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`Filed: June 6, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`COALITION FOR AFFORDABLE DRUGS VI LLC
`Petitioner,
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`v.
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`CELGENE CORPORATION
`Patent Owner
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`________________
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`Case IPR2015-01096
`Patent 6,315,720
`________________
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`PATENT OWNER OBJECTIONS TO EVIDENCE
`SUBMITTED BY PETITIONER PURSUANT TO 37 C.F.R. § 42.64(b)(1)
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`Filed: June 6, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`COALITION FOR AFFORDABLE DRUGS VI LLC
`Petitioner,
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`v.
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`CELGENE CORPORATION
`Patent Owner
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`________________
`
`Case IPR2015-01096
`Patent 6,315,720
`________________
`
`PATENT OWNER OBJECTIONS TO EVIDENCE
`SUBMITTED BY PETITIONER PURSUANT TO 37 C.F.R. § 42.64(b)(1)
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`Patent Owner Objections
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`IPR2015-01096
` Patent 6,315,720
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`Pursuant to 37 C.F.R. § 42.64(b)(1), Patent Owner Celgene Corporation
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`(“Celgene”) objects as follows to the admissibility of evidence relied upon by
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`Petitioner in its May 27, 2016 Reply (Paper 52).
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`1.
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`Exhibit 1075 at 168:5-11, 166:3-7, and 306:4-10 is objected to under
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`Fed. R. Evid. 401-402 because it is irrelevant to whether Dr. Lourdes Frau’s POSA
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`would have been able to design the inventions claimed in U.S. Patent. No.
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`6,315,720 (the “’720 patent”). The cited testimony does not concern whether any
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`POSA would be able to design the inventions claimed in the ’720 patent.
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`2.
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`Exhibit 1075 at 168:5-11 and 166:3-7 is objected to under Fed. R.
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`Evid. 403 because its minimal probative value is substantially outweighed by the
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`fact that it is misleading and unfairly prejudicial. Exhibit 1075 at 168:5-11 and
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`166:3-7 is also objected to under Fed. R. Evid. 106 because Petitioner only
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`introduces part of Dr. Frau’s deposition testimony on this issue and, in fairness,
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`another portion of that deposition testimony ought to be considered at the same
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`time. Petitioner’s use of Exhibit 1075 at 168:5-11 and 166:3-7 is objected to under
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`Fed. R. Evid. 401-403 because it mischaracterizes Dr. Frau’s full testimony on this
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`issue. Specifically, Dr. Frau explained that her POSA would not have been able to
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`design the inventions claimed in U.S. Patent No. 6,045,501 (the “’501 patent”)
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`because “[s]uch POSAs would not have had the information that the inventors had.
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`If my POSA would have the information, then they would have been able to - -
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`Patent Owner Objections
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`IPR2015-01096
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`they would have been able to, but they didn’t have what the inventors had.” Ex.
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`1075 at 333:6-25. Dr. Frau further testified that her POSA would have been
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`capable of designing the inventions claimed in the ’501 patent because they had the
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`skills to do so. Id. at 334:3-335:8.
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`3.
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`Exhibit 2061 at 190:15-18 and 192:10-14 is objected to under Fed. R.
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`Evid. 401-402 because that testimony is not relevant to any material issue of fact in
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`dispute in this IPR. Whether Dr. Jeffrey Fudin’s POSA could design an
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`unspecified “risk management program that was successful” is irrelevant to
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`whether his POSA could design the inventions claimed in the ’720 patent, which is
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`at issue in this IPR.
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`4.
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`Exhibit 1073 is objected to under Fed. R. Evid. 401-402 because it is
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`not relevant to any material issue of fact in dispute in this IPR. Exhibit 1073 was
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`published in 2013 (13 years after the filing date of the ’720 patent), and is not prior
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`art to the ’720 patent. Exhibit 1073 provides no evidence of Dr. Joseph DiPiro’s
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`opinion of a pharmacist’s role at any time relevant to the validity of the
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`’720 patent.
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`5.
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`Exhibit 1075 at 75:22-77:2, 81:12-83:5, 129:11-133:7, 152:12-154:21,
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`and 185:12-187:8 is objected to under Fed. R. Evid. 401-402 because it is
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`irrelevant to the issue of Dr. Frau’s credibility. The fact that Dr. Frau carefully
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`IPR2015-01096
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`considered Petitioner’s counsel’s questions and asked for clarification when the
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`questions were confusing is irrelevant to Dr. Frau’s credibility.
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`6.
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`Exhibits 1077-1081 are objected to under Fed. R. Evid. 401-402
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`because they are irrelevant to the issue of Dr. Frau’s credibility. The fact that
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`Dr. Frau carefully considered Petitioner’s counsel’s questions and asked for
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`clarification when the questions were confusing is irrelevant to Dr. Frau’s
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`credibility.
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`7.
