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Cipla Limited v. Gilead Sciences, Inc.

Docket IPR2025-00033, Patent Trial and Appeal Board (Oct. 28, 2024)
Case TypeInter Partes Review
Patent
11744802
Patent Owner Gilead Sciences, Inc.
Petitioner Cipla Limited
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7 Notice Notice filing date accorded: Notice Notice filing date accorded to petition

Document IPR2025-00033, No. 7 Notice Notice filing date accorded - Notice Notice filing date accorded to petition (P.T.A.B. Nov. 19, 2024)
For more information, please consult the Office Patent Trial Practice Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012), which is available on the Board Web site at http://www.uspto.gov/PTAB.
Patent Owner is advised of the requirement to submit mandatory notice information under 37 C.F.R. § 42.8(a)(2) within 21 days of service of the petition.
The parties are advised that under 37 C.F.R. § 42.10(c), recognition of counsel pro hac vice requires a showing of good cause.
Such motions shall be filed in accordance with the “Order -- Authorizing Motion for Pro Hac Vice Admission” in Case IPR2013-00639, Paper 7, a copy of which is available on the Board Web site under “Representative Orders, Decisions, and Notices.” The parties are reminded that unless otherwise permitted by 37 C.F.R. § 42.6(b)(2), all filings in this proceeding must be made electronically in the Patent Trial Appeal Case Tracking System (P-TACTS), accessible from the Board Web site at http://www.uspto.gov/PTAB.
Many non-profit organizations, both inside and outside the intellectual property field, offer alternative dispute resolution services.
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4 Motion PHV: Motion for Christopher Sorenson Pro Hac Vice Admission

Document IPR2025-00033, No. 4 Motion PHV - Motion for Christopher Sorenson Pro Hac Vice Admission (P.T.A.B. Oct. 28, 2024)
showing there is good cause for the Board to recognize counsel pro hac vice during the proceeding.” The Order further provides the motion is to be “accompanied by an affidavit or declaration of the individual seeking to appear attesting to the following: i.
Mr. Sorenson has agreed to be subject to the United States Patent and Trademark Office Rules of Professional Conduct, as set forth in 37 C.F.R. §§ 11.101 et.
V. Analysis Part 42.10(c) of 37 C.F.R. states that the “Board may recognize counsel pro hac vice during a proceeding upon a showing of good cause, subject to the
Conclusion For the reasons stated above, Petitioners respectfully requests that the Board admit Christopher J. Sorenson to appear pro hac vice in this proceeding.
The undersigned hereby certifies that Petitioners’ Motion for Admission Pro Hac Vice of Christopher J. Sorenson Under 37 C.F.R. § 42.10(c) was served via email directed to counsel of record for the Patent Owner at the following:
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8 Other other: Petitioners Motion for Admission Pro Hac Vice of Christopher J Sorenson

Document IPR2025-00033, No. 8 Other other - Petitioners Motion for Admission Pro Hac Vice of Christopher J Sorenson (P.T.A.B. Jan. 6, 2025)
showing there is good cause for the Board to recognize counsel pro hac vice during the proceeding.” The Order further provides the motion is to be accompanied by an affidavit or declaration of the individual seeking to appear attesting to the following: i.
Statement of the Facts The following facts, supported by the attached Declaration of Christopher J. Sorenson in Support of Petitioners’ Motion for Admission Pro Hac Vice, establish good cause to recognize Mr. Sorenson pro hac vice in this proceeding.
Mr. Sorenson has agreed to be subject to the United States Patent and Trademark Office Rules of Professional Conduct, as set forth in 37 C.F.R. §§ 11.101 et.
Conclusion For the reasons stated above, Petitioners respectfully requests that the Board admit Christopher J. Sorenson to appear pro hac vice in this proceeding.
The undersigned hereby certifies that Petitioner’s’ Motion for Admission Pro Hac Vice of Christopher J. Sorenson Under 37 C.F.R. § 42.10(c) was served electronically via email directed to counsel of record for the Patent Owner at the following:
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9 Notice Exhibit list: Updated Exhibit List

