Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 1 of 28 PageID #: 915
`Case 1:15—cv—OO311—RGA Document 42-2 Filed 12/07/15 Page 1 of 28 Page|D #: 915
`
`
`
`EXHIBIT 2
`
`EXHIBIT 2
`
`
`
`
`Case 1:15—cv—OO311—RGA Document 42-2 Filed 12/07/15 Page 1 of 28 Page|D #: 915
`
`
`
`EXHIBIT 2
`
`EXHIBIT 2
`
`
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 1 of 27 PageID #: 499Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 2 of 28 PageID #: 916
`
`1
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`CA NO. 13-1104-RGA
`December 13, 2013
`
`11:00 o'clock a.m.
`
`: : : : : : : : : :
`
`ALZA CORPORATION, et al.,
`
`Plaintiffs,
`
`v.
`
`PAR PHARMACEUTICAL INC, et
`al.,
`
`Defendants.
`.............................
`
`TRANSCRIPT OF DISCOVERY DISPUTE
`BEFORE THE HONORABLE RICHARD G. ANDREWS
`UNITED STATES DISTRICT JUDGE
`
`APPEARANCES:
`
`For Plaintiff:
`
`ASHBY GEDDES
`BY: STEVEN J. BALICK, ESQ
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 2 of 27 PageID #: 500Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 3 of 28 PageID #: 917
`
`2
`
`For Defendants:
`
`-and-
`SIDLEY AUSTIN LLP
`BY: LISA A. SCHNEIDER, ESQ
`
`PHILLIPS, GOLDMAN & SPENCE
`BY: JOHN C. PHILLIPS JR., ESQ
`-and-
`RAKOCZY MOLINO MAZZOCHI SIWIK
`BY: PETER J. CURTIN, ESQ
`For Defendant Osmotica
`
`RICHARDS, LAYTON & FINGER
`BY: STEVEN J. FINEMAN, ESQ
`For Defendant Par
`
`Court Reporter:
`
`LEONARD A. DIBBS
`Official Court Reporter
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 3 of 27 PageID #: 501Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 4 of 28 PageID #: 918
`
`3
`
`P R O C E E D I N G S
`
`(The proceedings commenced as 10:10 o'clock a.m. as
`
`follows:)
`
`THE COURT: Good morning, everyone.
`(All counsel responded, "Good morning, your Honor.")
`THE COURT: Please be seated.
`So I take it you are, Mr. Curtin?
`MR. CURTIN: I am, your Honor.
`THE COURT: I know I've seen you before, Ms. Schneider.
`MS. SCHNEIDER: Yes, you have.
`THE COURT: Good morning, Mr. Balick, Mr. Phillips, Mr.
`
`Fineman.
`
`Mr. Fineman.
`MR. FINEMAN: Yes, your Honor.
`THE COURT: Oh, I see. You know, I'm looking at the
`caption of case, which has one party.
`I'm looking and seeing two defendants being
`represented, but that's because there are two defendants.
`MR. FINEMAN: Correct, your Honor.
`THE COURT: Okay. So you can see what level of
`analysis that I'm doing today.
`So, ALZA Corporation vs. Par Pharmaceutical, Civil
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 4 of 27 PageID #: 502Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 5 of 28 PageID #: 919
`
`4
`
`Action No. 13-1104.
`I've gotten the two letters, which apparently I only
`brought one with me. I just -- I can tell you we're not
`operating at a high level today.
`MR. FINEMAN: Which one do you need, your Honor?
`THE COURT: I brought them both, so it doesn't really
`
`matter.
`
`I've got Docket Item 76, which is, I guess, is the
`response. I did read the original letter, too.
`MR. CURTIN: Here's one for your Honor.
`THE COURT: Thanks.
`We've got the Patent Prosecution Bar, how far it
`extends into reexamination, inter partes review, whatever kinds
`of proceedings, and we've got this FDA Bar.
`Are those the two issues?
`MS. SCHNEIDER: Yes, your Honor.
`MR. CURTIN: Yes, your Honor.
`THE COURT: All right.
