BRISTOL MYERS SQUIBB COMPANY v. SIGMAPHARM LABORATORIES LLC HEC USA (2021)

United States Court of Appeals, Federal Circuit.

BRISTOL-MYERS SQUIBB COMPANY, Pfizer Inc., Plaintiffs-Appellees v. SIGMAPHARM LABORATORIES, LLC, Sunshine Lake Pharma Co. Ltd., HEC Pharm USA Inc., Unichem Laboratories, Ltd., Defendants-Appellants

2020-2229, 2020-2252, 2020-2258

Decided: September 03, 2021

Before Moore, Chief Judge, Newman and O'Malley, Circuit Judges.

William F. Lee, Wilmer Cutler Pickering Hale and Dorr LLP, Boston, MA, argued for plaintiffs-appellees. Also represented by Timothy Andrew Cook, Andrew J. Danford, Katherine P. Kieckhafer, Madeleine C. Laupheimer, Kevin Scott Prussia; Heather M. Petruzzi, Amy K. Wigmore, Washington, DC. Paul Hilger Kochanski, Lerner, David, Littenberg, Krumholz & Mentlik, LLP, Cranford, NJ, argued for defendants-appellants Sunshine Lake Pharma Co. Ltd., HEC Pharm USA Inc. Also represented by Kendall K. Gurule, William L. Mentlik, Tedd W. Van Buskirk. Peter Branko Pejic, Greenblum & Bernstein, P.L.C., Reston, VA, argued for defendant-appellant Unichem Laboratories, Ltd. Also represented by Paul Braier, Jill Browning. Donald J. Mizerk, Husch Blackwell LLP, Chicago, IL, argued for defendant-appellant Sigmapharm Laboratories, LLC. Also represented by Philip D. Segrest, Jr., Marc Richard Wezowski; Thomas P. Heneghan, Madison, WI; Dustin Taylor, Denver, CO.

Having reviewed the district court's thorough and thoughtful opinion, we affirm. We specifically adopt its construction of the following terms from U.S. Patent No. 6,967,208 (“the ’208 patent”): (1) “substituted with [N] R,” see Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc., 477 F. Supp. 3d 306, 340 (D. Del. 2020), and (2) “pharmaceutically acceptable salts,” see id. at 312 ¶ 13. And, we adopt its construction of the following terms from U.S. Patent No. 9,326,945 (“the ’945 patent”): (1) “apixaban particles have a D90 equal to or less than about 89 microns,” see id. at 313 ¶ 19, and (2) “crystalline apixaban particles,” see id. We also find no error, and certainly no clear error, in the district court's findings of fact, including its expert witness credibility determinations. Because we believe the district court's patent infringement and invalidity determinations flow directly from its claim construction and factual findings, we affirm.

AFFIRMED

O'Malley, Circuit Judge.

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