Case 1:17-cv-00663-JFB-SRF Document 142 Filed 02/05/19 Page 1 of 765 PageID #: 6700
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`1
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`AMN1038
`Amneal v. Almirall, LLC
`IPR2019-00207
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`

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`Case 1:17-cv-00663-JFB-SRF Document 142 Filed 02/05/19 Page 2 of 765 PageID #: 6701
`Case 1:17-cv-00663-JFB-SRF Document 142 Filed 02/05/19 Page 2 of 765 PageID #: 6701
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`ANDA and accompanying Paragraph IV certification, Taro seeks to market a dapsone 7.5% gel
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`product (“Taro’s ANDA Product”) prior to the expiration of United States Patent No. 9,517,219
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`(“the ’219 Patent”), listed in the FDA’s Orange Book for ACZONE® (dapsone) Gel, 7.5%.
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`Plaintiff asserts infringement of claims 1, 2, 4, and 5 of the ’219 Patent.2
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`2.
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`Taro seeks declaratory judgment of non—infringement and invalidity of the ’219
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`Patent.
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`B.
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`3.
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`Plaintiff’s Comfllaints and Asserted Claims
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`Allergan filed suit on June
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`1, 2017, and July 28, 2017, against Taro
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`Pharmaceutical Industries Ltd. and Taro Pharmaceuticals, Inc., respectively, for infringement of
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`the ”219 Patent based on the filing of Taro’s ANDA and the accompanying Paragraph 1V
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`certification. (ill. 1 .)
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`4.
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`On August 29, 2017, Case No. 17—1048, Allergan Inc. v. Tare Pharmaceuticals,
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`Inc, was consolidated with Case No. 17-663, Allergan. Inc. v. Taro Pharmaceutical Industries
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`Ltd, by agreement of the parties, for all purposes including trial, and all filings were ordered to
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`be made in the lead case CA. No. 17-663 (VAC) (SRF) (Consol.).3 (13.1. 15; CA No. 17-1048,
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`D1. 11.)
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`C.
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`5.
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`Taro’s Answer, Defenses and Counterclaims
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`On July 20, 2017 and August 21, 2017, Taro filed its Answers to Plaintiff’s
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`Complaints.
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`(D1. 10.,
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`l7—cv—l—48 D.I. 08). Taro asserted defenses of noninfringement and
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`invalidity for failure to satisfy one or more provisions of Title 35 of the United States Code,
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`including but not limited to §§ 101, 102, 103, and 112.
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`
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`2 Taro represents that its PlV Certification was also as to the ”926 Patent. Plaintiff did not assert
`infringement of the ’926 Patent in this litigation.
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`Case 1:17-cv-00663-JFB-SRF Document 142 Filed 02/05/19 Page 3 of 765 PageID #: 6702
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`6.
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`Taro also asserted Counterclaims for a declaratory judgment of noninfringement
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`and invalidity under one or more provisions of 35 U.S.C. §§ 101, 102, 103, and 112.
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`(D1. 10.,
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`17—cv—1-48 D.I. 08)
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`D.
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`7.
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`Plaintiffs Answer to Taro’s Counterclaims
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`On August 10, 2017, Plaintiff replied to Taro’s July 20, 2017r Counterclaims,
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`denying its substantive allegations and each prayer for relief. (D1. 13.)
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`E.
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`8.
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`Stipulations and Dismissals
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`On October 19, 2018, the parties stipulated to the substitution of Almirall for
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`Allergan as Plaintiff due to Taro being informed of a transfer of, inter alia, all right, title, and
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`interest in the ’219 Patent from Allergan to Almirall. (DJ. 1 1 1..)
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`F.
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`9.
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`Claim Construction
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`On August 23, 2018,
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`the Court adopted the Report and Recommendation of
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`Magistrate Judge Sherry R. Fallon (D.I. 87) construing the single disputed term in the ’219
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`Patent, “polymeric Viscosity builder,” to mean “a polymer or polymer—based thickening agen .”
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`(13.1. 107.)
