not A POSA ............................................... 20
(b)
Dr. Fudins Opinions Are

Unsupported, Verbatim Recitations Of
CFADs Conclusory Arguments .................................... 22
Ground 1: The Claimed Inventions Would Not Have

Been Obvious Over Powell, Mitchell, and Dishman ................ 23
(a)
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CFAD Fails To Address Both The

Claims And The Prior Art As A Whole ...................... 23
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(b)
(c)
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CFAD Has Not Provided A Motivation To
Combine Powell With Dishman Or Mitchell ................. 24
The Ground 1 References Fail To
Disclose, Teach, Or Suggest
Key Elements Of The Claimed Inventions..................... 29
i.
ii.
3.
1)
Elements 1(a), 1(b), and 1(c) ..................... 29
2)
Element 1(d)............................................... 32
Dependent Claims 2-10 Would

Not Have Been Obvious Over
Powell, Mitchell, And Dishman ........................... 34
Ground 2: The Claimed Inventions Would Not Have

Been Obvious Over the NIH Reference And Honigfeld .......... 36
(a)
CFAD Fails To Address Both the

Claims and the Prior Art As a Whole ......................... 36
(b)

Combine The NIH Reference And Honigfeld ................ 37
(c)
The Cited References Fail To

Disclose, Teach, Or Suggest
Key Elements Of The Claimed Inventions..................... 40
i.
ii.
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Independent Claim 1 Would

Powell, Mitchell, And Dishman ........................... 29
Claim 1 Would Not Have Been Obvious

Over The NIH Reference and Honigfeld ............. 40
1)
Element 1(c) ............................................... 40
2)
Element 1(d)............................................... 41

The NIH Reference And Honigfeld ..................... 43
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4.
IV.
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CFAD Fails To Address The Objective Evidence Of
Nonobviousness Regarding The 501 Patent ............................ 44
(a)
Long-Felt Need Further Supports The

Nonobviousness Of The Claimed Inventions ................. 45
(b)
Commercial Success Further Supports The

(c)
Third-Party Praise And Awards Further Supports

The Nonobviousness Of The Claimed Inventions ......... 47
(d)
Licensing by Others Further Supports The

(e)
Unexpected Results Further Supports The

C.

Under 35 U.S.C. 314(a) And 316(b) .............................................. 49
D.

For Failing To Name All Real Parties-In-Interest .............................. 52
CONCLUSION.............................................................................................. 55
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I.
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INTRODUCTION
Pursuant to 35 U.S.C. 313 and 37 C.F.R. 42.107(a), Patent Owner
Celgene Corporation (Celgene) submits this Preliminary Response to Coalition

For Affordable Drugs VI LLCs (CFAD ) Petition for Inter Partes Review (the
Petition) of U.S. Patent No. 6,045,501 (the 501 patent).
The 501 patent describes and claims methods for delivering a teratogenic
drug, such as thalidomide, to a patient while preventing fetal exposure and related
birth defects. The inventions were conceived as part of Celgenes efforts to obtain
approval from the U.S. Food and Drug Administration (FDA) to market a
thalidomide drug product in the United States. In the 1950s and 1960s,
thalidomide was responsible for more than 10,000 severe birth defects worldwide.
The United States refused approval of the drug in the early 1960s, and it remained
unlawful in the United States for decades. But after discovery of important new
uses for thalidomide, the methods developed at Celgene and claimed in the 501
patent convinced the FDA to lift its nearly 40-year ban on marketing the drug in
the United States.
No other prior-art method for controlling access to pharmaceutical drug
products was able to accomplish what the invention embodied in the 501 patent
(and other of Celgenes patents) dida 100% success rate in preventing drugrelated birth defects. In fact, the inventions of the 501 patent were so successful
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and innovative that the FDA required other drug manufacturers to copy Celgenes
patented methods if they wanted to keep their products on the market, resulting in
licenses to several of Celgenes patents, including the 501 patent.
Notwithstanding Celgenes significant innovations, CFAD has filed the
present Petition as part of a hedge fund investment strategy developed by the real
parties-in-interest (RPI). CFADs Petition has several fatal defects.
First, CFADs petition fails to establish that all of its Ground 2 references
are prior-art printed publications upon which an inter partes review (IPR) may
be instituted. Specifically, CFAD has failed to show that the NIH reference
constitutes prior art to the 501 patent, and there is strong evidence that the NIH
reference was first made public after the patents priority date. CFAD has
therefore failed to show that Ground 2 justifies review.
Second, CFAD relies heavily on an expert declaration that is entitled to little
or no weight because the declarant is not a person of ordinary skill in the art
(POSA), and because the declaration merely reiterates CFADs conclusory
arguments.
Third, CFADs Grounds 1 and 2 both fail on the merits, as they do not
demonstrate a reasonable likelihood that the challenged claims are unpatentable.
Specifically, even if the NIH reference is prior art, all references asserted in both
Grounds 1 and 2 fail to disclose, teach, or suggest key elements of the challenged
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claims. CFADs proposed modifications to, and combinations of, the prior-art
disclosures are driven entirely by hindsight and supported only by conclusory
assertions by CFADs declarant, who merely parrots the arguments in the Petition.
Moreover, CFAD ignores disclosures in the prior art teaching away from the
claimed inventions, including disclosures teaching that prior methods did not
prevent drug-related birth defects. CFADs arguments do not warrant an IPR trial
of the 501 patent.
Fourth, CFADs petition is an improper use of the IPR proceedings.
Specifically, CFAD and the RPI are abusing and misusing the IPR process in an
attempt to effectuate changes in the stock prices of the targeted innovator
pharmaceutical companies. The self-serving actions of the RPI create unwarranted
burdens on both patent owners and the Board. The Board should exercise its
discretion under 35 U.S.C. 314(a) and 316(b) and deny the Petition.1
Fifth and finally, the Petition should also be denied because it fails to name
all RPIa threshold requirement for an IPR. Specifically omitted from the RPI
identification are the investors in the Hayman funds responsible for filing the
Petition. Having failed to name all RPI, the Petition cannot be considered.
With the Boards permission, Celgene has separately moved to dismiss the
Petition pursuant to 37 C.F.R. 42.12.
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II.
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BACKGROUND
Celgene is a biopharmaceutical company that is committed to improving the
lives of patients through research and development of drug products that treat
cancers and other devastating conditions. Three drug products developed by
Celgene are relevant to this IPR: Thalomid, Revlimid, and Pomalyst.
Thalomid is approved for the treatment of (1) erythema nodosum leprosum
(ENL)an inflammatory condition associated with leprosy; and (2) newly
diagnosed multiple myeloma (MM) (in combination with dexamethasone). Ex.
2001 at 1. The active ingredient in Thalomid is thalidomide, which is well known
for its teratogenicity (or ability to cause severe birth defects). Unfortunately, as
described in more detail below, the devastating effects of thalidomide were felt
worldwide during the thalidomide tragedy of the 1950s and 1960s, and continue
today for the surviving victims. Ex. 1001 at 1:19-24; Ex. 2002 at 1.
Revlimid is approved for the treatment of (1) transfusion-dependent anemia
due to low- or intermediate-1-risk myelodysplastic syndromes associated with a
deletion 5q abnormality, with or without additional cytogenetic abnormalities;
(2) MM (in combination with dexamethasone); and (3) mantle cell lymphoma in
certain patients whose disease has relapsed or progressed after two prior therapies.
Ex. 2003 at 1. Pomalyst (in combination with dexamethasone) is approved for
the treatment of MM in patients who have received at least two prior therapies and
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whose disease has progressed. Ex. 2004 at 1. The active ingredient in Revlimid
is lenalidomide, and the active ingredient in Pomalyst is pomalidomide. Ex. 2003
at 1; Ex. 2004 at 1. According to the FDA-approved package inserts, lenalidomide
and pomalidomide are thalidomide analogue[s], and if these drugs are used
during pregnancy, [they] may cause birth defects or embryo-fetal death. Ex. 2003
at 1,3, 7, 22-23; Ex. 2004 at 1, 2, 4, 14 and 24. As described herein, due in large
measure to the inventions claimed in the 501 patent (and other of Celgenes
patents), Celgenes FDA-approved systems for preventing fetal exposure to the
active ingredients in Thalomid, Revlimid, and Pomalyst have been 100%
successful in preventing drug-related birth defects.
Because of the known teratogenicity of thalidomide, Celgene realized that if
it were to market Thalomid, a system would need to be developed for safely
controlling patient access to the drug. Celgene was thus faced with a great
challengefind a way to effectively avoid the teratogenic side effects of
thalidomide while still making the drug available to patients in need. Indeed,
Celgene recognized that it would need to create a system that was so effective at
preventing birth defects of the type associated with teratogenic drugs that it would
convince skeptical FDA regulators, and understandably vocal and concerned
thalidomide victims around the world, that Thalomid could be safely marketed.
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In other words, the new system would need to convince the FDA to lift its nearly
40-year ban on thalidomide.
That is precisely what the inventors of the 501 patent did. Their innovative
solution to the problemoriginally known as the System for Thalidomide
Education and Prescribing Safety, or S.T.E.P.S., and what has now become the
FDA-approved Thalomid Risk Evaluation and Mitigation Strategy (REMS)is
claimed in the 501 patent (with later iterations claimed in other Celgene patents,
including U.S. Patent No. 6,315,720, at issue in IPR2015-01096, -01102, and
01103). Thalomid was first approved by the FDA in 1998, in large measure due
to S.T.E.P.S. Revlimid and Pomalyst were later approved by the FDA, again in
large measure due to the inventions of the 501 patent and later patents (including
the 720 patent). Had Celgene not developed the claimed methods for preventing
fetal exposure to teratogenic drugs, Thalomid, Revlimid, and Pomalyst would
not be available to patients today.
A.
The Challenge of Protecting A Fetus From A Teratogenic

