Friday, September 03, 2021

The CAFC does crystallography in BRISTOL-MYERS SQUIBB COMPANY v. SIGMAPHARM LABORATORIES

From the opinion


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


D90 or DV (0.9) means that 90% of the total particles are smaller than this size.

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