United States Court of Appeals for the Federal Circuit ______________________

MERCK SHARP & DOHME B.V., MERCK SHARP & DOHME, LLC, Plaintiffs-Appellees

v.

AUROBINDO PHARMA USA, INC., AUROBINDO PHARMA LTD., USV PRIVATE LIMITED, GLAND PHARMA LIMITED, MANKIND PHARMA LTD., LIFESTAR PHARMA LLC, FRESENIUS KABI USA, LLC, DR. REDDY'S LABORATORIES, INC., DR. REDDY'S LABORATORIES, LTD., SUN PHARMACEUTICAL INDUSTRIES, INC., SUN PHARMACEUTICAL INDUSTRIES LIMITED, SANDOZ INC., LEK PHARMACEUTICALS, D.D., MYLAN API US LLC, MYLAN PHARMACEUTICALS INC., MYLAN INC., EUGIA PHARMA SPECIALTIES LIMITED, Defendants-Appellants

LUPIN LTD., LUPIN PHARMACEUTICALS, INC., LUPIN INC., TEVA PHARMACEUTICALS USA, INC., Defendants ______________________

2023-2254 ______________________

Appeal from the United States District Court for the District of New Jersey in Nos. 2:20-cv-02576-CCC-LDW, 2:20-cv-02750-CCC-MF, 2:20-cv-02751-CCC-MF, 2:20-cv- Case: 23-2254 Document: 118 Page: 2 Filed: 03/13/2025

2 MERCK SHARP & DOHME B.V. v. AUROBINDO PHARMA USA, INC.

02786-CCC-MF, 2:20-cv-02787-CCC-MF, 2:20-cv-02892- CCC-MF, 2:20-cv-02909-CCC-MF, 2:20-cv-02964-CCC-MF, 2:20-cv-03007-CCC-MF, 2:20-cv-03068-CCC-MF, 2:20-cv- 03072-CCC-MF, 2:20-cv-03112-CCC-MF, 2:20-cv-03117- CCC-MF, 2:20-cv-03270-CCC-MF, 2:20-cv-03314-CCC-MF, 2:20-cv-03795-CCC-MF, Judge Claire C. Cecchi. ______________________

Decided: March 13, 2025 ______________________

DAVID M. KRINSKY, Williams & Connolly LLP, Wash- ington, DC, argued for plaintiffs-appellees. Also repre- sented by STANLEY E. FISHER, SHAUN PATRICK MAHAFFY, ASHWIN SHANDILYA; SHAYNA S. COOK, ALAN ERNST LITTMANN, DOUG J. WINNARD, Goldman Ismail Tomaselli Brennan & Baum LLP, Chicago, IL; SARAH GEERS, Jones Day, New York, NY; ANTHONY INSOGNA, San Diego, CA; ANDREA WEISS JEFFRIES, Los Angeles, CA.

ERIC THOMAS WERLINGER, Katten Muchin Rosenman LLP, Washington, DC, argued for all defendants-appel- lants. Defendants-appellants Mylan API US LLC, Mylan Pharmaceuticals Inc., Mylan Inc. also represented by TIMOTHY H. GRAY; JOSEPH JANUSZ, JITENDRA MALIK, Char- lotte, NC; DEEPRO MUKERJEE, LANCE SODERSTROM, New York, NY BRIAN SODIKOFF, Chicago, IL; MATTHEW GREINERT, Mylan, Canonsburg, PA.

MAUREEN DONOVAN QUELER, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, argued for amicus curiae Coke Morgan Stewart. Also represented by SARAH E. CRAVEN, AMY J. NELSON, FARHEENA YASMEEN RASHEED.

TIMOTHY H. KRATZ, Kratz & Barry LLP, Atlanta, GA, for defendants-appellants Aurobindo Pharma USA, Inc., Aurobindo Pharma Ltd., Eugia Pharma Specialties Case: 23-2254 Document: 118 Page: 3 Filed: 03/13/2025

MERCK SHARP & DOHME B.V. v. AUROBINDO PHARMA USA, INC. 3

Limited. Also represented by GEORGE BARRY, III; MICHAEL PATRICK HOGAN, Philadelphia, PA; R TOUHEY MYER, Wil- mington, DE.

ROBERT FLORENCE, Parker Poe Adams & Bernstein LLP, Atlanta, GA, for defendant-appellant USV Private Limited. Also represented by TASNEEM DHARAMSI, Green- ville, SC; ELIZABETH CROMPTON, Washington, DC.

IMRON T. ALY, ArentFox Schiff LLP, Chicago, IL, for de- fendant-appellant Gland Pharma Limited. Also repre- sented by KEVIN MICHAEL NELSON; MATTHEW THOMAS WILKERSON.

DMITRY SHELHOFF, Shelhoff Canfield & Chin LLC, Short Hills, NJ, for defendants-appellants Mankind Pharma Ltd., Lifestar Pharma LLC. Also represented by KENNETH CANFIELD; JULIA S. KIM, EDWARD D. PERGAMENT, Pergament & Cepeda LLP, Florham Park, NJ.

BRIAN TIMOTHY BURGESS, Goodwin Procter LLP, Wash- ington, DC, for defendants-appellants Fresenius Kabi USA, LLC, Dr. Reddy's Laboratori