Drug While Allowing A Patient Access to Its Efficacy
Beginning in 1958, thalidomide was marketed in Europe as a sedative and a

treatment for pregnant women with morning sickness. See Ex. 1001 at 1:19-24;
Ex. 2002 at 1. Shortly after entering the European market, it was discovered that
thalidomide caused deformities in children born to mothers who had taken the drug
during pregnancy. Id. As a result, by 1962, thalidomide had been withdrawn from
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all markets. Id. By then, the damage had been done. Thalidomide had been
linked to more than 10,000 birth defects in at least 46 countries. Id. The birth
defects were severe. Some children were born with missing or abnormal limbs,
feet, or hands, a condition known as phocomelia (from the Greek for seal
limb). Id. Many other deformities and complications were linked to
thalidomide, including abnormal or absent ears, and heart and kidney problems.
Id. As a result of this tragedy, drug regulatory authorities worldwide, including the
FDA, revised their regulations to ensure that new drugs were screened for safety in
addition to efficacy, and were specifically investigated for their potential to cause
harm to a developing fetus. Id; Ex. 2005.
Years later, it became clear that despite its teratogenicity, thalidomide had
the power to benefit certain patient populations. Ex. 1001 at 1:25-36.
Accordingly, Celgene believed it would be beneficial if the drug were made
available to those patient populations. Due to its known teratogenicity, however,
Celgene realized that to market thalidomide, it needed to develop a system that
would allow patients in need of thalidomide to access it while ensuring that no
thalidomide-related birth defects would occur. Ex. 1001 at 1:39-47.
In response to this realization, Celgene developed the methods claimed in
the 501 patent (described below). When the FDA approved Thalomid for the
treatment of ENL in July 1998, the approval letter stated that Thalomid was being
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approved under a special regulation, 21 CFR 314.520 (Subpart H), which
allowed the FDA to approve drugs that were shown to be effective, but that could
only be used safely under restricted conditions. Ex. 1016 at 0002. Specifically,
the approval letter stated that Thalomid was being approved because Celgene had
presented adequate information to demonstrate that the drug would be safe and
effective for use when marketed under S.T.E.P.S., which is claimed in the 501
patent. Id. When Thalomid was approved for the treatment of newly diagnosed
MM in 2006, the FDA maintained the same restrictions on distribution of the drug.
Ex. 2006 at 1. Similarly, the FDA conditioned its approval of both Revlimid and
Pomalyst (for all indications), on Celgenes use of the same restrictions applied to
Thalomid. Ex. 2006 at 1; Ex. 2007 at 7-10.
Those restrictions are reflected in the 501 patents claims. They include
various checks and controls to ensure that patients who need the drug receive it,
and that no child is born with a drug-related birth defect as a result. See generally
Ex. 1001.
B.
Previous Attempts To Control Access To

Other Drugs Were Unsuccessful
Others attmpted to control access to the drugs Accutane (isotretinoin) and

Clozaril (clozapine) before Celgene invented S.T.E.P.S., but as described below,
those attempts failed to meet their goals. Both failed to provide a workable
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solution for dealing with a drug like thalidomide, where even a single drug-related
birth defect was unacceptable.
Accutane contains isotretinoin, a form of vitamin A (a vitamin A analogue)
that has been used as a treatment for severe cystic acne since 1982. Ex. 1006 at
101. Isotretinoin can and has caused birth defects in children whose mothers are
taking the drug. Id. Because of the teratogenic effects of isotretinoin, and instead
of removing the drug from the market, the manufacturer of isotretinoin
implemented the Pregnancy Prevention Program (PPP).
The PPP, however, was not effective in preventing women who were taking
Accutane from becoming pregnant or preventing birth defects. In fact, the
Mitchell reference that CFAD relies upon discloses that there were more than 400
pregnancies that occurred during isotretinoin treatment, at least six of which
resulted in live born infants with at least minor anomalies, and at least one with
major anomalies. Id. at 103-04. Mitchell further reports that in the first several
months of the PPP, there was incomplete compliance with several parts of the
program, such as failures to ensure negative pregnancy tests before beginning
treatment, failures to wait until menses begins before treatment, and failures to use
effective birth control before, during, and after treatment. Id. at 104. Compliance
remained incomplete even after the manufacturer changed the packaging to
highlight the most important parts of the PPP. Id.
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Publications in prominent scientific journals also disparaged the PPP. For
instance, an article in the New England Journal of Medicine reported that [s]ince
the [PPP] program was implemented in 1989, a substantial number of fetuses have
been exposed to the drug. As many as 30 percent of the women with exposed
fetuses did not use any mode of contraception, even though they were cognizant of
the high fetal risk. Ex. 2009 at 1130.
Clozaril contains clozapine, and is used to treat schizophrenia. Ex. 1007 at
899. Its release into the market was permitted only with certain prescribing and
distribution restrictions implemented by the manufacturer. Id. These restrictions
were put in place because the use of clozapine is associated with a high frequency
of agranulocytosis, a potentially fatal blood disorder. Ex. 1009 at 52. Clozapine is
not a teratogenic drugit does not cause birth defectsand the system employed
to monitor its use was not tailored to restrict or prevent birth defects. Instead, the
manufacturer developed a program called the Clozaril National Registry to
enhance patient safety by facilitating early detection of potentially dangerous
white blood cell suppression. Id. at 52-53. But like the PPP, the clozapine system
was also a failure. Specifically, during its first five years, 382 patients developed
agranulocytosis, and 12 of those patients died as a result. Id. at 55.
When Celgene invented S.T.E.P.S. and the methods claimed in the 501
patent, the programs in place for both the Accutane and Clozaril were
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ineffective. The 501 patent was a significant innovation over those systems. To
date, Celgenes FDA-approved systems for preventing fetal exposure to the active
ingredients in Thalomid, Revlimid, or Pomalystall of which are covered by
the claims of the 501 patenthave been 100% successful in preventing birth
defects of the type associated with thalidomide. Celgenes patented methods were
so successful that, in 2006, it became clear that the PPP (and later attempts at
managing the distribution of isotretinoin) were ineffective by comparison.
Consequently, the FDA required the manufacturers of isotretinoin to use Celgenes
patented methods if they wanted to keep their products on the market. This
resulted in licenses to several of Celgenes patents, including the 501 patent, in
connection with the distribution of isotretinoin under a program known as iPledge.
See Ex. 2010; Ex. 2011; Ex. 2012.
C.
The 501 Patent
As described above, the 501 patent describes and claims methods for
delivering a teratogenic drug to a patient while preventing fetal exposure to the
drug. The claims all require various steps including checks and controls that
ensure safe methods of treatment, thereby avoiding birth defects that may result
from exposure to the drug. See Ex. 1001 at 2:10-3:9; see also id. at Abstract. For
example, independent Claim 1 of the 501 patent recites:
A method for delivering a teratogenic drug to patients in need of the
drug while avoiding the delivery of said drug to a foetus comprising:
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a. registering in a computer readable storage medium prescribers who
are qualified to prescribe said drug;
b. registering in said medium pharmacies to fill prescriptions for said

drug;
c. registering said patients in said medium, including information
concerning the ability of female patients to become pregnant and
the ability of male patients to impregnate females;
d. retrieving from said medium information identifying a
subpopulation of said female patients who are capable of becoming
pregnant and male patients who are capable of impregnating
females;
e. providing to the subpopulation, counseling information concerning
the risks attendant to fetal exposure to said drug;
f. determining whether patients comprising said subpopulation are
pregnant; and
g. in response to a determination of non-pregnancy for said patients,
authorizing said registered pharmacies to fill prescriptions from
said registered prescribers for said non-pregnant registered
patients.
See id. at Claim 1. The dependent claims further limit and define the controls to
avoid delivery of a teratogenic drug to a fetus. See id. at Claims 2-10.
III.
ARGUMENT
The Petition should be denied due to several fatal defects. First, CFAD has
failed to establish that the NIH reference that it relies on for Ground 2 is a prior-art
printed publication upon which an IPR petition may be based. Second, CFAD
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relies heavily on an expert declaration that is entitled to little or no weight because
the declarant is not a POSA, and because the declaration merely parrots CFADs
conclusory arguments. Third, CFAD has not shown that any combination of
references set forth in Ground 1 or 2 establishes a reasonable likelihood that the
challenged claims are unpatentable. Fourth, CFADs petition is an improper use
of the IPR process, and should be denied under 35 U.S.C. 314 and 316. Fifth,
pursuant to 35 U.S.C. 312(a)(2), CFADs petition fails to name all RPI.
A.
Ground 2 Should Be Denied Because

