UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner
`
`
`
`
`Case No. IPR2020-00770
`U.S. Patent No. 9,604,901
`
`
`
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`MOTION TO EXCLUDE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner
`
`
`
`
`Case No. IPR2020-00770
`U.S. Patent No. 9,604,901
`
`
`
`
`PETITIONER’S OPPOSITION TO PATENT OWNER’S
`MOTION TO EXCLUDE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
`
`
`
`
`I.
`
`INTRODUCTION
`Liquidia Technologies, Inc. (“Petitioner” or “Liquidia”) opposes Patent
`
`Owner’s Motion to Exclude Exs. 1002 and 1012.
`
`II. ARGUMENT
`A. Ex. 1002
`First, UTC’s motion to exclude Ex. 1002 under 35 U.S.C. § 25, 37 CFR
`
`§ 42.2, and/or as hearsay should be denied. Paper 31 at 3-4. UTC contends that
`
`Dr. Winkler inadvertently omitted the oath at the end of his declaration and, as such,
`
`his declaration should be excluded.
`
`As an initial matter, UTC waived its argument regarding Dr. Winkler’s
`
`declaration under 37 C.F.R. § 42.63, because it did not timely object to the issue
`
`with “sufficient particularity . . . to allow correction in the form of supplemental
`
`evidence.” See Campbell Soup Co. v. Gamon Plus, Inc., IPR2017-00091, Paper 84
`
`at 52 (P.T.A.B Apr. 11, 2018) (“Although Daubert is related to FRE 702,
`
`challenging an expert as generally not being ‘qualified’ (Paper 16, 1) does not
`
`provide the ‘sufficient particularity’ as required by 37 C.F.R. § 42.64(b)(1) ‘to allow
`
`correction in the form of supplemental evidence.’”). In its objections filed after the
`
`Institution Decision, UTC only generically restated FRE 802, 901, and 902, and
`
`never identified the oath as the issue. Paper 10 at 3 (“Patent Owner objects to Exhibit
`
`1002 under FRE 802 as hearsay without exception. Patent Owner objects to Exhibit
`
`
`
`1
`
`
`
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
`
`1002 under FRE 901-902 as lacking authentication and not self-authenticating
`
`because it lacks sufficient indicia that the exhibit is what it purports to be.”). Because
`
`UTC failed to preserve the objection asserted here, the Board should “not consider
`
`these arguments in [the] Motion to Exclude because they have been waived.”
`
`Campbell Soup Co., Paper 84 at 52.
`
`Regardless, as addressed in Petitioner’s Reply, any omissions in Dr. Winkler’s
`
`declaration with respect to the oath or perjury statement were harmless and have
`
`been cured. Paper 15 at 1-2. UTC deposed him on the opinions he presented therein.
`
`See generally EX2026; see also Google LLC v. CyWee Grp. Ltd., IPR2018-01257,
`
`Paper 69 at 2-4 (P.T.A.B. Sept. 6, 2019) (granting party authorization to correct
`
`unsworn declaration when opposing party cross-examined the expert); Fid. Info.
`
`Servs., LLC v. Mirror Imaging, LLC, CBM2017-00064, Paper 54 at 5-8 (P.T.A.B.
`
`Jan. 2, 2019) (same). Dr. Winkler also refiled Ex. 1002 as Ex. 1039 with no changes
`
`other swearing to the truth of his statements therein. See EX1039, ¶241 (declaring
`
`that “all statements made herein are identical to my declaration filed as Ex. 1002”).
`
`Importantly, UTC has not moved to exclude Ex. 1039 or any Dr. Winkler’s opinions
`
`therein. UTC is exalting form over substance in renewing this objection before oral
`
`argument. Accordingly Ex. 1002 should not be excluded under 35 U.S.C. §25, 37
`
`CFR §42.2, and/or as hearsay.