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`G.
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`Pending Motions
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`10.
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`The parties” respective motions in liming and Taro’s Daubert motions are
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`pending.
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`II.
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`JURISDICTION
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`11.
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`This is an action for patent infringement arising under the patent laws of the
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`United States, Title 35 of the United States Code, including 35 U.S.C. § 271, the Declaratory
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`Judgment Act, 28 U.S.C. §§ 2201 and 2202, and the Hatch—Waxman Amendments to the Federal
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`3 Additional filings made by the parties in Case No. 17—1048 are not discussed herein.
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`

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`Food, Drug and Cosmetic Act, see 21 U.S.C. §355(j). This Court has subject matter jurisdiction
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`over this action under 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202. Subject matterjurisdiction is
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`not disputed. For purposes of this action, no party has contested personal jurisdiction or venue.
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`III.
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`FACTS
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`A.
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`Uncontested Facts
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`12.
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`A joint statement of uncontested facts is attached as Exhibit 1. These proposed
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`stipulated facts require no proof at trial and will become part of the evidentiary record in this
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`case.
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`B.
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`Contested Facts
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`13.
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`Almirall’s statement of contested issues of fact, with a brief statement of what
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`Almirall intends to prove, is attached as Exhibit 2.
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`14.
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`Taro’s statement of contested issues of fact, with a brief statement of what Taro
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`intends to prove, is attached as Exhibit 3.
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`15.
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`If this Court determines that any issue identified in the statements of issues of fact
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`is more properly considered an issue of law, it should so be considered.
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`16.
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`Any headings used in any of Exhibits 173 shall be for convenience only and shall
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`not limit the character of any fact if proven as evidence to any particular claim or defense.
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`IV.
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`ISSUES OF LAW
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`17.
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`Almirall’s statement of the issues of law that remain to be litigated is attached as
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`Exhibit 4.
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`18.
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`Taro’s statement of the issues of law that remain to be litigated is attached as
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`Exhibit 5.
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`19.
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`If this Court determines that any issue identified in the statements of issues of law
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`is more properly considered an issue of fact, it should be so considered.
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`V.
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`WITNESSES
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`A.
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`List of Witnesses the Parties Expect to Call
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`1)
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`Expert Witnesses
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`20.
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`In Exhibit 6, attached hereto, Almirall identifies the expert witnesses it intends to
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`call to testify at trial. Taro’s objections to any identified witness are included in Exhibit 6.
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`21.
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`In Exhibit 7, attached hereto, Taro identifies the expert witnesses it intends to call
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`to testify at trial. Almirall’s objections to any identified witness are included in Exhibit 7.
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`2)
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`Non—expert Witnesses
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`22.
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`in Exhibit 6, attached hereto, Almirail identifies the fact witnesses it intends to
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`call to testify at trial, and whether the witness will testify in person or by deposition. Taro’s
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`objections to any identified witness are included in Exhibit 6.
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`23.
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`In Exhibit 7, attached hereto, Taro identifies the fact witnesses it intends to call to
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`testify at trial and whether the witness will testify in person or by deposition. Almirall’s
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`objections to any identified witness are included in Exhibit 7.
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`24.
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`Any witness not listed in Exhibits 6 and 7 will be precluded from testifying,
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`absent good cause shown, except that each party reserves the right to call such rebuttal witnesses
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`(who are not presently identifiable) as may be necessary and permitted by the Court.
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`25.,
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`The parties agree that live fact witnesses listed on both Exhibits 6 and 7 will be
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`called just once, and that the opposing party cross examining such witnesses will be permitted to
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`cross examine the witness beyond the scope of the direct. For clarity, nothing herein limits 3
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`party from calling a fact witness in its rebuttal case, but such testimony will be limited to the
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`parties’
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`rebuttal case. The parties agree that nothing in this paragraph pertains to expert
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`witnesses.
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`3)
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`Agreements Regarding Presentation and Identification of Witnesses
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`26.
