Paper 15
`Trials@uspto.gov
`Entered: January 11, 2018
`Tel: 571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioner,
`v.
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`
`Case IPR2017-01446
`Patent 7,049,328 B2
`
`
`Before LORA M. GREEN, JEFFREY N. FREDMAN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`FREDMAN, Administrative Patent Judge.
`
`
`
`
`DECISION
`Request for Rehearing
`37 C.F.R. § 42.71
`
`Patent Owner, Apotex Technologies, Inc., filed a request for rehearing
`
`(Paper 11, “Req.”) of the Decision on Institution (Paper 7, “Dec.”) instituting
`inter partes review of claims 1, 2, 4–17, and 19 of U.S. Patent No. 7,049,328
`B2 (Ex. 1001, “the ’328 patent”). In its request, Patent Owner contends the
`Decision misapprehended the law regarding inherency. Req. 2–13. The
`request for rehearing is denied.
`
`
`
`Trials@uspto.gov
`Entered: January 11, 2018
`Tel: 571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`TARO PHARMACEUTICALS U.S.A., INC.,
`Petitioner,
`v.
`APOTEX TECHNOLOGIES, INC.,
`Patent Owner.
`
`Case IPR2017-01446
`Patent 7,049,328 B2
`
`
`Before LORA M. GREEN, JEFFREY N. FREDMAN, and
`ZHENYU YANG, Administrative Patent Judges.
`
`FREDMAN, Administrative Patent Judge.
`
`
`
`
`DECISION
`Request for Rehearing
`37 C.F.R. § 42.71
`
`Patent Owner, Apotex Technologies, Inc., filed a request for rehearing
`
`(Paper 11, “Req.”) of the Decision on Institution (Paper 7, “Dec.”) instituting
`inter partes review of claims 1, 2, 4–17, and 19 of U.S. Patent No. 7,049,328
`B2 (Ex. 1001, “the ’328 patent”). In its request, Patent Owner contends the
`Decision misapprehended the law regarding inherency. Req. 2–13. The
`request for rehearing is denied.
`
`
`
`
`IPR2017-01446
`Patent 7,049,328 B2
`
`
`ANALYSIS
`When rehearing a decision on institution, the Board will review the
`decision for an abuse of discretion. 37 C.F.R. § 42.71(c). The applicable
`standard for a request for rehearing is set forth in 37 C.F.R. § 42.71(d),
`which provides in relevant part:
`A party dissatisfied with a decision may file a request for
`rehearing, without prior authorization from the Board. The
`burden of showing a decision should be modified lies with the
`party challenging the decision. The request must specifically
`identify all matters the party believes the Board
`misapprehended or overlooked, and the place where each
`matter was previously addressed in a motion, an opposition, or
`a reply.
`
`Patent Owner “submits that the evidence of record fails to show that
`any of Hoffbrand 1998, Olivieri Abstract 1995, and Olivieri 1995
`‘unavoidably teaches’ the treatment of patients who have an iron overload
`condition of the heart or iron-induced cardiac disease.” Req. 2.
`Hoffbrand 1998
`Patent Owner specifically contends:
`Hoffbrand 1998 never discloses that any patient has an iron
`overload condition of the heart or iron-induced cardiac disease
`on the basis of liver iron content. Instead, Hoffbrand 1998
`states—as quoted by the Board—that the 10 patients had liver
`iron content “‘that has been associated with cardiac disease.’”
`
`Req. 4. Appellants contend “although the Federal Circuit has made clear
`that inherency cannot be established based on ‘probabilities or possibilities,’
`the Board based its conclusion on an ‘association’ between liver iron content
`and cardiac disease. An ‘association,’ however, does not meet the strict
`requirement of inevitability.” Id. at 5.
`
`2
`
`
`
`IPR2017-01446
`Patent 7,049,328 B2
`
`
`We agree with Patent Owner on the legal standard for inherency. As
`we acknowledged in our Decision, “[i]nherency . . . may not be established
`by probabilities or possibilities. The mere fact that a certain thing may result
`from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l.
`Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).” Dec. 14.
`However, we remain persuaded at this stage of the proceeding on the
`current factual record based on Hoffbrand 1998 and the Mehta Declaration,
`that Petitioner established a “reasonable likelihood” that Hoffbrand 1998
`necessarily disclosed treatment of patients with “an iron overload condition
`of the heart” with a therapeutically effective amount of deferiprone. See
`Dec. 16–20; 35 U.S.C. § 314(a).