The NIH Reference Is Not Prior Art
A threshold issue for all patentability inquiries in an IPR is that a claim may
be challenged only on the basis of prior art consisting of patents or printed
publications. 35 U.S.C. 311(b); see also Boehringer Ingelheim Intl v. Biogen
Inc., IPR2015-00418, Paper 14 at 7,14 (July 13, 2015) (holding that the Board will
not institute review of an asserted ground of unpatentability that relies on a
reference that the petitioner has not established is a prior-art patent or printed
publication). Here, the Board should decline to institute review of Ground 2
because it relies on the NIH reference (Ex. 1015), and CFAD has not established
that the NIH reference is a prior-art printed publication to the 501 patent.
CFAD bears the burden of proving that each of its references are printed
publications. See Cisco Sys., Inc. v. Constellation Techs. LLC, IPR2014-00871,
Paper 12 at 11(Dec. 19, 2014). The Federal Circuit has held that public
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accessibility is the touchstone in determining whether a reference is a printed
publication. See In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). To establish that a
reference was publicly accessible, CFAD must make a satisfactory showing that
[the reference] has been disseminated or otherwise made available to the extent
that persons interested and ordinarily skilled in the subject matter or art exercising
reasonable diligence, can locate it. A.R.M., Inc. v. Cottingham Agencies Ltd.,
IPR2014-00671, Paper 10 at 7 (Oct. 3, 2014) (citing Bruckelmyer v. Ground
Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006)). Further, when the reference
in question is [a] reference prepared for a conference, as CFAD alleges it is here,
CFAD must demonstrate that it was actually disseminated at [the] conference
without restriction. Ciena Corp. v. Cirrix Sys., Appeal 2011-013123, 2012 WL
946543, at *4 (B.P.A.I. Mar. 16, 2012) (citing Mass. Inst. of Tech. v. AB Fortia,
774 F.2d 1104, 1109 (Fed. Cir. 1985)).
As discussed below, CFAD has not met its burden of proving that the NIH
reference was either made available or disseminated to a POSA, and thus, has not
proven that the NIH reference is a prior-art printed publication to the 501 patent.
Because at least one reference in the combination of references relied on by CFAD
in Ground 2 is not prior art, Ground 2 should be denied. See Actavis, Inc. v.
Research Corp. Techs. Inc., IPR2014-01126, Paper 22 at 13-14 (Jan. 9, 2015)
(denying institution of IPR where one reference in a combination of several
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references asserted to prove obviousness was not prior art); L-3 Commcn
Holdings, Inc. v. Power Survey, LLC, IPR2014-00832, Paper 9 at 18 (Nov. 14,
2014) (same); A.R.M., IPR2014-00671, Paper 10 at 6-8 (same).
1.
CFAD Has Not Proven That The NIH

Reference Was Publicly Available
CFAD makes two arguments to support its contention that the NIH reference
was publicly available prior to the 501 patents August 28, 1998 priority date.
Both lack merit.
First, CFAD relies on an NIH press release (the Press Release) that directs
viewers to a link for the website http://rarediseases.info.nih.gov/ord/ (the Link),
where [a] complete agenda and background information on the meeting, along
with an extensive bibliography on thalidomide research is available. Pet. at 1718; Ex. 1017. Based on the date of the Press Release, CFAD concludes that the
NIH reference was available no later than September 5, 1997. Pet. at 17.
CFAD, however, has not provided any evidence that any documents were
available through the Link, let alone that the NIH reference was available at that
location at any time prior to the August 28, 1998 priority date of the 501 patent.
Instead, CFAD merely assumes that the NIH reference was available at that
location. But evidence of a document being a printed publication must rest on
facts, not assumptions. See AT&T Corp. v. Microsoft Corp., No. 01-4872, 2004
WL 292321, at *6-7 (S.D.N.Y. Feb. 17, 2004); Cisco Sys., IPR2014-00871, Paper
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12 at 11 (finding Petitioner lacked evidence of publication where there was no
evidence to back up the naked assertion that it was published).
The facts demonstrate that the NIH reference was not available at the Link
prior to the 501 patents priority date. Evidence from the Internet Archive
Wayback Machine confirms this fact. The Wayback Machine collects archived
versions of web pages as they exist as of their date of capture by web crawlers.
The accessibility of a particular web page cannot be established before its earliest
archived date. The Wayback Machine takes a person to the closest available
date for the Link. Ex. 2013 at 10.
Exhibit 2014 depicts the Wayback Machine archive record associated with
the Link. The archive record excerpt, shown below, states the address of the
webpage archived, and most importantly, the range of dates during which the
webpage was archived. Here, the excerpt, with annotations, shows that the Link in
the Press Release was archived 260 times, with the first archive occurring on
December 2, 1998months after the 501 patents priority date.2
Notably, the Wayback Machines archives of the main NIH website go back
until at least December of 1997 (see http://web.archive.org/web/*/http://nih.gov),

and archives of rarediseases.info.nih.gov go back until at least January of 1998
(see http://web.archive.org/web/*/http://rarediseases.info.nih.gov).
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The Wayback Machine does not have an image of the webpage associated
with the Link in December 1998, but the first image of that webpage from
February 1999 shows that the Link did not go to the NIH reference at that time.
Rather, it went to the Office of Rare Diseases home page:
Ex. 2015.
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Further, and independent of the Wayback Machine, the Press Release itself
does not establish that the NIH reference could be accessed at the Link at any time
because the Press Releases description does not match the NIH references
content. Specifically, the Press Release describes a document that includes an
extensive bibliography of thalidomide research. Ex. 1017. But the NIH reference
does not contain a bibliography of thalidomide research, let alone an extensive
one. See Ex. 1015. The Press Release also describes the document found at the
Link as having [a] complete agenda and background information on the meeting.
Ex. 1017. But the NIH Reference does not have background information on the
meeting. Rather, it is composed of abstracts for each speaker, further
distinguishing its content from the unidentified document (if it even exists) that is
described in the Press Release. As such, the evidence demonstrates that the NIH
reference was not available at the Link referenced in the Press Release.
Second, CFAD relies on the following disclosure within the NIH reference:
This book is designed for the use of participants in the workshop and
as a pertinent reference document for anyone interested in the
workshop subject. We are grateful to the authors who have
summarized their materials and made them available in a timely
fashion.
See Pet. at 18; Ex. 1015 at 15. The content of the NIH reference, however, is
irrelevant to whether it was publicly available before the 501 patents priority
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date. Indeed, CFAD does not provide any explanation as to how this disclosure
relates to the references public availability as of the 501 patents priority date.
Notably, CFAD does not provide any evidence concerning when the NIH
reference was published, or when, if at all, the reference was actually made
available to any person who attended the workshop. Rather, CFAD again assumes
that the excerpt it relies on means that the NIH reference was published before the
workshop, as opposed to after. But there is nothing in the disclosure that evidences
CFADs assumption. Accordingly, CFAD has not established that the NIH
reference was publicly available prior to the 501 patents priority date.
2.
CFAD Has Not Offered Any Evidence of Dissemination
Even assuming that CFAD had alleged sufficient facts to show that the NIH
reference was made available in some fashionit has notCFAD still has not met
its burden of showing that the NIH reference was disseminated to a POSA at the
conference without restriction. See Ciena, 2012 WL 946543, at *4. In fact, CFAD
has not offered any proof that the NIH reference was distributed to a single person
at the conference. Nor has CFAD offered any evidence that anyone at the
conference actually downloaded the NIH reference from the Link in the Press
Release, or, as discussed above, that it was ever possible to do so.
In addition, CFAD has not put forth any information regarding the details of
the workshop. CFAD has not even provided information regarding the number of
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attendees and whether the attendees were POSAs. All of this information is
necessary to establish that the NIH reference is a printed publication. See Mass.
Inst., 774 F.2d at 1109 (finding a scientific paper was prior art only where it was
presented to between 50 and 500 persons having ordinary skill in the art, and the
paper itself was actually distributed to at least six persons).
For this additional reason, CFAD has not demonstrated that the NIH
reference is a printed publication and, as a result, Ground 2 should be denied.
B.
The Petition Should Be Denied Because

CFAD Has Failed To Show A Reasonable
Likelihood That The Claims Would Have Been Obvious
1.
CFADs Expert Declaration Is

Entitled To little or no weight
As discussed below, CFADs Petition relies heavily on the declaration of Dr.

Jeffrey Fudin. See generally Pet. (citing Ex. 1002). Dr. Fudins opinions,
however, are entitled to little or no weight, including because: (1) Dr. Fudins
experience does not qualify him as a POSA; and (2) his opinions are unsupported,
verbatim recitations of CFADs conclusory arguments.
(a)
Dr. Fudin Is Not A POSA
Dr. Fudin does not have the knowledge of a POSA or any experience with
the problem that is solved by the 501 patent. CFAD defines a POSA as a
pharmacist. Pet. at 20. In particular, a POSA under CFADs definition would
typically have either a Pharm.D. or a BS in pharmacy with approximately 5-10
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years of related experience and a license to practice as a registered pharmacist in
any one or more of the United States. Id. This definition improperly ignores the
true field of the claimed inventions, which is avoidance of adverse events
associated with drug products (i.e., pharmaceutical drug product risk management).
As such, Celgene disagrees with CFADs definition of a POSA, and proposes that
a POSA would have had at least a bachelors degree and at least 2 years of
experience in risk management relating to pharmaceutical drug products, or a B.S.
or M.S. in pharmaceutical drug product risk management or a related field.
Celgenes definition of a POSA is supported by the claims and specification
of the 501 patent. See generally Ex. 1001. CFADs POSA, on the other hand, is
intentionally shaped to mirror the skills of Dr. Fudin and the alleged prior-art
references on which CFAD relies. While Dr. Fudin work[ed] in close
collaboration with medical staff members in the management of various acute and
chronic pain disease states, and has experience with . . . computerized billing and
patient record systems through his work as a pharmacist (Ex. 1002 at 5, 8), he
does not have the knowledge of a POSA or any experience with the problem that is
solved by the 501 patent. For example, a POSA would have experience in
designing and implementing systems for controlling access to pharmaceutical drug
products that have the potential for life threatening adverse eventsthe subject
matter of the 501 patent.
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Because Dr. Fudins opinions regarding the patentability of the 501 patent
claims are not from the view of a POSA, they are entitled to no weight.
(b)
Dr. Fudins Opinions Are Unsupported, Verbatim

