IPR2017-01446
`U.S. Patent No. 7,049,328
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioners,
`
`v.
`
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`________________
`
`Case IPR2017-01446
`U.S. Patent No. 7,049,328
`
`Title: USE FOR DEFERIPRONE
`________________
`
`
`PATENT OWNER’S OBSERVATIONS ON THE CROSS EXAMINATION
`OF DR. JAYESH MEHTA
`
`LEGAL\36966684\1
`
`
`U.S. Patent No. 7,049,328
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioners,
`
`v.
`
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`________________
`
`Case IPR2017-01446
`U.S. Patent No. 7,049,328
`
`Title: USE FOR DEFERIPRONE
`________________
`
`
`PATENT OWNER’S OBSERVATIONS ON THE CROSS EXAMINATION
`OF DR. JAYESH MEHTA
`
`LEGAL\36966684\1
`
`
`
`Pursuant to the Scheduling Order (Paper 8), Patent Owner Apotex
`
`IPR2017-01446
`U.S. Patent No. 7,049,328
`
`
`Technologies, Inc. (“Apotex”) submits the following observations on cross-
`
`examination of Dr. Jayesh Mehta.
`
`I.
`
`Inherent Anticipation
`
`1.
`
`In Exhibit 2040, at 18:6-17 and 20:2-16, Dr. Mehta testified that
`
`practicing the prior art methods of dosing deferiprone to blood transfusion-
`
`dependent patients will not achieve the claimed results of the ’328 patent in every
`
`single patient and that a possibility or probability of something happening would
`
`meet the standard for inherent anticipation. This testimony is relevant to Dr.
`
`Mehta’s opinions in paragraphs 20, 67, 74, 75, and 77 of his Declaration (Ex.
`
`1002) and paragraphs 35 and 41 of his Reply Declaration (Ex. 1060) that “prior art
`
`may still anticipate if that element is ‘inherent’ in its disclosure, that is, if it is
`
`necessarily found in the prior art” (Ex. 1002 at ¶ 20), and that the administration of
`
`75 mg/kg/day of deferiprone in Hoffbrand 1998, Olivieri Abstract 1995, and
`
`Olivieri 1995 inherently anticipates the claims of the ’328 patent. The testimony is
`
`relevant because Dr. Mehta uses an improper legal standard for inherent
`
`anticipation to conduct his analysis of the prior art. The testimony is also
`
`inconsistent with Dr. Mehta’s opinions that the administration of 75 mg/kg/day of
`
`deferiprone in the prior art inherently anticipates the claims of the ’328 patent.
`
`2.
`
`In Exhibit 2040, at 8:1 – 9:4, 10:8 – 12:7, and 24:24 – 27:7, Dr. Mehta
`
`1
`
`
`
`testified that the claims of the ’328 patent require a therapeutically effective
`
`amount to achieve a specific outcome in individual patients, that the ability of
`
`deferiprone to bind iron and remove it from the body depends on the dose, and that
`
`75 mg/kg/day will not bind and reduce cardiac iron in each and every patient at
`
`that dose. This testimony is relevant to Dr. Mehta’s opinions in paragraphs 37, 61,
`
`66, 67, 74, 75, and 77 of his Declaration (Ex. 1002) and paragraphs 15, 20, 27, 38,
`
`and 41 of his Reply Declaration (Ex. 1060) that “clinical experience has shown
`
`that treatment with 75/mg/kg/day of deferiprone is effective at maintaining a non-
`
`toxic level of iron in the blood of transfusion-dependent patients, thereby treating
`
`iron overload.” (Ex. 1002 at ¶ 37.) This testimony is relevant because it is
`
`inconsistent with Dr. Mehta’s opinions that the administration of 75 mg/kg/day of
`
`deferiprone in the prior art inherently anticipates the claims of the ’328 patent.
`
`II. Claim Construction
`
`3.
`
`In Exhibit 2040, at 8:1 – 9:4, 10:8 – 12:7, and 16:16 –18:4, Dr. Mehta
`
`testified that, under the district court’s claim construction, the “sufficient to”
`
`clauses in the claims of the ’328 patent and the like define the therapeutically
`
`effective dose in the claims. This testimony is relevant because it is inconsistent
`
`with Dr. Mehta’s opinions in paragraphs 55, 56, 66 and 71 of his Declaration (Ex.
`
`1002) and paragraph 18 of his Reply Declaration (Ex. 1060) that the “sufficient to”
`
`language in the claims of the ’328 patent “adds nothing to the claimed method”
`
`
`
`2
`
`
`
`and does not require a person attempting to practice the claims to, for example,
`
`change the dose administered to the patient being treated. This testimony is also
`
`relevant because it is inconsistent with Dr. Mehta’s opinions that the “sufficient to”
`
`language in the claims of the ’328 patent is “not limiting because the method is
`
`performed in the identical manner of whether the particular results are achieved.”
