UNITED STATES PATENT AND TRADEMARK OFFICE
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`Page 1
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`DR. REDDY'S LABORATORIES,
`
`LTD.
`
`AND DR.
`
`REDDY'S LABORATORIES,
`
`INC.,
`
`Petitioner,
`
`V .
`
`MONOSOL Rx, LLC,
`
`Patent Owner .
`
`Case IPR2016-01111
`
`Patent 8,603,514
`
`Case IPR2016—01112
`
`Patent 8,017,150
`
`Case IPR2016-01113
`
`Patent 8,475,832
`
`Teleconference
`
`New York,
`
`New York
`
`August 1,
`
`2016
`
`3:01 p.m.
`
`Transcript of Proceedings
`
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`lDr.RBddysV.RA0n0S01
`IPR2016—01112
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`
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`Page 1
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`DR. REDDY'S LABORATORIES,
`
`LTD.
`
`AND DR.
`
`REDDY'S LABORATORIES,
`
`INC.,
`
`Petitioner,
`
`V .
`
`MONOSOL Rx, LLC,
`
`Patent Owner .
`
`Case IPR2016-01111
`
`Patent 8,603,514
`
`Case IPR2016—01112
`
`Patent 8,017,150
`
`Case IPR2016-01113
`
`Patent 8,475,832
`
`Teleconference
`
`New York,
`
`New York
`
`August 1,
`
`2016
`
`3:01 p.m.
`
`Transcript of Proceedings
`
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`Page 2
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`A P P E A R A N C E S:
`
`Presiding:
`
`The Honorable ERICA A. FRANKLIN,
`
`Administrative Patent Judge
`
`Attorneys for Petitioner:
`
`JEFFERY B. ARNOLD, ESQ.
`
`LESLIE-ANNE MAXWELL, ESQ.
`
`ANDREW C. RYAN, ESQ.
`Cantor Colburn LLP
`
`1180 Peachtree Street, N.E.
`
`Atlanta, GA 30309
`
`Attorneys for Patent Owner
`1111 and 1112:
`
`in Cases
`
`HAROLD H. FOX, Ph.D.
`
`Steptoe & Johnson LLP
`
`1330 Connecticut Avenue, N.W.
`
`Washington, DC 20036
`
`Attorneys for
`ANDREA G.
`
`Patent Owner
`
`in Case 1113:
`
`REISTER, ESQ.
`
`Covington
`620
`
`& Burling LLP
`
`Eighth Avenue
`
`New
`
`York, New York 10018-1405
`
`DUSTIN B. WEEKS, ESQ.
`Troutman Sanders LLP
`
`600 Peachtree Street,
`
`N.E.
`
`Suite 5200
`
`Atlanta, GA 30308
`
`ALSO PRESENT:
`
`JUDGE TINA E. HULSE
`
`JUDGE CHRISTOPHER G. PAULRAJ
`
`JUDGE TONI R. SCHEINER
`
`JUDGE ZHENYU YANG
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`Page 3
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`—Proceedings-
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`HON. FRANKLIN:
`
`This is a
`
`conference call for cases
`
`IPR2016-0111, 1112 and 1113. With me
`
`on the call are two other panel
`
`judges
`
`for cases 1111 and 1112, Judges Hulse
`
`and Paulraj. Also with me on the call
`
`are two of the panel
`
`judges for case
`
`1113 Judges Scheiner and Yang.
`
`The
`
`third judge on that panel may join us
`
`that is Judge Bonita.
`
`As counsel for the parties
`
`introduce themselves, we would like to
`
`confirm that they approve holding this
`
`joint conference for all three cases
`
`as the Patent Owner
`
`in the 1111 and
`
`1112 cases differs from the Patent
`
`Owner
`
`in the 1113 case. Also please
`
`indicate whether you have arranged for
`
`a court reporter for this call.
`
`Petitioner, let's begin with
`
`you.
`
`MR. ARNOLD: Did you say
`
`Petitioner?
`
`HON. FRANKLIN:
`
`That is correct.