Recitations Of CFADs Conclusory Arguments
Dr. Fudins opinions are also entitled to little or no weight because they are
unsupported and largely verbatim recitations of CFADs conclusory arguments.
See infra. To the extent that Dr. Fudin fails to cite any underlying factual bases for
his opinions, they are entitled to little or no weight. See 37 C.F.R. 42.65(a);
Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir.
1985) (stating a lack of factual support for expert opinion may render the
testimony of little probative value in a validity determination).
Indeed, the Board has been clear that it will exercise its well-established
discretion to give little weight to conclusory, unsupported expert testimony, such
as testimony that d[oes] not elaborate on [the Petitioners] position because it
simply repeat[s the Petitioners] conclusory statements verbatim. TRW
Automotive US LLC v. Magna Elecs., Inc., IPR2014-00258, Paper 18 at 10-11
(Aug. 27, 2014); see also Apple Inc. v. Smartflash LLC, CBM2014-00111, Paper 7
at 21 (Sept. 30, 2014) (denying institution where the expert declaration simply
reiterates [the Petitioners] contentions and conclusory reasoning). Celgene
submits that the Board should do the same here.
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Ground 1: The Claimed Inventions

Would Not Have Been Obvious Over
Powell, Mitchell, and Dishman
CFADs Ground 1 lacks merit because CFAD: (1) fails to address both the
claims and the prior art as a whole; (2) does not identify a colorable motivation to
combine or modify the cited art; and (3) cannot show that the prior art disclosed,
taught, or suggested each and every element of the claims.
(a)
CFAD Fails To Address Both The

Claims And The Prior Art As A Whole
CFADs obviousness analysis is improper because it fails to address both the

claims and the prior art as a whole. [A] patent composed of several elements is
not proved obvious merely by demonstrating that each of its elements was,
independently, known in the prior art. KSR Intl Co. v. Teleflex Inc., 550 U.S.
398, 418 (2007). Indeed, [i]f identification of each claimed element in the prior
art were sufficient to negate patentability, very few patents would ever issue. In
re Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998). CFAD ignores this well settled
principal of patent law. Instead, with hindsight, CFAD parses each individual
element of the challenged claims for the purpose of identifying corresponding
portions of the prior art that allegedly suggest that element to a POSA. Not once
does CFAD address the combination of claim elements as a whole. For this reason
alone, its obviousness ground should be denied.
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The law also requires CFAD to consider the prior art as a whole, including
teachings that point away from the claimed invention. Leo Pharm. Prods. v. Rea,
726 F.3d 1346, 1353-56 (Fed. Cir. 2013). As described below, CFAD also fails to
conduct this critical analysis. Instead, it picks and chooses only those portions of
the prior art that allegedly support its obviousness position. For this additional
reason, CFADs obviousness analysis is legally flawed and should be rejected.
(b)

Combine Powell With Dishman Or Mitchell
CFADs Petition should also be denied because it does not explain how the
teachings of the references would be arranged or combined by a POSA, or why a
POSA would have made such a combination without the benefit of hindsight. A
Petitioner must show some reason why a [POSA] would have thought to combine
particular available elements of knowledge, as evidenced by the prior art, to reach
the claimed invention. Heart Failure Techs., LLC v. Cardiokinetix, Inc.,
IPR2013-00183, Paper No. 12 at 9 (July 31, 2013). Indeed, obviousness cannot
be sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness. In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
The Board has repeatedly denied institution where a petitioner fails to
demonstrate that it would have been obvious to combine or modify references,
holding that conclusory or general statements regarding alleged reasons to combine
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or modify references are insufficient. See, e.g., TRW Auto. US LLC v. Magna
Elecs., IPR2014-00293, Paper 19 at 17 (July 1, 2014); Moses Lake Indus. v.
Enthone, Inc., IPR2014-00243, Paper 6 at 20 (June 18, 2014); Biodelivery Sci. Intl
v. Monosol Rx, LLC, IPR2015-00167, Paper 6 at 26-27 (May 20, 2015). Absent an
articulated reasoning with a rational underpinning to support the legal conclusion
of obviousness, CFAD fails to establish a prima facie case of obviousness. See
TRW Auto. US LLC v. Magna Elecs., IPR2014-00257, Paper 16 at 7, 12 (June 26,
2014) (denying petition where Petitioner failed to set forth motivation to combine).
Here, CFAD has not provided any analysis that supports a motivation to
combine Powell, Mitchell, and Dishman. Its arguments should be rejected because
they: (1) are rooted in hindsight, using the 501 patents disclosures as a basis to
combine the references; (2) are based on unsupported conclusory statements;
(3) fail to account for the fact that the references are directed to different endeavors
and also teach away from the claimed inventions; and (4) ignore that there can be
no motivation to combine because the prior art does not disclose each and every
element of the claimed inventions.
First, CFAD improperly uses the 501 patents disclosures as its basis to
combine the references. Specifically, CFAD contends that a POSA would look to
Powell for guidance on the clinical use and dispensing of thalidomide, and
would garner from it recommendations for delivering a teratogenic drug to
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patients in need of the drug while avoiding the delivery of said drug to a foetus.
Pet. at 21 (emphasis added). CFAD admits, however, that the emphasized
language is from the 501 patents preamble. Id.; Ex. 1001 at 10:44-46. CFAD
thus defin[es] the nature of the problem to be solved as the specific problem
solved by the invention . . . [CFAD] has relied on impermissible hindsight to
supply the reason to combine. Purdue Pharma L.P. v. Depomed, Inc., IPR201400379, Paper 72 at 28 (July 8, 2015); see also Texas Instruments Inc. v. Vantage
Point Tech. Inc., IPR2014-01105, Paper 8 at 17 (Jan. 5, 2015) (finding it
impermissible to use the challenged patents description of the invention as a
roadmap to piece together the prior art). As such, its argument lacks merit.
Second, CFAD improperly basis its motivation argument on only its experts
unsupported and conclusory opinions. Specifically, CFAD alleges that a POSA
would: (1) implement Powells teachings in clinical and pharmacy settings in
view of the Accutane and Clozaril programs disclosed in Mitchell and
Dishman, respectively; and (2) recognize that Powell and Dishman address the
shortcomings of the Accutane program . . . disclosed in Mitchellnamely, that the
use of the registry was not mandatory for all patients, and that the system did not
involve verification by pharmacists that a patient was authorized to receive the
drug. Pet. at 21-22.
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The only support that CFAD offers for this conclusory argument, however,
is its experts opinion at 89, which recites the exact same conclusory statement
without the rational underpinning required to establish obviousness. Dr. Fudins
opinion should, therefore, be given little to no weight since it d[oes] not elaborate
on [CFADs] position because it simply repeat[s CFADs] conclusory statements
verbatim. TRW Auto., IPR2014-00258, Paper 18 at 10. CFADs alleged
motivation argument should be rejected for this additional reason.
Third, CFAD fails to account for the fact that the prior art references are
directed to completely different endeavors and also teach away from the claimed
inventions. Specifically, CFAD ignores that, at the very least, a POSA would not
have been motivated to combine Dishman with Powell or Mitchell because
Dishman is not directed to a system designed to prevent exposure of a drug to a
fetus and, thus, fetal birth defects. Further, a POSA looking to develop a system
for universal use would not find a distribution system isolated to the Department of
Veteran Affairs (as Dishman is) to be particularly instructive. In that regard, the
risks associated with commercial pharmacy distribution of a teratogenic drug are
far more complex, and require different management, than distribution to a small
group of individuals at the Department of Veterans Affairs.
Furthermore, even if a POSA would look to the system disclosed in
Dishman, they would not ignore the prior art as a whole, which teaches away from
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the Clozaril system discussed in Dishman because that system, as a whole, was a
failure. See supra at II.B. As such, a POSA would have been taught away from
combining Dishman with any reference, including Powell or Mitchell. A reference
that teaches away cannot serve as a basis for obviousness. See, e.g., In re Gurley,
27 F.3d 551, 553 (Fed. Cir. 1994). A reference may be said to teach away when a
[POSA], upon reading the reference, would be discouraged from following the
path set out in the reference, or would be led in a direction divergent from the path
that was taken by the applicant. Id. That is exactly what Dishman does here.
Similarly, a POSA would not have relied on the Accutane system described
in Mitchell because it was also a failure. As discussed above, Mitchell discloses
that compliance with the program was not complete and, as a result, there were
hundreds of pregnancies during isotretinoin treatment, at least six of which resulted
in fetal birth defects. See supra at II.B. CFAD ignores this additional reason that a
POSA would not have been motivated to combine Powell, Mitchell, and Dishman.
Fourth, CFAD ignores that there can be no motivation to combine the
references because the prior art does not disclose each and every element of the
claimed inventions. Specifically, the Federal Circuit has instructed that motivation
to combine is only a consideration if all the elements of an invention are found in
a combination of prior art references. Medichem, S.A. v. Rolabo, S.L., 437 F.3d
1157, 1164 (Fed. Cir. 2006). As discussed below, the prior art does not disclose all
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of the elements of the challenged claims. CFAD has failed to meet its burden of
showing a motivation to combine for this additional reason.
For the foregoing reasons, CFAD has failed to set forth a motivation to
combine the prior art as set forth in Ground 1. This ground should be denied.
(c)
The Ground 1 References Fail To Disclose, Teach, Or

Suggest Key Elements Of The Claimed Inventions
CFAD relies on Powell, Dishman, and Mitchell as teaching the elements of

the 501 patent. None of these references, however, teach all of the elements of the
claimed subject matter, and certain elements are missing from every reference.
Attempting to fill in the missing elements, CFAD relies only on attorney argument,
its experts unsupported and conclusory statements, and impermissible hindsight.
CFAD falls far short of showing a reasonable likelihood that the challenged claims
would have been obvious.
i.
Independent Claim 1 Would Not Have Been

