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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
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`MYLAN PHARMACEUTICALS INC.,
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`Petitioner,
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`v.
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`BAUSCH HEALTH IRELAND LIMITED,
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`Patent Owner.
`
`__________________
`
`Case IPR2022-01103
`U.S. Patent No. 9,616,097
`__________________
`
`PATENT OWNER’S SUR-REPLY REGARDING DISCRETIONARY
`DENIAL UNDER 35 U.S.C. § 325(d)
`
`
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`
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`TABLE OF AUTHORITIES
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` Page(s)
`
`Cases
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte
`GmbH,
`IPR2019-01469, Paper 6 (PTAB Feb. 13, 2022) ........................................ 1, 3, 4
`
`Agrinomix, LLC v. Mitchell Ellis Products, Inc.
`IPR2017-00525, Paper 6 (PTAB June 14, 2017) ................................................ 5
`Apotex, Inc. v. Auspex Pharms., Inc.,
`IPR2021-01507, Paper 9 (PTAB Mar. 9, 2022) ..................................... 1, 2, 3, 4
`Kyocera Senco Indus. Tools Inc. v. ITC,
`22 F.4th 1369 (Fed. Cir. 2022) ........................................................................... 5
`
`SolarEdge Techs. Ltd v. SMA Solar Tech. AG
`IPR2020-00021, Paper 31 (PTAB Oct. 25, 2022) .............................................. 4
`
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`
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`
`
`i
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`
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`Mylan’s reply is yet another impermissible attempt to allege “fraud” as the
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`basis for inter partes review. This time, Mylan recklessly attacks the Examiner and
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`improperly exceeds the scope of the reply authorized by the Board in an effort to
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`bolster its deficient Petition. Indeed, Mylan does not address—let alone dispute—
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`the substantial similarities between the asserted art and the art previously presented
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`to the Office. The only question then is “whether Petitioner shows sufficiently that
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`the Examiner erred in a manner material to the patentability of the challenged
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`claims.” Apotex, Inc. v. Auspex Pharms., Inc., IPR2021-01507, Paper 9 at 23 (PTAB
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`Mar. 9, 2022) (citing Advanced Bionics, LLC v. MED-EL Elektromedizinische
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`Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2022) (precedential)).
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`As discussed below and in Bausch’s Preliminary Response, Mylan has not shown
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`that the Examiner committed any material error, and accordingly, the Board should
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`deny institution.
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`At the outset, Mylan mischaracterizes the prosecution history of the ’097
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`patent, which included four substantive novelty and obvious rejections. Citing the
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`third office action, Mylan wrongly alleges that the Examiner “held formulating
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`plecanatide tablets with a low-moisture carrier and a lubricant was prima facie
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`obvious.” Reply at 1 (citing EX1022, 4449-51) (emphasis added). Contrary to
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`Mylan’s inaccurate arguments, none of the then-pending independent claims recited
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`a “lubricant.” In any event, the Examiner ultimately withdrew her rejections,
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`1
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`determined that the claimed invention was non-obvious, and allowed the application
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`after considering Applicants’ amendments and arguments. EX1022, 5103-05.
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`Importantly, Mylan has not established that the Examiner relied on the
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`Comiskey Declarations in allowing the application. The first Comiskey Declaration1
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`was submitted in response to the first office action. After that submission, the
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`Examiner issued three more substantive office actions before allowing the
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`application. In allowing the application, the Examiner provided more than a page of
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`reasons for allowance, including discussion of how the prior art was distinguishable
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`from the claimed invention. Neither the Comiskey Declarations nor the unexpected
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`results argued therein were mentioned in the Examiner’s reasons for allowance.
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`EX1022, 5103-04.
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`Even if the Examiner had materially relied upon Comiskey Declarations in
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`allowing the application, which Mylan has not established, Mylan’s arguments are
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`“insufficient to support a finding of material Examiner error.” Apotex, Paper 9 at
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`35. In Apotex, for example, the petitioner challenged the patent owner’s data
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`1 Applicants submitted two additional Comiskey Declarations, one during
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`prosecution of the ’097 patent and another during prosecution of a related patent,
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`both of which included similar data and arguments as compared to the first
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`Comiskey Declaration.
