`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`COALITION FOR AFFORDABLE DRUGS II LLC,
`
`Petitioner,
`
`v.
`
`NPS PHARMACEUTICALS, INC.
`
`Patent Owner.
`____________
`
`
`Cases IPR2015-00990 and IPR2015-01093
`(Patent 7,056,886 B2)1
`
`
`MOTION PRESENTING PATENT OWNER’S OBSERVATIONS
`REGARDING CROSS-EXAMINATION OF IVAN HOFMANN
`
`
`
`
`
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`1 Pursuant to the Board’s Scheduling Order in these IPRs, “the word-for-word
`identical paper is filed in each proceeding identified in the heading.” See, e.g.,
`IPR2015-00990, Paper 29, footnote 1.
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`Pursuant to the USPTO Trial Practice Guide, 77 Fed. Reg. 157, 48767-68,
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`48769 (August 14, 2012) and the Scheduling Order in these IPRs, Patent Owner
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`NPS Pharmaceuticals Inc. (“NPS”) submits this motion to present observations
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`regarding the May 6, 2016 cross-examination testimony of Ivan Hofmann. See Ex.
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`2170. Mr. Hofmann is a reply declarant of the Petitioner. See Ex. 1042.
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`OBSERVATIONS REGARDING TESTIMONY OF MR. HOFMANN
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`1.
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`In Ex. 2170, at 9:8-10:2, Mr. Hofmann testified he has a bachelor’s degree
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`and “obtained continuing education,” but he does not hold a masters, a Ph.D., or
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`any university positions. See also id. 11:23-23-24 (alleging LES membership,
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`available by paying dues, qualifies him to provide expert economic testimony).
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`That testimony is relevant to whether Mr. Hofmann is qualified and credible as an
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`economics expert on the subjects of long-felt need and commercial success, as
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`presented in his declaration (Ex. 1042) and relied on in Petitioner’s Reply (Reply2
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`at 22-25). This testimony is also relevant because it establishes that Mr. Hofmann’s
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`qualifications do not rise to the level at which he should be considered a credible
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`expert, such that his testimony should be afforded little weight.
`
`
`2 For convenience, citations to “Reply” encompass both IPRs, but refer specifically
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`to Paper 42 in IPR2015-00990. Paper 40 in IPR2015-01093 is substantively
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`identical, with different pagination.
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`2.
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`In Ex. 2170, at 101:7-17, 117:4-118:21 and 144:8-15, Mr. Hofmann
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`testified that alternatives to formulations claimed in the ‘886 patent are “possible”
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`or “approvable”, i.e., that “other things” in a formulation with teduglutide would
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`make it stable, but when asked whether he could point to stabilizers that could be
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`used, Mr. Hofmann admitted, “I don't have examples of others coming up with
`
`formulations,” which he attempted to attribute to a lack of economic motivation to
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`develop alternatives due to obstruction by “the compound patent [US 5,789,379]
`
`and other exclusivities.3 That testimony is relevant to Mr. Hofmann’s Declaration
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`(Ex. 1042 at ¶¶ 34-35, 44-47, 63-65) and Petitioner’s Reply (Reply at 23-25),
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`which assert that commercial success of GATTEX® is not attributable to the ‘886
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`patent claims. This testimony is also relevant to whether or not there are known
`
`alternatives to the stabilizing formulation for teduglutide claimed in the ‘886
`
`patent, such that the claimed formulation is necessary for Gattex to be a stable and
`
`commercially viable product, and thus enjoy its commercial success.
`
`3.
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`In Ex. 2170, at 37:22-38:20, when asked whether the involved patent
`
`claims encompass more than teduglutide, Mr. Hofmann testified, “[t]here may be
`
`other APIs [besides teduglutide] that could fall within [the scope of the ‘886
`
`
`3 “The ‘886 patent” is involved US Patent 7,056,886 (Ex. 1003); “the 379 patent”
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`is the so-called “blocking” or “compound” patent, US 5,789,379 (Ex. 1029).
