`
`Paper No. ___
`Filed: July 27, 2017
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC. and AKORN INC.,1
`Petitioners,
`
`v.
`
`ALLERGAN, INC.,
`Patent Owner.
`
`_____________________________
`
`Case IPR2016-01127 (US 8,685,930 B2)
`Case IPR2016-01128 (US 8,629,111 B2)
`Case IPR2016-01129 (US 8,642,556 B2)
`Case IPR2016-01130 (US 8,633,162 B2)
`Case IPR2016-01131 (US 8,648,048 B2)
`Case IPR2016-01132 (US 9,248,191 B2)
`_____________________________
`
`PETITIONERS’ RESPONSE TO PATENT OWNER’S MOTION FOR
`OBSERVATIONS ON THE CROSS-EXAMINATION TESTIMONY OF
`MR. IVAN T. HOFMANN
`
`
`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017-
`00596, IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017-00599,
`IPR2017-00585 and IPR2017-00600, and IPR2017-00586 and IPR2017-00601,
`have respectively been joined with the captioned proceedings. The word-for-word
`identical paper is filed in each proceeding identified in the caption pursuant to the
`Board’s Scheduling Order (Paper 10).
`
`
`
`
`
`
`
`
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`Petitioner submits this Response to Patent Owner Allergan’s Motion for
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`Observations on the Cross-Examination Testimony of Ivan T. Hofmann
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`(“Observations”) pursuant to the Standing Order (Paper 9) and the Scheduling
`
`Order (Paper 10).
`
`Mr. Hofmann’s Testimony That Restasis® Sales Do Not Prove Commercial
`Success of the Claimed Invention
`
`Allergan omits relevant testimony and mischaracterizes the cited testimony.
`
`Observations at 1. Mr. Hofmann testified that the commercial performance of
`
`Restasis does not provide objective indicia of nonobviousness in this case. EX2084
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`at 7:24-8:3. While the lack of nexus between the novel aspects of the alleged
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`inventions and the commercial success is one reason for this belief, it is one among
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`several. EX2084 at 7:24–8:12. (“Well, I mean, I defer to the entirety of my
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`declaration. I think there are many reasons I [don’t believe commercial
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`performance of Restasis® provides objective indicia of nonobviousness of the
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`claims], including, you know, the blocking patents, and I’m sure we’ll get into
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`everything, but among them is the lack of nexus.”). Importantly, Mr. Hofmann’s
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`declaration and deposition testimony make clear his opinion that the blocking
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`patents prevent the performance of Restasis from providing objective indicia of
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`nonobviousness of the claims-at-issue. Id. at 82:13–19. (“We’re talking about the
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`patents at issue, which have a very specific claimed range that do cyclosporine,
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`that do use a specific formulation. Those are blocked by the ’979 and ’342 patent.
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`-1-
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`So we can’t learn anything about those patents at issue with the performance of
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`Restasis.”); EX1041 ¶¶30, 33–38. Allergan omits this opinion in its observations.
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`Mr. Hofmann’s Critique of Dr. Maness for Failing to Define a Relevant
`Market
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`Allergan omits relevant testimony and mischaracterizes the cited testimony.
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`Observations at 1–2. While Mr. Hofmann has not done a “definitive definition of
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`what products would comprise the relevant market,” he has identified a number of
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`different products that treat dry eye and would be competitors to Restasis. EX2084
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`at 18:6–17. Mr. Hofmann has not completed the definitive definition because
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`Allergan did not produce a complete data set to analyze. Id. at 18:21–22. Mr.
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`Hofmann testified that he rightly criticized Dr. Maness because “He’s asserting
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`commercial success. I’m saying he hasn’t done so properly with respect to defining
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`the relevant market. I don’t have a data set to do an alternative calculation, but that
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`doesn’t mean just because he did it for the wrong market, that that should stand.”
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`Id. at 20:9–14.
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`Mr. Hofmann’s Discussion of Product Marketing and Nexus
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`Allergan omits relevant testimony and mischaracterizes the cited testimony.
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`Observations at 2. Mr. Hofmann testified that “The point here is not whether the
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`marketing itself is excessive. It’s the contribution that marketing has made in
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`combination with all the other points that I’ve made in my declaration. I think that
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`it has clearly been a marketing intensity at a level that is significant. And that’s just
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`-2-
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`
`
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`not my words. That’s the words of Allergan, both internally and externally.” Id. at
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`44:19–45:2.
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`Mr. Hofmann’s Discussion of Marketing as a Percentage of Sales
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`Allergan omits relevant testimony and mischaracterizes the cited testimony.
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`Observations at 3. In his testimony, Mr. Hofmann carefully qualified Dr.
`
`Maness’s calculations of marketing expenses as a percentage of sales as “a little bit
`
`of an apples and oranges.” Id.at 42:17–43:8 (“I don’t quantitatively have a dispute
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`with how he’s pulled this together. I do think that this is a different data set than is
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`typically used for when one’s looking at these ratios based on IMS data because
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`IMS data uses . . . retail value of samples. This is actual cost of samples.”). He
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`further cautioned, “So in terms of the math, I don’t disagree with it, but I don’t
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`know that it truly reflects the economics as a percentage.” Id. at 44:1–8. Moreover,
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`Mr. Hofmann questions the utility of analyzing marketing as a function of sales:
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`I’ve looked at the role of marketing and I’ve looked at it considering
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`this as one metric, and I feel like, as I’ve explained in my report, this
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`percentage of sales metric masks the true intensity. And when one
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`looks at it relative to the Allergan documents and the testimony and
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`the public statements made by Allergan and looks at that in context,
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`when one looks at that in context with the promotion, rebates,
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`discounts, other financial incentives, looks at it in combination with
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`everything else, it definitely supports the opinion that there’s no
`
`objective evidence of nonobviousness. You can’t pick out one metric
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`-3-
`
`
`
`
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`from one spreadsheet over a 13-year period and say, does this tell us
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`the answer. You’re looking at it in the context of all the different
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`information, evidence, and data sets.
