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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`Case IPR 2017-01053
`Patent 8,268,299
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner
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`v.
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`ALCON RESEARCH, LTD,
`Patent Owner
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`Case IPR2017-01053
`Patent 8,268,299
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`ALCON RESEARCH, LTD.’S MOTION FOR OBSERVATIONS ON THE
`DEPOSITION OF PETITIONER’S EXPERT JOHN C. STAINES, JR.
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`Case IPR 2017-01053
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`Patent 8,268,299
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`Pursuant to 77 Fed. Reg. 48,767-68, Paper 7 at 6, and Paper 34 at 2, Patent
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`Owner Alcon Research, Ltd. (“Alcon”) submits this motion for observations
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`regarding cross-examination of Petitioner’s reply declarant John C. Staines, Jr.,
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`following his deposition on May 8, 2018 (Exhibit 2168).
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`Observation 1. Mr. Staines testified:
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`Q. I think you make the point in your report that that’s
`ultimately what the commercial success inquiry is about
`in your understanding, whether or not a competitor has
`an incentive to enter the market; is that right?
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`A. Yes. That would have been developed. If it had been
`obvious, somebody else would have already developed it
`and made that money. So we wouldn’t have made the
`money here; Alcon wouldn’t have.
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`Ex. 2168 at 13:7-15.
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`Q. So your understanding is that the invention is a
`preservative system in a formulation that also contains
`Travoprost as an API? Is that --
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`A. Right. It’s a reformulation of Travatan that
`incorporates an alternative preservative. . . .
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`Q. Did you consider whether the ’299 patent does not require
`Travoprost as an active pharmaceutical ingredient?
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`A. No.
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`Ex. 2168 at 47:19-48:5 (Argentum’s objection omitted).
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`Q. Weren’t Lumigan and Xalatan competitive products to
`Travatan and Travatan Z at the time that Travatan Z was
`brought to market?
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`Case IPR 2017-01053
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`Patent 8,268,299
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`A. They were, I think, competitive alternative products,
`yes.
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`Ex. 2168 at 55:6-10.
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`Q. . . . Pfizer could have looked at its prostaglandin
`analog product [Xalatan] and had the same incentive that
`Alcon had with Travoprost because it too could have
`benefited from accommodative marketing, pricing and
`ultimately the removal of the original Pfizer product from
`the market; right?
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`A. I’m unaware of the – that the ’299 patent can be used
`for other products. It may well. I didn’t consider that.
`And so for that reason I can’t really – I’d have to go back
`and think about the implications of that, but I haven’t
`considered that.
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`Ex. 2168 at 85:18-87:6 (Argentum’s objection omitted). This testimony is relevant
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`to Petitioner’s argument that “the comparisons of sales and prescriptions between
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`TRAVATAN® and TRAVATANZ® reported by Dr. Grabowski fail to account for
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`the advantages that successor product status gave to TRAVATANZ®,” Paper 35 at
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`27, and Mr. Staines’ statement that “[a]n alternative developer of a product based
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`on the ’299 patent technology would not have benefited from this accommodative
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`marketing, pricing, and ultimately Travatan® removal strategy . . . ,” Ex. 1094
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`¶ 34. The testimony is relevant because it undermines Petitioner’s argument,
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`demonstrates that Mr. Staines’ opinion is based on a misunderstanding of the ’299
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`patent technology, and contradicts Mr. Staines’ statement in Paragraph 34 of
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`Exhibit 1094.
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`Observation 2. Mr. Staines testified:
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`Case IPR 2017-01053
`Patent 8,268,299
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`Q. Is it possible to predict ex-ante when – let’s assume a
`commercially successful pharmaceutical product [--] is
`going to hit its saturation or mature phase?
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`A. It’s impossible to predict that accurately. People can
`make estimates and maybe forecast, basically. So you
`can forecast it, and you’re either right or wrong. You
`might be close or you might be way off.