`Patent Owner does not identify a definition of the phrase “iron
`overload condition of the heart” in the ’328 patent Specification that
`distinguishes the claimed patient population from Hoffbrand’s disclosure of
`“10 patients [that] had a liver iron content above 15.0 mg/g dry weight, ie,
`falling within the range that has been associated with cardiac disease.” Ex.
`1007, 297. The reasonable understanding of Hoffbrand’s teaching of this
`association between liver iron content and cardiac disease is that all ten
`patients with the elevated iron levels also necessarily fell into the spectrum
`of having “an iron overload condition of the heart.”
`Indeed, Patent Owner’s Declarants do not rebut Hoffbrand’s teaching
`that liver iron content above 15.0 mg/g identifies patients with cardiac
`disease, and, therefore, with “an iron overload condition of the heart.”
`Dr. Coates simply notes that Hoffbrand 1998 reports five treated “patients
`suffered fatal complications. . . . Four of the five reported fatalities resulted
`from congestive heart failure.” Ex. 2001 ¶ 37. Cf. Pennell Decl. Ex. 2003
`
`3
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`IPR2017-01446
`Patent 7,049,328 B2
`
`¶ 37. That statement supports the position that Hoffbrand 1998 treated
`patients who inherently had an ultimately fatal “iron overload condition of
`the heart” with 75 mg of deferiprone, acknowledged by claim 15 of the ’328
`patent as a therapeutically effective amount. Ex. 1007, 295; Ex. 1001,
`28:33–37.
`We recognize that Dr. Pennell stated that “a patient with a liver iron
`content above 15 mg/g dry weight is at risk of developing cardiac disease
`not that such liver iron content definitely establishes cardiac disease.”
`Ex. 2003 ¶¶ 50–51, citing Exhibits 2007, 2015, and 2016. The Exhibits
`cited by Dr. Pennell do not identify evidence showing a single patient with a
`liver iron content that exceeds 15.0 mg/g but failed to display an “iron
`overload condition of the heart.” See Ex. 2003 ¶ 51. Exhibit 2007 states
`“while whole liver iron levels >15 mg/g dry weight . . . have been shown to
`predict patients at highest risk of cardiac death, it is not known how these
`variables relate to cardiac iron deposition.” Ex. 2007, 1. No specific patient
`data is provided in Exhibit 2007 comparing liver iron levels of particular
`patients with “iron overload.” See id. Similarly, Exhibits 2015 and 2016
`also do not identify any patients with elevated liver iron content >15 mg/g
`dry weight with normal cardiac iron levels.
`Therefore, the evidence currently of record in Hoffbrand 1998,
`identifying ten patients as having liver iron levels associated with cardiac
`disease, provides factual support for finding a reasonable likelihood that
`these patients necessarily have an “iron overload condition of the heart.”
`See Ex. 1007, 297.
`
`4
`
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`IPR2017-01446
`Patent 7,049,328 B2
`
`
`Olivieri Abstract 1995
`Patent Owner contends “Olivieri Abstract 1995 never equates
`abnormal TRT values with ‘an iron overload condition of the heart’ or ‘iron-
`induced cardiac disease.’” Req. 6. Patent Owner contends:
`the Board nonetheless instituted trial on the basis of inherent
`anticipation thereby committing legal error in at least three
`respects. First, although the Federal Circuit has made clear that
`inherency cannot be established based on “probabilities or
`possibilities,” the Board improperly based its conclusion on the
`notion that abnormal TRT values indicate high cardiac iron,
`which in turn indicates cardiac disease.
`
`Id. at 7. Patent Owner contends: “Second, the Board committed legal error
`when it based its assumptions on unsubstantiated testimony from Dr.
`Mehta.” Id. at 8. Patent Owner contends “Dr. Mehta’s statement that ‘lower
`TRT values indicate cardiac disease due to iron overload.’ (see Ex. 1002 at
`¶ 75) is not based on any underlying fact or data, but instead is mere
`conjecture.” Id. at 8.
`Patent Owner contends also:
`Third, the Board appeared to improperly shift the burden of
`proof . . . The proper focus is not whether the Patent Owner,
`and its Declarants, provided evidence rebutting that Olivieri
`Abstract 1995 taught patients having an iron overload condition
`of the heart (which, to be clear Patent Owner did (see
`Preliminary Response at 43–44)), but whether Petitioner came
`forth with evidence sufficient to demonstrate this limitation was
`disclosed in Olivieri Abstract 1995.