`
`
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`—Proceedings-
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`MR. ARNOLD: This is Jeffery
`
`Arnold at Cantor Colburn. With me on
`
`the call is Andrew Ryan and
`
`Leslie—Anne Maxwell also of Cantor
`
`Colburn.
`
`We represent the
`
`Petitioners.
`
`We approve of the joint
`
`conference, and we did not arrange for
`
`a court reporter.
`
`HON. FRANKLIN: Okay.
`
`Thank
`
`you. And, Patent Owner, we'll start
`
`with Patent Owner for 1111 and 1112
`
`cases.
`
`MR. FOX:
`
`Good afternoon.
`
`This
`
`is Harold Fox at Steptoe and Johnson.
`
`I represent Monosol RX in these
`
`proceedings, Patent Owner
`
`in the 1111
`
`and 1112 proceeding.
`
`I'm alone on
`
`this call. We approve the joint
`
`nature of this call, and we do have a
`
`court reporter on the line for this
`
`proceeding.
`
`HON. FRANKLIN: Okay,
`
`then, Mr.
`
`Fox,
`
`I will ask you to file a copy of
`
`the transcript as an exhibit.
`
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`—Proceedings-
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`MR. FOX: Yes,
`
`this is a court
`
`reporter for all three proceedings,
`
`so
`
`we will do that in all three and
`
`counsel for the 1113 I
`
`think will
`
`confirm that.
`
`HON. FRANKLIN:
`
`Thank you.
`
`MS. RIESTER: This is Patent
`
`Owner for the 1113 proceeding for
`
`Indivior. This is Andrea Reister from
`
`Covington and also on the line is
`
`Dustin Weeks.
`
`And we will ensure that
`
`a transcript gets recorded in the 1113
`
`proceeding and Indivior also consents
`
`to the joint conference call.
`
`HON. FRANKLIN:
`
`Thank you.
`
`So
`
`my understanding is that the Patent
`
`Owners have requested this conference,
`
`so you can decide which of you would
`
`like to begin.
`
`MR. FOX:
`
`This is Harold Fox.
`
`I
`
`will start.
`
`So we requested this
`
`conference seeking authorization to
`
`file a motion to obtain discovery on
`
`issues of a real party in interest in
`
`
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`—Proceedings-
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`privity.
`
`We have raised these issues
`
`and requested some limited discovery
`
`from Petitioner and Petitioner's
`
`counsel and they have not agreed to
`
`provide that request for discovery.
`
`And that is what brings us here.
`
`HON. FRANKLIN: Would you
`
`describe that discovery?
`
`MR. FOX: Yes.
`
`So specifically
`
`to put it in context,
`
`these two
`
`patents have encountered petitions
`
`previously,
`
`thus petitions were denied
`
`as being time barred in the 1111 and
`
`the 1112 proceedings.
`
`Those filings
`
`were by TEVA as the Petitioner.
`
`Shortly after the filing of
`
`these two petitions,
`
`there was
`
`activity in the press and early June
`
`that explained the Petitioner in this
`
`proceeding, Dr. Reddy's Laboratories,
`
`was
`
`taking possession of the ANDA of
`
`the underlying product that is covered
`
`by these patents.
`
`These patents are
`
`Orange Book listed and are the subject
`
`
`
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`Page 7
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`—Proceedings-
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`of litigation for the product
`
`Suboxone.
`
`So we sought this discovery and
`
`asked for information relating to the
`
`timing of that deal as the press
`
`releases came out, as I said, shortly
`
`after these petitions were filed.
`
`So
`
`the scope of discovery, obviously,
`
`relates to the agreements in question,
`
`not only the final agreement but also
`
`any other correspondence and
`
`communications including term sheets
`
`or letters of intent or things that
`
`led up to this definitive agreement
`
`that, you know, happened --
`
`HON. FRANKLIN:
`
`SO you are
`
`speaking in terms of document
`
`production only or request for
`
`admissions?
`
`Can you describe it
`
`specifically?
`
`MR. FOX:
`
`We have asked for the
`
`documents at this point.
`
`We asked for
`
`some other information.