`So it's defendants' request. So before I ask
`defendants to articulate their request, Ms. Schneider, I saw in
`there that you have said that you, and I guess the members of
`your firm, have been representing ALZA on litigation relating to
`these patents over a long period of time?
`MS. SCHNEIDER: The members of my firm have, and some
`of the people that filed a Notice of Appearance have. I,
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 5 of 27 PageID #: 503Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 6 of 28 PageID #: 920
`
`5
`
`personally, have not, but Mr. Kushan, and Mr. Pritikin, and Mr.
`Choi all have been representing ALZA in Concerta matters for
`quite some time.
`THE COURT: And is the reason why there has been quite
`some time, because I think I -- and have they -- I saw -- I
`actually did look to see.
`The last one was with Judge Stark?
`MS. SCHNEIDER: I apologize, your Honor.
`I do not know which Judge that was with. There were
`two prior litigations that my firm has represented ALZA on with
`respect to --
`THE COURT: Okay. And from what I could tell, because
`I looked at the Protective Order, that didn't seem to address
`this issue.
`MS. SCHNEIDER: That's my understanding as well.
`THE COURT: Okay. And are there any -- and I realize
`this is not dispositive one way or the other -- but are there
`any actual pending proceedings going on at this moment to which
`this Prosecution Bar could actually apply?
`MS. SCHNEIDER: Not to my knowledge.
`There are no post-issuance proceedings going on at the
`moment to which the bar could apply.
`THE COURT: I forget.
`How many patents are involved here?
`MS. SCHNEIDER: One patent is involved in this
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 6 of 27 PageID #: 504Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 7 of 28 PageID #: 921
`
`6
`
`litigation.
`THE COURT: Is this the same patent that was involved
`in the earlier litigations?
`MS. SCHNEIDER: It is not.
`THE COURT: Okay. But it's the same family I guess?
`MS. SCHNEIDER: The same family. Related -- related --
`same drug, the same ALZA drug that's on the market.
`THE COURT: When does -- when was this patent issued,
`the one in this case?
`MS. SCHNEIDER: About a year-and-a-half ago.
`THE COURT: All right.
`And the people you mentioned, I think -- I forget what
`their names were -- do these -- but the other attorneys you said
`had more history with this -- with ALZA, this -- I guess this is
`Concerta?
`
`MS. SCHNEIDER: Concerta is the drug.
`THE COURT: On Concerta.
`Do the people have more history, or do you typically do
`patent prosecution or reissue, or who does that for ALZA?
`MS. SCHNEIDER: None of us do original application
`prosecution for ALZA. They hire another firm to do all of that
`sort of work.
`Our firm has been involved extensively in post-issuance
`proceedings, although, not on this drug, because there have been
`none on this drug.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 7 of 27 PageID #: 505Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 8 of 28 PageID #: 922
`
`7
`
`THE COURT: On this drug or this patent?
`MS. SCHNEIDER: I don't believe there have been any
`post-issuance proceedings on this drug. There definitely have
`not been any on this patent.
`THE COURT: Okay. All right.
`So why don't I hear from you, Mr. Curtin.
`Tell me what the highlights of your argument are?
`MR. CURTIN: Very well, your Honor.
`Well, the highlights -- and obviously you've got the
`papers and I don't want to repeat too much from what's in
`them -- is that, you know, defendants -- I mean the dispute here
`is not about whether there should be a Prosecution Bar. The
`dispute is whether it should apply to post-issuance proceedings,
`and defendants believe that it should.
`We think that the -- it's common for Protective Orders
`to limit both access to and use of the producing party's
`protected information, and that's because -- I mean a use
`restriction, by itself, is often not enough to protect against a
`risk of inadvertent disclosure or competitive -- you know,
`misuse or advantage of the defendants' confidential information,
`because people just can't segregate what they know.
`You know, an attorney knowing -- that has access to the
`defendants highly confidential information to our abbreviated
`new drug applications, if that attorney is later -- later or at
`the same time involved in a post-issuance proceeding before the
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 8 of 27 PageID #: 506Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 9 of 28 PageID #: 923
`
`8
`
`Patent Office where the claims covering that drug
`methylphenidate HCL, can be amended. And not all these are
`narrowing proceedings, your Honor.
