Trials@uspto.gov
`571-272-7822
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`Paper 94
`Entered: September 12, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`SUPERNUS PHARMACEUTICALS, INC.
`Patent Owner.
`____________
`
`Case Numbers IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Numbers 8,206,740, 8,394,405 and 8,394,406
`____________
`
`Held: August 12, 2014
`____________
`
`
`
`Before: LORA M. GREEN, SCOTT E. KAMHOLZ, and
`GEORGIANNA WITT BRADEN, Administrative Patent Judges.
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`H. KEETO SABHARWAL, ESQUIRE
`
`
`PAUL A. AINSWORTH, ESQUIRE
`
`
`Sterne Kessler Goldstein Fox
`
`
`1100 New York Avenue, NW
`
`
`Washington, DC 20005
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`Paper 94
`Entered: September 12, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`SUPERNUS PHARMACEUTICALS, INC.
`Patent Owner.
`____________
`
`Case Numbers IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Numbers 8,206,740, 8,394,405 and 8,394,406
`____________
`
`Held: August 12, 2014
`____________
`
`
`
`Before: LORA M. GREEN, SCOTT E. KAMHOLZ, and
`GEORGIANNA WITT BRADEN, Administrative Patent Judges.
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`H. KEETO SABHARWAL, ESQUIRE
`
`
`PAUL A. AINSWORTH, ESQUIRE
`
`
`Sterne Kessler Goldstein Fox
`
`
`1100 New York Avenue, NW
`
`
`Washington, DC 20005
`
`
`
`
`
`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
`
`
`ON BEHALF OF PATENT OWNER:
`
`
`GERALD J. FLATTMAN JR., ESQUIRE
`
`
`GREGORY A. MORRIS, ESQUIRE
`
`
`Paul Hastings
`75 East 55th Street
`
`
`
`
`New York, New York
`
`
`-and-
`
`
`STEPHEN B. MAEBIUS, ESQUIRE
`
`
`ANDREW S. BALUCH, ESQUIRE
`
`
`Foley & Lardner, LLP
`
`
`3000 K Street, NW
`
`
`Washington, DC 20007-5109
`
`
`
`The above-entitled matter came on for hearing on Tuesday,
`August 12, 2014, commencing at 1:00 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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` P R O C E E D I N G S
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`- - - - -
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`JUDGE KAMHOLZ: Can everyone in the room hear Judge
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`Braden? Judge Braden, would you speak again, please?
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`JUDGE BRADEN: Yes, I can. Can everyone in the room
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`hear me?
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`JUDGE KAMHOLZ: I think that will suffice.
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`Good afternoon. We will hear argument now in Case
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`Numbers IPR2013-00368, 00371, 00372, Amneal Pharmaceuticals,
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`LLC, versus Supernus Pharmaceuticals, Incorporated. Counsel for the
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
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`parties, would you please introduce yourselves, starting with the
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`Petitioner?
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`MR. SABHARWAL: Good afternoon, Your Honors. On
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`behalf of Amneal Pharmaceuticals, Keeto Sabharwal of the law firm
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`Sterne, Kessler, Goldstein and Fox.
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`MR. AINSWORTH: Good afternoon, Your Honor, Paul
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`Ainsworth, also with Sterne, Kessler, Goldstein and Fox.
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`JUDGE KAMHOLZ: And Patent Owner?
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`MR. FLATTMANN: Yes, Your Honor. I'm Gerald
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`Flattmann of the law firm of Paul Hastings for the patent holder,
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`Supernus.
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`MR. MORRIS: I'm Greg Morris, Your Honor, from the law
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`firm of Paul Hastings, also for Supernus.
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`MR. MAEBIUS: Also Steve Maebius of Foley and Lardner
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`on behalf of Supernus.
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`JUDGE KAMHOLZ: Welcome, everyone, to the Board.
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`Per our order dated July 18, 204, each side will have one
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`hour to argue during this hearing. The Petitioner will argue first and
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`present all of its arguments concerning all cases and may reserve
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`rebuttal time. You should begin your presentation by indicating how
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`much time you will reserve, if any. The Patent Owner may not
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`reserve rebuttal time.
