UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG,
`TEVA PHARMACEUTICALS USA, INC.,
`AUROBINDO PHARMA U.S.A., INC.,
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`SUN PHARMA GLOBAL FZE and
`AMNEAL PHARMACEUTICALS LLC
`Petitioners,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`Case: IPR2015-013401
`U.S. Patent No. RE44,186
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`PATENT OWNER’S MOTION FOR OBSERVATIONS REGARDING THE
`CROSS-EXAMINATION OF DEFOREST MCDUFF
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`
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`1 Petitioner Wockhardt from IPR2016-01029, Petitioner Teva from IPR2016-
`01122, Petitioner Aurobindo from IPR2016-01117, and Petitioners Sun/Amneal
`from IPR2016-01104 have been added as Petitioners to this proceeding.
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`
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`MYLAN PHARMACEUTICALS INC.,
`WOCKHARDT BIO AG,
`TEVA PHARMACEUTICALS USA, INC.,
`AUROBINDO PHARMA U.S.A., INC.,
`SUN PHARMACEUTICAL INDUSTRIES, LTD.,
`SUN PHARMA GLOBAL FZE and
`AMNEAL PHARMACEUTICALS LLC
`Petitioners,
`
`v.
`
`ASTRAZENECA AB,
`Patent Owner.
`
`Case: IPR2015-013401
`U.S. Patent No. RE44,186
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`
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`PATENT OWNER’S MOTION FOR OBSERVATIONS REGARDING THE
`CROSS-EXAMINATION OF DEFOREST MCDUFF
`
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`
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`1 Petitioner Wockhardt from IPR2016-01029, Petitioner Teva from IPR2016-
`01122, Petitioner Aurobindo from IPR2016-01117, and Petitioners Sun/Amneal
`from IPR2016-01104 have been added as Petitioners to this proceeding.
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`
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`Patent Owner AstraZeneca AB submits this Motion for Observations
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`Regarding Cross-Examination of DeForest McDuff pursuant to the Scheduling
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`Order (Paper No. 17) and the Joint Notice of Stipulation (Paper No. 57).
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`Observation #1 - In Ex. 2220 at 15:14-16:3, Dr. McDuff testified that he did
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`not review the entirety of the record generated in the parallel district court
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`proceeding involving the RE’186 patent on the issue of commercial success. This
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`testimony is relevant to statements and conclusions in Dr. McDuff’s declaration
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`and Petitioners’ Reply brief regarding commercial success (Exs. 1060, 1060A;
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`Reply at 24-27), specifically, to the weight and understanding to be given to his
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`statements and conclusions because it raises concerns that he has not considered all
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`relevant information on the issue of commercial success.
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`Observation #2 - In Ex. 2220 at 16:8-20:20, Dr. McDuff testified that he
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`reviewed Dr. Meyer’s cross-examination but not her direct examination; he also
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`testified that he reviewed Dr. Hofmann’s expert report but not Dr. Meyer’s expert
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`report. This testimony is relevant to statements and conclusions in Dr. McDuff’s
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`declaration and Petitioners’ Reply brief regarding commercial success (Exs. 1060,
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`1060A; Reply at 24-27), specifically, to the weight and understanding to be given
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`to his statements and conclusions because it raises concerns that he selectively
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`considered information on the issue of commercial success.
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`1
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`Observation #3 - In Ex. 2220 at 53:3-54:7, Dr. McDuff testified that he has
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`never testified that a branded pharmaceutical product is commercially successful.
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`This testimony is relevant to statements and conclusions in Dr. McDuff’s
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`declaration and Petitioners’ Reply brief regarding commercial success (Exs. 1060,
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`1060A; Reply at 24-27), specifically, to the weight and understanding to be given
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`to his statements and conclusions because it raises concerns regarding his
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`impartiality and credibility.