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`The parties will identify by email to the opposing parties the witnesses they intend
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`to call, and whether those witnesses will be called live or by deposition, by 7:00 pm. two
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`calendar days before such witness may be called to testify. For example, if the party expects to
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`conduct the examination of a witness on Thursday, notice of the same must be given to the
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`opposing party by 7:00 pm. on Tuesday. The other party shall
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`identify any objections to
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`testimony by such witness(es) by 7:00 pm. the following day, and the parties shall meet and
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`confer to resolve any objections by 9:00 pm. that same evening. If good faith efforts to resolve
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`the objections fail, the party objecting to the witness shall bring its objections to the Court’s
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`attention prior to the beginning of the proceedings the following day. Each party shall update its
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`list of expected witnesses and exhibits by 7:00 pm. at the end of each trial day.
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`27.
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`Plaintiff” 5 Position: The presentation of evidence will follow the burden of proof.
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`For clarity, the presentation at trial will occur in the following order: (1) Plaintiffs” Opening
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`Statement, (2) Taro’s Opening Statement, (3) Plaintiff’s case-in—chief on infringement, (4) Taro’s
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`rebuttal case on infringement and case—in—chief on invalidity, (4) Plaintiff’s rebuttal case on
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`infringement and case on validity, (5) Taro’s rebuttal case on invalidity, (6) Plaintiff’s Closing
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`Argument (if permitted by Court), (7) Taro’s Closing Argument (if permitted by Court). The
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`parties will notify opposing counsel by 8:00 pm. two calendar days before as to the expected day
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`that the party intends to complete its presentation of evidence. Notwithstanding the foregoing,
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`Plaintiff may, in stage (3) above, and Taro may in stage (4) above, call any expert witness out of
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`order, however, if any party so elects, the expert witness called shall not be permitted to testify at
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`any later time during the trial under any circumstances, including during any rebuttal case of the
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`offering party.
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`28.
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`Taro’s Position: The presentation of evidence will follow the burden of proof. For
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`clarity,
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`the presentation at trial will occur in the following order:
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`(1) Plaintiffs’ Opening
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`Statement, (2) Taro’s Opening Statement, (3) Plaintiff’s case—in—chief on infringement, (4) Taro’s
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`rebuttal case on non—infringement (4) Plaintiff’s rebuttal case on infringement (if permitted by
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`Court) (5) Taro’s case—in-chief on invalidity, (6) Plaintiff’s rebuttal case on validity (7) Taro’s
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`rebuttal case on invalidity (if permitted by Court) (8) Plaintiffs Closing Argument (if permitted
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`by Court), (9) Taro’s Closing Argument (if permitted by Court).
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`The parties will notify
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`opposing counsel by 8:00 pm. two calendar days before as to the expected day that the party
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`intends to complete its presentation of evidence.
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`B.
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`29.
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`Testimony by Deposition
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`The deposition testimony that Plaintiff may offer into evidence is identified in
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`Exhibit 8. The deposition testimony that Taro may offer into evidence is identified in Exhibit 9.
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`This pretrial order contains the universe of deposition designations, counter~designations,
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`rebuttal designations and objections to admission of deposition testimony; none of the foregoing
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`shall be supplemented without consent of all parties or leave of the Court, on good cause shown.
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`30. With reSpect to those witnesses whom the parties have identified in Exhibits 6 and
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`7 who may be called to testify live at trial, no deposition designations or counter—designations are
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`required. Should a fact witness identified in Exhibit 6 or 7' as testifying live at trial become
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`unavailable (as defined in FRE 804(a)), the parties may designate specific pages and lines of
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`transcript that they intend to read or play in lieu of the witness’s appearance upon reasonable
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`notice, subject
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`to any objections and admissibility under the Federal Rules of Evidence.
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`Reasonable notice shall mean no less than 1 day for witnesses whose testimony has been
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`designated in Exhibit 8 or 9, and no less than 3 days for all other witnesses identified in Exhibit 6
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`or 7.
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`31.
