IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.
`Patent Owner.
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor
`Inter Partes Review No.: IPR2020-00040
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`MYLAN PHARMACEUTICALS INC.
`Petitioner,
`v.
`MERCK SHARP & DOHME CORP.
`Patent Owner.
`U.S. Patent No. 7,326,708 to Cypes et al.
`Issue Date: February 5, 2008
`Title: Phosphoric Acid Salt of a Dipeptidyl Peptidase-IV Inhibitor
`Inter Partes Review No.: IPR2020-00040
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`TABLE OF CONTENTS
`INSTITUTION SHOULD NOT BE DENIED BASED ON §325(D) ............ 1
`A.
`Petitioner’s Asserted Grounds Were Not Considered during
`Prosecution (Becton Factors (a-e)). ....................................................... 1
`Additional Evidence and Facts Presented in the Petition Warrant
`Reconsideration of the Prior Art (Becton Factor (f)). ........................... 4
`§314(A) DOES NOT SUPPORT DENIAL OF THE PETITION .................. 5
`THE PTAB SHOULD EVALUATE MERCK’S ANTEDATING
`EVIDENCE AFTER INSTITUTION ............................................................. 7
`
`B.
`
`I.
`
`II.
`III.
`
`i
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Acrux DDS Pty Ltd. v. Kaken Pharm. Co., Ltd.,
`IPR2017-00190, Paper 12 (PTAB May 1, 2017) ................................................. 7
`Agrinomix LLC v. Mitchell Ellis Products Inc.,
`IPR2017-00525, Paper 8 (PTAB Jun. 14, 2017) .............................................. 3, 4
`Alarm.com Inc. v. Vivint, Inc.,
`IPR2015-01967, Paper 12 (PTAB Mar. 30, 2016) ............................................... 3
`Amgen Inc. v. Alexion Pharms. Inc.,
`IPR2019-00740, Paper 15 (PTAB Aug. 20, 2019) ............................................... 2
`Amneal Pharms. LLC et al. v. Almirall LLC,
`IPR2019-00207, Paper 39 (PTAB Dec. 31, 2019) ............................................... 8
`Apotex, Inc. v. UCB Biopharma, SPRL,
`IPR2019-00400, Paper 17 (July 15, 2019) ....................................................... 1, 5
`Associated British Foods, PLC v. Cornell Research Foundation Inc.,
`IPR2019-00578, Paper 25 (PTAB July 25, 2019) ................................................ 8
`Becton, Dickinson and Company v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) ............................................. 4, 5
`Celltrion, Inc. v. Genentech, Inc.,
`IPR2017-01373, Paper 16 (PTAB Dec. 1, 2017) ................................................. 7
`Clim-A-Tech Indus., Inc. v. William A. Ebert,
`IPR2017-01863, Paper 13 (PTAB Feb. 12, 2018) ................................................ 3
`Hyperbranched Medical Technology, Inc., v. Confluent Surgical, Inc.,
`IPR2018-01097, Paper 14 (PTAB Nov. 14, 2018) ............................................... 2
`Pfizer Inc. v. Genetech, Inc.,
`IPR2018-00300, Paper 13 (PTAB July. 9, 2018) ................................................. 2
`Polycom Inc. v. Directpacket Research, Inc.,
`IPR2019-01233, Paper 14 (PTAB Nov. 5, 2019) ................................................. 8
`
`ii
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`Quest USA Corp. v. PopSockets LLC,
`IPR2018-00497, Paper 8 (PTAB Aug. 13, 2018) ................................................. 8
`RJ Reynolds Vapor Co. v. Fontem Holdings 1 BV,
`IPR2017-01642, Paper 10 (PTAB Jan. 16, 2018) ................................................ 3
`Sandoz Inc. v. Pharmacyclics LLC,
`IPR2019-00865, Paper 8 (PTAB Sept. 26, 2019) ..................................... 5, 6, 7, 8
`TRW Automotive US LLC v. Magna Electronics Inc.,
`IPR2014-00261, Paper 19 (PTAB June 26, 2014) ............................................... 2
`Statutes
`35 U.S.C. §314(a) .......................................................................................... 5, 6, 7, 8
`35 U.S.C. §325(d) .......................................................................................... 1, 2, 3, 5
`
`iii
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`I.
`
`INSTITUTION SHOULD NOT BE DENIED BASED ON §325(D)
`A.
`Petitioner’s Asserted Grounds Were Not Considered During
`Prosecution (Becton Factors (a-e)).