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`Observation #4 - In Ex. 2220 at 161:1-2 and 161:18-162:3, Dr. McDuff
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`testified that he obtained his Ph.D. in 2009 and has never authored any publications
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`of the issue of commercial success or presented on the issue of commercial success
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`in any of his speaking engagements. This testimony is relevant to statements and
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`conclusions in Dr. McDuff’s declaration and Petitioners’ Reply brief regarding
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`commercial success (Exs. 1060, 1060A; Reply at 24-27), specifically, to the weight
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`and understanding to be given to his statements and conclusions because it raises
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`concerns regarding his credibility and the level of his expertise on the issue of
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`commercial success.
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`Observation #5 - In Ex. 2220 at 52:4-13 and 69:4-14, Dr. McDuff testified
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`that he understood that the patent owner has the burden of proof on commercial
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`success. This testimony is relevant to statements and conclusions in Dr. McDuff’s
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`declaration and Petitioners’ Reply brief regarding commercial success (Exs. 1060,
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`2
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`1060A; Reply at 24-27), specifically, to the weight and understanding to be given
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`to his statements and conclusions because it raises concerns that he applied the
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`wrong burdens of proof in his opinions.
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`Observation #6 - In Ex. 2220 at 47:24-50:25, Dr. McDuff testified that he
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`understood that commercial success must be attributed to the novel parts of the
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`invention and not to factors unrelated or already known. In Ex. 2220 at 117:24-
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`118:5, Dr. McDuff also testified that saxagliptin’s status as the first-invented,
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`FDA-approved DPP-4 inhibitor was not a primary consideration. This testimony is
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`relevant to statements and conclusions in Dr. McDuff’s declaration and Petitioners’
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`Reply brief regarding commercial success (Exs. 1060, 1060A ¶¶ 29-34; Reply at
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`26), specifically, because it raises concerns that his assertions that Onglyza and
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`Kombiglyze are not particularly differentiated or unique products does not take
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`into account saxagliptin’s status as the first-invented, FDA-approved DPP-4
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`inhibitor.
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`Observation #7 - In Ex. 2220 at 21:6-13, 22:17-25:25, 28:6-31:15, and
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`35:16-36:5, Dr. McDuff testified that he did not dispute any of the calculations in
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`Tables 2(a), 3, 4, 5, 6(a), 6(b), 7, and 8 of Dr. Meyer’s declaration (Ex. 2059,
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`2059A). This testimony is relevant to statements and conclusions in Dr. McDuff’s
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`declaration and Petitioners’ Reply brief regarding commercial success (Exs. 1060,
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`3
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`1060A; Reply at 24-27), specifically, because it establishes that he does not dispute
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`any of the data on which Dr. Meyer bases her opinions.
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`Observation #8 - In Ex. 2220 at 62:2-66:14, Dr. McDuff testified that it did
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`not make sense to him to characterize $2.5 billion in net revenue as substantial
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`without drawing any comparisons. In Ex. 2220 at 69:15:70:14, Dr. McDuff also
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`testified that he did not seek to provide a “complete guidance or set of opinions on
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`what one could compare saxagliptin revenues to.” This testimony is relevant to
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`statements and conclusions in Dr. McDuff’s declaration and Petitioners’ Reply
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`brief regarding commercial success (Exs. 1060, 1060A; Reply at 24-27),
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`specifically, because it raises concerns that he has not offered an opinion on what
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`is the relevant market in his opinions on commercial success.
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`Observation #9 - In Ex. 2220 at 42:15-17, Dr. McDuff testified that he was
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`not providing opinions in rebuttal to Dr. Lenhard’s declaration. This testimony is
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`relevant to statements and conclusions in Dr. McDuff’s declaration regarding Dr.
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`Lenhard’s opinion that vildagliptin is a failure because it was not approved by the
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`FDA and is approved in Europe with a twice-daily dosing regimen and significant
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`safety precautions due to liver toxicity (Exs. 1060, 1060A ¶ 18), specifically, to the
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`weight and understanding to be given to his statements and conclusions because it
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`establishes that his opinions on the issue of commercial success do not address Dr.
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`Lenhard’s opinions on the issue of failures of others.