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`A party may rely on any of the opposing party’s deposition designations or
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`counter—designations. For convenience and sake of brevity, the parties have listed counter—
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`designations in response to specific affirmative designations by their opposing parties. To the
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`extent-an opposing party withdraws any affirmatively designated testimony or seeks to limit the
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`manner of presentation of testimony through the designation process, a party may present its
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`counter-designation testimony in response to other specified affirmative testimony by the
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`opposing party, or re-designate its counter—designated testimony affirmatively. Similarly, a party
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`may designate testimony identified as affirmative testimony in this order as a counter-
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`designation or counter—counter designation.
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`32.
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`Unless otherwise agreed between the parties,
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`the party offering deposition
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`testimony (other than for the purpose of impeachment) shall identify the deposition testimony to
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`be offered from previously exchanged designations by 7:00 pm. two calendar days before their
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`anticipated use, and objections and counter—designations in accordance with Paragraph 34 will be
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`provided no later than 7:00 pm. the following day (one calendar day before their anticipated
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`use). The parties will meet—and—confer by 10:00 p.m. that same night (one calendar day before
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`their anticipated use) concerning any objections. A party may choose not to introduce deposition
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`testimony designated in this Pretrial Order, but may not designate additional deposition
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`testimony after the filing of this Pretrial Order.
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`33.
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`All irrelevant and redundant material, including colloquy between counsel and
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`objections, will be eliminated when the deposition is read, viewed at trial, or submitted according
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`to the Court’s instructions.
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`34.
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`Unless the Court requests submission otherwise, when deposition designation
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`excerpts are introduced, all admissible deposition counter—designation excerpts, whether offered
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`by videotape or by transcript, will be introduced simultaneously in the sequence in which the
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`testimony was originally given. To the extent a party wishes to read or play specific portions of
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`the deposition, and the Court approves, those portions shall be read or played in page order. If
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`an exhibit is referenced in a deposition designation, the exhibit is admitted into evidence if it is
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`included on the offering party’s trial exhibit list and is deemed admissible over any objection
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`preserved and raised at trial, or if it is included on the joint trial exhibit list.
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`35.
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`Unless a different process is requested by the Court, when the witness is called to
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`testify by deposition at trial, the party calling the witness shall provide the Court with two copies
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`of the transcript of the designations and counter—designations that will be read or played. The
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`parties will be charged for all time that elapses from the time the witness is called until the next
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`witness is called, according to the proportions to be provided by the parties.
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`36.
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`The above procedures regarding deposition designations do not apply to portions
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`of deposition transcripts and/or video used for impeachment or cross—examination of a witness.
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`Any deposition testimony may be used at trial for the purpose of impeachment, regardless of
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`whether a party specifically identified that testimony on its list of deposition designations, if the
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`
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`testimony is otherwise competent and admissible for such purpose.
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`VI.
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`EXHIBITS
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`A.
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`Exhibits
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`37.
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`The patties’ joint list of trial exhibits is attached as Exhibit 10, identified with
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`JTX prefixes. Plaintiff’s iist of triai exhibits is attached as Exhibit 11, identified with PTX
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`prefixes. Taro’s list of trial exhibits is attached as Exhibit 12, identified with DTX prefixes.
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`Exhibit 12 contains Almirall’s objections to Taro’s trial exhibits and Exhibit 11 contains Taro’s
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`objections to Almirall’s trial exhibits. The parties’ reSpective Keys to their objection codes are
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`appended at the end of each exhibit. The parties intend and agree to consider narrowing their
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`respective exhibit lists and objections where possible and will accordingly submit any revised or
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`joint exhibit list or objections, if any, before exhibits are due to the Court.
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`38.
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`Subject to the provisions of Paragraphs 39, 40, and 47, this pretrial order contains
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`the universe of exhibits to be used by a party at trial as well as all objections to the admission of
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`such exhibits, neither of which shail be supplemented without consent of all parties or leave of
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`the Court. Exhibits not listed will not be admitted into evidence unless good cause is shown.
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`39.