`
`We initially
`
`asked to confirm that Dr. Reddy's was
`
`
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`—Proceedings-
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`seeking to obtain the property
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`interest in the ANDA Suboxone which
`
`underlies this proceeding and that
`
`ANDA is owned by TEVA.
`
`The
`
`Petitioners denied confirming that,
`
`but we
`
`found in a FTC notice that was
`
`issued on July 27th of this year that
`
`indeed that as confirmed in the public
`
`record Dr. Reddy's is obtaining this
`
`ANDA in question from TEVA.
`
`And so, we are seeking documents
`
`to help us understand the timing of
`
`the deal because we believe that is
`
`germane to the time bar that may have
`
`already passed in this case.
`
`HON. FRANKLIN: And, for
`
`example,
`
`in your request for
`
`production did you list a certain
`
`number of categories or did you just
`
`request one category of documents and
`
`how and were any documents submitted
`
`to you in response or just double
`
`negative?
`
`MR. FOX:
`
`A full negative was
`
`
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`Page 9
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`—Proceedings-
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`received but specifically we asked for
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`four categories of documents.
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`One was
`
`the definitive agreement that is
`
`referenced in the press release.
`
`The
`
`second is any correspondence or
`
`communications relating to those
`
`agreements such as term sheets and the
`
`like.
`
`And the other is the third
`
`category are correspondence,
`
`communications between the Petitioners
`
`and the prior Petitioner and its
`
`counsel.
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`And the final is information
`
`about discussions relating to the
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`Suboxone and us specifically.
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`So any
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`other conversations or exchanges of
`
`information that happened between TEVA
`
`and Dr. Reddy's relating to this
`
`product that is central
`
`to this case.
`
`HON. FRANKLIN:
`
`So in terms of
`
`RPI and privity, are you saying that
`
`your basis for believing that
`
`Petitioner has not disclosed or named,
`
`for example, all the real parties is
`
`based on the press release and the FTC
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`
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`—Proceedings-
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`notice?
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`MR. FOX: Yes,
`
`that is the
`
`documentary evidence we have of
`
`the
`
`deal right now, and we are seeking
`
`additional information about
`
`the
`
`timing of agreement
`
`in principle.
`
`HON. FRANKLIN: Okay.
`
`So just
`
`based on those two and nothing else?
`
`I
`
`just want
`
`to make sure I understand
`
`it completely.
`
`MR. FOX: Yes.
`
`There were a
`
`couple of articles that were published
`
`on and around early June based on
`
`press releases from Dr. Reddy's and
`
`subsequently late last week, we
`
`learned of this notification from the
`
`Federal Trade Commission resolving a
`
`dispute about dispensing or
`
`distributing out some of the
`
`properties of TEVA based on a
`
`different acquisition.
`
`And in that
`
`list of properties that were going to
`
`be divested to other entities, it
`
`confirmed that Suboxone was going to
`
`
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`Page 11
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`—Proceedings-
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`Dr. Reddy.
`
`And so we specifically
`
`asked for information involved in that
`
`transaction.
`
`HON. FRANKLIN:
`
`And let me ask
`
`when this request was made?
`
`MR. FOX: Our specific request
`
`or initial request was made in a
`
`telephone call —— Andrea, do you have
`
`the date, July 6th?
`
`MS. REISTER: Yes.
`
`And then we
`
`did a follow-up communication.
`
`MR. FOX:
`
`On July 14th for a
`
`more specific request.
`
`MS. REISTER: Correct.
`
`HON. FRANKLIN:
`
`IS there
`
`anything else you wanted to mention?
`
`MR. FOX:
`
`I didn't have
`
`anything.
`
`Andrea, do you?
`
`MS. REISTER: This is Andrea
`
`Reister for the Patent Owner
`
`in the
`
`1113 proceeding. That patent is
`
`basically the subject of the same fact
`
`pattern.
`
`There was a petition in
`
`
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`Page 12
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`—Proceedings-
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`there filed by TEVA that was
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`substantively denied, but other than
`
`that difference,
`
`I
`
`think the facts are
`
`basically the same as Mr. Fox has
`
`explained for the 1111 and 1112
`
`proceeding.
