UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Taro Pharmaceuticals U.S.A., Inc.
`Petitioner,
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`v.
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`Apotex Technologies, Inc.
`Patent Owner
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`Case No.: IPR2017-01446
`Patent No. 7,049,328
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S OBSERVATIONS
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Taro Pharmaceuticals U.S.A., Inc.
`Petitioner,
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`v.
`
`Apotex Technologies, Inc.
`Patent Owner
`
`
`Case No.: IPR2017-01446
`Patent No. 7,049,328
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`PETITIONER’S OPPOSITION TO PATENT OWNER’S OBSERVATIONS
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`Response to Observation 1:
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`In his Reply Declaration (Ex. 1060), Dr. Mehta opined on the inherent
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`anticipation of claims 6-101: for patients in Olivieri 1995 and Hoffbrand 1998 who
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`were successfully treated (i.e., their results showed a decrease in cardiac iron), this
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`meant that “to the extent that deferiprone preferentially chelated cardiac iron in the
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`claimed population as of the filing date of the patent, deferiprone administered to
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`the claimed population resulted in preferential chelation as of the publication date
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`of [the prior art].” (Ex. 1060 at ¶ 35; see also id. at ¶ 41.)
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`On page 18 of his second deposition (Exhibit 2040), Dr. Mehta provided his
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`opinion that the “intended results” “will occur in some patients, and [] will not
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`occur in other patients.” (Ex. 2040 at 18:15-17.) Dr. Mehta explained that it
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`would be unrealistic to believe that every patient responds the same way to
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`treatment, “just like give you give antibiotics for pneumonia, and not every single
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`patient always responds.” (Id. at 19:4-6.) This testimony is not inconsistent with
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`Dr. Mehta’s opinions expressed in his Reply Declaration where Dr. Mehta focused
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`on successfully treated patients, and opined on the behavior of deferiprone in the
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`bodies of those successfully treated patients.
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`1 Patent Owner states that Dr. Mehta opined that “the prior art inherently
`anticipates the claims of the ’328 patent.” To be clear, Dr. Mehta offered opinions
`on inherent anticipation only with respect to claims 6-10 of the ’328 patent. He
`opined that claims 1, 2, 4, and 5 are expressly anticipated by the prior art.
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`On page 20 of Exhibit 2040, Dr. Mehta testified about the standard for
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`inherent anticipation. He also expressed the standard for inherent anticipation in
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`his First Declaration (see Ex. 1002 at ¶ 20), and he used this standard in forming
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`his opinions in this matter. Dr. Mehta’s testimony about probabilities and
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`possibilities is not inconsistent with his opinions expressed in his Reply
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`Declaration, which focused on successfully treated patients.
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`Response to Observation 2:
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`Dr. Mehta did not testify that the “claims of the ’328 patent require a
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`therapeutically effective amount to achieve a specific outcome in individual
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`patients,” as asserted by Patent Owner in Observation 2. Patent Owner takes Dr.
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`Mehta’s testimony at 8:1-9:4 and 10:8-12:7 out of context: Dr. Mehta agreed that
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`he had provided certain testimony in a different deposition, for the parallel district
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`court litigation, where a different claim construction standard applies, and where
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`the district court entered a different claim construction than that adopted by the
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`Board in this proceeding.2
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`Even under the different claim interpretation, Dr. Mehta never testified that
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`the claims “require” an effect in “individual patients.” (See Ex. 2040 at 8:1-9:4
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`and 10:8-12:7.) Dr. Mehta similarly did not testify in the other cited portion of his
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`2 Patent Owner has admitted that statements regarding the claim construction
`adopted by the district court “have no probative value should the PTAB maintain
`its preliminary construction adopted in instituting these proceedings.” (Paper 44 at
`6.)
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`2
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`testimony (id. at 24:24-27:7) that the claims “require a therapeutically effective
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`amount to achieve a specific outcome in individual patients.” He testified that
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`when treating patients, physicians tweak individual patient’s treatments, depending
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`on how the individual’s disease behaves (id. at 25:12-23), and that physicians
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`always look at results in individual patients (id. at 27:2-3).
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`Dr. Mehta’s deposition testimony about whether deferiprone works in “each
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`and every patient” is not inconsistent with the opinions in his declaration, in which
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`he focused on individual patients who were successfully treated with a
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`therapeutically effective dose of 75 mg/kg/day of deferiprone, and whose cardiac
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`iron was preferentially chelated (to the extent that is how deferiprone works in the
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`body of a successfully treated patient). (Ex. 1060 at ¶¶ 22-23, 30-31, 34, 38-40.)
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`Response to Observation 3:
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`In the referenced testimony at 8:1-9:4, 10:8-12:7, and 16:16-18:4, Dr. Mehta
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`confirmed his testimony—taken at a different deposition, for the parallel district
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`court litigation, where a different claim construction standard applies, and where
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`the district court entered a different claim construction than that adopted by the
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`Board in this proceeding—that the intended results define the therapeutically
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`effective dose of the claims. Dr. Mehta’s opinions here that the intended results
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`clauses of the claims are not limiting, however, are consistent with the Board’s
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`claim construction, the Board’s rejection of Patent Owner’s proposed construction
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`3
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`in the Institution Decision (see Paper 7 at 6-9), and the Board’s finding that 75
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`mg/kg/day of deferiprone “necessarily constitutes a value that is a ‘therapeutically
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`effective amount’ as recited in claims 1, 2, and 4-10.” (Id. at 7.)
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`The testimony cited by Patent Owner is not relevant to claim construction in
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`this proceeding as it does not reflect the “broadest reasonable construction” in light
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`of the specification which determines the proper claim construction in an IPR.