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`Any party may use an exhibit that is listed on the other party’s exhibit list, to the
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`same effect as though it were listed on its own exhibit list, subject to all evidentiary objections.
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`Any exhibit, once admitted into evidence, may be used by any party, subject to any limitations as
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`to its admission.
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`40.
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`Exhibits to be used solely for impeachment need not be included on the lists of
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`trial exhibits or disclosed in advance of being used at trial, however such exhibits will not be
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`admitted into evidence.
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`41.
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`The parties served on the opposing party electronic cepies of their respective pre—
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`marked non-demonstrative exhibits in PDF format on January 4, 2019. Plaintiff and Taro will
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`it)
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`continue to work on finalizing a joint exhibit list before exhibits are due to the District Court, and
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`will submit pre—marked joint (JTX) exhibits at that time. A party will provide a list of trial
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`exhibits that may be used in connection with direct examination by 7:00 pm. the day before their
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`anticipated use, and objections will be provided no later than 9:00 pm. the same night. The
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`parties will meet-and—confer by 10:00 pm. that same night concerning any objections.
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`If good
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`faith efforts to resolve the objections fail, the party objecting to the exhibits shall bring its
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`objections to the Court’s attention prior to the beginning of proceedings the following day.
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`Failure to comply with these procedures, absent an agreement by the parties and approval by the
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`Court, will result in waiver of the use of an exhibit or waiver of objection to the exhibit.
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`42.
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`Exhibits not objected to that are the subject of testimony by a witness at trial will
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`be received into evidence by the operation of the Final Pretrial Order without the need for
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`additional foundation testimony. Nothing herein shall be construed as a stipulation or admission
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`that the document is entitled to any weight in deciding the merits of this case. The parties agree
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`that any description of a document on an exhibit list is provided for convenience only and shall
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`not be used as an admission or otherwise as evidence regarding the listed document or any other
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`listed document.
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`43.
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`The listing of a document on a party’s exhibit list is not an admission that such
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`document is relevant or admissible when offered by the opposing side. Each party reserves the
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`right to object to the relevance of any evidence offered by the other party, at the time such
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`evidence is offered, in view of the specific context in which such evidence is offered.
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`44.
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`Complete legible copies of documents may be offered and received in evidence to
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`the same extent as an original unless a genuine question is raised as to the authenticity of the
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`original, or in the circumstances it would be unfair to admit the copy in lieu of the original.
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`11
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`Legible copies of United States patents and the contents of the Patent and Trademark Office file
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`histories may be offered and received in evidence in lieu of certified copies thereof, subject to all
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`other objections that might be made to the admissibility of certified copies.
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`45.
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`The exhibit lists indicate whether each trial exhibit has previously been marked as
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`a deposition exhibit. To remove duplicates and improve legibility of the exhibits used at trial,
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`the parties agree that the trial exhibit shall be treated as identical to the indicated deposition
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`exhibit regardless of whether it bears a deposition exhibit sticker.
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`46.
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`On the first day of trial, counsel will deliver to the Courtroom Deputy a
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`completed A0 Form 187 exhibit list for each party.
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`B.
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`Demonstrative Exhibits
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`47.
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`The parties agree that the demonstrative exhibits that the parties intend to use at
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`trial do not need to be included on their respective exhibit lists that are part of this Final Pretrial
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`Order. Plaintiffs’ demonstrative exhibits will be identified with PDX numbers, starting with
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`PDX 1. Defendants’ demonstrative exhibits will be identified with DDX numbers, starting at
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`DDX l. Demonstrative exhibits shall not be admitted into evidence.
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`48.
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`A party will provide demonstrative exhibits to be used in connection with opening
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`statements, direct examination, and any closing statements by 7:00 pm. the day before their
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`anticipated use, and objections will be provided no later than 9:00 pm. the same night. The
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`parties will meet—and—confer by 10:00 pm. that same night concerning any objections. If good
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`faith efforts to resolve the objections fail, the party objecting to the demonstrative shall bring its
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`objections to the Court’s attention at the beginning of proceedings the following day. Failure to
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`comply with these procedures, absent an-agreement by the parties and approval by the Court,
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`will result in waiver of the demonstrative or waiver of objection to the demonstrative.