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`HON. FRANKLIN: Okay. And let
`
`me go back and ask regarding the press
`
`release, what was the date of that?
`
`MR. FOX:
`
`The press release that
`
`we had a copy of was a June 11th press
`
`release and it was a press release
`
`announcing the definitive agreement
`
`between entities.
`
`So we believe
`
`there's a high likelihood that the
`
`conversation about this property had
`
`been ongoing for some time before that
`
`definitive agreement.
`
`HON. FRANKLIN: Okay,
`
`I
`
`understand.
`
`And if there's nothing
`
`more that you want
`
`to add now,
`
`I
`
`just
`
`want
`
`to confirm you are seeking
`
`document production, you are not
`
`seeking depositions or other
`
`
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`Page 13
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`—Proceedings-
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`discovery;
`
`is that correct?
`
`MR. FOX: That's correct.
`
`HON. FRANKLIN: Okay.
`
`And, Petitioner, how do you
`
`respond?
`
`MR. ARNOLD:
`
`We would like to
`
`address the timeline provided with
`
`relevant information we previously
`
`provided Patent Owners.
`
`We will
`
`provide some additional information in
`
`this call that was requested with
`
`Patent Owners and to address the
`
`agreement and issue, and lastly,
`
`a
`
`case called Synopsis versus Mentor
`
`Graphics which is a recent federal
`
`circuit opinion relevant to the
`
`incident discussion.
`
`The three IPRs were filed on 31,
`
`May 2016. At
`
`the time the petitions
`
`were filed,
`
`the Petitioners were not
`
`time barred under Section 315b.
`
`on
`
`June 11, 2016, Dr. Reddy's issued a
`
`press release discussing agreement
`
`between Dr. Reddy's and TEVA
`
`
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`Pharmaceuticals Industries Limited and
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`Allergan PLC. Allergan was Actavis.
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`They had a name change or an
`
`acquisition.
`
`And the press release in
`
`pertinent part reads as follows:
`
`"Dr. Reddy's Laboratories has
`
`entered into a definitive agreement
`
`with TEVA Pharmaceuticals Industries
`
`Limited, an affiliate of Allergan PLC,
`
`to acquire a portfolio of eight
`
`abbreviated new drug applications in
`
`the U.S.
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`for 350 million in cash at
`
`closing." At closing is an important
`
`part here.
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`"The acquired portfolio
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`consists of products that are being
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`divested by TEVA as a precondition to
`
`its closing of the acquisition of
`
`Allergan's generic business.
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`The
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`acquisition of these ANDAs is also
`
`contingent upon the closing of the
`
`TEVA Allergan's generics transaction
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`and approval by the U.S. Federal Trade
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`Commission of Dr. Reddy's as buyer."
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`The press release did not identify any
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`of the ANDAs or associate
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`pharmaceuticals.
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`It wasn't until
`
`today that we had knowledge, until
`
`just a
`
`few moments ago, we had
`
`knowledge that the FTC has indicated
`
`that the Suboxone in hand is a part of
`
`the deal, but as I will explain later,
`
`I still can't comment on that.
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`It's
`
`dealing with confidentiality.
`
`So as I said,
`
`the press release
`
`does not identify any of the ANDAs or
`
`associated pharmaceuticals.
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`To our
`
`knowledge,
`
`the TEVA Allergan closing
`
`has not occurred.
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`We believe that
`
`Patent Owners can independently verify
`
`this for themselves.
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`The FTC's
`
`approval for Dr. Reddy's acquisition
`
`of the ANDAs alluded to in the press
`
`release has not yet occurred.
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`Patent
`
`Owners can again since they are aware
`
`of the FTC work,
`
`they can
`
`independently confirm this fact with
`
`the FTC.
`
`The TEVA Dr. Reddy's closing has
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`not occurred. More to the point,
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`the
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`TEVA Dr. Reddy's closing had not
`
`occurred prior to or on May 31, 2016
`
`the following day of the petitions.