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`patent].” See also, id. at 63:12-83:19 (agreeing that each involved claim
`
`encompasses GLP-2 and/or GLP-2 analogs, i.e. not just teduglutide). That
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`testimony is relevant to Mr. Hofmann’s Declaration (Ex. 1042 at ¶¶ 28-30, 35) and
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`Petitioner’s Reply (Reply at 24-25), which allege that the long felt need addressed
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`by Gattex was a result “of the ‘379 patent limit[ing] the possibilities for
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`development of other GLP-2 products that could have satisfied any purported need
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`for GLP-2 products now identified by PO” (Reply at 25). This testimony is
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`relevant because, by admitting that other APIs could fall within the scope of the
`
`‘886 patent, it addresses whether or not the ‘379 patent, by claiming teduglutide
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`and not GLP-2 and many other GLP-2 analogs, precluded other GLP-2 products
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`that could have satisfied the long felt need addressed by Gattex.
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`4.
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`In Ex. 2170, at 90:3-94:10 and 96:17-23, Mr. Hofmann testified that
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`alternative stable formulations of any GLP-analog could be developed without
`
`infringing the ‘379 patent, because “they’re permitted” and “the safe harbor
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`provisions do allow such research,” and neither the ‘379 patent nor Gattex's orphan
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`drug exclusivity precluded others from developing a stable formulation as claimed
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`in the '886 patent (and licensing to NPS/Shire), to share in the profits of Gattex – a
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`product with “hundreds of millions” in annual sales. That testimony is relevant to
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`Mr. Hofmann’s Declaration (Ex. 1042 at ¶¶ 28-30) and Petitioner’s Reply (Reply at
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`24-25), which assert that “other companies did not have the economic incentive or
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`ability to commercialize a GLP-2 analog product as a result of the blocking nature
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`of the ‘379 Patent that covers Gattex®.” This testimony is also relevant because it
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`addresses that a party was not precluded from developing a stable formulation of
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`teduglutide and would have had an economic incentive to do so and license a
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`resulting patent to NPS to share in the revenues of such a product.
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`5.
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`In Ex. 2170, at 15:23-16:5, Mr. Hofmann testified that, “it's not atypical for
`
`the sponsor … to put some marketing effort behind a drug,” which can “vary by
`
`degree;” and at 178:21-180:16 and 184:15-186:23, he testified that “it’s typical that
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`some level of marketing is put behind most branded drugs at some stage of their
`
`life cycle” and it “can generate demand,” which “really varies” under the
`
`circumstances, although “I don’t know” what sales representatives said” about
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`Gattex and “promotional sensitivity” does not indicate whether or not sales were
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`driven by the properties of Gattex. At 148:23-151:24, Mr. Hofmann testified that
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`Gattex is marketed to physicians, “primarily gastroenterologists,” who are
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`“specialized” and have “higher levels of training and education.” That testimony is
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`relevant to Mr. Hofmann’s Declaration (Ex. 1042 at ¶¶ 48-51) and Petitioner’s
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`Reply (Reply at 23), which assert that “the performance of Gattex® is driven by
`
`marketing” (Reply at 23). This testimony is relevant because it acknowledges that
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`(1) Gattex marketing is not unlike marketing for all other marketed drugs and (2)
`
`the demand for a drug resulting from marketing efforts “really varies”, yet Mr.
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`Hofmann’s declaration does not indicate what portion of Gattex’s commercial
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`success, if any, results from marketing (Ex. 1042 at ¶¶ 48-51).
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`6.
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`In Ex. 2170, at 182:8-184:14, Mr. Hofmann testified he did not know
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`whether Shire leveraged its Lialda sales force to promote Gattex; Shire could not
`
`have done so “prior to acquiring” NPS; and Gattex was approved years earlier, on
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`December 21, 2012. That testimony is relevant to Mr. Hofmann’s Declaration (Ex.
`
`1042 at ¶ 51) and Petitioner’s Reply (Reply at 22), which assert that commercial
`
`success of Gattex cannot be attributed to the ‘886 patent claims, because sales
`
`could have been driven by Shire’s plan to leverage the Lialda sales force. This
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`testimony is relevant because Mr. Hofmann admits he does not know if Shire did
`
`so, which anyway it could not do prior to Shire’s acquisition of NPS, and could not
`
`have contributed to Gattex’s commercial success before the acquisition.
`
`7.