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`Ex. 2168 at 26:22-27:6 (Argentum’s objection omitted).
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`Q. You concede in your expert declaration that
`extrapolations like you’ve made on Exhibit C are subject
`to uncertainty, right?
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`A. Yes.
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`Ex. 2168 at 91:4-7.
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`Q. Is linear growth typical during the first 10 years after a
`pharmaceutical product’s launch?
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`A. I don’t know what is really typical. I don’t know that
`it’s atypical or typical. I think there’s a lot of different
`growth patterns. You would see increasing growth for a
`number of years and could see increasing growth for 10
`years, but it’s linear. Sometimes it’s accelerating and it
`can be for 10 years, but it just – every product is different
`depending on what market forces are working on it.
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`Q. Is logarithmic growth, as you depicted in the dashed
`blue line, typical during the first 10 years after a
`pharmaceutical product’s launch?
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`A. Again, I wouldn’t say it’s typical or atypical. It’s
`plausible.
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`Case IPR 2017-01053
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`Patent 8,268,299
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`Ex. 2168 at 103:13-104:4. 8:23-109:3 (Argentum’s objection omitted). This
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`testimony is relevant to Petitioner’s argument that “Dr. Grabowski fail[s] to
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`account for the advantages that successor product status gave to TRAVATANZ®.”
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`Paper 35 at 27. This testimony is also relevant to evaluating the reliability of Mr.
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`Staines’ statement that “the linear regression extrapolation of Travatan®’s 2001 to
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`2006 sales forward to 2007 to 2010 in Exhibit C indicates that Travatan® sales
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`were on track to slightly exceed the combined Travatan®/Travatan Z® franchise
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`sales actually generated in those years.” Ex. 1094 ¶ 40 and Ex. C. The testimony
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`is relevant because it is undermines the reliability of Mr. Staines’ analysis, and
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`Petitioner’s arguments based on that analysis.
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`Observation 3. Mr. Staines testified:
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`Q. So, so far as Dr. Grabowski uses numbers to do his
`own calculations in his expert declaration, there’s none of
`those that you think he did wrong, that he calculated
`incorrectly; is that right?
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`A. Right. Again, I haven’t done a thorough examination
`of them, but the ones that I did and in general just
`looking at the reasonableness, I’m unaware of any
`calculation errors.
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`Q. And if you had found any calculation errors, you
`would have pointed it out in your expert declaration?
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`A. I would have been all over it.
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`Ex. 2168 at 44:13-24. This testimony is relevant to Petitioner’s argument that “the
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`actual net revenue levels and growth are lower than reported by the Grabowski
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`Case IPR 2017-01053
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`Patent 8,268,299
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`Declaration. Paper 35 at 27. The testimony is relevant because it contradicts
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`Petitioner’s argument.
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`Dated: May 18, 2018
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`Respectfully submitted,
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`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
`Lead Counsel for
`Patent Owner
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`Williams & Connolly LLP
`725 Twelfth Street NW
`Washington, D.C. 20005
`202-434-5338 (Telephone)
`202-434-5029 (Facsimile)
`dkrinsky@wc.com
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`Case IPR 2017-01053
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`Patent 8,268,299
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`The undersigned hereby certifies that the foregoing “ALCON RESEARCH,
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`LTD.’S MOTION FOR OBSERVATIONS ON THE DEPOSITION OF
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`PETITIONER’S EXPERT JOHN C. STAINES, JR.” was served on May 18, 2018,
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`via electronic mail upon the following attorneys of record for the Petitioner:
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`Michael R. Houston
`Joseph P. Meara
`James P. McParland
`FOLEY & LARDNER LLP
`mhouston@foley.com
`jmeara-pgp@foley.com
`jmcparland@foley.com
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`Tyler C. Liu
`ARGENTUM PHARMACEUTICALS LLC
`tliu@agpharm.com
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`Dated: May 18, 2018
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`Respectfully submitted,
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`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
`Lead Counsel for Patent Owner
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