`
`What originally started with this was
`
`the articles that were referenced
`
`before in which according to analysts
`
`at least two of the products that
`
`Dr. Reddy's required included the
`
`Suboxone and ANDA, but this was
`
`speculation on their part.
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`And so as
`
`a result,
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`they are further speculating
`
`that TEVA has a real party interest in
`
`the subject petitions or that privity
`
`exists between Petitioners and TEVA on
`
`or before May 31, 2016.
`
`So Dr. Reddy's press release
`
`itself confirms that only Petitioners
`
`are the real party in interest and no
`
`privity existed at
`
`the time the
`
`Petitions were filed.
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`There is
`
`closing, no acquisition, no control,
`
`no privity.
`
`And I will also note that
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`Patent Owners are currently in
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`litigation with TEVA Allergan and have
`
`the ability to obtain discovery from
`
`those defendants on this matter.
`
`Information previously provided
`
`to Patent Owners.
`
`So as indicated
`
`before,
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`there was a telephone
`
`conference on 6, July 2016 between
`
`counsel for Petitioners and Patent
`
`Owners.
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`A subsequent e-mail was sent
`
`to the Patent Owners‘ representatives
`
`on 11, July 2016 recapping the
`
`conference.
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`I spoke on behalf of the
`
`Petitioners.
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`And during the telephone
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`conference which was supplemented by
`
`the e—mail
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`the following statements
`
`representations were made:
`
`I was without authority to
`
`confirm or deny the agreement between
`
`TEVA Petitioners including a TEVA
`
`and/or Allergan Suboxone related ANDA.
`
`And I will explain in a few minutes I
`
`remain without such authority.
`
`The
`
`following information was provided to
`
`the Patent Owners. At
`
`the time the
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`respective complaints against TEVA and
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`Allergan were filed, Petitioners were
`
`neither a real party in interest nor
`
`had any control over such litigation.
`
`For verification I suggest
`
`the
`
`Patent Owners review the respective
`
`Suboxone litigation dockets for
`
`mandatory disclosures of real parties
`
`in interest.
`
`No document exists
`
`identifying Petitioners as a real
`
`party in interest.
`
`Patent Owners were
`
`informed at
`
`the time the three IPR
`
`petitions were filed.
`
`HON. FRANKLIN:
`
`I want
`
`to stop
`
`you there.
`
`I'm listening intently to
`
`everything you are saying, but
`
`I want
`
`you to repeat that last statement
`
`regarding no documents indicating.
`
`MR. ARNOLD:
`
`That is correct.
`
`In district court you are required to
`
`file mandatory disclosures identifying
`
`the real parties in interest, parties
`
`who have an interest in the
`
`litigation.
`
`There is no such document
`
`
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`in any court in any district
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`identifying Dr. Reddy's as a party
`
`having interest in the Suboxone
`
`litigation.
`
`HON. FRANKLIN:
`
`SO you are not
`
`saying there are not documents that
`
`could indicate?
`
`MR. ARNOLD:
`
`I
`
`am saying there
`
`are no documents period that would
`
`indicate Dr. Reddy's as a party in
`
`interest of the Suboxone in
`
`litigation.
`
`HON. FRANKLIN: Okay.
`
`You can
`
`continue.
`
`MR. ARNOLD:
`
`So the Patent
`
`Owners were also informed at the time
`
`the three IPR petitions were filed
`
`there was no privity between TEVA
`
`and/or Allergan or controlled by
`
`Dr. Reddy's over Suboxone and the
`
`litigation in which TEVA and Allergan
`
`are respective defendants.
`
`As of
`
`today this remains unchanged.
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`Patent Owners were informed that
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`
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`at
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`the time the three IPR petitions
`
`were filed there was no agreement of
`
`income between TEVA and/or Allergan
`
`and Petitioner for prospective TEVA
`
`and/or Al1ergan's respect
`
`to Suboxone
`
`ANDA. At
`
`the filing time there was no
`
`communication between TEVA and
`
`Allergan or their respective counsel
`
`and Petitioners or Cantor Colburn
`
`regarding Petitioner's three IPR
`
`petitions prior to filing.