`There is no dispute that the Examiner never put forth any prior art rejection
`
`during prosecution of the ’708 patent, including the grounds advanced in the
`
`Petition. Instead, Merck’s entire argument is premised on three facts: (1) an IDS
`
`listing the ’871 patent and WO ’498; (2) a hurried account of WO ’498 in the
`
`specification of the ’708 patent; and (3) Merck’s speculations as to the Examiner’s
`
`actions. Even Merck concedes that the Examiner did not initial the listing of WO
`
`’498 on the IDS. POPR at 17, EX1010 at 157. Absent the Examiner’s initials, as
`
`the IDS explicitly states, WO ’498 was not considered. Id. (“Initial if reference
`
`considered.”). To address any confusion, in minutes, Merck could have resubmitted
`
`an IDS with WO ’498, filed an RCE with an IDS, or simply called the Examiner.
`
`Merck did not. Instead, without explanation, Merck asks that its inaction be excused
`
`and institution of Mylan’s petition be denied. Finally, as Merck admits, the
`
`specification of the ’708 patent discusses WO ’498 but not the ’871 patent. POPR
`
`14-15. It is not incumbent upon the Examiner to link the ’871 patent and WO ’498.
`
`“The Board has consistently declined to exercise its discretion under §325(d)
`
`based on the mere citation of references in an IDS that were not applied by the
`
`Examiner.” Apotex, Inc. v. UCB Biopharma, SPRL, IPR2019-00400, Paper 17 at 24
`
`(July 15, 2019); Amgen Inc. v. Alexion Pharmaceuticals Inc., IPR2019-00740,
`
`1
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`Paper 15 at 65 (PTAB Aug. 20, 2019) (citing cases). Prior art “simply being of
`
`record, but not applied in any rejection by the Examiner during examination . . . ,
`
`provides little impetus for [the PTAB] to exercise [its] discretion to deny institution
`
`under §325(d).” Hyperbranched Medical Technology, Inc., v. Confluent Surgical,
`
`Inc., IPR2018-01097, Paper 14 at 24 (PTAB Nov. 14, 2018).
`
`Merck presumes that an IDS bearing both WO ’498 (unsigned—indicating the
`
`Examiner did not consider it) and the ’871 patent, along with a short account of WO
`
`’498 in the specification of the ’708 patent, meant that the Examiner was aware of
`
`this prior art and “there is no evidence that the Office did not evaluate this argument
`
`and the relevant art during examination.” POPR at 16-17. Presumptive awareness,
`
`however, is not enough for a §325(d) denial. TRW Automotive US LLC v. Magna
`
`Electronics Inc., IPR2014-00261, Paper 19 at 12 (PTAB June 26, 2014).
`
`The fact that the specification of the ’708 patent provides a hurried account of
`
`WO ’498 changes nothing. Absent a further showing that the Examiner applied the
`
`reference, the PTAB has previously declined exercising its §325(d) discretion based
`
`merely on disclosures in the specification. Pfizer Inc. v. Genetech, Inc., IPR2018-
`
`00300, Paper 13 at 9 (PTAB July. 9, 2018). (“Andya is described in the ’142 patent
`
`specification . . . we decline to exercise our discretion under §325(d) based upon that
`
`bare assertion as Patent Owner has not demonstrated adequately that the Examiner
`
`substantively considered Andya.”). For that matter, Merck does not cite a single
`
`2
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`decision where the PTAB denied a petition on the basis of §325(d) because a
`
`reference was disclosed to the Examiner on an IDS and discussed in the
`
`specification, but not applied during Examination.1 Although never previously cited
`
`by Merck, the closest PTAB decision Petitioner could locate is Agrinomix LLC v.
`
`1 The three cases cited on page 21 of the POPR involve very different factual
`
`situations. RJ Reynolds Vapor Co. v. Fontem Holdings 1 BV involved a situation
`
`where the prior art presented in the petition was the same “in all material respects”
`
`as the art applied by the Examiner. IPR2017-01642, Paper 10 at 11 (PTAB Jan. 16,
`
`2018). In Clim-A-Tech Indus., Inc. v. William A. Ebert, the issue of whether “Marley
`
`Plastics, and specifically the question of whether Marley Plastics discloses or
`
`suggests the disputed elements of the challenged claims, was previously considered
`
`by the Patent Office.” IPR2017-01863, Paper 13 at 19 (PTAB Feb. 12, 2018).
`
`Finally, in Alarm.com Inc. v. Vivint, Inc., the prior art asserted in the Petition “were
`
`among a very small number of references that the Examiner uncovered in a pre-
`
`issuance search and considered before allowing the challenged claims.” IPR2015-
`
`01967, Paper 12 at 21 (PTAB Mar. 30, 2016). The Examiner found in the prior art;
`
`it takes little imagination to conclude that he or she read and considered that art. Id.
`
`(“[W]e are unwilling to assume that, after having uncovered a very limited amount
`
`of relevant art, the Examiner failed to consider at least that art.”).