`
`Req. 9.
`We address these arguments seriatim. Regarding the first argument,
`we found “Olivieri Abstract 1995 inherently anticipates even under a
`requirement ‘that the claimed method have been actually performed.’
`
`5
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`IPR2017-01446
`Patent 7,049,328 B2
`
`Montgomery, 677 F.3d at 1382, because deferiprone was administered in
`amounts claimed by the ’328 patent as ‘therapeutically effective’ to patients
`with evidence of iron overload of the heart. Ex. 1010.” Dec. 24.
`No specific degree of “iron overload” of the heart is required by the
`claims of the ’328 patent. Therefore, for purposes of institution, any excess
`amount of iron subject to treatment in order to reduce the iron levels is
`reasonably interpreted as a degree of “an iron overload condition of the
`heart.” As discussed in the Decision, the Olivieri Abstract 1995 determined
`that treatment with deferiprone reduced iron levels in patients with
`thalassemia major. See Dec. 22, citing Ex. 1010. Thus, because Olivieri
`Abstract 1995 is reasonably understood as demonstrating reduction in
`cardiac iron levels in patients being treated to reduce cardiac iron levels,
`Olivieri Abstract 1995 necessarily treats “an iron overload condition of the
`heart.”
`Regarding the second argument, Dr. Mehta relied upon specific facts
`within the Olivieri Abstract 1995 itself to support the conclusion that “lower
`TRT values indicate cardiac disease due to iron overload. Ex. 1010 (Olivieri
`Abstract 1995).” Ex. 1002 ¶ 75. In particular, Olivieri Abstract 1995 states
`“MRI demonstrates changes consistent with reduction in cardiac iron in L1
`[deferiprone]-treated pts, in who baseline T2 relaxation time (TRT of
`23.9±6.4 msec (normal >32) has increased to 32.4±9.3msec.” Ex. 1010.
`Olivieri Abstract 1995’s identification of the value of “32” as normal for
`TRT levels with lower values such as “23.9±6.4” as associated with elevated
`cardiac iron levels that require treatment with deferiprone, provides factual
`support for Dr. Mehta’s conclusion that patients with these lower TRT
`
`6
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`IPR2017-01446
`Patent 7,049,328 B2
`
`values inherently have “an iron overload condition of the heart.” See Ex.
`1002 ¶ 75.
`Regarding the third argument, we do not agree that we placed the
`burden of production on Patent Owner. As discussed in Dynamic Drinkware
`there are two distinct burdens of proof: a burden of persuasion
`and a burden of production. . . . the burden of persuasion is on
`the petitioner to prove “unpatentability by a preponderance of
`the evidence,” 35 U.S.C. § 316(e), and that burden never shifts
`to the patentee. . . . A second and distinct burden, the burden
`of production, or the burden of going forward with evidence, is
`a shifting burden, “the allocation of which depends on where
`in the process of trial the issue arises.” [citing Tech. Licensing
`Corp. v. Videotek, Inc. 545 F.3d 1316, 1326–27 (Fed. Cir.
`2008)].
`
`Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375, 1378–
`79 (Fed. Cir. 2015). In the instant case, our Decision to Institute found
`Petitioner has satisfied both the burden of production to show that Olivieri
`Abstract 1995 is anticipating prior art and a reasonable likelihood to satisfy
`Petitioner’s burden of proof at institution to demonstrate that Olivieri
`Abstract 1995, as supported by the Mehta Declaration, supports a reasonable
`likelihood of claim invalidity.
`As the Decision notes, we found that the evidence presented by
`Petitioner provided a reasonable likelihood of anticipation by the Olivieri
`Abstract 1995. See Dec. 24. We then addressed whether Patent Owner had
`provided evidence, that when considered with Petitioner’s evidence, was
`sufficient to conclude that Olivieri Abstract 1995 did not anticipate the
`claims. We found that Patent Owner’s experts provided no particularized
`facts demonstrating that the evidence regarding the specific treatment of
`specific patients with 75 mg of deferiprone that result in reduction of cardiac
`
`7
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`IPR2017-01446
`Patent 7,049,328 B2
`
`iron levels in the Olivieri Abstract 1995 was incorrect. See Dec. 24.