Obvious Over Powell, Mitchell, And Dishman
1)
Elements 1(a), 1(b), and 1(c)
In Ground 1, CFAD alleges that Powell and Dishman teach (a) registering
in a computer readable storage medium prescribers who are qualified to prescribe
said drug; (b) registering in said medium pharmacies to fill prescriptions for said
drug; and (c) registering said patients in said medium, including information
concerning the ability of female patients to become pregnant and the ability of
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male patients who are capable of impregnating females. Pet. at 25-29. CFAD is
incorrect.
As an initial matter, CFAD admits that Powell does not disclose the use of a
computer readable storage medium. Id. at 26; Ex. 1002 at 113. Rather, CFAD
cites to In re Venner, 262 F.2d 91, 96 (CCPA 1955) for the proposition that
automation of known manual processes is obvious, and argues that it would be
routine optimization to have electronic records of the information disclosed in
Powell. Pet. at 26. But in Venner, unlike here, all of the limitations in the claims
were disclosed in the alleged prior-art references. Thus, CFADs reliance on
Venner is inapplicable to the present facts, where the art does not disclose all
elements of claim 1. See In re Ralf Wollenhaupt, Matthias Pietsch, & Matthias
Michanicki, Appeal No. 2007-3142, 2008 WL 685165, at *3 (P.T.A.B. Mar. 13,
2008) (distinguishing Venner on the same grounds).
CFAD then cites to its expert, who merely parrots the same conclusory
assertion that an advantage of having computer records is ease in sharing and
storing information . . . for purposes such as communicating with managed care
organizations. Pet. at 26; Ex. 1002 at 114. The alleged advantage proffered
by Dr. Fudin is irrelevant here. No aspect of the claimed invention relates to
communication with managed care organizations, and CFAD has not even
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attempted to explain why a POSA would have been motivated to focus on such
communications at the time of the 501 patents invention.
Recognizing the deficiency in its obviousness argument, CFAD next argues
that [a]rmed with these disclosures from Powell and Mitchell, a POSA would
look to Dishman to further implement a computerized registry for avoiding birth
defects from a teratogenic drug. Pet. at 26-27.3 CFAD alleges that a POSA
would have looked to Dishman because the clozapine program described therein
was allegedly proven successful. Pet. at 27. Of course, CFAD does not cite
anything to support the alleged proven success[] of the Dishman system, nor
could it. Instead, CFAD relies solely on its experts say-so. Id. (citing Ex. 1002 at
117). CFADs unsupported declarant testimony is entitled to little or no weight.
See 37 C.F.R. 42.65(a). Further, as described above, the clozapine program was
recognized to be a failure, as evidenced by the dozen deaths that occurred on its
watch. A POSA would not have looked to Dishman and would not have been
motivated to combine Dishman with Powell or Mitchell.
Moreover, CFAD admits that Dishman does not disclose registering
pharmacies with the Clozaril National Registry. Pet. at 28. Yet, CFAD argues
CFAD has not pointed to any disclosure in Mitchell for support that these claim
elements are met. See Pet. at 25-29. Its argument is baseless for this reason alone.
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that a POSA would have understood that pharmacist information would need to
be collected and stored as part of the registry. Id. As alleged support for its
argument, CFAD cites Dr. Fudins quotation of a statement in Dishman indicating
that cooperation between patients, physicians, laboratories, and pharmacies is
required for the process. Id. (citing Ex. 1002 at 121). This statement, however,
does not disclose, teach, or suggest that the registry collects pharmacy information
or that this information would need to be collected. A POSA would only come
to such a conclusion by using the 501 patent as a roadmap to navigate the prior
art. This is the epitome of hindsight and cannot be used to render the claim
obvious. See Texas Instruments, IPR2014-01105, Paper 8 at 16-17 (finding it
impermissible to use the challenged patents description of the invention as a
roadmap to piece together the prior art). CFAD has failed to show that its cited
references disclose, teach, or suggest Elements 1(a), 1(b), and 1(c).
2)
Element 1(d)
CFAD asserts that Powell and Mitchell disclose the element retrieving from
said medium information identifying a subpopulation of said female patients who
are capable of becoming pregnant and male patients who are capable of
impregnating females. Pet. at 22. Again, CFAD is incorrect.
First, CFAD has failed to put forth any argument regarding whether Powell
or Mitchell disclose the beginning portion of this claim element: retrieving from
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said medium. Instead, CFAD and its declarant completely ignore this portion of
the claim, arguing only that a POSA would have understood the desirability of
identifying the subpopulations of female and male patients required by this claim
element. Id.; Ex. 1002 at 91. For this reason alone, CFADs argument fails.
Second, CFAD does not argue that either Powell or Mitchell disclose, teach,
or suggest anything regarding male patients who are capable of impregnating
females. Pet. at 23. Instead, CFAD relies on only Dr. Fudins declaration, in
which he asserts that a POSA would have included in the subpopulation any
individual that could be affected by the teratogenic nature of the drug. Id. (citing
Ex. 1002 at 95.) For support for this assertion, Dr. Fudin cites Mann 1982s
disclosure that thalidomide was known to be present in male sperm. Pet. at 23; Ex.
1002 at 96 (citing Ex. 1018 at 7-8).
Mann 1982, however, is not asserted in any ground of unpatentability or
even discussed generally in the Petition. CFADs argument should be disregarded
for this reason alone. See Boehringer Ingelheim Intl v. Biogen, Inc., IPR201500418, Paper 14 at 17 (July 13, 2015) (citing 37 C.F.R. 42.104(b)(2)) (holding
that its impermissible to rely on external references to establish obviousness); see
also 37 C.F.R. 42.6(a)(3) (arguments may not be incorporated from other
documents into the Petition). The Board should also disregard this argument
because CFAD has not alleged, let alone made a sufficient showing, of any
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motivation to combine Mann with Powell or Mitchell to arrive at the claimed
inventions. See Norman Intl, Inc. v. Hunter Douglas Inc., IPR2014-00276, Paper
No. 11 at 20 (June 20, 2014) (denying institution and stating that the motivation to
combine analysis should be made explicit).
Further, Mann 1982 does not show the state of the art at the time of the 501
patents invention. Specifically, CFAD fails to analyze the prior art as a whole.
Despite relying on Powell elsewhere in its Petition, here CFAD ignores Powells
later published disclosure that states, with respect to thalidomide, no effects on
male sperm are recognized. Ex. 1005 at 903. Thus, a POSA would not have
been motivated to include males in any subpopulation, as Powell teaches away
from doing so. [R]eferences that teach away cannot serve to create a prima facie
case of obviousness. McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1354
(Fed. Cir. 2001).
For the foregoing reasons, CFAD has failed to show that there is a
reasonable likelihood that claim 1 is obvious.
ii.
Dependent Claims 2-10 Would Not Have Been

Obvious Over Powell, Mitchell, And Dishman
Because CFAD has failed to show that there is a reasonable likelihood that
claim 1 is obvious, it also has failed to show that there is a reasonable likelihood
that any of claims 2-10, which depend from claim 1, are obvious. See In re Fine,
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837 F.2d 1071, 1076 (Fed. Cir. 1988) (holding that a dependent claim that depends
from a non-obvious independent claim is also nonobvious).
CFAD has also failed to demonstrate a reasonable likelihood that claim 7 is
obvious for additional reasons. Claim 7 depends from claim 1 and adds the
limitation that said prescriptions are filled for no more than about 28 days. Ex.
1001 at Claim 7. CFAD argues that claim 7 would have been obvious over Powell
and the general knowledge of the field. Pet. at 33. CFAD does not argue,
however, that Powell discloses the 28-day-prescription limitation. Id. In fact,
CFAD acknowledges that the only temporal limitation put on prescriptions in
Powell is 3 months. Id.; Ex. 1005 at 904. Claim 7s additional limitation is not
disclosed in the prior art, and CFAD cannot prove obviousness. See 37 C.F.R.
42.104(b)(4) (The petition must specify where each element of the claim is found
in the prior-art patents or printed publications relied upon.); see also Toshiba
Corp. v. Optical Devices, LLC, IPR2014-01446, Paper 7 at 16 (Mar. 10, 2015) (A
prior art reference demonstrating the feature of claim 3 was not provided.
Petitioner, therefore, has not shown a reasonable likelihood that it would prevail in
showing that claim 3 is obvious over the applied references.).
Further, CFAD does not argue that anything in Powell or in the other cited
references would have motivated a POSA to modify Powells teaching to use a 3month supply to arrive at the claimed 28-day limtiation. Without any reason or
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explanation as to why a POSA would have modified the prior art based on the
general knowledge of the field, CFADs argument fails. CFAD has failed to show
there is a reasonable likelihood that claim 7 is obvious for this additional reason.
3.
Ground 2: The Claimed Inventions Would Not Have Been

Obvious Over the NIH Reference And Honigfeld
CFADs argument that Claims 1-10 are obvious over the NIH reference in
view of Honigfeld (Pet. at 45) also fails on the merits. As already discussed, the
NIH reference is not prior art, would not have been available to a POSA and,
therefore, cannot render the claimed inventions obvious. See supra at III.A. As
discussed below, even if the NIH reference is prior art, CFAD has not shown a
reasonable likelihood of prevailing on the challenged claims because CFAD:
(1) fails to address both the claims and the prior art as a whole; (2) does not
identify any colorable motivation to combine or modify the cited art; and
(3) cannot show that the prior art disclosed, taught, or suggested each and every
element of the claims.
(a)
CFAD Fails To Address Both the