`
`3
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`Mitchell Ellis Products Inc., IPR2017-00525, Paper 8 at 8-11 (PTAB Jun. 14, 2017).
`
`In Agrinomix, the prior art (i.e., Nöthen) was discussed in the specification and
`
`disclosed in an IDS. Id. at 8-9. But even those facts did not excuse a further showing
`
`that the prior art was applied by the Examiner during prosecution. Id. at 11 (PTAB
`
`explaining “the Examiner relied upon [Nöthen] in rejecting certain claims during
`
`prosecution.”). Here, no such showing can be made. The Examiner applied neither
`
`WO ’498 nor the ’871 patent during prosecution. Therefore, Becton factors (a)-(e)
`
`favor of institution. Becton, Dickinson and Company v. B. Braun Melsungen AG,
`
`IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential).
`
`B.
`
`Additional Evidence and Facts Presented in the Petition Warrant
`Reconsideration of the Prior Art (Becton Factor (f)).
`In support of its Petition, Petitioner submitted a 75 page declaration by its
`
`expert, Dr. Choghade. Merck suggests the ’708 patent’s short account of WO ’498
`
`is entirely duplicative of Petitioner’s positions and the information contained within
`
`Dr. Choghade’s Declaration. POPR at 14 (“But Merck presented WO ’498 and this
`
`precise argument to the Office”). Merck is incorrect. As but two examples: while
`
`the ’708 patent’s specification states that “[p]harmaceutically acceptable salts of this
`
`compound are generically encompassed within the scope of [WO ’498]”, at no point
`
`does it state that WO ’498 contains a small “[p]articularly preferred” list of the
`
`salts—one of which is the phosphoric acid salt. EX1001, 1:49-57; EX1002, ¶¶69-
`
`70, 72-74, 78, 81, 99-100, 108; EX1004, 10:14-15. Further, as Dr. Choghade
`
`4
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`explains, WO ’498 expressly teaches the 1:1 sitagliptin salt, but again, the
`
`’708 patent’s specification does not mention this fact. EX1002, ¶¶75-77, 99-100,
`
`fn.15, 116, 132, 162; EX1001, 1:49-57.
`
`Merck also admits Petitioner provided additional art that was not before the
`
`Examiner. POPR at 15 (“Although neither of those secondary references—Bastin
`
`and Brittain—was before the Office during examination”). Even if Merck wishes to
`
`characterize the additional art as “secondary”, the fact is these references were not
`
`before the Examiner but are utilized as primary references in Mylan’s Petition.
`
`Becton Factor (f) weights against the PTAB exercising its §325(d) discretion.
`
`II.
`
`§314(A) DOES NOT SUPPORT DENIAL OF THE PETITION
`Merck improperly relies on the existence of a concurrent ANDA litigation
`
`involving the ’708 patent with various generic pharmaceutical litigants to argue that
`
`overall judicial efficiency would be best served if the PTAB simply deny the
`
`Petition. POPR at 24-31. “The Leahy-Smith America Invents Act, Pub. L.
`
`No. 112-29, 125 Stat. 284, 329 (2011) does not guarantee increased judicial
`
`efficiency in resolving patent disputes in each case, and no litigant is required to
`
`adopt a strategy that increases judicial efficiency at a cost of reducing its likelihood
`
`of prevailing in the dispute.” Apotex, IPR2019-00400 at 32-33.
`
`Merck’s arguments are identical to those rejected in Sandoz Inc. v.
`
`Pharmacyclics LLC, IPR2019-00865, Paper 8 at 9-11 (PTAB Sept. 26, 2019). In
`
`Sandoz, the PTAB instituted Sandoz Inc.’s (“Sandoz”) petition over a §314(a)
`5
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`challenge by Patent Owner Pharmacyclics LLC (“Pharmacyclics”). Like Petitioner
`
`Mylan, Sandoz also was involved in concurrent ANDA litigation with other generic
`
`pharmaceutical litigants challenging the same patent it sought PTAB review. Id. at
`
`2-3. As Sandoz explained, the fact there is a concurrent litigation has no bearing
`
`because “[t]he AIA explicitly contemplates that a party may choose to file an inter
`
`partes review on a patent that is involved in concurrent litigation.” Id. at 10.
`
`In Sandoz, Pharmacyclics (like Merck) argued that the concurrent ANDA
`
`litigation involved “the same or substantially similar issues, arguments, and
`
`evidence.” IPR2019-00865 at 9; POPR at 25 (“All the issues raised in this IPR will
`
`be litigated in the MDL.”). Pharmacyclics therefore argued (like Merck)—citing E-
`
`One and NHK (like Merck)—“that [the PTAB] should exercise [its] discretion
`
`[under §314(a)] to deny institution because instituting a trial would be an inefficient
`
`use of Board resources.” IPR2019-00865 at 9; POPR at 25, 28-29.