`Reexamination, the claims can only be narrowed.
`Reissue, the claims can be broadened.
`THE COURT: And I guess there's two years to follow
`reissue proceedings?
`MR. CURTIN: Yes, your Honor.
`But, in this case -- and I want to back up and point
`something out -- that while there's one patent involved in this
`case, and that patent -- presently -- and that patent issued
`about a year-and-a-half ago, there are five pending
`applications, at least that the defendants know of that ALZA has
`in the Concerta patent family related to these patents.
`One of them is almost certainly going to issue early
`next month. Another one is going to issue before -- by the
`spring of 2014. And the other three are in various stages
`before the office.
`When those patents issue -- I mean, obviously, we don't
`know what ALZA is going to do, but we -- we think it's likely
`that those patents will be listed in the Orange Book, and if
`that happens, it is likely -- I mean our sales -- it's likely
`there will be a Paragraph 4 Notice filed, and that they will be
`swept into this case, because I would suspect, in that
`situation, both sides would want it all to be dealt with, you
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 9 of 27 PageID #: 507Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 10 of 28 PageID #: 924
`
`9
`
`know, in one litigation.
`So given that situation, there is a realistic
`possibility of post-issuance proceedings that involve -- I mean
`it could be reexaminations where claims can only be narrowed.
`It could also be reissue proceedings where the claims can be
`broadened.
`And in either of those cases, the risk of inadvertent
`disclosure, and competitive use of defendants' highly
`confidential information in this -- in these proceedings, which
`are under the Deutsche Bank analysis -- In Re: Deutsche Bank --
`I mean there's competitive decision-making going on.
`When you're amending --
`THE COURT: Well, I think that's not really at issue.
`The issue is the balancing.
`MR. CURTIN: Yes. And, so, it is the -- I mean having
`-- I would argue that defendants then having met the threshold
`inquiry of whether there's a risk and whether there is
`competitive decision-making going on, the question is the
`balancing after that that the Court has to get to.
`And we submit that -- I would like to point out a
`couple of points then.
`Defendants believe they shouldn't face a situation in
`which plaintiffs' counsel, whether it is trial counsel or
`in-house, who had access to our highly confidential information,
`have the ability to shepherd the plaintiffs' Concerta patents
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 10 of 27 PageID #: 508Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 11 of 28 PageID #: 925
`
`10
`
`through post-issuance proceedings, whether it's reexamination,
`reissue, or post-grant review.
`As Judge Sleet recognized in the Bear Creek vs.
`Verizon, Footnote 6, as your Honor just acknowledged,
`reexaminations can involve competitive decision-making despite
`the fact that the claim scope can't be broadened.
`And we say that's true even more so for reissue
`proceedings where the patentees express they are able to broaden
`their claims.
`The plaintiffs cite to Judge -- in their letter to
`Judge Thynge's opinion in Xerox vs. Google, you know, holding
`that a Prosecution Bar in that case should not apply to
`reexaminations.
`I would say that's -- that is one critical distinction
`there. That case only involved the reexamination. It dealt
`with reexamination. Not the full scope of all post-issuance
`proceedings. So the risk there is somewhat different.
`THE COURT: So would that mean that if the patent
`Prosecution Bar was extended reissue proceedings, but not the
`other sorts of post-grant proceedings, you would say, Okay,
`you're exactly consistent with Judge Thynge in the Xerox vs.
`Google?
`
`MR. CURTIN: I would say, your Honor -- I mean Judge
`Thynge didn't address that issue at all, so I don't know how she
`would have come out on it. I would say it's not inconsistent
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 11 of 27 PageID #: 509Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 12 of 28 PageID #: 926
`
`11
`
`with what was done in Xerox vs. Google, if that was the
`decision.
`
`Secondly, while it is true that the defendants' product
`information is not relevant to the validity of patent claims and
`reexamination, as Judge Thynge noted -- in his other cases noted
`-- the risk of inadvertent use or competitive misuse still
`exists.