Claims and the Prior Art As a Whole
CFADs obviousness analysis is improper because it fails to address both the

claims and prior art as a whole. [A] patent composed of several elements is not
proved obvious merely by demonstrating that each of its elements was,
independently, known in the prior art. KSR, 550 U.S. at 418. Indeed, "[i]f
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identification of each claimed element in the prior art were sufficient to negate
patentability, very few patents would ever issue. Rouffet, 149 F.3d at 1357.
CFAD ignores this well settled principal of patent law. Rather, with hindsight,
CFAD parses each individual element of the challenged claims for the purpose of
identifying corresponding portions of the prior art that allegedly suggest that
element to a POSA. Not once did the CFAD address the combination of claim
elements as whole. For this reason alone, its obviousness argument fails.
The law also requires CFAD to consider the prior art as a whole, including
teachings that point away from the claimed invention. Leo, 726 F.3d at 1353-56.
As described below, CFAD also fails to conduct this critical analysis. Instead, it
picks and chooses only those portions of the prior art that allegedly support its
obviousness contentions. For this additional reason, Ground 2 should be denied.
(b)

Combine The NIH Reference And Honigfeld
CFAD argues that a POSA would have been motivated to combine the NIH
References alleged disclosures regarding the PPP with Honigfelds alleged
disclosures regarding clozapine because those programs were recognized methods
to avoid the delivery of drugs to contraindicated individuals. Pet. at 46. In other
words, CFAD argues that a POSA would have combined the references because
they are both allegedly directed to the same endeavor. CFAD is incorrect.
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As an initial matter, CFADs alleged motivation is insufficient to carry its
burden because it is general and conclusory.4 The Board has consistently denied
institution where the only alleged motivation to combine is that all references were
directed to the same field or endeavor. See, e.g., Cisco Sys., Inc. v. C-Cation
Techs. LLC, IPR2014-00454, Paper 12 at 13-15 (Aug. 29, 2014); Norman Intl,
IPR2014-00276, Paper 11 at 19-20; Microsoft Corp. v. Enfish, LLC, IPR201300561, Paper 13 at 23-24 (Mar. 4, 2014); OpenTV, Inc. v. Cisco Tech., Inc.,
IPR2013-00329, Paper 9 at 28-30 (Nov. 29, 2013); Heart Failure, IPR2013-00183,
Paper 12 at 9.
In any event, the NIH reference and Honigfeld are not directed to the same
endeavor. In particular, Honigfeld is not directed to preventing fetal birth
abnormalities. A POSA looking to design a system to prevent drug-related birth
defects would not look to the Honigfeld system because it was designed for a
completely different purpose. Moreover, as discussed above (see supra at II.B), a
POSA would have been aware that, based on Honigfeld itself, the clozapine system
was a failure and, thus, taught away from adopting its alleged disclosures. Indeed,
a reference that teaches away cannot serve as a basis for obviousness. See, e.g., In
Dr. Fudin likewise offers the same insufficient general motivation to combine in
his declaration. (Ex. 1002 at 176.)
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re Gurley, 27 F.3d at 553. A reference may be said to teach away when a
[POSA], upon reading the reference, would be discouraged from following the
path set out in the reference, or would be led in a direction divergent from the path
that was taken by the applicant. Id. That is exactly what Honigfeld does.
CFADs motivation argument fails for this additional reason.
Recognizing the failure of prior-art systems, CFAD alleges that a POSA
would have sought to implement the methods described in NIH and Honigfeld in
order to improve upon the non-mandatory registration and unrestricted pharmacy
methods of the Accutane program. Pet. at 46. For this argument, CFAD relies
solely on Dr. Fudins conclusory opinion, verbatim. See Pet. at 46 (citing Ex.
1002 177.). Dr. Fudin does not provided any explanation as to why a POSA
would seek to improve upon the Accutane program, let alone why a POSA would
seek to specifically improve the non-mandatory registration and unrestricted
pharmacy methods of the program. CFADs alleged motivation to combine is not
supported by the factual record, and Dr. Fudins opinion is entitled to little or no
weight. See TRW Auto., IPR2014-00258, Paper 18 at 10; see also 37 C.F.R.
42.65(a). CFADs argument should be rejected for this additional reason.
Finally, the Federal Circuit has instructed that motivation to combine is only
a consideration if all the elements of an invention are found in a combination of
prior art references. Medichem, 437 F.3d at 1164. As discussed below, the prior
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art does not disclose all of the elements of the challenged claims. Thus, CFAD has
failed to meet its burden of showing a motivation to combine.
(c)
The Cited References Fail To Disclose, Teach, Or

Suggest Key Elements Of The Claimed Inventions
In Ground 2, CFAD relies on the NIH reference and Honigfeld as teaching

the elements of the 501 patents claims. Neither of these references, however,
disclose, teach, or suggest all of the elements of the claimed subject matter, and
certain elements are missing from each reference as discussed below. Attempting
to fill in the missing elements, CFAD relies only on attorney argument, its experts
unsupported and conclusory statements, and impermissible hindsight. CFAD falls
far short of showing a reasonable likelihood that the challenged claims are obvious.
i.
Claim 1 Would Not Have Been Obvious Over

The NIH Reference and Honigfeld
1)
Element 1(c)
CFAD argues that Element 1(c), registering said patients in said medium,
including information concerning the ability of female patients to become pregnant
and the ability of male patients who are capable of impregnating females, would
have been obvious over Honigfeld. Pet. at 49. CFAD is incorrect.
As an initial matter, CFAD does not argue that Honigfeld discloses the
portion of Element 1(c) reciting including information concerning the ability of
female patients to become pregnant and the ability of male patients to impregnate
females. Pet. at 49. Rather, as CFAD acknowledges, Honigfeld discloses
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recording information regarding white blood cell counts. Id.; see also Ex. 1009 at
53. Recognizing this deficiency, CFAD turns to Dr. Fudins conclusory and
unsupported assertion that a POSA would have known to modify this teaching and
record information concerning pregnancy in the case of a teratogenic drug as part
of the records entered into the computer database. Id. at 50 (citing Ex. 1002 at
207.) Dr. Fudins unsupported statement is entitled to little or no weight. See 37
C.F.R. 42.65(a). Indeed, only with hindsight and the claimed invention in mind
would a POSA take such an action. CFAD has not pointed to any teaching in the
prior art to support this position. It has, therefore, failed to show there is a
reasonable likelihood that this element would have been obvious. See 37 C.F.R.
42.104(b)(4) (The petition must specify where each element of the claim is
found in the prior art patents or printed publications relied upon.); see also
Toshiba, IPR2014-01446, Paper 7 at 16 (denying petition where a prior-art
reference demonstrating the feature of a claim was not provided).
2)
Element 1(d)
CFAD alleges that Element 1(d), retrieving from said medium information
identifying a subpopulation of said female patients who are capable of becoming
pregnant and male patients who are capable of impregnating females, is taught by
the NIH reference. Pet. at 46; Ex. 1002 at 175-182. CFAD is wrong.
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As an initial matter, CFAD has failed to put forth any argument regarding
whether the NIH reference discloses the first portion of this claim element,
retrieving from said medium. Indeed, CFAD has completely ignored this
language, instead arguing only that the NIH reference teaches the identification of
a subpopulation of patients who are capable of becoming pregnant or capable
of impregnating females. Pet. at 46. From this, CFAD concludes that the NIH
reference teaches retrieving information, without providing any specific
evidence or explanation directed towards this language. Id. at 47. CFADs expert,
Dr. Fudin, similarly fails to provide any support for this portion of the claim
element and instead, mimicking CFAD, provides a conclusory assertion that the
NIH reference teaches retrieving information about patients to identify the
subpopulation described in claim 1. Ex. 1002 at 175-182. Conclusory
assertions, without more, cannot establish obviousness. See 37 C.F.R. 42.65(a).
For this reason alone, CFADs argument fails.
CFAD also cites to select portions of several abstracts in the NIH reference
to conclude that a POSA would have understood that information about the ability
to become pregnant or impregnate would also be included in a database of
individual patients taking thalidomide. Pet. at 46. In so arguing, CFAD concedes
that this element is not explicitly taught by the NIH reference. There is no
indication or teaching by the NIH reference, or any other reference, that the
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database of individual patients to track regulatory documentation and assess
safety-related trends cited to by CFAD would include information regarding a
womans ability to become pregnant or a males ability to impregnate a female.
Indeed, CFAD has not pointed to any such teaching. Only with hindsight and the
claimed invention in mind would a POSA reach the conclusion that CFAD relies
upon. This is improper and CFADs argument should be rejected.
Accordingly, for the foregoing reasons, CFAD has failed to show there is a
reasonable likelihood that claim 1 is obvious.
ii.

