By Memorandum Opinion entered by The Honorable Colm F. Connolly in Pharmacyclics LLC et al. v. Alvogen Pine Brook LLC et al., Civil Action No. 19-0434-CFC-CJB (D.Del. August 19, 2021), the Court set forth its findings of fact and conclusions of law on the asserted infringement claims and invalidity defenses with respect to U.S. Patent Nos. 8,008,309 (“the ‘309 patent”), 8,754,090 (“the ‘090 patent”), 9,655,857 (“the ‘857 patent”), and 9,725,455 (“the ‘455 patent”) following a seven-day bench trial.  Plaintiffs’ claims centered under the Hatch Waxman Act, 21 U.S.C. § 355(j), and arose out of Defendants’ submission of an Abbreviated New Drug Application (ANDA) to the U.S. Food & Drug Administration (FDA) seeking approval to market generic versions of Plaintiffs’ brand-name drug Imbruvica®.  Plaintiffs asserted infringement of the four patents-in-suit by Defendants’ ANDA product and Defendants asserted numerous invalidity defenses for the patents asserted against them.

Among its numerous findings of fact and conclusions of law contained in the Opinion, the Court concluded that the ‘309 patent is not invalid due to anticipation by the Pan article.  Id. at *13-31.  In reaching that conclusion, the Court found that claim 10 of the ‘309 patent has a priority filing date of September 22, 2006 – the date of the #720 provisional application; is presumed to have been invented on that date; and, therefore could not have been anticipated by the Pan article, which was published on December 12, 2006.  Id.

A copy of the Memorandum Opinion, which is comprehensive, is attached.