`
`And, in fact, you know, Judge Thynge acknowledged that
`defendants had raised a, quote, "legitimate concern that their
`confidential information could be competitively misused in
`strategically narrowing plaintiffs' patent claims during
`reexamination.
`And you can do so -- and this applies also certainly
`more to reissue and also to post-grant review. And you can do
`this --
`
`THE COURT: Well --
`MR. CURTIN: -- and I'm not talking about any kind of
`misconduct.
`THE COURT: All right.
`But post-grant review, you can't expand the claims in
`it, you can only narrow them, right?
`MR. CURTIN: I believe that's the case, your Honor.
`I'm not a patent attorney. I've not appeared in such
`proceedings, but I understand that all claims can be amended. I
`think -- I think your Honor is correct there.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 12 of 27 PageID #: 510Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 13 of 28 PageID #: 927
`
`12
`
`And you can do so both in terms of strategic -- when
`you have to narrow, the strategic narrowing can take the form
`both of amendments and of statements made on -- on the record at
`the Patent Office, which your Honor know can also effect future
`claim construction.
`You know, it's a -- and the Xerox Court sort of moved
`past that concern by noting that, Well, plaintiffs would
`undoubtedly seek the broadest coverage possible in
`reexamination, regardless of their counsel's knowledge of
`defendants products.
`That's Page 185. So, in her view, the risk was
`attenuated.
`But I would submit that that analysis doesn't give
`enough weight to the potential impact of the knowledge of
`competing products. And we're not -- I want to clarify -- we're
`not talking about bad faith here.
`THE COURT: No. I understand you're talking about
`inadvertence.
`MR. CURTIN: Inadvertence.
`And putting it in a tough situation where, if as a
`lawyer -- and the patent counsel involved in this has had access
`to confidential information -- and they've got to narrow. They
`some prior art in the reexamination, or whatever proceeding, and
`they say, Oh, this art is rough. I've got to make some
`arguments to get a claim around that.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 13 of 27 PageID #: 511Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 14 of 28 PageID #: 928
`
`13
`
`Are they going to -- I mean how do they -- they narrow
`it enough to get around the prior art, but they would still want
`to be able to -- obviously, you want as much coverage as you can
`to still capture competing -- I mean that's a tough conflict to
`be in. I'm sputtering a little bit here. But that's tough
`conflict to be in, in terms of your duty to your client, to
`zealously advocate their interest, and yet your duty to not make
`use of information that you know of from another situation, from
`a litigation. That's an imposs -- I think a very difficult
`situation for counsel.
`THE COURT: All right.
`Well, I think I've got the highlights there.
`Mr. Schneider?
`MS. SCHNEIDER: Sure, your Honor. We would not concede
`that they've met their burden of showing an unreasonable risk.
`There are plenty of cases out there that say the risk in
`post-issuance proceedings is greatly reduced.
`That is the only thing we're talking about here. We
`did not believe that a Prosecution Bar was necessary for outside
`counsel, but we consented to it, because they had that concern,
`and we didn't want to add yet another fight to -- to your
`docket.
`
`But we do not think that when you're talking about only
`post-issuance proceedings, there is a serious risk to
`defendants' confidential information.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 14 of 27 PageID #: 512Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 15 of 28 PageID #: 929
`
`14
`
`THE COURT: Do you agree with the idea that I've
`floated out there that whatever the balance, the weight is,
`there's, you know, some slightly greater risk in the reissue
`proceeding than the other kinds of post-grant proceedings?
`MS. SCHNEIDER: I would agree that you can broaden your
`claim for two years, if you file -- two years after your patent
`issues, you can file a reissue that allows you to broaden your
`claims.
`
`Whatever claims you've broadened, however broad you
`make your claims, they still have to be supported by what is in
`specification, so that information still has to be there. In
`that sense, I don't think the risk is that significant, because
`it already has to be there.
`THE COURT: But as a theoretical matter, the post --
`the reissue proceeding is slightly riskier for the inadvertent
`disclosure effecting, you know, being tied in with strategic
`choices that counsel is making, just because you could expand
`the scope.