`
`And in
`
`fact as of this date,
`
`there has not
`
`been any communications whatsoever
`
`regarding the IPRs between Patent
`
`Owners or their representatives and
`
`TEVA or their representatives or
`
`Allergan and their representatives.
`
`There's been no communication
`
`whatsoever regarding the IPRs.
`
`TEVA has no interest in or
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`control over the respective IPRs
`
`petitions by Petitioners.
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`And for
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`verification, we are going to refer
`
`again to the statement of real parties
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`in interest in all three petitions.
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`only Dr. Reddy's Laboratories Inc. and
`
`Limited are identified as real parties
`
`in interest and that is because they
`
`are the only real parties in interest.
`
`We were asked if TEVA was funding any
`
`of the IPRs. Petitioners are self
`
`funding of the subject IPRs. Neither
`
`TEVA nor Allergan are obligated to
`
`fund the subject
`
`IPRs on behalf of
`
`Petitioners.
`
`And again, we refer back
`
`to the identification of the real
`
`parties in interest in the respective
`
`petition.
`
`HON. FRANKLIN:
`
`And I
`
`just want
`
`to interrupt again to confirm my
`
`understanding is the facts that you
`
`are going through here now were
`
`provided in writing to the Patent's
`
`Owner's counsel?
`
`MR. ARNOLD:
`
`That is correct.
`
`HON. FRANKLIN: Okay.
`
`You can
`
`continue.
`
`MR. ARNOLD:
`
`TEVA provided no
`
`
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`guidance on the preparation and filing
`
`of Petitioner's IPR petitions.
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`We
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`were aware of the three failed IPR
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`petitions, but that was public record,
`
`but we did not communicate in any form
`
`or fashion regarding it.
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`My belief is
`
`TEVA if they are even aware that we
`
`filed the three IPRs would have been
`
`surprised completely that it was done.
`
`The subject
`
`IPR petitions are directed
`
`solely by Petitioners nor are the
`
`parties involved with the Petitioners.
`
`Related to the aforementioned
`
`communications on the 27, June 2016,
`
`Patent Owners representative requested
`
`"the name and contact information for
`
`the appropriate Dr. Reddy's in—house
`
`counsel
`
`to whom Indivior's PC, Javier
`
`Rodriguez can direct settlement
`
`communications."
`
`On the next day
`
`Patent Owners were provided with the
`
`requested information.
`
`On 29,
`
`June 2016, Mr. Rodriguez
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`e-mailed Dr. Reddy's in-house counsel
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`requesting the date and time "to
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`discuss ongoing ANDA litigation."
`
`on
`
`30, June 2016 via e—mail Dr. Reddy's
`
`in—house counsel responded, and DRL is
`
`the abbreviation for Dr. Reddy's.
`
`"DRL is not
`
`involved in the Suboxone
`
`litigation at this time. At this time
`
`DRL is not a real party in interest
`
`and nor has any control over the
`
`current litigation between Indivior
`
`and/or any defendants regarding
`
`Suboxone." And we believe that Patent
`
`Owner has these communications because
`
`they were sent to their client.
`
`So
`
`there were additional
`
`information
`
`requests about Patent Owners which was
`
`mentioned a moment ago on 14, July
`
`2016 Patent Owners requested discovery
`
`for Petitioners on the following,
`
`parts of which will be addressed now.
`
`One,
`
`they want
`
`the definitive
`
`agreement referenced in Petitioner's
`
`June 11, 2016 press release any drafts
`
`to the agreement, any term sheets or
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`
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`letter of intent related to the
`
`agreement and any common interest or
`
`other agreement related to the
`
`agreement.
`
`So our response to that is
`
`drafts and agreement are not relevant
`
`for establishing privity or control
`
`rather such drafts prove a lack of
`
`privity and control.
`
`This is a
`
`classic contract law issue negotiation
`
`shows offer, counteroffer but no
`
`acceptance necessary to form a
`
`contract.
`
`Regarding term sheets our
`
`response is that there are no
`
`documents responsive to the request
`
`regarding a letter of intent related
`
`to the agreement. Our response is
`
`there are no documents responsive to
`
`the request regarding any common
`
`interest or other agreement related to
`
`the TEVA Dr. Reddy's agreement.