Not Have Been Obvious Over The
NIH Reference And Honigfeld
Because CFAD has failed to show that there is a reasonable likelihood that
claim 1 is obvious, it also has failed to show that there is a reasonable likelihood
that any of claims 2-10, which depend from claim 1, are obvious. See In re Fine,
837 F.2d 1071 (holding that a dependent claim that depends from a non-obvious
independent claim is also nonobvious).
CFAD has also failed to show that there is a reasonable likelihood that claim
7 is obvious for additional reasons. Claim 7 depends from claim 1 and adds the
limitation that the prescriptions are filled for no more than about 28 days. Ex.
1001 at Claim 7. CFAD argues that claim 7 would have been obvious over
Honigfeld and the general knowledge of the field. Pet. at 53. CFAD admits,
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however, that Honigfeld does not disclose a 28-day-prescription limitation. Id.
Rather, CFAD acknowledges that the only temporal limitation put on prescriptions
in Honigfeld is 7 days. Id. Recognizing this deficiency in the prior art, CFAD
then relies on Dr. Fudins declaration for his unsupported conclusion that a POSA
would have understood to limit the drugs supply to a short period of time and
particularly a 28-day period since it aligns with the menstrual cycle. Id.; Ex. 1002
at 230. Neither CFAD nor Dr. Fudin have explained, however, why a POSA
would have been motivated to limit the drugs supply to a short time period and
both have ignored the prior art as a whole. For example, Powell, a reference
CFAD relies on in Ground 1 of its argument, discloses a 3-month temporal
limitation on prescriptions of thalidomide. Ex. 1005 at 904. Only with hindsight
and the claimed invention in hand would a POSA reach the same conclusions
reached by CFAD and Dr. Fudin. This is improper. CFAD has failed to show that
there is a reasonable likelihood that claim 7 is obvious for this additional reason.
4.
CFAD Fails To Address The Objective Evidence Of

Nonobviousness Regarding The 501 Patent
Objective indicia of nonobvious are not just cumulative or confirmatory

part of the obviousness calculus but constitute[] independent evidence of
nonobviousness. Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358,
1365 (Fed. Cir. 2008). In fact, the Federal Circuit has observed that objective
indicia can be the most probative evidence of nonobviousness in the record, and
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enable[] the . . . court to avert the trap of hindsight. Crocs, Inc. v. Intl Trade
Commn, 598 F.3d 1294, 1310 (Fed. Cir. 2010). Here, CFAD does not address or
challenge the merits of Patent Owners secondary consideration evidence, and
thus its petition fails for this additional reason. Omron Oilfield & Marine, Inc. v.
MD/Totco, IPR2013-00265, Paper 11 at 16 (Oct. 31, 2013).
(a)
Long-Felt Need Further Supports The

Nonobviousness Of The Claimed Inventions
The existence of a long-felt and unsolved need for the patented invention
supports a finding of nonobviousness. See Georgia-Pacific Corp. v. U.S. Gypsum,
195 F.3d 1322, 1330 (Fed. Cir. 1999). Before the development of the patented
inventions, there was a long-felt and unsolved need for a system that would protect
the public from the horrors associated with teratogenic drugs like thalidomide.
Celgene developed S.T.E.P.S., which is covered by the methods claimed in the
501 patent, to address that need. Without the inventions of the 501 patent,
Thalomid, Revlimid, and Pomalyst would not be on the market today.
Accordingly, the inventions claimed in the 501 patent provided a way for patients
in need to receive valuable, life-altering treatments, including cancer treatments.
The need for the therapies provided by Thalomid, Revlimid, and
Pomalyst is evidenced by the fact that the FDA granted Orphan Drug Exclusivity
to each product for meeting an unmet need felt by relatively small, untreated
patient populations. Ex. 2016; Ex. 2017; Ex. 2018. Moreover, all three drugs were
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approved under accelerated approval regulations during the FDA approval process
so that they could reach patients in need faster. See, e.g., Ex. 2006-2008.
Of course, as noted above, none of these approvals would have been
possible without the inventions claimed in the 501 patent, which ultimately were
required as conditions for approval by the FDA. See Ex. 1016 at 0002; Ex. 2006 at
1; Ex. 2007 at 1; Ex. 2008 at 7-10 (discussing the drugs approvals subject to
Subpart H). The problems associated with safe access to teratogenic drugs
addressed by the claimed inventions were not solved by the prior-art Clozaril and
Accutane systems. The FDAs grant of ODE and accelerated approval for these
drugs, which contain actual or potential teratogens, also demonstrates the faith that
the FDA placed in the inventions claimed in the 501 patent, which represent the
gold standards in pharmaceutical risk management.
(b)
Commercial Success Further Supports The

Commercial success is usually shown by significant sales in a relevant

market. J.T. Eaton & Co. v. Atl. Paste & Glue Co., 106 F.3d 1563, 1571 (Fed.
Cir. 1997); see also Neupak, Inc. v. Ideal Mfg. & Sales Corp., 41 F. Appx 435,
440 (Fed. Cir. 2002) ([S]ales figures alone can provide satisfactory evidence of
commercial success.).
Here, commercial success of the patented inventions is evidenced by the
sales of Thalomid, Revlimid, and Pomalyst, which together have annual U.S.
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revenues of billions of dollars. See Ex. 2019 at 62. Each sale of these drugs is
made pursuant to, and is only possible as a result of, a restricted distribution or
REMS program that is covered by one or more claims of the 501 patent. See Ex.
1016 at 0002; Ex. 2006 at 1; Ex. 2007 at 1; Ex. 2008 at 7-10 (discussing the drugs
approvals subject to Subpart H). In other words, nexus is present because, but for
the methods claimed in the 501 patent, no sales of Thalomid, Revlimid, and
Pomalyst would have occurred.
(c)
Third-Party Praise And Awards Further Supports

The Nonobviousness Of The Claimed Inventions
Praise in the industry tends to indicate that the invention [is] not obvious.
Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1370 (Fed. Cir.
2012). Here, awards and industry recognition for the patented inventions also
support a finding of nonobviousness. Industry recognition is evidenced by the fact
that the National Organization for Rare Disorders (NORD) honored Celgene for
its development of Thalomid, including the development of S.T.E.P.S., which is
covered by the 501 patent. Ex. 2020. It is also evidenced by praise for those
systems in the published literature. See, e.g., Ex. 2021.
(d)
Licensing by Others Further Supports The

Objective evidence of nonobviousness may also include licenses showing

industry respect. WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1359
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(Fed. Cir. 1999). Here, licensing by others is evidenced by the fact that third
parties have licensed the 501 patent. For example, at the FDAs urging, several
manufacturers of isotretinoin (the active ingredient in Accutane) licensed several
patents, including the 501 patent, in connection with the restricted-distribution
program known as iPledge after it became clear that the PPP (and later attempts at
managing the distribution of isotretinoin) were ineffective. See Ex. 2010; Ex.
2011; Ex. 2012.
(e)
Unexpected Results Further Supports The

Unexpected results are important indicia of nonobviousness. See United

States v. Adams, 383 U.S. 39, 51-52 (1966). [T]hat which would have been
surprising to a person of ordinary skill in a particular art would not have been
obvious. In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995).
Here, evidence of unexpected results is demonstrated by the fact that the
inventions claimed in the 501 patent have enabled the unexpected benefit of safely
administering teratogenic and potentially teratogenic drugs to patients who might
not otherwise have had access to them. Unexpected results are also demonstrated
by the fact that S.T.E.P.S.which is covered by the claims of the 501 patent
has been 100% successful in preventing birth defects of the type associated with
thalidomide. This stands in stark contrast to the birth defects associated with the
PPP and deaths associated with the Clozaril National Registry.
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Celgenes results are especially unexpected in the face of skepticism
regarding the alleged impossibility of zero risk of drug-related birth defects before
the patented inventions were marketed. See, e.g., Ex. 2022 at 235 (We know that
when this drug is used by women of childbearing potential, the risk for causing
serious birth defects can never be lowered to zero.); id. at 241 (Unfortunately,
even with a stronger program for thalidomide, some affected infants will also be
born.); Ex. 2023 at 28 (Its important to remember that a zero risk is not
achievable. There is no system that will prevent the single birth of a child with
phocomelia.); Ex. 2024 at 33 ([N]o matter how exemplary the conduct of the
manufacturers is, no matter how good a job of warning the physicians and the
pharmacists do, there will be children born with birth defects as a result of
thalidomide. Its a fact. There will be.); Ex. 2025 at 2 (It is the view of the
Thalidomide Victims Association of Canada that babies will be born disabled. No
system is foolproof.). These unexpected results further support a finding of
nonobviousness.
For the foregoing reasons, CFAD has failed to show a reasonable likelihood
that any of claims 1-10 of the 501 patent would have been obvious.
C.
The Petition Should Be Denied Under

35 U.S.C. 314(a) And 316(b)
As explained above, CFADs petition should be denied because it fails on

the merits. The Petition should also be denied because it is being used for an
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improper purpose. Specifically, the RPI are non-practicing entities who are
abusing and misusing the IPR process as part of an investment strategy aimed at
causing changes in the stock prices of targeted innovator pharmaceutical
companies. The law gives the Board discretion over which petitions to accept, and
permits the Board to reject petitions that hinder the ability of the Office to timely
complete [IPR] proceedings. 35 U.S.C. 314(a) and 316(b). The Board should
use its discretion and deny this Petition.
The Petitioner, CFAD, is one of fifteen Coalition For Affordable Drugs
companies set up by one or more of the RPI. Ex. 2026 at 1; Ex. 2027 at 1-2. Each
CFAD entity is a wholly-owned subsidiary of Hayman Credes Master Fund, L.P.,
which, through a series of other Hayman investment firms, is controlled by RPI
J. Kyle Bass. Pet. at 1-2. RPI Erich Spangenberg and his notorious non-practicing
entity, IPNav, are paid consultants to the Hayman investment firms. Pet. at 1-2.
The RPI and CFAD are not pharmaceutical companies that seek to compete in the
space covered by the 501 patent. In fact, neither the RPI nor CFAD have any
legitimate business interest in the targeted patent or the products it covers.5
Consequently, were the Board to deny CFADs petition, it would not invade
any legal right conferred upon CFAD. See Consumer Watchdog v. Wis. Alumni
Research Found., 753 F.3d 1258, 1262 (Fed. Cir. 2014) (holding that because
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Instead, CFAD exists for the sole purpose of filing and publicizing [IPR]
patent challenges against pharmaceutical companies while also betting against their
shares. Ex. 2028 at 1. Indeed, Mr. Bass has publicly trumpeted his investment
strategy of attacking patents in the pharmaceutical industry in what he termed a
short activist strategy. Ex. 2029 at 1. Unsurprisingly, two of the RPI admittedly
exist for the primary purpose of . . . generat[ing] superior risk-adjusted returns
through long or short positions with regard to selected companies, primarily in the
pharmaceuticals sector. Ex. 2030 at 5. In fact, the RPI, through seven different
CFAD entities, have filed a combined sixteen IPRs against ten innovators,
including five against Celgene. See IPR2015-00720, -817, -988, -990, -1018, 1076, -1086, -1092, -1093, -1096, -1102, -1103, -1136, -1169, -1241, -1344.
If the RPI are permitted to file IPRs for the sole purpose of profiting by
causing changes in public companies stock prices, then the Board will be overburdened with similar petitions. In fact, two other hedge funds have also recently
filed IPRs, following the RPIs model. See IPR2015-00858, -1046, -1047. Such
improper petitions will divert the Boards resources from other, properly filed
Consumer Watchdog did not have any connection to the challenged patent, the
Boards denial of Consumer Watchdogs [inter partes reexamination] request did
not invade any legal right conferred upon Consumer Watchdog).
04841.00006/7042670.1
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petitions.6
IPR2015-01092
Patent 6,045,501
Celgene respectfully submits that the Board should use its discretion
under 314(a) and 316(b) to ensure that proper proceedings (those used as less
costly alternatives to litigation) are timely resolved; it should not be overburdened
by abusive petitions filed solely for the purpose of executing hedge fund
investment strategies. For this additional reason, the Petition should be denied.
D.
The Petition Should Be Denied For

Failing To Name All Real Parties-In-Interest
The Petition should further be denied because it is procedurally defective.