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`4
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`Observation #10 - In Ex. 2220 at 75:20-76:2, Dr. McDuff testified that he
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`did not study the relative efforts of AstraZeneca and Novartis to promote and
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`market saxagliptin-containing products and vildagliptin-containing products
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`outside of the United States. This testimony is relevant to statements and
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`conclusions in Dr. McDuff’s declaration and Petitioners’ Reply brief regarding
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`vildagliptin-containing products having more worldwide annual and cumulative
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`sales than saxagliptin-containing products (Exs. 1060, 1060A ¶ 18; Reply at 25),
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`specifically, to the weight and understanding to be given to his statements and
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`conclusions because it establishes that he has not considered Novartis’s efforts to
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`promote and market vildagliptin-containing products in his opinions on
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`commercial success.
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`Observation #11 - In Ex. 2220 at 82:5-83:25 and 112:7-15, Dr. McDuff
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`testified that Merck’s Januvia had a first-mover advantage that “tended to be
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`stronger” and was “impactful.” This testimony is relevant to statements and
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`conclusions in Dr. Meyer’s declaration regarding Onglyza’s ability to garner and
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`maintain a substantial market share in a marketplace with a product with a
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`substantial first-mover advantage (Ex. 2059, 2059A ¶¶ 42-43), specifically,
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`because it provides context for analyzing the Onglyza family’s ability to reach a
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`market share of almost 20 percent of monthly total dispensed prescriptions.
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`5
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`Observation #12 - In Ex. 2220 at 91:20-92:10 and 95:15-96:6, Dr. McDuff
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`testified that he did not have any data that would allow for a calculation of the cost
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`of commercializing Onglyza and Kombiglyze. This testimony is relevant to
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`statements and conclusions in Dr. McDuff’s declaration regarding the “expected
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`cost of commercializing Onglyza and Kombiglyze” (Exs. 1060, 1060A ¶¶ 23-24),
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`specifically, to the weight and understanding to be given to his statements and
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`conclusions because it raises concerns regarding the bases for his proposed
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`“expected cost of commercializing Onglyza and Kombiglyze.”
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`Observation #13 - In Ex. 2220 at 100:4-14, Dr. McDuff testified that as
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`compared to how much AstraZeneca spent promoting the Onglyza family products,
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`Merck spent approximately twice as much promoting the Januvia family products.
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`This testimony is relevant to statements and conclusions in Dr. McDuff’s
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`declaration and Petitioners’ Reply brief regarding sales of the Januvia family of
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`products (Exs. 1060, 1060A ¶¶ 18, 30, 32; Reply at 25-26), specifically, because it
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`provides context for analyzing the Onglyza family’s sales and market share.
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`Observation #14 - In Ex. 2220 at 125:8-12 and 127:25-128:22, Dr. McDuff
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`testified that he did not consider whether the increased risk of hospitalization for
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`heart failure was published prior to the 2016 FDA warning but that prior
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`publication of the increased risk of hospitalization for heart failure would lessen
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`the impact of the 2016 FDA warning. This testimony is relevant to statements and
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`6
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`conclusions in Dr. McDuff’s declaration regarding the “likely decline” in sales of
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`Onglyza and Kombiglyze (Exs. 1060, 1060A ¶¶ 35-37), specifically, to the weight
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`and understanding to be given to his statements and conclusions because it
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`establishes that his opinions regarding the “likely decline” in sales of Onglyza and
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`Kombiglyze did not take into account the prior publication of the increased risk of
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`hospitalization for heart failure.