`
`
`
`2
`
`
`
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
`
`Second, UTC’s argument that Dr. Winkler is unqualified to testify on the
`
`relevant subject matter under Federal Rules of Evidence 701 and 702 should be
`
`denied. UTC is utilizing its motion to exclude as another opportunity to repeat
`
`arguments from the parties’ briefing regarding whether Dr. Winkler meets UTC’s
`
`expert’s1 definition of a person of ordinary skill in the art, and otherwise argues
`
`issues directed to the weight, not admissibility of his testimony.
`
`UTC’s argument is without merit. The Board stated that “for purposes of this
`
`Decision, . . . the level of ordinary skill in the art is reflected by the prior art,
`
`including Phares and Moriarty.” Paper 7 at 22 (citing In re GPAC Inc., 57 F.3d
`
`1573, 1579 (Fed. Cir. 1995) (“The person of ordinary skill in the art is a hypothetical
`
`
`1 UTC’s citation to Dr. Hall-Ellis’s declaration is a distraction. Paper 31 at 4 (citing
`
`EX1015, ¶16). Dr. Hall-Ellis made a typographical mistake in her definition of a
`
`person of ordinary skill in art by inadvertently taking a definition from a different
`
`IPR proceeding. See EX1052, ¶5. This is evident from her definition referring to
`
`“radiation oncology,” which clearly is unrelated to the ’901 patent at issue. Dr. Hall-
`
`Ellis has filed a supplemental declaration correcting this error and explaining that
`
`her opinion relied on the same skilled artisan definition as Petitioner and Dr.
`
`Winkler. Id. at ¶¶6-8. Neither Petitioner nor its expert submitted any substantive
`
`testimony or argument relying on Dr. Hall-Ellis’s typographical mistake.
`
`
`
`3
`
`
`
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
`
`person who is presumed to know the relevant prior art.”)). Dr. Winkler was qualified
`
`and accepted as a person of skill in the art in a prior IPR proceeding involving UTC,
`
`the ’901 patent’s parent, and the same “relevant prior art” Phares and Moriarty (Ex.
`
`1008 and 1009). See, e.g., EX1005 at 49, 27-28, 71 (Final Written Decision finding
`
`that the “level of ordinary skill in the art is reflected by the prior art of record” and
`
`repeatedly citing to Dr. Winkler’s declaration). For the same reasons, Dr. Winkler
`
`similarly qualifies as a POSA here, as reflected by the same prior art.
`
`Further, as detailed in Petitioner’s Reply, UTC’s repeated attempts to inflate
`
`the level of ordinary skill in the art is without support in the claims or specifications
`
`of the ’901 patent. See Paper 15 at 8-10. UTC does the same again in referring to
`
`“manufacturing requirements in the United States” or “development considerations”
`
`(Paper 31 at 5-6),2 without any connection to the language in the ’901 Patent claims.
`
`
`2 UTC follows in the footsteps of its expert in mischaracterizing Dr. Winkler’s
`
`testimony, stating that Dr. Winkler was “unable to answer” counsel’s questions
`
`(Paper 31 at 5-6), simply because counsel did not like or disagreed with Dr.
`
`Winkler’s answers. Such self-serving attorney argument is not a basis for exclusion
`
`of expert opinions. The Board is fully capable of reading Dr. Winkler’s testimony
`
`for itself and assessing what weight to accord it. EX1005 at 85 (“UTC has not
`
`explained adequately why we should exclude conclusory expert testimony, instead
`
`
`
`4
`
`
`
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
`
`Regardless, there is plenty of evidence in the record that Dr. Winkler qualifies as a
`
`skilled artisan under even UTC’s inflated definition of a skilled artisan. See, e.g.,
`
`EX1017 at ¶¶ 7-14 (describing qualifications as organic and process chemistry
`
`expert who has repeatedly developed greater than 2.9 gram quantities of chemical
`
`compounds, including “scale-up of drug production of API for both in vitro testing
`
`and animal studies”), 27 (stating, “I have consulted for process chemistry groups of
`
`several pharmaceutical companies, worked for Bristol Myers Squibb advising their
`
`medicinal and process chemistry groups, and have overseen the scale-up of drugs
`
`developed in my laboratory for commercial use (e.g., as startup company drug
`
`candidates), including for the claimed ‘at least 2.9 gram’ quantities.”); EX1003 (Dr.