`
`Our
`
`response is there are no documents
`
`responsive to the request. They've
`
`asked for correspondence or
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`communications related to the
`
`agreement
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`to term sheets identified
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`category one which don't exist or B,
`
`the Suboxone related ANDAs.
`
`And we
`
`respond correspondence or
`
`communication related to the agreement
`
`of the Suboxone related ANDAS are not
`
`related to show privity or control.
`
`HON. FRANKLIN:
`
`If you could put
`
`a mark there in your notes,
`
`I'm going
`
`to stop you for a moment, but
`
`I want
`
`to stop and talk to Patent Owners for
`
`a moment.
`
`And what
`
`I would like to
`
`talk about is it sounds as though the
`
`Petitioner is reading their responses
`
`to requests that you have already
`
`submitted.
`
`So I'm a little confused
`
`where we are in this process because
`
`you are asking us to submit discovery
`
`requests.
`
`It sounds like that was
`
`already done and it sounds as though
`
`Patent Owners has responded.
`
`Can you
`
`clarify this for me?
`
`MR. FOX:
`
`This is Harold Fox.
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`
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`The responses that counsel for
`
`Petitioner was
`
`just reading with
`
`respect
`
`to the existence or
`
`nonexistence of agreements in the
`
`requested categories,
`
`these answers
`
`are being provided for the first time
`
`today, at least I have not seen them
`
`in writing.
`
`HON. FRANKLIN:
`
`So you did not
`
`receive the responses in writing?
`
`MR. FOX: Not that these
`
`documents did not exist.
`
`HON. FRANKLIN: Okay. Let me
`
`stop you there then and go back to Mr.
`
`Arnold.
`
`MR. ARNOLD: Yes, Judge.
`
`HON. FRANKLIN:
`
`So the responses
`
`that you are reading now were not
`
`provided yet
`
`in writing to Patent
`
`Owner's counsel?
`
`MR. ARNOLD:
`
`That is correct.
`
`We are happy to do so.
`
`HON. FRANKLIN:
`
`Okay because
`
`what we don't want this to do is to
`
`
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`turn into an oral argument.
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`MR. ARNOLD:
`
`Sure.
`
`HON. FRANKLIN: What we're
`
`assessing here is whether to allow a
`
`motion to be filed for discovery.
`
`So
`
`I will let you finish your
`
`presentation but just in keep in mind
`
`this not oral argument.
`
`MR. ARNOLD: Understood.
`
`And
`
`Mr. Fox is correct we had not
`
`responded to his requests, but we will
`
`send a response in writing to them on
`
`these issues.
`
`And finally, let's
`
`see --
`
`HON. FRANKLIN: Well, my
`
`question then for you is, and I
`
`apologize for interrupting your
`
`thought again,
`
`if you plan to respond
`
`to those requests why was your -- why
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`did Patent Owner's counsel earlier
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`characterize you as not willing to
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`respond?
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`MR. ARNOLD:
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`I can't answer
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`that
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`question.
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`HON. FRANKLIN: Mr. Fox?
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`MR. FOX: Because we had not
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`received a response until the one you
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`just heard.
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`HON. FRANKLIN:
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`It sounds like
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`there was room for more meeting and
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`conferring prior to involving us, but
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`at this point,
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`I
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`think we have heard
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`enough.
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`I'm going to give each
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`counsel an opportunity to state some
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`final remarks and then what we will do
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`the separate panels, we will meet and
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`issue an order in the next day or so
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`indicating whether the motion is
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`authorized; okay?
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`I
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`interrupted I
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`believe Mr. Fox, were you speaking or
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`was it Mr. Arnold?
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`MR. ARNOLD: Arnold.
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`HON. FRANKLIN: Mr. Arnold,
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`would you like to briefly conclude?
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`MR. ARNOLD:
`
`Sure.
`
`Thank you,
`
`Your Honor.