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`Id. at 45:15–46:13.
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`Mr. Hofmann’s Discussion of Marketing Expenditures of Other Products
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`Allergan omits relevant testimony and mischaracterizes the cited testimony.
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`Observations at 3–4. Mr. Hofmann testified:
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`I reject the utility of looking at [whether the percentage of marketing
`
`expenses as a function of revenue is within range of products in the
`
`pharmaceutical industry]. As I explain, I think it mutes the marketing
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`intensity. I complain of some of the general statements that Mr.
`
`Maness makes about how this fits within general averages, but that is
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`kind of broadly looking at various therapeutic classes. I haven’t seen a
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`data set that allows me to look at that relative to other products in the
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`class, and a lot of the products in the class are over-the-counter so I’m
`
`not even sure -- you would have to get comparable data. So no, I don’t
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`think a useful or meaningful data set exists so I haven’t done it.
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`Id. at 38:1–39:5. Instead Mr. Hofmann has looked at the totality of other sources to
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`determine the importance of marketing to Restasis. Id. at 41:11–42:2 (“What I’ve
`
`done is I’ve looked at the absolute data. I’ve looked at all the statements that
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`Allergan makes in their internal documents, all the statements that Allergan makes
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`in their external documents, some of the testimony. And together they tell the story
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`of the absolute importance of the marketing efforts that have been made.”).
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`-4-
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`
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`
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`Mr. Hofmann’s Critique of Dr. Maness for Failing to Apportion
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`Allergan omits relevant testimony and mischaracterizes the cited testimony.
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`Observations at 4–5. Mr. Hofmann testified:
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`Well, [my lack of apportionment] goes back to he’s the one asserting
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`commercial success on all six of these patents using the same sales
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`and applying it across all these patents and all these claims. I did not
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`do my own apportionment analysis among the patents at issue. I did
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`highlight the significant and important role of the ’979 and ’342
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`patent, which is, I guess, some level of qualitative apportionment . . . .
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`Id. at 85:24–86:17. Moreover, based on his understanding from the technical
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`experts regarding claim scope (Id. at 88:18–21), Mr. Hofmann testified, “the
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`existence of the ’979 and ’342 patent, both from a blocking perspective and from a
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`prior art perspective, really leave nothing to the patents at issue as showing -- as
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`driving the sales of Restasis.” Id. at 86:12–17; EX1041 at ¶¶29–30 (“Therefore,
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`Examiner cannot ascertain whether the commercial success of the claimed
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`composition was due to the claimed features which are distinct from those
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`embodiments in Ding et al. or other factors such as the fact that the composition
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`was the only composition for treating dry eyes FDA approved and thus,
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`commercially available for sale to the public.”).
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`Mr. Hofmann’s Reliance on Experts to Interpret Scope of Patent Claims
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`
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`Allergan omits relevant testimony and mischaracterizes the cited testimony.
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`Observations at 5. Mr. Hofmann testified that while he may not have cited to a
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`-5-
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`technical expert within a specific footnote, he is still “relying on those experts
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`broadly” and he has “included citations to the underlying documents that they’ve
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`cited.” EX2084 at 69:3–11. He further testified, “Sometimes when I say I
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`understand, I’m referring also to understandings on technical issues. It doesn’t look
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`like I have a reference there, but I know I have many references on the same
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`substantive issue throughout the declaration.” Id. at 67:8–12.
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
`
`
`
`
`
`Dated: July 27, 2017
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`-6-
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`
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`CERTIFICATE OF SERVICE
`
`This is to certify that I caused to be served true and correct copies of the
`
`foregoing Petitioners’ Response to Patent Owner’s Motion for Observations on the
`
`Cross-Examination of Testimony Mr. Ivan T. Hofmann on this 27th day of July,
`
`2017, on the Patent Owner at the correspondence address of the Patent Owner as
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`follows:
`
`Dorothy P. Whelan
`Michael Kane
`Susan Morrison Colletti
`Robert M. Oakes
`Jonathan Singer
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: IPR13351-0008IP1@fr.com
`Email: IPR13351-0008IP2@fr.com
`Email: IPR13351-0008IP3@fr.com
`Email: IPR13351-0008IP4@fr.com
`Email: IPR13351-0008IP5@fr.com
`Email: IPR13351-0008IP6@fr.com
`Email: PTABInbound@fr.com
`
`And on the remaining petitioners as follows:
`
`
`Gary Speier
`Mark Schuman
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST & SCHUMAN, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Email: gspeier@carlsoncaspers.com
`Email: mschuman@carlsoncaspers.com
`Attorneys for Teva Pharmaceuticals USA, Inc.
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`-7-
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`
`
`Michael Dzwonczyk
`Azadeh Kokabi
`Travis Ribar
`SUGHRUE MION, PLLC
`2100 Pennsylvania Ave., NW
`Washington, DC 20037
`Email: mdzwonczyk@sughrue.com
`Email: akokabi@sughrue.com
`Email: tribar@sughrue.com
`Attorneys for Akorn Inc.
`
`Dated: July 27, 2017
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`
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`
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`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee, Lead Counsel
` Reg. No. 31,990
`
`
`
`
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`-8-
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