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`2
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`submitted during prosecution as allegedly expected, yet the Board denied institution,
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`finding the “petitioner’s information insufficient to support a finding of material
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`Examiner error.” Id. The Board explicitly held that “[i]f reasonable minds can
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`disagree,” it is the Board’s “commitment to defer to previous Office evaluations of
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`the evidence of record.” Id. (citing Advanced Bionics, Paper 6 at 9).
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`The same is true here. Mylan improperly disregards the initial impurity levels
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`(at 0 months) in assessing the unexpected results set forth in the Comiskey
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`Declarations. Mylan mischaracterizes Bausch’s arguments, asserting that Bausch
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`limited the unexpected results to only “the initial purity difference.” Reply 2. But
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`contrary to Mylan’s characterizations, the unexpected results include the differences
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`in impurity levels between formulations containing a regular-grade carrier (Avicel
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`102) and formulations containing a low-moisture carrier (Avicel PH 112) initially
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`and throughout the duration of the test.
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`Mylan asserts that Bausch’s interpretation is “conclusory,” “unsupported and
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`absurd.” Reply at 2. But Bausch’s interpretation is supported by the statements
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`made in the Comiskey Declarations as well as the arguments made during
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`prosecution of the ’097 patent. POPR at 21-22. Mylan further attempts to obfuscate
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`the issues by focusing on the “‘storage’ stability limitation” recited in the claims.
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`But the claims recite that “the peptide has a chromatographic purity of no less than
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`91 % after storage for at least three months”; i.e., initially and for at least three
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`3
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`months. At least because “reasonable minds can disagree” with Mylan’s
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`interpretation of the data, the Board should reject Mylan’s arguments and deny
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`institution. Apotex, Paper 9 at 35; Advanced Bionics, Paper 6 at 9.
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`Faced with these fatal flaws in its argument, Mylan recklessly attacks the
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`Examiner, alleging that she “failed to apply applicant admissions.” Reply at 3.
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`Mylan is wrong. Contrary to Mylan’s arguments, Shailubhai (EX1005) does not
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`disclose any specific formulation of plecanatide along the lines of those claimed in
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`the ’097 patent, and Mylan has not established that Shailubhai’s statements about
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`possible dosage forms would have provided a POSA any expectation of successfully
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`arriving at the formulation of claim 1 of the ’097 patent.
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`Moreover, Mylan’s reliance on SolarEdge Techs. Ltd v. SMA Solar Tech. AG,
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`is inapposite at least because SolarEdge pertained to “statements in the specification
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`of the challenged patent,” not statements in the specification of an unrelated patent.
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`IPR2020-00021, Paper 31, at 14-16 (PTAB Oct. 25, 2022). Similarly, Mylan has
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`not established and cannot establish that Remington or Doelker discloses a drug
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`formulation that includes an API and the two specific inactive ingredients recited in
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`the ’097 patent claims. Accordingly, Mylan’s arguments that the Examiner failed to
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`consider “Bausch’s admission that Remington teaches well-known methods” and
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`that “Remington’s and Doelker’s teachings of a routine direct-compression tablet
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`satisf[ies] the ‘consisting of’ limitation” should be rejected. Reply at 4.
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`4
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`
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`Mylan further admits that Shailubhai ’683 (EX2001), which has substantially
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`the same specification as Shailubhai, was considered and relied upon in rejecting
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`claims during prosecution. Reply at 4. Yet Mylan baselessly argues that the
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`Examiner relied on only part of that patent document. Id. Indeed, the Board has
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`previously considered and rejected this very argument. In Agrinomix, LLC v.