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`In Ex. 2170, at 58:3-5, 60:4-10, and 153:22-25, Mr. Hofmann recognized
`
`that Gattex must be stable for at least 90 days, at 152:15-153:9, he testified that,
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`“the extent that the stability or lack of stability [of a drug] has implications with
`
`respect to safety and efficacy . . . and could affect [FDA] approval,” and at 163:18-
`
`164:22, he admits FDA approval is a prerequisite to a product attaining commercial
`
`success. He also admitted, at 37:18-38-21, 143:2-10 and 145:9-148:16, that a drug
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`product is “a finished dosage form involving the active ingredient,” and that the
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`‘886 patent claims the “commercial embodiment of Gattex,” which he understands
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`is a lyophilized formulation and contains teduglutide as the GLP-2 analog API and
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`which “includes L-histidine and a bulking agent of mannitol and/or sucrose.” See
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`also Ex. 2170 at 159:9-169:14; 170:7-171:4 (acknowledging Petition’s admission
`
`of a design need for a stable GLP-2 formulation to meet FDA requirements). That
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`testimony is relevant to Mr. Hofmann’s Declaration (Ex. 1042 at ¶¶ 33) and
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`Petitioner’s Reply (Reply at 22-24) and the Decision to Institute (IPR2015-00990,
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`Paper 28 at 18; IPR2015-01093, Paper 26 at 18), which assert that commercial
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`success of Gattex is attributed to the use of the active drug teduglutide (claimed in
`
`the ‘379 patent) rather than to the formulated product, Gattex, and its ability to
`
`provide teduglutide in a stable formulation (claimed in the ‘886 patent). This
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`testimony is also relevant to the nexus between the ‘886 patent and Gattex’s
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`commercial success and Gattex’s solution to a long felt need, e.g., the design of a
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`stable formulation of teduglutide, without which no sales or commercial success
`
`would have been possible.
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`8.
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`In Ex. 2170, at 49:13-53:18, Mr. Hofmann testified that, for his opinions on
`
`commercial success: (a) he did not consider the instructions in the Gattex label
`
`(Ex. 2088) that, prior to injection, a user must ensure particles are not formed; (b)
`
`he acknowledged “there are varying degrees of stability that exist with respect to
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`marketed drugs”; (c) from “over a hundred” formulations, he is aware of products
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`that “when reconstituted, have a shelf life of only a few hours”; and (d) although
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`he did study the Gattex label (Ex. 2088), he did not actually consider shelf-life and
`
`stability requirements, nor have an opinion whether forming particles upon
`
`reconstituting the lyophilized formulation is a problem. That testimony is relevant
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`to Mr. Hofmann’s Declaration (Ex. 1042 at ¶¶ 33) and Petitioner’s Reply (Reply at
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`22-24) and the Decision to Institute (IPR2015-00990, Paper 28 at 18; IPR2015-
`
`01093, Paper 26 at 18), which question the nexus between formulations of the ‘886
`
`patent claims and the commercial success and solution to a long felt need provided
`
`by Gattex. The testimony is also relevant because Mr. Hofmann admits he did not
`
`consider, in his nexus analysis, whether Gattex requires the stability provided by
`
`the ‘886 patent in order to be safe and effective.
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`9.
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`In Ex. 2170, at 17:6-18:15, Mr. Hofmann counted about 750 patient
`
`assistance programs listed for drugs on the Medicare formulary (IPR2015-00990,
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`Exs. 2161, 2162; IPR2015-01093, Exs. 2162, 21734), at 30:21-31:3, he stated that
`
`inclusion on this formulary “may or may not matter” for commercial success, and
`
`at 186:25-187:11, he testified that a drug paid for by a formulary, e.g, an insurance
`
`company, Medicare, or Medicaid, can still be a commercial success. That
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`testimony is relevant to Mr. Hofmann’s Declaration (Ex. 1042 at ¶¶ 58-62) and
`
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`4 Ex. 2173 in IPR2015-01093 is identified as Ex. 2161 in the deposition transcript
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`of Mr. Hofmann (Ex. 2170) and is identical to Ex. 2161 in IPR2015-00990.
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`Petitioner’s Reply (Reply at 23), which assert that commercial success of Gattex
`
`does not come from the ‘886 patent claims, because the impact of formulary
`
`patient assistance programs has not been ruled out. This testimony is also relevant
`
`because it indicates that Mr. Hofmann does not opine that the Gattex’s patient
`
`assistance programs are different from the programs of other drugs, (Ex. 1042 at ¶¶
`
`52-62), and because it addresses whether or not commercial success is attributable
`
`to a patient assistance program, per se, compared to the ‘886 patent.