Document IPR2025-00033, No. 9 Notice Exhibit list - Updated Exhibit List (P.T.A.B. Jan. 6, 2025)
Shah et al., “Dolutegravir: A New Integrase Strand Transfer Inhibitor for the Treatment of HIV,” 34(5) PHARMACOTHERAPY 506– 20 (2014) (“Shah”) EX-1024 Highlights and Prescribing Information on Triumeq, © 2014, revised and issued August 2014 (“Triumeq Label”)
US Patent Publication 2016/0016973 (US ’973) Tsiang et al., “Antiviral Activity of Bictegravir (GS-9883), a Novel Potent HIV-1 Integrase Strand Transfer Inhibitor with an Improved Resistance Profile,” 60(12) ANTIMICROBIAL AGENTS AND CHEMOTHERAPY 7086–97 (2016) (“Tsaing”)
Sabin et al., “Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multi-cohort collaboration,” 371 LANCET 1417–26 (2008) (“Sabin”) Press Release, Gilead, “Gilead Announces Phase 3 Result for Investigational Once-Daily Single Tablet HIV Regimen Containing Tenofovir Alafenamide (TAF)” (November 5, 2015) (“Gilead November 2015 Press Release”) Stellbrink et al., “Dolutegravir in Antiretroviral-naive Adults with HIV-1: 96-week Results from a Randomized Dose-ranging Study,” 27 AIDS 1771–78 (2013) (“Stellbrink”) Highlights and Prescribing Information on Epzicom, © 2004 (“Epzicom Label”) Benjamin E. Blass, “Drug Discovery and Development: An Overview of Modern Methods and Principles” in BASIC PRINCIPLES OF DRUG DISCOVERY AND DEVELOPMENT 1–34 (Elsevier Sci. & Tech., 2015), published April 27, 2015 (“Blass Chapter 1”) Benjamin E. Blass, “Medicinal Chemistry” in BASIC PRINCIPLES OF DRUG DISCOVERY AND DEVELOPMENT 203–43 (Elsevier Sci. & Tech., 2015), published April 27, 2015 (“Blass Chapter 5”) Chen et al., “Prediction of Absolute Hydroxyl pKa Values for 3‑Hydroxypyridin-4-ones,” 3 J.
Michael R. Franklin & Donald N. Franz, “Chapter 57: Drug Absorption, Action, and Disposition,” in 21 REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY 1142–70 (Lippincott Williams & Wilkins ed., 2006) (“Remington Chapter 57”) Paul M. Beringer & Michael E. Winter, “Chapter 59: Clinical Pharmacokinetics and Pharmacodynamics,” in 21 REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY 1191–1205 (Lippincott Williams & Wilkins ed., 2006) (“Remington Chapter 59”) Raymond E. Galinsky & Craig K. Svensson, “Chapter 58: Basic Pharmacokinetics and Pharmacodynamics,” in 21 REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY 1171–90 (Lippincott Williams & Wilkins ed., 2006) (“Remington Chapter 58”) “Chapter 17: Ionic Solutions and Electrolytic Equilibria,” in 21
Description Zolopa et al., “Activity of Elvitegravir, a Once-Daily Integrase Inhibitor, against Resistant HIV Type 1: Results of a Phase 2, Randomized, Controlled, Dose-Ranging Clinical Trial,” 201 J.
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6 Notice Power of Attorney: Notice Power of Attorney

Document IPR2025-00033, No. 6 Notice Power of Attorney - Notice Power of Attorney (P.T.A.B. Nov. 18, 2024)
Pursuant to 37 C.F.R. § 42.10(b), Patent Owner appoints the practitioners associated with the firm of Bartlit Beck LLP (counsel for Gilead Sciences, Inc.), including the following lead and back-up counsel, as its attorneys to transact all business in the U.S. Patent & Trademark Office associated with the above-captioned Inter Partes Review of U.S. Patent No. 11,744,802.
Gilead Sciences, Inc.
/Samantak Ghosh/ By: Samantak Ghosh Senior Counsel, IP
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5 Notice Mandatory Notice: Notice Mandatory Notice