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`Observation #15 - In Ex. 2220 at 132:14-135:5 and 134:8-16, Dr. McDuff
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`testified that he did not know the net sales adjustments or managed market rebates
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`for vildagliptin specifically. In Ex. 2220 at 136:14-137:7, Dr. McDuff also
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`testified that he did not know what percentage of Novartis’s net sales were from
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`vildagliptin. In Ex. 2220 at 136:14-137:7, Dr. McDuff further testified that net
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`sales adjustments vary across pharmaceutical companies, therapeutic areas, and
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`even within the same therapeutic class. This testimony is relevant to statements
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`and conclusions in Dr. McDuff’s declaration and Petitioners’ Reply brief regarding
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`the net sales adjustments and managed market rebates for Onglyza and
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`Kombiglyze as compared to the net sales adjustments and managed market rebates
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`for Novartis’s “pharmaceutical products.” Exs. 1060, 1060A ¶¶ 41-43; Reply at
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`24-25. Specifically, this testimony is relevant to the weight and understanding to
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`be given to Dr. McDuff’s statements and conclusions because it raises concerns
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`regarding the appropriateness and relevance of his comparison of the net sales
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`7
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`adjustments and managed market rebates for Onglyza and Kombiglyze to
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`Novartis’s “pharmaceutical products.”
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`Observation #16 - In Ex. 2220 at 145:14-146:7, Dr. McDuff testified that it
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`may be possible that the rebate for Januvia may have been higher than the rebate
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`for Onglyza. This testimony is relevant to statements and conclusions in Dr.
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`McDuff’s declaration and Petitioners’ Reply brief regarding the net sales
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`adjustments and managed market rebates for Onglyza and Kombiglyze (Exs. 1060,
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`1060A ¶¶ 41-43; Reply at 24-25), specifically, because it provides context for
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`analyzing how comparable the net sales adjustments and managed market rebates
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`for Onglyza and Kombiglyze are to those for other DPP-4 inhibitors.
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`Observation #17 - In Ex. 2220 at 151:2-11, Dr. McDuff testified that from
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`2011 through 2015, promotional expenditures for the Onglyza family totaled
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`approximately $398 million whereas promotional expenditures for the Tradjenta
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`family totaled approximately $460 million. In Ex. 2220 at 151:12-21, Dr. McDuff
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`also testified that from 2011 through 2015, the Onglyza family garnered 15.5% of
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`prescription shares whereas the Tradjenta family garnered 7.4% of prescription
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`shares. This testimony is relevant to statements and conclusions in Dr. McDuff’s
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`declaration and Petitioners’ Reply brief regarding the performance of the Tradjenta
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`family (Exs. 1060, 1060A ¶ 31; Reply at 26-27), specifically, to whether the
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`Onglyza family has underperformed relative to the Tradjenta family.
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`8
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`Respectfully submitted,
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`Dated: December 12, 2016
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`By: /Anthony A. Hartmann/
`Anthony A. Hartmann, Reg. No. 43,662
`Finnegan, Henderson, Farabow,
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`Garrett & Dunner, L.L.P.
`901 New York Avenue, NW
`Washington DC 20001
`Counsel for Patent Owner
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`9
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that copies of the foregoing PATENT OWNER’S
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`MOTION FOR OBSERVATIONS REGARDING THE CROSS-
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`EXAMINATION OF DEFOREST MCDUFF was served electronically via e-
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`mail on December 12, 2016, in its entirety to the following:
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`Counsel for Petitioner Mylan Pharmaceuticals Inc.:
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`Steven W. Parmelee
`sparmelee@wsgr.com
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`Richard Torczon
`rtorczon@wsgr.com
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`Jad A. Mills
`jmills@wsgr.com
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`Douglas H. Carsten
`dcarsten@wsgr.com
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`Counsel for Petitioner Wockhardt BIO AG.:
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`Patrick Gallagher
`PCGallagher@duanemorris.com
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`Gary Speier
`gspeier@carlsoncaspers.com
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`Iain McIntyre
`imcintyre@carlsoncaspers.com
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`Counsel for Petitioner Teva Pharmaceuticals U.S.A., Inc..:
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`Counsel for Petitioner Aurobindo Pharma U.S.A., Inc..:
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`Sailesh K. Patel
`SPatel@schiffhardin.com
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`George Yu
`GYu@schiffhardin.com
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`Samuel Park
`SPark@winston.com
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`Andrew Sommer
`ASommer@winston.com
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`By: /Lauren K. Young/
`Lauren K. Young
`Litigation Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
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`11
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`Dated: December 12, 2016
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`Counsel for Petitioners Sun/Amneal:
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