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`I will remind the parties that the Petitioner bears the burden
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`of proving any proposition of unpatentability by a preponderance of
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`the evidence. I will also remind the parties that this hearing is open to
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
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`the public and a full transcript of everything that is said will become
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`part of the public record.
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`Please bear in mind that the third member of this panel,
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`Judge Braden, is attending this hearing by telephone from our office
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`in Dallas. Please remember also to mention by number every slide as
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`you refer to it. This is especially important to ensure that Judge
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`Braden can follow the proceedings.
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`With that, I would like to invite Petitioner to begin.
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`MR. SABHARWAL: Thank you, Your Honors. Your
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`Honor, just a couple of preliminary matters. First of all can you hear
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`me? Does this work. Does that work? Hello?
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`(Discussion off the record.)
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`MR. SABHARWAL: I can speak loud.
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`JUDGE KAMHOLZ: Why don't you do that. Someone is
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`coming, and we'll deal with it.
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`MR. SABHARWAL: Great, thank you. Just a couple
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`preliminary matters, Your Honors. First of all, with respect to the
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`time allocation, with the Board's permission, we would like to allocate
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`40 minutes for our opening presentation and then 20 minutes for
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`rebuttal.
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`Also, we have hard copies of our demonstratives, if the
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`Board would like that.
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`JUDGE KAMHOLZ: Yes, please.
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`MR. SABHARWAL: Could you hand those out, please.
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`Excuse me.
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
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`(Discussion off the record.)
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`JUDGE KAMHOLZ: Please proceed.
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`MR. SABHARWAL: Thank you. One other thing, Your
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`Honors, in terms of the allocation, I will be addressing the prima facie
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`and secondary consideration issues in part of our opening, and Mr.
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`Ainsworth will be discussing the alternative arguments, the
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`incorporation by reference, the antedation issue and CREATE Act
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`issue.
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`JUDGE KAMHOLZ: Thank you. Please make sure that
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`you speak up and into the microphone so Judge Braden can hear.
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`MR. SABHARWAL: All right. If for any reason you can't
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`hear me, please let me know.
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`JUDGE BRADEN: Thank you. It would be nice.
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`MR. SABHARWAL: Sure. Your Honors, on December 17
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`of 2013, this Board instituted the foregoing IPRs based upon the '932
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`Ashley reference as well as the Sheth reference.
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`In the ensuing eight months, Petitioner's case has been
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`strengthened based upon at least three principal reasons: Number 1,
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`the express disclosures of the '932 reference and the Sheth reference.
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`Your Honors, it doesn't matter what Mr. Flattmann or I say. The
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`references say what they say, and we believe that they strongly
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`demonstrate unpatentability of the alleged invention in this case.
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`Secondly, based upon deposition testimony as well as the
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`pleadings and other exhibits, the Patent Owner, Supernus, has failed
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`to demonstrate that any of the secondary considerations overcome our
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
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`case of obviousness, and then finally, and perhaps most uniquely, we
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`are going to be addressing today critical admissions that both
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`Supernus' expert, as well as their real party in interest, Galderma,
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`made with respect to the core issues in this case.
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`First let me talk about their primary liability expert, Dr.
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`Edward Rudnic. Dr. Edward Rudnic was deposed for seven hours in
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`this proceeding in May of 2013. Dr. Rudnic testified as part of his
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`declaration with Patent Owner's response that it would be
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`inconceivable, inconsequential for a person of ordinary skill in the art
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`to use an IR/DR formulation of doxycycline, in a sworn declaration
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`submitted with the Patent Owner's response.
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`Nevertheless, what Dr. Rudnic did not inform the Board is
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`that in May of 2004, over ten years ago, Dr. Rudnic himself was the
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`primary inventor on a patent that issued from the Patent Office that
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`claimed an IR/DR formulation of doxycycline, so on the one hand, we
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`have Dr. Rudnic saying to the Board in 2014 or 2013, There's no way
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`that I would ever use -- a person of ordinary skill in the art would ever
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`do an IR/DR formulation of doxycycline.