`“[T]estimonial evidence will be viewed in the light most favorable to the
`petitioner solely for purposes of deciding whether to institute an inter partes
`review.” 37 C.F.R. § 42.108(c).
`Therefore, the evidence currently of record in Olivieri Abstract 1995,
`identifying thalassemia major patients as having TRT levels associated with
`increased cardiac iron levels who were treated with 75 mg of deferiprone
`resulting in normal TRT levels, provides support for concluding that
`Petitioner had established a reasonable likelihood that these patients
`necessarily have an “iron overload condition of the heart.” See Ex. 1010.
`
`Olivieri 1995
`
`Patent Owner contends
`Olivieri 1995 merely discloses the treatment of ten patients who
`had hepatic iron stores at levels “associated with an increased
`risk” of cardiac disease, but Olivieri 1995 never characterized
`any patient as actually having “an iron overload condition of the
`heart” or “iron-induced cardiac disease,” a disclosure that
`neither Petitioner nor Dr. Mehta relied upon in alleging inherent
`anticipation. The Board nonetheless instituted trial based on
`inherent anticipation, and in doing so committed legal error.
`Patients having an increased risk of cardiac disease does not
`and cannot establish the required inevitability that the patients
`in Olivieri 1995 had cardiac disease.
`
`Req. 11.
`We remain unpersuaded by these arguments for the reasons given in
`the Decision. See Dec. 30–31. In particular, Patent Owner does not identify
`a definition of the phrase “iron overload condition of the heart” in the ’328
`patent Specification that distinguishes the claimed patient population from
`Olivieri 1995’s disclosure of “10 patients in whom deferoxamine had failed
`
`8
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`
`
`IPR2017-01446
`Patent 7,049,328 B2
`
`to reduce hepatic iron stores to a level below 80 μmol of iron per gram
`(levels associated with an increased risk of cardiac disease and early death).”
`Ex. 1012, 921. The reasonable understanding of Olivieri 1995’s teaching of
`this association between hepatic iron stores and cardiac disease is that all ten
`patients with the elevated iron levels also necessarily fell into the spectrum
`of having “an iron overload condition of the heart.” See Dec. 31.
`Obviousness
`Patent Owner contends: “For the same reasons as discussed above, the
`Petitioner has not made a threshold showing that each of these three
`references teach patients having an iron overload condition of the heart or
`iron-induced cardiac disease, and the Board improperly applied the
`inherency standard when it found otherwise.” Req. 13.
`We find this argument unpersuasive for the reasons given above.
`Summary
`As noted in the decision on institution (Dec. 2), the standard for
`instituting an inter partes review is set forth in 35 U.S.C. § 314(a), which
`provides:
`THRESHOLD – The Director may not authorize an inter partes
`review to be instituted unless the Director determines that the
`information presented in the petition filed under section 311
`and any response filed under section 313 shows that there is a
`reasonable likelihood that the petitioner would prevail with
`respect to at least 1 of the claims challenged in the petition.
`
`As also noted in the decision on institution, we have considered both
`the Petition and Patent Owner Preliminary Response, and determined that
`the information presented in the Petition demonstrates that there is a
`reasonable likelihood that Petitioner would prevail with respect to the
`
`
`
`9
`
`
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`IPR2017-01446
`Patent 7,049,328 B2
`
`challenged claims. Dec. 2. Therefore, we applied the correct threshold
`standard for instituting the inter partes review.
`As such, Patent Owner has not shown that we misapprehended or
`overlooked any matters in instituting inter partes review. See 37 C.F.R.
`§ 42.71(d). Thus, for the forgoing reasons, Patent Owner has not shown that
`the Board abused its discretion in instituting this inter partes review.
`
`
`CONCLUSION
`Patent Owner’s request for rehearing is denied.
`
`10
`
`
`
`IPR2017-01446
`Patent 7,049,328 B2
`
`PETITIONER:
`Huiya Wu
`Robert V. Cerwinski
`Sara Fink
`GOODWIN PROCTER LLP
`hwu@goodwinlaw.com
`rcerwinski@goodwinlaw.com
`sfink@goodwinlaw.com
`
`PATENT OWNER:
`W. Blake Coblentz
`Aaron S. Lukas
`COZEN O’CONNOR
`WCoblentz@cozen.com
`ALukas@cozen.com
`
`11
`
`
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