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`(See 37 C.F.R. § 42.100(b) (“A claim in an unexpired patent that will not expire
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`before a final written decision is issued shall be given its broadest reasonable
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`construction in light of the specification of the patent in which it appears.”).)
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`Response to Observation 4:
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`Patent Owner’s observation does not reflect Dr. Mehta’s testimony. In the
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`first part of the testimony cited by Patent Owner, Dr. Mehta testifies on the
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`unremarkable proposition that doctors treat individual patients. (Ex. 2040 at
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`24:24-25:23.) In the second part of the cited testimony, Dr. Mehta answers Patent
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`Owner’s counsel’s question about a physician “trying to understand if they were
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`successfully practicing the claim[ed] method” of claim 1. In other words, Dr.
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`Mehta was asked to assume that claim 1 requires “successfully practicing” the
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`method, which is not consistent with the Board’s claim construction. For the same
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`reasons as discussed above in the Response to Observation 3, the testimony cited
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`4
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`by Patent Owner does not reflect the broadest reasonable construction and is not
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`relevant to claim construction here.
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`This cited testimony is also not inconsistent with Dr. Mehta’s opinions on
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`the term “therapeutically effective amount” and the “sufficient to” language in the
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`claims. Indeed, Dr. Mehta opined on individual patients who were successfully
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`treated with a therapeutically effective dose of 75 mg/kg/day of deferiprone. (Ex.
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`1060 at ¶¶ 22-23, 30-31, 34, 38-40.)
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`Response to Observation 5:
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`Patent Owner selectively quoted from Dr. Mehta’s testimony in this section.
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`Dr. Mehta explained in his Reply Declaration that Liu 1996 taught the “well
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`defined relationship” between cardiac MRI TRT and cardiac iron concentration.
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`(Ex. 1060 at ¶ 26.) During his deposition, Dr. Mehta confirmed that, despite
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`“caveats” attendant to the use of MRI TRT, Liu 1996 states that it “is the first
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`demonstration of a well defined relationship between NMR observable T2
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`relaxation time and tissue iron content in multiple organs.” (Ex. 2040 at 52:18-24.)
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`Dr. Mehta explained that caveats are common to scientific papers: “I think one
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`should remember that the way this is worded is the way any responsible and
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`reasonable scientist would word a paper… none of what is mentioned here negates
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`any of the findings in any way.” (Id. at 54:14-55:2.) This testimony is thus not
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`inconsistent with Dr. Mehta’s opinion in paragraph 26 of his Reply Declaration.
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`5
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`Response to Observation 6:
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`The testimony cited by Patent Owner regarding why there was no dose
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`adjustment in the ’328 patent study is not relevant to claim construction,
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`anticipation, or obviousness. In his Reply Declaration, Dr. Mehta commented on
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`the lack of dose adjustment in the ’328 patent to demonstrate that successful
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`practice and dosage adjustments are not necessary elements of the challenged
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`claims, as construed by the Board. (Ex. 1060 at ¶ 15.) The reason behind why
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`there was no dose adjustment is not relevant. To the extent it is relevant, Dr.
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`Mehta also testified that dose adjustments were known, and were also used with
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`the first-generation iron chelator, deferoxamine. (Ex. 2040 at 7:14-24.)
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`Response to Observation 7:
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`Patent Owner misrepresented both Dr. Mehta’s testimony and the conclusion
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`reached in Hoffbrand 1998. Dr. Mehta testified that Hoffbrand and his coauthors
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`suggested that deferoxamine would be better for certain patients than deferiprone
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`“because of the severity of the cardiac disease.” (Ex. 2040 at 35:12-13.)
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`Hoffbrand and coauthors did not “determine that treatment with deferiprone is an
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`inappropriate therapy for patients with iron-induced cardiomyopathy,” as Patent
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`Owner asserts. (Observations at 5.) Hoffbrand and coauthors stated that their
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`“findings imply that deferiprone is inappropriate therapy for patients with iron-
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`induced cardiomyopathy in whom continuous intravenous DFX is needed to cause
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`6
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`continuous removal of toxic, nontransferrin-bound iron from plasma.” (Ex. 1007
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`at 299 (emphasis added).)
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`Dr. Mehta’s opinion that these patients were successfully treated with
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`deferiprone “for some time” is not implicated by the later condition of these
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`patients. (Ex. 1060 at ¶¶ 38-40.) Dr. Mehta testified as much with respect to
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`Hoffbrand’s patients treated with deferiprone: “And in the interim period the
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`ferritin remained the same, the heart function remained the same. And to me that
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`is implication that the drug was successful to the extent that it kept the situation
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`stable despite ongoing overload with transfusions.” (Ex. 2040 at 32:24-33:4; see
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`also id. at 28:5-31:12.)
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`Dated: July 12, 2018
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`Respectfully submitted,
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`/Huiya Wu/
`Huiya Wu (Reg. No. 44,411)
`Sarah Fink (Reg. No. 64,886)
`GOODWIN PROCTER LLP
`620 Eighth Avenue
`New York, NY 10018
`Phone: (212) 813-8800
`Fax: (212) 355-3333
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`Counsel for Petitioner
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`7
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 12th day of July, 2018, I
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`caused to be served a true and correct copy of the foregoing “PETITIONER’S
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`OPPOSITION TO PATENT OWNER’S OBSERVATIONS” via electronic mail
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`on the following attorneys of record:
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`W. Blake Coblentz
`Aaron S. Lukas
`Barry Golob
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`Email:
`wcoblentz@cozen.com
`alukas@cozen.com
`bgolob@cozen.com
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`By: /Sarah Fink/
` Sarah Fink
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