`MS. SCHNEIDER: Theoretically, yes, you might be able
`to make that argument, but that is not what their bar is limited
`to. Their bar goes far beyond that.
`THE COURT: Right.
`MS. SCHNEIDER: And it encompasses proceedings in
`which, by their own admission, you can only narrow the claims.
`In those kinds of circumstances, the patent either
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 15 of 27 PageID #: 513Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 16 of 28 PageID #: 930
`
`15
`
`covers their product now, or it doesn't, and nothing we can do
`in reissue -- in reexamination proceedings will change that.
`THE COURT: Do the attorneys at your firm who are
`working on this case, are also people who work on post-grant
`proceedings, do they get involved in reissue proceedings?
`MS. SCHNEIDER: On occasion, yes. Yes, your Honor.
`THE COURT: Okay.
`MS. SCHNEIDER: But there are no pending reissue
`proceedings in this case.
`THE COURT: To the extent that there are never any
`reissue proceedings, then it is moot on that, right?
`MS. SCHNEIDER: Right. That is true. That is true.
`And I also think that, in this particular case, there
`is a significant harm to all of us if their counsel is not
`allowed to participate in post-issuance proceedings.
`Counsel has -- Sidley Austin as well as in-house that
`is handling this case, have extensive knowledge about the
`product, about the prior art, about potential ways to get around
`the prior art if that ever becomes a concern, and to -- to sort
`of yank those people off the case and say, No, you cannot have
`any role in post-issuance proceedings, even though those
`proceedings may impact the litigation, and may adversely impact
`the litigation, you can't have any role in that is grossly
`unfair given the long history these counsel have had.
`THE COURT: As kind of a sideline, because I looked
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 16 of 27 PageID #: 514Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 17 of 28 PageID #: 931
`
`16
`
`rather quickly, the prior litigations, have either of the two
`cases that were in Delaware, did either of them actually result
`in a trial, or were they resolved by some other kind of means?
`MS. SCHNEIDER: One was a trial, as I understand it,
`that then went up on appeal.
`THE COURT: Is that the earlier of the two?
`MS. SCHNEIDER: I couldn't answer that. I believe that
`is the case. I believe that is the case.
`THE COURT: Okay.
`MR. BALICK: I think so as well, your Honor. I'm not
`positive, but I was involved in it and I think it was the
`earlier one.
`THE COURT: And, so, whatever decisions were made about
`the patents in that case, probably has not much impact on this
`case, since we're talking about a new patent and --
`MS. SCHNEIDER: I think the parties are likely going to
`have a difference of opinion on that. I would certainly take
`that view. I'm not sure the defendants will take that view.
`THE COURT: Okay. And I'm sorry, because I don't know
`what the result of the first case -- the trial was in the
`Federal Circuit, what did they end up holding?
`MS. SCHNEIDER: The particular claim at issue was
`invalidated.
`THE COURT: All right.
`You were talking, Ms. Schneider?
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 17 of 27 PageID #: 515Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 18 of 28 PageID #: 932
`
`17
`
`MS. SCHNEIDER: Sure. I was just saying that I think
`there's a potential harm to them, if they are deprived of their
`counsel.
`
`And ALZA has a legitimate interest in formulating a
`coherent and consistent litigation strategy. Choices before the
`PTO may impact that strategy.
`Post-issuance proceedings are often seen as an
`extension of a litigation. And, in fact, many of them can only
`be filed by somebody other than ALZA, so those typically get
`filed by defendants or somebody with similar interests as
`defendants, and to not allow ALZA's counsel to participate in
`all these types of proceedings, would be unfair and prejudicial
`to ALZA.
`
`THE COURT: Okay. All right.
`I think I got it.
`I do think quoting In Re: Deutsche Bank Trust, that
`strategically amending or surrendering claim scope during
`prosecution, which is what the case says, is, essentially,
`competitive decision-making, and there is the risk of an
`inadvertent disclosure.
`And, so, I do think there is an issue here, but I do
`think then you get to the balancing.