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`JUDGE KAMHOLZ: What timeframe was that declaration
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`or that statement directed to?
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`MR. SABHARWAL: I'm sorry, Your Honor?
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`JUDGE KAMHOLZ: What timeframe was that statement
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`of his directed to?
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`MR. SABHARWAL: The declaration, Your Honor?
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
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`JUDGE KAMHOLZ: Your reference to his testimony that
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`no one would consider an IR/DR.
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`MR. SABHARWAL: Do we have the slide? Your Honor,
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`this was going -- this was in the Rudnic declaration that was submitted
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`with Patent Owner's response.
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`JUDGE KAMHOLZ: This is slide 12?
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`MR. SABHARWAL: Yes, Your Honor, this is slide 12.
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`And in his declaration, he said "had one of ordinary skill in the art
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`been aware of the narrow absorption window of doxycycline, it would
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`have been counterintuitive to formulate a drug composition as a DR
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`drug product or with a DR component."
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`But, Your Honor, let's look --
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`JUDGE KAMHOLZ: What timeframe was that made with
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`reference to?
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`MR. SABHARWAL: The Patent Owner response? What's
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`the date on that? That was -- that was -- I'm sorry, Your Honor, that
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`was as of the earliest priority date, which is April 7 of 2003. I'm
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`sorry. I thought Your Honor asked for what the date was of Patent
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`Owner response.
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`JUDGE KAMHOLZ: No.
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`MR. SABHARWAL: Okay. But, however, this
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`application, Your Honor, published in 2002, before the earliest
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`priority date, and it claims a once a day antibiotic product, which is a
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`tetracycline that has an immediate release and a delayed release, and
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`in Claim 2, Dr. Rudnic claimed the product of Claim 1 wherein said
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
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`tetracycline is doxycycline, and I asked Dr. Rudnic during his
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`deposition, Does your invention also encompasses minocycline, and
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`he says, Yes, it does.
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`Now, we don't -- it's not just Dr. Rudnic's admission. We
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`also have the real party in interest here, Galderma, who is identified in
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`paper number 5 by Supernus as the exclusive licensee and the real
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`party in interest making a statement directly contrary to what
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`Supernus is arguing today.
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`What do I mean by that? As we put in our reply brief, in
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`December -- on December 22 of 2010, during prosecution of the '240
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`application, which has a nearly identical spec to the '854 provision,
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`Galderma, relying on the same language that the Board and Petitioner
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`relied upon to argue that the Ashley teaches an IR/DR, on that --
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`based upon that same sentence, they stated that the claim that they
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`sought to allow cannot include a prolonged release agent. Can we go
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`to that slide?
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`So, Your Honors, on December 17 of 2013, the Board
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`relying in part upon this language in the Ashley stated --
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`JUDGE KAMHOLZ: Is that slide 16?
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`MR. SABHARWAL: Yes, I'm sorry, Your Honor, that's
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`slide 16. The Board stated that the composition can include an IR and
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`DR combination based upon this language. Petitioner relied in part
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`upon this language to argue in its petition that Ashley teaches an
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`IR/DR, and Galderma, the real party in interest, agrees with the Board
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`and the Petitioner.
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
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`In December of 2010, Galderma stated that "the only
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`controlled release agents present in the capsules recited in amended
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`Claim 82 are an instantaneous release agent and a delayed release
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`agent. The capsules retied in Claim 82 cannot include a prolonged
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`release agent."
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`It is impossible to reconcile the contradictions. We have
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`Galderma stating to the Patent Office in December 2010 one thing and
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`Supernus stating to this Board something completely and directly
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`opposite of that.
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`JUDGE KAMHOLZ: Is there any relationship between the
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`'854 application and the '240 application?
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`MR. SABHARWAL: Yes, Your Honor. The '240
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`application has an identical spec to the '854, and it claims priority to
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`the '854 provisional. The '240 was the national phase application of
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`the '106 PCT publication, and again it's the same specification, so
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`here's how this gets even more interesting. Supernus has now tried to
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`convince the Board that under the CREATE Act, they should be
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`treated as essentially a single entity, that Supernus, Shire, Collagenics,
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`which is the predecessor to Galderma, should all be added to the
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`specification of the '740 patent.