`
`Winkler’s CV); EX2026, 24:13-25:18 (testifying as to process chemistry
`
`experience), 26:5-16 (testifying “we certainly have done many, many reactions, and
`
`published them” involving “multi gram quantities of chemicals and their
`
`intermediates”), 27:5-21 (testifying as to commercial-scale production experience),
`
`29:23-30:21 (same).
`
`
`of giving it little or no weight.” (citing Donnelly Garment Co. v. N.L.R.B., 123 F.2d
`
`215, 224 (8th Cir. 1941) (“One who is capable of ruling accurately upon the
`
`admissibility of evidence is equally capable of sifting it accurately after it has been
`
`received . . . .”)).
`
`
`
`5
`
`
`
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
`
`Finally, UTC asks the Board to exclude hundreds of paragraphs consisting of
`
`Dr. Winkler’s opinions and testimony, only on the basis that UTC’s expert, Dr. Pinal,
`
`disagrees with Dr. Winkler or asserts his opinions are “unreliable.” Paper 31 at 6-
`
`8.3 That two experts disagree is not a basis to exclude testimony. At most, UTC
`
`presents classic “battle of the experts” disputes appropriately raised in briefing (not
`
`motion practice), that go to the weight, not admissibility, of Dr. Winkler’s
`
`declaration Ex. 1002. See, e.g., Juniper Networks, Inc. v. Chrimar Sys., Inc.,
`
`IPR2016-01389, Paper No. 69 at 96 (P.T.A.B. Jan. 23, 2018) (denying motion to
`
`exclude declaration where party did not demonstrate that the declaration “lacks
`
`relevance” but instead made arguments “directed to the merits of the testimony,”
`
`
`3 In his Reply Declaration, Dr. Winkler specifically addressed Dr. Pinal’s criticisms
`
`that Patent Owner now points to. See, e.g., Ex. 1017, ¶¶ 90-91 (explaining the ’075
`
`patent describes synthesis of treprostinil), 96 (explaining Dr. Pinal’s attempt to
`
`complicate the record with extensive discussion of differential scanning calorimetry
`
`is “ultimately irrelevant” because the patent does not claim a specific polymorph),
`
`103 (explaining that Dr. Pinal’s argument that a POSA would have to first neutralize
`
`KOH before adding diethanolamine is incorrect), 156 (explaining Dr. Pinal’s
`
`arguments that relate to the stability of one polymorph over another are irrelevant
`
`because the claims are not specific to one polymorph).
`
`
`
`6
`
`
`
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
`
`which “raise[d] a question of the weight, not admissibility”). Moreover, Dr. Pinal
`
`has not established that a POSA would consider Dr. Winkler’s opinions and
`
`testimony “unreliable,” only that in Dr. Pinal’s opinion, a POSA would reach a
`
`different conclusion. Again, this is not a basis to exclude testimony.
`
`In sum, Dr. Winkler’s opinions in Ex. 1002 have been authenticated, he has
`
`been deposed on them, his status as a person of ordinary skill in the art has been
`
`previously confirmed and fully briefed for the Board, and the alleged “unreliability”
`
`of his opinions is classic expert and party disagreement going to the weight, not
`
`admissibility of the exhibit. Accordingly, UTC’s motion to exclude Ex. 1002 should
`
`be denied.
`
`B.
`Ex. 1012
`Ex. 1012 is exactly the same Kawakami document that was submitted in the
`
`IPR2016-00006 as Ex. 1007. Compare Ex. 1012, with Ex. 1048 (IPR2016-00006
`
`Kawakami English translation); see EX1005 at 6 & n.9 (Board citing Kawakami in
`
`final written decision invalidating ’901 patent’s parent patent). UTC knows this
`
`reference and should recognize it as such, because it was the Patent Owner in both
`
`that and this IPR proceeding. Liquidia notes that UTC did not move to exclude the
`
`identical Kawakami translation in IPR2016-00006, and the Board relied on the same
`
`translation for an entire ground in its final written decision. See EX1005 at 7, 84.
