Bioverativ Inc. v. CSL Behring LLC

Bioverativ Inc. v. CSL Behring LLC

Opinion

MEMORANDUM OPINION

ANDREWS, UNITED STATES DISTRICT JUDGE:

Before me are five motions submitted by Bioverativ and CSL Behring. This memorandum opinion will address Defendants' Motion for Summary Judgment of No Willful Infringement or Enhanced Damages. (D.I. 211). I have reviewed the parties' briefing and related papers. (D.I. 217, 227, 237). I heard oral argument on February 21, 2020. After full consideration of the briefing, I will grant Defendants' motion.

I. BACKGROUND

Plaintiffs Bioverativ Inc., Bioverativ Therapeutics Inc., and Bioverativ U.S. [*2]  LLC filed this lawsuit against Defendants CSL Behring LLC, CSL Behring GmbH, and CSL Behring Lengau AG on July 7, 2017, asserting infringement of U.S. Patent Nos. 9,670,475 ("the '475 patent"), 9,623,091 ("the '091 patent"), and 9,629,903 ("the '903 patent") (collectively, "the Asserted Patents"). (D.I. 1).

Plaintiffs assert that Defendants infringe claims 1 and 24 of the '091 patent, claims 1 and 22 of the '903 patent and claims 1, 12, 14, 17, 18, 19, and 29 of the '475 patent. (D.I. 1). All claims of the three patents are method claims.

Independent claim 1 of the '091 patent is as follows:

A method of treating hemophilia B in a human subject in need thereof comprising intravenously administering to the subject multiple doses of about 50 IU/kg to about 100 IU/kg of a chimeric factor IX ("FIX") polypeptide comprising FIX and an FcRn binding partner ("FcRn BP") at a dosing interval of about 10 days to about 14 days between two doses, wherein the FcRn BP comprises Fc or albumin, wherein the administration maintains the plasma FIX activity of the subject above 1 IU/dL between the dosing interval, and wherein the administration treats the human subject by reducing the frequency of spontaneous bleeding.

(D.I. 221-1, Exh. 2 at 79:25-36). Claim 1 of the '903 patent and Claim 1 of the '475 patent are similar but provide other FIX activity ('903 patent) and dosing intervals [*3]  and amounts ('475 patent). Idelvion, the accused product, is a chimeric FIX polypeptide that comprises FIX and albumin as its FcRn binding partner. (D.I. 217 at 2).

Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.