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`if any of
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`12
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`the demonstratives change after the deadline, the party intending to use the demonstrative will
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`promptly notify the opposing party of the change(s).
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`49.
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`The party seeking to use a demonstrative exhibit
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`in connection with direct
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`examination will provide a color representation of the exhibit to the other side in PDF or PPT
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`form. However, for video or animations, the party seeking to use the demonstrative will provide
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`it to the other side in an appropriate electronic format to view the video or animation. For
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`irregularly sized physical exhibits, the party seeking to use the demonstrative will provide a color
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`representation as a PDF of 8.5 " x 11" copies of the exhibits.
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`50.
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`These provisions regarding demonstrative exhibits do not apply to demonstratives
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`created during testimony or demonstratives to be used for cross—examination, neither of which
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`need to be provided to the other side in advance of their use.
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`In addition, blownups or highlights
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`of exhibits or parts of exhibits or testimony are not required to be provided to the other side in
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`advance of their use.
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`VII. DAMAGES AND lNJUNCTIVE RELIEF
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`51.
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`This case does not involve any claims for damages other than in each party’s
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`ciaim that this is an exceptional case under 35 U.S.C. § 285.
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`52.
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`Plaintiff requests the following relief from the Court:
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`3)
`
`b)
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`Ordering that the effective date of any approval of Taro’s ANDA
`be not earlier than the expiration date of the ’219 Patent, or any
`later date of exclusivity to which Piaintiff is or becomes entitled, if
`following the conclusion of trial the patent is adjudged infringed
`and not invalid;
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`Imposing a permanent injunction restraining and enjoining Taro
`and its officers, agents, attorneys, and employees, and those acting
`in privity or concert therewith, from engaging in the commercial
`manufacture, use, offer for sale, sale and/or import, of Taro’s
`ANDA Product, untii the expiration of the latest expiration date of
`the ”219 Patent, or any later date of exclusivity to which Plaintiff is
`or becomes entitled, if so adjudged;
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`13
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`c)
`
`Declaring this case exceptional under 35 U.S.C. § 285 and granting
`Plaintiff its attorneys’ fees ;
`
`d)
`
`Awarding Plaintiff its costs and expenses;
`
`' e)
`
`Denying each request for relief made by Defendants; and
`
`f)
`
`Granting such other and further relief as this Court may deem just
`and proper.
`
`53.
`
`Taro requests the following relief from the Court:
`
`a)
`
`b)
`
`e)
`
`d)
`
`e)
`
`f)
`
`g)
`
`Denying each request for relief made by Plaintiff;
`
`Declaring the claims of the ‘219 patent are not infringed and will
`not be infringed by the manufacture, use sale, offer for sale,
`marketing or importation into the United States of Tarc’s ANDA
`Products;
`
`Declaring the claims of the ‘219 patent invalid;
`
`Declaring Taro has a lawful right to obtain FDA approval for the
`product as described in ANDA. No. 210191, and that Taro has a
`lawful right to manufacture, import, use, sell, or/or offer to sell the
`product as described in ANDA No. 2l019l;
`
`Declaring this case exceptional under 35 U.S.C. §285 and granting
`Taro its attorneys” fees;
`
`Awarding Taro its costs and expenses;
`
`Awarding Taro such other and further relief as the Court deems
`just and proper.
`
`VIII. BIFURCATED TRIAL
`
`54.
`
`All issues will be tried without bifurcation unless otherwise ordered by the Court.
`
`IX. MOTIONS INLIMINE
`
`55.
`
`Plaintiff’s motion in Ermine,
`
`including Tarc’s opposition brief,
`
`is attached as
`
`Exhibit 13.
`
`14
`
`

`

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`56.