An IPR petition may be considered only if . . . the petition identifies all real
parties in interest. 35 U.S.C. 312(a)(2). Here, the Petition fails to meet that
threshold requirement. Specifically, the Petition fails to name each investor in the
Hayman funds responsible for filing the Petition. The unnamed investors are RPI
not only because they fund the Petition, but also because CFAD is merely a proxy
for the unnamed investors who stand to gain or lose financially from the Petition.
As Senator Kyl explained, Congresss decision to provide the PTO with the
authority to govern the procedure before it under 35 U.S.C. 316 reflects a

legislative judgment that it is better that the [PTO] turn away some petitions . . .
than it is to allow the [PTO] to develop a backlog of instituted reviews that
precludes the [PTO] from timely completing all proceedings. 157 Cong. Rec.
S1377 (daily ed. Mar. 8, 2011).
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[T]he real party-in-interest is the party that desires review of the patent.
Thus, the real party-in-interest may be the Petitioner itself, and/or it may be the
real party or parties at whose behest the petition has been filed. Zoll Lifecor
Corp. v. Philips Elecs. N.A., IPR2013-00606, Paper 13 at 9 (Mar. 20, 2014). A
party who funds a petition is likely to be an RPI. 77 Fed. Reg. at 48760. A
petition fails to name all RPI when it is filed by a proxy who is at most, a
nominal plaintiff with no substantial interest in the[] IPR challenge[] apart from
those of its client[s]. RPX Corp. v. VirnetX, Inc., IPR2014-00171, Paper 52 at 710 (June 23, 2014).
As explained above, Mr. Bass went on a public relations campaign, pitching
wealthy investors to contribute to his hedge fund to file the present IPR. Ex. 2028
at 4. The fund require[d] a minimum $1 million investment. Id. The RPIs plan
was to file petitions on a big-selling drug [to] rattle investors, anticipating that
the filing of petitions would cause a change in public companies stock prices. Ex.
2031 at 2. Eighty percent of the profits resulting from the investments would be
returned to the unnamed investors. See Ex. 2028 at 4 (Mr. Basss firm will keep
20% of all profits earned.). The unnamed investors funded the petition.
Specifically, Hayman investment materials evidence that investors will generally
bear costs associated with their investments, including outside professional fees
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Patent 6,045,501
and expenses, including those of attorneys, and litigation expenses. Ex. 2030 at
8. As such, the unnamed investors are RPI.
The unnamed investors are also RPI because CFAD is nothing more than a
proxy for the unnamed investors to execute their investment strategy. In fact,
CFAD has no substantial interest in the[] IPR challenge[] apart from those of its
client[s]the unnamed investors. See RPX, IPR2014-00171, Paper 52 at 7-10.
As noted above, CFAD is a wholly owned subsidiary of Hayman Credes
Master Fund, L.P. (Credes). Pet. at 1-2. Credes is funded by a network of other
hedge funds, several of which are not named as RPI here, even though they invest
substantially all of their assets in, and conduct substantially all of their activities
through, one or more of the RPI. See, e.g., CFAD II LLC v. NPS Pharms., Inc.,
IPR2015-00990, Paper 19 at 30-41 (Jul. 24, 2015). The Petition also fails to name
any of the beneficial owners of any of the RPI funds. See id. at 34-35.
Additionally, general partners, managers, trustees, and directors have some control
and decision-making authority over the finances and activities of an organization,
especially hedge funds, but the Petition does not identify any partners, managers,
trustees, or directors of any of the RPI funds, other than Mr. Bass. See id. at 34-36.
The Petition should be denied due to the omission of the additional hedge funds,
beneficial owners, and partners, managers, trustees, and directors, all of whom are
RPI.
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IV.
IPR2015-01092
Patent 6,045,501
CONCLUSION
For the foregoing reasons, the Board should deny institution of the Petition.
Date: July 28, 2015
Respectfully submitted,
By: /F. Dominic Cerrito (Reg. No. 38,100)/
F. Dominic Cerrito (Reg. No. 38,100)
QUINN EMANUEL URQUHART &
SULLIVAN, LLP
51 Madison Avenue, 22nd Floor
New York, NY 10010
Tel: (212) 849-7000
Fax: (212) 849-7100
nickcerrito@quinnemanuel.com
Anthony M. Insogna (Reg. No. 35,203)
JONES DAY
12265 El Camino Real
Suite 200
San Diego, CA 92130
Tel: (858) 314-1200
Fax: (858) 314-1150
aminsogna@jonesday.com
Attorneys for Celgene Corporation
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UNITED STATES PATENT AND TRADEMARK OFFICE

________________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________
COALITION FOR AFFORDABLE DRUGS VI LLC
Petitioner,
v.
CELGENE CORPORATION
Patent Owner
________________
Case IPR2015-01092
Patent 6,045,501
________________
CERTIFICATE OF SERVICE
04841.00006/7042670.1
CERTIFICATE OF SERVICE
Pursuant to 37 C.F.R. 42.6(e), the undersigned hereby certify that
PATENT OWNER PRELIMINARY RESPONSE PURSUANT TO 35 U.S.C.
313 AND 37 C.F.R. 42.107 and accompany exhibits (Exs. 2001-2031) were
served on July 28, 2015 by filing these documents through the Patent Review
Processing System, as well as e-mailing copies to
sarah.spires@skiermontpuckett.com, parvathi.kota@skiermontpuckett.com, and
paul.skiermont@skiermontpuckett.com.
Date: July 28, 2015
Respectfully submitted,
By: /F. Dominic Cerrito (Reg. No. 38,100)/
F. Dominic Cerrito (Reg. No. 38,100)
QUINN EMANUEL URQUHART &
SULLIVAN, LLP
51 Madison Avenue, 22nd Floor
New York, NY 10010
Tel: (212) 849-7000
Fax: (212) 849-7100
nickcerrito@quinnemanuel.com
Anthony M. Insogna (Reg. No. 35,203)
JONES DAY
12265 El Camino Real
Suite 200
San Diego, CA 92130
Tel: (858) 314-1200
Fax: (858) 314-1150
aminsogna@jonesday.com
Attorneys for Celgene Corporation
04841.00006/7042670.1

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Paper No.

PATENT OWNER PRELIMINARY RESPONSE

Patent Owner Preliminary Response

The Challenge of Protecting A Fetus From A Teratogenic

Previous Attempts To Control Access

The 501 Patent ................................................................................... 11

Ground 2 Should Be Denied Because

CFAD Has Not Proven That The NIH

CFAD Has Not Offered Any Evidence of Dissemination ........ 19

The Petition Should Be Denied

CFADs Expert Declaration

Dr. Fudin Is Not A POSA ............................................... 20

Dr. Fudins Opinions Are

Ground 1: The Claimed Inventions Would Not Have

CFAD Fails To Address Both The

Patent Owner Preliminary Response

Elements 1(a), 1(b), and 1(c) ..................... 29

Dependent Claims 2-10 Would

Ground 2: The Claimed Inventions Would Not Have

CFAD Fails To Address Both the

CFAD Has Not Provided A Motivation To

The Cited References Fail To

Independent Claim 1 Would

Claim 1 Would Not Have Been Obvious

Element 1(c) ............................................... 40

Dependent Claims 2-10 Would

Patent Owner Preliminary Response

Long-Felt Need Further Supports The

Commercial Success Further Supports The

Third-Party Praise And Awards Further Supports

Licensing by Others Further Supports The

Unexpected Results Further Supports The

The Petition Should Be Denied

The Petition Should Be Denied

Patent Owner Preliminary Response

Celgene Corporation (Celgene) submits this Preliminary Response to Coalition

Patent Owner Preliminary Response

Patent Owner Preliminary Response

Petition pursuant to 37 C.F.R. 42.12.

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Patent Owner Preliminary Response

The Challenge of Protecting A Fetus From A Teratogenic

Beginning in 1958, thalidomide was marketed in Europe as a sedative and a

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Patent Owner Preliminary Response

Previous Attempts To Control Access To

Others attmpted to control access to the drugs Accutane (isotretinoin) and

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The 501 Patent

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b. registering in said medium pharmacies to fill prescriptions for said

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Ground 2 Should Be Denied Because

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CFAD Has Not Proven That The NIH

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until at least December of 1997 (see http://web.archive.org/web/*/http://nih.gov),

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