`
`10. In Ex. 2170, at 32:16-33:6, Mr. Hofmann testified, “all drugs have certain
`
`mandatory discounts,” “coupons”, and “incentives.” That testimony is relevant to
`
`Mr. Hofmann’s Declaration (Ex. 1042 at ¶¶ 52-62) and Petitioner’s Reply (Reply at
`
`23), which assert that the commercial success of Gattex cannot be attributed to the
`
`involved patent claims, because the impact of such discounts has not been ruled
`
`out. This testimony is also relevant because it indicates that Mr. Hofmann did not
`
`opine that the Gattex discounts, etc. are different from the programs of other drugs,
`
`and because it addresses whether or not commercial success is attributable to
`
`discounts, etc. per se, compared to the ‘886 patent. See Ex. 1042 at ¶¶ 52-62.
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`11. In Ex. 2170, at 234:6-235:2, Mr. Hofmann testified that even though
`
`formularies will negotiate the best price they can, the cost of orphan drugs is “very
`
`high and has been trending upward” because “orphan drugs have been able to raise
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`prices without having the same restrictions and negotiations that the manufacturers
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`have experienced on products which affect a greater number of covered lives.” At
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`21:6-23:24, Mr. Hofmann testified that a year supply of Gattex is about $400,000
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`and is subject to a discount/rebate of “around 10 percent”, and although he believes
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`patients are insulated from the full price of Gattex, “third-party payers bear the
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`brunt of that cost,” paying Shire about $359,700 to $360,000 per patient annually.
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`That testimony is relevant to Mr. Hofmann’s Declaration (Ex. 1042 at ¶¶ 28, 29,
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`43, 65) and Petitioner’s Reply (Reply at 24-25), which assert that the commercial
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`success of Gattex® is not attributable to the ‘886 patent. This testimony is also
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`relevant to the economic incentive for others to develop a stable, and thus
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`commercially viable, formulation of teduglutide to treat SBS-IF, according to the
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`‘886 patent.
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`12. In Ex. 2170, at 27:22-29:25, Mr. Hofmann testified that various
`
`exclusivities (data, patent, NCE, and orphan drug or “ODE”) do not necessarily
`
`preclude commercial success, because “with each of these, one would need to look
`
`at the specific facts and circumstances.” That testimony is relevant to Mr.
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`Hofmann’s Declaration (Ex. 1042 at ¶¶ 28-30, 35, 63-65) and Petitioner’s Reply
`
`(Reply at 23-25), and whether he considered such circumstances, in asserting that
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`the commercial success of Gattex is attributable to these various exclusivities, per
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`se, rather than to benefits conferred by the ‘886 patent.
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`13. In Ex. 2170, at 96:21-97:9, 99:8-22, and 100:21-101:6, Mr. Hofmann
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`testified that the ODE and NCE exclusivities for Gattex apply only to teduglutide
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`and would not deter development of “other molecules”, e.g., GLP-2 or other GLP-
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`2 analogs, within the claims of the ‘886 patent. That testimony is relevant to Mr.
`
`Hofmann’s Declaration (Ex. 1042 at ¶¶ 63-65) and Petitioner’s Reply (Reply at
`
`24), which assert that these “various exclusivities for Gattex provide disincentives
`
`for competitors to market products for the treatment of SBS” (Reply at 24). The
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`testimony is also relevant because it addresses that the regulatory exclusivities
`
`granted to Gattex arose after the ‘866 invention was made (i.e., the ‘866 priority
`
`date), and did not preclude anyone from developing other stable formulations of
`
`GLP-2 or GLP-2 analogs in competition with the ‘866 inventor, e.g., to solve a
`
`long felt need – treatment for SBS-IF.