`You know, I give some credit to Ms. Schneider's
`representations, which are obviously undisputed that her firm
`has a history of representing ALZA in relations over these -- to
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 18 of 27 PageID #: 516Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 19 of 28 PageID #: 933
`
`18
`
`these patents, which includes appearances before the PTO. And,
`so, that there would be some prejudice to ALZA, and any bar
`works to prejudice ALZA.
`And I also take into account, which neither counsel
`have discussed, but which seemed to me the patent Prosecution
`Bar was narrowly tailored -- I forget exactly what the right --
`the right words were -- but it was specified as a drug. And I
`thought that -- you know, sometimes the definition of a subject
`matter is too broad. Here the subject matter seemed to be
`appropriately narrow, so I think you get to a balancing test.
`And, of course, I should say, as always is the case,
`you know, we are talking about inadvertent disclosure here, so
`that there is no -- you know, we are talking about human nature,
`not something where there is any hint or allegation of any
`untoward behavior by counsel.
`So what I'm inclined to do is, you know, is to say that
`the patent Prosecution Bar should extend to reissue proceedings,
`but not to any other kind of post-grant proceedings, because I
`think there's a greater risk. It might not be a much greater
`risk, but there is a greater risk in those kinds of proceedings
`where the scope of the claims can go either way.
`There are some cases, and it kind of makes sense that
`the -- even inadvertently the ability to use or to have what
`you've learned about confidential information, affect your
`judgments about narrowing the scope, which really have to do
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 19 of 27 PageID #: 517Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 20 of 28 PageID #: 934
`
`19
`
`more with the prior art than with confidential -- men with
`knowledge of the products that you've been infringing. The
`balance there -- the -- the risk is not that -- not as great.
`That is what I'd like you to do. I assume the actual
`wording of that probably doesn't require any input from me?
`MS. SCHNEIDER: I'm confident that we can agree on that
`
`wording.
`
`THE COURT: So, then, we also have this FDA Bar.
`Do you want to say a word about that, Mr. Curtin?
`MR. CURTIN: Yes, your Honor.
`And I will say -- I'll address it very briefly.
`I think that the plaintiffs' letter brief gave the
`defendants short shrift, short of brushed them aside a bit.
`Of course, an FDA Bar is designed to guard against what
`may happen. Not what has happened.
`And, in that sense, the possibility is speculative that
`that also applies to post-grant proceedings before the
`Prosecution Bar. At the same time, the defendants concerns
`here, and the policies concerns involved are real, they're not
`far-fetched.
`You know, sure, in this letter all we say -- all I say
`
`is --
`
`THE COURT: Well, it seemed to me that your argument --
`and tell me if have I misunderstood it, because it is possible
`that I have -- it seems that your argument on the FDA was,
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 20 of 27 PageID #: 518Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 21 of 28 PageID #: 935
`
`20
`
`essentially -- and I may have the term wrong -- but a citizen's
`petitions, which, I guess as a theoretical matter, ALZA could
`file something making some references to your generic product,
`right? That is the citizen's petition that you are worried
`about?
`
`MR. CURTIN: Well, that is -- yes, that is one type of
`citizen's petition that could be filed.
`Another example is one that happened just this year in
`a case that I'm involved in now in this district where I'm
`representing the defendant in the Hatch/Waxman case and the
`plaintiff's filed a citizen's petition, which ask the FDA to
`drastically change the requirements approving bioequivalence to
`their drug products.
`And not surprisingly -- I mean because -- and this is
`-- I mean defendants -- you know, an abbreviated drug
`application was designed to meet the current standards for
`bioequivalence. And this -- this -- if granted by FDA would
`have --
`
`THE COURT: But -- but --
`MR. CURTIN: -- so that's what would have made it
`impossible for that drug to be approved.
`THE COURT: -- but that's something -- you know, part
`of the reason why the FDA Bars are seen more in frequently is,
`presumably, it's not going to be Ms. Schneider who learns stuff
`about your -- you know, gets discovery, and then decides to do
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 21 of 27 PageID #: 519Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 22 of 28 PageID #: 936
`
`21
`
`this bioequivalent thing, because she's already barred from
`doing that. I mean --
`MR. CURTIN: Yes. I mean that's -- yes, but all
`counsel with access are barred from doing it.