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`Exhibit 1075 at 307:3-4 is objected to under Fed. R. Evid. 403
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`because its minimal probative value is substantially outweighed by the fact that it
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`is misleading and unfairly prejudicial. Exhibit 1075 at 307:3-4 is also objected to
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`under Fed. R. Evid. 106 because Petitioner only introduces part of Dr. Frau’s
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`answer to a deposition question and, in fairness, both the full answer and the
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`question that preceded it should be considered at the same time. Petitioner’s use of
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`Exhibit 1075 at 307:3-4 is objected to under Fed. R. Evid. 401-403 because it
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`mischaracterizes Dr. Frau’s full testimony on this issue. Specifically, the question
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`that led Dr. Frau to testify that “her interpretation of prior art may not be accurate”
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`was whether she “agree[d] that the ’501 patent is prior art to the ’720 patent.” Ex.
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`1075 at 306:11-12. Dr. Frau’s full answer was: “I am not a lawyer, so my
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`interpretation of prior art may not be accurate. It may not even be the same that
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`you have. So . . . In my interpretation of your statement prior art and what I think
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`IPR2015-01096
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`is prior art, even though I’m not a lawyer, I’m going to say it may have been so - -
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`but I’m not a lawyer, so my interpretation of prior art and yours may be different.”
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`Id. 307:3-11.
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`8.
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`Exhibit 1075 at 204:10-18 is objected to under Fed. R. Evid. 403
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`because its minimal probative value is substantially outweighed by the fact that it
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`is misleading and unfairly prejudicial. Exhibit 1075 at 204:10-18 is also objected
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`to under Fed. R. Evid. 106 because Petitioner only introduces part of Dr. Frau’s
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`deposition testimony on this issue and, in fairness, another portion of that
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`deposition testimony ought to be considered at the same time. Petitioner’s use of
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`Exhibit 1075 at 204:10-18 is objected to under Fed. R. Evid. 401-403 because it
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`mischaracterizes Dr. Frau’s full testimony on this issue. Specifically, the very next
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`question and answer state: “Q. My last question was just about what you have
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`written in your report in paragraph 70, which is that terms are to be given their
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`broadest reasonable constructions as would be understood by a POSA . . . And do
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`you agree with that statement? A. Yes, yes, I do. But I wasn’t sure if that was the
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`follow-up to your previous question. So I wasn’t totally sure whether you were
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`trying to say, well, that refers to the previous question. So I had to say no, I wasn’t
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`totally sure which way you were going. So if you were only addressing that one
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`statement, I agree.” Ex. 1075 at 204:19-205:9.
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`9.
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`IPR2015-01096
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`Exhibit 1072 is objected to under Fed. R. Evid. 401-402 because it is
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`not relevant to any material issue of fact in dispute in this IPR. Exhibit 1072 was
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`published in 2011 (11 years after the filing date of the ’720 patent), and is not prior
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`art to the ’720 patent. Exhibit 1072 is irrelevant to the knowledge of a POSA as of
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`the ’720 patent’s filing date. Further, Exhibit 1072 states: “By April 2010, about
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`300,000 patients worldwide had been exposed to Celgene thalidomide, with four
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`confirmed fetal exposures in female patients.” The four fetal exposures to
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`thalidomide that occurred worldwide are irrelevant to the success of the S.T.E.P.S.
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`program (an embodiment of the ’501 patent) in the United States.
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`10. Exhibit 2061 at 515:1-516:16 is objected to under Fed. R. Evid. 401-
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`402 because it is not relevant to any material issue of fact in dispute in this IPR.
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`Exhibit 2061 at 515:1-516:16 discusses Exhibit 1072. Exhibit 1072 was published
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`in 2011 (11 years after the filing date of the ’720 patent), and is not prior art to the
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`’720 patent. Exhibit 1072 is irrelevant to the knowledge of a POSA as of the ’720
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`patent’s filing date. Further, Exhibit 1072 states: “By April 2010, about 300,000
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`patients worldwide had been exposed to Celgene thalidomide, with four confirmed
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`fetal exposures in female patients.” The four fetal exposures to thalidomide that
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`occurred worldwide are irrelevant to the success of the S.T.E.P.S. program (an
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`embodiment of the ’501 patent) in the United States.
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`IPR2015-01096
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`Patent Owner Objections
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`11. Petitioner’s use of Exhibit 1075 at 129:1-133:7 is objected to under
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`Fed. R. Evid. 401-403 because it mischaracterizes Dr. Frau’s testimony.
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`Specifically, Dr. Frau did not refuse and did answer the identified questions,
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`including “And that was done through avoiding fetal exposure to thalidomide;
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`correct?” by stating “It was accomplished through more than that, so not just that.”
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`See Ex. 1075 at 130:4-11.
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`12. Petitioner’s use of Exhibit 1012 (mistakenly cited as Exhibit 1011 in
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`the Reply (see Paper 52 at 13)) is objected under 37 C.F.R. § 42.23(b) because
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`Petitioner relies on Exhibit 1012 for the first time in reply to allege that there was a
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`motivation to come up with the inventions claimed in the ’720 patent. Since
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`proving that there was a motivation to arrive at the claimed inventions is
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`Petitioner’s burden, this evidence should have been presented in a prior filing.