`
`There was one important
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`part was because of the
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`confidentiality provisions in the
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`
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`agreement between TEVA and
`
`Dr. Reddy's,
`
`I could not,
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`I cannot
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`release any information that is
`
`contained in the agreement itself, and
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`this agreement is highly confidential
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`and contains extremely sensitive
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`information about eight different
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`ANDAs.
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`This would require heavy
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`redaction.
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`There will be in support of our
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`response if this motion is granted,
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`there will be an affidavit on the part
`
`of Petitioner which again opens up for
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`additional discovery and depositions.
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`Also importantly is this really is
`
`just all speculation.
`
`The dates don't
`
`add up and if you look at Synopsis
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`Inc. versus Mentor Graphics 814 F.3d
`
`1309 which is a Fed circuit case from
`
`2016 based on IPR 2012-00042, Mentor
`
`filed a writ of mandamus seeking
`
`discovery on this issue.
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`And the
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`question before the federal circuit
`
`was
`
`this privity at the time of this
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`
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`IPR institution but not at time of
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`complaint filing or petition filing
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`triggered the time bar of 1315b? And
`
`the answer to that is no.
`
`And then the Synopsis case there
`
`was actually an agreement before the
`
`petition was filed.
`
`So the closing
`
`didn't occur until after the petition
`
`was filed, and there the federal
`
`circuit and the board both said that a
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`time bar was not applicable,
`
`that you
`
`look at whether there was litigation
`
`control at the time that the complaint
`
`was filed, was the Petitioner in
`
`privity or in control of the
`
`litigation.
`
`And in our case the
`
`answer is no. And then you look at
`
`whether or not at the time the
`
`petition was filed whether or not TEVA
`
`would have had privity or control over
`
`the petitions.
`
`And in that case the
`
`answer is no.
`
`And I have said all along
`
`there's no documents in response to
`
`
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`any of
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`these.
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`There is an agreement
`
`between the two companies.
`
`They have
`
`not closed and that is fairly easy for
`
`the Patent Owners to track down. Once
`
`it's closed, once the TEVA Allergan
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`contract is closed then the
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`Dr. Reddy's can close but only if
`
`there's FTC approval.
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`And so what we have is
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`speculation and the burden put on the
`
`Petitioners for producing this
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`information and also protecting
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`information because there is a
`
`tremendous amount of information that
`
`is highly secretive that we would not
`
`want anybody to see outside of the
`
`TEVA and Dr. Reddy's.
`
`So the document
`
`itself would have to be extremely
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`redacted.
`
`And so it's their burden to
`
`bring evidence for that there is a
`
`real party in interest.
`
`We have explained that
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`Dr. Reddy's is the only party in
`
`interest,
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`the two Dr. Reddy's
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`
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`entities.
`
`And so we ask that this
`
`board deny the requests.
`
`HON. FRANKLIN:
`
`And I want
`
`to
`
`clarify were you raising the Synopsis
`
`case and conceding that there is
`
`privity now?
`
`MR. ARNOLD: No,
`
`I
`
`am not
`
`conceding there's privity,
`
`there's
`
`still not privity. There's none
`
`whatsoever. Dr. Reddy's does not own
`
`the eight ANDAs
`
`that were mentioned in
`
`the press release. There's no
`
`agreements between the two other than
`
`the agreement that is subject to FTC
`
`approval.
`
`There is no -- they didn't
`
`ask, but
`
`there are no joint defense
`
`agreements, at least not with respect
`
`to Suboxone.
`
`I'm not aware of any
`
`others because Dr. Reddy's, TEVA and
`
`Allergan are big in the generic
`
`business and they are in many
`
`ligations.
`
`So whether or not there's
`
`some other unrelated joint defense
`
`agreement,
`
`I don't know. But as we
`
`
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`speak right now,
`
`there is not privity.
`
`HON. FRANKLIN: Okay.
`
`IS there
`
`anything else you would like to add?
`
`MR. ARNOLD: No, Your Honor.
`
`HON. FRANKLIN: Okay.
`
`I would
`
`like to ask counsel for the Patent
`
`Owners if during this conference today
`
`whether they have heard anything that
`
`would cause them to modify or alter
`
`their plan
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