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`Galderma and Supernus have engaged in a ten-year
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`campaign to assert these patents together. They have litigated this
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`against Amneal and Mylan together. Mr. Flattmann represented both
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`entities in the District Court, and now all of a sudden, the only
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`proffered excuse that they have for this critical admission is, Well,
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
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`that was Galderma, not Supernus. We said something totally
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`different. That's not the point. The point is that you want the Board
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`to adopt a joint status when it's convenient, and then you want to flee
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`from it when it directly contradicts your position.
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`Now, aside from these, Your Honor, we also have
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`Supernus, as part of their presentation today, running away from the
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`express language of the actual references, and that's again the most
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`important thing. On the one hand Supernus will argue that a person of
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`ordinary skill in the art would never have relied upon a reference that
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`talks about minocycline to treat rosacea, but the express language, as
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`we pointed out in our petition, teaches the use of minocycline to treat
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`rosacea, 38 milligrams to be precise.
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`They will also argue today that the Sheth reference teaches
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`what's called a, quote, modified sustained release. That's the teaching
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`of the Sheth reference. There's only one problem with that. The
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`words sustained release don't appear in Sheth. The words modified
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`sustained release don't appear in Sheth, and they want to rewrite the
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`express language of the Sheth reference to change it from delayed
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`release to modified sustained release in order to pigeonhole this into
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`their position.
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`JUDGE KAMHOLZ: What arguments and evidence are in
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`the record concerning the proper construction of delayed release?
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`MS. SABHARWAL: Your Honor, neither party proffered a
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`construction of the term delayed release. However, in his petition, Dr.
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`Van Buskirk did proffer an interpretation of delayed release, which is
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
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`essentially anything other than an instantaneous release. In other
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`words, there's a lag, and it would not be an immediate release, but
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`everything else would fall into the rubric of delayed release, and the
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`specification actually supports a broad interpretation.
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`The BRI we would submit or the plain and ordinary
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`meaning is a broad interpretation that would include a lag and then a
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`rapid release, or a release that may start in the stomach. For example,
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`the specification, I believe it is in column 5, talks about an uncoated
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`matrix tablet. Well, an uncoated matrix tablet is essentially a
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`sustained release, and this is what Chang claimed as part of a
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`sustained release.
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`I asked Dr. Rudnic because Dr. Rudnic said delayed release
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`is only a lag and then rapid release, so I said, Okay, Dr. Rudnic, how
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`do you make it -- according to your interpretation of delayed release,
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`how do you make a formulation that's an uncoated matrix tablet as
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`recited in Chang. His answer, I don't know.
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`They also talk about a pulsatile delivery system. Pulsatile
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`delivery system is what's talked about in the Sheth reference as a
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`delayed release. Dr. Rudnic told me that his patent, the IR/DR, is a
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`pulsatile delivery system, so the delayed release construction under
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`the BRI should be broad, and it ensnares the prior art.
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`Your Honor, let me now turn to the secondary
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`considerations experts. Supernus proffered declarations from Dr.
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`Webster, Dr. -- Mr. Grabowski, Dr. Rudnic, based upon the various
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`considerations such as long-felt need, commercial success, copying.
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
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`Dr. Webster admitted in deposition that there is no
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`evidence, no evidence that a once a day formulation is more effective
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`than a twice a day 20 milligram formulation, which is in the prior art,
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`so, in other words, what Galderma and Supernus want is to obtain a
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`patent and enforce a patent where the only conceivable thing that
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`could be invented is the fact that you have taken a Periostat
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`formulation, which is 20 milligrams administered twice a week, and
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`you make it once a day. That's it, and once a day teaching of
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`doxycycline is expressly taught in the '932 reference.
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`Dr. Webster could not point to any specific need for once a
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`day formulation, nor could he show that there was any long-felt need
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`based upon patient compliance. There was no study that he could
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`point to that addressed patient compliance, increased patient
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`compliance as a result of a once a day formulation.