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`13. Exhibit 1076 is objected to under Fed. R. Evid. 401-402 because
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`Petitioner has not established that Exhibit 1076 is prior art to the ’720 patent.
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`Petitioner’s use of Exhibit 1076 is also objected under 37 C.F.R. § 42.23(b)
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`because Petitioner relies on Exhibit 1076 for the first time in reply to allege that
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`there was a motivation to come up with the inventions claimed in the ’720 patent.
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`Since proving that there was a motivation to arrive at the claimed inventions is
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`Petitioner’s burden, this evidence should have been presented in a prior filing.
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`IPR2015-01096
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`Patent Owner Objections
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`14. Exhibit 1076 at 119 is objected to under Fed. R. Evid. 403 because its
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`minimal probative value is substantially outweighed by the fact that it is
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`misleading and unfairly prejudicial. Exhibit 1076 at 119 is also objected to under
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`Fed. R. Evid. 106 because Petitioner only introduces part of Mr. Williams’
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`statement and, in fairness, Mr. Williams’ full statement on this issue ought to be
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`considered at the same time. Petitioner’s use of Exhibit 1076 at 119 is objected to
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`under Fed. R. Evid. 401-403 because it mischaracterizes Mr. Williams’ full
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`statement on this issue and is irrelevant to any information that a POSA would
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`have at the time of the ’720 patent’s invention. Specifically, Mr. Williams states
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`that the survey responses collected by Sloane Epidemiology Unit (“SEU”) for the
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`registry that will provide feedback—that provides Celgene with the opportunity to
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`go back and take corrective action—will be confidential. See Ex. 1076 at 118-119.
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`The confidential information that the inventors knew, and how they used that
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`confidential information to arrive at the inventions claimed in the ’720 patent, is
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`irrelevant to any motivation or actions of a POSA.
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`15. Petitioner’s use of Exhibit 1076 at 137 and 250 is objected to under
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`Fed. R. Evid. 801-802 because Petitioner is using Exhibit 1076 at 137 and 250 for
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`impermissible hearsay purposes. There is no evidence in the record concerning
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`what Exhibit 1076 at 137 and 250 would mean to a POSA, despite Petitioner
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`IPR2015-01096
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`having the opportunity to submit an expert declaration with its reply, but choosing
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`not to do so.
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`16. Petitioner’s use of Exhibit 1024 at 611-612 is objected to under Fed.
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`R. Evid. 801-802 because Petitioner is using the quoted language from Exhibit
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`1024 at 611-612 for impermissible hearsay purposes. There is no evidence in the
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`record concerning what the quoted language from Exhibit 1024 at 611-12 would
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`mean to a POSA, despite Petitioner having the opportunity to submit an expert
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`declaration with its reply, but choosing not to do so.
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`IPR2015-01096
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`Date: June 6, 2016
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` Respectfully submitted,
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`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` Andrew S. Chalson (pro hac vice)
` Eric C. Stops (Reg. No. 51,163)
` Frank C. Calvosa (Reg. No. 69,064)
` 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
` ericstops@quinnemanuel.com
` andrewchalson@quinnemanuel.com
` frankcalvosa@quinnemanuel.com
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`Anthony M. Insogna (Reg. No. 35,203)
`J. Patrick Elsevier (Reg. No. 44,668)
`JONES DAY
`12265 El Camino Real
`Suite 200
`San Diego, CA 92130
`Tel: (858) 314-1200
`Fax: (858) 314-1150
`aminsogna@jonesday.com
`jpelsevier@jonesday.com
`
`Gasper J. LaRosa
`JONES DAY
`222 E 41st Street
`New York, NY 10017
`Tel: (212) 326-3939
`Fax: (212) 755-7306
`gjlarosa@jonesday.com
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`Attorneys for Celgene Corporation
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`COALITION FOR AFFORDABLE DRUGS VI LLC
`Petitioner,
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`v.
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`CELGENE CORPORATION
`Patent Owner
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`________________
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`Case IPR2015-01096
`Patent 6,315,720
`________________
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`CERTIFICATE OF SERVICE
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that
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`PATENT OWNER OBJECTIONS TO EVIDENCE SUBMITTED BY
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`PETITIONER PURSUANT TO 37 C.F.R. § 42.64(b)(1) was served on June 6,
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`2016 by filing this document through the Patent Review Processing System, as
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`well as e-mailing a copy to sarah.spires@skiermontderby.com,
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`parvathi.kota@skiermontderby.com, sadaf.abdullah@skiermontderby.com and
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`paul.skiermont@skiermontderby.com.
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`Date: June 6, 2016
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` Respectfully submitted,
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`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
` General Tel: (212) 849-7000
` Fax: (212) 849-7100
` nickcerrito@quinnemanuel.com
`
`Lead Counsel for Celgene Corporation
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