`
`14. In Ex. 2170, at 101:18-102:2, 106:3-108:22 120:9-128:22; and 133:1-
`
`137:16, Mr. Hofmann testified that he would defer to medical doctors, clinicians,
`
`or technical experts for questions about parenteral nutrition (“PN”) and its
`
`complications; he did not know the annual per-patient cost of parenteral nutrition
`
`or who bears those costs; and he did not consider, as in Ex. 2165, whether catheter
`
`use from PN increases risk or infection, sepsis or other complications; although he
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`did acknowledge that Ex. 2167 “says that the first patient to receive PN was in
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`1968;” he “may have heard” of at least some clinical complications identified in
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`Ex. 2163; he agreed “one would be happier not to have septic shock” and other
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`complications (see also Ex. 2166); and he admitted that “really reducing the need
`
`for PN to some degree is going to improve quality of life.” That testimony is
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`relevant to Mr. Hofmann’s Declaration (Ex. 1042 at ¶¶ 26-27) and Petitioner’s
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`Reply (Reply at 24-25), which assert that Gattex failed to provide a solution to a
`
`long felt need. This testimony is also relevant because, although Petitioner asserts
`
`that Gattex provides no solution to a long felt need because “most patients taking
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`Gattex will not be able to fully wean themselves from parenteral nutrition” (Reply
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`at 24-25), the reduction (and in some cases elimination) in PN treatment needed by
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`patients admittedly improves their quality of life and is relevant to addressing a
`
`long felt need.
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`15. In Ex. 2170, at 109:4-115:20, Mr. Hofmann testified that what he knows
`
`about the drug Zorbtive is that “it’s out there,” although he did not know: (a) how
`
`many patients with SBS take Zorbtive; (b) whether Zorbtive is indicated only for a
`
`limited period of time (from the Zorbtive label, Ex. 2083, or otherwise); (c) how
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`Zorbtive is discounted (although he agreed Ex. 2164 states “up to 75 percent”); (d)
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`the annual sales of Zorbtive; and (e) the degree of off-label use of Zorbtive that
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`could be driving its sales. That testimony is relevant to Mr. Hofmann’s Declaration
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`(Ex. 1042 at ¶¶ 31-32) and Petitioner’s Reply (Reply at 25), which assert there was
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`no long felt need for an effective treatment for SBS-IF because another product –
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`Zorbtive – was available prior to Gattex.
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`16. In Ex. 2170, at 188:3-20 and 122:11-123:22, Mr. Hofmann testified that,
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`although he did not believe an 11-18% patient use of Gattex indicates a
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`commercial success, he did not know why more eligible patients did not use
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`Gattex, and he did not compare Gattex to other drugs and could not say what level
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`of Gattex use he would consider a commercial success. That testimony is relevant
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`to Mr. Hofmann’s Declaration (Ex. 1042 at ¶¶ 66-67) and Petitioner’s Reply
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`(Reply at 23), which assert that Gattex’s “limited patient penetration” was
`
`indicative that it was not a commercial success. This testimony is also relevant
`
`because it indicates that Mr. Hofmann’s opinion regarding patient penetration is
`
`subjective.
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`17. In Ex. 2170, at 189:20-191:22 and 192:15-200:19, Mr. Hofmann testified,
`
`in connection with the drug Finacea and Ex. 2167, that the court in a previous case,
`
`where he have gave opinions regarding “the heavy marketing and promotion and
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`sampling of Finacea,” on balance “credited commercial success” for a drug having
`
`$562 million in net sales,” even though it appeared to have a relatively low patient
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`penetration. That testimony is relevant to Mr. Hofmann’s Declaration (Ex. 1042 at
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`¶¶ 66-67) and Petitioner’s Reply (Reply at 23), which assert that Gattex’s “limited
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`patient penetration” was indicative that it was not a commercial success.
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`18. In Ex. 2170, at 215:10-219:9, 219:24-226:19, and 227:4-228:10, Mr.
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`Hofmann acknowledged that three of the top ten selling orphan drugs in 2014 –
`
`Advate®, Revlimid®, and Velcade® - achieved patient penetration levels of 11%,
`
`15%, and 15%, respectively. That testimony is relevant to Mr. Hofmann’s
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`Declaration (Ex. 1042 at ¶¶ 66-67) and Petitioner’s Reply (Reply at 23), which
`
`assert that Gattex’s “limited patient penetration” was indicative that it was not a
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`commercial success. This testimony is also relevant because it shows that orphan
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`drugs can still be commercially successful when they obtain patient penetration
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`levels similar to that of Gattex, at 11-18%.
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`19. In Ex. 2170, at 239:15-242:2, Mr. Hofmann testified that although a drug
`
`product launch “technically . . . does happen on a day that its commercially
`
`available,” he “do[es]n’t disagree that the uptake and prescribing volume happens
`
`over time, not a particular day,” but he did not “have an opinion one way or the
`
`other” on whether 85% of launches have a trajectory that is set in the first six
`
`months (e.g., per Ex. 2168), and at 242:10-245:4, Mr. Hofmann testified that the
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`NPS stock price, as depicted in Ex. 2169, appears to have “negative slope” from
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`January 1 through February 25, 2013 and “certainly has a positive slope” after
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`February 25, 2013. That testimony is relevant to Mr. Hofmann’s Declaration (Ex.