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`Let me turn to Mr. Grabowski. Mr. Grabowski alleged that
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`this formulation was commercially successful. On deposition, during
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`cross examination, he admitted that the once a day formulation is not
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`the key driver of sales. The fact is that Oracea is the only FDA
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`approved drug, doxycycline drug to treat rosacea. Obviously the sales
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`will be high. There's no generics. There's no other formulation, but at
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`the end of the day, the only thing that they can rely on is a once a day
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`40 milligram, when the 20 milligram twice a day is taught in the '932,
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`and the 40 milligram doxycycline is taught in the '932.
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`JUDGE GREEN: But does that mean that any kind of
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`drug -- I don't know, does that mean any kind of drug that has FDA
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` 12
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`
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
`
`approval, that you can't have commercial success because of the FDA
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`approval?
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`MR. SABHARWAL: Certainly not, Your Honor, but at the
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`end of the day, if a party is arguing that commercial success is due to
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`the patented features, they have to point to and demonstrate evidence
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`of what patented feature leads to the commercial success. There may
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`be situations where there are generics on the market, but nevertheless,
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`the branded drug is prevailing, and that may be due to the patented
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`feature, but that's not the case here.
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`JUDGE GREEN: But the two 20 milligrams twice a day is
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`on the market, even though it's not FDA approved?
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`MR. SABHARWAL: Correct, it is on the market. That's
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`correct.
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`JUDGE GREEN: And there's no difference in efficacy
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`between the two?
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`MR. SABHARWAL: There's no difference in efficacy, and
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`there's also no difference in the adverse event profile, and we asked
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`Dr. Webster about that. He could not say that the 20 milligram twice
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`a day is more toxic.
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`JUDGE GREEN: And there's no argument that the generic
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`twice a day is much cheaper than the FDA approved once a day?
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`MR. SABHARWAL: There is no -- there has been no
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`argument about that. Certainly I would suspect that a generic entrant
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`would have a cheaper formulation.
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` 13
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`
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
`
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`JUDGE GREEN: No. I'm talking about at this point in
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`time, the generic twice a day, which I admit would be an off label use,
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`that would still be cheaper than the once a day formulation that's been
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`FDA approved?
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`MR. SABHARWAL: Yes, it would be cheaper, I think.
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`I've covered a number of things here. I just want to briefly
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`talk about the claims. Can we go to slide 3, please?
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`Your Honors, with the Board's permission, we're going to
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`be talking primarily about the '740 patent, but the limitations of the
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`'405 and the '406 are subsumed within the disclosure of the '740, and
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`it is our position that they all fall together and Supernus has not made
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`any type of distinction either in their papers or vis-a-vis their evidence
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`or declarations of any alleged distinctions between and amongst these
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`limitations.
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`Next slide, please. On December 17, the Board held with
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`respect to the '740 patent that there's a reasonable likelihood that both
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`the independent and dependent claims are unpatentable in view of
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`Sheth as well as the Ashley '932 disclosure, and it is our position that
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`the Board should not disturb that decision, and instead conclude with
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`a finding of obviousness on patentability based upon these references.
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`I am now on slide 5. Again these are the two references
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`that the Board relied on in its December 17 decision: The Ashley '932
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`publication, and the Sheth '748 patent.
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`Next slide, please, slide 6. Your Honors, we've already
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`submitted detailed claim charts and explanations for all of the various
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` 14
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
`
`limitations. Just for the Board's convenience, we have a slide here
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`that is just a snapshot of some of the salient disclosures in Ashley.
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`Just as a point of note, we have on the very top box -- let me
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`see if I can use this thing here, right here. It says: "In a preferred
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`embodiment, the tetracycline is doxycycline: We cited Ashley '854,
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`but this disclosure is also in the Ashley '932 as set forth in our
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`petition. In fact, all of the disclosures are set forth in the '932. All of
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`the limitations of the patents in this case are set forth in Ashley '932.
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`Ashley '854 we believe is incorporated by reference based upon the
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`prevailing case law, but at the end of the day, it's still in Ashley '932.
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`Next slide, please. I'm on slide 7. Again this is an
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`independent claim 19, which talks about, in the Ashley disclosure,
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`using doxycycline to treat acne and specifically rosacea.