`THE COURT: Well, and, so the -- you know, the thing
`is, I mean it just seems really remote that the situated Sidley
`and Austin attorneys, or the in-house counsel who are involved
`in this case. You know, you're trying to guard against
`inadvertent stuff, and really the example you're giving me is
`pretty much advertent stuff.
`MR. CURTIN: There are situations where -- I mean, you
`know, if it was advertent, and obviously I think this has
`happened in cases before, including the Urander (phonetic), the
`case with Judge Robinson, you know, the plaintiff's wanted to
`file a citizen's petition. They went to the Court and said, We
`found information that we think is important, your Honor, in
`this litigation and we would like permission to the citizen's
`petition. We need permission under the Protective Order.
`In that situation, it's not inadvertent. It is
`advertent and the Court ruled on that.
`THE COURT: Well that was with the Court's --
`MR. CURTIN: Permission and approval. Absolutely.
`I'm saying that's a very different kind of situation.
`But if we're talking about a situation, your Honor,
`where it is this inadvertent situation, the question that I
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 22 of 27 PageID #: 520Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 23 of 28 PageID #: 937
`
`22
`
`would ask, and the defendants would ask is, Why is there any
`reason that counsel, trial counsel in this litigation, or the
`in-house litigation counsel at Johnson and Johnson, who are
`supervising this litigation -- they are the ones that have
`access to the defendants' highly confidential information -- why
`does ALZA need them to be involved in the communications?
`THE COURT: That's sort of shifting the burden to them,
`but it's actually your burden?
`MR. CURTIN: It is our burden to show good cause, your
`Honor, but I think that having articulated a -- a real -- a
`possibility of real prejudice.
`I suppose what I'm saying is, the -- the argument that
`there is no need for them to be involved goes to the balancing
`that the Court was talking about earlier.
`THE COURT: Well, so --
`MR. CURTIN: Because balancing the harm to -- the harm
`to ALZA from excluding them, I -- there's nothing that indicates
`there would be significant harm.
`THE COURT: So besides the citizen petition possibility
`-- and I think I did have one other case, and I think Mr.
`Phillips might have been involved in it -- where I actually
`heard about the citizen petitions. I can't remember exactly
`what it was about at this point. Even such things are
`occasionally at least filed.
`But besides for that possibility, what other
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 23 of 27 PageID #: 521Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 24 of 28 PageID #: 938
`
`23
`
`possibilities -- what other thing do you have in mind that --
`that you think could arise where we could have some inadvertent
`disclosure, or use of your -- not disclosure so much -- but use
`of your confidential information in front of the FDA?
`MR. CURTIN: Well, your Honor, I think the citizen's
`petition and venue is the one that we're particularly concerned
`about.
`
`In plaintiffs' letter brief -- and I read their paper
`filed yesterday -- they talk about the scope of this bar as
`being vastly overbroad.
`Well, all I've got to say is that we never negotiated
`about scope, because the position -- the plaintiffs' position
`from the outset was an FDA Bar is not appropriate, so we never
`talked about that.
`THE COURT: Okay. But, so, citizen's petition, other
`than that, you don't have any particular specters that you are
`worried about?
`MR. CURTIN: No, your Honor. Certainly not intended to
`apply to, say, adverse offender reporting Orange Book listings
`or things like that, or, you know, statements regarding their
`own -- to the FDA regarding their own product that they're
`required to make.
`THE COURT: All right.
`Ms. Schneider?
`MS. SCHNEIDER: The problem with this bar, setting
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`
`Case 1:13-cv-01104-RGA Document 78 Filed 12/17/13 Page 24 of 27 PageID #: 522Case 1:15-cv-00311-RGA Document 42-2 Filed 12/07/15 Page 25 of 28 PageID #: 939
`
`24
`
`aside the fact that it's very, very much overbroad as I think
`counsel has now recognized, is th
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