`
`Taro’s motions in. limine, including Plaintiff’s opposition briefs: are attached as
`
`Exhibit 14. Taro’s motions in lz'mine are as follows:
`
`a Motion 1: Motion in Limine to Exclude Argument, Evidence or Testimony
`
`Relying on Plaintiffs Commercial Product to Prove Infringement;
`
`a Motion 2: Daubert Motion to Exclude Dr. Majella E. Lane from Offering the
`
`Opinion Taro’s Thickening Agent
`
`is Equivalent
`
`to Acrylamide/Sodium
`
`Acryloyldimethyl Taurate Copolymer;
`
`0 Motion 3: Motion in Limine to Exclude Argument, Evidence or Testimony
`
`Relying on the Doctrine of Equivalence to Provide Infringement Because Plaintiff
`
`is Barred by the Doctrine of Ensnarement;
`
`0 Motion 4: Motion in Limine to Exclude Argument, Evidence or Testimony
`
`Relying on Plaintiffs Improper Lead Compound Obviousness Analysis; and
`
`0 Motion 5: Daubert Motion to Exclude Dr. Julie Harper From Testifying About
`
`the Obviousness of the Asserted Claims of the ’219 Patent.
`
`X.
`
`DISCOVERY
`
`57.
`
`Discovery is complete.
`
`XI.
`
`NUMBERS OF JURORS
`
`58.
`
`This is a non—jury trial.
`
`XII. NON-JURY TRIAL
`
`59.
`
`60.
`
`The parties propose the following post—trial briefing schedule:
`
`Per the Scheduling Order, the parties will meet and confer at the completion of
`
`trial and submit a post-trial briefing schedule for the Court’s consideration in view of the
`
`15
`
`

`

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`evidence presented at trial. Per the Scheduling Order, post—trial briefing shall conclude no later
`
`than May 10, 2019.
`
`XIII. LENGTH OF TRIAL
`
`61.
`
`Unless otherwise ordered by the Court, the trial will be timed. Unless otherwise
`
`ordered,
`
`time will be charged to a party for
`
`its opening statement, direct and redirect
`
`examinations of witnesses it calls (including by designation), cross—examination of wi’messes
`
`called by any other party (including by designation), any closing argument, and the
`
`moving/objecting parties” argument on any motions or objections a party raises to another
`
`party’s exhibits and demonstrative exhibits.
`
`62.
`
`Unless otherwise ordered by the Court, the Courtroom Deputy will keep a running
`
`total of trial time used by counsel.
`
`If any party uses all of its allotted trial time, the Court will
`
`terminate that party’s trial presentation.
`
`63.
`
`The parties note that the Court has set aside five (5) days for trial. Considering
`
`the Court’s procedures for counting time, and considering the nature and extent of the parties”
`
`disputes, the parties request that the total time be equally split between Plaintiff and Defendants.
`
`XIV. MOTIONS FOR JUDGMENT AS A MATTER OF LAW
`
`64.
`
`The parties will address the procedure for motions pursuant to Fed. R. Civ. P.
`
`52(c) with the Court at the Pretrial Conference.
`
`XV. AlVIENDMENTS OF THE PLEADINGS
`
`65.
`
`There are no amendments to the pleadings desired by any party.
`
`XVI. ADDITIONAL MATTERS
`
`66.
`
`- Plaintiff intends to seek guidance and/or relief from the Court concerning whether
`
`the Taro Pharmaceutical Industries Ltd’s Notice of Paragraph IV Certification, received by
`
`16
`
`

`

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`Allergen, Inc. on or about April 17, 2017, was proper under the Hatch—Waxman Act so as to
`
`trigger the 30—month stay of approval attendant to this case.
`
`67.
`
`Taro intends to seek guidance and/or relief from the Court relating to any and all
`
`arguments disclosed by Almirall for the first time in its contested facts on January 4, 2019,
`
`and/or in its responses to Taro’s Motions in Limit/re or Daubert Motions served on January 7,
`
`2019, for which there is no expert testimony.
`
`XVII. SETTLEMENT
`
`68.
`
`The parties certify that they have engaged in a good faith effort to explore the
`
`resolution of this controversy by settlement.