Document IPR2025-00033, No. 5 Notice Mandatory Notice - Notice Mandatory Notice (P.T.A.B. Nov. 18, 2024)
Pursuant to 37 C.F.R. § 42.8(a)(2), Patent Owner Gilead Sciences, Inc. provides the following Mandatory Notices.
These notices are timely filed within 21 days of service of the Petition for Inter Partes Review filed by Petitioner Cipla Limited.
Gilead Sciences, Inc. v. Lupin Limited, et al., 1:22-cv-00615 (D.
Patent Owner respectfully requests that all electronic correspondence be directed to Lead Counsel and Back-Up Counsel at the above addresses.
Patent Owner also consents to electronic service by email at the following address: Dated: November 18, 2024
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2 Notice Exhibit list: Notice exhibit list

Document IPR2025-00033, No. 2 Notice Exhibit list - Notice exhibit list (P.T.A.B. Oct. 28, 2024)
Highlights and Prescribing Information on Tivicay, © 2013, revised August 2013 (“Tivicay Label”) Shah et al., “Dolutegravir: A New Integrase Strand Transfer Inhibitor for the Treatment of HIV,” 34(5) PHARMACOTHERAPY 506– 20 (2014) (“Shah”)
US Patent Publication 2016/0016973 (US ’973) Tsiang et al., “Antiviral Activity of Bictegravir (GS-9883), a Novel Potent HIV-1 Integrase Strand Transfer Inhibitor with an Improved Resistance Profile,” 60(12) ANTIMICROBIAL AGENTS AND CHEMOTHERAPY 7086–97 (2016) (“Tsaing”)
EVALUATION AND RESEARCH (CDER), “Guidance for Industry: Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules,” (June 2015) (“CDER Guidance”) Sabin et al., “Use of nucleoside reverse transcriptase inhibitors and risk of myocardial infarction in HIV-infected patients enrolled in the D:A:D study: a multi-cohort collaboration,” 371 LANCET 1417–26 (2008) (“Sabin”) Press Release, Gilead, “Gilead Announces Phase 3 Result for Investigational Once-Daily Single Tablet HIV Regimen Containing Tenofovir Alafenamide (TAF)” (November 5, 2015) (“Gilead November 2015 Press Release”) Stellbrink et al., “Dolutegravir in Antiretroviral-naive Adults with HIV-1: 96-week Results from a Randomized Dose-ranging Study,” 27 AIDS 1771–78 (2013) (“Stellbrink”) Highlights and Prescribing Information on Epzicom, © 2004 (“Epzicom Label”) Benjamin E. Blass, “Drug Discovery and Development: An Overview of Modern Methods and Principles” in BASIC PRINCIPLES OF DRUG DISCOVERY AND DEVELOPMENT 1–34 (Elsevier Sci. & Tech., 2015), published April 27, 2015 (“Blass Chapter 1”) Benjamin E. Blass, “Medicinal Chemistry” in BASIC PRINCIPLES OF DRUG DISCOVERY AND DEVELOPMENT 203–43 (Elsevier Sci. & Tech., 2015), published April 27, 2015 (“Blass Chapter 5”) Chen et al., “Prediction of Absolute Hydroxyl pKa Values for 3‑Hydroxypyridin-4-ones,” 3 J.
Michael R. Franklin & Donald N. Franz, “Chapter 57: Drug Absorption, Action, and Disposition,” in 21 REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY 1142–70 (Lippincott Williams & Wilkins ed., 2006) (“Remington Chapter 57”) Paul M. Beringer & Michael E. Winter, “Chapter 59: Clinical Pharmacokinetics and Pharmacodynamics,” in 21 REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY 1191–1205 (Lippincott Williams & Wilkins ed., 2006) (“Remington Chapter 59”) Raymond E. Galinsky & Craig K. Svensson, “Chapter 58: Basic Pharmacokinetics and Pharmacodynamics,” in 21 REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY 1171–90 (Lippincott Williams & Wilkins ed., 2006) (“Remington Chapter 58”) “Chapter 17: Ionic Solutions and Electrolytic Equilibria,” in 21
Description Howard Y. Ando & Galen W. Radebaugh, “Chapter 38: Property- Based Drug Design and Preformulation,” in 21 REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY 720–44 (Lippincott Williams and Wilkins ed., 2006) (“Remington Chapter 38”) Zolopa et al., “Activity of Elvitegravir, a Once-Daily Integrase Inhibitor, against Resistant HIV Type 1: Results of a Phase 2, Randomized, Controlled, Dose-Ranging Clinical Trial,” 201 J.
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