`
`(Ex. 1002 at ¶ 66.)
`
`4.
`
`In Exhibit 2040, at 24:24 – 27:7, Dr. Mehta testified that physicians
`
`would adjust a chelation regimen based on an individual patient’s response to
`
`treatment, and that a physician attempting to practice the claims of the ’328 patent
`
`would look at the results achieved in an individual patient in order to know if the
`
`claimed methods were successfully practiced. This testimony is relevant because it
`
`is inconsistent with Dr. Mehta’s opinion that “the term ‘therapeutically effective
`
`amount’ must be understood to mean an amount that is in general successful, even
`
`if not successful in each and every patient treated.” (Ex. 1060 at ¶ 15.) This
`
`testimony is also relevant because it also is inconsistent with Dr. Mehta’s opinions
`
`that the “sufficient to” language in the claims of the ’328 patent is “not limiting
`
`because the method is performed in the identical manner of whether the particular
`
`results are achieved.” (Ex. 1002 at ¶ 66.)
`
`III. MRI T2 Relaxation Time (“TRT”)
`
`5.
`
`In Exhibit 2040, at 40:15 – 46:5 and 49:16 – 55:3, Dr. Mehta
`
`
`
`3
`
`
`
`confirmed that Liu et al. (Ex. 1062) disclosed that serum ferritin does not
`
`accurately reflect the differential iron storage between the organs in the body, that
`
`in the 1994-1996 timeframe, the authors were still evaluating the usefulness of
`
`MRI TRT measurements of tissue iron, and that there were caveats to MRI TRT
`
`that required independent validation of the process in humans before wide
`
`application. This testimony is relevant because it is inconsistent with Dr. Mehta’s
`
`opinions in paragraph 26 of his Reply Declaration (Ex. 1060) that the “prior art
`
`shows that clinicians in the field of iron overload treatment recognized that cardiac
`
`MRI TRT was a reliable measure of heart iron concentration.”
`
`IV. The Clinical Study Described in the ’328 Patent
`
`6.
`
`In Exhibit 2040, at 6:6 – 7:25, Dr. Mehta testified that the study
`
`described in column 14, line 43 through column 26, line 5 of the ’328 patent was a
`
`retrospective study and thus it was not possible to adjust the deferiprone dose in
`
`such a study. This testimony is relevant to Dr. Mehta’s opinions in paragraph 15
`
`of his Reply Declaration (Ex. 1060) because it explains why the inventors did not
`
`adjust the dose of deferiprone in the study described in column 14, line 43 through
`
`column 26, line 5 of the ’328 patent.
`
`V. Anticipation by Hoffbrand 1998
`
`7.
`
`In Exhibit 2040, at 35:7-13, Dr. Mehta testified that Hoffbrand and his
`
`coauthors determined that for the 5 patients that died of cardiac disease, treatment
`
`
`
`4
`
`
`
`with deferoxamine would have been better than deferiprone. This testimony is
`
`relevant to Dr. Mehta’s opinions in paragraphs 37-41 of his Reply Declaration (Ex.
`
`1060) that the patients described in Hoffbrand 1998 that died of cardiac disease
`
`were successfully treated with deferiprone. This testimony is relevant because
`
`Hoffbrand and coauthors determined that treatment with deferiprone is an
`
`inappropriate therapy for patients with iron-induced cardiomyopathy. (Ex. 1007
`
`at 5.)
`
`Date: June 28, 2018
`
` Respectfully submitted,
`
` By: /s/ W. Blake Coblentz
`W. Blake Coblentz
`Reg. No. 57,104
`COZEN O’CONNOR
`1200 Nineteenth Street, N.W.
`Washington, D.C. 20036
`(202) 912-4837
`
`5
`
`
`
`IPR2017-01446
`U.S. Patent No. 7,049,328
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on June 28, 2018, I caused a true and correct copy of
`
`Patent Owner’s Observations on the Cross-Examination of Dr. Jayesh Mehta
`
`to be served via electronic mail on the following attorneys of record:
`
`Huiya Wu
`Sarah Fink
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`HWu@goodwin.law.com
`SFink@goodwinlaw.com
`
`Date: June 28, 2018
`
`/s/ W. Blake Coblentz
`W. Blake Coblentz
`Reg. No. 57,104
`COZEN O’CONNOR
`1200 Nineteenth Street, N.W.
`Washington, DC 20036
`(202) 912-4837
`
`
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