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`Next slide, please. Now I'm on slide 8. As I said before,
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`Your Honors, Ashley '932 expressly teaches minocycline, so we have
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`Supernus saying and their expert saying, Well, no one would ever use
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`minocycline. It would be counterintuitive to do that, but we have
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`Ashley talking about a sub-antibacterial dosage of 38 milligrams of
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`minocycline to treat rosacea.
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`We have the Ashley '932 talking about the fact that that
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`formulation can achieve a steady-state blood plasma level within the
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`claimed range, and let me just pause for a moment and talk about this
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`allegedly narrow claimed range.
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`Your Honors, by their own documents, they have shown
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`that there are many different types of formulations that can fall and
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` 15
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`
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
`
`meet this 0.1 micrograms to 1.0 micrograms per milliliter. We have
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`in silico modeling that they have showing 20 milligrams BID, 20
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`milligrams twice a day, 40 milligrams, 80 milligrams, IR/DR. They
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`work.
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`No matter what happens, you're going to get this particular
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`disclosure of .1 micrograms per milliliter to 1.0 micrograms per
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`milliliter. This is like hitting the broadside of a barn. Nevertheless,
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`they want to claim that this is somehow inventive because a once a
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`day formulation on this allegedly critical ratio of 75 to 25 will achieve
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`this. Well, there's lots of formulations that will achieve it based upon
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`their own disclosure. We're going to get to that.
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`All right. We have Dr. Van Buskirk as part of our petition
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`talking about the fact that minocycline and doxycycline are
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`comparable tetracycline drugs, and then we have the Board saying the
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`close relatedness of the two drugs, meaning minocycline and
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`doxycycline, makes information about one formulation relevant to the
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`other.
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`Next slide, please. I'm now on slide 9. Not only do we
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`have the Board and Dr. Van Buskirk and Amneal as part of its
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`argument talking about the similarity, this, Your Honors, is evidence
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`that we submitted from their expert, Dr. Guy Webster. Dr. Guy
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`Webster has published before the earliest priority date teachings that
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`talk about how you can use minocycline to treat rosacea. I'm in the
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`top left-hand box. He talks about 50 to 100 milligrams once or twice
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`daily, 50, 75 or 100 milligrams of minocycline. Bottom left box,
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` 16
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`
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
`
`"ocular rosacea and more severe inflammatory rosacea respond well
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`to oral doxycycline or minocycline," and then finally, he says in this
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`publication: "Doxycycline and minocycline have the most beneficial
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`effects on acne are and well tolerated and safe."
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`So Supernus has two experts that are proffering directly
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`contradictory statements. Dr. Rudnic says you wouldn't use
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`minocycline. Dr. Webster says it has the most beneficial effect for the
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`condition that we're talking about here, and this all came out during
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`the course of this proceeding.
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`Next slide, please. All right. One of the other arguments
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`that we make here today -- thank you. One of the other arguments
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`that we make here today is that the -- somehow there's something
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`magical about this sub-antibacterial dose. Well, it's pretty simple. If
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`you want to use a sub-antibacterial dose, you use a lower dosage.
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`That's it, and they talk about the fact that well Sheth -- the Board
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`should not look at Sheth because Sheth only talks about antibacterial
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`doses. That also is wrong.
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`Here is the teaching from Sheth that talks about a
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`sub-antibacterial dosage of 25 milligrams. You can go -- Ashley said
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`you can go to 38 milligrams, which is sub-antibacterial so again that's
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`wrong.
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`Next slide, please.
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`JUDGE KAMHOLZ: Just so Judge Braden is with us, it's
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`slide 11 now.
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`MR. SABHARWAL: Yes, I'm sorry, slide 11.
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` 17
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`
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
`
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`JUDGE BRADEN: I was going to ask that.
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`MR. SABHARWAL: I'm sorry? Can she hear us all right?
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`JUDGE GREEN: Judge Braden, can you hear us?
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`JUDGE BRADEN: Yes. We're on slide 11, correct?
