Takeaway: When presented with asserted grounds for a certain set of claims including (1) anticipation based on a reference A, (2) anticipation based on a reference B, (3) obviousness based on A by itself, and (4) obviousness based on A in combination with B, the Board has discretion to institute trial with respect to grounds (2), (3), and (4), but not ground (1), if ground (1) relies upon the same teachings of the reference A relied as a relied upon in ground (4).

In its Decision, the Board concluded that a reasonable likelihood had been shown that challenged claims 1-7, 12-28, and 32-45 of the ‘967 patent are unpatentable. Thus, the Board instituted trial with respect to each of these claims.

The Petition had challenged the above-noted claims on various grounds, including: anticipation of claims 1-7, 12-17, 20-28, and 32-45 under 35 U.S.C. § 102(a), (e) in view of the ‘226 patent; anticipation of claims 1-5, 12-17, 22, 26-28, 32-35, and 42-45 under 35 U.S.C. § 102(b) in view of Woodworth; obviousness of claims 1-7, 12-28, and 32-46 under 35 U.S.C. § 103 in view of the ‘226 patent; and obviousness of claims 1-7, 12-28, and 32-46 under 35 U.S.C. § 103 in view of the ‘226 patent and Woodworth. Petitioner provided the testimony of Dr. Alexander Shepherd in support of these asserted grounds.

The ‘967 patent relates to, for example, a method for administering daptomycin which comprises administering to a human patient a therapeutically effective amount of daptomycin in a dose of a specified amount of daptomycin at a dosage interval that minimizes skeletal muscle toxicity. The Board began its analysis by conducting claim construction for certain claim terminology using the broadest reasonable interpretation (BRI) standard. The claim terminology construed by the Board included “at a dosage interval that minimizes skeletal muscle toxicity.”

In connection with the anticipation ground based on the ‘226 patent, the Board concluded that the disclosure in the ‘226 patent “of administering daptomycin at a dosage level between 1.4 mg/kg and 14 mg/kg provides sufficient specificity to anticipate the claimed range of 3 to 75 mg/kg.” The Board also agreed with Petitioner’s asserted ground of anticipation based Woodworth, as well as with Petitioner’s asserted ground of obviousness based the ‘226 patent taken in combination with Woodworth. The Board did not institute trial with respect to the challenged claims based on the ground of obviousness in view of the ‘226 patent alone. As reasoned by the Board,    “[b]ecause this ground relies upon the same teachings of the ‘226 patent that are relied upon with respect to the obviousness ground based on the combination of the ’226 patent and Woodworth, we exercise our discretion not to institute an inter partes review on this asserted ground. See37 C.F.R. § 42.108(a).”

Fresenius-Kabi USA LLC v. Cubist Pharmaceuticals, Inc., IPR2015-00227

Paper 13: Decision on Institution of Inter Partes Review

Dated: May 14, 2015

Patent: 6,468,967 B1

Before: Lora M. Green, Tina E. Hulse, and Christopher G. Paulraj

Written by: Paulraj

Related proceedings: Cubist Pharms., Inc. v. Fresenius-Kabi USA LLC, 1:14-cv-00914-GMS (D.Del.); IPR2015-00223