`
`This order shall control the subsequent course of the action, unless modified by the Court to
`
`prevent manifest injustice.
`
`l7
`
`

`

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`MORRIS, NICHOLS, ARSHT & TUNNEL}. LLP
`
`PHILLIPS, GOLDMAN, MCLAUGHLFN &
`HALL, RA
`
`/s/flntfiony GD. Raucci
`
`/s/jolin C. @liiflips, jr.
`
`Jack B. Blumenfeld (#1014)
`Jeremy A. Tigan (#5239)
`Anthony D.'Raucci (#5943)
`1201 North Market Street
`PO. Box 1347
`Wilmington, DE 19899
`(302) 65 8—9200
`jblumenfeld@mnat.com
`jtigan@mnat.com
`araucci@mnat.eom
`
`Attorneys for PlaintiflAlmiraH, LLC
`
`OF COUNSEL
`
`James S. Trainor
`Vanessa Park—Thompson
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`(212) 921-2001
`jtramor@fenwick.com
`Vpark—thornpson@fenwick.com
`
`Ewa M. Davison, Ph.D.
`
`Elizabeth B. Hagan, PhD.
`FENWICK & WEST LLP
`
`1191 Second Avenue, 10th F1oor
`
`Seattle, WA 98101
`
`(206) 3894510
`edavison@fenwick.com
`ehagan@fenwick.com
`
`Rebecca A.E. Fewkes
`FENWICK & WEST LLP
`
`801 California Street
`
`Mountain View, CA 94041
`
`(650) 988—8500
`rfewkes@fenwick.eom
`
`January 8, 2019
`
`John C, Phiilips, Jr. (#110)
`David A. Bilson (#4986)
`1200 North Broom Street
`W’ilmingtona DE 19806
`(302) 655-4200
`jcp@pgmhlaw.com
`dab@pgmhlaw.com
`
`Attorneys for Defendants Taro Pharmaceutical
`Indusmes Ltd. and Taro Pharmaceuticals, Inc.
`
`OF COUNSEL
`
`Stephen P. Benson
`Kimberly A. Beis
`
`KATTEN MUCHIN R0 SENMAN, LLP
`525 W. Monroe Street
`Chicago, IL 60661
`(312) 902-5200
`Stephen.benson@katten1aw.corn
`Kimberly.beis@katten1aw.com
`
`1.8
`
`

`

`Case 1:17-cv-00663-JFB-SRF Document 142 Filed 02/05/19 Page 19 of 765 PageID #: 6718
`Case 1:17-cv-00663-JFB-SRF Document 142 Filed 02/05/19 Page 19 of 765 PageID #: 6718
`(cid:40)(cid:59)(cid:43)(cid:44)(cid:37)(cid:44)(cid:55) (cid:20)
`EXHIBIT 1
`
`(cid:56)(cid:49)(cid:44)(cid:55)(cid:40)(cid:39) (cid:54)(cid:55)(cid:36)(cid:55)(cid:40)(cid:54) (cid:39)(cid:44)(cid:54)(cid:55)(cid:53)(cid:44)(cid:38)(cid:55) (cid:38)(cid:50)(cid:56)(cid:53)(cid:55)
`UNITED STATES DISTRICT COURT
`(cid:41)(cid:50)(cid:53) (cid:55)(cid:43)(cid:40) (cid:39)(cid:44)(cid:54)(cid:55)(cid:53)(cid:44)(cid:38)(cid:55) (cid:50)(cid:41) (cid:39)(cid:40)(cid:47)(cid:36)(cid:58)(cid:36)(cid:53)(cid:40)
`FOR THE DISTRICT OF DELAWARE
`
`.
`.
`(cid:51)(cid:79)(cid:68)(cid:76)(cid:81)(cid:87)(cid:76)(cid:73)(cid:73)(cid:15)
`Plamtlffi
`
`(cid:38)(cid:17)(cid:36)(cid:17) (cid:49)(cid:82)(cid:17) (c