`
`
`
`7
`
`
`
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
`
`UTC now disingenuously asks the Board to exalt form over substance in moving to
`
`exclude the exhibit here.
`
`Nonetheless, Liquidia attaches additional documentation from IPR2016-
`
`00006, which UTC and the Board are already aware of, including the original
`
`Japanese version of Kawakami and declarations attesting to and confirming the
`
`accuracy of the translation. Ex. 1047-1051 (filed as Exhibits 1006, 1007, 1011,
`
`1019, and 1020 in IPR2016-00006).
`
`The filing of these exhibits remedies any failure to comply with § 42.63(b) or
`
`FRE 902(3), which in any event is harmless error. See L’Oréal USA, Inc. v. Liqwd,
`
`Inc., PGR2017-00012, Paper 119 at 42 (P.T.A.B. Dec. 9, 2020) (“failure to file the
`
`required affidavit . . . was remedied when Petitioner filed [exhibits including] a
`
`declaration”); Perfect Surgical Techs., Inc. v. Olympus Am., Inc., 841 F.3d 1004,
`
`1006-07 (Fed. Cir. 2016) (finding that Board’s acceptance of the partially-translated
`
`document was harmless error); Mexichem Amanco Holdings S.A. v. Honeywell Int’l,
`
`Inc., IPR2013-00576, Paper 50 at 30 (P.T.A.B Feb. 26, 2015) (Board has discretion
`
`to waive the requirements of § 42.63(b) under 37 C.F.R. § 42.5(b)). Accordingly,
`
`the Board should deny UTC’s motion to exclude Ex. 1012.
`
`III. CONCLUSION
`For these reasons, Petitioner respectfully requests that the Board to deny
`
`Patent Owner’s Motion to Exclude Exhibits 1002 and 1012.
`
`
`
`8
`
`
`
`Petitioner’s Opposition to Patent Owner’s Motion to Exclude
`IPR2020-00770
`
`
`Dated: June 1, 2021
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW
`Suite 700
`Washington, DC 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`
`Respectfully submitted,
`
`
`/Ivor R. Elrifi/
`Ivor R. Elrifi
`Reg. No. 39,529
`Counsel for Petitioner
`
`
`
`
`
`By:
`
`
`
`
`
`
`
`
`9
`
`
`
`Petitioner’s Motion for Pro Hac Vice Admission
`IPR2020-00770
`
`
`CERTIFICATE OF SERVICE
`
`
`
`Pursuant to 37 C.F.R. §§42.6(e)(4)(i) et seq., a complete copy of the attached
`PETITIONER’S OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE, and related documents are being served via email on the 1st day of
`June 2021, upon Patent Owner’s attorneys of record:
`
`UTC-901@foley.com
`Stephen B. Maebius (smaebius@foley.com)
`George Quillin (gquillin@foley.com)
`Daniel R. Shelton (dshelton@foley.com)
`FOLEY & LARDNER LLP
`
`Douglas Carsten (dcarsten@mwe.com)
`April E. Weisbruch (aweisbruch@mwe.com)
`Judy Mohr (jmohr@mwe.com)
`MCDERMOTT WILL & EMERY LLP
`
`Richard Torczon (rtorczon@wsgr.com)
`WILSON, SONSINI, GOODRICH & ROSATI
`
`Shaun R. Snader (ssnader@unither.com)
`UNITED THERAPEUTICS CORP.
`
`
`
`
`By:
`
`
`
`
`
`/Ivor R. Elrifi/
`Ivor R. Elrifi
`Reg. No. 39,529
`Counsel for Petitioner
`
`
`
`Dated: June 1, 2021
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW
`Suite 700
`Washington, DC 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`
`
`
`
`
`
`
`
`10
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