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`MR. SABHARWAL: Yes, I'm on slide 11, Judge Braden.
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`JUDGE BRADEN: Thank you.
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`MR. SABHARWAL: So during Dr. Rudnic's deposition, I
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`also asked him repeatedly, Are you saying that you would never use
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`delayed release, that somehow you as a formulator with all of these
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`years of experience wouldn't use delayed release as opposed to
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`sustained release. Finally, after about ten minutes of going around
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`and around, he finally -- I said: "So you're saying that a person of
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`ordinary skill in the art would consider delayed release as one of the
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`possibilities, but would ultimately decide on using a sustained release
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`or a gastroretentive release."
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`He finally said: "In general, that's more or less it." That is
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`not teaching away. That is not teaching away. Teaching away is
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`pointing to some sort of disclosure that criticizes or discredits.
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`Let's go to the next slide. I'm now on slide 12. We already
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`talked about this. We have Dr. Rudnic contradicting himself based on
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`his own patent.
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`Next slide. I'm now on slide 13. One of the other things
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`that we're going to hear from Mr. Flattmann or Mr. Morris is the
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`alleged criticality of this 75/25. In other words, this is somehow the
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`magical formulation, that if you get this formulation and only this
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` 18
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`
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
`
`formulation, you will achieve a steady-state blood level. Well, we
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`only need to look to the '740 reference itself to show that that is not
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`correct.
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`Your Honor, this is figure 4, which has been cited in our
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`petition and also in our reply. Figure 4 shows what I was talking
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`about earlier. We have a 20 milligram IR, instant release twice a day.
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`We have a 40 milligram IR, 40 milligrams instant release once a day.
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`We have a ratio outside of this critical 75/25, and we have another
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`ratio outside of this allegedly critical 75/25, and look at this.
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`Their own evidence shows that no matter what dosage
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`formulation you use, you are going to achieve the steady-state
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`limitation of .1 micrograms per milliliter to 1.0 micrograms. They're
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`going to be able to hit that broadside of a barn, and that's not all. They
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`actually went ahead and claimed it too. They actually talked about
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`ratios that are from 99 percent IR, 99 parts IR, one part DR, to 70/30,
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`but they will still tell this Board that the 75/25 was critical. This, by
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`the way, is also in the specification of the '740 patent.
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`Can you go to the next slide, please?
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`JUDGE KAMHOLZ: Claim 1 --
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`JUDGE BRADEN: Moving on to slide 14?
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`MR. SABHARWAL: Yes, I'm on slide 14.
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`JUDGE BRADEN: Thank you.
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`JUDGE KAMHOLZ: Just before we proceed, what range
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`of ratio is Claim 1 limited to in the '740 patent?
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` 19
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`Case Nos. IPR2013-00368, IPR2013-00371 and IPR2013-00372
`Patent Nos. 8,206,740, 8, 394,405 and 8,394,406
`
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`MR. SABHARWAL: 75/25, 30 parts -- 30 milligrams IR,
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`10 milligrams DR.
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`JUDGE KAMHOLZ: I only ask because I note that the
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`weight -- the massives of doxycycline are specified as comprising, so
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`as I read, an immediate release portion -- an immediate release IR
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`portion comprising 30 milligrams doxycycline. Is that limited to 30
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`milligrams doxycycline?
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`MR. SABHARWAL: Well, if it uses the comprising
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`language, perhaps not. There may be something else in there, but they
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`didn't specify anything beyond the 30 milligrams of IR, but, Your
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`Honor, just going back, they -- just to make it clear, can we go back to
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`the claim language again?
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`Let me just, if I may, just point this out here. If this was so
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`critical, why didn't you claim 99/1 and 70 to 30? Why didn't you
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`claim 80/20 to 70/30? Why didn't you talk about this as your
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`preferred disclosure? Nothing that they say makes sense. Nothing
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`that they say makes sense.
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`All right. Can we go to the next slide? We also got Dr.
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`Rudnic to finally admit that he misunderstood the legal doctrine of
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`teaching away. I said: "Do you think teaching something different is
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`the same thing as teaching away?"
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`Essentially he said: "When you are saying that someth
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