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`Mitchell Ellis Products, Inc., for example, the Board denied the institution, holding
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`that “although the Examiner may only have relied upon [a reference] to address the
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`limitation of a dependent claim, that fact does not obviate that [the reference] was
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`before the Examiner and that the Examiner relied upon it in rejecting certain claims
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`during prosecution.” IPR2017-00525, Paper 6 at 11 (PTAB June 14, 2017).
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`Shailubhai ’683 was relied upon in rejecting claims during prosecution, and Mylan’s
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`arguments should therefore be rejected.
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`Mylan also improperly exceeds the scope of reply authorized by the Board.
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`The Board limited the scope of Mylan’s reply to Bausch’s § 325(d) arguments, yet
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`Mylan improperly addresses its experts’ qualifications, which is well beyond the
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`scope of § 325(d). Mylan does not argue that Dr. Christians is a pharmaceutical
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`formulator; undeniably, he is an anesthesiologist and pathologist. Accordingly, Dr.
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`Christians’s testimony relating to “formulating” pharmaceutical compositions
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`should be considered “neither relevant nor reliable.” Kyocera Senco Indus. Tools
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`Inc. v. ITC, 22 F.4th 1369, 1377 (Fed. Cir. 2022).
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`5
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`
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`Mylan also uses its limited reply to re-argue obviousness and, in particular,
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`routine optimization. But routine optimization is a standard obviousness theory,
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`which the Examiner asserted in rejecting the claims, and which the Applicants
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`overcame. And even if the Examiner did not consider some aspect of dosage
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`design—an allegation that Mylan does not substantiate—this alleged error cannot be
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`material. In particular, the Examiner allowed the claims of U.S. Patent No.
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`9,925,231, which do not recite the dosage claim element but are the same in all other
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`aspects as the claims of the ’097 patent. The Examiner clearly determined that the
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`claims of the ’097 and ’231 patents are patentable, irrespective of the dosage claim
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`element. Even crediting Mylan’s unsubstantiated allegations, any alleged error with
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`respect to the dosage claim element cannot be material, and Mylan’s arguments
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`should be rejected at least for this additional reason.
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`Mylan does not dispute that the Examiner considered the same or substantially
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`the same prior art asserted in the Petition. Mylan’s Petition amounts to an
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`impermissible attempt to allege “fraud” as the basis for inter partes review. Without
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`sufficient showing of material error by the Examiner, which Mylan has not provided,
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`the Board should deny institution of Mylan’s Petition.
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`
`
`Date: November 22, 2022
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`Respectfully submitted,
`
`
`/Justin J. Hasford/
`By:
`Justin J. Hasford, Reg. No. 62,180
`6
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`
`
`
`Lead Counsel
`Bryan C. Diner, Reg. No. 32,409
`Back-up Counsel
`Joshua L. Goldberg, Reg. No. 59,369
`Back-up Counsel
`Kassandra M. Officer Reg. No. 74,083
`Back-up Counsel
`Lauren J. Robinson Reg. No. 74,100
`Back-up Counsel
`Caitlin E. O’Connell, Reg. No. 73,934
`Back-up Counsel
`Kyu Yun Kim, Reg. No. 72,783
`Back-up Counsel
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner
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`7
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`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Patent Owner’s Sur-
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`Reply Regarding Discretionary Denial Under 35 U.S.C. § 325(d) was served
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`electronically via email on November 22, 2022, in their entirety on the following:
`
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati PC
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`jmills@wsgr.com
`
`Richard Torczon
`Wilson Sonsini Goodrich & Rosati PC
`1700 K Street N.W., 5th Floor
`Washington, DC 20006
`rtorczon@wsgr.com
`
`Nicole W. Stafford
`Dennis D. Gregory
`Wilson Sonsini Goodrich & Rosati PC
`900 South Capital of Texas Highway, Las Cimas IV, Fifth Floor
`Austin, TX 78746-5546
`nstafford@wsgr.com
`dgregory@wsgr.com
`
`4869-2213-2498@mail.vault.netdocuments.com
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`
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`Dated: November 22, 2022
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`/Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER LLP
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`8
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