`
`Sandoz disagreed that E-One and NHK supported a §314(a) denial. As Sandoz
`
`explained, in E-One the concurrent litigation had reached an advanced stage.
`
`IPR2019-00865 at 10 (issued decisions on claim construction and a preliminary
`
`injunction). “In addition, the district court in E-One, unlike the district court here,
`
`was scheduled to complete trial in the parallel district court case before a final
`
`decision would be due.” Id. Likewise, “the district court proceeding in NHK, where
`
`trial was set to conclude six months before a final Board decision would be due . . .
`
`6
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`appears to have been substantially more advanced than the district court proceeding
`
`is here.” Id. at 11. The PTAB’s final decision in the instant matter is due five
`
`months before trial. POPR at 26. The difference between the instant Petition and
`
`Sandoz is that the concurrent litigation in Sandoz had advanced much further. In
`
`Sandoz, trial was scheduled to begin “over two weeks after any final written
`
`decision.” IPR2019-00865 at 11. Because Mylan filed its Petition very early—so
`
`early that the PTAB’s final decision is due five months before trial (POPR at 26)—
`
`Merck’s §314(a) arguments are even weaker than those rejected in Sandoz.
`
`III. THE PTAB SHOULD EVALUATE MERCK’S ANTEDATING
`EVIDENCE AFTER INSTITUTION
`The PTAB has routinely found that antedation issues are best resolved during
`
`trial with the benefit of a full record and after petitioners have had a chance to
`
`challenge the alleged antedation evidence. Acrux DDS Pty Ltd. v. Kaken Pharm.
`
`Co., Ltd., IPR2017-00190, Paper 12 at 12 (PTAB May 1, 2017); Celltrion, Inc. v.
`
`Genentech, Inc., IPR2017-01373, Paper 16 at 10 (PTAB Dec. 1, 2017); Quest USA
`
`Corp. v. PopSockets LLC, No. IPR2018-00497, Paper 8 at 11 (PTAB Aug. 13, 2018);
`
`Associated British Foods, PLC v. Cornell Research Foundation Inc., IPR2019-
`
`00578, Paper 25 at 21 (PTAB July 25, 2019). This Panel made the same observation
`
`EX1017, 22:13-21 (Hearing Tr.) (“[As to] antedation evidence, it’s very difficult for
`
`the Board to deny on that basis at institution because at that point it’s usually
`
`evidence that has not been tested and for which Petitioner has not had an opportunity
`
`7
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`to test it. So that being said, you may decide you want to focus your eight pages
`
`somewhat more on the other issues, if you want.”).
`
`To support its alleged antedation, Merck submitted four declarations which
`
`include various technical documents. Obviously, Merck handpicked these select
`
`portions from its technical documents, and there is no evidence they are complete.
`
`Further, EX2004 is based on the declarant’s recollection of events that occurred
`
`years ago. EX2005 acknowledges that the documents are partially incomplete.
`
`EX2005, ¶¶13-15. EX2003 provides hearsay evidence attesting to the actions of
`
`and/or documents produced by Vicky Vydra, Leigh Shultz, Yun Liu, and Cindy
`
`Starbuck. EX2003, ¶¶12, 13, 15, 16. EX2003 and EX2004 also appear to be from
`
`alleged inventors but they do not seem to explain their inventive contribution. Mylan
`
`should have the opportunity to seek the depositions of the declarants and the people
`
`referenced in EX2003 who provided its alleged factual underpinnings. Amneal
`
`Pharmaceuticals LLC et al. v. Almirall LLC, IPR2019-00207, Paper 39 at 8 (PTAB
`
`Dec. 31, 2019). Further, with the benefit of the full record, during trial, Mylan will
`
`show that Merck’s antedation claims are neither sufficient nor meritorious. Finally,
`
`Mylan will also serve its objections (including incomplete and hearsay objections)
`
`within the proscribed time period. Polycom Inc. v. Directpacket Research, Inc.,
`
`IPR2019-01233, Paper 14 at 5 (PTAB Nov. 5, 2019).
`
`Date: March 13, 2020
`
`
`
`Lead Counsel for Petitioner: /Jitendra Malik/
`
`8
`
`
`
`CERTIFICATION OF SERVICE ON PATENT OWNER
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4), and 42.105, the undersigned
`
`certifies that on March 13, 2020, a complete copy of the foregoing Paper was served
`
`via email to the Patent Owner’s counsel at:
`
`sfisher@wc.com
`jberniker@wc.com
`smahaffy@wc.com
`asheh@wc.com
`bgenderson@wc.com
`
`Respectfully submitted,
`Katten Muchin Rosenman LLP
`By: /Jitendra Malik/
`
`
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