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`1042 at ¶ 84) and Petitioner’s Reply (Reply at 24), which assert that “the
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`commercial launch of Gattex® did not have a significant impact on the stock price
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`of NPS.” This testimony is also relevant because it addresses whether or not
`
`movement in the NPS’s stock price coincided with and resulted from the Gattex
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`launch (see Ex. 2041 at ¶ 58).
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`20. In Ex. 2170, at 246:19-251:15 and 256:23-257:10, Mr. Hofmann testified
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`that product sales contribute to stock price, and in connection with Ex. 2172, he
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`testified that: (a) the stock price of NPS “about doubled” between October 2012
`
`and August 2013, while the XBI index increased by 50%; (b) the stock price of
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`NPS increased “greater than four-fold” between October 2012 and February 2015,
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`while the XBI index increased about 130%; (c) he did not normalize the index data
`
`he relied upon; and (d) “for the period of time after February 2013, the [NPS stock]
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`price is up.” That testimony is relevant to whether Gattex contributed to a
`
`substantial increase in the NPS stock price that coincides with and resulted from
`
`the Gattex launch, as discussed in Mr. Hofmann’s Declaration (Ex. 1042 at ¶¶ 81-
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`92) and Petitioner’s Reply (Reply at 24). That testimony is also relevant because
`
`while Dr. Hofmann stated in his declaration that “NPS’s stock increase is generally
`
`consistent with the increases in [the XBI] ind[ex]” (Ex. 1042, ¶ 90) (emphasis
`
`added), he testified during his deposition that between October 2012 (five months
`
`prior to the Gattex launch) and August 2013 (five months after the launch), NPS’s
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`stock price had increased more than double the XBI index price, and between
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`October 2012 and February 2015 (three years after launch), the NPS stock price
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`had increased by more than triple the XBI price.
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`21. In Ex. 2170, at 257:20-267:13, Mr. Hofmann testified that actual
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`performance and historical scales are among the factors used to make a projection
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`of future sales; Shire had a strong financial incentive to perform due diligence
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`regarding the NPS purchase; the value of Gattex would naturally be considered in
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`an acquisition; Shire had no financial interest in NPS before the acquisition; future
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`projections of an unlaunched product would not indicate commercial success; and
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`Shire actually paid $5.2 billion in cash and stock to acquire NPS, of which (Ex.
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`2127) $ 4.7 billion was allocated to marketed products, of which there were only
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`two – Gattex and Natpara. That testimony is relevant to Mr. Hofmann’s
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`Declaration (Ex. 1042 at ¶¶ 93-103) and Petitioner’s Reply (Reply at 23-24), which
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`assert that Shire’s acquisition of NPS does not indicate commercial success, even
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`though Shire paid a very large sum of money and NPS shareholders profited, most
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`of which was due to the value of Gattex, thus evidencing that Gattex is a
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`commercial success.
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`CONCLUSION
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`Patent Owner respectfully requests that its Observations be considered.
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`IPR2015-00990; -01093
`Patent Owner’s Observations
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`Respectfully submitted,
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`Dated: May 18, 2016
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`/Joseph R. Robinson/
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`Joseph R. Robinson, PTO Reg. No. 33,448
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` Heather M. Ettinger, PTO Reg. No. 51,658
` Dustin B. Weeks, PTO Reg. No. 67,466
` Attorneys for Patent Owner
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`IPR2015-00990; -01093
`Patent Owner’s Observations
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing MOTION
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`PRESENTING PATENT OWNER’S OBSERVATIONS REGARDING CROSS-
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`EXAMINATION OF DR. IVAN HOFMANN has been on attorney for Petitioner,
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`served via electronic mail on May 18, 2016, to the following addresses provided by
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`Petitioner:
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`Jeffrey D. Blake, Esq.
`jblake@merchantgould.com
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`Dated: May 18, 2016
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` Respectfully submitted,
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`/Dustin B. Weeks/
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` Dustin B. Weeks, PTO Reg. No. 67,466
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